Pfizer

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

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

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

approximately 3 hours prior to expiring the patient was experiencing forceful emesis. later was found to have expired, patient was comfort care only.

Seizures Narrative: Hospital employee found aphasic & altered gaze, then tonic-clonic seizure witnessed. Employee intubated in internal ED. Employee drank 1/2-1 gallon Vodka, last drink 24 hours prior to onset. Employee has history alcohol-induced seizure.

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

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

Patient received 1st dose of Pfizer Covid vaccine on 3/3/2021 without any apparent problems; was monitored for 15 minutes and discharged. Patient was reportedly found lifeless in his apartment by his mother on 3/11/2021.

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

Rhabdomyolysis. Persistent muscle aches persisting from time of vaccine to time of presentation and diagnosis 1 mo later. Muscle weakness started 2 wks after vaccination

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

had a stroke that left him paralyzed; had a stroke that left him paralyzed; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 at 09:45 (lot number: EW0158) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 27Apr2021 at 11:15, the patient had a stroke that left him paralyzed. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The events were considered serious (hospitalization, disability, life threatening). Therapeutic measures were taken as a result of the events which included full stroke treatment (as reported). The patient had Covid-19 nasal swab test with unknown results on 27Apr2021. The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.

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

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

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

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

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

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

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

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

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

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

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

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

Patient presented to the ED and was subsequently hospitalized for Acute respiratory failure with hypoxia and hypercapnia within 6 weeks of receiving COVID vaccination.

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

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

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

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

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

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

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

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

Persistent swelling, hives, anaphylaxis (over 30 days). Able to suppress with prednisone 20mg daily. No long-term solution yet

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

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

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

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

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

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

on 12/24/2020 I started feeling a little tired on 12/25/2020 I was feeling exhausted i had a cough and breathing problems, also had headaches & fatigue. I'm taking antibiotics for pneumonia Visited urgent care twice

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

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

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

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

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

RECEIVED PFIZER VACCINES ON 01/08/21 & 01/29/21. 02/05/21 SAW PCP IN OFFICE REGARDING NEW RT ARM REDNESS/PAIN. X2 DAYS. DX: CELLULITIS 02/09/21 WENT TO ER TO REPORT WORSENING ARM REDNESS R/T CELLULITIS. REFUSED INPT TREATMENT ABX AND WAS DISCHARGED ON ORAL ABX. 02/12/21 RETURNED TO ER FOR WORSENING ARM CELLULITIS DESPITE ORAL ABX. ADMITTED FOR DX SEPSIS AND CELLULITIS.

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

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

Developed fever to 104 degrees on the morning after vaccination and had a grand mal seizure that lasted about 1 minute followed by generalized tremors that lasted about 10-15 minutes and resolved with administration of rectal Diastat 5mg. Tremors resolved within 5 minutes. Temp treated with Ibuprofen 600mg and cool sponge bath. Temp down to 101 within one hour and afebrile after 8 hours. Temp did not recur. Normal postictal mental status. Somewhat lethargic for a day or two then gradual return to baseline cognitive and physical functioning over 10 days. Wilmer has had this type of seizure with high fever in the past.

Grand mal seizure, wife found patient lying on the ground with eyes fixed and loss of urine. Wife called EMS around 2:22 and patient came to about 15 minutes later.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Patient started not feeling well and told friends and family that he was not feeling well and that his doctor believed he was having a side effect to the 2nd dose of his COVID-19 Vaccine. He died 11 days after receiving his vaccine.

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

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

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

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

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

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

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

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

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

Dose #1 received on 4/21/21. Dose #2 received on 5/12/21. Difficulty breathing beginning on 5/5/28/21. Diagnosed with multiple blood clots in right lung on 5/30/21.

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

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

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

Systemic: Death-Severe, Additional Details: Patient's wife called and told us that on the day that he passed (6/13/21), he did yard work all morning, then came in for a meal and to watch the soccer game. He then went to their bedroom to lay down and about 15 mins later she heard a strage noise and went check on him. Upon entering the room is when she found that he had passed. Cause of death is unknown

My dad suffered what I believe to be a blood clot in his lung on April 6th, directly related to the second pfizer covid vaccination. Though chronically ill, he was not sick at the time, which was 4 days after the vaccine. He walked up the stairs, collapsed at the top, walked again to the chair, collapsed and then made his way into the chair where he told me "I can't breathe." and then slumped over. My mom and I lifted his limp body up and noticed he was not breathing. We moved him to the floor and started life support measures. About 5 minutes later the paramedics arrived. They were eventually able to get his heart and breathing going again about 14 minutes later. He was moved to critical care. After it became apparent he suffered irreparable brain damage, I stopped the life support measures (ventilator) and he passed away shortly after on Friday the 9th. They were continuously removing blood from his lungs while he was there. There was no indication he would die prior to this incident. Though we attempted to tell the critical care doctors about his recent vaccination, they were not receptive to the suggestion that this may have caused the incident that proceeded his passing. My mom did try the heimlich and there were indications that he had breathed in vomit, but he had stopped breathing before this and therefore his cause of death WAS NOT aspiration. He also had fallen the day after the vaccination (Saturday) and the notes indicated his broken ribs were from the CPR measures but this is in error as well as he had broken his ribs in the fall. It is my opinion the broken ribs caused a bruise in the lungs, the vaccination caused excessive clotting, and when he was coughing shortly before the incident it loosened the clots that then caused a pulmonary embolism.

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

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

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

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

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

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

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

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

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

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

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

Fainting spell; blood clot; low heart rate for extended period of time; This is a spontaneous report from contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:30 (Batch/Lot Number: EW0162) as dose 2, single for Covid-19 immunization. The patient received the 1st dose of Comirnaty (Lot number: ER8727) on 19Mar2021 09:30 AM (at the age of 61years) in left arm for Covid-19 Immunization (no reaction). Medical history included femoral artery aneurysm from Jan2020 to an unknown date. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported; and acetylsalicylic acid (ASAPRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 28May2021 16:00, the patient experienced fainting spell, blood clot, and low heart rate for extended period of time. The patient was hospitalized for the events for 6 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The treatment received for the adverse events included Stent inserted and heart rate monitor implanted. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered with sequel on an unspecified date. Seriousness criteria was reported as hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage].

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

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

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

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

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

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

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

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

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

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

Patient remained at baseline until noted at 2130 unresponsive and abnormal VS. Sent to ED and patient passed away in ED

The recipient was feeling well immediately after the vaccination, all day on 2.8 and in the morning of 2.9. His daughter in law text him at 0930 and he did not respond to the text (atypical) and then he missed a morning meeting. His wife was downstairs in a meeting herself and after the meeting was over she called to him and he did not respond. She found him with no pulse and was not breathing. She called 911 and attempted CPR. They did not complete an autopsy, they stated that they believe the cause of death was either an embolism, Heart attack or aneurism. The wife stated that she does not believe the death was due to the vaccination; however, there were no tests completed to prove or disprove.

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

DEATH Narrative: 61 y.o. male with pmh afib, substance dependance, renal failure, recent admissions in the community for acute hypotension and acute kidney injury (11/2020 & 2/2021). Was found deceased in his apartment on the afternoon of 03/01/2021. Request sent to ME office for report if one exists. Patient was listed as having no known allergies.

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

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

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

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

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

DECEDENT WAS NOTED TO BE COUGHING FOLLOWING THE ADMINISTERING OF THE VACCINE. FAMILY INTERVIEWED COULD NOT RECALL WHETHER THE DECEDENT WAS COUGHING PRIOR TO RECEIVING THE VACCINE.

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

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

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

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

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

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

Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered. Follow-up attempts are needed. Information on batch/lot number was available.

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

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

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

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

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

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

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

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

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

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

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

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

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

Patient passed away on 4/29/2021. A member of our staff noticed his name on the obituary section of our local news. We do not know of any other details.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Patient presented to the ED and was subsequently hospitalized for severe sepsis with septic shock on 5/10/2021; this is within 6 weeks of receiving COVID vaccination.

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

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

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

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

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

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

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

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

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

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

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

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

Systemic: Patient was found at home passed away. no autopsy was performed to determine cause of death-Severe, Additional Details: Patient received his vaccine from our pharmacy. He waited for 15 minutes after vaccine and no adverse effects were reported. Niece states he went home and was found passed away in his room two hours later

Recurrence of Atrial fibrillation; Recurrence of Atrial fibrillation; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 25Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included hyperlipidemia, GERD (gastrooesophageal reflux disease), and atrial fibrillation, all from an unknown date and unknown if ongoing. The patient had prior ablations for Afib. The patient had no allergies to medications, food, or other products. On 04Jan2021, 18:00, the patient took the first dose of BNT162B2 (lot number and expiry date unknown) via an unspecified route of administration on the right arm at a single dose for COVID-19 immunization. Concomitant medications included dofetilide, diltiazem, loratadine, rosuvastatin calcium (CRESTOR), and omeprazole (OMEPRA); the patient received these medications within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 28Jan2021 02:00, the patient experienced recurrence of atrial fibrillation after 6 months, the last episode was within a month after an ablation. No treatment was received in response tot eh event. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The reported recurrence of atrial fibrillation was more likely due to natural recurrence of underlying atrial fibrillation, and unlikely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

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

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

Patient's daughter called to report that about 30 hours after receiving the vaccine he passed away at home. She said she didn't know the cause of death but she felt like she should let us know about it.

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

No known side effects; however, on 1/20 the decedent suffered lethargy. On 2/12/2021, the decedent had a possible seizure and was transported to emergency department where shortly after arrival, he was pronounced dead.

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

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

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

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

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

Died from cardiac arrest; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 24Mar2021 as single dose for COVID-19 immunization. Medical history included heart disease, kidney issues, and physical disability from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin; spironolactone; lisinopril; and ubidecarenone, vitamin e NOS (COQ10 COMPLEX) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 on 03Mar2021 11:00 AM, on Left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was reported to have died from cardiac arrest on 26Mar2021. The reporter did not know if it was related to vaccine. The patient died on 26Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: It appears he died from cardiac arrest.

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

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

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

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

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

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

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

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

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

He was healthy before vaccine. After vaccine a small amount of chills for a couple days. He was sicker and was exposed to COVID 19, so went to hospital 4/14/2021 tested neg for influenza and + Coronavirus. Died on 4/15/2021

My father complained of soreness and body aches from the shot Sunday night to my mom and Monday morning to his boss at work. My sister found him that afternoon in my parent's home unresponsive and call proceeded to call 911 and start CPR. But it was to late and he was already gone.

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

Within 6 hours of getting my shot, I went into A-Fib; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration at 63-years, at single dose in right arm on 17Mar2021 at 09:30 (Lot Number: ER2613) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, within 6 hours of getting his shot, he went into A-Fib (on 17Mar2021). He was in it for 18 hours before going back into the clinic. They took him to ER where he was electro-cardioverted. The adverse event resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". And the patient received treatment of electro-cardioverted for the event. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Event outcome was recovered.

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

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

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

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

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

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

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

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

Patient presented to the ED and was subsequently hospitalized for COVID-19 within 6 weeks of receiving COVID vaccination. He was in intensive care with pneumonia and severe sepsis.

Pneumonia; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; This is a spontaneous report from a contactable consumer (reporting for self). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),dose 1 via an unspecified route of administration, administered in Left Arm on 03Apr2021 (Batch/Lot Number: ER8732) as SINGLE DOSE (at the age of 63 years) for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (diagnosed for a decade), ongoing hypertension (diagnosed for a decade), ongoing type 2 diabetes mellitus (5-6 years ago diagnosed, very well maintained type 2 diabetes), ongoing pneumonia (He has been hospitalized 4 different times for pneumonia. In Dec2020 when he had pneumonia, they did not hospitalize him. He has had pneumonia 5 time since 1982. Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. "He gets the flu shot every, and he has had the shingles shot. He also gets the pneumonia vaccine every 2 years." The patient experienced pneumonia (hospitalization) on an unspecified date with outcome of not recovered, itchy, on 08Apr2021 with outcome of unknown, dry cough on 08Apr2021 with outcome of not recovered and non-productive cough on 08Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on Oct2020. On 13Apr2021 He reported it to the doctor and he told the patient to skip a dose of Lisinopril that sometimes it can have those symptoms of a deep nonproductive cough. He skipped the medication, and it hasn't gotten better. He thinks it is from the COVID vaccine. At the peak of his cough, he probably had 6 days where he coughed uncontrollably for 24 hours in a day. He still has a cough. Therapeutic measures were taken as a result of pneumonia. The doctor didn't do a chest X-ray or COVID test.

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

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

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

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

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

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

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

Patient was hospitalized 5/7/2021 after testing positive for COVID-19 on 4/30/2021. Patient was fully vaccinated. He died 5/18/2021.

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

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

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

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

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

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

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

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

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

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

Patient was diagnosed with COVID-19 on 6/13/2021 and subsequently died on 6/17/2021. Patient was considered to be fully vaccinated as of 3/24/2021 having received both doses of Pfizer.

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

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

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

After 2nd dose I felt sluggish and started running a fever of 103 I was taking Tylenol to bring it down I was in bed till Saturday was taken on Saturday to the ER where they told me I had pneumonia and my lab work said I had MDS and I was transferred to a different hospital. at the hospital I got a picc line and got chemo I'm pending a bone marrow transplant.

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

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

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

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

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

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

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

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

Received vaccine in the morning 08:00 am, took acetaminophen 1 GM at 09:00 am due to pain in arm. By 10:30pm, I began having flu like symptoms, (aches, low grade fever, sinus symptoms) took another acetaminophen 1 GM. At 11:00 pm, developed severe rigors that lasted for approximately 2 hours. I am an RN and I have seen many cases of sepsis and felt like I was experiencing similar symptomatology. By 1:45 am, the rigors finally ceased and the body, muscle and joint pain became severe (on a pain scale of 1-10, it was an 8). At 7:00 am, I took another acetaminophen 1 GM, the body pain became much less and I was experiencing a global headache. I do not get headaches, so this was unusual. By 10:00 am, the headache was minimal, body aches were gone, only sinus symptoms persisted.

Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted from vaccine administration, but reporting as required because pt died 7 days later. Narrative: Reporting this event because patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to underlying terminal illness.

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

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

Pt received first dose of Pfizer COVID-19 vaccine on 2/6/2021. Pt subsequently developed symptoms of COVID-19 and presented to the ER on 2/15/2021. Chief complaint was cough, fever, and shortness of breath. Reports that he had a negative nasal swab as recently as 2 weeks ago. Reported that symptoms of cough, sob, and weakness started 3 days prior to presenting at ER (2/12/2021). Chest Xray had features of bilateral pneumonia. Pt is still currently inpatient at our hospital, receiving treatment for COVID-19, including dexamethason and remdesivir. He is currently receiving 3L of supplemental O2 via NC.

Death Narrative: Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: "due to sepsis (related to bed sores) and aspiration pneumonia"

It was reported to us that at @1822 the patient sustained a Seizure at home. EMS was called and arrived to initiate CPR. CPR was performed but the patient was declared deceased by EMS at his home.

Death Narrative: On 3/3/21 an MSA from the Decedent Affairs Office received a call from the Office of the Chief Medical Examiner. The ME office informed the MSA that an autopsy was conducted on 3/2/21 and is pending results. No further information was given. A clinical review was conducted by the PCP but no conclusions could be made until autopsy results are received. The Office of Decedent Affairs will be reaching out periodically to the ME's office to retrieve these results. This Issue Brief will be updated by 3/17/21.

Client had clonic/tonic seizures x2 within one minute of receiving the COVID-19 vaccine, first dose. Within 3-4 minutes of the seizure activity, client was awake, alert, oriented x3. Client was placed on a stretcher by paramedics and transferred via a stretcher to the observation area. Client remained awake, alert, oriented x3. No incontinence noted. Client was transferred to the hospital by the paramedics to the hospital within 10-15 minutes after seizure activity. No other family members were present with client.

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

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

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

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

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

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

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

Death Narrative: Death on 12/27/20. 1st dose 10 days before serious event. Patient was admitted for hospice care at the facility with bladder cancer with mets to liver, lung, and bone. There are no indications that death was related to the vaccine.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Client was screened as per CDC guidelines and had no contraindications for receiving the vaccine on 4/14/2021. LCHD had no notice of any adverse issues. He did not present to the 2nd dose clinic and follow up phone calls revealed that he had died on 4/28/2021.

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

Pt had symptoms start 05/24 including difficulty breathing, chills, 102 fever, pneumonia. Patient was hospitalized from 05/25 through 05/29 for pneumonia and covid.

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

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

His dad took the shot and died 3 days later, mucked up his arteries, his heart; This is a spontaneous report from a contactable consumer (patient son). A 64-year-old male patient received second dose of BNT162B2 on 15May2021 (at age of 64-year-old) at single dose for COVID-19 immunization. Medical history included Heart Condition (around 1997-1999), High Blood Pressure (all about the same time), Aneurysm (about 2017, 2015-2017 area. He wants to say 2015, because he was there when he found out about them) and open heart surgery (about 1997, 1995, somewhere around there). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 05Apr2021 (at age of 64-year-old) for COVID-19 immunization. Family Medical History Relevant to AE(s): Caller states not that he knows of. All he knows from the emergency technician is that it looked like he went back to his car and his dog was in the car and he dropped dead. According to you guy's thing, it says muscle cramps, muscle pains and chest pains are all side effects of this and he does believe that the vaccine contributed to the chest pain which contributed to the heart attack that exploded his heart. He states his dad took the shot and died 3 days later (18May2021, also reported as died on Memorial day weekend. He died on Sunday). Caller stated the coroner's has already stated that he died by the coronavirus shot and mucked up his arteries, his heart. It is pretty sad. He was doing something he enjoyed, watching the races, gets up takes two steps, falls dead in his tracks. Vaccination Facility Type was hospital. He does not know Additional Vaccines Administered on Same Date of the Pfizer Suspect, but he highly doubts it. Events not require a visit to Emergency Room or Physician Office. Information about lot/batch number is requested.; Reported Cause(s) of Death: His dad took the shot and died 3 days later, mucked up his arteries, his heart: Death

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

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

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

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

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

Medical Examiner at time of autopsy ordered Covid testing 06/30/2021 08:30 Nasal swab- reported SARS-CoV-2 RNA detected and confirmed at lab. Cause of death: Complication of Covid-19 Other significant conditions: Chronic A-Fib, HTN, Chronic systolic heart failure, COPD

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

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

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

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

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

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

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

Systemic: Other- unknown, depot store received call from facility on 1/22 that patient passed around 7pm

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

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

Since getting first shot and again after the second shot, have had frequent afib/apc's; Since getting first shot and again after the second shot, have had frequent afib/apc's; This is a spontaneous report from a contactable Physician (ophthalmologist) reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: eh9899), intramuscular on 21Dec2020 at 15:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was not receiving concomitant medications. Medical history included ongoing paroxysmal afib (atrial fibrillation). The patient has known allergies to squid. The patient reported having a long history of paroxysmal afib, very fit, play tennis at the national level. Prior to vaccine have had 2-3 brief bouts of afib/year. Since getting first shot and again after the second shot, have had frequent afib/apc's (atrial premature contractions) at least 6 episodes. Adverse event start date was reported as 21Dec2020 at 02:00 AM (pending clarification). No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: The event is considered possibly related to the suspect product based on the reportedly positive temporal association in a subject with a positive medical history of atrial arrhythmias. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

patient passed away subsequent to receiving dose on 02/01. Staff does not have reason to believe vaccine was involved.

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

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

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

pneumonia; Diagnosed with COVID after getting the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (reporting for himself). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on his right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient was diagnosed with COVID after getting the first dose of the vaccine and experienced pneumonia. The outcome of the event was unknown. Information about batch/lot number requested.

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

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

Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer vaccine on 2/26/2021. Patient is admitted for sepsis secondary left diabetic foot ulcer.

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

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

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

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

After about 5 min of receiving his second Pfizer vaccine, pt suddenly developed generalized raise erythematous rash on arms legs, back . Hx: In anticipation onset of anaphylaxis, after appearance of rash on lt arm, pt put on stretcher , undressed immediately, and generalized rash noted. none pruritic. v/s and sat NORMAL. airway NORMAL. lungs clear. given pt's very concerning rash but lack of indication of impending anaphylaxis, given 50mg po benadryl. rescue called for trans and observation in ER where given 30mg prednisone po and monitored. was observed in ER and discharged after 2 hrs observation. 24 hrs later, pt continues to do well. Dx : acute allergic reaction to pfizer vaccine.

Patient has substantial bilateral lung PE 12 days post vaccination; This is a spontaneous report from a contactable other health professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (at the age of 65 years) as single dose for covid-19 immunisation. Medical history included allergies: penicillin and testim. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on an unspecified date for covid-19 immunization. The patient had substantial bilateral lung PE (pulmonary embolism) 12 days post vaccination on 14Mar2021 (as reported, pending clarification). The event resulted in emergency room/department or urgent care and hospitalization in Mar2021. Treatment of heparin infusion with rivaroxaban (XARELTO) initiation planned was received for the event. The patient had no covid prior vaccination and had not tested post vaccination. Outcome of event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event pulmonary embolism cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

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

He was admitted with acute right sided pulmonary embolus and extensive left leg DVT. His vaccine second dose was mid Febrary ( I do not have the exact date). He had brief swelling in left leg a few days after vaccination that resolved. This recurred 4/3/21 and he was admitted 4/6/21.

stroke; stroke; This is a spontaneous report from a contactable nurse (reporting for her husband). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (at the age of 65years) as single dose for Covid-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing, stroke from 03Dec2018 to an unknown date, and cancer from an unknown date and unknown if ongoing. Concomitant medication included unspecified medication (He is taking medication for his diabetes, his stroke the 2nd stoke that he had in last 2 weeks he is taking medication). It was reported that the patient had a Covid vaccine this month on 11Mar2021. That was the 1st vaccine the patient had. Next day on the 12Mar2021, the patient stated having some unbalanced in walking and in his train of thinking. The reporter (nurse) ended up on 15Mar2021 taking the patient to Emergency room, and he had a stroke. The reporter stated, "Now, he had a stroke 2 year before. I called to let you know I talked to the neurologist he has sent him to his family doctor for checkup and his family doctor wanted me to let you know that this happen. Does not know if there is any relation or not but just to let you all know and this coming Thursday, he is supposed to get his 2nd vaccine. I am, just calling to let you know". The patient was taking medication for his 1st stroke and now he is taking medication for his 2nd stroke (treatment). He is taking physical therapy and occupational therapy and for his cancer, he is taking medication for that. The patient was hospitalized for stroke from 15Mar2021 to 17Mar2021, then he was discharged. The outcome of event was not recovered. Follow-up needed; further information has been requested.; Sender's Comments: Event stroke represents an intercurrent medical condition and unrelated to BNT162B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

He received his first COVID19 shot (Pfizer) reportedly on 3/2/21, then began a new chemotherapy regimen on 3/10/21. On 3/18, he fell to the floor and could not get up. He was admitted to the hospital for sepsis, pneumonia, and chemotherapy-induced neutropenia, treated on IV antibiotics and discharged on PO antibiotics. His home insulin was also decreased but continued to have hypoglycemic to hyperglycemic events. Insulin was decreased in clinic afterward and was compliant on antibiotics. Returned to hospital again a few days later for sepsis and pneumonia/effusion. He later went to a nursing facility / on hospice. He ultimately required supplemental oxygen and breathing increasingly became labored. Patient ultimately died on 4/9/21.

First covid vaccine on 3/3 and presented to the ER on 3/22 with CP. Second covid vaccine on 4/3 and presented to the ED on 4/15 with complaints of shortness of breath, lower extremity swelling, and 20 pound weight gain x 2 weeks. ED Workup: NT Pro BNP: 558 Hs-cTroponinT: 17>16 CXR: No acute findings EKG: NSR First Degree AVB D-Dimer: 1830 CTA: negative for PE Admitted for HFpEF exacerbation. Treated with IV diuretics, ECHO ordered. Stress test for CP with exertion - negative. Patient still admitted on 4/17/21. ECHO pending.

DEATH. Narrative: Patient died after receiving COVID vaccine dose #1. 07/18/20: admitted to hospital for weakness/lightheadedness causing legs to give out and fall backwards, resulting in hematoma 12/15/20: seen by PCP, stable 02/03 seen in ID clinic for HIV follow up, nothing out of the ordinary 03/02 COVID vaccine dose #1 03/14 Pt died Cause of death unknown and undocumented at this time. Patient did not have an ADR immediately after vaccine or hospitalized before or after vaccine. Last hospitalization was July 2020 due to fall and associated hematoma. Death not likely due to vaccine, but due to comorbidities, including active HIV infection with detectable viral load. No known previous COVID infection.

Left lower extremity DVT- symptoms within days of vaccination, did not present for diagnosis for about 3 weeks.

Pt received vaccine on 4/20/21 at 1:00pm, observed 30 mins post injection with no adverse reaction noted. Pt collapsed at home early morning on 4/21 & transported to ED via ambulance where he later expired.

Patient was recently hospitalized for pulmonary embolism with acute cor pulmonale. First noticed increased shortness of breath on 4/4/21 when shoveling mulch and describes feeling "more winded than usual" with physical activity. He presented to the outpatient primary care clinic on 4/6/21 for evaluation and serum labs and TTE were ordered. Labs were notable for a WBC 13.22 and Cr 0.76. TTE showed hyperdynamic LV function with EF >65% and no tricuspid regurgitation with no concern for right heart strain. A follow-up d-dimer was ordered and returned at 1661 resulting in the recommendation to present to the ED. Upon presentation to the ED, he was hemodynamically stable with an SpO2 of 97% on room air. CT Chest PE protocol was ordered and showed multiple bilateral lobar, segmental, and subsegmental PE with findings suggestive of right heart enlargement was well as areas of pulmonary hemorrhage and developing infarcts. He was given a heparin bolus and he was admitted to the Adult Hospitalist Service. The following morning, patient's hemoglobin remained stable and he continued to feel clinically well. He was transitioned from the heparin infusion to subcutaneous enoxaparin. He was discharged on 4/9/21 with a plan for self-injection of enoxaparin and close follow-up with his PCP.

I have had Paroxysmal AFib since 2012 and had an ablation in 2016. It cured the Afib about 90-95 percent, but I still get intermittent episodes, ALWAYS brought on by some catalyst, (alcohol, sexual relations, drinking a cold beverage, exercise). However, appr. two weeks after the vaccine, I began getting random bouts of Afib, longer in episodes, but shorter in duration. Since the vaccine, I have had appr. 12+ episodes of Afib, occurring at various times, even at rest. Since the ablation, I got about 12 episodes per year, now it's been 12 episodes in 2 months. Sometimes, I'll get several episodes a day, at random times for no reason. This has been totally opposite of what I was experiencing pre-vaccine. What concerns me is that the episodes are random and there are not catalysts to bring them on.

My father had a massive stroke and brain hemorrhage that took his life.; My father had a massive stroke and brain hemorrhage that took his life.; This is a spontaneous report from a contactable consumer. A 65-year-old male patient (reporter's father) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 65-years-old on 15Mar2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Not diagnosed with COVID prior vaccination. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The reporter stated that, "My father had a massive stroke and brain hemorrhage that took his life" on 15Apr2021 09:30 PM. No treatment received for the events. The events resulted in Emergency room/department or urgent care. The patient died on 18Apr2021. It was not reported if an autopsy was performed. Unknown if tested for COVID post vaccination. Information about lot/batch number has been requested.; Reported Cause(s) of Death: My father had a massive stroke and brain hemorrhage that took his life.; My father had a massive stroke and brain hemorrhage that took his life.

Within a couple days of the vaccine my husband had a small TIA. This included numbness in his left arm. The numbness subsided. On the 12th, the numbness returned which extended from his left ear down his left arm and down his left side to about the waist. We took him to the ER. A brain MRI showed he had a thrombotic stroke.

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

Onset of dry cough and chest tightness ~48 hours later; delayed diagnosis of acute pulmonary embolus confirmed 4/29/21

Same day symptoms fever, myalgia, arthralgia, shortness of breath, leg swelling, transaminitis, hyponatremia. Found to have pericardial and pleural effusions. Proteinuria and hematuria on urine test. Kidney biopsy performed confirmed diagnosis of fibrillary glomerulonephritis. Diagnosed with serum sickness like reaction

Admit 4/16. Vaccine 3/3, 3/24. Admit for sepsis, PNA, however MD states difficult to attribute it to COVID. Treated w/abx and steroids. DC'd home.

Stroke; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 09:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure, bleeding ulcer and helicobacter pylori infection both from 15Feb2021, and ongoing tumor on his heart. Concomitant medication included lisinopril taken for high blood pressure. The patient previously took the first dose of bnt162b2 in the left arm on 26Feb2021 (lot number: EN6203) for COVID-19 immunisation. Right before he had his first shot, he was in the hospital on 15Feb2021 with a bleeding ulcer and a helicobacter pylori infection. He had been in the hospital and isn't sure what all they gave him then. The patient started lisinopril 4 or 5 years ago when he was diagnosed with high blood pressure. His blood pressure was under control with the lisinopril but the patient is no longer on it. The patient's father had a stroke when he was 42 but he had high blood pressure and didn't get it treated. The patient got up around 07:00 in the morning on 27Mar2021. The patient's wife got up at 08:30 when she realized something was wrong. The patient said when he got up around 07:00, he experienced his right side being numb. The patient went to the emergency room and was treated there. He had a stroke. The patient was hospitalized from 27Mar2021 to 30Mar2021. The patient's wife doesn't know if it has anything to do with the shot. After his stroke, they put him on "carvilo". When the patient was in the hospital for the stroke, they found other issues. He has a tumor in his heart that's a pretty good size and the doctor said it had been there for awhile. So, they put her husband on "carvilo" to help with his blood pressure and his heart. She doesn't think the tumor had anything to do with the shot because the doctor did say the size of the tumor was as big as it was because it had been there a while. They found the tumor while trying to find out why he had the stroke. They still haven't found a reason as to why he had the stroke. The tumor is on the right side of his heart and they said they didn't think that had anything to do with the stroke. The tumor was found on 28Mar2021. They did an MRI and a CT scan on his head when he was in the emergency room (ER) on 27Mar2021. They also did an ultrasound on his heart, chest, and abdomen. Since he's been out, they did an MRI on his heart. They also did X-rays on his lungs. He is getting ready to go back to the hospital for open heart surgery on 07May2021. Outcome of the event was unknown.

the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he can't stand up and walk up straight; feeling unwell and was unable to work for a few days; he had tingling on the left side that moved to his right side; he has difficulty speaking/ word finding/Slurring his speech; tinnitus; nausea; pain in the rear of his neck, between the neck and skull; His symptoms continue to be severe and is unable to work; he cannot coordinate his thoughts and fantasies; dizziness, he felt his head was spinning; He had some kind of palsy where his face was not reacting bilaterally; pressure in his brain; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; This is a spontaneous report from a contactable consumer (patients wife). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the neurologist agreed that the vaccine has attacked nervous system (nervous system disorder) (hospitalization) on an unspecified date with outcome of unknown , developed signs of stroke, he can't stand up and walk up straight (cerebrovascular accident) (medically significant) on an unspecified date with outcome of unknown , feeling unwell and was unable to work for a few days (malaise) (medically significant) on an unspecified date with outcome of unknown , he had tingling on the left side that moved to his right side (paraesthesia) (medically significant) on an unspecified date with outcome of unknown , he has difficulty speaking/ word finding/slurring his speech (dysarthria) (medically significant) on an unspecified date with outcome of unknown , tinnitus (tinnitus) (non-serious) on an unspecified date with outcome of unknown , nausea (nausea) (non-serious) on an unspecified date with outcome of unknown , pain in the rear of his neck, between the neck and skull (neck pain) (non-serious) on an unspecified date with outcome of unknown , his symptoms continue to be severe and is unable to work (loss of personal independence in daily activities) (medically significant) on an unspecified date with outcome of unknown , he cannot coordinate his thoughts and fantasies (coordination abnormal) (medically significant) on an unspecified date with outcome of unknown , dizziness, he felt his head was spinning (dizziness) (medically significant) on an unspecified date with outcome of unknown , he had some kind of palsy where his face was not reacting bilaterally (paralysis) (medically significant) on an unspecified date with outcome of unknown , pressure in his brain (head discomfort) (non-serious) on an unspecified date with outcome of unknown , got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms (illness) (non-serious) on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

This 65 year old white male received the Covid shot on 2/27 /21 and went to the ED on 4/1/21 and was admitted on 4/2/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

I63.9 - Stroke (CMS/HCC) I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

Patient was admitted to Hospital from 3/28 - 4/2 after suffering a stroke two days post second Pfizer dose. Patient continues to have left sided weakness, particularly in the LUE. - Acute right MCA stroke - Left hemiparesis - Left-sided neglect -Situational depression

Per report from family, pt had been feeling unwell for 3-4 weeks prior to event on 4/27 where he collapsed and suffered a cardiac arrest. No interventions were performed until EMS arrived 10-15 mins later (again, per family report). Pt was revived following CPR, and suffered a 2nd episode of cardiac arrest (possible in the ED). Pt was noted to have PEA at that time. Pt was intubated and vented in ICU. Pt was cooled x24 hours (unsure of protocol name) and rewarmed over 24 hours more. Pt was weaned from all paralytics, etc. Per RN reports, pt failed all neuro tests except R eye went from 3 > 2 mm (4/29 +). Pt was transitioned to comfort care on 4/30 and passed within 5 minutes.

Left intracerebral brain hemorrhage; Right hemiparesis; His platelets were 46; Systolic blood pressure 220; only responsive to touch and pain; Unresponsive; This is a spontaneous report from a non-contactable healthcare professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On 04May2021, the patient was found unresponsive by family, taken to Emergency department where left intracerebral brain hemorrhage was diagnosed. His platelets were 46 and systolic blood pressure 220. He has right hemiparesis and is only responsive to touch and pain. He is currently on hospice. The patient was hospitalized for 3 days and received platelet transfusion. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and known drug profile it is unlikely that the reported events were causally related to bnt162b2 . The patient's history of hypertension is a risk factor for the reported left intracerebral brain hemorrhage and. blood pressure systolic increased. Case will be reassessed if additional information is received

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

Approx 3 weeks after the second shot the same leg I had a blood clot in 5 years ago in 2016 had my ankle puffed up with soreness in the calf. I knew it was another blood clot, took almost one week to get a doppler scan and they confirmed that I had another clot. I was put on Eliquis the same day.

Guillian barre Syndrome ~2 weeks following second shot of Pfizer vaccine ; ultimately resulting in intubation and invasive ventilation

Patient suffered CVA on 3/10/2021 affecting the left side of his body, and subsequently spent three days at Hospital as the result of this incident.

Positive COVID-19 test on April 24th, and on April 28, 2021. Hospitalization on April 28th with Pneumonia due to COVID-19 virus, COVID, Hypoxia, Acute respiratory failure with hypoxia (HCC)

He received both doses March 2021. second dose on 3/26. on 4/26 presented to ER with Epistaxis, came to about a month after Pfizer series pt went to Hospital ER 3 times that week for care of what was thought nose bleeds from picking, and later ENT for care that required travel. Pt stopped Plavix use and 6 days later on 5/1 returned to Hospital ER with serious symptoms, developed multiple thrombotic events that lead to clotting of leg/bowel/coronary. Transferred to Hospital on 5/1/2021. Multiple MI events and expired at Hospital on 5/3/2021

Blood clots causing pulmonary embolism on 3/29 . Hospitalized on 4/6-4/8. Clots also caused a mild stroke on 5/5. Hospitalized 5/5-5/6

On May 19th at approximately 10-1030 pm. My father suffered a heart attack with no warning and died instantly. He was fine all day long, fine since the second shot. We don?t believe the vaccine was the cause but maybe it jumpstarted something. We wanted to alert someone for knowledge or research. We did not have an autopsy.

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

The second vaccine shot put my heart into AFIB. My heart beat was normal for 7 years and within 5 days after the second shot I noticed I was in AFIB.

Patient presented to the ED and was subsequently hospitalized for atrial fibrillation with RVR within 6 weeks of receiving COVID vaccination.

march 9th received first vaccine, march 20th woke up coughing and couldn't breathe, went home after work and did teledoc who recommended the emergency room. Tested negative for COVID, bipap provided. was in the hospital for 7 days states, "half the heart stopped working" and was diagnosed with heart failure. EF is 30-35%. Is having a nuclear medicine test Friday to evaluate if further intervention is needed. Stress test two years ago was normal

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

Subsequently, on February 19 I exhibited slight paralysis, by late evening on February 20th was convinced I was having a strok, went to ER and was admitted for apparent stroke due to presence of multiple fine bloodclots transiting area of brain controlling my right side (mostly arm/shoulder/hand paralysis), accompanied by irreguar heartbeat, leakage of heartvalves - these weer all new, never before reported symptoms. Examination and blood tests showed sudden elevation of blood pressure, cholesterol, glucose, throid, liver and kidney values, all of which subsequently decline and returned to usual levels after treatment and release from hospital (02/24/2021). Arrythmia has not been detected since and other measurement/blood indicators are back down/under control. Only residual symptoms are slight loss of speed of operation f/righ arm/hand and confirmed "moderate leakage in both heart valves".

Developed low blood pressure 3 days after vaccine. Then diagnosed with multiple blood clots in the legs and a 2" saddle pulmonary embolism 10 days after vaccine, and admitted to the hospital (3/30/2021).

Stroke; hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk; tired; sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a 65-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm on 12Mar2021, dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin, fish oil and vitamins (unspecified). The patient did not have prior vaccinations within 4 weeks from the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 on 19Feb2021 AT 16:00 in the right arm. The patient experienced a stroke on 17May2021. It was after his second dose of the Covid vaccine. The reporter said that the most worrying thing is through all of the tests they can't find anything that attributed to the stroke. The patient plays tennis one level below pro and played 4 times that week, he played golf that Saturday, cut the grass on Sunday and there is nothing to attribute to the stroke. The patient has hemiparalysis on the left side and a long road back. The patient can talk but his left arm and left foot are paralyzed and he can't walk, he is in a wheel chair and undergoing intense Physical Therapy. The patient was also tired and he had a sore arm. The patient was hospitalized from 17May2021 to 04Jun2021 due to the events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk. The patient visited the physician's office on 08Jun2021. The events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk were recovering while the events tired and sore arm have recovered on an unknown date. Information on the lot/batch number has been requested.

After a few days very fatigue, went to get a sleep study and doctor said he needed a sleep pap machine The sleep study was completed on 4/20/21. Also had shortness of breath on after shot called pcp on 4/23/21 and told him to go to the ER. Went to ER pulse rate was high and showed signs of a heart attack. Stayed over night got a echocardiogram and he passed out as he was trying to walk on 4/24/21. 4/25 echocardiogram turned out good. 4/26 found blockage in heart and was told he needed bypass surgery. He had surgery 4/28/21 during heart surgery they did and ultrasound on the artery between the lungs and he had a 4 inch saddle embolism which they removed and continued with the heart surgery. All his problems was actually caused by the embolism.

initial shot on 2/26/2021....rash developed by 3/6/2021 by 3/9/2021 had painful lump in left breast... rash comes and goes... second shot on 3/18/2021... rash comes and goes... 0n 4/24/2021 had an ischemic stroke...

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

I had the second dose on 03/27/2021. I got the main symptoms of headache, body aches, pains the following day. I went to urgent care 3 days later, Tuesday 30th. Went in for pain I thought I had a rib out, they had a chiropractor checked me out, he did not do anything, I went to urgent care twice. Both times my lungs were clear. No pneumonia. They did an x-ray which was clear. I had nebulizer treatment, and then it came back to the same. I went to the doctor the following week on 04/13/2021 and he checked me over and could not find anything. He heard some crackling in the lower part of my lungs, which he found interesting but he could not find out why I was having that pain. I left there. Before getting home he called me and said that it could be a sign of a blood clot. He had me get a CT scan, I got it in 06/14/2021. They found that I had 1 blood clot on each lung. The biggest one on the right one. They gave me blood thinners. I had fluids on my lungs. They were not able to take it all out so I might have to have surgery. The blood clots have resolved themselves with the medication.

65-year-old with history of TBI and end-stage renal disease subsequently initially admitted to the floor secondary to fever and chills. Found to have COVID-19 pneumonia. On June 13 a rapid response was called for worsening respiratory failure. Subsequently transferred to ICU. Initially on CPAP at 100% FiO2. CTA negative for PE but did show diffuse ground glass infiltrates. Completed 10 days of dexamethasone. Not a candidate for remdesivir given end-stage renal disease. Additionally on cefepime and Rocephin for 10 days subsequently restarted on meropenem. Fortunately patient continued to have hypoxemia unresponsive to noninvasive ventilation. He was intubated on June 19. At the time of intubation he expresses desire not to be intubated for an extended period of time. Unfortunately they are unable to wean from ventilator. Remains on 100% FiO2 with PEEP of 18 and was on nitric oxide. In addition was on paralytics. Remained on prednisone taper off of dexamethasone. In addition to above patient had complications A. fib with RVR further complicated by hypotension. Was on 3 pressors. Suspect multifactorial to sedation and patient with severe Covid who also has end-stage renal disease. SLED initiated while in-house. On the afternoon of June 23 palliative team did meet with patient's siblings. That time determined to transition to comfort care. Compassionate extubation performed. Patient passed away shortly after extubation. Patient died of COVID-19 despite being fully vaccinated against it. Death Certificate Information: Part I: Cause of Death A. Respiratory Failure B. Pneumonia C. COVID-19 Part II Other Significant Conditions: Hypertension, Diabetes Mellitus Type 2, End Stage Renal Disease

Patient presented to the ED on 5/2/2021 for left ankle swelling. Patient presented to the ED on 5/10/2021 for diabetic ulcer of right midfoot and pneumonia and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.

Tingling/numbness in feet on 3/27/2021. By 3/29/2021 woke up and could not stand. Went to local ER. Transferred to other hospital that evening. Put on ventilator 3/30/2021 for 2 weeks. Diagnose Guillian Barre Syndrome. Adverse reaction to GBS treatment caused kidney failure and many complications. In ICU 2 months then dies on 05/29/2021.

Patient had no problems at the time of either first or second vaccine. He started having chest pain and hemoptysis on 7/2/2021 and was seen an a local emergency hospital on 7/6/2021. He was diagnosed with a pulmonary embolism, by CTA. No history of VTE and no provoking factors - had short flight prior to onset of symptoms.

Office of the Regulatory Authority reported to the Dept. of Health that this patient had a "sudden collapse witnessed by a friend" approximately one hour after receiving vaccine. Notified in March. At that time no VAERS reports found or noted by CDC. As of today, no VAERS received from CDC for this patient so submitting the limited information available. Final findings were released on 7/18/21 (decided on 7/16/21) were: "CAUSE A: Anaphylaxis CAUSE B: Status post COVID vaccination Should you have any questions about this case please contact Dr. Please note he is leaving state service at the end of this month."

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

He felt slightly unwell after the first dose of vaccine but recovered after a day or two On evening of 2nd dose, he developed severe chest pain, shortness of breath, and generalized malaise, without fever or cough. He requested to see me after 5 days of symptoms getting worse such that he felt short of breath doing very little, like walking just up a few steps, or talking, I saw him on 7/19. his physical exam was grossly normal, although he reported presence of pressure on the chest and shortness of breath with walking and talking. After blood test finding elevated BNP, I tried to get him to schedule an echo, and sent Rx for diuretic. But he got too short of breath at home and called 911. When the ambulance arrived, he was not to the hospital I was affiliated with, but another hospital nearer to his home, so I have no direct assess to his record, but at the time of discharge 4 days later, I spoke to his discharging hospitalist to obtain the full medical course, in addition to his own account.

1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased

he was in AFIB for about 3 hours after receiving his first dose of the COVID19 Vaccine; he noticed the rest of the day, right up to going to bed that he felt cold; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284) at arm, left upper, via an unspecified route of administration on 29Dec2020 06:15 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (Afib) formally diagnosed around Jan2020. There were no concomitant medications. The patient reported he got the COVID-19 Vaccine at 06:15 on 29Dec2020 and had to sit for 15 minutes afterwards before he could leave. He said everything was fine, and he walked out to the hospital lobby, and was speaking with a work associate for 10 minutes before he headed to his car. When he got ready to leave, he got in his car, and started his car. He started driving home, and realized he was in AFIB. He did have an AFIB issue. His AFIB has been pretty well controlled for a year now, as long as, he didn't do something stupid. He had a moderately aggressive run of AFIB. He said his "smart" watch told him his heart rate was 117. His normal heart rate is around 60-70. He was in AFIB for about 3 hours. His typical runs of AFIB are considerably shorter. He only had a total of 2 episodes of AFIB in the last year. His prior AFIB episodes would have been about 4-5 minutes. The last time he had AFIB that lasted any length of time was when he was hospitalized for AFIB around Jan2020. He said at that time, he was hospitalized overnight for observation. He received medication during the hospitalization and his AFIB broke. He didn't remember what medications were given to him during the hospitalization. He said he had flutters before that hospitalization, but the flutters were always gone after a few minutes, so he never sought treatment because there would be nothing to treat. The patient reported he noticed the rest of the day on 29Dec2020, right up to going to bed that he felt cold. His house wasn't cold, and he didn't have a fever. He said the cold feeling went away during the night while he was sleeping. He said the cold feeling easily lasted for a 12 hours. He said the cold feeling could have been something else. The outcome of "he was in afib for about 3 hours after receiving his first dose of the covid19 vaccine" was recovered on 29Dec2020; of "he noticed the rest of the day, right up to going to bed that he felt cold" was recovered on 30Dec2020.

Developed pulmonary embolism in right lung one week after vaccination. Sharp pain on right side when breathing. Treated with IV Apixaban while inpatient for 2 days, oral Apixaban 5 mg, 2 tabs twice daily 1/5/21-1/11/21, then one 5 mg tab twice a day. Pain has subsided as of 1/14/21.

died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021, which was reported as fatal. The clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the middle of night. It was reported that it was not clear what exactly happened, but they are looking into this. The clinical outcome of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of death was not reported. An autopsy was not performed (was reported to be taking place soon). The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days after receiving the vaccine

Pt had witnessed arrest by wife. Pt wife started CPR and called EMS. CPR started at 15:12. Continued by EMS. Pt arrived to medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He was unresponsive to verbal and tactile stimulus and had fixed unreactive pupils. He was pronounced at 16:13.

Patient with past medical history of CAD, CKD, sCHF, LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN, complete heart block, T2Diabetes,thyroid issues, stroke, papillary CA of thyroid, dyslipidemia, anemia, hypercalcemia, pulmonary nodule, hypoparathyroidism, pacemaker, bilat carotid stenosis, afib, pleural effusion, pancytopenia, cardiomyopathy, severe aortic stenosis, sick sinus syndrome, Dressler syndrome, empyema, ESRD

DVT and probable pulmonary embolus based on hypoxia Patient is physician who cares for patients in NH and ALF where there is documented COVID First dose COVID vaccine 12/20/20, second dose 1/10/20 Some shortness of breath developed about 1/10, not severe 1/30 Leg pain, fever to 101.6 abrupt onset extreme fatigue, ER eval 1.31 negative eval including neg rapid and PCR COVID tests Persistent sx led to repeat ER eval including LE dopper confirming occlusive femoral vein thromboxis; no hypoxia at rest but desat to 85% on exertion (climbing one flight of steps) Started anticoagulants 2/4/21 on home treatment; not working since 1/30/21

on 2/1/21 at ~7AM pt was noted by the RN to have rt sided weakness & was sent to Hospital ED for evaluation. They felt he could have had a TIA, or extension of a prior CVA (nothing new on MRI, has small vessel ischemic disease), or a COVID vaccine reaction. Symptoms have mostly resolved, he is not always cooperative so subtle weakness is difficult to detect. He was hospitalizaed, started on ASA & increased BP meds, and returned to his home, where he has resided for several years.

I got the shot at 5pm. When home and I was relaxing watching tv. At 8pm, my heart was racing very fast and took blood pressure, It was very high, 152/105 pulse 74. I called 24hr nurse on call. She said call 911. Ambulance was on site within 5 minute and transported me to hospital. I was in the ER at least 6 hours, moderating my heart. They said I had an A FIB attack. They got it down and admitted me to the hospital. I also experienced pain in my bladder, I could not urinate. They had to drain it 2 times. I was released from the hospital at 8pm the next day. Any questions, don't hesitate to ask me or my doctor.

Pt had only complained of a sore arm after receiving the vaccine- pt died on 2/25/21 from what they feel was a massive heart attack- unsure if related to vaccine at all

Patient is a 66 y.o. male who presents as a transfer to Hospital from an outside hospital for ICH. Patient states around 1130 he was running on the treadmill and noticed sudden left-sided weakness and decrease in station. He arrived outside hospital and was found to have left-sided hemibody weakness, left-sided decrease in station and a right gaze preference. CT at outside hospital showed large ICH with 3 mm of midline shift and vasogenic edema. repeat scan was performed and showed 7 x 2 x 4 cm frontal parietal region hemorrhage. Patient is now in rehab and states he has left sided paralysis

Reported by EMS per report from wife that he was "sick after shot" and got worse during the night. Wife found him the following morning cold and pale, pulseless. Dispatch called at 719AM. Pt pronounced on the scene and taken to Funeral Home. Uncertain if Medical Exam is planned

Appeared unwell after vaccination. After returning home, sat down in chair and became unresponsive. Resuscitation unsuccessful. Autopsy performed 2/17/2021 showed severe hypertensive and coronary heart disease with congestive heart failure and no signs of anaphylaxis (postmortem serum tryptase = 9.2 mcg/L; RR <= 10.9).

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

Non-productive cough, shortness of breath, increase in blood pressure (170/90) and increased heart rate (85 bpm). Symptoms began shortly after second dose of vaccine on 2/26/2021

Had a stroke 36 hours after getting second vaccine. Lost ability to speak and see clearly, had word salad. Was identified quickly by my wife and was taken by ambulance to hospital where they gave me TPA clot buster infusion after identifying a clot in my left back side of brain and luckily I responded well and have all speech function back we believe so far.

Patient was hospitalized within 4 days of getting the vaccine and passed away 6 days after getting the vaccine

multiple bilateral DVTs; pulmonary embolus; This is a spontaneous report from a contactable Physician (Patient). A 66-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration, in Arm Left on 23Feb2021 13:15 as single dose, the first dose via an unspecified route of administration, a in Arm Left on 02Feb2021 13:15 as single dose for covid-19 immunization. Medical history included Subarachnoid hemorrhage (SAH), hypertension (htn), degenerative discs, malignant melanoma and prostatectomy (2 years 3 months). Concomitant medications included atorvastatin calcium and lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalosporin for allergies. After receiving the second dose patient experienced pulmonary embolus on an unspecified date in 2021 and multiple bilateral DVTs diagnosed on 11Mar2021. As per the reporter seriousness criteria reported as emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient did not receive any other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient was not tested Covid post vaccination. Therapeutic measures were taken as a result of pulmonary embolus multiple bilateral dvts. The outcome of the events was not recovered.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Pulmonary Embolus and Deep Vein Thrombosis 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.

Approximately 30 minutes after vaccination the patient experienced a cardiac arrest. He was brought to the hospital where resuscitation efforts were continued but ultimately proved to be unsuccessful. The patient was pronounced deceased.

3/28/21 ER HPI 66 y.o. male who presents with cardiac arrest. Wife said patient went to load machines in the truck between 6:30 p.m. to 7:00 p.m. and about 745 p.m. when she did not see him, she went searching for him and found him about 8:15 p.m. without pulseless and cold. EMS was called and they got there about 8:23 p.m. and started CPR and brought the patient to the emergency room at at 9:05 p.m. and he was certified dead at 2110 p.m.

Received email from Public Health Nurse that patient had passed away on 3-16-21. The coroner did not believe it was associated with the vaccine, just reporting the death. Requested VAERS form still be filled out.

3/17/21: patient presented and was admitted through ED for chest pain. Patient had recent event of NSTEMI and stent was placed last Friday. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

My Ooxgyen was dipping into high 70s tolow 80s with oxygen @4 lpm, Also very dehydrated and went to hospital dur to feet and ankles swelling up alot.. In the hospital for 9 days to lower clots from legs and constant high oxygen therapy also hemoglobin and hematicrit went upper range. Im home now doing better, but I dont think I should take the 2nd dose.

4/4/21 woke up more tired than usual. Progressed from there, prominent fatigue for the next couple days, slept on the couch on and off for a couple days which was unusual for him. Mild SOA and weakness 4/7/21. Died in his sleep into the morning of 4/8/21.

Friday April 2, 2021 ? Got Phizer COVID shot at noon. No reactions that day Saturday 4/3 ? Woke up to body aches, fatigue, and sweats. Fever of 100.4 most of the day. ? Stayed in bed and slept until 6:00. Did not eat or drink much today. ? Felt dizzy when I got up. Drank water and had 2 bananas and ½ a bowl of chicken soup. ? Felt the same all day. Easter Sunday 4/4 ? Felt better but still fatigued. Body aches were not as bad, and temp was normal. ? Drank a lot more water and had a little to eat in the morning. ? Kids came over for Easter Brunch. We ate about 11:00. ? Whenever I stood up quickly, I got very dizzy. Happened quite a few times throughout the day (I never had this problem before). ? When walking into the kitchen from outside, I got very dizzy and could not get up the steps on my own, I just kind of stopped. Did not black out but felt close. The kids helped me in, and I sat down. ? Drank more water and took it easy. ? The kids left about 2:00. Before they left, friend told me to go to a fire station and have my blood pressure checked. ? 2nd friend took me to 3 fire stations before we found one open, south of hardware store? They were nice, took my blood pressure, oxygen level and an EKG. ? They thought I was experiencing A-FIB. Told me to go to the emergency room right away. Wanted me to go by ambulance but I told them 2 friend could take me. They recommended medical center , which was better equipped for this. ? Got to the emergency room about 4:30 and checked in. ? Nurse checked me out and asked a lot of questions. I gave her the EKG print out from the fire station. ? She had us go back to the waiting area and was going to talk with the doctor. ? After a while they took us back to emergency ward and plugged in a saline bag and monitor. ? They hooked me up to an EKG machine again and took a reading. ? The doctor. came in and diagnosed me with A-FIB and discussed what it is, what can happen and how to treat it. She said that this could be a temporary episode of A-FIB or it could be permanent. ? She put me on a blood thinner and had me make an appointment with my cardiologist, Dr. Monday 4/5: ? Felt better got dizzy a couple of times but drank a lot of water and ate. ? Finally got the blood thinner prescription at about 4:00. Tuesday - Friday: ? Kept drinking a lot of water. No real issues with dizziness.

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

Patient received his first Pfizer shot on March 20th. He began to have pain in the back of his right knee which sent him to the ED. Upon further investigation, he was found to have a blood clot and was given Eliquis as a blood thinner. His physician requested that he make a report as he received his first COVId shot 8 days prior to the blood clot. He denies any diabetes, chemotherapy that may have irritated his vessels. Gabapentin,

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

elevated blood pressure, garbled speech, TIA Pt presented for acute stroke-like symptoms (L hemibody weakness, dysarthria, L gaze preference, dysarthria, word-finding difficulties) following a COVID vaccination (about 1-15 min after) at 1230 on 3/18/21. PMHx notable for multiple prior TIAa, HTN, HLD, PVD c/b R femoral artery thrombus (2017, no intervention, on Plavix), T2DM (prior A1c 6.5%, recently 6.2% not on meds), COPD, prior splenectomy (childhood re: car accident), chronic L ulnar neuropathy, bilateral hearing loss, complex partial seizure disorder following Rocky Mountain spotted fever. Symptoms resolved fully within 24 hours of event; diagnosed with TIA. MRI without new ischemic findings; chronic small vessel disease and chronic small R cerebellar stroke noted. TIA likely occurred in setting of hypertensive event with systolic BP to 220s. ED attending reported an NIHSS of 9. Of note, blood pressure was in the 210s systolic on admission, and subsequently down trended. Per resident, initially had left gaze deviation however on exam had full ocular motility. Pupils were of equal (size: OD 3, S 3) and reactive. Ocular motility was full without nystagmus. Facial sensation normal. Initial mild left facial droop, which also resolved. As the exam progressed, the patient's symptoms began resolving. Patient was able to articulate his thoughts better without dysarthria and strength markedly improved in the left upper and lower extremities to full 5/5 strength within about 30-45 minutes. NIHSS improved from 9-1. Of note, the patient reported having several episodes similar in nature, in the setting of significant hypertension as well. Denied ever having a true stroke in the past.

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

Patient had just been advised that his cancer had stopped growing and would be able to resume his immunotherapy drug Tagrisso. After receiving his first dose he went downhill very quickly. On the evening of 2/23 he had an unexplained seizure and went to the ER through 2/26. He was discharged to Hospice and passed away on 2/28.

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

Stroke; This is a spontaneous report from a contactable Physician. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose intramuscular, administered in Arm Left on 31Jan2021 (at 66 years old), singe dose for covid-19 immunisation. Medical history included lymphoma, hypertension, polycystic kidneys. Concomitant medications included losartan potassium. The patient had first dose of bnt162b2 vaccine on 10Jan2021 (at the age of 66 years old) for Covid-19 Immunisation, via intramuscular route on left arm. No other vaccine in four weeks. The patient experienced stroke on 21Feb2021 with outcome of recovering. The patient was hospitalized for stroke for 4 days. Information on the lot/batch number has been requested.; Sender's Comments: The event of stroke is assessed as possibly related to the suspect vaccine based on strong temporal association, but consider also possible contributory effects from patient's medical history of hypertension and polycystic kidney disease. 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.

big heart blood clot; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 66 years). Medical history was reported as none. There were no concomitant medications. The patient experienced big heart blood clot on 23Mar2021 14:00. Therapeutic measures were taken as a result of big heart blood clot. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient potentially received a saline only injection for the second dose of the pfizer covid vaccine on 3/31/2021. As per the CDC recommendation the patient was offered a dose 2 extra of vaccine. The patient received the dose 2 extra on 4/21/2021. In the evening of 4/22/2021 the patient had a fever to 102F and went to the ER his temp at 8pm was 104.7F and BP 123/66. Patient was admitted to Hospital for fever and found to be in rapid Afib. Afib reverted back to sinus rhythm on 4/25 and patient discharged on 4/26.

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

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

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

Shortness of breath with progressive Dyspnea. Found to have bilateral PE with right sided pulmonary infarct.

First issue was severe neck and shoulder pain (nerve pain) which occurred the day after second vaccination. Primary concern occurred April 13. Suddenly and unexpectedly went into cardiac arrest (V-fib). Suffered full cardiac arrest at least 3 times over a period of 12 to 24 hours. Hospitalized for 8 days in cardiac critical care unit. No previous history of heart issues. No family history either. Treatment included dosing with amiodarone, placement of an ICD (defibrillator/pacemaker) and presciption for amiodarone following hospital discharge. Currently recuperating at home.

Pt developed a very large DVT in his left lower extremity. The symptoms started approximately 10 days after receiving his first Covid vaccine

Patient had several ED visits within 6 weeks of receiving COVID vaccination. He first presented to the ED on 4/8/21, was admitted on 4/9/21 for 2 days. He was admitted again on 4/20/21 for 6 days. He presented to the ED on 5/8/21 with cardiac arrest and died.

afib; 104.7 fever; tired; Third dose on 21Apr, (second dose did not meet requirements of CDC guidelines).; Third dose on 21Apr; This is a spontaneous report from a Pfizer sponsored Program. A contactable other HCP and clinician (as reported) reported that a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown),via an unspecified route of administration on 01Mar2021 as single dose, second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 10Apr2021 to 22Apr2021, at 1 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced afib, 104.7 fever, tired, third dose on 21Apr. Verbatim and Event Description received as, fever, Atrial fibrillation (AFib), hospitalization, tired, and takes the medication as directed. Patient states Vaccination 01Mar2021, 31Mar2021. Called 4/1 wanted me to take the third dose (second dose did not meet requirements of CDC guidelines). Third dose on 21Apr2021, 22Apr2021 had 104.7 fever, AFib, in hospital four days. Stopped 22Apr2021 Inlyta. See oncologist 28Apr2021. Felt good when I was on it. Little bit tired, doing okay. The patient underwent lab tests and procedures which included pyrexia: 104.7 on 22Apr2021. Therapeutic measures were taken as a result of afib, 104.7 fever and tired with the medication as directed. Outcome of the events afib, 104.7 fever and tired was recovered for on an unknown date and remaining events were unknown. Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events of atrial fibrillation and fever cannot be excluded, due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.

I61.9 - ICH (intracerebral hemorrhage) (CMS/HCC) I63.9 - CVA (cerebrovascular accident) (CMS/HCC) I63.81 - Right-sided lacunar stroke (CMS/HCC N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

Acute kidney failure, unspecified Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

I developed a severe blood clot in my left calf. I needed to be admitted in the hospital. I was there for 4 days.

Z79.01 - Chronic anticoagulation J18.9 - Left lower lobe pneumonia R29.6 - Multiple falls A41.9 - Sepsis (CMS/HCC) R09.02 - Hypoxemia J44.1 - COPD exacerbation (CMS/HCC) I50.9 - CHF exacerbation (CMS/HCC) R79.89 - Elevated brain natriuretic peptide (BNP) level

This patient went to his vascular doctor on 5-10-21 and a clot was discovered on the groin area of the left leg. The MD said it did not warrant going to the ER. He has 2 stents in the right leg, (1 in thigh and 1 in calf). Patient reported it being uncomfortable but not "painful". Md placed him on Eliquis 10 mg, BID for 7 days then reducing the dose to 5 mg BID thereafter for about 5 months/

ED to Hosp-Admission Discharged 4/16/2021 - 4/20/2021 (4 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Patient: Date: 4/20/2021 DOB: Admission Date: 4/16/2021 MRN: Length of stay: 4 Days PCP: Discharging provider: Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Unknown Acute on chronic renal insufficiency Yes Diabetes mellitus type 2 in nonobese (CMS/HCC) Yes Cardiomyopathy (CMS/HCC) Yes Overview Addendum 3/23/2021 10:42 AM Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Formatting of this note might be different from the original. Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Persistent atrial fibrillation (CMS/HCC) Yes Acute respiratory insufficiency Yes Hospital Course HPI: 66-year-old male admitted with COVID-19 infection on 4/15. COVID-19 infection: In setting of immunosuppressive therapy. Patient was hypoxic on admission. He was treated with remdesivir?completed 5-day course on 4/20. Was treated with convalescent plasma. Patient was weaned off oxygen during hospital stay?his saturation was 96% on room air. He was not getting desaturation on activit during his hospital stay. He will not require dexamethasone on discharge. Atrial fibrillation: Patient remained in atrial flutter?patient recent pacemaker placement done. He was having tremors in extremities and so amiodarone was decreased to 200 mg once a day after discussing with cardiology team. He will follow-up next week for device check and subsequently with electrophysiologist. He was maintained on anticoagulation for stroke prophylaxis. Hypertension: Remained stable?patient will be off clonidine. He was advised to continue with Imdur, carvedilol, nifedipine?blood pressure was ranging between 100?140s systolic. History of renal transplant?renal function remained stable. Patient was maintained on immunosuppressive therapy with CellCept and tacrolimus. Patient will discharge on 4/20?agrees with plan of care.

Blood clot in leg; This is a spontaneous report from a contactable consumer (patient). A 66 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 at 12:45 (Batch/Lot Number: EN6198) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Nov2020 to an unknown date: came down with COVID virus in November and it felt like mild flu symptoms. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 08Mar2021 at 12:45 (Batch/Lot Number: EN6198) as a single dose in the right shoulder for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any adverse events following prior vaccinations. The patient's medical history included: father had a blood clot in his 50s. Concomitant medication (other medications taken in two weeks) were none. On an unspecified date in Apr2021, the patient experienced blood clot in leg. Relevant test included: ultrasound on 15Apr2021 showed blood clot. The clinical course was as follows: On 04Apr2021 or 05Apr2021 he started to notice a problem on his right leg. He went to see the doctor and it was determined he has a vascular problem. This problem got worse and ended up in the emergency room and was informed he had a blood clot in his leg. The clot started down by his ankle and had moved up towards half way to knee. Then moved up higher. He went to the emergency room on 15Apr2021and was diagnosed with a blood clot with an ultrasound scan that was done. He was then prescribed a blood thinner. He was informed it is a superficial thrombosis. The patient clarified the problem he started to notice with his right leg as it was like a bump, and sore. He was not sure what it was. He thought at first he may have banged his leg. Then he noticed it was sore and getting higher. He went to see his physician who referred him to a vascular surgeon. It took a while to get in to be seen by the vascular surgeon because so busy. A few days after that he went to the hospital, the emergency room because he was not getting better. That is when he found out he had a blood clot. Treatment for the blood clot in leg included, patient was prescribed rivaroxaban (XARELTO) 10mg once a day. The patient confirmed the blood clot was getting better. The outcome of the event blood clot was recovering. No follow-up attempts are needed. No further information is expected.

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

Pinched middle finger, got a 1/4 diameter blood clot under skin.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 20Apr2021 12:00 (Batch/Lot Number: er8735) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The most recent COVID-19 vaccine was administered in facility. The patient experienced pinched middle finger, got a 1/4 diameter blood clot under skin on 09May2021 13:00. Patient was scheduled to go there tomorrow for the second dose. Had an accident yesterday and pinched the right middle finger. Usually when that happens, he gets a boil and it fills with a clear liquid pus. This time, it turned into a giant blood clot, well not giant but about a quarter inch in diameter in the tip of his finger. He has never had that happen before. He may have never damaged his finger in that way before. That is why it turned into a blood clot and not clear fluid. Patient was worried a little with the blood clot because he knew it has been an issue. When he first got a little worried about the blood clot, he thought he would take 2 aspirin and it might thin the blood a little bit. Patient ate some pineapple because he heard that was a blood thinner too. No treatment received for event. The patient underwent lab tests and procedures which included nasal swab: negative on 10Jun2020. Outcome of the event was unknown. Information on lot/batch number was available. Additional information has been requested.

3 clots were discovered on the groin area of the left leg; patient has two stunts in the right leg (1 in thigh and 1 in calf) and reported that it had been uncomfortable but not painful; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8732), via an unspecified route of administration, administered in the right deltoid (reported as right arm) on 26Mar2021 at 03:55 as a single dose for COVID-19 immunization. Medical history included two stunts in the right leg (1 in thigh and 1 in calf) on an unknown date. The patient had no allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 24Feb2021 (lot number:EN6201), intramuscular in the right arm at 65 years of age. The patient went to his vascular doctor on an unspecified date (reported as 05Oct2021) and 3 clots were discovered on the groin area of the left leg. The MD said it did not warrant going to the ER. The patient has two stunts in the right leg (1 in thigh and 1 in calf) and reported that it had been uncomfortable but not painful. The MD placed him on Eliquis 10 mg, BID for 7 days then reduced the dose at 5 mg BID thereafter for about 5 months. The outcome of the events was unknown.; Sender's Comments: "The causal association of the events of ‘clots on the groin area of the left leg' and ‘leg uncomfortable' with the suspect drug BNT162B2 cannot be excluded due to limited information in the case. The case will be reassessed once new 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."

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

1. within a few days of second Pfizer Covid-19 injection: shortness of breath, high chest pains; went to emergency room; admitted on 3/31/2021, only finding was evidence of a previously unknown A-Fib, released 4/2. 2. returned to emergency room on 4/11/2021; found abnormally build-up of fluid in pericardial lining of heart; diagnosis was acute pericardial effusion; emergency surgery required to drain fluid; insertion of discharged 4/16/2021 3. returned to emergency room on 4/30/2021 with same symptoms as earlier; no additional fluid found around heart, but draining led to some pleural effusion; general belief that the heart lining was still inflamed; discharged 5/3/2021

Atrial fibrillation; mild stroke; my skin was kind of different looking you know like aging a little bit you know like wrinkling; seeing flash burn every once in a while; have a obstruction in the main artery of left eye; went totally blind in my left eye; probably got macular degeneration; pain in the arm; This is a spontaneous report from a contactable consumer reported for himself. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration in the left arm upper muscle on 02Apr2021 11:45 at age of 66-year-old (Lot Number: ER8737) as 2nd dose, single for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT number was EN6204) for Covid-19 immunisation in Mar2021, at age of 66-year-old and experienced pain in the arm. Medical history included Barrett's esophagus, Diverticulitis, Gastrooesophageal reflux disease, Generalised anxiety disorder, Cataracts, Kidney stones, Chlamydial infection, Left ventricular hypertrophy, Vertigo, hiatal hernia repair done, hypertension, had a colonoscopy quite often in another words to remove the polyps from his colon. Concomitant medication included omeprazole taken for GERD (gastrooesophageal reflux disease) and paracetamol (TYLENOL). The patient experienced atrial fibrillation on an unspecified date with outcome of unknown, mild stroke on an unspecified date with outcome of unknown, went totally blind in my left eye on 09Apr2021 with outcome of not recovered, probably got macular degeneration on 09Apr2021 with outcome of unknown, pain in the arm on 02Apr2021 with outcome of unknown , my skin was kind of different looking you know like aging a little bit you know like wrinkling on an unspecified date with outcome of unknown , seeing flash burn every once in a while on 09Apr2021 with outcome of unknown , have a obstruction in the main artery of left eye on 09Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included CAT scan and EKG both with unknown results on 24May2021. The events result in Physician Office Visit, no treatment was received. Clinical course: Consumer stated, "Well, I got my first Pfizer shot I just thought I should just call and discuss this with somebody bit of some sheet I got I got the Pfizer vaccine and I got that one on 15Mar2021 the first one and then I received the second one 02Apr2021 and when after I received the second one I had the pain in the arm like normal but it was a lot more severe than I got from the first one but it went away but you know normal 3 to 4 days it went away so I did not wasn't that concerned but I also know this to ask. After I got my skin was kind of different looking you know like aging a little bit you know like wrinkling but then all of a sudden it cleared up too that went away probably about the same time a week after I got the shot I started having vision problem(distorted voice and incomplete sentence). I visited an ophthalmologist an regular eye doctor it was an ophthalmologist (distorted voice and incomplete sentence) and he said no I don't see that you have a stroke I don't see that you have vision problems with your retina this time you probably got macular degeneration going on so anyways he said comeback if you have an issue then I said so you are telling me that even though my vision is going in my left eye I am not gonna go blind and I didn't have a stroke he said yes. Ok, so anyways exactly a month after that I went totally blind in my left eye my vision came back, my vision came back. I forgot to tell you my vision came back fully for a while but it was different in my left eye like I was seeing flash burn every once in a while when I was in the sunlight and stuff. Anyway a month later after I got the second shot when I went totally blind in my left eye and so I got upset about the doctor's here and I had to go to (Address) to pick my new eyeglasses anyway so I had to drive to (Address) with one eye which is 230 miles from me anyways, so when I got my glasses there at they were the right prescription thank god and I told them about the eye issue so they didn't throw a eye test really thorough and said yes I definitely see a problem in your left eye looks like a flash burn or something like that so then they had me setup an appointment with really good ophthalmologist in (Address) because I wanted a second opinion whether my insurance covered it or not. So I went to this retinal specialist and I was in his office for like 3 hours they were checking me out in there you know he said yes definitely you have an obstruction in the main artery of your left eye and that's why you lost your vision and this doctor said there's only two things it could be it it could be you had a stroke or that you had a bad reaction to the Pfizer vaccine and so anyway he wanted me to go either into the emergency room a good (Address) to further do testing, I said no I don't wanna do that because that's all out of my own pocket that would have been thousands of dollars you know, but I don't know I am all confused about this medical care. I am just trying to give you all a scenario from day 1 going forward you know anyway so I refused to go to good (Name) and he said well it should be okay anyway because it's been so much time since the original problem that you would be probably alright to just back to your hometown there and go to the hospital and have your testing then there I did and the next day I got back to (Address) from (Address) I went to the hospital there they did an EKG on my heart and they did a CAT scan on my head and they said they couldn't see anything from the EKG or the CAT scan that I had but that doesn't mean you didn't have(Incomplete sentence), so they said you could have a mild stroke and you know anyway we want you to go further testing well I had a primary care physician appointment two weeks later which is still coming up so I have to her so they want to order an MRI and some other tests on my heart because they think I have might have an AFib atrial fibrillation where the blockage I mean where the blood flow properly to my heart you know if I want to do those tests too but I am just letting you know this cause the one doctor said it could be that you have the eye problem because of the vaccine that's what I am calling you about." Consumer Stated, "Yes, you can follow up sure because I am more anyway cause on the 09June2021 I have an appointment with my primary care physician which is the one that have to do the order in heart chest and the MRI and the following week. I am going back to (Address) to that Ophthalmologist that said that it might because of Pfizer vaccine I am going back to him I got a follow up with him because he wants to me to take care of my eye issue so maybe I can get my eye sight back in other words or so." Date adverse event started: Consumer stated, "I had my first shot on Friday 02Apr2021. The exact day that I started having issues was exactly one week later on 09Apr2021. Other than the normal you now pain in the arms because that started and went away normal that started you know. Well that started basically right after I got the shot on 02Apr2021 with the pain and the arm thing that was right after I got the shot 02Apr2021 and it was the little bit more severe than the original shot. 09Apr2021 is when I stated having eye problem." Anatomical Sites of administered: Consumer Stated, "The first one I had them do it in my right arm in the muscle top in my right arm and the second one was done in the left arm upper muscle." Other Medical Conditions: Consumer Stated, "Nothing life threatening but I have chronic health conditions, quite a few of them. I got Barrett's esophagus, then Diverticulitis of the sigmoid colon then electro cardiogram(Further not clarified) they did was abnormal they said. I got GRD Gastroesophageal reflux disease. I got generalized anxiety disorder, GAD. I have Cataracts. They said I had a genital disorder I don't know what that means. I got history of Calculus in the kidneys, kidney stones but I haven't had a problem with that from quite a while, I changed my diet. I have past Chlamydial infection which is an STD. I had hiatal hernia repair done, so surgery. I have hypertension disorder they say, left ventricular hypertrophy which I guess has something to do with the heart, I think that's why they wanna do more test of my heart. I got polyps in colon (Further not clarified) and occasionally I get Vertigo so I have to have a colonoscopy quite often in another words to remove the polyps from my colon." Treatment medication for medical conditions: Consumer Stated, "Well they only I take Vitamin D3 and I take Vitamin C but that's vitamins basically the only meds and I am taking. I am using Eye Drops right now over the counter stuff basically the only meds I really take is Omeprazole which is for my GRD disorder you know my gas my stomach gas it controls my stomach gas and then extra strength Tylenol I take that as needed sometimes." Start date of taking the medication: Consumer Stated, "Well the Omeprazole I probably been taking that for 10 years at least 8 years or 7 years. I really couldn't give that to you without going through a pile of paper work." When asked about if consumer is taking any other medication, consumer Stated, "No, Just Omeprazole." Lab test: Consumer Stated, "Well they did an EKG and they did a CT scan and that was just recently because of my issue that I got right now going on. Yeah, that was done at (Name)." Date of test: 24May2021. Result of test: Consumer Stated, "Only the doctor has that I don't have that I have to go to my primary physician on 09May2021 to get those results." Event Details: Event Date: Consumer Stated, "When I had the first shot I didn't have any side effects at all except for the minor arm pain." When confirmed event date as 02Apr2021 and 09Apr2021, consumer stated, "Yes that's when I started having adverse side effects." Still experiencing the problem: Consumer Stated, "Yeah, I am still blind in my left eye yes." Outcome: Consumer Stated, "Well I don't know it's kind of early if they are gonna improve or not they want to do more testing the doctor know more when they did more tests I don't have all the information because they still doing test on me to figure out what's going on but I decided to call you know before it got too late in the whole situation you know." Treatment: Consumer took for the adverse events consumer stated, "No I don't think they gave me any drugs or anything for the tests." Consumer hung up abruptly hence further probing could not be done.

Developed symptoms of Fatigue, shortness of breath, fluid retention prominently noted around the date of May 8. Went to urgent care on May 17th and was admitted for new onset atrial flutter/fibrillation with slow heart rate in the 30's with pauses > 3 seconds. My condition was monitored via telemetry, echocardiogram, TEE, CT scan of the chest, and cardiac cath Monday PM through Thursday. I had cardio conversation on Thursday along with a pace maker placement. I was diagnosed with a pericarditis (pericardial effusion), pulmonary edema, new onset A Fib, and bradycardia.

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

This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration on 19Apr2021 (at the age of 66-years-old) as dose 2, single for COVID-19 immunization. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included restless legs from an unknown date. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The patient does not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included pramipexole; and amitriptyline hydrochloride (AMITRIPTYLIN) both were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) on 22Mar2021 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization. It was reported that the patient started noticing shortness of breath 2 weeks after second vaccine (reported as 07May2021), then noted his heart rate was 120. He went to family doctor, his EKG was abnormal, then went to hospital. CT showed multiple pulmonary clots and some massive, they noted extensive clot in right leg. He was then admitted to ICU. Have no history or underlying cause for clots, no travel related. The doctors felt highly related to vaccine . The doctor stated likely to never be back to level of health before vaccine. The patient was hospitalized due to the reported events from 07May2021 to 11May2021. The reported events were considered life-threatening and disabling. Therapeutic measures were taken as a result of the reported events as the patient received blood thinners. The reported events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was recovered with sequel on an unspecified date in 2021. Since the vaccination, the patient has not been tested for COVID-19.

Patient noted with decline in condition starting from his first vaccine and expired shortly after 2nd vaccine.

66 y/o male presents to the ED with generalized weakness, slurred speech, ataxia that started yesterday at 5:00pm while he was driving. He had his second dose of the Covid vaccine at 4:30pm. He woke this morning (6/30), still having symptoms, so his son brought him to the ED. Diagnosis of stroke, acute CVA

My wife drove me to the hospital because I had a heart attack after receiving the 2nd dosage (suffered mild cardio inflection) which meant that there was a blockage in the left circumplex artery and I had to have an angioplasty (surgical stint). I was placed on Plavix for one year along with baby aspirin indefinitely. I spent one night in the hospital as a result of the adverse event and will be starting Cardiac rehab on June 12, 2021.

Since he received the Pfizer vaccine, he's incurred fatigue, bleeding where he's had to receive several units of blood/hemoglobin four times. He was admitted into the hospital for these treatments. To beat it all, he developed jaundice and is now getting ready to undergo treatment for pancreatic cancer.

Patient was fully vaccinated in February, admitted to acute care hospital, positive for COVID19 in July. Patient diagnosed with COVID pneumonia, completed treatment, was considered recovered from COVID. Patient while still in acute care expired on 7/26/2021

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

Resident was vaccinated on 12/31/20. Then on 1/14/21 he tested positive for SARS-CoV-2 on routine surveillance PCR testing. Another resident on the same hall was COVID positive on 1/11/21. Results of the PCR test were obtained on 1/16/21. He appeared asymptomatic at that time. Given his COVID positive status, all aerosol generating procedures had to be stopped. Overnight on 1/16/21 into 1/17/21, he had the onset of acute respiratory failure and was transported to the hospital. Per notes, he was put on BiPAP for several hours, but his CO2 level did not improve. Per prior advance directives completed with the resident and his two brothers, he had DNR/DNI orders. The hospital physician spoke with his brother and the decision was made to move to comfort care. He was discharged to inpatient hospice and died around 4pm on 1/18/21. This outcome does not appear to be vaccine-related, but death from COVID-19 infection is listed as a reportable event following COVID-19 vaccination.

heart attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (BNT162B2, lot # EL9263) at single dose at left arm on 23Jan2021 14:15 for Covid-19 immunisation. Medical history included hypertension, high cholesterol. No known allergies. The patient had not experienced Covid-19 prior vaccination. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 24Jan2021 06:00, the morning after he received the COVID-19 vaccine, he had a heart attack. The patient was hospitalized for heart attack for 2 days and evet was considered life threatening. The doctor placed 2 stents in his arteries. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 24Jan2021.

Pt c/o coughing and SOB pt states he received 1st dose of covid vaccine on the 01/22/21 presented to the ED with fever, chills and shortness of breath. He tested positive for covid. In the ED he was hypoxic to 87% on RA. # Hypoxic respiratory failure: 2/2 covid pna. Room air sats 87%, up to 92% on 4L # COVID pneumonia: no suspicion for bacterial etiology. REMDESIVIR administration started on 1/25/21. Transferred to Hospital, (2/3/21) for higher level of care Intubated COVID 19.

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

Resident did not exhibit any side effects from the vaccine. Staff spoke with him in his room at approximately 7:20am and returned to his room just a few minutes later and he was unresponsive. When the RN got to the room he had CTB. Physician documented heart failure and end stage kidney disease on the death certificate.

Patient had no reaction at the time of vaccination. Waited the required 15 minutes and was allowed to go home.

Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered.

No symptoms or signs on the day 1st dose of vaccine was received (2/11/2021). 3 days later, (2/14/2021) patient experienced chills for approximately 6 hours, followed by severe (visible) chest spasms, and then cardiac arrest. 911 was called upon witnessing chest spasms, but cardiac arrest/death occurred before patient could be transported to the hospital.

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

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

Patient was into the clinic on the afternoon of 2/23/21 for a COVID-19 vaccine. He had a podiatry clinic visit after his vaccine same day. It was reported by the patients family physician that patient stated he didn't feel well and suddenly collapsed at home at approximately 4:45 pm. Emergency medical personnel were not able to revive him. Patient died at approximately 4:45 pm on 2/23/21.

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

DEATH Narrative: Pt he reports he developed chills SOB body aches the same night as receiving the COVID vaccine on 1.26.2021-pt is currently reporting CheSt tightness and SOB Admitted to hosp: ICU with Bilateral Pulmonary Emboli, LLE DVT, NSTEMI, Arrhythmia.

stroke; Joint pain; In the palm of my hand I might jump out of my skin; ; arm was hardly sore at all; right arm at the shoulder, elbow, and fingers is hurting at the joints; This is a spontaneous report from a contactable consumer. This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9269) single dose, dose 1 via unknown route of administration in the left arm for COVID-19 vaccination on 12Feb2021 at 14:30. There were no additional vaccines administered on the same date as the COVID-19 vaccine. Medical history included pneumonia five times on an unknown date, septicemia one time, melanoma cancer in 2015, Factor V Leiden, high blood pressure and blood thinner. Prior Vaccinations (within 4 weeks): Concomitant medications included lisinopril from 2008 and ongoing for high blood pressure and warfarin 9.5 mg daily from 2008 and ongoing for blood thinner. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient's arm was hardly sore at all and he had a stroke. On 13Feb2021, the patient experienced joint pain, in the palm of his hand if he presses right in the dead center he thinks he is going to jump out of the skin and right arm at the shoulder, elbow and fingers is hurting at the joints. When he first felt it in his right arm it wasn't horrible and it seemed like it got worse the next day. Then it seemed like it tapered off a little bit. On 16Feb2021, the pain woke him up in the middle of the night. The events did not require an emergency room or physician's office visit. He gets the flu shot every year and he has no symptoms whatsoever. The clinical outcome of stroke, joint pain, in the palm of my hand I might jump out of my skin, arm was hardly sore at all and right arm at the shoulder, elbow, and fingers is hurting at the joints were unknown.

evening of vaccination developed fatigue, sweats, palpitations and subsequent DOE and orthopnea that persisted and led to hospitalization 3/7/2021 for atrial fibrillation with rapid ventricular response and acute on chronic decompensated systolic CHF.

Pt received Pfizer COVID Vaccine 3/9/21 at 13:25 At Clinic. Lot #EN6205 Exp 6/21 to right deltoid. No issues noted while patient dialyzing. Pt came off treatment 16mns early due to concerns of transportation. Pt a/o, VSS, pt in W/c no issues noted at discharge. Pt's comorbid conditions per hospital discharge records: <20% EF, deteriorating health status, physician recommended hospice care but pt refused. On March 11th, significant other notified facility that patient had passed away in his sleep and was found by workers at the rehab facility he was in.

Patient developed Gilliam Barre after administration of the second dose of Covid vaccine on 2/15/21; After multiple calls, clinic was where patient received vaccine with LOT #EN6200 (expiration date unavailable in computer system per pharmacist); pt then went to a hospital and was diagnosed as above; treated in the ED for several days per notes at the hospital and was not put in a room due to bed shortages so was transferred to another hospital; patient subsequently developed an NSTEMI, seizures, and was intubated.

Two days following vaccine infection, noticed severe heart arrhythmia, for several days. Very sore arm where vaccine was done. This seemed to pass, then a heart attack.

chest pains; chest pains; blood clot; light headedness; low fever; blacked out for about 5 minutes; onset of major body ache and fatigue; onset of major body ache and fatigue; Body aches at injection site and into upper back; Body aches at injection site and into upper back; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 23Feb2021 10:30 AM (at age of 67 years old) as single dose for COVID-19 immunisation. Medical history included high cholesterol. Concomitant medications included atorvastatin; levobunolol (eye drops); latanoprost (LATANO). The patient previously received his first dose of BNT162B2 on 05Feb2021 for COVID-19 immunisation (brand=Pfizer; lot number: EL9269; administration time 03:30 PM; vaccine location=Left arm; dose number=1). 6 hours after injection on 23Feb2021, the patient experienced body aches at injection site and into upper back. After 24 hours after injection on 24Feb2021, started light headedness, low fever, blacked out for about 5 minutes, onset of major body ache and fatigue. Spent the next 36hrs in bed. 72hrs after injection recovered back to normal slowly. On 04Mar2021 at 8pm, started with chest pains called, admitted to Hospital with heart attack, immediately taken to Cardiac Cath Lab for coronary catherization in both legs, to partial remove blood clot and insert continuous balloon pump, IV Heparin infusion Troponin 6542.3 ng/l (critical), NO previous health issues for blood clots. Discharged 07Mar2021, Apixiban 5mg twice a day, Clopidogrel 75 mg /day. AE resulted in: Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event. Number days hospitalization: 3 days. The outcome of events was unknown.

Patient had no known immediate ill effects or complaints directly after receiving his second COVID-19 vaccination on 03/11/2021. However, on 03/22/2021, he suffered a fatal cardiac arrhythmia while exercising on his home elliptical machine.

Wife found husband dead two days after2nd dose. This Health Department was made aware of the death by the the Kidney Center. The patient failed to show up for a scheduled dialysis appointment on 03/24/2022. The clinic obtained information of the passing from the wife. The patient received his SECOND dose of COVID-19 vaccine on 3/22/21, reported feeling ill 3/23/21 and then passing on 3/24/21. The clinic called the health department to report the death of the patient on 3/24/2021.

Pt received COVID-19 vaccine on 2/23. He felt tired and unwell after. He had a syncopal episode on 3/4 and presented to ED. He was in complete heart block. Pacer placed. No CAD on coronary angiogram. Normal heart function. Discharged home. Presented unwell to ED with chest pain and elevated troponin on 3/16 found to have cardiomyopathy EF around 25% (medically managed, sent home) Repeat left heart cath done at the time showed no CAD. Presented to ED 3/22 with cardiogenic shock, EF 10%. Proceeded to have multiorgan system failure, impella placed, had cardiac arrest, transferred to another facility for further support. Was placed on VA ECMO. Heart biopsy done 3/25 revealed giant cell myocarditis. Pt is in critical condition and not expected to live d/t sequelae from cardiogenic shock: shock liver, AKI, ischemic bowel with ecoli bacteremia.

My leg and foot swelled on Thursday. We elevated and treated with heating pad & Advil. The swelling went down, so we started for home, drove 4hrs. My leg & foot swelled back up. We went to the ER they gave me an ultrasound, and said I had 2 blood clots in my leg. They prescribed, Eliquis.

Patient expired 3/8/2021 at home. Coroner pronounced time of death at 0415 and assumed cause of death was history of transplant and cardiac.

Pt had occipital occlusion stroke (Rt anterior medial thalamus) and was treated at Hospital and then transferred to level 3 facility. He was in-patient for 4 days at which time he had almost complete resolution of sxs. He was referred to a neurologist with stroke specialty at the Hospital and clinics.

Thrombocytopenia and neutropenia associated with fever, body ache, fatigue, chest tightness. Symptoms began about 1 day after vaccination and continued for about two weeks. About 8 days after vaccination, the patient sought medical attention and was diagnosed with the lab derangements noted above, PLT 120 and WBC 2.6. Covid test negative at that time. He was first seen by me about one week after that where his blood counts had improved but not normalized and he was still having some symptoms. He was last seen by me today, 3/30/21 and now asymptomatic and blood counts normalized. No specific treatment was done.

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

Patient took the Pfizer Corona Virus shot does 1 on march 1, 2021. He passed away on march 20, 2021. Reported being fatigued and exhausted after taking does 1. Was sleeping up 10 hours a day. On the day he passed, he reported being light-headed and struggling to breath. The paramedics worked on him for 40 minutes to try and revive him.

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

DEATH Narrative: 66 yo male with PMH of HTN, HFpEF, COPD, T2DM, CKD, tobacco use disorder and bipolar disorder was found dead in his home on 2/16/2021 after police did a wellness check per request of patient's sister. Patient received the covid19 vaccine (Pfizer) on 2/9/2021, vaccine was administered without complications. No prior positive for covid19. After patient received his covid19 vaccine, he was seen at same day access for increased SOB/DOE, worsened orthopnea. Per progress notes, at this last appt, patient had expressed a number of medications which he was not willing to take, attributing his worsened health to their effects. Pt has continued spironolactone despite being advised to stop it by his medical provider. At the time of visit, provider noted that this kidney function was declining (patient does have CKD). Provider discussed the importance of medication adherence and patient was started on torsemide. Hctz was discontinued, minoxidil was increased due to patient preference. Prior to this same day access/express care visit, patient was hospitalized from 1/26 through 1/28/2021 for hypertensive urgency (211/105) and that at that time, pt already had orthopnea, SOB, and dyspnea. Patient was also admitted from 1/7 to 1/8 and left AMA. While inpatient, his MRI revealed a pontine lacunar infarct that was found to be chronic. It was recommended that patient be treated with aspirin/plavix for 21 days then aspirin alone but patient declined.

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

On 3/29/21 at 11:00pm my dad began having chills and uncontrollable shaking. My mother contacted Pfizer who instructed us to alternate Tylenol and Motrin. Tylenol given and Motrin given 4 hours later as instructed by Pfizer. On 3/30/21 around 11:10am my dad was found unresponsive, not breathing and did not have a pulse. My mother immediately called 911 and my aunt began CPR. When EMS arrived he was found to be in cardiac arrest and after 25 min of efforts by EMS my father passed away less than 24 hours after receiving his 2nd covid vaccine.

Hypertensive crisis at 180/95; Vascular thrombosis; Head is spinning; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm, on 16Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. In Mar2021, the patient's head was spinning, there was a hypertensive crisis at 180/95 for 2 times, and there may be a vascular thrombosis. It was unknown if treatment was received for the adverse events. The events were considered non-serious by the patient. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

I was hospitalized due to severe blood clotting for four days following surgery to remove scar tissue from the urinary/prostate area and am now on blood thinner medication.

Patient began getting dizzy within 24-48 hours after vaccine. Within 2-3 days developed persistent fevers as high as 103. Was found to have febrile neutropenia & thrombocytopenia. AKI developed, now requiring hemodialysis. Patient also required mechanical ventilation. Has been diagnosed with Hemophagocytic lymphohistiocytosis now being treated with dexamethasone & etoposide. He remains intubated.

3 days after first shot (given 2/19/21) I started having heart palpitations and shortness of breath. They went away in 3 more days. 3 days after second dose (given 3/12/21) I started having heart palpitations and shortness of breath again. Went to GP and diagonosed with A Fib. Went to cardiologist who confirmed A fib. Cardiologist said I was the second patient that day presenting with A Fib following a dose of Pfizer. Now after 5 weeks I am getting slowly better but still have some A fib.

I ended up with shortness of breath beginning on April 9, 2021. It got worse over the weekend and saw my PCP at 2pm on Monday April 12. They sent me to the emergency room

all joints in my body ached, headache, fever 102, full body rash, itching, diahreah, all started on the 13th. next day after shot. went to hospital on 04/22/2021 and released on 04/28/2021

found down unconscious; unwitnessed fall; oxygen was in the 60s; submassive bilateral pulmonary emboli; right femoral vein emboli/ occlusive thrombus visualized in the right proximal femoral vein; some degree of right heart dysfunction; blood sugar very high; A1C elevated; Haptoglobin elevated; elevated troponin; This is a spontaneous report from a contactable nurse. A 67-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 67-year-old, on 25Feb2021, as SINGLE DOSE for covid-19 immunisation. Medical history included Traumatic brain injury at the age of 29 which resulted in a CVA (right sided stroke)because the hospital did not know how to give Mannitol, behavioral problems in 2008, run over by a train in 2008, wears two AFOs (one on the left leg from having a right sided stroke, he also wears one on his left leg from having a stroke with right sided weakness, the right AFO was worn since he was 29, and then the other one he started wearing in 2008 when he was run over by a train and almost had his leg severed and he wears a left AFO), dementia diagnosed 4-5 years ago, head surgeries, depression, affective disorder, anxiety. The patient had multiple hospitalizations, and he has hyper reflexivity like all brain patients have. The patient has no history of blood clots or emboli. Concomitant medications included olanzapine (ZYPREXA) taken for depression and oxcarbazepine (TRILEPTAL) taken for affective disorder and anxiety. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) single dose for covid-19 immunisation, pneumonia and flu vaccine in 2008 for immunization and has no reaction. The patient received his second dose of the vaccine on 25Feb2021 and two weeks later he was found down/ was found down unconscious at the nursing home and his oxygen was in the 60's on 15Mar2021. The nursing home did not know if her brother hit his head because it was unwitnessed. The patient was found down, not responsive, and it was an unwitnessed fall. The patient was treated as a trauma patient and that this occurred around 10 oclock on 15Mar2021. At that time, he was transferred to a local hospital to the emergency room and put on oxygen. They transferred him within 4 hours because they did not know what to do. Caller adds that the hospital thought that he had a subdural hematoma but the hospital does not have a neuro radiologist, so the hospital transferred to the other hospital that somebody with head knowledge can look at his CAT scan. The patient was misdiagnosed with a subdural hematoma because there were changes in his CT scan from his 3 previous brain surgeries. The patient had a traumatic brain injury when he was 29, and experienced changes. The patient was found to have submassive bilateral pulmonary emboli on 15Mar2021 described as central lobar sub segmental PEs in both lungs, PE was within the distal right main artery, pulmonary artery distal left main, left middle lobe, middle right lobe / upper right lower lobe and middle lobar, segmental and sub segmental pulmonary arteries. The patient also had pulmonary emboli in the distal left main pulmonary artery of left middle lobe and left lower lobe, pulmonary arteries. There was also some degree of right heart dysfunction which was diagnosed by contrast. On 15Mar2021, the patient also had right femoral vein emboli/ occlusive thrombus visualized in the right proximal femoral vein. The patient is in a nursing home, the doctor did not want to listen to the reporter because her brother is a nursing home patient and they just assume he is immobile but he is not. The patient underwent lab test and procedures which included Blood sugar very high (they think it was because of heart strain and acute injury because then it came down down down), A1C elevated, Haptoglobin elevated, elevated troponin. These results were all elevated and from acute injury. At the time of the report, the patient is feeling better and needs less oxygen. The events found down unconscious, unwitnessed fall and oxygen saturation low, pulmonary embolism, right femoral vein emboli/ occlusive thrombus visualized in the right proximal femoral vein, and some degree of right heart dysfunction caused hospitalization from 15Mar2021 to 18Mar2021. The reporter absolutely does believe the events and the suspect drug are correlated. Outcome of found down unconscious, unwitnessed fall and oxygen saturation low, pulmonary embolism was recovered on 18Mar2021 while it was unknown for the other events.

Pneumonia , walking Pneumonia. Dr. gave me Azithromycin Tablets250mg. for 5 days. I herd weazing from my lungs while breathing when i was in bed. I had a regular check up with my doctor and told him and he sent me for an X-Ray.. Thats when they said it was Pneumonia.

On April 24, 2021, a vein in my arm swole up like a blood clot, the a cephalic vein. I started experiencing nerve burning and tingling in hands, arms and shoulders. The blood clot was in an area that I had damaged years ago and is now clogged. Today is 4/27/2021 and I still have the blood clot and tingling, sometimes in my face also, burning in the shoulder blades, very similar to symptoms of brachial neuritis. I am scheduled for my second shot on 5/4/2021, but thinking I may not get the shot since I am having so much trouble. I have an appointment schedule with a vascular doctor to have an arterial dopler on 5/6/2021, and have the vascular doctor advise.

covid vaccine 3/31/2021 Pt reports left leg pain 4/1/2021 Pt went to PCP (myself) 4/5/2021 and c/o left calf pain x 1 week Ordered venous duplex Lower extremity left leg Pt went to ultrasound radiology 4/7/2021 Same day referred to ER for treatment/Referred to ER given complex history indication for IV heparin Pt went to ER 4/8/2021, Patient received 1 dose of LMWH and then started on apixaban -induction, then maintenance therapy. Seen for follow up 4/28/2021 outpatient

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

PULMONARY EMBOLISM Patient reported to OSH 24 days after second Pfizer COVID-19 Vaccine with SOB--diagnosed with bilateral PE/DVT and remained inpatient for approximately 3 days. Patient also diagnosed with Afib and new onset CHF during admission. Discharged home with anticoagulation.

Thrombocytopenia; He had clot in the legs and in the lungs; He had clot in the legs and in the lungs; Low platelet count; This is a spontaneous report from a contactable Other-HCP. A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 67 years). Medical history included diabetes. Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]); colecalciferol (VITAMIN D [COLECALCIFEROL]); lisinopril; insulin taken for diabetes mellitus. The patient experienced thrombocytopenia, he had clot in the legs and in the lungs and have a low platelet count on an unspecified date. The patient was hospitalized for the events on an unspecified date. The patient underwent lab tests and procedures which included CBC: unknown result on 08Apr2021, Heparin associate antibody: unknown result, comprehensive metabolic panel (CMP): unknown result and platelet count: low on an unspecified date. Therapeutic measures were taken as a result of thrombosis included Heparin drip and Argatroban. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The reported events are considered unrelated to BNT162B2 vaccine, being rather intercurrent occurrences. Clots in the legs and in the lungs were likely favored by the mentioned diabetes and by a possible hyperlipidemia (the patient was taking atorvastatin) in a setting of possible arterial hypertension (the patient was taking lisinopril). 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.

ECHO FEB 8, 2021; EF 55%. REREAD AGAIN IN APRIL AND EF 55% CONFIRMED. ON MARCH 5, HE PRESENTED WITH A 5 DAY HX OF SOBOE, ORTHOPNEA AND SEVERE PRECORDIAL CHEST PAIN. HE DESCRIBED THE ONSET AS SUDDEN, ABRUPT AND SO SEVERE THAT HE WAS UNABLE TO CALL 911. THE SEVERITY OF THE CHEST PAIN DISSIPATED SOMEWHAT, BUT THE DYSPNEA AND ORTHOPNEA HAD WORSENED. HE TRIED ALBUTEROL AEROSOLS BUT THESE ONLY GAVE HIM VERY PARTIAL RELIEF. PHYSICAL EXAMINATION REVEALED A NEW CARDIAC S4, CLEAR CHEST TO AUSCULTATION BUT HE WAS UNABLE TO TAKE A DEEP INSPIRATION DUE TO TO THE PLEURITIC CHEST PAIN. HIS WEIGHT WAS UNCHANGED. NO PERIPHERAL EDEMA NOTED. EKG SHOWED RBBB, LPFB; BIFASCICULAR BLOCK. NO PREVIOUS EKG FOR COMPARISON.

A few days after the vaccine started feeling uncomfortable in the left leg. It did not get better with rest and time so went to the ER and an ultrasound and found a clot from the groin to the ankle. He had no injury to preclude this clot. He was put on an anticoagulant (Xarelto) and standing and walking is very painful. He has a follow up appointment set with his PCP 5/6/21 He was told he might have to be on this medication for months maybe longer.

typical reported symptoms that mimic COVID; I went into a-fib; itchy inner arm; This is a spontaneous report from a contactable other HCP (healthcare professional/patient). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that the patient had no known diseases or conditions. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") were reported as no. It was reported that the patient was not on any medications prior to the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL9266) via an unspecified route of administration in the right arm on 03Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and experienced sore arm. On 25Mar2021 at 08:45 the patient experienced I went into a-fib and itchy inner arm and on an unspecified date the patient experienced typical reported symptoms that mimic COVID. The clinical course was reported as follows "I had just sore arm after shot 1, but after shot 2 I went into a-fib. I also had the typical reported symptoms that mimic COVID and itchy inner arm." The adverse events I went into a-fib and itchy inner arm resulted in a physician office visit and the event I went into a-fib required treatment with blood thinner and calcium blocker. The patient was tested for COVID-19 post vaccination on 07Apr2021 with a nasal swab which was negative. The clinical outcomes of the events I went into a-fib and itchy inner arm were not recovered/not resolved and the clinical outcome of typical reported symptoms that mimic COVID were unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Atrial fibrillation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.

Presented with incidental finding of thrombocytopenia (plts 7K) on 4/10/21. No bleeding noted, no adenopathy. Treated with IVIG x2 with platelets increased to 40,000. Normal CBC several months earlier.

This 67 year old white male received the Pfizer Covid shot on 2/23/21 and went to the ED on 3/22 /21 and was admitted on 3/23/21 with the following diagnoses listed below. Thrombocytopenia, unspecified

This 67 year old white male received the Pfizer Covid shot on 2/20/21 and went to the ED on 4/20 /21 and was admitted on 4/20/21 with the following diagnoses listed below. Thrombocytopenia, unspecified

Right knee swelled and felt like it dislocated; Right knee swelled and felt like it dislocated; Pain in groin; Felt like a muscle cramp; Blood clot as well as fluid on that knee/blood clot right leg; Muscle tear; the pain went to his knee; Pain in the arm opposite that he received the injection; his other leg "got messed up"; Blood clot as well as fluid on that knee; Knee was stiff as a board; He could not walk on either of his knees for a couple of days; Inflammation in the calf; His leg was stiff; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in left arm on 30Mar2021 10:45 as single dose for COVID-19 immunization. Medical history included knee surgery, dislocated shoulder (he has dislocated that shoulder in the past several times but had no recent issues), carpal tunnel syndrome and, rheumatoid arthritis, all from an unknown date and unknown if ongoing. There were no concomitant medications. In Mar2021, the patient experienced pain in the arm opposite where he received the injection. He reported he like had a muscle tear that it has an intense excruciating pain. He took three aspirin and put a heating pad on it that didn't touch it. He then reported that the pain went to his knee and it "got all blow up" and stated that that knee had to be drained. He then stated that the calf on his other leg "got messed up" and was found to have a blood clot as well as fluid on that knee. He reported that it was as stiff as a board and that he could not walk on either of his knees for a couple of days. He reported that he still has problems with the one knee that "blew up" and had to be drained but stated that the inflammation in the calf where blood clot was has receded and is back to normal. He stated that he had to visit the emergency room twice and see an orthopedic surgeon for these issues and has been prescribed Xarelto to take to treat the blood clot. In the morning his leg was stiff. It was also reported that the patient's right knee swelled and felt like it dislocated on 16Apr2021, blood clot on right leg on 12Apr2021, and pain in groin on 13Apr2021. The pain in his groin went down, but his calf swelled to twice the size and it felt like a horse because he was favoring it. It felt like a muscle cramp. The orthopedic saw him for his left knee and he was seen in the Emergency Room for his right and they called his primary doctor. He tried to work and paid the price with his left knee. He has been taking Tylenol and icing it. The last two days (unspecified date) he has been babying it, the weather has been not so great, so he is laying low and give it a rest, but knows he is supposed to get up and move around so he has been doing that and elevating it. He would like to know if, based on these symptoms he experienced after the vaccine, he should get the second dose of the vaccine, which he states he is supposed to get on Tuesday. The outcome of the events "Right knee swelled and felt like it dislocated", and "Pain in groin" was recovering, and for other events was unknown.

was diagnosed with a heart attack at the hospital; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01May2021 at 14:00 (Lot Number: EW0173; Expiration Date: Aug2021) as 1st dose, single for covid-19 immunisation. Medical history included cardiac catherization, 2 weeks ago (Apr2021). The patient's concomitant medications were not reported. The patient had his 1st dose of the Pfizer COVID Vaccine last Saturday, 01May2021 at 2:00PM and between 7:30 to 7:45 PM, he started having chest issues. He said he felt like something was pushing down on his chest, like he was having a heart attack. He sat and waited, and then the feeling got into his arm. He said as soon as the pain went into his arm, he knew it was a heart attack. He said he got 2 nitroglycerin and took them. He said the feeling in his chest and arm didn't go away, so he called 911, and an ambulance took him to the hospital and went to the ER. He said the first blood draw on 01May2021 that was done at the hospital didn't show anything. He said the second blood draw on 01May2021 showed his cardiac enzymes were elevated, and that he had a heart attack. He was diagnosed with a heart attack at the hospital. He said 2 weeks prior (Apr2021), he had a procedure done (clarified as a cardiac catheterization). He said his cardiologist checked his stents, and the stents were all OK, and there were no issues with his heart. He said his cardiologist just did the same procedure again (cardiac catheterization) on 01May2021, and it was normal, there was nothing there (in his heart). He said he was putting his heart attack as caused by the COVID-19 Vaccine shot. He said he knows about a study that reported people were having heart attacks after getting the COVID-19 Vaccine. Clarified that he had a cardiac catheterization through his wrist while at the hospital, and it was same procedure he had 2 weeks earlier with his cardiologist. He said both cardiac catheterizations didn't show anything wrong with his heart. He was asking that if should he get the second dose if he had a side effect after the first dose of the vaccine. The patient was hospitalized for the event from 01May2021 to 04May2021. Outcome of the event was unknown.

06/09/2021 : 1205 Pt admitted with SOB, AFIB and tested poitive for Covid19. Pt being treated for Covid 19 and is being reported as breakthrough case. Pt. Vaccinated on April 12th 2021 and May 5th 2021 with Unknown Lot # and Body Site

Around 6 pm on March 5 I experienced a TIA -- transient, ischemic attack. Symptoms of wooziness, difficulty talking and walking. Went to Emergency Room within 30 minutes. Had Cat scan and no visible evidence of stroke. Kept overnight for observation in ER. By next morning symptoms had subsided. Since then, no symptoms.

8 weeks after second shot, I developed 2 superficial blood clots in my left leg. At the time, I was taking a daily low-dose of aspirin as recommended by my doctor for people my age. I experienced a little over a week of pain before the clots dissolved. I have no history of blood clots.

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

Shortness of Breath. pain in back and chest area. Went to Hospital and they found multiple blood clots had formed in my lungs. Currently they are trying to determine what caused my body to form these blood clots

Difficulty breathing which progressively got worse over a two month period. Treatment was for blood cots in lungs and heart on July 1, 2021 spending five days in ICU.

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

Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest

Was diagnosed with A-fib. Healthcare professional provided patient with blood thinners. Patient was hospitalized for 5 days. Was unable to walk. Has seen 3 cardiologists.

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

Per report on 6/28/21 patient began to suffer with acute onset pleuritic, left sided chest and shoulder pain. Was able to go for a walk but was suffering shortness of breath. CT angiogram showed bilateral pulmonary emboli with no evidence of right heart strain, or bibasilar atelectasis. Patient was initiated on a heparin drip and changed to rivaroxaban 15 mg PO BID for three weeks followed by maintenance dose of 20 mg daily on 6/30/21.

Pt had 2 hours of atrial fibrillation for first time starting 7 hours after the shot and lasting 2 hours-had never at it before

Systemic: reported by staff patient expired under suspicious circumstnces after receiving vaccine. Patient was on hospice, reported not expected to pass this soon; symptoms lasted 0 days

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

acute myocardial infarction; He was found by his secretary unconscious; feeling unwell; This is a spontaneous report from a contactable nurse. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular in the left arm on 19Jan2021 (at 68-years-old) as a single dose for COVID-19 immunization. Medical history included blood cholesterol of 200 (not further specified). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2020 at 08:00, after the vaccine, that patient was at work and was feeling unwell and the patient was found by his secretary unconscious. An ambulance was called. The patient's blood pressure was 79/38 and electrocardiogram showed acute myocardial infarction. He underwent one stent placement with the remaining arteries normal. He was also started on ticagrelor (BRILINTA), metoprolol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient immediately improved and was feeling well and resumed exercise. The clinical outcomes of the unconscious, acute myocardial infarction, and feeling unwell were recovering. The events required emergency room visit and were assessed as serious for requiring hospitalization for 2 days and being life-threatening. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that reported events acute myocardial infarction, unconsciousness and feeling unwell are related to BNT162B2. The events are more likely intercurrent medical condition for this elderly patient. 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.

Cardiac Arrest; Ventricular Fibrillation; This is a spontaneous report from a contactable physician reporting for a patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) in two weeks. It was unknown if the patient received Other vaccine in four weeks, if patient had Covid prior vaccination, if Covid was tested post vaccination. Patient went for Running after returning home suffered Cardiac Arrest, Ventricular Fibrillation on 28Jan2021, CPR (Cardiopulmonary resuscitation) by Wife, Intubated by EMS (Emergency Medical Service) brought to the Hospital. The adverse events resulted in visiting Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of cardiac arrest and ventricular fibrillation which included CPR and Intubated. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac arrest and ventricular fibrillation cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Stroke; leukemia; This is a spontaneous report from a contactable consumer. This consumer reported for a 68-year-old male (consumer's husband) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL0140, Expiry Date: Mar2021), via an unspecified route of administration on 31Dec2020 13:30 at single dose on right upper shoulder for COVID-19 prophylaxis. Medical history included smoker for 50 years, and blockage in his carotid artery. His grandma died of a stroke and his folks, his dad died of lung cancer and his mom died of uterine cancer. Both his parents had high blood pressure. His dad had a heart attack and his mom had Parkinson's because her hands would shak. There were no concomitant medications. On the 08Jan2021 at about 8PM he had a massive stroke and they had to life flight him to hospital from 08Jan2021 to 19Jan2021. He did have a blockage in his carotid artery but they have been told. She says her husband just had his second vaccine with lot is EL1283 and exp is Apr2021 and all of this could be a coincidence but he told her to call so that was why she was calling. Also he was diagnosed with, it is 4 words and then leukemia and he had an appointment with doctor to get his blood drawn every 2 weeks. The neurosurgeon that did surgery on him on 09Jan2021 at 4 am said that his carotid artery in his neck was plugged and he went in and cleaned it out and put in a stent and he said that his carotid artery was plugged all the way to his temple and he tried to get that out and couldn't. He had his stroke at 8PM on the 08Jan2021. They had dinner at 5 pm and at 6pm they were sitting on the couch and all of sudden he started slurring his words and he said his mouth felt like someone give him Novocain and then he had his arm around her and all of sudden it felt like he was choking her so she grabbed his hand and his fingers started rolling up, started closing up tight so she started playing with his fingers and then he went out in the kitchen and then he hit the floor and she called # and the paramedics came up there. When they got there he could squeeze both hands and lift both feet by that time it was 7:30, they had just brought in a chair, by time they got done bringing in the chair they realized his left side was becoming paralyzed and so they had to go back and get the stretcher so they were there for about 30 minutes, maybe 15 minutes then they headed up the hill toward the hospital at about 8pm and they came in and gave anti-blood clotting medicine and took him for a scan with dye, they found he still had a blockage on his brain so at 2AM on the 9th they came in with a medical helicopter and flew him to (institution name withheld) in (place name withheld) and they did an MRI on and seen his carotid blockage there so he had emergency surgery at from # that morning of the 09Jan2021 at (institution name withheld) and he was in ICU from Saturday until a week ago at 3 oclock 13Jan2021 he was placed in a regular room and on the 19Jan2021 at 7:30PM he was moved (hospital name) in (place name withheld) for 14 days having 15 hours per day of therapy for a week and then he will go to (place name withheld) (rehab name withheld) and he could be there 2-3 weeks. Wednesday right before they moved him he needed a therapist in the back and one in the front and a 6 inch belt to help him stand up. He started out 08Jan2021 and was put in (institution name withheld) on the 09Jan2021 and then he was discharged to rehab on the 19Jan2021 7:30 pm She has been told it may take up to year for recovery as much as he can. The week of his stroke they were adding on to his home and he was doing the electrical upstairs so it is not like he just sat around and ate bon bons, he was very active. The outcome of the events was unknown.

Patient was coded and expired Code Blue: Patient was in dialysis, after 30 minutes his sbp dropped to 60s he was given 4 albumin. Patient who was responsive before that became unresponsive, had seizure like activity, lost pulse and spontaneous breathing. HD stopped. Code called. Cpr started. A few minutes into cpr patient started to profusely bleed - gi bleed and ventilation became very hard., intubation was very difficult and ventilation hard as we suctioned large amounts of aspirated blood. Patient was eventually intubated. More than 8 doses of epi ws given, sodium bicarbonate * 2 given with continuous cpr. It was mostly PEA with one shockable rhythym. And shock delivered for vfib. patient continued to profusely bleed, og insertion was not successful and effective ventilation was very tough due to massive aspiration,. Possible variceal rupture with cpr from his cirrhosis is likely scenario. After 30 minutes of unsuccessful ventilation and acls protocol. Code was stopped.

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

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

Admitted to ER on 2/19/21. CT scan showed two pulmonary embolisms one in each lung. I'm currently on blood thinners.

Chills , Night Sweats, aches, collapsed a week after 2nd dose and then diagnosed with DVT - entire right leg involved.

Pt received 2nd Pfizer BioNTech Covid 19 EUA vaccine @1:50 pm; Pt released from Observation @2:09 pm. Approximately 2:18 pm RN called to parking lot and observed pt having difficulties. Called for EMS & crash cart. Vitals taken 2:20 BP 83/55, no respirations noted, pt unresponsive. AED attached. EMS arrived 2:22 and took over care of pt. and transported @2:40 pm to Hospital. Per wife, pt has history of PE in Oct. 2020, HTN, diabetes with insulin pump, obesity, gastroparesis, home oxygen and uses motorized scooter. Wife also said pt had allergy to iodine not previously reported, and MD had stopped Zarelto subsequent to 1st Pfizer vaccine 2/8/21 "due to breathing difficulty". Patient was unable to be resuscitated. Time of death 14:59.

Something like a mini stroke occur; some kind of injury to his neck; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored program Covax US Support. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), via an unknown route of administration on 27Jan2021 (at the age of 68-years-old) as a single dose for Covid-19 immunization. Medical history included a heart patient prior to the vaccine for which he takes heart medications from an unknown date. The patient's concomitant medications were reported as a lot of medications and heart medications for which he has been taking for years (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 16:00, the patient experienced something like a mini stroke; and he had some kind of injury to his neck from an unknown date. The patient was hospitalized due to heart problems describes as mini stroke on 15Feb2021. The patient underwent lots of test (unspecified) on an unknown date with unknown results. The clinical outcome of the event mini stroke and neck injury was unknown. The patient was still hospitalized.

8 hours after receiving the vaccine, my heart went into Afib (very high heart rate. I had to go to the Emergency Room for treatment. I took Cardizum to reduce the heart rate caused by the vaccine.

On 3/5/21 at approximately 0200 became congested suddenly. Doctor was notified with N.O. Torsemide 20 mg tab via PEG-tube NOW, IM Rocephin 1 mg QD x7 days for possible aspiration, Chest X Ray, CBC/BMP in morning, and may suction resident if tolerated PRN. Received both Torsemide and the Rocephin and then deceased at 0350.

PATIENT PASSED AWAY BEFORE THEY COULD RECEIVE THE SECOND DOSE OF THE SHOT. WE ARE NOT SURE IF IT WAS VACCINE RELATED OR NOT.

Chest and Shoulder pain, shortness of breath, extreme pain when inhaling, Pulmonary Embolism diagnosed at hospital after ct scan and blood tests showed several lung infarctions, given xarelto for 6 months and follow up with gp. and tylenol for pain

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

small ischemic stroke; elevated white blood count; fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269, expiration date May2021), via an unknown route of administration on 15Feb2021 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 Prevention/ immunization. The patient's medical history included a dental procedure on 18Feb2021 for a cracked tooth from an unknown date. The patient received procaine hydrochloride (NOVOCAIN) on 18Feb2021 for the dental procedure. On 18Feb2021 the patient experienced fever, body aches, chills, and a headache; and on an unknown date in Feb2021 the patient experienced a small ischemic stroke. The patient was hospitalized for the ischemic stroke on 19Feb2021. The patient underwent lab tests and procedures which included a Magnetic resonance imaging (MRI) of the brain on 20Feb2021 which showed a small ischemic stroke and white blood cell count which was elevated (in the low 20s) on 19Feb2021 and on 20Feb2021, white blood cell count was normal. Therapeutic measures were taken as a result of the ischemic stroke which included Plavix. The clinical outcome of the ischemic stroke was unknown; fever, body aches and chills were recovered on 19Feb2021; white blood cell count increased recovered on 20Feb2021; headache was not recovered. The patient was hospitalized for three days. The patient mentioned that he was not associating the stroke with the vaccine but rather associates it with the added stress on his body.

Patient was placed in observation area post Pfizer COVID vac administration. After Approximately 10 minutes, patient Passed out and was found on the floor with wound on (L) side of forehead with bleeding noted. Large knot noted above (L) eyebrow. BP 116/60 Awake, responsive, diaphoretic, bounding pulse, pale. Patient was assisted to stretcher with O2 at 2L NC and ED team transported to ER. Given fluids in ER.

Afib; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration in right arm on 09Mar2021 at 09.15 AM at single dose for COVID-19 immunization. Medical history included: allergy to penicillin and high blood pressure. Patient did not have COVID prior to vaccination and was not tested post vaccination. Approximately 8 hours after receiving the vaccine, on 09Mar2021 at 05.00 PM, the heart began racing very fast. Patient had to go to the Emergency Room. The doctor said it was atrial fibrillation. Patient received treatment with Cardizum 12.5 mg. Outcome of event was recovered. Information regarding Lot/Batch number has been requested.

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

Upon my return home, I felt very dizzy, weak, nearly fainted, where a sensation ran through the left side of the body. I then was assisted to the bed, where my left arm and left leg felt numb. I rested assuming this would fade away, being I has some numbness from the 1st vaccine. On 3/24/21, as I attempted to get up from the bed, I could not maintain my balance and gait. The numbness was still in my entire left arm and entire left leg, yet I was able to raise move and wiggle my limbs, toes, fingers to a degree.

Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25.

3 weeks very mild flu like feeling no temperature after that two weeks much worse 99 to 101 temperature sore throat headache and severe muscle aches almost couldn?t walk in the middle of that went into a fib and was hospitalized for three days and brought undercontrol CT scan of lungs negative to PC your Covid test was found negative now feeling better but very weak on blood thinner and beta blockers also echocardiogram was fine

weakness, fatigue, body ache Narrative: 67-year-old male with past history of diabetes type 2, hyperlipidemia, left BKA, who presented to hospital 2/14/21 with generalized weakness, fatigue, body aches and left leg pain for the past 5 days. He reported it started after receiving his COVID-19 vaccine on 2/09/21. He also had associated nausea, vomiting, diarrhea. He denied fever, chest pain, shortness of breath, abdominal pain. Labs showed mild leukocytosis 12k, AKI with Cr 4.6, K 3.2, Bili 2.9, trop 0.01, lactate 2.2. He was given 3L IVF, vanco blue in ED at 18:35. Asystole on monitor. ACLS initiated and once eventually stabilized he was transferred to ICU. Pt again coded 2 more times while in ICU with were halted due to medical futility.

I had a stroke on the right side of my brain; My whole left side is paralyzed; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 at 10:30 (Lot Number: EN7539) (at the age of 68-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing and pituitary tumor from 2004 to an unknown date. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Feb2021 at 10:30 (Lot Number: EN6205) (at the age of 68-year-old) as single dose for COVID-19 immunisation. On 19Mar2021 at 21:00, the patient reported that: "I had a stroke on the right side of my brain. My whole left side is paralyzed. I am an invalid walker. This has changed every aspect of my life". The events were serious, after emergency room visit the patient was hospitalized for 2 days, the events were also life-threatening and disabling. Therapeutic measures were taken as a result of the events and included physical therapy. On an unspecified date, the patient underwent lab tests and procedure which included electrocardiogram (ECG), chest X-rays, magnetic resonance imaging (MRI), all results were unknown. The patient outcome of the events was not recovered.

I had no reactions after my first Pfizer injection. 2 Days after my second injection my right calve started to hurt. This grew increasingly worse each day to where walking was painful. A week later on Monday, March 15 my left knee started to hurt and then my left calf. On Tuesday, March 16 I went to the Hospital Emergency room. They did a number of tests and one of them was ultrasound of both of my legs. They found DVTs in both legs and started me on Lovenox injections. About 5 years ago I had a DVT in my right leg but never had any pain or other adverse symptoms from this DVT. Also I was taking Xarelto to prevent any further DVTs. On Saturday, March 20 I went back to the ER because my leg pain was still bad. They did new leg ultrasounds and the DVTs were gone. My left knee still hurts and my doctor is trying to find out why. Anyway none of this may be related to the vaccine, but everyone is curious of why I would get these new DVTs when I was taking Xarelto daily and I had never had a problem for 5 years. The other odd thing is that i had so much pain when my prevous DVT had no pain symptoms. So now I am continuing the Lovenox injections and we are trying to determine why my left knee is still in so much pain. It might be something like arthritis in that knee but it seems like such a coincedence that it happened at the same I got these DVTs and I have no history of joint pain anywhere in my body, not even any back pain.

Fell out of bed; tonic clonic seizure; postictal (confusion); This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 22Feb2021 10:15 (lot number: EN6203) as single dose for COVID-19 immunisation. The patient's medical history included hypertension. The patient's concomitant medications included losartan and OTC vitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 03:45PM (lot number: EL9262) for COVID-19 immunisation. On 12Mar2021 06:30, the patient fell out of bed and wife witnessed tonic clonic seizure of 5+ minutes. And when EMS arrived on 12Mar2021 06:30, the patient was postictal (confusion). The events resulted to Emergency Room visit and patient was hospitalized for 3 days. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures and included blood test and scan, both with unknown results on an unspecified date and nasal swab/NAAT: negative on 12Mar2021. Therapeutic measures were taken as a result of the events and included numerous scans, blood tests and levetiracetam. The vaccination facility type was hospital. The outcome of the events were recovered with sequel.

Chills; seems to have some kind of hypothermia/kept reading 94.7; hemorrhoids; pulmonary embolism in his right lower lobe; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EN6198; Expiration Date: 30Jun2021), at the age of 68-years at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included paraplegic, he has been paralyzed for 45 years. The patient received first dose of the vaccine on 10Feb2021 with lot number: EN5318, expiration 31May2021. There were no concomitant medications. The patient went on Monday to the ER for an unrelated condition and they did a CT scan and found a blood clot, a pulmonary embolism in his right lower lobe. He confirms the pulmonary embolism was diagnosed on Monday, 15Mar2021. He got home that night and read the headline in the (Withheld) times that said several European countries are pulling the Astra Zeneca vaccine over concerns about blood clots even though there has not been any causal relationship found. He thought that with the drug companies, they should be able to have data regarding potential adverse effects for Pfizer so he was calling report that. He discusses it with the ER doctor and he couldn't really figure out why he had a blood clot, it was incidental to what he was being scanned for, it surprised him. They put him on Eliquis so he is on an anticoagulant, which will cost him a fortune. Today will be the third day he has been on the Eliquis. He is at home and he would say his only concern is that he does have hemorrhoids so when he has bowel movement tomorrow, because he doesn't go every day, but when he goes he is concerned if he starts to bleed that the anti-coagulant might cause the bleeding to be more significant than it usually is. No further information provided. His only other concern is he seems to have some kind of hypothermia, he is not entirely sure because of his thermometer is not very good. That is the reason he went into the Emergency Department because it kept reading 94.7 and he googled it and it said if it is below 95 it is a medical emergency and go to the ER so he got to the Emergency Department and it was 97.6 and now he checked his temperature again with the thermometer and it was 96.8 so either he has a faulty thermometer or something but he is experiencing some kind of chills. The outcome of the events was unknown.

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

Pfizer-BioNTECH Covid 19 vaccine EUA , side effect was a stroke affecting loss of vision in both eyes

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

Developed signs and symptoms of right lower leg DVT starting the day after vaccination with mild pain and becoming more prominent at the time of diagnosis 1 week later

extensive proximal right lower extremity deep vein thrombosis; This is a spontaneous report received from a contactable physician. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, at the age of 68-year-old, on 05Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and chronic kidney disease. The patient's concomitant medications were not reported. The patient experienced extensive proximal right lower extremity deep vein thrombosis (medically significant) on 05Mar2021. Therapeutic measures taken as a result of extensive proximal right lower extremity deep vein thrombosis included anticoagulation agent. 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 and has not been tested for COVID-19. Outcome was recovering at the time of the report. Information about batch/lot number has been requested.

I had a stroke a day after the vaccine and now going through physical therapy to learn how to walk again

Developed atrial fibrillation, palpitations and hr of 150. 1 month prior to vaccine pacemaker was checked. Result was normal sinus rhythm. Now on blood thinners permanently

The patient had stomach pains nausea thowing up diarehha 33 hours after came in waves and neck pain and pain in top of shoulder blade.. we dind't realize it because it was on the right side......... not the left looking back IT WEAKENED HIS HEART and kille dhim he went to be March 21, 2021 just fine....... woke up at 2:30 lost control of bowels dind't know what was wrong i called 911 his heart rate was 40's and his BP 79/51 took him to facility in ambulance he was dead by 5:17 am ................ this covid killed him....... they tried to shock his heart and in tubed but coudn't save him

Swollen right leg in AM four days after vaccine. Diagnosis of DVT next day, five days after vaccine. Have been on eliquis for about 4 months. Leg is still swollen. Not surprising since the covid spike protein causes blood clots.

Patient passed away suddenly (heart failure) on Feb 15th, 11 days after receiving the 1st Pfizer shot. I know he had other health issues, but he had a good bill of health from his doctors prior to this. I thought this should be reported.

Initially no response, around March severe headaches, six times lost feeling in hands/arm/jaw (both right and left on different instances, one side at a time), sent for MRV, diagnosed as having CVST (cerebral venous sinus thrombosis), admitted to hospital with 4 large clots, put on heparin, kept for 3 days, released with LMW heparin shots for 3 weeks, changed to pradaxa today, will test by MRV in 4 months to determine if can stop treatment. Long list of other blood test to determine cause, none came back with any reason for the disease. Could have still caught Virus and had asymptomatic case which led to CVST?

68-year-old male with history of tobacco use and left hip surgery of most a year ago on aspirin 81 mg daily presents as a stroke alert left-sided weakness. His stroke scale on arrival was 9, due to left upper extremity weakness, gaze preference to the right, dysarthria, and left facial droop. Symptom onset was 1600 this afternoon. Patient was on a stool and fell due to weakness. Reports taking aspirin 81 mg every day but denies taking any medications. States that he did have alcohol today-1 can of Budweiser only. Denies any other medical history. Denies being on any other medication. Patient taken immediately for CT head and found to have right temporal brain bleed.

Patient became unresponsive in his chair at home. CPR was attempted by patients wife and paramedics without success. Patient is deceased.

Severe Shortness of Breath 10 days after vaccine. Discomfort in the right lower chest that radiates to the back.

Lower leg pain, swelling. Admitted to the emergency room on 03/29/2021. Ultrasound was done. Diagnosis was left leg DVT. Treatment prescribed is 15 mg of Xaralto twice a day. Had a follow up visit with a physicians assistant on 04/09/2021. She prescribed 20mg of Xarelto once a day for the upcoming 2-3 months. Also prescribed Bisoprolol Fumarate 2.5 mg once per day.

ON 3/18/2021 I had a massive stroke due to several blood clots in the caratid artery and in the brain. I survived and am now in the process of rehab to regain full mobility.

admitted to ER Saturday morning with massive heart attack; feeling unwell Friday evening; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 13:30 (at the age of 68years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EN6200) on 02Mar2021 (at the age of 68years) for Covid-19 immunization. The patient's medical history was not reported, no known allergies. Concomitant medications included rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was feeling unwell on Friday evening (as reported); patient admitted to ER (emergency room) Saturday morning with massive heart attack. Onset date for both events was reported as 26Mar2021 21:45. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for both events from 27Mar2021 to 01Apr2021 (as reported duration of hospitalization: for 5 days). Treatment of events included 2 Stents. The patient had Covid test post vaccination on an unspecified date: Nasal Swab =Negative. The outcome of events was recovering. The outcome of events was recovering.

within 14 days i had 3 afib events around the same time 1am-3am. on different days documented on a doctor prescribed heart monitor i was wearing at the time. on day 14 i was admitted to the hospital diagnosed with splenic infarction. i lost a large part of my spleen, but did not require surgery

I had a blood clot on right side of brain resulting in stroke and not being able to use left side of body.

Contacted Veteran's son. He did mention that his father was not healthy, but also that his father did not voice any specific changes to his health as recently as Tuesday (4/13) when they last spoke after receiving his second dose of vaccine on 4/10. He did mention that the coroner had declared his father?s death ?natural? and was not planning to do an autopsy.

68-year-old gentleman presented with dyspnea and found to have bilateral PE, right lower extremity DVT. He was started on IV heparin, Coumadin. Patient was found to have acute kidney injury and urinary retention, bilateral hydronephrosis. Foley catheter was placed, this resulted in improvement in renal function and resolution of hydronephrosis. First cath urine was bloody but subsequent urine has been clear. A CT urogram did not reveal any other abnormality of the urothelial system. Prostate is enlarged.

Stroke; Mild headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at right arm on 23Mar2021 (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient had no COVID prior vaccination and no known allergies. There were other concomitant medications (unspecified) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 02Mar2021 at 16:15 (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. On an unspecified date in 2021, the patient experienced mild headache day after second vaccine. On 27Mar2021 at 09:45, patient had a stroke. The adverse events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days. Therapeutic measures were taken as a result of the events and included "testing regarding stroke" (as reported). The outcome of the events was recovering. Information on the lot/batch number has been requested.

blood clot in lessor saphenous vein left leg; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 15:15 (lot number EN6207) as single dose for covid-19 immunization, administered at the hospital. The patient received the first dose on 24Feb2021 at 15:15 in the right arm (lot number EN6198) for covid-19 immunisation. The patient did not receive other vaccines in four weeks. Medical history included type 2 diabetes, deep vein thrombosis (DVT), and pulmonary embolism (PE). The patient has not had COVID prior to vaccination and not tested for COVID post vaccination. The patient's concomitant medications were not reported. The patient experienced blood clot in lessor saphenous vein left leg on 27Mar2021 at 18:00 with outcome of recovering. The patient's hematologist put the patient on Eliquis 5mg 2 BID and at the time of report, this medicine has started to dissolve the clot.

Chest pains which were eventually diagnosed as a result of Pericardial effusion. Sternotomy was performed to remove fluid.

102 deg F temp; shivering; abnormal general body fatigue; Atelectasis; double blood clot in left lung lower left lobe; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 17:00 (Batch/Lot number was not reported) at the age of 68-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Inclusion Body Myositis, Sjogren's syndrome and Known allergies included Penicillin, Lamisil, Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included unspecified other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Got up 9:30AM on 14Apr2021. Experienced abnormal general body fatigue. Began shivering at 1:00 PM and went back to bed. 102 degree F temp at 3:00 PM. Called primary care physician, who advised we go to Emergency room (ER). Got into ER about 6:00pm. Covid polymerase chin reaction (PCR) Nasal Swab test negative, full viral panel negative. Chest X-Ray showed some Atelectasis, Computerised tomogram (CAT) scan revealed double blood clot in left lung lower left lobe. Sent to Hospital at about 1:00 AM 15Apr2021. Treatment with 16ml/hr Heparin plus 5mg/day warfarin. Discharged 06:00 PM on16Apr2021. Adverse event resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The outcome of the events was recovering. Information on the lot/batch number has been requested.

dry heaves; chest pain; heart attack; Sweats and chills the next morning; Sweats and chills the next morning; tiredness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 29Mar2021 17:45 (Batch/Lot Number: EP1534) as SINGLE DOSE for covid-19 immunization. Medical history reported as "none before this event". Patient previously received the first dose of BNT162B2 (lot number: EN6203) on 08Mar2021 17:45 in the left arm for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced sweats and chills the next morning, tiredness, then went to dry heaves and chest pain after 2:30 PM -- on 30Mar2021 all these side effects started from early morning and at 5:30 went to ER and was told he was having a heart attack. The patient underwent lab tests and procedures on 30Mar2021, which included Covid (sars-cov-2) test with negative results. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of the events includes angiogram and stent on right side of heart. The events were considered as serious since events involved inpatient hospitalization and persistent or significant disability or incapacity. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

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

Leg started swelling 4/22 and became painful. Saw Dr. on Monday 4/26 and had venous ultrasound which showed a "blood clot" was started on xarelto

Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer. A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation. Medical history was none. Known allergies was none. The patient did not have Covid prior to vaccination. No other vaccine was given in last four weeks. There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering. Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021. Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner. Information about lot/batch number has been requested.

BP and oxygen all over; 06Apr went to ER been in and out of ICU battling covid/ pneumonia as they say; 06Apr went to ER been in and out of ICU battling covid/ pneumonia as they say; day one normal tenderness at injection site; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 10:00 (Batch/Lot Number: EN6204) (at the age of 68-years-old) as single dose for Covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and weak immune system. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient underwent nasal swab COVID test on 10feb2021 with negative result, nasal swab rapid PCR COVID test on 15Feb2021 with negative result. On day one (12Mar2021), patient experienced normal tenderness at injection site, by day 3 (14Mar2021), got sick, had daughter call in LEVAQUIN 7 days worth. The patient experienced continuing chest pain from continuous coughing, BP and oxygen all over, over next 2 weeks less physical activity. On 06Apr2021, patient went to ER, had been in and out of ICU battling COVID/ pneumonia as they say. He received plasma from recovered COVID patient and Remdesivir. The patient stayed so isolated in his home; his daughter did all his shopping meds everything. Her family had been tested and was tested several times. The patient stated that he was afraid his COPD and weak immune system couldn't handle the vaccine. The events required a visit to the Doctor or other healthcare professional office/clinic, Emergency room/department or urgent care and led to prolongation of hospitalization (as the vaccine was received during existing hospitalization (as reported)). The events were assessed by the reporter as life-threatening (immediate risk of death from the event). The patient was hospitalized for 21 days. The outcome of the events was unknown.

TIA Had my left arm go limp and slurred speech for about three minutes. Treatment is baby aspirin and Atorvastatin 40mg 1/day Complete recovery

Shortly after receiving this first dose,my husband's breathing went downhill, two months later he was dead. They could not find the cause. I told them I knew the cause. It was the Covid shot! I reported it to his pulmonologist and to the hospital staff. He was stable with all other conditions until he got this shot!

2/4/21 Woke with bad headache continued all day 2/5,2/6 Bad headache continued-Tylanol no help 2/8 AM Loss of conshance. Loss of ability to speak. Taken to hospital. Briefly gained conshanceness. Still unable to speak. 2/27 Died.

This 68 year old black male received the Pfizer Covid shot on 3/22/21 and went to the ED on 3/31/21 and was admitted on 3/31/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

Subject suffered a massive heart attack while mowing the law . May be attributable to the Covid vaccine as the subject had been to the cardiologist prior to both vaccine and EKG and Stress test were perfectly normal

Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter.

3/4, admitted 3 days after covid vaccine. Presented to ED with complaint of weakness, onset 1 wk ago. Endorses fatigue, leg swelling, ankle swelling, fluid retention. Last EF was 6 and "he feels like that same feeling now". On Eliquis and 4mg of Bumex 2x daily. Acute exacerbation of CHF (congestive heart failure) patient with known severe heart failure and ejection fraction of 24% presented with shortness of breath,profound edema, 11 pound weight gain. Respiratory PCR negative. IV Lasix 40 twice daily-continue with Lasix 40 p.o. twice daily at home. Metolazone 2.5 once a day as needed weight in excess of 235 pounds. Patient continues on Toprol-XL and spironolactone. Spironolactone was raised to 25 twice daily to try to help manage his potassium fluctuations.

Patient was vaccinated on 1/22/2021 and 2/12/2021 and had out of hospital cardiac arrest on 5/5/2021 where he was tested for COVID-19 and was positive. He had previously tested negative on 4/19/2021.

02-20-2021 Heart Attack. 100% blockage of LAD artery, Stent, 4 day hospitalization at Medical Center. Recovered heart function. Cadiac rehab.

death R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified SHORTNESS OF BREATH LEG SWELLING ASCITES

Patient presented to the ED for bradycardia and dyspnea present for one week prior to admission, he was found to have a second degree AV block. He underwent a procedure to correct atrial lead dislodging/placement of pacemaker. Patient was also started on anticoagulation therapy for a clot in lung. Discharged after 5 days inpatient.

Patient received second COVID 19 vaccine on 4/13/21 at Site. Patient tested positive for COVID on 5/16/2021. Patient had worsened short of breath on 5/25/2021 and was admitted to Medical and placed on a vent. Patient expired on 5/26/2021.

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

30 May 2021 I was diagnosed as an otherwise healthy male with pulmonary embolism in the lower right lung. No predispositions to blood clots.

Pneumonia; muscles aches; neck pain; shoulder pain; have soreness in my shoulder, in my neck and in my arm; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, lung cancer, back disorder, from an unknown date and unknown if ongoing. Concomitant medication(s) included formoterol fumarate, glycopyrronium bromide (BEVESPI AEROSPHERE) taken for chronic obstructive pulmonary disease, start and stop date were not reported; salbutamol sulfate (PROAIR HFA) taken for chronic obstructive pulmonary disease, start and stop date were not reported. On an unspecified date patient experienced pneumonia, muscles aches- myalgia, neck pain, shoulder pain- arthralgia, pain in my arm- pain in extremity. The patient underwent lab tests and procedures which included sars-cov-2 antibody test, x-ray with result unknown. Patient has been taking treatment for back problem with Hydrocodone or Vicodin. The outcome of Pneumonia, myalgia was unknown, Neck pain was recovered and arthralgia, pain in arm was not recovered. Information about lot/batch no has been requested.

stomach pain last about for 2 or 3 days, stomach pain came back after second dose; The pain was so bad he couldn't stand up.; The x-ray showed he had a big black spot in his stomach and the doctor told him it was a blood clot.; This is a spontaneous report from a contactable consumer (patient) and a physician. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EN6198) on 26Feb2021, and the second dose of BNT162B2 (lot number: EN6208) in arm on 19Mar2021 , both at the age of 68 years old at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously received flu vaccine in Oct2020 or Nov2020. The patient had his first dose of BNT162B2 on 26Feb2021 and about 4 days later he had stomach pain on 02Mar2021. It lasted about 2 or 3 days then the stomach pain let up. The patient thought the stomach pain was over. Then the patient received his second dose of BNT162B2 and in about the same amount of time after receiving BNT162B2, the stomach pain came back. On Mar2021, the pain was so bad he couldn't stand up. The patient went to the doctor and he was given 4 ground up Aspirin to take. The patient screamed when the doctor pressed on one spot of his stomach. The patient was taken to the x-ray room and his stomach was x-rayed. He was asked where the pain was and when the doctor pushed on that spot, his back arched up in the air because it hurt. The x-ray showed he had a big black spot in his stomach and the doctor told him it was a blood clot. The doctor on call said it was a blood clot and his regular doctor told him it was a blood clot. The doctor's determined the blood clot was from BNT162B2 because the blood clot happened right after he received the vaccine. Besides his regular doctor who is listed in the formal field, he also saw another doctor when he went in that day with the stomach pain. He was told his regular doctor was busy and he had to see another doctor. The patient didn't have any blood drawn at the doctor just the x-ray of his stomach. The doctor said he had a blood clot, a black spot, about the size of a silver dollar in his stomach. The doctor clamped her index finger and thumb together in a circle to show him how big the black spot was. The x-ray technician and two doctors told him it was a blood clot. He had the 4 aspirin ground up and the doctor told him the aspirin got rid of the blood clot. He also took some pills for 2 to 3 days but he can't recall the name of the pills. He says the x-ray tech zeroed in on the spot that was causing him pain in his stomach. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of blood clot cannot 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 Committees and Investigators, as appropriate.

Patient presented to urgent care with shortness of breath. Patient had positive D-dimer and referred to the ER for CT. At ER visit, he reports progressive worsening shortness of breath over the past 3 to 4 weeks. Dyspnea on exertion 5/20/2021. Patient was admitted to the hospital with diagnoses of bilateral PE with small saddle embolus and left DVT (left popliteal vein occlusion). Treatment included heparin drip in the hospital with a conversion to Eliquis.

Sixteen hours after the vaccine I awoke in Atrial Fibrillation. My doctor said it was "possible" that I went back into AFIB due to my bodies reaction to the vaccine. Up until this point in time my AFIB was being controlled by medicine after one Heart Ablation for the past two and one-half years. He changed my medicine from Flecainide Acetate to Propafenone and when that didn't revert me to normal rhythm he scheduled me for a second ablation which took place four weeks later. I was in AFIB the whole time which wasn't normal for me. 90 days after the 2nd Ablation he took me off of Propafenone. Now I'm only on Eliquis for the AFIB condition. Heart is in normal rhythm.

Did Xray found a big black spot on top of left side of stomach. dr said it was blood clot from the vaccine.; Severe stomach pain; This is a spontaneous report received from a contactable consumer (patient). This 68-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as 2nd dose, single at the age of 68-year-old for covid-19 immunisation. The patient received the 1st dose of bnt162b2 on unknown date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe stomach pain. Did Xray found a big black spot on top of left side of stomach. Dr said it was blood clot from the vaccine. Happened week after taking shot. The product was used by the patient. The outcome of event was unknown. Information on the lot/batch number has been requested.

27May21 approximately 5:45 P.M had blacked out fell down approximately 10 stairs paramedics was called taken to ER admitted on 27May21 CT showed bilateral pulmonary embolism without; 27May21 approximately 5:45 P.M had blacked out fell down approximately 10 stairs paramedics was called taken to the hospital, admitted on 27May21. CT showed bilateral pulmonary embolism without; 27May21 approximately 5:45 P.M had blacked out fell down approximately 10 stairs paramedics was called taken to hospital and admitted on 27May21 CT showed bilateral pulmonary embolism without; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0168, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 26May2021 at 12:15 pm (age at vaccination was 68 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history and known allergies. The patient did not receive concomitant medications or any other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0176, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 05May2021 at 12:15 pm (age at vaccination was 68 years) as 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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. On 27May2021 approximately 5:45 pm, the patient had blacked out fell down approximately 10 stairs paramedics was called taken to withheld admitted on 27May2021. CT showed bilateral pulmonary embolism without right heart strain. The adverse events resulted in Emergency room/department or urgent care and hospitalization. The patient was hospitalized for 4 days from 27May2021 to 31May2021. The patient received the treatment with Eliquis for the adverse events. Since the vaccination, the patient has been tested for COVID-19 which included nasal swab Coronovirus Sar-Cov-2 test on 28May2021, and the result was negative. The device date and device timestamp date was reported as 12Jun2021. The events were reported as serious (hospitalization). The outcome of the events was resolving. Information on Lot/Batch number was available. Additional information has been requested.

diagnosed with blood clots in the lungs; Coughing; diagnosed with pneumonia; She thinks that he had a blood clot in his leg that travelled. He was having leg pain, so he probably had a blood clot then; really, really sleeping; really bad leg pain; This is a spontaneous report from a contactable pharmacist (patient's wife). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, initially reported as FR8729 then stated it is an E) via an unspecified route of administration on 03Apr2021 around 10:00 or 11:00 am (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure (also reported as family medical history), ongoing eurofibromatosis (Has had all of his life), varicose veins, overweight, rheumatoid arthritis. Concomitant medications included ongoing etanercept (ENBREL) for rheumatoid arthritis (Has been on a few years but does not remember how long exactly). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration at arm on 13Mar2021 (68-year-old at time of vaccination) for COVID-19 immunization. The patient previously received flu vaccines in Oct2021 (67-year-old at time of vaccination). There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. The wife states her husband (patient) got 2 doses of the Pfizer vaccine. The middle of last month, he was complaining of really bad leg pain (from middle of May2021). He does have varicose veins and is on Enbrel and is overweight. He was really, really sleeping. She told him that he really needed to go see a doctor. The wife states she is in a rehab facility and is a pharmacist who worked at the hospital for over 34 years, mentions licenses in (states name). The wife stated she sent him to urgent care and they said he had varicose veins but had no problems with his leg. They did diagnose him with pneumonia. They sent him home on an antibiotic, Doxycycline 100mg, she didn't actually see the prescription, it was either for 7 or 10 days. He was down to one dose the day before yesterday. While he was at home, she heard him coughing (from 03Jun2021) and he couldn't stop coughing for about 5 minutes. She asked him when his follow up was and he told her not until Friday. She said he needed to see somebody so yesterday, he went to urgent care again. Three hours later they transferred him by ambulance to the hospital, he had blood clots in his lungs (from 03Jun2021). She is highly suspect of the Covid vaccine because he has never had problems like blood clots before. He was just admitted on the day before reporting (hospitalization for coughing and blood clots in the lungs from 03Jun2021 and ongoing). The wife is thinking maybe they misdiagnosed him approximately 10 days ago. She thinks that he had a blood clot in his leg that travelled. He was having leg pain, so he probably had a blood clot then, and they misdiagnosed him as pneumonia. The wife does not remember exact date but that it was in middle of May. His first trip to urgent care was 10 days before going to the hospital. Coughing started the same night, she asked him to go to the doctor Thursday morning and they sent him from urgent care to the hospital. He was admitted to the hospital and is still there now. Adverse events did not result in physician office visit; coughing and blood clots in the lungs resulted in emergency room visits; patient went to urgent care twice, second time was sent to emergency room via ambulance. Tests: They have been doing tests on him all day. They did an echocardiogram on the day of reporting (on 04Jun2021) and they are doing blood work on him. The wife does not know the results, she is a rehab facility a half a mile away. Treatment: They gave him some kind of shot. He doesn't give medication to himself. She has no idea, maybe something like Lovenox or something like that but she just doesn't know. Therapeutic measures were taken as a result of the event coughing and blood clots in the lungs and included some kind of shot; therapeutic measures were taken as a result of the event pneumonia and included antibiotic, Doxycycline. The outcome of the events was unknown. Causality assessment: The pharmacist (patient's wife) states she was highly suspect, as soon as they told him it was a blood clot in his lungs. Relatedness was assessed as related for all events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported serious events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pain in the back becoming so severe level 8. Went to local doctors in Healthcare for four weeks trying to get help. Could not walk after the fourth week. Went to medical center and diagnosed within two hours of having acute osteomyelitis. On the verge of sepsis.

Patient admitted 6/3/2021 found to be COVID-19 positive Event Description: Allergies (drug/food and reaction):__cephalosporine, clarithromycin Date of Vaccination 1 :__2/23/2021- Pfizer-Lot EN6198- uk- Left arm Date of Vaccination 2 :__3/23/2021- Pfizer ?lot EN6208- UK- right arm

Lost 10 pounds; diagnosed with a blood clot in his 'stomach'; couldn't eat; stomach hurt 'bad'; This is a spontaneous report received from a contactable consumer or other Non-health care professional (patients wife). A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 15Mar2021 (age at vaccination 68yearsold) as single dose for covid-19 immunization. She doesn't know which arm he got the vaccine in. Medical history included blood cholesterol from an unknown date and unknown if ongoing History: He took a small dose of Rosuvastatin for his cholesterol (he has taken it for a couple of years, and dose of it was reported as may be 10mg). Prior Vaccinations patient received flu shot but that was always in the fall within four weeks prior to the first administration. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for blood cholesterol, start and stop date were not reported (He has taken it for a couple of years). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported) on unspecified date (was around the beginning of March or maybe late February) for covide-19 immunization. Patients states that in the last 1-2 weeks, her husband started complaining that his stomach hurt badly. This past week, he went to a doctor, had a CT scan on 09Jun2021 and was diagnosed with a blood clot in his 'stomach'. He was being treated at home with Eliquis. her husband's age is 68 yrs .It was reported that she believes it is because of the pfizer covid vaccine as he was previously healthy prior to the vaccine. Patient had pfizer vaccines as they knew they couldn't see their grandchild if they didn't get it. They were kind of forced to. They were perfectly healthy all through Covid and went and did everything they wanted to and never got Covid. They did take vitamins. Then after the shot he has this. Reporter stated that stomach hurt started around the beginning of June, maybe 01Jun2021. He thought it would get better and go away, but he had no clue what it was. It didn't get better. He had to go see his internist, and they did a CAT scan on 09Jun2021 and that's when they saw the blood clot. They put him on Eliquis and on Omeprazole for some reason, probably to soothe his stomach. He slept through the night which he hasn't been able to, but he was now. Reporter stated that patient couldnt started around when all of this started. He just felt pain in his stomach, and he could hardly describe it to her. He quit eating or cut down his eating because he felt full he said. That was probably 04Jun2021 that started. When asked if this has improved, worsened, or is persisting, she states he will eat a little bit about half of what he used to eat. lost 10 pounds on an unspecified date. The clinical outcome of the events was unknown. Therapeutic measures were taken as a result of diagnosed with a blood clot in his stomach, stomach hurt bad. Follow-up attempts are needed. Information on Lot/Batch number has been requested.

My father became ill after the 2nd does and did not recover. His legs began to hurt. He found it hard to walk. He didn?t want to go to the doctor from fear of COVID. But his legs began to swell and he couldn?t walk, so he went to ER on 4/18/2021 and released on 04/20/2021. He then went to his PCP on 04/28/2021. He went to see a cardiologist who said his heart was good on 04/30/2021. He passed away on 05/06/2021 in his sleep. Please help.

It was a very odd thing that happened, I was at work and dog that I was chasing pulled me over. I started bruising and knew something was off. I went to the ER and tests were run. My doctor determined that I have ITP and what it is that my immune system is killing off palates quickly and cannot clot. I'm going through Chemo Therapy and Steroids (don't have cancer) it has not been successful yet (resulted in a 4 day hospitalization). I have been having blood tests two to three times per week now and it's become a part of my life right now.

The following Tuesday i started with a low grade fever. As the week went on the fever started to rise. I contacted my doctor and he put me on prednisone. I was tested for COVID-19 and the results came back that positive. The following week my temp continued rise to over 105 and I realized things were getting out of hand and call the emergency response. i bled out, had hematoma, I had heart failure, and lost my ability to walk. Was admitted to for 12 days. I was then transferred to Select Speciality for recovery.

Exactly 1 week to the day I received the vaccine, I had a dental appointment where I was having work done on a crown. I was in the dentist?s chair where they took my blood pressure. My blood pressure's top number was at 188. My usual number is around 130. I got up from the dental chair and I had perspired through all my clothes and on the chair. My dental appointment was cancelled. I drove home and once home, my wife saw me and said I was totally grey. She gave me Tylenol and I went to bed and slept for 2 hours. I got up and then went back to bed and slept more again. After I woke up my wife said my color was back. I went to the ER, and then the cardiologist. I had 2 stents put in in 2000 and 2002. The EKG showed afib. This is the first time in my life that this has ever happened. They ended up sending me to another group where I was administered blood thinners. I am now on warfarin for the rest of my life. I have to go back to the hospital each week for them to check the viscosity of my blood. I then went to my internist, and then a hospital where my lungs were checked for clots. My brain was then checked via cat scan. I also just had an echocardiogram and stress test. All these tests have come back normal. The cat scan on the brain came back normal for my age

Patient passed away 18 days after vaccine receipt. Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had end-stage Parkinson's dementia which was the cause of death. Not attributed to vaccination.

On April 9, 2021 deceased was sitting at table after Vax , his left arm became totally limp and weighted. immediately called ambulance and went to hospital, diagnosed intercranial hemorrhage side effect of Thrombo cytopenia

This is a spontaneous report from contactable consumer (patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: ER8734) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, vitamin D deficiency from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin allergy). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 23Mar2021 (Batch/Lot Number: EN6208) age at vaccination of 68-years-old, for COVID-19 immunization. Concomitant medications included fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported; finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) 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-19 vaccine. The patient experienced low platelets, congestive heart failure, atrial fibrillation and pulmonary edema all started on 24May2021. The events resulted in doctor or other healthcare professional office/clinic visit; caused/prolonged hospitalization and life threatening. The patient was in ICU and was put on iv drip for congestive heart failure, cardizem drip. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Stroke; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 08Apr2021 10:15 (Lot Number: EW0151) (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing kidney disease from Jan2021, he was at the final stage of kidney disease, ongoing hypertension for years, since he was a kid, arthritis. The patient's concomitant medications were not reported. The patient previously received hepatitis vaccine and influenza vaccine on 01Mar2021 and experienced no AE. The patient received his first dose of BNT162B2 08Apr2021, later had a stroke at an evening around 18:00 in the end of Apr2021 and missed his second dose of the vaccine. Stroke required a visit to emergency room but not physician office. The patient was hospitalized for stroke from Apr2021 to Jun2021 for 60 days with rehabilitation and all of that. The patient was home now from the hospital. He didn't get the vaccine with his primary doctor. They were told that his stroke wasn't because of the vaccine. They were told what they assumed of how the stroke happened. The patient underwent lab tests and procedures which included continuous bloodwork in the hospital to check the levels of his kidneys and to check various things because he had the stroke with unknown results in 2021. He had CAT scans done with unknown results in 2021 because he had a minor brain bleed. He had X-rays with unknown results in 2021 also because he has arthritis. Body height: 173 cm in 2021, weight: 90.72 kg in 2021. Outcome of the event was unknown.

About 4 hours after the second dose I began the most intense headache I have ever had. I kept expecting it to go away. After 10 days of enduring this I went to the ER. I was admitted with blood clots and bleeding from the face. (but probably more wrong) I was initially treated for a PE and meds to try to stop the headache. Nothing seemed to work. About 3 days into the hospital stay, my pre-existing Stills disorder began to show. I was then treated with 60mg of prednisone daily to control the Stills. About the same time, we discovered that a standard migraine medicine would control the extreme headache, morphine would not. My CRP results were off the charts and almost 4 months later it is still high. My treating doc says 2 more months of prednisone treatment. I had an immediate weight loss of 25 pounds in the hospital. I am struggling to this day to put the weight back on. I have lost hearing in my left ear as a result.

Anaphylaxis throat itchiness, throat tightness, sinus swelling, ear fullness Narrative: Patient reported throat itchiness, throat tightness, sinus swelling, ear fullness. Transported via EMS to nearest ER

1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08: Pronounced deceased.

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

Multiple co-morbidities history of COVID-19 6/8/2020 and 12/28/2020. At time of vaccination fighting osteomyelitis. 1st dose 1/13/21, 2nd dose 2/3/2021 expired 2/8/2021.

Patient was admitted for acute CVA, hyperglycemia, and mild thrombocytopenia. Patient was treated and discharged on appropriate medications

The patient is a 69 y.o. male with a past medical history notable for atrial fibrillation, CHF, COPD, history of GI bleed, coronary artery disease. The patient presents for evaluation of worsening issues with nose bleeds and shortness of breath. Patient is found in the ER to have a significant nose bleed which required packing. Patient was also found to be in atrial fibrillation. Patient was previously at skilled care facility undergoing care and it is unclear patient had been using illicit substances. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

Four days after first Pfizer dose, experienced onset of atrial fibrillation, a new condition. Since then frequent episodes of AF despite flecainide 100mg BID without signs of resolution. Second dose Feb 22, arrhythmia continues. MD feels that inflammatory action of vaccine may have caused or triggered onset.

Patient started to feel right leg pain the evening of 3/2/2021, four days after receiving the COVID-19 vaccination. Patient came to the ER where a DVT was discovered in the right popliteal, peroneal, and posterior tibial veins. Patient was given apixaban 10 mg x1 and a prescription to continue apixaban outpatient. Patient was discharged from ER to home.

On March 6, I had a mild stroke. Left arm, leg, and foot went numb for 15 minutes. Hospital performed diagnostic tests. Stayed overnight for observation and tests. Symptoms went away. I had an EKG, CT scan of brain, ultrasound of neck veins, brain MRI, and echo cardiogram.

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

I suffered a stroke 24 hours after receiving vaccine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Left arm on 20Feb2021 (at the age of 69-year-old) at 11:15 AM at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no Covid prior vaccination and patient had COVID tested post vaccination. The patient suffered a stroke about 24 hours after receiving vaccine on 21Feb2021 at 10:30. The event result in hospitalization for 2 days in Feb2021 and considered as life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included Nasal swab was negative on 23Feb2021. Treatment included blood thinner. The outcome of the event was not recovered. Information on lot number/batch number has been requested.

Acute respiratory failure (CMS/HCC) CHF (congestive heart failure) (CMS/HCC) Renal insufficiency NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pneumonia due to COVID-19 virus Covid-19

admitted to the ICU with acute respiratory failure. h/o DM and HL, prior h/o smoking and EtOH and opium abuse (none x 28 yrs, per family). Received second dose of the Pfizer COVID vaccine in AM of 3/16, having had severe adverse reactions (fever up to 104, n/v) to the first dose three weeks earlier. Experienced recurrent fevers (up to 103) beginning by the evening of 3/16, for which he took acetaminophen. Awoke at 3 AM w/ recurrent fevers, for which he took ibuprofen. Felt better in AM, had breakfast, and retired back to bed. Awoke shortly after noon w/ severe n/v and AMS. Was brought to the ED by the EMS. Febrile (T 39.6) w/ rigors, tachycardic, tachypneic, and poorly responsive on arrival. Continued to experience episodes of emesis, and was felt to have possibly had a seizure episode ("looked to the side and was shaking"; no clear tonic-clonic movements noted). Was thus intubated for airway protection. Initial laboratory w/u revealed presence of mild leukocytosis (WBC 12.6, 47p49L0Eo), lactic acidosis (LA 5.2), hyperglycemia (glu 297), elevated lipase level (161) renal insufficiency (Cr 1.23). extubated on 3/19. received antibiotics for positive blood culture (streptococcus parasanguinis). diagnosis: ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE

Pt suffered an embolic stroke to left MCA on 3/16/2021, 4 days after his vaccine. He was also within 90 days of PCR confirmed COVID-19 infection (tested positive 1/5/2021 and was still positive on 3/16/2021). This is likely unrelated as patient had multiple risk factors for stroke, but felt it worth reporting as no association cannot be found if people don't report events like this.

Patient was admitted to the ED with left deep peroneal vein thrombosis on Feb. 9 2021 after patient noticed prolonged edema in both ankles. Patient started talking 10 mg of Eliquis twice a day on Feb. 11, 2021. And on Feb. 17 2021, 2 more blood clots were found in the patient's peripheral veins within the limbs. Patient descreased dose of Eliquis to 5mg twice a day on Feb. 18 2021. Patient continues to take 5mg of Eliquis twice a day.

heart attack; pass blood clots in his urine; nauseous; really tired; knocked him on his butt/did not get out of bed, did not do anything for 2 weeks; couldn't stay awake/ slept for two weeks; couldn't eat anything; the sight or smell of food made him gag; bruise on his arm about the size of a half dollar where he got the shot; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered on the right arm at the age of 69 years, on 18Feb2021 16:00 at a single dose for COVID-19 immunisation. Medical history included known for a history of heart disease, stage 4 kidney failure and polycystic disease. He had been bleeding from the kidneys for a week prior to receiving the vaccine, heart attack and cholesterol. He stated he needs some reassurance and added he has Stage 4 kidney failure with polycystic disease. He already consulted with his heart doctor and kidney doctor and they say get the vaccine. He mentioned that every now and then he gets blood from a cyst rupture. On the day of the first shot he was having a little bit of bleeding in his urine. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) taken for cardiac disorder; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal; amlodipine (AMLODIPINE) taken for blood pressure abnormal and multivitamins. The first shot knocked him on his butt. He slept for two weeks then he started to pass blood clots in his urine. He read that the vaccine can cause clotting and he doesn't know if that might have caused the clots right after the shot. He just needs someone to hold his hand about getting the second shot. He has to leave in a couple of hours to get it. He was asking do we see a pattern where people have had a bad first reaction with the first shot and they don't have a bad a reaction the second time around. He clarified he received the first dose of the Pfizer COVID 19 vaccine on 18Feb2021 at 1600 in the right arm. He was fine until Saturday (20Feb2021) when he woke up nauseous; really tired; could not get out of bed; and then really didn't do anything for two weeks. He added he couldn't stay awake even sitting up in his chair. He couldn't eat anything because the sight or smell of food made him gag, even in the grocery store. He added he also noticed he started to get the blood clots in his urine the second day after the shot (20Feb2021). On 19Feb2021, he mentioned he had a bruise on his arm about the size of a half dollar where he got the shot and he usually does not bruise. He stated he felt like he had all the symptoms of COVID. All of these symptoms lasted two weeks. When he finally felt better the only thing he wanted to eat was a burger and fries. He is still bleeding but it is not clotting anymore. The clots only lasted about a week. He also thought he was having a heart attack, but was too tired to go to the hospital. After speaking to his physician/specialist, they encouraged him to go ahead and get the 2nd dose. The patient would like to know whether the benefits outweigh the risks for him to receive the 2nd dose of the Pfizer covid vaccine based on his medical history. The patient would like to know whether one dose of the Pfizer covid vaccine provides some protection. The patient was asking whether he might die from receiving the 2nd dose of the Pfizer covid vaccine. The outcome of the events heart attack was unknown; events bruise on his arm about the size of a half dollar where he got the shot and blood clot in urine was recovered on 27Feb2021 while other events were recovered on 06Mar2021.

stroke; Left side stroke which affected his speech, and right side; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number En6199 and expiration date unknown), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 at a single dose for COVID-19 immunization. Medical history included myasthenia gravis, rheumatoid arthritis, and high blood pressure. Concomitant medications included pyridostigmine (PYRIDOSTIGMINE), metoprolol (METOPROLOL), tamsulosin (TAMSULOSIN) and amlodipine (AMLODIPINE). The patient had known allergies with aspirin [acetylsalicylic acid]. The patient had no other vaccine in four weeks. The patient had a left side stroke which affected his speech and right side, on Tuesday morning 48 hours after taking the vaccine (on 09Mar2021 at 05:00). The event resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. It was also reported that treatment was administered for the events and the patient was still in the hospital. The patient had no COVID-19 prior vaccination and has tested post vaccination (09Mar2021), with a pending result. The patient was recovering from the events at the time of the report.

Patient is a 69 y.o. male patient who originally presented to the hospital on 3/23/2021 due to shortness of breath. Patient had 1 week of shortness of breath. He starts experiencing 2 weeks of pain in edema right lower extremity. Did notice increasing dyspnea on exertion. Was noted to have bilateral PEs with evidence of RV strain on CT scan. She admitted to the ICU on heparin drip he did undergo tPA. Echocardiogram documented to be improving. Patient now baseline ambulatory in the room without oxygen stable.

Left leg basically numb and rubbery/ leg had just gone to sleep; Tried to stand up and fell; Urinating almost non-stop; going about every 2 hours and going a lot; he had no strength except a smidgen of strength in the right leg; trying to learn how to walk/ He can't walk to the commode very well; Weight: States 201; then mentions that during the night he thought about how much he was urinating and got on the scale out of curiosity and it said he weighs 191; Afraid he was having a stroke; he had trouble holding his fork/Like a cramp in hand; Sore Arm; This is a spontaneous report from contactable consumer (patient). A 69-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) at the age of 69-years-old, via an unspecified route of administration in right arm on 12Mar2021 at single dose for COVID-19 immunization. Medical history included blood clots (reported as blood thinner). Concomitant medication included apixaban (ELIQUIS) from 2019 and ongoing as blood thinner. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) at the age of 69-years-old, via an unspecified route of administration in right arm on 16Feb2021 at 14:00 at single dose for COVID-19 immunization which gave him severe diarrhea, nausea, gastrointestinal distress, a sore arm and it wore him out. After the second dose of the vaccine on 13Mar2021 which was administered in a public health department, the patient experienced sore arm. He was concerned because around 02:00 on 19Mar2021, he got up to go to the bathroom and noticed his left leg was basically numb and rubbery. As soon as he tried to stand up, he fell. He thought the second vaccine was the one everyone says will be harder than the first. They even gave him a sheet of paper that scared the hell out of him. Thought he was okay after the second vaccine until around 02:00. At first, he thought his leg had just gone to sleep. It was like having noodles for legs. The patient has been urinating almost non-stop which also started around 02:00, this was what woke him up. He had to crawl on hands and knees after falling to get into the bathroom, he had no strength except a smidgen of strength in the right leg. On 18Mar2021, while eating dinner, he had trouble holding his fork and did not think much about it. He had a cramp feeling in right hand. Today, while eating lunch with a fork, he also had a difficulty. The patient eats with his right hand. The patient has been trying to learn how to walk since early this morning. He has worn out his wife since she was cleaning up after him in the bathroom and helping him walk. He couldn't walk to the commode very well, couldn't hold his water, and has been making a mess all day. He was at first afraid he was having a stroke but had no stroke symptoms. The patient reported that his weight was 201, then mentioned that during the night he thought about how much he was urinating and got on the scale out of curiosity and it said he weighs 191. At this time, his leg weakness persists but he was able to stand and hold his own body weight. Issue with holding fork and cramp feeling in right hand was persisting. Urinating was persisting and stated he was going about every 2 hours and goes a lot. The outcome of the event pain in arm was recovered on 17Mar2021; unknown for stroke, fall, and weight loss; and not recovered for all other events.

Patient admitted to inpatient at Hospital on 4/1/2021 at 4:30 pm for new acute onset A.Fib with controlled ventricular response, acute on chronic combined diastolic and systolic CHF, and cardiomegaly. Anticoagulation started. Patient was discharged on 4/3/2021. Of note-on 4/1/2021 (date of admission) patient tested positive for "asymptomatic COVID-19". Per physician discharge summary, "patient did not have active COVID by physical exam or history". Also of note, patient was positive for COVID-19 on 8/29/2020, and was vaccinated with Pfizer COVID-19 vaccine on the following dates: 1/28/2021 (1st dose) and 2/18/2021 (2nd dose)

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

Recipient of vaccine is a family member (father) of employee of Hospital. Recipient was vaccinated with Dose 2 Pfizer Covid vaccine on 3/19/2021 and observed on-site for 15 minutes after vaccination with no apparent concerns. On 3/23/2021, his daughter (our employee) notified clinic that on 3/22/2021, recipient had died. 4/7/2021 his daughter (our employee) states the medical examiner indicated his autopsy showed evidence of cardiac arrest.

multiple deep vein thrombosis of left lower leg, started on Xarelto, hematology referral, swelling improving

Headache started 2-23, on 3-5 had MRI brain that showed central venus sinus thrombosis from transverse sinus to sigmoid sinus and jugular vein. Treated with SQ Lovenox followed by oral Coumadin. Headache has resolved and I am still alive. I have not yet had repeat MRI to recheck thrombosis.

Patient's daughter in law called to report the adverse event and will be submitting a VAERS as well. Pt rcvd first dose of vaccine 03/03 and 16 days later on 03/19 he was hospitalized for respiratory unrest, cause unknown. It was not suspected to be caused by the vaccine at that time. Doctors encouraged him to rcv the second dose and pharmacy staff was informed pt had been given the go ahead to do so. Pt marked that he was not currently ill on his informed consent form and that he had not had a previous reaction to the vaccine. 5 days after rcving his second dose (03/30) he arrested again resulting in hospitalization later death on 4/4.

4-2 2am awakened with chest pain antacid taken. 2pm taken to ED. EKG tachycardia with frequent PVC.. 8pm EKG tachy AFIB. admitted to cardiac floor. more antacid given for continued pain. Lab results neg for MI. 4-3 diltiazem and heparin drip started. Blood pressure too low. Diltiazem stopped. Tachycardia persists, on bedrest. any activity increases rate 4-4 Flakil given by mouth8am no change11am diltiazem by mouth. EKG converte dto Normal sinus rhythm130pm. Discharged with new meds, Diltiazem, Eliquis, Pravachol

The patient is a poor historian and history is obtained from him and his partner. His symptoms have started yesterday after receiving the second dose of a Covid vaccine. The couple went to eat a meal of Chinese food, and that evening the patient developed persistent nausea and vomiting. He had multiple episodes of emesis. According to his partner, he continued to have episodes of emesis this morning. The emesis was nonbilious and nonbloody, described as watery. The patient says he woke up this morning and may have felt some palpitations. He thinks the palpitations may have been worse than usual. He says he generally just felt unwell. He could not get out of bed and move around very much due to the nausea and vomiting. He says that for this reason, he activated EMS who brought him to the hospital. Regarding his atrial fibrillation, he says he is mostly compliant with taking his medications, however he did not take any of his home medications today.In the ER, he was hypertensive to 141/111 and tachycardic to 141, tachypneic to 23. His heart rate went up to the 170s and he was given multiple doses of IV metoprolol. On labs, he had a leukocytosis with a white blood count of 12 and the D-dimer was elevated greater than 20. CTA was obtained to rule out pulmonary embolism which was negative. However, down in the scanner he developed an episode of unresponsiveness with questionable seizure symptoms. He was treated with an LR bolus 500 cc but due to the findings of increased pulmonary vascular congestion, was diuresed with Lasix 80 mg IV x1. Blood cultures x2 were obtained.

Found to have bilateral pulmonary emboli on CT scan done April 5, 2021. He was asymptomatic. Was a scheduled CT to follow-up on previous pulmonary nodules and the PE's were seen. No other reason for the PE's has been found at this time.

DVT left lower extremity treated with Xarelto. Symptoms have resolved. He also has a history of DVT 2003.

Patient was admitted on 4/14/21for work up of complaints of dizziness, lightheadedness, one episode of syncope, balance and gait issues, blurred vision, tinnitus that has been present for a little over a month. Patient underwent a CTA 4/14/21: intraluminal filling defects within the superior sagittal sinus and draining dural veins to the right and left of midline near the vertex. There are findings consistent with chronic thrombosis of the left transverse and sigmoid sinus with partial recanalization of the sigmoid sinus and jugular bulb at the skull base. Still in hospital today

Partially occlusive peroneal blood clot that developed the week after he received the second Pfizer COVID vaccine

Onset ~3/24/21 c/o SOB, DOE, intermittent fever and N/D. SOB/DOE worsened. Sought care at Medical Center 3/31/21 and admitted to another hospital hypoxemic on room air and tachycardic w/ respiratory distress. CHF Dx w/ EF 15-20% on 4/1/21. OGT placed 4/6/21. Multiple infarcts 4/15/21. NGT placed 4/16/21. Acute Motor Axial Neuropathy (variant GBS) on 4/19/21.

Hospitalization - comfort measures -acute on chronic combined CHF caused by ischemic cardiomyopathy with Cardiorenal syndrome + acute hypoxic respiratory failure, major decline, failed CABG

On day 16 after vaccination patient experienced sudden dyspnea, stridor, and respiratory distress/respiratory arrest followed by cardiac arrest. ACLS by paramedics, patient in PEA in field. Extubated on arrival to ER with no residual deficits

Blood Clots both legs; had other vaccine same date at 2nd dose in the left arm; had other vaccine same date at 2nd dose in the left arm; This is a spontaneous report from a contactable Consumer (patient). A 69-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 15Apr2021 12:00 PM at single dose for COVID-19 immunization. Medical history was unknown. The patient had no known allergies. The patient had no covid prior vaccination, no covid tested post vaccination. The patient had no other vaccine in four weeks or other medications in two weeks. Concomitant medications were none. The patient had other vaccine same date at 2nd dose in the left arm. The patient experienced blood clots both legs on 15Apr2021 12:15 PM. The patient had extensive dvt IVC and both legs as treatment for event. Outcome of the event blood clots both legs was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (duration: 5 days), Life threatening illness (immediate risk of death from the event).

had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative

HPI: This is 69 years old man with extensive cardiac history including coronary disease status post CABG in 1995, stable from that standpoint with recent negative stress test. The patient also has a history of A. fib for which he is on Xarelto. He was on Lopressor for years and complained to his primary care provider that he had a rectal dysfunction so this was discontinued on Thursday and he was started on Norvasc. He went to a bar to wash therapy with friends and after he had to severe he started feeling dizzy heaviness in the head and blurry vision. He denies having any chest pain, shortness of breath, headache, focal weakness numbness tingling. He has had no palpitation. He got concerned so he came to the emergency room. He had no symptoms in the ER. EKG showed atrial fibrillation with nonspecific ST-T change. Chest x-ray showed no acute intracranial abnormality.

atrial fibrillation; shortness of breath; This is a spontaneous report from a contactable consumer reporting for himself. This 69-year-old male consumer received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 at 13:15, in left arm, for COVID-19 immunisation. The first dose of BNT162B2 vaccine was given on an unspecified date. No other vaccine was given in 4 weeks. Medical history included bladder cancer, blood pressure controlled by lisinopril and allergy to fentanyl. COVID prior vaccination: no. COVID tested post vaccination: no. Concomitant medication included lisnopril for blood pressure. On 07Apr2021 at 13:00 the patient developed shortness of breath and atrial fibrillation which never had before. No treatment was required. The events resolved on an unspecified date in Apr2021. Information on the lot/batch number has been requested.

Pneumonia, unspecified organism Thrombocytopenia, unspecified Trigeminal neuralgia Unspecified convulsions

Other pulmonary embolism without acute cor pulmonale Pneumonia, unspecified organism Acute kidney failure, unspecified Pulmonary embolism Acute renal failure (ARF)

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

Death A41.50 - Gram-negative sepsis, unspecified K81.0 - Acute cholecystitis E86.0 - Dehydration E83.42 - Hypomagnesemia N39.0 - Urinary tract infection E87.2 - Respiratory acidosis R06.89 - Hypercarbia T85.518A - Cholecystostomy tube dysfunction, initial encounter D72.829 - Leukocytosis, unspecified type

3/9, admitted day after covid vaccine with new onset afib. Presented to ED with atrial arrhythmia and it was determined that it was not atrial fibrillation. Initially the patient was managed on the line of atrial fibrillation and heart rate was controlled and he converted to sinus rhythm. He was started on anticoagulation but later on anticoagulant was discontinued by cardiology because it was not typical atrial fibrillation. Echo was done. Because of low ejection fraction and global hypokinesia, Patient underwent cardiac catheterization. Advised him to follow-up with doctor.

Immune Thrombocytopenic Purpura (ITP) Admitted to Hospital 5/19 - 5/21/21 for severe thrombocytopenia with PLT down to 1. Responded to IVIG and steroids and discharged. Will have ongoing clinic follow with oncology, undetermined if will be recurrent or chronic.

Pfizer-BioNTech COVID-19 Vaccine : Pfizer-BioNTech COVID-19 Vaccine : patient presented to clinic with shortness of breath on exertion for one week. Obtained labs and imaging: found to have bilateral pulmonary embolism and left lower extremity DVT and sent immediately to emergency department where vitals were within normal ranges and the patient was not in respiratory distress. Long car ride 26 days prior to arrival. Patient received heparin, admitted to the hospital, transitioned to a direct-acting oral anticoagulant, and discharged to home medically stable. On follow-up after discharge patient is doing well and compliant with anticoagulation.

thought he was having a heart attack; It was all over his body and his left side, the pain/ left side hurts/ spread up his arm and down his hand and shoulders; left side hurts because that was where he got the shot; the first shot almost killed him, he has a defibrillator attached to his heart; This is a spontaneous report from a contactable consumer (patient himself). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8732) via an unspecified route of administration, administered in left arm, on 23Mar2021 (at the age of 69 years old), as 1st dose, single, for COVID-19 immunisation. The patient's medical history included stroke, weak heart, defibrillator/pacemaker insertion, impaired eyesight/ half-blind, pneumonia, headache, and ongoing prostate. The patient had a defibrillator attached to his heart, staples in his chest, and stitches. He got a weak heart from pneumonia which gave him a stroke and led to impaired sight. Patient stated everything else was working. The reason he's blind was because pneumonia hit his heart and caused a stroke along with the medication he was being given, and it happened before getting the COVID vaccine and has nothing to do with the shot. The stroke caused blindness, and they needed to add a defibrillator to his heart because the pneumonia weakened his heart even more than it was already weak. He had a defibrillator attached to his heart 14 years ago and it got took out about 7 years ago because his heart was better. He reported he had to get another defibrillator due a problem from pneumonia. The patient missed his first appointment for the first dose as he had back trouble and a headache. He called the hospital, and they listed off if you're feeling this or this don't come. The patient wasn't feeling well, so he didn't go; he did not seek medical treatment. The patient has compromising conditions; he has a defibrillator and he take blood pressure and heart medications. Every time they tested him, he was negative for COVID and he did not test positive. Concomitant medications included tamsulosin taken for prostate, start and stop date were not reported. The patient was also taking nearly 15 pills a day; 6 in morning, 2 in the afternoon/lunch, 6 at evening time and some at night before bed. He reported that he was pill popping because of his condition and he could sell and still have more than enough for himself to take, that is how bad it is for him. The patient reported about number one and number two shots of COVID vaccine. The number one shot scared him, so he was scared of getting shot number two. He didn't know what the deal of it. He received it at the hospital on 23Mar2021 (Tuesday), and it woke him up on Wednesday morning around 2 A.M (24Mar2021) and he thought he was having a heart attack. The patient wanted the second shot, but he didn't want to get it. He wanted to know whether you have to take the first shot over again or can you take the second; he heard the second shot was worse. He missed his appointment on 15Apr2021 because the first shot scared him, and he panicked. The patient stated that the first shot almost killed him, he has a defibrillator attached to his heart, and he was scared to get the second. The patient wanted to know what the deal was, if he can take second dose safely. He stated no big deal, and he's leery after the first shot woke him up. He had a pain from Wednesday morning to Sunday afternoon, stated he had a pain grade of 6-12. The patient also stated that he has been going crazy with other things, staying away from other things, with the condition he's in, he's blind, and he stayed in the house. When he went out, he was covered. The pain lasted Wednesday through Sunday, he didn't go anywhere and makes precaution to make sure not to catch something, he's always masked and always home. The patient reported that he was having pain at times when he touches his side. When he goes to bed, he sleeps on his right side with his arm across his body laying on a foam block because that side hurts. He clarified that his left side hurts because that was where he got the shot. He was surprised, the pain was so sharp, he thought he was having a heart attack. It came from his elbow, started there and spread up his arm and down his hand and shoulders. His left side hurt when he touched and pressed down, it was a pain of 12. He thought he was having a heart attack, and it scared him, that's why he didn't get the second shot. He heard the second one was worse than the first one. If the first one made him feel he was having a heart attack, the second one would surely kill him. He was worried so he decided to stay home. He felt like a kid staying home from school. The pain went away, it just scared him for how he woke up. If he had a pain grade face in the hospital, it was off the chart. He knew how he felt and how he looked, it would be off the chart. He thought in his mind he was dying, felt like he was having a heart attack, like he was dying. It took a little bit of time, he had to calm down and find where the pain was coming from, and where it was going. Pain was coming from his elbow, across his chest and hitting his defibrillator. Patient stated this was the reason he felt he was having a heart attack. The defibrillator woke him up, it had an effect on it, it woke him up and scared him. They had to put the defibrillator in because he needed it for his heart. He thought he was having a heart attack after all this, he was bugging. His son came in, and he told his son that he was in pain. His son told him not to get the shot and believed this was why the patient was hurting. His son said the vaccine and the defibrillator caused him to feel like he's having a heart attack, the shot did something to his elbow which caused the pain and when it hit, it hit everything and he had a pain grade of 20. It woke him up and scared him. He won't say what he wanted to say, it is personal, but it scared him that much he wanted to go there. The patient was supposed to get his second dose 15Apr2021 because the first shot scared him, and he panicked, he did not because he was scared to death. The patient reported that everything began on Wednesday, the pain was gone, and he has recovered completely. Patient stated his pain grade was a 6-12. The pain in his elbow has recovered completely. He stated his elbow showed pain when it gets cold or rains, when it gets wet. Patient wanted to make sure if he gets the second shot, does he have to get the first shot again since he missed the second shot appointment. Everybody was saying to get the COVID vaccine, to prevent him from getting COVID, they wanted everyone to get vaccinated. He was unable to read his vaccine card because he was half-blind and will have someone else look at it. The patient missed his second dose appointment due to the effect of the first dose of the vaccine; he had a bad reaction from the number 1 shot and that was why he did not get the number 2 shot because of him being compromised due to his condition and the medications he takes. He had the first dose on 23Mar2021 and scheduled to get the second dose on 25Apr2021 (more than 21 days). He believed the ingredients combined this caused it, when he had the event he thought that it did bother his defibrillator, he had pain that made him think he was having a heart attack. That with the meds it may have added to the pressure he received when he got the shot, where he got the shot. His left side was bothering him, he thought he had a heart attack; his defibrillator was thumping, and he had pain that hit his elbow and his defibrillator woke him up. He knew it had to do with COVID shot. It was all over his body and his left side, the pain. His heart medication and blood pressure medication were nothing different. He had pain in his side, that he does not normally have which branched out from the elbow, to the hand, to the defibrillator. His left side was sore and he could not lay on it and could not touch it since it was so painful. Patient confirmed the pain was all down the left side and he got the vaccine in his left arm. The only last effect he was having is that he was afraid to get that second shot, he was afraid to go to sleep as he won't wake up after getting the 2nd shot or how he will going to react to it. He was paranoid in his mind to get the second shot. He reported that everything was wrong with him and that the shot had to fight with his medications and his body pain for it. He reported his body is paying the price. He felt like he was having a heart attack, pain going up and down arm, his fingers felt like needles going into his hand, like life was going back through his hand. His pain went to his chest his face was nowhere on the pain chart, his pain was like a 16 on a scale of 1 to 10. When he woke up that night it was like a 20, then if he touched his arm the pain was like a 14-16. The patient could not sleep, he could not sleep on his left side. Patient had to put a foam pad on his left side he got from his friend or sleep on his right side. That started Wednesday morning at 2 A.M to Sunday morning, he was surprised when he woke up that Sunday, he was not in pain when he woke up on his back. Patient reported he was half blind and can't find his medications. He reported he put his medications down earlier and was not sure where they were.nAround that time he went to the hospital due to breathing issues, problems breathing. He went in twice and they discharged him on their own but, he had more problems breathing. What he did not know at the time he had because he did not look at the discharge paper and no one explained them to him was that he had Pneumonia when he went to the hospital. The outcome of the events vaccination site pain, heart attack was recovered on unspecified date in 2021; while for the remaining events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Two weeks to the day of my second injection (Fe. 25) I went to an ER for atrial fibrillation, the first time in my life. After I converted, I was was sent home with prescriptions for Eliquis and Metoprolol. On Sunday March 21 I went to another ER with A-Fib and was hospitalized until Tuesday. They changed the Metoprolol from succinate to tartate and did an echocardiogram. Upon release I saw a cardiologist and began a series of tests. I don't know whether the A-Fib could be related to the vaccine but I was encouraged to report this to the CDC. Thanks.

PAIN IN LOWER RIGHT LEG (STARTED 6/03/2021) CLOTS FOUND VIA ULTRASOUND SCAN (6/08/2021) LOVENOX INJECTIONS FOR 7 DAYS (120MG SUBCU) ELLIQUIS RECOMMENDED FOR 3-6 MONTHS (5MG 2X/DAY ) CURRENTLY STILL UNDER TREATMENT AS OF 6/19/2021

Note: following first vaccine patient had complaints on insomnia, and confusion for 1 and 1/2 days following the vaccination. Patient call today 6/29 to inform clinic that he had has a stroke three days following the 2nd dose of the Pfizer vaccine. Patient received vaccine 6/3 and on 6/6 patient noted numbness and weakness in right side and went to hospital, Patient was diagnosed as having a stroke. Patient was admitted to a hospital. Currently patient feeling better with some small limitations.

Atrial Fibrillation events went from 1/month or less, at one day, to 50% of all days. Still at that level as of July 4, 2021. The events now last 3-7 days.

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