Pfizer

Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II, non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea. .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily. Per MD note. While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.

TIA/mini stroke; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 5-decade-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included insulin dependent diabetic in mid 40s. The patient's concomitant medications were not reported. The patient experienced TIA (transient ischaemic attack) /mini stroke on same day he received COVID vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included nut allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included zolpidem tartrate (AMBIEN) and doxepin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 13:00, the patient experienced heart event that stopped him from breathing and the lack of air caused a stroke; all reported as life-threatening. On 14Jan2021, the patient underwent lab tests and procedures which included COVID-19 test which was negative. The patient was treated for the events which included being put on a ventilator and sedation. The clinical outcomes of the heart event stopped him from breathing, lack of air, and stroke, were not recovered.

Was at work on 1/26/21 and collapsed, no known complaints a the time. CRP was initiated immediately, transported to ER and pronounced dead

dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection. The death and syncope more likely are associated with the patient underlying medical conditions. More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Dead

Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, reportedly told fiance that he had taken some sleeping pills and was going to go to sleep. EMS was called after the patient was found unresponsive about 15 minutes later. Family attempted to do CPR. Upon EMS arrival to the patient's home, patient had a pulse, was in respiratory distress with agonal breathing. They also reported emesis in the airway. EMS performed nasal intubation and administered 10 mg IV Narcan en route. Upon arrival to the hospital, patient was moving arms more and gritting teeth. Patient had movements of decerebrate posturing of arms intermitting with a relaxed posture. GCS was 4 on arrival. Patient is currently still in ICU and has been extubated.

CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hypercoaguable work up negative. Managed conservatively. Improvement without resolution of symptoms to date.

Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision. patients wife called 911 and patient was taken to Hospital ER for emergency evaluation. CT scan revealed a brain bleed. patient was rushed to Hospital Neuro ICU for immediate care. patient was at Hospital from Sunday Feb. 14th - Tuesday Feb. 16th. patient blood pressure (which is usually well controlled) had spiked up to dangerous level and caused a rupture to an AVM in the tegmentum region of his brain. hospital treated patient and got his blood pressure regulated. Patient discharged on Tuesday Feb. 16th 2021 with the expectation of making a full recovery after several weeks of rest.

Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00AM at which time I as in the ER. Troponin levels were at 6.0 and I had a small abnormal finding on my EKG. The Cardiovascular physician on call said it could be something and they would do a cardiac cath to determine where a blockage may be. The angiogram cam back with no blockages. troponin levels reached a 10 by the end of the first day. The Echo the next day showed no issues in structure. The Cardiac MRI showed fluid and 4% of my heart had myocarditis from the issue. Troponin levels reduced to 7, then 6 by the end of the second day. On the third day I went home with new meds, an order for a follow up and cardiac rehab.

Patient died 12-15hrs after vaccination.; This is a spontaneous report from a contactable Consumer. A 40-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:45 (Batch/Lot Number: ER8727) at the age of 40-year-old as single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient patient died 12-15 hours after vaccination. The patient died on 26Mar2021. An autopsy was not performed. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.; Reported Cause(s) of Death: Patient died 12-15hrs after vaccination.

Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; injection site pain; paresthesias of hand on side of injection; This is a spontaneous report from a contactable physician (reporting for a patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly, administered in arm left on 15Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 prior to vaccination; patient had no known allergies. Concomitant medication included lisinopril. Patient had no other vaccine in four weeks and the COVID vaccine was received at a Public Health Clinic/Veterans Administration facility. On 15Mar2021, the patient experienced thrombocytopenia (109,000), elevated D dimer (3960), fatigue, subjective fever, headache, sweats, injection site pain and paresthesias of hand on side of injection. The adverse events resulted in emergency room/department or urgent care. The patient was tested for COVID post-vaccination through a nasal swab and Biofire PCR on 22Mar2021 which were both negative. Therapeutic measure taken as a result of the events included IV hydration. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all 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.

Pain underneath right rib cage and difficulty breathing. It got worse over two days and then I was hospitalized. Coughed up blood. Tested with Heparin drip and now I?m on Xarelto. No previous history of blood clots. This happened three days after second vaccine

I have chronic ITP but platelets have been fine for 12+ years. After first dose two weeks later my platelets dropped to 4,000 and had to be hospitalized

passed out/stopped breathing for 15-20 seconds.; passed out/stopped breathing for 15-20 seconds.; Felt faint; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 25Mar2021 11:00 (Lot Number: EN6205) as single dose for covid-19 immunisation at age 40 years old. The patient's medical history was not reported. No known allergies. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medication included loratadine (CLARITIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 14:00 (lot no: EN6200) in left arm for COVID-19 immunization at age 40 years old. On 25Mar2021 11:15, the patient felt faint, had trouble breathing, and passed out/stopped breathing for 15-20 seconds. The adverse events resulted in emergency room/department or urgent care. Treatment for the events included EMT monitoring onsite, saline and other meds (unspecified). The patient recovered from the event passed out/stopped breathing on 25Mar2021; while recovered from other events on an unspecified date in Mar2021.

On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and couldn't do more than 15 minutes. He was very winded. On March 7, we skipped exercise. On March 8, patient tried to do simple stretching exercise, and couldn't do it. He got winded and shaky. On March 9, he was seen at an urgent care where he was told he had an inverted T wave on his EKG and a very fast heart rate (125 resting pulse). He was told to not exercise and to make an appointment with a cardiologist. On March 9, I called the urgent care clinic to ask questions about monitoring his blood pressure and when to seek more medical care. I spoke with Dr, who prescribed Atenolol. Around 4:30 pm on

Patient found unresponsive and transported to ED. Currently hospitalized and admitted with following issues: Present on Admission: ? Intraventricular hemorrhage (HCC) ? Bilateral thalamic hemorrhage ? Acute encephalopathy ? Abnormal eye movements ? Respiratory failure requiring intubation (HCC) ? Mucoid impaction of bronchi

Multiple blood clots in the left leg had to be submitted to the Emergency Room at the hospital for immediate treatment; This is a spontaneous report from a non-contactable consumer. A 40-years-old male patient received 1 dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE) lot number: ER2613 via an unspecified route of administration, in arm left on 12Apr2021 at the age of 40 years as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced multiple blood clots in the left leg and he had to be submitted to the emergency room at the hospital for immediate treatment on 16Apr2021 12:00 with outcome of recovering. The patient was hospitalized for 2 days and was treated with unspecified treatment. Covid test post vaccination: Nasal Swab on 20Apr2021 result Negative No follow-up attempts are possible. No further information is expected.

Awakened at 2 am 5/1/21 with acute onset of chest pain, SOB, and diaphoresis. No cardiac history; no history of similar episode. Reported that, following his second dose of COVID vaccine, he was ill for 1 day with vomiting. Chest pain continued upon arrival to ER 5/1/21 about 7 am. EKG indicated STEMI. Adm with Acute ST elevation myocardial infarction.

This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 08:15 (Batch/Lot Number: EW0171) (at age 40 years old) as single dose for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, carpel tunnel, absent vas deferens, all from unspecified dates. No COVID prior to vaccination. He underwent Covid test post vaccination (nasal swab) on 29Apr2021 with negative result. The patient's concomitant medications included unspecified prescribed and store-bought medications. No other vaccines in four weeks. On 28Apr2021 22:00, the patient experienced chest pains and shortness of breath testing of EKGs, echo, CT scan, and cardiac cath show- NStemi heart attack showing from damage to heart caused by blood clot. No problems with arteries or existing with heart. Also, lower lobe of left lung shows collapsed. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events were considered serious: hospitalization (2 days), life threatening illness (immediate risk of death from the event), disability or permanent damage. Treatment included blood thinners- apixaban (ELIQUIS) and metoprolol. The patient was recovering from the events.

part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I developed severe abdominal pain in my left side during the evening; lack of appetite; bouts of severe discomfort; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167) via an unspecified route of administration, administered in Arm Left on 28Apr2021 12:15 (40-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Vaccination Facility Type was clinic. Concomitant medications included ibuprofen (ADVIL); desloratadine (CLARINEX). The patient previously took first dose of BNT162B2 (lot number=EN6208) on 07Apr2021 01:15 PM (40-years-old) on Left arm for COVID-19 immunization. It was reported that the patient developed severe abdominal pain in my left side during the evening of Wednesday, 28Apr2021 19:00. The pain appeared sporadically throughout the evening and continued through Friday, April 30. During this time, he experienced a lack of appetite and bouts of severe discomfort. Tried treating with GasX and Tylenol. Duration of Hospitalization reported as 3 days. On Saturday, 01May2021, starting around 10:30 a.m., the pain in his left-side abdominal area intensified and did not diminish. After 6 hours, he visited the ER at hospital. After being admitted to the ER, a series of blood, urine and imaging tests were performed on me. The doctor on duty reported that a CT scan showed that part of my left kidney was no longer receiving blood (disability). He was placed on Heparin and admitted to the hospital. He was diagnosed with a blood clot and placed on stroke protocols. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse events was Heparin, fluids, blood work, urine analysis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events abdominal pain, lack of appetite, and bouts of severe discomfort was recovering; while other events was unknown. Events reported as serious due to hospitalization and life threatening.

HCP indicated tracheitis; Less of a passageway; Fair amount of coughing/Dry cough; Swelling in the neck area; Fatigue; Is there any correlation between the delated anaphylaxis and ingredient?; Throat tightening with difficulty breathing; Throat tightening with difficulty breathing; This is a spontaneous report received from a contactable consumer (reported for himself). A 40-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0164) administered in left deltoid via an unknown route of administration on 16Apr2021 at 12:50 pm as 1st dose single for COVID-19 immunization. It was reported that that he received the vaccine in his left arm, the bicep muscle, or above the bicep. He states the muscle on the shoulder area. Patient states that asthma was in the lungs and chest. He has had mild intermittent asthma and gets it 4 times a year. There was no prior Vaccinations, no adverse events within 4 weeks. Medical history included asthma (patient was diagnosed 30 years ago), allergic to shellfish. The patient's concomitant medications were not reported. On 16Apr2021 patient experienced is there any correlation between the delated anaphylaxis and ingredient, throat tightening with difficulty breathing (Throat tightness and dyspnea), less of a passageway, fair amount of coughing/dry cough swelling in the neck area and fatigue. On 19Apr2021 at 10:15 HCP indicated tracheitis. The patient states that he got the vaccine on 16Apr2021 at 12:50 pm and isn't sure exactly when the swelling started because he got a little fatigued. Patient states that it was about 3-5 hours after and at a certain point he noticed it. It was reported that a half an hour to an hour later patient throat started to tighten, it gets triggered by certain stimuli, steam and vocalization, and rubbing the area. patient states that he could reproduce the issue if he rubs the area, the frequency has decreased, and in that case, it has improved. It was reported that patient was diagnosed with tracheitis on 19Apr2021 at 10:15 and it was still ongoing, or the effects of it are. Patient states that what he feels in the front of his throat near the trachea and up a little further was inflammation. Patient gets the symptoms of the tightening of the throat, and it is inflamed there is less area to breath. Patient states that his understanding of the tightening of the throat and dry cough are all symptoms of the tracheitis. It was reported that the first symptom experienced after the injection (at least 2-3 -4 hours), patient had fatigue first then probably a half an hour to an hour later the swelling started. patient believes the fatigue has gone away, but not 100 percent sure. patient states that there are times he has felt fatigue and is not 100 percent of the cause. patient states that if he does feel fatigue, he assumes it because of the tracheitis. patient states that these events happen when he needs to get area in his throat, and it might cause the fatigue. patient states that the coughing is parallel with the throat tightening, when he wants to open his airway or pass way the coughing seems to occur. Patient states he gets relief or a more open passageway and the coughing reflex or coughing bouts are less, when he gets the tightness of the throat or the inflammation he sort of goes into coughing. The outcome of the event for hcp indicated tracheitis was not recovered and unknown for the other events, whereas the outcome of the event fatigue was recovered. Follow up were needed, further information has been requested. 07May2021: Follow-up spontaneous report received from a contactable consumer. No new information was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524696 Pfizer

40 y/o M with no PMHx, non smoker, takes Finasteride 1 mg for hair growth, nonsmoker, received first Pfizer COVID-19 vaccine on 4/12/21 to left deltoid (had mild soreness x 2 days, without other sx) presented to ED 4/15/21. Presented to ED 4/20/21 with L calf pain x 4 days starting around the evening of 4/15 and into 4/16. Initially attributed symptoms to a muscle strain given pt bikes 25 miles a day and lifts/frequent exercise- was able to exercise on 4/16 but stopped after that to try to rest the leg. Has been applying ice and taking Aleve with no relief. Shortly after, noticed new swelling in the calf and this morning noted that swelling had also spread to the front of his shin. Denied numbness, tingling, weakness in the leg. Was advised by a family member who is radiologist to present to ED for further evaluation. Found on exam to have left calf swelling, Ultrasound Doppler with extensive deep venous thrombosis of the left lower extremity from the level of the posterior tibial extending proximally to the common femoral vein with areas of both occlusive and nonocclusive thrombus. Evaluated by interventional radiology, deemed no need for intervention. Initially treated with lovenox and then discharged from the ED on apixaban 5mg daily. Symptoms resolved in days after and as of 5/18 remains on apixaban symptom-free.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath, cough, and chest pain. Transferred to emergency department then admitted to current facility for a management of new onset heart failure with possible etiologies of myocarditis or sarcoid. Also found to have LV thrombus, anemia, and lymphadenopathy. Patient initiated on medications to manage heart failure and anemia and anticoagulated. Patient improved and discharged to home medically stable.

woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER. Stroke team diagnosed and began treatment of stroke. Had multiple tests run to include arterial ultrasounds, internal echo cardio, and CT and MRI of the brain. Confirmed left side of brain stroke but causes are still unknown. all tests and bloodwork came back normal and within range of an above average healthy adult.

50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.

patient called 911 with shortness of breath and chest pain. When squad arrived, he was still oriented and awake and told squad he had Pfizer vaccine the previous day. Thought was a pulmonary embolism had occurred. Then he lost consciousness and pulses. EMS started CPR. Despite aggressive ACLS maneuvers, the patient ultimately died.

Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.

Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of vaccine. On 5/25/2021 around 4 am, started having chills and headache. On 5/26-5/27/2021 headache worsened and by Friday on 5/28/2021, along with headache, left sided pain in chest and arm. Per patient was taken to ER by wife and admitted to hospital on 5/28/2021. Per Client, was told first by hospital that he was having a heart attack. Client reported having labs collected, EKG, Catheterization and Ultra Sound. Per Client, later diagnosed with "myocarditis" and is now taking multiple mediations. Per Client was discharged from hospital on 5/29/2021, that evening. Will be following up with PCP in one week.

Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went to ER and had CT scans to verify this diagnosis. Was treated with Ibuprofen and colchicine

Developed DVT in left leg from groin to ankle. Diagnosed on 01/29/2021. Pain, swelling, and difficulty walking lead to emergency room visit, admission to hospital for 2 days.

Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 01Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tonic clonic seizure on 01Feb2021, the same day. The patient received the dose at 14:00 and had the seizure around 19:00. Patient has recovered from the event on an unspecified date. No treatment was received for the event. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tonic clonic seizure and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt. He is a Service Member and reported high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness and discomfort to his right calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5. Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.

Blood clot in right hand. Could not feel right thumb pointer and middle fingers and they turned purple. Went to hospital and treated with Heprin. Outcome - still have the blood clot. Put on Eliquis. Also developed high blood pressure from event and put on valsartan

Anaphylaxis treated with EpiPen, Steroids & Benadryl It began as a hives on 04/16 around 8 PM, the morning of 04/17 I had swelling in my eyes, lips and tongue, Along with difficulty swallowing. I was treated with epinephrine on 04/17 around 1 pm and then again on 0/18 around 11 am.

I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea; inability to swallow; mouth going dry; unable to speak; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:00 (Lot Number: el3248) as single dose (at the age of 41-years-old) for covid-19 immunisation. Medical history included Heart disease, hyperlipidaemia, hypertension, pituitary adenoma. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he developed full anaphylaxis within 30 minutes of receiving his Covid-19 vaccine on 16Jan2021 (Adverse event start time reported as 12:00 P.M.). It started with dizziness, then nausea, then inability to swallow and mouth going dry, finally unable to speak. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient was treated for the events with epinephrine (EPIPEN) on site by emergency medical services (EMS) and transport to hospital. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 11Feb2021. Patient had no known allergies other than the Covid-19 vaccine. Patient recovered from the events on unknown date.

irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

TIA ( mini stroke) on fourth day after dose two.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208 and expiration date not provided), via an unspecified route of administration, administered in Arm Right second dose on 25Mar2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included Hypertension and Penicillin allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) and bupropion hydrochloride (WELLBUTRIN). The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201 and expiration date not provided) via an unspecified route of administration administered in Arm Right first dose on 04Mar2021 administration time: 04:00 PM for covid-19 immunisation. On 29Mar2021 10:00, the patient experienced TIA (mini stroke) on fourth day after dose two. The event resulted in physician office visit, Emergency room visit, and hospitalization for 1 day. The patient was treated and was placed on three medication (unspecified). The patient underwent lab tests and procedures which included Spectrum DNA test: negative on 15Apr2021. The outcome of the event was recovering.

8 days after receiving the shot I was out for a run and had a heart attack. The septal region of my heart was enlarged but nothing else was showing... all arteries wide open, heart functioning at 55, cholesterol 171. My troponin levels were 76...

He is a co worker and he passed away in his sleep I heard. One of 3 nurses that died in the medical center since the vaccine roll out

Acute myocardial infarction in the LAD. Chest pain migrating to left arm down through elbow. Cardiac catheterization s/p DES-pLAD. Chest pain started roughly 19 hours after the first dose of the Pfizer vaccine.

Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.

Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of my body.

My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest. He was shocked back to life where he lay in a coma. His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.

2nd dose of vaccine given 4/19/21. Developed URI symptoms (congestion) shortly after which coincided with young kids having URI as well. On or around 5/10/21 he began noticing exertional chest pain and tightness. Symptoms progressed to occurring with less exertion. Admitted 6/2/21 with late-presentation anterior STEMI, underwent emergent angioplasty of multiple lesions.

On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gone numb and he had vomited. Patient called his mother to come help him with the baby because he wasn't feeling well. When she got there 30 minutes later he was not breathing. They were not able to revive him. He died of a blood clot in the front of his heart.

The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, fever/chills felt for approx. ~1day post vaccination and then felt back to normal. Around day 3 post vaccination felt sudden, sharp, stabbing pain within chest cavity which forced me to take shallow, rapid breaths to avoid triggering pain. Lasted a few minutes before subsiding. Following day or so pain returned as a dull, diffused pain and was felt intermittently for several weeks. Generally I run fairly often for fitness, however activity level was reduced due the ongoing chest pain. Wanted to resume normal activity levels, but decided to consult a Doctor for peace of mind due to pain taking so long to resolve. Scheduled virtual appointment (06/24/21) who advised an ER visit due to it being a potentially risky chest issue, and the fact that they could run the appropriate tests to diagnose it relatively quickly. Walked over to a nearby ER that afternoon and was hospitalized for 1 night, who diagnosed an "Unprovoked VTE" with a "Pulmonary Embolism" in Right lung. Was treated with Lovenox injections at hospital and currently taking Eliquis medication. As a side note: my brother (43yrs old) who lives in another country, was administered the 1st dose of the AstraZeneca vaccine on 05/24/2021 and subsequently fell ill, went to the ER twice and was eventually diagnosed with VTE/Bilateral PE. He is also currently taking Eliquis medication.

vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving

Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine.; Tunnel vision; Extreme sense of coldness; Face planted to the floor.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer(patient) reported for himself thata 41-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot number: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 25Jun2021 18:00 (Age at vaccination 41 years) as single dose for COVID-19 immunisation. Medical history included hiatus hernia and diverticulitis. Concomitant medication(s) included paracetamol (TYLENOL). Patient had no known allergies. On 25Jun2021 18:00, the patient experienced atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine; tunnel vision; extreme sense of coldness and face planted to the floor. Patient was received treatment for events. It was reported that after patient received shot and exited the medical room, he had extreme sense of coldness come over me, tunnel vision, then face planted to the floor. Ambulance was called, patient regained consciousness about a minute or so later, and my chin was split open. They took me to ER, stapled my chin, and ran tests. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Other medications the patient received within 2 weeks of vaccination include Tylenol. Patient received Cardizem 1/day till doc follow-up visit. The clinical outcome of all events were unknown. Information on the lot/batch number has been requested.

Acute on chronic congestive heart failure, unspecified heart failure type; Elevated troponin; SOB (shortness of breath)

Immediately after administration the patient started bleeding and swelling/small bump appeared at the injection site. The patient's arm was elevated and the bleeding stopped. An ice pack was applied to the swelling for about 20 minutes. The patient was observed for a total of 40 minutes by pharmacy team. No further bleeding occurred and swelling/bump was going down when patient left pharmacy and he was advised to continue applying ice pack and go to ER if any further swelling, redness, itch or trouble breathing occurred. Pharmacy followed up with patient the morning after vaccine administration and he reported no further bleeding or swelling had occurred.

1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850.

Severe Anaphylaxis onset at 3:00am. Epinephrine administered at home. Transported to ER. BP 80/40 at admission. 2nd Epinephrine administered at ER. IV fluids. BP recovered and discharged at 7:30am. Prescribed Prednisone 20mg, Famotidine 20mg, and Cetirizine 10mg.

3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present. 3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted. 3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills. 3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.

small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when breathing; work up with terrible thoracic back pain with every breath; chills; low grade fever; Moderate stomach cramps; Much less arm pain then following first dose but still present; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) on 10Feb2021 at 11:30 am in left arm for Covid-19 immunisation. There were no other vaccines in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had 3/4 moderate stomach cramps day after vaccine on 04Mar2021. Much less arm pain then following first dose but still present on 04Mar2021. The patient 3/9 worked up with terrible thoracic back pain on 09Mar2021 with every breath and went to emergency room and received shot of Toradol and performed chest x-ray which was negative. Shortly thereafter, the patient had chills and low grade fever on 09Mar2021. Alternated naproxen and tylenol for the next two days as fever persisted. The patient had 3/11 moderate chest pressure when breathing and went back to emergency room on 11Mar2021. There was no fever or chills but had 3/12 light headedness, racing heartbeat and chills early afternoon on 12Mar2021. The patient went back to emergency room. The patient's symptoms improved over course of following 7 days. The patient underwent lab test and procedure which included flu test and resulted negative; blood work which showed positive D-dimer test on an unknown date and CT scan showed small pneumonia in lower left lung on 12Mar2021. The patient started to receive amoxicillin and Z-pack. Since the vaccination, the patient had been tested for COVID-19 by nasal swab on 11Mar2021 and tested negative. Events resulted in emergency room/department or urgent care. The outcome of event pneumonia was unknown; for other events was recovering. No follow-up attempts are possible. No further information is expected.

Approximately one week after my second dose my right leg began swelling. For three weeks after the swelling began it would get better than get worse. On Tuesday, March 30, 2021 my entire leg swelled to twice its normal size at which time I went to the emergency room and a blood clot was diagnosed in my right leg. I completed a multitude of tests and bloodwork with a hematologist and there are no factors or reasons they can identify as to why I developed a blood clot.

anaphylaxis. throat closing, tongue tingling, couldn't breathe within a few minutes of injection epipen and Benadryl given on site, sent to hospital for observation, treatment with allergy medications and steroids for five days after. Observed in hospital for four hours. Advised by primary care doctor not to get second dose or any other covid vaccines due to reaction.

3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats per minute. I ended up checking myself into the emergency room 5 hours after the vaccine shot because my heart rate wouldn't slow down and my blood pressure increased. They found out my heart had gone into atrial fibrillation. I have had no known history of atrial fibrillation in the past and prior EKG's at physicals have been normal. I am an otherwise healthy individual.The doctor conducted an emergency Cardioversion to return the heart rhythm to normal.

Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ". He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain. The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time. He was admitted to the ICU and has been there ever since. Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs. He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase. The doctor should fill in the rest.

Blood clot in leg; This is a spontaneous report from a non-contactable consumer reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 01Apr2021 02:00 PM at 42-year-old at single dose for COVID-19 immunisation. Patient had known allergies (unspecified) and other medical history (unspecified). There was no covid prior vaccination. There is no other vaccine in four weeks. Other medications in two weeks included antibiotics. Patient experienced adverse event: blood clot in leg on 03Apr2021 02:00 AM. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient received treatment for events included blood thinners. Patient had covid tested post vaccination on 21Apr2021: Nasal Swab: Negative. Patient was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Stroke caused by blood clot. Spent 6 days in medical facility as a result. Unknown if vaccine and blood clot are related - but it seemed wise to report for further investigation

On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chills and couldn't get out of the bed until 4:00pm that day. I was dizzy and drove to the hospital. They did blood work and did two Covid 19 tests. They released me and the next day I developed Heavy pains. On 27 April I woke up and went back to the hospital. They said I had elevated enzyme levels when they drew blood and they started three iv?s. They said I was having a non emergency heart attack. They had me transferred by ambulance to the another Hospital. They drew more blood and did elf?s and ultra sounds. The next day they said they were going to put a stint in my heart. The next day I was prepped for the procedure and they went in and said my heart didn?t need it. The surgeon said I had Myocarditis and at 7:00 pm that night I was released. My nose broke out with acne bumps and it feels like I have a chest cold and cough.

Stroke; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Right on 13Apr2021 12:30 as 2nd dose, single for COVID-19 immunization in a pharmacy/drugstore. Medical history included allergies: sulfa from unspecified date. Concomitant medications included hydrochlorothiazide and metoprolol succinate (TOPROL) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot number: ER8727) on 22Mar2021 9:00 AM at 42 years of age in the right arm for COVID-19 immunization. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 25Apr2021 18:00 the patient had a stroke. The event required emergency room and physician's office visit and the patient was hospitalized for 1 day. The patient was treated with unspecified blood thinners. The outcome of the event was recovering.

Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.

- Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very well, and woke up with a tightness of chest and unable to draw a full breath - Went to county ER and was advised I was suffering a heart attack (non stemi) (troponin levels were over 7,000) - transferred to hospital for further diagnosis and treatment - Had a echocardiogram, cardiac catheridisation and MRI, which found that I had inflammation of my heart muscles - treated symptoms with medication and was discharged after an overnight stay

3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his leg hurting; his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0172, Expiration Date 31Aug2021) via an unspecified route of administration, on 28Apr2021 at 09:00 (at the age of 42-years-old) as a single dose in the left "shoulder" for COVID-19 immunization. The patient's medical history and concomitant medications were denied (reported as "He has no medical conditions and does not take any regular medications"). The patient did not receive any other vaccinations within four weeks prior to the vaccine. The reporter says she is reporting on behalf of her husband with regard to the Pfizer COVID vaccination. She just wanted to report that her husband got the first shot 28Apr2021 and Friday 07May2021 he was admitted to the hospital with 3 pulmonary embolisms. When asked when the pulmonary embolism began she says the week before the hospitalization, so the week he actually got the first dose, he was complaining of the back of his leg hurting, in the upper calf area. She says it was either the day after the shot or the next day that he said his leg hurt but he did not think too much about it and it resolved after a couple days and then Wednesday, 05 May 2021 he started getting discomfort in his left upper quadrant, she clarifies his abdomen and rib cage area, and he started having really bad headaches Thursday that continued and during the night Thursday night his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as he had the severe headache so the doctor told him to go to the ER. The patient experienced three pulmonary embolisms on an unspecified date with outcome of not recovered. The patient was hospitalized for 3 pulmonary embolisms from 07May2021 to 08May2021. He also started having really bad headaches on an unspecified date with outcome of unknown and he was complaining of the back of his leg hurting on an unspecified date with outcome of recovered, his left shoulder started bothering him and it was radiating from his shoulder up to his chin on an unspecified date with outcome of unknown. The reporter commented that she and her husband wanted to report this because of the timing of getting the shot and they are waiting now to go see his primary care they are supposed to be calling to set up an appointment because he is supposed to be having the second dose 19May2021 so they do not know what is going to happen. Therapeutic measures were taken as a result of pulmonary embolism and included Eliquis which he would be on for at least 3 months.

This is not very clear that the Pfizer vaccine is actually the cause of the patient's Cerebral thrombosis, however, we are reporting to VAERS as this is a unique first case where the patient has Dural venous thrombosis within 2 weeks period of getting 2nd dose of Pfizer vaccine. 05/25/2021: CT HEAD/BRAIN W/ IV CONTRAST showed dural venous sinus thrombosis involving the superior sagittal sinus, right transverse, and sigmoid sinuses, extending into the proximal right internal jugular vein.

I had an acute anaphylactic reaction to a yellow jacket sting. Within 20 minutes of the sting, my whole body was swollen and airways began to constrict. I received epinephrine, type 1 and 2 antihistamines, and steroids, and the symptoms resolved. I am reporting this because I was stung by a yellow jacket in the same location a year earlier (pre-vaccine) and had no reaction. I had never had an anaphylactic reaction. Clearly, other factors could have caused the new response to what appears to be the same stimulus, but receiving an MRNA vaccine designed to stimulate immune response seems like a suspect worth investigating.

Pt states 04/11/2021 groggy, fatigued. May 5th high grade fever for 3 days continuing, ER visit with Negative Covid-19 test. Antibiotic prescribed and sent home. 04/17/2021 HBP, high pulse rate, A-fib, 06/11/2021 admitted into ICU for a week with palpations. Discharged 06/16/2021. Sent home with recommendation for follow up with Cardiologist. Currently in A-fib, July 7th appt. set to decide how to correct heart A-fibrillation.

PT was found on floor in dining room expired by wife on 6/20/21 at approximately 7:30. Body was hard and cold. Called EMS immediately , EMS provided treatment. Declared dead. Body taken to coroner for autopsy.

New onset atrial fibrillation; Myocarditis/inflammation of the heart; pericardial effusion/he had a significant amount of inflammation and fluid around the heart; pericarditis; Tightness of chest; He went in for difficulty breathing; very tired; chest pain; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 42 years on an unspecified date (Batch/Lot number was not reported) at 14:00 as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to AEs. There were no concomitant medications. The patient experienced new onset atrial fibrillation (AFib) since 27Apr2021 and hospitalized form 29Apr2021, myocarditis/ Inflammation of heart (2021), pericarditis (2021), and pericardial effusion (2021) after receiving second dose of the Pfizer BioNTech Covid-19 Vaccine. Patient sought medical treatment and was hospitalized twice, the first time being 29Apr2021. The patient was still dealing with issues and went into hospital 27Apr2021 (as reported). Since then, he has been going back and forth to hospital and was admitted twice for the same issues. He was diagnosed with Afib and inflammation of the heart. Reporter just wanted to know who needs to talk to because it seemed to be vaccine related. Patient has had to take time off of work and reporter has had to take time off work to take care of him. Patient stayed a week for the first AFib hospitalization. He got out of the hospital (2021) and was at home for a week. That Friday, he went back and was hospitalized for another week (2021). That admission was for both AFib and inflammation of the heart. They saw the inflammation the first time, but it was not a lot and said it was probably normal because of the AFib. When he went back for follow up, he had a significant amount of inflammation and fluid around the heart (2021). He was still dealing with it. He had another issue with going to ER and this was Friday before last. He went in for difficulty breathing (2021) and was told he had more fluid around the heart. He was not admitted for that one. They gave him more medication to control the fluid. Reporter later stated it was prednisone and she did not have a dose, lot or expiration. She then said the dose was increased after he went for follow up and had more fluid. The first time patient was taken to the emergency they could not find anything and the next day, she (reporter) called 911 from her home and saw that he was experiencing some cardiac issues and saw that he was admitted and told he had AFIB. When she called 911 from her home, they transported by ambulance to (#) Hospital in (#), (#) and that was when he admitted and diagnosed with AFIB. Since # was out of their network, he was transferred to # that same evening or day to # and he was there about a week. Then he was released after a week and still had a hard time breathing and walking a few steps with trying to catch his breath and had chest pain and was very tired (2021). Then he went to a follow up that Friday after being released. Unknown doctor in (#) and then he was readmitted at the follow up appointment to #. He was in the hospital for a week that time as well. He was discharged and they prescribed him medication and then he came back home on medication and he has been on several medications. The one to reduce inflammation, starts with a P and she cannot remember name. He finished it and went to a follow up. After he finished medication, he was experiencing side effects (2021) such as chest pain, difficulty breathing and tightness of chest. She then remembered it was Prednisone that he was on, unknown dose, and it is in pharmacy vial with no lot or expiration. There was no seal, and count size is unknown. He no longer has any left. He went to the ER in (#) because he was experiencing the same symptoms. They saw more fluid collecting and put him on the same medication but a higher dosage of Prednisone. This dose is 10mg, 4 tablets by mouth daily. It was also in a pharmacy vial with no lot or expiration. This was where he was now. He has been out of work and so has reporter. The patient had MRI, XRays, Echo, Blood Test and was still doing blood test (in 2021). He has to go back this week. Everything came back as unknown for what caused this. The outcome of events myocarditis/ Inflammation of heart and AFib was recovered/resolved with sequel in 2021, of other events was unknown. Information on the lot/ batch number has been requested.

Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.

anaphylaxis; This is a spontaneous report from a non-contactable healthcare professional (patient himself). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Jan2021. The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of 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 RAs, Ethics Committees, and Investigators, as appropriate.

I had experience of muscle cramps of left calf muscle in Feb / march and observed 3-4 times over a period of 2 months . I was thinking that could be due to dehydration . On 03/ 14 /21 morning , I got severe left leg pain and could not able to walk. I took pain killers and did not subside and that end up going to hospital emergency . I was diagnosed with 2 blood clots in left leg . I do not have family history of clots nor any h/o major medical issues . All my previous and recent blood reports normal . I am currently in use of blood thinners

Anaphylaxis at half hour after second shot , had allergic symptoms on following Thursday 3/18 and Thurs 3/25

Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.

pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Very fatigued; I was running 102-103 fever/very high fever; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer vaccine and ended up getting really sick and going into the hospital. They determined he had an infection and pneumonia. Things spiraled in the wrong direction. In the afternoon then by the next morning the patient was quite ill. He was sick for like 15 days. Temps for 102-103F. Night sweats to chills. Very fatigued. He would get better, then sick again, then better again and then ended up in the hospital. The events started on 20Feb2021. The patient was hospitalized for the events pneumonia, infection, and getting really sick from 07Mar2021 to 10Mar2021. The patient underwent lab tests and procedures which included body temperature: 102-103 fahrenheit on an unspecified date, investigation: unknown result on an unspecified date. Therapeutic measures were taken as a result of pneumonia, had an infection, getting really sick, i was quite ill, temps for 102-103f, night sweats to chills, night sweats to chills, very fatigued, i was running 102-103 fever/very high fever. Treatment for severe infection and Pneumonia : the patient had "a lot of injection going in his arm, they gave him fluids they gave medications, they tried to bring the Fever Down, they tried to bring the infection down to help clear out the Pneumonia." The outcome of the events was recovering. Information on the lot/batch number has been requested.

Massive Heart Attack. Was given stent and Dr believed the injection possibly pushed me over the edge with blockage

Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with chest pain and sweats. Pain intensified and brought to Urgent Care at 8 am where an EKG was completed and showed signs of a heart attack. Was rushed to Hospital Emergency room. Admitted and examined. Completed an angiogram and noted that there was a blood clot that appeared to dissolve. Troponin levels were high showing damage to the left artery. Spent the night in the hospital. Prescribed medication for cholesterol, blood thinners, and seeing a cardiologist.

Bilateral pulmonary embolism which was diagnosed on 4/14/21 after 2 days of severe shortness of breath. Associated with hypoxia requiring supplemental oxygen. Patient is morbidly obese which is only other risk factor for pulmonary embolism. He denies history of increased sedentary activity, denies recent travel, denies known history of a hypercoagulable disorder or family history of blood clots. No other causative factors for the pulmonary emboli have been identified.

I had a severe anaphylactic reaction; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 10:30 as a single dose for COVID-19 immunisation. There was no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 23:15, the patient experienced a severe anaphylactic reaction, with swallowing difficult, hives, significant swelling of the face, very puffy and watery eyes, and significant swelling in the throat and uvula that made breathing and swallowing difficult. The patient went to the emergency room (ER) and received epinephrine, prednisone, and a large dose of intravenous (IV) diphenhydramine (BENADRYL). Clinical outcome of the event severe anaphylactic reaction was recovering. Information on about lot/batch number has been requested.

Death by suicide sometime between late evening Wednesday, April 21st, 2021 and early morning April 22nd, 2021. He was found at about 8am that morning.

Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convulsing and then tipped over". AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc.

massive heart attack; knee pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206 and expiration date not provided) via an unspecified route of administration, administered in right arm on 12Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included heart attack in 2019, heart disorder (Heart), Blood cholesterol abnormal (cholesterol), hurt his knee at work prior and torn meniscus. Concomitant medications included ongoing ticagrelor (BRILINTA) for the heart; ongoing atorvastatin for cholesterol and ongoing carvedilol (COREG) for the heart. The patient previously took clopidogrel (PLAVIX) for heart attack. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No adverse events following prior vaccinations. The patient called about the COVID 19 vaccine. He received his first COVID-19 vaccine on 12Mar2021 and suffered a massive heart attack on the same day. After the event, his cardiologist reviewed video from the heart catherization to open the blockage and the cardiologist indicated that the area that was obstructed with this heart attack had not been obstructed 2 months ago. The cardiologist believed that the COVID 19 vaccine is the culprit in causing the massive heart attack. The cardiologist believed the area of the blockage was too dramatic. The cardiologist encouraged the caller to report the event and the cardiologist will offer his expertise in this matter if needed. The patient also tried to report to his local health department but is waiting on a call back from them. He reported that he had a heart attack in 2019. He was taking Plavix but after this heart attack his cardiologist has changed some of his medications. He reported he believes his medications were changed at his follow up visit with the cardiologist on 23Mar2021. He reported that he had continuous blood work done while in the hospital. They were monitoring his troponin levels. He also had a chest X-Ray, EKG and after the heart attack he had an echocardiogram to monitor the extent of the damage caused by the heart attack. He clarified that he did go to the emergency department on 12Mar2021, the same day he received the Covid 19 vaccine, but for knee pain. He received a pain relief injection of fentanyl that day. He had hurt his knee at work prior. He had previously had an MRI of his knee that showed a torn meniscus. He does not believe his knee pain on 12Mar2021 is related to the Covid 19 vaccine as he had already had an MRI that showed a torn meniscus. He had gone to the emergency department for pain management of his knee. He thought he would be given a lower strength pain medication but received Fentanyl. While the patient was at the emergency room for his knee, he suffered a massive heart attack. The patient clarified that he went to the emergency department because of pre-existing knee pain and while at the emergency department caller suffered a massive heart attack. The patient was hospitalized for massive heart attack from 12Mar2021 to 18Mar2021. The outcome of the event heart attack was recovering while the outcome of the event knee pain was unknown.; Sender's Comments: Based on temporal association, the causal association between BNT162B2 and the massive heart attack cannot be completely excluded. The knee pain was assessed as an intercurrent condition and is 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 RAs, Ethics Committees, and Investigators, as appropriate.

Pt received Pfizer COVID vaccine on 3/26 at facility. Pt presented to the ED on 3/30 for evaluation of chest pain at around 0722 on 3/30. Per ED provider note, "This patient is a 43 y.o. male who presents to the ED for evaluation of chest pain. The patient drove here two days ago and was feeling well when he went to sleep. He was awoken from sleep early yesterday morning with "intense" left sided chest pain with radiation and tingling sensation down his left arm. The patient says that his pain has since been fairly constant, waxing and waning in intensity. He says that his chest pain is still currently present, mostly localized in his left shoulder, but improved when compared to the pain that woke him up again this morning around 03:00. No reported vomiting, abdominal pain, fevers, chills, cough, or shortness of breath. Patient notes that he received the second dose of the COVID-19 vaccine 4 days ago. Patient reports family history of cardiac disease in his father. He denies any personal history of cardiac disease, and says that his last cardiac work up was a couple years ago for PVCs. The patient is not a smoker and denies any history of diabetes, hypertension, or high cholesterol. There are no other complaints. There are no other exacerbating or alleviating factors. There are no other reported associated signs or symptoms" Pt was given nitroglycerin ointment and aspirin chewable 324mg in the ED. " In addition, "This is a 43-year-old male presenting to the emergency department with just over 24 hours of left-sided chest pain with radiation into the left shoulder and down the left arm. Symptoms were more severe prior to the patient's arrival to the hospital. He was given nitroglycerin and aspirin upon arrival here. EKG shows subtle ST abnormality in the inferior lateral leads. Troponin is elevated at 11. Differential includes non ST-elevation myocardial infarction, myopericarditis. Patient will be admitted to telemetry. He will undergo a cardiac catheterization today." Pt was admitted, and per hospitalist note on 4/1, "Patient presented hospital with chest pain and EKG changes-there was initial concern for NSTEMI. Had cardiac catheterization with clean coronaries. Then thought to have pericarditis. Patient had trivial pericardial effusion on echocardiogram. Had MRI that demonstrated myocarditis as well. Patient improved on colchicine and NSAID therapy. Discussion had with cardiology will continue this and to be tapered in the office setting. Will continue NSAIDs for approximately 2 weeks then begin tapering. Will likely need colchicine for approximately 3 months. Patient was placed on beta-blocker to help with symptomatic treatment and help alleviate plain. Patient was started on metoprolol, was cautioned side-effects of hypotension, bradycardia, exercise intolerance .Patient should monitor heart rate and blood pressure daily. Hold if heart rate <50 or blood pressure less than 100 systolic and notify provider. Patient was advised he may follow-up with Dr. Caution GI upset, nausea vomiting diarrhea. If diarrhea with colchicine would recommend back down to daily from b.i.d. treatment. Patient was ambulatory and functional without significant symptoms, vital signs within tolerable limits, and agreeable to discharge plan.. Patient ultimately discharged in stable condition. All questions answered to apparent satisfaction. Patient cautioned side effects of medications. Patient was instructed if reoccurrence or any concerning symptoms to contact provider or present to nearest emergency department based on acuity. Patient and family voiced understanding of recommendations and in agreement with discharge plan."

Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patient states about 10 -12 hrs later, began an adverse cardiac event. Patient states the day before he injured his knee at work and went to ED from an injury the day before. At the ED they gave Fentanyl and he got sick and told the nurse that he was experience chest pain. Felt burning or falling asleep sensation in arm and chest. Told the nurse he felt like he was having a heart attack. They came in ED with crash cart and confirmed that he was having a heart attack while in ED. Transported from church to hospital.

Patient had systolic and diastolic heart failure on 02/20/2021 possibly related to COVID-19 Vaccination given 12/30/21 & 2nd Dose on 01/20/21 (heart inflammation?); Grade III left ventricular diastolic dysfunction was observed during hospital stay; cause unknown; EF of Lt. Ventricle has increased form 21% on 02/22/21 to 33% on 04/29/21 per two echocardiograms on each date. Pt. was given meds for Heart Failure, BP and Hyperlipemia; Pt. had a Cardiac Cath of Rt. & Left Heart on 02/23/21; no signs of coronary disease. Pt. is receiving ongoing outpatient chronic care treatment for issue.

Fever, severe chest pain/throbbing of the chest area, heart arrhythmia. Fever began Thursday 5/13, with the chest pain, throbbing and arrhythmia following early morning on Friday 5/14. 911 was called Saturday afternoon, 5/15. Was taken by ambulance to hospital, after which several tests were administered including a chest X-ray, blood tests, heart stress test, as well as an ultrasound of the heart/chest area. Stayed in hospital for from Saturday 5/15 to Monday, 5/17. Was released 5/17 at approximately 6:00 pm. Further treatments included prescriptions of Amoxicillin, Atenolol, and Ibuprofen.

Over a period of about a month I had 3 superficial blood clots the first being in the left leg and the 2nd 2 in the right leg each about a week apart.

I start having SOB and fast heartbeat around the end of April. It got worst through May. I went to the ER They did blood work, that came back abnormal. So, they did a CT scan, it show that a had pulmonary embolism, which confirmed that I had a blood clot. The blood clot caused a strain on my right side of my heart. I am not taking blood thinners. I have never had blood clots before the vaccination.

I developed acute right posterior pleuritic chest pain and shortness of breath. Diagnosed with multiple pulmonary emboli (see below). I was started on Eliquis initially, but then had worsening symptoms on 2/4/21 and switched to Lovenox injections. Symptoms have been slowly improving since then.

small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.

After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two days later, on Monday morning, I contacted my primary care physician's office, who told me to go to the ER to be evaluated for a blood clot. At the ER, they performed a doppler ultrasound on my right leg and found a superficial clot in the greater saphenous vein of my right leg. There was no evidence of a DVT in the right leg.

He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had difficulty breathing, shortness of breath, fatigue, shakes, chills and feeling of weakness/dizziness. It lasted a few days. Then, April 9, 2021, he received his second Covid19 Pfizer shot, same lot at 12:15 pm and the next morning, Saturday, April 10th around 9 am Ira felt the same symptoms from shot 1, but more intense. He was feeling weak, had chills, shakes, profuse sweating, difficulty breathing, shortness of breath, dizziness and vomiting. He was unable to keep water down and stayed in bed. A little after 12pm, he complained of difficulty breathing and possibly not getting enough oxygen so I grabbed my equipment (since I'm a CNA) and checked his vitals. His B/P was very high ( 166/107), no fever (96.7), pulse was normal 72, and low respiration but oxygen was above 90. He said he needed to use the bathroom, I suggested using his urinal but he said he needed to have a bowel movement. Once he was in the bathroom, I went downstairs for a glass of water and then suddenly I heard a huge thump. I ran upstairs, knocked on the bathroom-no response but I could hear noises, so I opened the door and I saw he was face down on the floor, head under the bathroom sink counter, blood everywhere, and he was convulsing. I grabbed him immediately and moved him to his side (I had my fitbit on, it said it was 12:30pm), and he kept seizing. He looked discolored almost blueish color. I held him on his side, he vomited, making noises, but unable to speak, continuing to have a seizure. Seizure lasted three minutes. At 12:33pm, once he had calmed, I ran downstairs to find my phone. I was back at his side calling 911 at 12:35. Paramedics arrived 9 minutes later and took him to the hospital. My brother picked me up and took me to the hospital. Once outside his door, I noticed he was finishing taking X-Rays when he suddenly had another seizure.

Patient's physician reported this adverse event by phone to Medical Center administration on 4/13/2021. Per the physician, the patient received his 2nd Pfizer COVID19 vaccination dose on Friday 4/9/2021 at the drive through vaccination clinic. On Saturday 4/10/2021 the patient told to his wife that he felt ill, continuing through Sunday. On Sunday, 4/11/2021, at his home, the patient told his wife that he felt ill and went to sleep. The patients wife found him not breathing, called 911 and started CPR. The patient was pronounced deceased at his home and was not transported to hospital.

Patient was seen at Hospital for seizure, fall and head injury. Subsequent workup following transfer to another hospital revealed L frontal lobe parenchymal hematoma with overlying subarachnoid hemorrhage, no underlying aneurysm or vascular malformation. He had MRI with and without contrast revealing partial occlusion and thrombus of the superior sagittal sinus with adjacent hemorrhage and edema. Treated with heparin, transitioned to coumadin.

March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial blood clot in left leg via ultrasound, treated with baby aspirin for 3 days and heat pad, symptoms slowly lessened till 2nd dose of vaccine on April 2nd, after second dose symptoms worsened again, both legs still fatigue very quickly to this day (April 15 2021) when I'm sitting down on chairs, seats etc. April 8 2021, 12:30pm - heart pain for 30 minutes, felt very weak, similar to light heart attack, ER visit later that day couldn't find any explanation

Patient passed away on 4/13 after presenting to local hospital with near syncope and AKI. Records from local hospital are unavailable, unclear regarding cause of death and circumstances thereforth.

Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by the family. Per nurse practitionar who is the aunt of the deceased), patient passed away on Monday, 4/19/2021. He was found unresponsive on a jogging trail, where he had been jogging, by a third party person. They had called an ambulance and could not revive him. Family requested a VAERS report due to the proximity in time to his 2nd Pfizer vaccination. He had received his vaccination at 9:56am on 4/14/21 (lot ER8730) and per father the only side effect he indicated was a sore arm. Autopsy pending per family.

Developed Deep VEIN thrombosis (DVT) in the left leg and a Pulmonary Embolism. Was hospitalized for 5 days and had to have a surgical procedure to insert a screen into my inferior vena cava

ITP - he received the Pfizer COVID vaccine the day prior to admission. He subsequently felt fatigued and awoke this morning with intermittent petechiae. While golfing, he subsequently noticed increased bruising over his left shoulder. He had two episodes of epistaxis for which urgent care and then ED evaluation revealed evidence of thrombocytopenia. Platelets found to be 3,000, normal Hb, normal WBC, no splenomegaly, no lymphadenopathy,. Oncology saw recommended decadron 40mg daily for 4 days

Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consulted for medical management. Thrombocytopenia: - plt count stable today, Hgb stable - hematology consulted, appreciate recs: plan to send for serum antibodies to test for drug induced thrombocytopenia for carbamazepine and valproic acid - will hold protonix as possible offender - peripheral smear (Mercy OKC, 5/8/21): macrocytic red blood cells, moderate thrombocytopenia, rare focal platelet clumping present - less likely vaccine induced TCP---usually this is seen with the AstraZenca and Johnson and Johnson vaccine, not in Pfizer vaccine - if plt remains stable, may d/c home with plan for f/u with Dr outpt COVID-19: - case discussed with Health Department, COVID test for variant testing sent 5/6 - for now, will cont care in isolation - patient with positive COVID-19 test - positve COVID-19 test in January 2021, negative COVID-19 screen in April 2021 - pt with no active respiratory sx AMS: unchanged - waxing and waning mental status - improved AMS with improved renal fxn Acute renal failure: improving - Cr: 1.64, cont PO intake LE edema: - unchanged, low albumin levels, need to increase protein intake Chronic systolic heart failure: stable - cont to hold diuresis Disposition: - cont care in COVID unit, Pulmonary to follow Estimated length of stay is 5 day(s).

Patient hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was multiple subsegmental pulmonary embolism.

This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches for about 7-8 days. Says was having body aches for about 8 days, had COVID 19 vaccine first dose on 5/14/21. Since then, had worsening body aches and also started having fever(not sure how much). Urine color changed to brown in the past week. No change in appetite or nausea or vomiting prior to admit as per him. No new medications and does not consume recreational drugs. Not an alcoholic, no recent trauma, does not work out and was not exposed to extreme heat or cold recently. In ER, patient was found to having AKI, shock liver, CK level which is too high to be calculated, had 1 episode of high-grade fever. He was therefore started on IV fluids and admitted for further management of rhabdomyolysis. Overnight had no urine output and having poor urine output since this a.m.. Had 1 episode of nausea and vomiting this morning. No more fever since on the floor. Complaining of epigastric pain that woke him up from sleep this afternoon.

5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuana use, who presents for slurred speech. Accompanied by wife. Patient was in his normal state of health until Friday when he got his Pfizer Covid vaccine. About 5 hours later he was noted to have a headache and some slurred speech but patient and wife did not think anything of it. They went to some graduation parties this weekend and his speech continued to get worse which is what prompted them to present to the ED today. He denies that this is happened before. Feels like it is difficult for him to find words but not to actually say words. He does surf but denies being in murky water or swimming in fresh water. He denies IVDU. No underlying coagulopathy or cardiac history.

Patient who had been infected with COVID19 in December 2020 and received bamlanivimab therapy. After recovery he received his COVID-19 vaccine series 4/1/2021 & 4/22/2021 with Pfizer-BioNTech. Patient then developed headache, chills, fever, body aches, thrombocytopenia, and elevated troponin levels on 5/10 and was admitted to the hospital 5/14. Concern for COVID-19 vaccine induced MIS-A or myocarditis. Patient received IVIG after ruling out other diagnosis and had a good recovery resulting in discharge home.

Blood clotting; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 21Apr2021 at 09:00 (at the age of 44-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: FR2613), administered in arm left on 25Mar2021 at 09:30 AM, for COVID-19 immunisation. The patient experienced blood clotting on 16May2021 at 22:00. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date (prior to vaccination). There was no treatment received for the event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.

Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given as "he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.

Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, case send to a medical examiner. Case was noted upon chart review by reporter.

Severe stiffness and pain in upper neck/base of skull. Severe headaches. Blurred vision. No treatment.

Extensive right lower extremity DVT; "Extensive occlusive thrombus in multiple calf veins extending throughout the external iliac vein and becomes partially occlusive in the distal common." found July 22. Likely developed much sooner.

Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Now having diabetes issue; Two trips to ER in June with abnormal heart beat and breathing issues; Two trips to ER in June with abnormal heart beat and breathing issues; Having reactions to anything with sodium over 50mg.; Sea salt allergy went from mild to anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021(age at vaccination:44 Years) as single dose for covid-19 immunization. Patient didn't received other vaccination within 4 weeks prior to vaccination. Medical history included iodine allergy from an unknown date and unknown if ongoing, food allergy sea salt allergy from an unknown date and unknown if ongoing. Concomitant medications included testosterone (TESTOSTERONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested to COVID-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number EN6204) via an unspecified route of administration in Arm Right on 21APR2021 as single dose for covid-19 immunisation. It was reported that blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis. Trip to ER on 29May from Turkey with sea salt. Since then having reactions to anything with sodium over 50mg. Went on low sodium diet. Two trips to ER in June with abnormal heart beat and breathing issues. Now having diabetes issues. Doctors are puzzled that it all started with first Pfizer shot. Was given Benadryl shot with second Pfizer shot on 12May2021. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm. Patient went for Emergency room and physician office visits for the events. The outcome of the events anaphylactic reaction, diabetes mellitus, heart rate irregular, dyspnoea, hypertension, heart rate decreased, reaction to food additive was not recovered. Information on the lot/batch number has been requested.

This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Right on 21Apr2021 (Lot Number: EN6204) as DOSE 1, SINGLE at the age of 44 years old for COVID-19 immunization. Medical history included iodine dye sea salt allergy from an unknown date. Concomitant medications included testosterone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient has not been COVID-19 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 21Apr2021, the patient experienced having blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis in 2021. Trip to ER on 29May2021. Two trips to ER in June with abnormal heart beat and breathing issues in 2021. Now having diabetes issues in 2021. Doctors are puzzled that it all started with first Pfizer shot. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm in 2021. The events resulted in doctor or other healthcare professional office/clinic visit; and emergency room/department or urgent care. The outcome of the events was not recovered. No treatment given to the patient for the events.

coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. 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.

The next morning I started to have some pain in my right calf which worsened throughout the day. The following day I went to the ER with a DVT. I was given Xarelto for treatment.

45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his first dose. He began having bilateral lower extremity pain the following evening. In addition to the pain, he has been dealing with headaches, dizziness, auditory hallucinations, and large areas of redness and warmth on the left upper extremity and bilateral lower extremities. He went to the ER on 1/27/2021. Upon review of those records, he had microscopic hematuria. The patient states that he passed some kidney stones this week. Other abnormal labs include very elevated liver enzymes which the patient has not had before. He does not drink any alcohol. No new medications. He also had thrombocytopenia. O) Gen: Patient is in a wheelchair during today's exam. This is the first time he ever been in the exam room in a wheelchair. He required assistance to stand up. He says the pain is what makes it so difficult to stand up. Skin: On the left forearm, there is a large area of redness and swelling. The redness is relatively faint. On the lateral aspect of the right thigh, there is a large area of redness and swelling which is more prominent. ASSESSMENT 1. Severe myalgias 2. Elevated liver enzymes 3. Thrombocytopenia PLAN 1. Check sed rate and CRP. 2. Recheck CMP along with viral hepatitis panel and lipase. 3. Recheck CBC with differential. 4. Further recommendations based on these results. ADDENDUM Patient called on 2/1/2021 and reports his pain is getting worse to such an extent that he has been unable to make it to the bathroom fast enough and has been having accidents.

Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform rash. He tested negative for the flu and was given empiric oseltamivir. He had persistent fever and was given doxycycline and ceftriaxone by urgent care on 2/2. On 2/4 at urgent care he was noted to be hypotensive and referred to ER. He had findings of cardiogenic shock and intra-aortic balloon pump was placed. He was treated for acute heart failure with improvement in symptoms. He was also treated for pneumonia with piperacillin/tazobactam as well as amoxicillin / clavulanic acid. He was discharged with resolved fever, resolved rash, and improvement in EF based on cardiac MRI. Workup for other viral causes of myocarditis was negative.

Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left side of my face began to feel pressure. My wife injected me with my EpiPen. Within 10-15 minutes, the symptoms began to recede.

Acute right index finger digital ischemia after initial complete numbness from PIP joint distally absent any previous symptoms ever. Recurrence Jan 20 of same symptoms. Suspect antibody complex clot blocking terminal branches of digital arteries.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium

I received the vaccine on 3/21. On 4/1 I had a breakthrough grand mal seizure walking down the street after being seizure free for almost 5 years. The seizure resulted in a fractured vertebra (T12). On 4/5, while resting at home I woke up and had another seizure sitting in a relax the back chair. I had a mri on my brain that I understand came back normal. The doctors aren?t sure what caused the seizures but increased my dosage by 500 mgs per day despite my previous dosage controlling my seizures for about 5 years prior to my vaccine. No doctor has definitively stated the seizures were caused by the vaccine. However, the timing has prompted me to notify you of these events.

patient called to report that not right after his shot but later that night when he was going to bed his throat started closing up and he couldn't swallow. Pt proceeded to the emergency room where he received treatment for anaphylactic reaction. Patient states he is better now.

DVT in calf that turned in to substantial pulmonary embolisms in both lungs with no prior blood clot history. Treatment included a TPA to dissolve clots as well as vascular surgery to remove clots not dissolved in the left lung.

- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.

Suffered ischemic pontine stroke 4 days after vaccine received. Does have significant risk factors including DM2, HTN, hyperlipidemia, family history of stroke.

Patient received his second Pfizer vaccine on Friday. Saturday he came down with symptoms that we considered were like the stereotypical second dose. Fever, cough, shortness of breath, coming and going. It lingered until Tuesday, at which time he got a Covid test- negative. Went to dr, and he said there was a possibility of blood clots. Tests showed that he had severe pulmonary embolisms in both lungs- the main and 3 secondary arteries.

8 hours after 2nd pfizer covid vaccination. Fever 101.3 , chest pain with diaphoresis, trended troponins to a nadir of 19.0. EKG changes with ST changes in 3 non-contiguous leads. Initially treated for an NSTEMI with heparin. Transitioned to colchicine and ibuprofen for myocarditis.

Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed.

mini stroke; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm, on 30Mar2021 at 09:00, as a single dose, for COVID -19 immunisation. The patient's medical history included slight issues with cholesterol and pre diabetic, but the patient has been healthy. The patient has no known allergies and other medical histories. Concomitant medication was not reported. On 03Apr2021, 4 days after the patient received the vaccine shot, he was diagnosed with a mini stroke. The patient was shocked as he was too young and have had no medical issues in his entire life, only change was the shot. The patient also experienced numbness in his right arm and hand which subsided but he still has some numbness on the right side of this face. The patient was hospitalized for 1.5 days and treatment included taking low dose aspirin and Lipidore (as reported). The patient had no COVID prior vaccination and no COVID tested post-vaccination, the patient also had no other vaccine in four weeks and other medications in two weeks. Outcome of the event was recovering. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and disability or permanent damage. Information on the Lot/Batch number has been requested.

acute dyspnea started 4/10, 1 day after second vaccination, no other provoking factors, symptoms persisted for 3 days, CT chest 4/13 showed extensive bilateral PE

Pt presented to the hospital after a cardiac arrest. Work up showed renal artery thrombosis b/l causing renal failure and hyperkalemia. ROSC was achieved and pt coded multiple times after. We were unable to obtain CT A 2/2 to pt being unstable so only U/S imaging with doppler was used for diagnosis. Pt was treated with heparin gtt., hematology work up was sent but cause not identified. ECHO did not show thrombosis in the heart. CCRT was attempted but pt expired.

stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.

Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was pronounced dead several hours later. Patient had no health issues and was 45 years old.

three blood clots in right leg; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613, Expiry date not reported), via an unspecified route of administration, administered in the left arm on 25Mar2021 15:00 (age at vaccination was 45 years) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity (sulfonamide allergy) from an unknown date and unknown if ongoing, and seasonal allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included fluticasone propionate taken for an unspecified indication, start and stop date were not reported; olopatadine hydrochloride (PATADAY) taken for seasonal allergy, start and stop date were not reported. The patient experienced three blood clots in right leg on 09Apr2021 20:00 with outcome of recovering. Therapeutic measures were taken as a result of three blood clots in right leg (thrombosis) that included blood thinners (Eliquis). The event was reported as serious, medically significant. No follow-up attempts are possible. No further information is expected.

Myopericarditis with fatigue, myalgias, joint pains, and dispnea on exertion since his second COVID 19 shot. Pt also found to have a DVT.

Deep vein thrombosis (DVT). Woke up on 4th day after vaccine (May 5, 2021) with pain in calf. Swelling continued to get worse. Went to an emergency room just over one week after vaccine (May 8, 2021) and was diagnosed with DVT in the lower left calf (after D Dimer test and ultrasound). No family history of clotting issues. And no personal history of clotting issues. Currently on Rivaroxaban (Xarelto), 15 mg twice per day. Will be on for at least 3 months (moving to 20 mg once per day after the first 21 days).

Anaphylaxis with swollen lips; Anaphylaxis with swollen lips; felt like throat was closing; difficulty breathing, could not take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 at 12:00 (Lot Number: ER8B2) as SINGLE DOSE for COVID-19 immunization. Medical history included possible rheumatoid arthritis from an unknown date and allergy to poultry from an unknown date. There were no concomitant medications. No other medications were received by the patient within 2 weeks of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 23:00, the patient experienced anaphylaxis with swollen lips and reported that he felt like his throat was closing and had difficulty breathing, could not take a deep breath. The patient went to emergency room as well as the physician office for the reported events. As therapeutic measures multiple Intravenous (IVs), oral benadryl and steroids were taken by the patient for the reported events. The outcome was reported as recovered with sequel for the reported events.

patient was Diagnosed with Pulmonary Embolism after her second covid vaccine. patient symptoms were dyspnea and syncope . Patients treatment is to take Eliquis everyday.

pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on Mar2021 at 11:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing venous insufficiency since 2019. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient stated that he received his first dose on 30Mar2021 or 31Mar2021. On an unspecified date, the next day after the first vaccination, the patient experienced pain in his leg that felt like a clot for the first week and a half to two weeks. Then, the patient got a little bit better, even though he had almost gone to the emergency room, but he got better after a couple weeks. The clinical outcome of "pain in his leg that felt like a clot " was resolved on Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021507016 Same patient/drug, different dose/event

Developed high heart rate >150bpm with irregular rhythm on 5/16 around 12:00pm, Sought care at Emergency Department, diagnosed with paroxysmal atrial fibrillation, first known occurrence. Treated with metoprolol and metoprolol tartrate, and returned to normal rate and sinus rhythm by 3:00pm.

My brother had his second vaccine shot on 4/30. When I talked to him on 5/5 he told me he'd had a lot of joint pain and fatigue but thought he would go into work the next day. Thursday he left work feeling sick with a lot of 'rib pain'. At some point that night he passed away. We still do not have an autopsy report, but the timing seems odd.

Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmonary edema related to heart failure, ejection fraction and improved and patient successfully discharge from the hospital. Of note, patient also tested positive for rhino/entero on RVP and FIP1L1-PDGFRA rearrangement.

Patient went to sleep and died within 12 hours of vaccination; feeling sick; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 45-year-old on 20May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 45-year-old healthy male patient received Pfizer Covid vaccine in the morning, reported feeling sick by the evening on 20May2021. Patient went to sleep and died within 12 hours of vaccination on 20May2021. Event took place after use of product. The patient died on 20May2021. It was not reported if an autopsy was performed. The outcome of event feeling sick was unknown. The outcome of event 'Patient went to sleep and died within 12 hours of vaccination' was fatal. Information on lot number/batch number has been requested.; Reported Cause(s) of Death: Patient went to sleep and died within 12 hours of vaccination

-tightness in inner thigh- day or so after first dose -tightness in calf worsened over the course of a couple weeks -swelling and soreness in calf gradually increased until doctor visit -doctor visit and ultrasound found multiple blood clots in mid thigh and calf -doctor prescribed blood thinner -continued swelling and tightness in thigh and calf

1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2/25), I experienced symptoms of a minor stroke - I experienced lack of coordination in typing and later that evening experienced difficulty with speaking and comprehension, but only for a few minutes. A few days later, that weekend, I had some issues playing songs on the piano I had played before, making a lot of mistakes. About another 2 weeks afterwards, on 3/9/2021, I experienced more symptoms of stroke. For most of the day I had issues with typing, and later that evening I had some coordination issues with closing a soda bottle. On the morning of 3/10/2021, I continued to experience issues with typing and also had difficulty speaking and understanding my wife. At this point I went to the emergency room and was found/diagnosed to have experienced multiple TIA strokes.

My stepfather on 31May2021 was diagnosed with Covid and right now has pneumonia; My stepfather on May 31 was diagnosed with Covid and right now has pneumonia; He had some trouble breathing; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (Patients Stepchild) via medical information team. A 45-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23May2021 (at the age of 45-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing (it was a light condition. Arthritis was not getting worse he takes some medication). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient did not have any adverse events. On 31May2021, the reporter stated that patient was diagnosed with Covid and right now had pneumonia. Patient went to the hospital 2 days after that. Patient had to go back to the hospital a second time because he had some trouble breathing (unknown date in 2021). After the second time going to the hospital was when he was diagnosed with pneumonia. Patient was diagnosed with pneumonia a week ago (unknown date in May2021). Patient still had pneumonia, but it was much better with the medication. The reporter clarified that the patient had COVID-19 PCR testing and it took 2 days for the results to come back and patient went to the hospital he was referring to the Emergency Room for trouble breathing. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31May2021. Therapeutic measures were taken for the results of the event pneumonia. The events covid-19 and pneumonia assessed as serious. The clinical outcome of the event pneumonia was recovering and outcome of the other events was unknown. The patient scheduled to received second dose of Pfizer COVID Vaccine on 13Jun2021. Follow-up attempts are needed; information about lot/batch number can be obtained.

After receiving my first dose of the Pfizer vaccine I experienced erratic heartbeats/afib. It started on Saturday, two days after receiving the shot and I debated on whether to go to the ER. I ended up seeing my cardiologist the following week but by then was feeling better. The irregular heartbeats last about 3 days, getting progressively better by the third day, but it was a very slow process. Obviously very scary since it was pretty severe at first and I didn't know if I was having a cardiac event.

First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and lasting until ~36 hours after. The subsequent illness I reported in V-safe seems unrelated to my vaccination. I experienced fever (up to 102 degrees) and general malaise for three successive nights starting on June 4th, 2021 (2+ months after second dose). The fever only came at night and broke in the early morning each night. I had two COVID screenings on June 7th, both came back negative. The final fever occurred the night of June 6th. I continued experiencing malaise and general weakness and had some bloodwork done. My bloodwork came back indicating Fe deficiency anemia, and I have been experiencing this condition since. The cause is suspected to be due to overuse of NSAIDs in dealing with a bulging disc in my cervical spine from early March onward. I am scheduled for endoscopy to further investigate whether I am having bleeding issues causing the anemia. as previously mentioned, seems unrelated to vaccination.

Within 48 hours of receiving Pfizer vaccination on 4/7/21, I developed a significant DVT blood clot in my right leg, which I've been receiving treatment for ever since. No prior condition/diagnosis of this. Noticed on 4/9/21, didn't hurt, but it felt like there was something in my leg. Woke up 4/11/21 and could barely walk. Thought I strained my calf/leg. Had to travel for work. Returned home on 4/25/21. Took myself to ER on 4/27/21 and received treatment, including diagnosis, ultrasound, eliquis. Have been seeing vein doctor monthly ever since.

experienced significant shortness of breath, heavy wheezing, and coughing on the weekend of 2/6/2021. Slight wheezing had been ongoing for months (difficulty breathing in January of 2020 when diagnosed with influenza A and intermittent slight wheezing continued throughout the year). Symptoms became worse throughout the weekend. I did continue my normal routine (taking trash to the dump, helped move a heavy tank out of a walkout basement, and moving twelve 40 pound bags of wood pellets from store into truck then from truck into my home on day of hospitalization) Hospitalized on 2/7/2021

On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.

Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath. The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. 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 had an unwitnessed cardiac arrest while outside walking his dog. AED in the field initially advised shock and was shocked 3 times without effect. At the time EMS ALS arrived, patient was in PEA arrest. He was transferred to Hospital with CPR in progress. Time of death called at 1857.

Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient himself). A 46-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 Left arm on 23Feb2021 12:00 pm (at 46-year-old) at single dose for COVID-19 immunisation in hospital. Medical history included Seminoma from 2011, Suframides allergy. The patient's concomitant medications were not reported. The patient experienced Atrial fibrillation on 25Feb2021 02:30 am. No other vaccine in four weeks. No Other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The events were not resulted in emergency room visit or physician office visit. No treatment received. The outcome of the event was Recovered on 25Feb2021. Information on the lot/batch number has been requested.

Approximately 3 minutes post-vaccination, the patient suffered a witnessed tonic-clonic seizure, which lasted less than a minute.

Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf pain 2 daysafter that. Was diagnosed with DVT via Doppler ultrasound on Monday, March 8, 2021.

left pontine stroke patient had right sided weakness of upper and lower extremity 3 days after vaccination and presented to the emergency department on day 6 when he was found to have a stroke on MRI

Rapid heart rate triggered an A Fib needed to be hospitalized and put on medic to lower blood pressure and fix heart rythm . I currently still have elevated blood pressure. Never had a fib before never was on meds for heart.

Within an hour of receiving the vaccine I felt a sharp pain shoot down the back of my knee to my heal. I continued to work with the pain. The next day my knee and calf was sizeably larger. I went to the urgent care on March 19, 2021. Then to the Emergency room on March 20, 2021. They performed an ultrasound of my leg and found a blood clot. It is in a superficial vein. Followed up with a vein doctor and will go again in three months for another follow up.

On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration with syringe (a Haiou, 1ml, 23g, 1'', Lot 20JC2, Exp: 10-17-25) resulted in needle going into patient's arm, but the 2 piece retractable distal needle and hub separated from the proximal tube part of the syringe resulting in COVID vaccine dose being lost. None of the 1st dose entered patient's arm. With needle and distal hub still fully immersed in patient's arm, RN removed it and held pressure on bleeding. RN informed patient that needle failed, to which pt stated he was "shocked," and felt an "electric" sensation when needle was inserted. Patient tolerated well. Bleeding abated. RN administered a 2nd dose of vaccine to the patient with no problems on the same LUE, more medial by about 2 inches than the first attempt. Bandage applied to both sites due to scant bleeding. Patient tolerated well, but showed no emotion. Pt complied with all instructions, and RN thanked patient for coming in.

DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM THAT EVENING ON 3/15/2021 WENT TO BED WITH CHEST PAIN AND DID NOT WAKE UP THE NEXT MORNING PARAMEDICS WERE UNABLE TO REVIVE HIM, PRONOUNCED HIM DEAD AT THE SCENE.

Patient was found deceased on arrival in his living quarters after not showing up for work. This was approximately 14 days after his second pfizer vaccination. We have no reports of previous signs or symptoms in the days preceding his death. Patient had not visited the clinic since receiving his second shot in the series

Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf pain and swelling. Got worse over the following 3 days so he presented to Urgent care. DVT was identified in UC on bedside ultrasound, started on Eliquis that day.

Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: PT HAD FLUSHING AT 9 PM HEADACHE AND PASSED OUT FRACTURING HIS MANDIBLE IN PROCESS. PT HAD ATRIAL FIBRILLATION PT IS IN STABLE CONDITION ON DILTIAZEM HAD NO HX OF HEART DISORDERS PRIOR TO VACCINE

Patient presented to Hospital 5 days after second Pfizer dose with myocardial infarction involving the Left Anterior Descending artery. He had no significant risk factors for coronary artery disease. He reports feeling very fatigue and dyspneic after first dose, and started to have chest pain after second dose.

a 46-year-old male with no known past medical history who initially presented complaining of headache and neck stiffness with onset the morning of 04/03/2021. The patient states that his headache was initially gradual in onset and eventually decreased in severity on 4/5 however, on 04/06 after a day at the beach the patient developed a severe headache with rapid onset that he described as the worst headache in his life. He did try to medicate himself at home with 600-800 mg of ibuprofen every 6 hr with minimal decrease in his headache pain. As result he presented to urgent care for initial evaluation who sent him to the emergency department for possible brain bleed. On arrival to the emergency department the patient had a head CT which showed trace subarachnoid hemorrhage in the basilar cisterns likely due to ruptured cerebral aneurysm. He was transferred to for continued workup of the subarachnoid hemorrhage with CTA and possible IR intervention. At time my evaluation patient was resting comfortably in the bed. He continued to complain of severe headache and neck stiffness. He additionally notes that light and loud sounds make his headache worse. He denied any focal weakness, paresthesia's, numbness, speech difficulty, visual changes, or any other concerning neuro symptoms. Patient was hypertensive during my evaluation despite being on a Cardene drip. Patient's mother was at bedside and was able to assist with history.

Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bilateral leg pain + swelling. He was seen in hospital ER on 3/8/2021 and diagnosed with non occlusive dvt in distal fem vein of Right lower extremity

Multiple pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 10:00 (Batch/Lot Number: Ew6202) as single dose, for covid-19 immunisation at a pharmacy/drug store. Medical history included diabetes. The patient has no known allergies and no COVID prior to vaccination. The patient has other medications in two weeks but no other vaccine in four weeks. The patient experienced multiple pulmonary embolism in both lungs on 28Feb2021 08:00. The patient was hospitalized for multiple pulmonary embolism in both lungs for 3 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit, and considered life threatening illness (immediate risk of death from the event). The patient was treated with blood thinners. The patient had the second dose of BNT162B2 on 18Mar2021 at 11:00 am in the left arm. The patient was tested for Covid post vaccination via nasal swab (rapid) on 10Apr2021 which was negative. The outcome of the event was not recovered.

Started with dizziness then anaphylaxis like symptoms and lymph node symptoms of tingling lockjaw hard to swallow very difficult to breathe a little bit of chest pains, called EMS and paramedics to took blood oxygen levels, blood pressure which were all normal by then the symptoms had started to subside

I had a stroke. Assumed blood clot traveled from my leg, up through a hole that was discovered in my heart (PFO) and to my brain.

I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the hospital and was told I had a stroke in the right side of my brain from a clot in my brain, which they took the clot out using a catheter through my leg. I am currently undergoing rehabilitation at a rehab hospital.

46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.

Patient presented to the ED and was subsequently hospitalized for 3 days on 1/9/2021. On 1/21/2021 he presented to the ED with rash and hypertension. On 1/23/2021 patient presented to the ED and was subsequently hospitalized for 6 days for SIRS.

Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.

calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels tight,; pain running up the right arm up to the shoulder; pain running up the right arm up to the shoulder/his calf pain, started to feel tight, started within the last 2- 3 weeks; He asks if someone can tell him if it is a blood clot in the back of his calf; his eyes also hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. There was no medical history reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6202) at the age of 46-years-old for covid-19 immunisation and experienced If it is a blood clot in the back of his calf, Regular pain feeling, Headache, Muscle pain, Calf feels tight, stiff, it feels like dead weight, Pain running up the right arm up to the shoulder and Calf pain, started to feel tight. The patient reported that he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes on 12Mar2021. However, he says that the last few days there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping on an unspecified date. It wakes him up at times. He also reports pain running up the right arm up to the shoulder on an unspecified date. He says he is just curious in terms of what that might be. He asks if someone can tell him if it is a blood clot in the back of his calf on an unspecified date. The headache went away after 2-3 days. He says his eyes also hurt a little bit on 12Apr2021 and was the same time frame as the headache. He says those things were just mild, nothing major. He did not take anything for it. He confirmed he no longer has muscle pain. He just has pain behind the calf and right arm up to his shoulder. He says his calf pain, started to feel tight, started within the last 2- 3 weeks. The arm pain in right arm up to shoulder started maybe within the last 2 days. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient reports onset of symptoms on Wednesday (4/7). He states that initially it just felt like a cramp in his calf. He states that over the past couple days, the pain has gotten significantly worse. He states the pain is now sharp and severe in nature. He states that he is having due to the severity of the pain. He states the pain is now moving up into his medial thigh. Patient states that around noon on 4/10, he began having chest pain and shortness of breath. Patient describes a tightness across his chest and states that he cannot breathe associated with this. Patient does have a history of asthma and states that he has had a couple of episodes like this in the past. Patient also reports a history of diabetes, hypertension. Patient does report a family history of coronary artery disease as well as a family history of blood clots. He received his Pfizer Covid vaccine 2nd dose on 4/9/2021 (Lot # ER8729) and 1st dose (Lot # EN6204) given on 3/12/2021 at an outside facility He does report arm soreness but is otherwise doing well. No recent travel. No recent immobilization. Upon evaluation in the ED, he was noted to have positive US for DVT in the LLE. Follow up CTA Chest was positive for bilateral lobar and segmental PE with right heart strain. CVM was consulted for possible PE intervention evaluation. Patient started on therapeutic Lovenox, but discharged home on 4/11 with Eliquis. . The next day 4/12/21 he returned to ED for SOB/Wheezing and LLE pain. On 4/15/21 he underwent EKOS, IVCF and iliac stent placement per Vascular surgery and subsequently sent home on Eliquis 4/16/21. Pt returned to the ER again 4/21/21 for recurrent SOB. CTA chest with no significant change in clot burden, no associated hypoxia.

I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER 8729), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 46-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had a stroke. Blood clot travelled to his brain and effected left side of his body and ability to speak on 15Apr2021 at 17:30. The events resulted to emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received unspecified treatments for the event. Covid test post vaccination on 15Apr2021 with result of negative. The outcome of the events was recovering.

This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.

About 12 days after the vaccine, I woke up in the middle of the night with sharp pain in my chest. Since then I have had heaviness in my chest and other symptoms like difficulty breathing while walking or talking, etc. I was otherwise previously healthy -- non-smoker, drink very occasionally, mostly vegetarian, light on sugar consumption, daily exercise. I went to the doctor and then the ER at a local hospital on April 28. They found fluid and possible inflammation around the hearth along with very high blood pressure. Since then I have had medication for inflammation and high BP. They are still doing tests to figure out what is wrong with me.

He completely lost mobility on the left side of his body; Stroke; They found they clot, but could not extract it from what he understood; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 46 years old) for COVID-19 immunisation. The patient has no medical history. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. Since his stoke, he is doing better. He completely lost mobility on the left side of his body. His mobility on the left side of his body is slowly coming back. His job is in jeopardy. The doctors told him that there is no guarantee that he will regain full mobility. They did not give him a patient record card. If they did give him one, he left it at the house. He has been in the hospital ever since his stroke. They put him on blood thinners after his stroke. Whenever he was in the ambulance, he did not have high blood pressure. They were able to catch his stroke quick. They found they clot, but could not extract it from what he understood. Adverse events reqiored Emergency Room. The patient was hospitalized on 01Apr2021. The outcome of clot was unknown and other events was recovering. Information on the lot/batch number has been requested.

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt apeared to have HTN crisis / seizure like aftivity 3 min after injection. Airway and then consiousness was lost with no breathing. EMS was called pt was assisted to floor and after opening airway and stimulation regained consiousness.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Acute hypoxemic respiratory failure due to COVID-19 .

Blood clot in left leg; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 25Jan2021 10:30 (lot: EL3302) as 1ST DOSE, SINGLE then on 17Feb2021 10:30 (lot: EL9264) as 2ND DOSE, SINGLE; both via an unspecified route of administration in left arm (at the age of 46-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Medical history included covid-19 (prior to vaccination, diagnosed with COVID) and no past drug event. The patient's concomitant medications were not reported. The reported event was blood clot in left leg on 18Apr2021 at 22:00. The event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event was an unspecified medication. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Blood Clot in my lower right leg. Which can be life threatening if it were to dislodge and travel to the lungs and or Heart. Treatment: 30 day starter pack Eliquis 5mg tabs blood thinner, Methylprednisone 4mg dospak 21s, Acetaminophen 325mg 2@-6hrs or as needed

Patient with no known past medical history received his 2nd dose of Pfizer COVID-19 vaccine on 3/29/21 presented 5/19/21 with sudden chest pain presented to ED via EMS with acute inferior ST elevation MI. Cardiac cath reveled 95% ostial stenosis not consistent with ECG changes. Treated for myopericarditis with NSAIDs and steroids with resolution of chest pain.

nstemi; Myocarditis; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) via an unspecified route of administration on 26Apr2021, SINGLE for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 27Apr2021, the patient reported to the hospital with complaints of chest pain with electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. On 27Apr2021, the patient experienced non-ST-elevation myocardial infarction (NSTEMI) and myocarditis. The patient was hospitalized for one day. and the event required an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood test: negative on 02May2021, covid-19: negative on 02May2021, electrocardiogram: unknown showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers, myocarditis: unknown. Cath report did not reveal coronary artery disease (CAD). Therapeutic measures were taken as a result of NSTEMI (acute myocardial infarction), myocarditis (myocarditis), chest pain (chest pain), EKG showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. The outcome of non-ST-elevation myocardial infarction (NSTEMI), myocarditis, chest pain and electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers was recovered on an unknown date. It was also reported that since the vaccination, the patient was tested for COVID-19 on 02May2021 and was negative. Information on lot number/batch number was requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on currently known drug profile it is unlikely that events non-ST-elevation myocardial infarction (NSTEMI) and myocarditis are related to BNT162B2. This case will be re-evaluated upon receipt of additional 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 RAs, Ethics Committees, and investigators, as appropriate.

It went into my lungs/lung infection/shortness of breath; pain; cough; My lungs hurt when i breathed; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08May2021 10:30 (Batch/Lot Number: E100171) as 1ST DOSE, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included gout from an unknown date and unknown if ongoing, known allergies to latex. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The day after the vaccine on 09May2021 at 06:00 AM, patient developed a cough. It went into his lungs within a couple of days and was eventually put on strong antibiotics with a lung infection. His lungs hurt when he breathed, patient had shortness of breath. It's currently 20May2021 and patient still had pain when he cough but it seems to be improving. The events resulted in Doctor or other healthcare professional office/clinic visit. Events treatments included an inhaler, antibiotics, cough pearls. Covid test post vaccination included Nasal Swab COVID 19 test on 18May2021 and the result was pending. Patient was not recovered from events.

blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown. Information on the lot/batch number has been requested.

Deep vein thrombosis in left gastrocnemius vein; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Apr2021 at 11:00 (at the age of 46 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included drug hypersensitivity (known allergies: Penicillin) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Apr2021 at 03:00, the patient experienced deep vein thrombosis in left gastrocnemius vein. Therapeutic measures taken as a result of the event deep vein thrombosis in left gastrocnemius vein included apixaban (ELIQUIS). The outcome of the event deep vein thrombosis in left gastrocnemius vein was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Pt passed out unconscious with no pulse. A neighbor who is an ER doctor performed CPR for 5 minutes, then paramedics tried to resusitate Pt and took him to local Hospital ER, less than a mile away. He was not resusitated. No cause of death was found - doctor said it was likely a heart attack.

On April 17, 2021 following my initial vaccine shot on May 29, 2021 I had a stroke requiring emergency surgery for removal of the blood clot in my brain. I was hospitalized in icu for two days and am currently receiving follow up care. Testing shows that it was not heart nor genetically related.

patient received 1 dose of coronavirus vacccine in January. He was admitted to the hospital on 7/2/2001 with signs of acute hypoxic respiratory failure on 2 L of oxygen, with nasal pharyngeal swab PCR positive for coronavirus.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: After giving the vaccine to the patient he fainted and fell off the chair hitting his head on the floor. This was a few minutes after the vaccine was administered. After fainting the pt was a little out of it and was bleeding on his nose/forehead. I gave him a water and ice pack for his head. I had him stay sitting on the floor and after 20 mins we decided to the ambulance because his family was not coming. He was checked out and decided not to go to the hospital.

46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymphoma (dx 5/19/21) (5/2021, chemo scheduled later this month) presents with cough and SOB x6 days. 1) COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 7/15. COVID positive on 7/16. Pt was fully vaccinated on 4/1/21. Pt presented satting 88%. In the ED, he was put on 2L O2, solumedrol, remdesivir, and offer tocilizumab, which he refused at first. Pt took Tocilizumab at night. Pt now on 12L oxymizer. Offered tocilizumab again and increased methylprednisolone to Q6h. - 12L Oxymizer. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Methylprednisolone 125mg IV Q6h for 5 days (7/21 - 7/25) and taper down - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (7/21 - 7/25 ) - f/u daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - CRP, D-dimer, LDH, ferritin elevated. Trend QOD - Lovenox 40mg SQ BID and hold for Plt <25k, Fibrinogen <100, active bleeding - Tocilizumab 600mg IV x2 - Tessalon for cough - Encourage IS - Isolyte 500cc x1

This is a 46-year-old gentleman who states that he has had 2 doses of the Pfizer vaccine in April. States he did go to an amusement park a couple weeks ago and on 07/05, he started having symptoms of fever, chills, diarrhea, shortness of breath, so went to a local pharmacy and a couple days later was told that he was positive. EMS was called to the house and his oxygen saturation was 60% on room air. Patient was admitted on 7/12 to PCU and started on COVId treatment for pneumonia and respiratory failure. He was discharged 7/19.

Increase of Atrial Fibrillation (Afib) events and severity. For the 20 years preceding the Covid shot, I had 1-2 Afib events in low severity about every 8 months and only one severe event in 2008. Since getting the Covid shot, I've had 1 event every week with 2 severe events and 2 emergency room visits. Three cardiologists have confirmed my condition and verified my event history and the increase in frequency. My workouts have been relatively the same for 3 years. Now, after any workout that I push to failure, onset of Afib occurs approximately 4-6 hours later with a medium to high severity. Afib Severity: Low; occasional light headed when exerting. Medium; weakness, need to sit. Severe; semi/or unconscious.

Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial fibrillation.

Pfizer-BioNTech COVID-19 Vaccine Hospital Emergency Room Provider reported cause of death as COVID vaccine administered 11 days prior to death. Additional information being reported from LTCF.

Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.

onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/2021), developed cough and low grade fever. Symptoms continued to progress with continued cough, fatigue, and generalized weakness with shortness of breath. Had O2 sat of 88% with activity on 2/9/2021 and went to emergency department and was diagnosed with pneumonia. Treatment started for community acquired pneumonia with Amoxicillin and Azithromycin. Patient discharge home from emergency department

Patient died; This is a spontaneous report from a contactable consumer (parent's patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route on 13Feb2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Feb2021 the patient died. The cause of death was unknown. An autopsy was not performed. No COVID prior vaccination. The patient had not been tested for COVID post vaccination. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Patient died

Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021 Patient/Date: 3/18/2021 Subjective: a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative, Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM

Had a stroke; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at 09:00 (age at vaccination: 47-years) at a single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, kidney disease, Penicillin allergy and Covid-19 prior vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); trazodone; insulin aspart (NOVOLOG); insulin lispro (HUMALOG); and pantoprazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 08:00, the patient had a stroke. The event resulted to hospitalization on an unspecified date. The patient received an unspecified treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. Information about the lot/batch number has been requested.

Mandatory EUA Reporting - Patient received COVID-19 vaccine on 1/12/21 and then tested positive for Covid the same day. Was admitted to hospital from rehab (resides in rehab for chronic respiratory failure). Patient deteriorated throughout hospitalization, was transitioned to comfort care, and expired on 2/10/21.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose

Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progressive jaundice, feeling unwell and eventually went to the hospital, found to be in cardiogenic shock with bi-ventricular failure, acute liver failure and acute kidney failure. Currently still hospitalized for workup of his cardiomyopathy.

he died while on his routine daily run; medical examiner agreed he should have an autopsy which showed coronary artery disease/likely an acute cardiac event

Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound confirmed superficial blood clot from ankle to knee.

Flu-like symptoms; Rhabdomyolysis; loss of consciousness; dehydration; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 (at the age of 47-years old) as single dose for COVID-19 immunisation. The patient received the first dose on 05Mar2021 in arm left (lot number EN6198). Medical history included hypertension and gastrooesophageal reflux disease (GERD). The patient had n known allergy. He did not have COVID prior vaccination and he was not COVID tested post vaccination. Concomitant medications included omeprazole and hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ). The patient experienced flu-like symptoms starting 6-8 hours after shot and continuing into the following day, rhabdomyolysis, loss of consciousness and dehydration. Adverse event start time was reported as 06:30 PM. The patient was hospitalized 3 days in ICU, plus 3 additional days. The events resulted in resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization and life-threatening illness (immediate risk of death from the event). The events were treated with IV Fluids and treatment to raise sodium. The outcome of event was recovering.

AFIB; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 25Mar2021 17:45 as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing , atrial fibrillation (AFIB) from an unknown date and unknown if ongoing, surgery from an unknown date and unknown if ongoing, ablasion completed in 15Apr for AFIB. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (CARTIA [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10 [UBIDECARENONE]) taken for an unspecified indication, start and stop date were not reported; omega-3-acid ethyl ester (LOVAZA) taken for an unspecified indication, start and stop date were not reported; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had an ablasion completed in 15Apr2021 for AFIB and had no symptoms since. On 02Apr2021, he had a routine electrocardiogram (EKG) and it showed AFIB was back. He had no symptoms prior. The onset date of afib was reported as 02Apr2021 at 09:00. There was an emergency room (ER) or physician office visits. The patient underwent lab tests and procedures which included electrocardiogram: afib was back on 02Apr2021. Therapeutic measures taken as a result of afib included dronedarone hydrochloride. The outcome of afib. was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt was found with DVT and PE

DVT behind left knee detected at ER on 08Apr. Pain behind left knee started on 4Apr; This is a spontaneous report from a contactable consumer (patient himself). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 02Apr2021 at 12:00 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunization. Relevant medical history included prior deep vein thrombosis (DVT) behind right knee from an unspecified date in 2010 to an unknown date. Concomitant medication included finasteride (PROPECIA) taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen (ADVIL), acetylsalicylic acid (ASPIRIN), and unspecified salicylates, from which the patient had known allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 at 12:00 PM (lot number: EN6204) at the age of 47 years, administered in the left arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient had DVT behind left knee detected at the emergency room (ER) on 08Apr2021; the pain behind left knee started on 04Apr2021. The adverse event (AE) resulted in an emergency room/department or urgent care. Therapeutic measures were taken as a result of the event, which included that the patient was prescribed apixaban (ELIQUIS). The patient was not recovered from the event.

he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again; fall; presuming he had a stroke; This is a spontaneous report from a contactable consumer (reporting for her fiance). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205), via an unspecified route of administration, administered in the right arm (in his right arm up by the shoulder joint) on 06Apr2021 at 14:30 (at the age of 47-years-old) as single dose for COVID-19 immunization (to stay safe and so he doesn't get it). The patient's medical history included diabetic for years, and End stage renal disease. There were no concomitant medications. There were no additional vaccines administered on the same date as BNT162B2. There were no prior vaccinations within 4 weeks. The reporter stated that they were presuming he had a stroke and were doing diagnostics. Everything was pointing to a stroke. The reporter stated it started Monday, 12Apr2021, he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again. This started Monday evening. The reporter stated that she called 911 as she couldn't get the patient to the car. He kept falling and there was something clearly wrong. The patient was taken to the ER and was admitted around 1am on Tuesday morning (13Apr2021) and was still hospitalized. The patient has had lots of blood work to include checking electrolytes, thyroid, and vitamin and mineral deficiencies; all with unknown results on an unspecified date. Additional lab tests included Computerized tomogram (CT) scan on 13Apr2021, Electrocardiogram (EKG) on 13Apr2021, and Magnetic resonance imaging (MRI) on 15Apr2021; all with unknown results. The outcome of the events was unknown.

Random Heart palpitations. Eventually 2 separate issues of atrial fibrillation. One on April 4th and one on the 11th. No previous history of palpitations.

Patient was found at home Saturday afternoon passed out. Patient was rushed to the hospital where it was discovered he had a blood clot. He is going to hospitalized for a few days per patients mother.

The Covid vaccine was given April 20 of 21 within eight days of having the vaccine I started to develop shortness of breath fatigue chest pain, I ended up at our local emergency room and was admitted with pulmonary embolism, blood clots in both lungs I stayed a total of three days hospitalized.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was severe sepsis with septic shock.

Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of dizziness and feeling different since second vaccine

Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when walking, started on June 12, 2021. I never had such pain before and thought it's just a stomach virus or so. As the pain continues, I called my primary-care Dr. early morning of June 17 and scheduled appointment for a week later. But around 9:30 pm that day, June 17, the pain became so severe, in addition to nausea and shortness of breath. I went to emergency room and have been told that there is acute heart attack in progress and was moved to the Critical Care Unit in the Heart and Vascular Center. A blockage has been removed and a stent was installed in morning of June 18, through heart catheterization procedure. As there was damage to the heart muscle due to the heart attack, I am supposed to go back later, in 4-6 weeks, to remove couple more blockages and install stents.

About 3 days after the 2nd dose, I started to feel chest pressure like a muscle pull on the chest. About 7 days after the vaccine, it started to worsen. I felt pain, chest pressure, back shoulder pain, jaw pain, and shortness of breath. I called the main local hospital number and was instructed to go to the ER. I did go to the ER and they did blood work, EKG which confirmed that I was having a heart attack. I was stabilized and was then transferred my via ambulance to A Medical Center which is bigger hospital and better equipped. I was admitted and the next day, I had surgery for a heart catheter. They also placed 2 stents in my heart. I was in the hospital for 4 days and was discharged with a prescription for Furosemide 40mg, rest, cardiac rehab, and to follow up with cardiologist. Prior to the heart attack, I only had hypertension.

Had 2nd vaccine a few days earlier and died of cardiac arrest. Was healthy and active prior to vaccine with no known health problems.

At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked my wife to call 911, I went into the bathroom to change into clothes to get ready to go. I do not remember going to get dressed, I passed out and 911 had arrived and they believed I was in cardiac arrest. I went to the ER, there was a right artery blockage and put in a stint. They also found out I had 8 facial facial fractures due to the fall I had. I was all swelled up in my face so in May I went back for surgery on my face to fix the multiple facial fractures. And now I am back to normal, except I am on blood thinners. The DR could not find anything wrong after follow up, so no one knows why the cardiac happens.

I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.

On 1/23/21 at approximately 3:30pm I began to develop headaches. Approximately 2-3 hours later I began to feel nauseous and began to vomit. I then was taken to the Emergency Room where I had begun to suffer from an Addisonian Crisis where I was given Stress Dose steroids. The stress does steroids where given through 1/24/21 and medicine for the headaches are still be used to relieve the pain from the headaches. I was released from the hospital the late morning in the late morning of 1/25/21

Patient was diagnosed with first occurrence of atrial fibrillation in June 2017 with no episodes since. he received his first dose of COVID-19 vaccine on 1/30/21. Eleven days later on 2/10/21, he developed atrial fibrillation.

I administered dose to patient and then he stood up and was going to go to the next station to schedule his second appointment and he fell straight back and hit his head on concrete which caused bleeding. He was conscious and asking what happened by the time I could get to him. He remained alert. An ambulance was called and he did go to ER to be checked out.

After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. After 5 min, patient reported feeling light-headed and tried to stand up. The patient sat down on the floor and leaned against the wall. Patient was able to stand and walk to the provider room for closer observation. Patient felt hot and looked pale. The provider placed a blood pressure cuff on the patient, at which point the patient slumped forward and stopped breathing. A carotid pulse was not able to be appreciated. The patient was pulled to the floor, positioned airway open and was given oxygen. BP was 96/40. Blood sugar was checked (104) and the AED pads were placed. EMS was called. AED advised no shock, patient had a pulse and was breathing. Patient gradually became alert, though reported not feeling well. Patient was disoriented and was not aware of passing out nor the current event. Repeat BP 115/50. Patient began vomiting (~300-400 mL). Patient left with EMS to be evaluated at local Emergency Department. Of note, patient reports history of vasovagal syncope events 2/2 to various situations.

Vomiting. 24hrs Diarrhea 30 hrs Headache Muscle Ache Chills Hives (severe) Nausea Stomach pain Anaphylaxis

documented MRI stroke; Appears to be thromboembolic; This is a spontaneous report from a contactable physician (reported for himself). A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 04Jan2021 07:00 as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. On 27Jan2021 14:00, it was reported that patient had documented MRI stroke, and appeared to be thromboembolic. Patient have no risk factors for CVA, and stroke occurred. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): stroke on 27Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency visit and disability or permanent damage. Therapeutic measures were taken in response to the events which included patient had started on aspirin. The patient was not tested for covid post vaccination. The outcome of the events stroke and thromboembolic was recovering. Information about lot/batch number is requested.; Sender's Comments: The causal association cannot be excluded between the reported events of "MRI stroke and appeared to be thromboembolic" and BNT162B2 use. 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 AE. 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.

C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed with CVA event. Still being treated at this time.

I got my second Pfizer covid shot on 2/17/21. Since then I have ahad 2 large blood clots form in my lower right leg. I had one in the same place 24 years ago.

The night after my first shot, I felt pressure on my lungs, It felt as if I had the onset of Pleurisy as I have had that issue in the past. I figure I would wait to get it treated as it is not always picked up in the x-ray in its infant stages (based on past experience). On March 2, the pain became unbearable and I went into a urgent care center to get an x-ray and something to help with my issue. The urgent care did not take my x-ray they immediately sent me to the hospital strongly intimating that the problem was probably more serious than I thought. I was in the emergency room, they ran tests and made me comfortable enough as they also gave me a ct-scan which is when they found the bi-lateral pulmonary embolisms. I have since gone to my primary care physician and he directed me to a hematologist/oncologist. The event was found to be unprovoked. I am on blood thinners for 6 months.

Heart stopped 6 times; unresponsive; soreness; felt like unwell; vomiting; Body aches; achiness; passed out 7 times; fever; chills; Left arm soreness at injection site and up back of shoulders; Left arm soreness at injection site and up back of shoulders; This is a spontaneous report from a contactable consumer.A 48-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number: EN5318), intramuscular, administered in left arm on 27Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included asthma, myocarditis and allergies to Fruit or nut that grows on trees. Concomitant medication included esomeprazole magnesium (NEXIUM). The patient's heart stopped 6 times on 29Jan2021, he had a low grade fever, achiness and chills at 01:30, but they were gone the next day. Basically, at first, he took the shot and got the reactions that everyone else does, right arm soreness 01:30. On 07Jan2021 17:00, patient took the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number: EL1042), intramuscular, administered in left arm. No prior vaccination was given within 4 weeks. He fell in the shower and passed out and hit his head at 18:00. He was not hooked up to a machine. About 18:30, his wife got him to the couch. He drank carrot juice and ate a granola bar. At 18:30 his eyes were wide open, but he was unresponsive. About every 30 minutes, he was going down. The third one came about 18:45-19:00. The pass outs lasted 15-20 seconds. and all he remembers was waking up to her screaming at him. The next one came at 19:15 and was in the ambulance on the way to the hospital and that is when he vomited in the ambulance and on the couch. Pass out number 3 was at home and 4 was in the ambulance. There was vomiting with both of them. Pass out number 5 was in the hospital when she was getting in the bed and was not hooked up in the room yet. Finally, they got him hooked up to a machine at 20:30 and into a room. They said if you feel dizzy, press the button. He found out his heart rate went from 80's down to 30's. That was the 6th pass out. This was the first time he was on a machine. His heart did not actually stop, it just went down to 30's and would come back. Then, it happened one more time on the machine and at that point, they were hooking him up to an IV and giving him medication to keep him from vomiting. He does not have the name of that medication or the dose or lot or expiration. He got stabilized but they had him hooked up shockpads in case anything happened. They recorded his heart stopping 6 times during the night and of those 6 times, he does not have the times.2 seconds was the longest time of all of the stops. He does not know how many each were. This was when he woke up on 30Jan2021. He later stated he was hospitalized 28Jan2021 at 7pm and those 6 stops occurred 29Jan2021 through the night previously. The patient was hospitalized for heart stopped 6 times from 29Jan2021 and discharged on 01Feb2021. The patient underwent lab tests and procedures which included body temperature was low grade fever, echocardiogram, brain scan and electrocardiogram shows normal,heart rate: 80 beats, heart rate was down to 30 on his heart beat. They gave shot in the leg for blood clots, nausea medication and a bunch of pills given as treatment. The outcome of heart stopped 6 times was recovered with Sequel, patient passed out 7 times, body aches, fever and chills, left arm soreness at injection site and up back of shoulders was recovering, unresponsive and soreness next day felt like unwell and vomiting was unknown, achiness was recovered. No follow-up attempts are possible. No further information is expected

4/11/21 generalized fatigue 4/14/21 shortness of breath and chest pain 4/15/21 right lower extremity Deep vein thrombosis and bilateral Pulmonary emboli 4/16/21 mechanical thrombectomy of pulmonary emboli 4/15/21 - 4/18/21 treatment with heparin infusion which was transitioned to eliquis

Patient presented to ER with left leg swelling, diagnosed with extensive Left leg DVT and extensive bilateral pulmonary emboli

Heart Attack, 100% blockage with blood clot. I had to have three stents put in, but survived. I was in hospital for 2 days,

He was immunized by our pharmacist . He was told to sit in the observation area. After 10 minutes , One other person came to our terminal reported that there is a person on the floor. I rushed to check on him. He was on the floor flat . I asked him if he is ok and if I can call 911. He said he is fine . He was helped to sit on the chair. He was wearing a black mask and seating. I asked him if he wants to me to call 911. He said he is feeling better. There was blood dripping out the mask. I asked him to check . His lips were split and his mouth was bloody. He fell flat on his face, that resulted in the bloody mouth. I gave him a ice pack and sat next to him . He called his wife and waited in the same area. I sat next to him. His wife came in and took him to the immediate care .

NSTEMI; Pulmonary Embolism; left upper arm thrombosis; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 (at the age of 48-years-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine received in four weeks. On 15Apr21, the patient presented to hospital with complaints of dyspnea, chest pain and arm swelling. The patient was found to have left upper arm thrombosis, pulmonary embolism, and NSTEMI. The adverse events started on 15Apr2021 and resulted in emergency room/department or urgent care visit, hospitalization on 15Apr2021 and life-threatening illness (immediate risk of death from the events). An unspecified treatment was received in response to the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

My husband received the shot on the 22nd. He died in his sleep on the 24th. He was complaining how the second shot really was giving him a lot of trouble, but nothing that would indicate life-threatening symptoms

Heart attack a two weeks after 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-Year-Old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via unspecified route of administration in the left arm on 21Mar2021 at 12:45 PM at single dose, for COVID-19 immunization. The relevant medical history included diabetic and high blood pressure from unspecified date. Concomitant medications included insulin, empagliflozin (JARDIANCE), atorvastatin, lisinopril. No other vaccine in four weeks. The patient experienced heart attack a two weeks after 1st dose of vaccine on 06Apr2021 at 08:00 AM. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and life threatening illness (immediate risk of death from the event). The patient had hospitalization for 3 days. The patient received treatment including stent for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovered with sequel.

Patient experienced acute atraumatic rhabdomyolysis with paraspinal myositis as well as secondary AKI requiring dialysis. Patient initiated on dialysis 4/16 and continued onto discharge.

This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 (Batch/Lot Number: el1284) as single dose for covid-19 immunisation at a hospital. Medical history included hypertension. The patient has no covid prior to vaccination and no known allergies. Concomitant medications included bisoprolol fumarate (CONCOR), amlodipine and metformin. The patient has no other vaccine in four weeks. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: eh8899) on 18Dec2020 in the left arm for Covid-19 immunization. On 03Feb2021 (also reported as "21 days after vaccination"; pending clarification), the patient had Afib episode and ACS needed a coronary stent. The patient was hospitalized for 2 days. The patient was tested for covid post vaccination via nasal swab on 06Mar2021 which was negative. The outcome of the events was recovered with sequel.

On day following, suffered high fever and aches for the following 36 hours. On Sunday, experienced NSTEMI due to myocarditis (not previously diagnosed) and remained hospitalized for two days following.

Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: PE and DVT more prominent in/on the right side of body than left-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: patient was diagnosed with COVID-19 in October 2020, but asymptomatic with underlying cough

This 48 year old male received the Covid shot on 12/22/20 and went to the ED on 1/5/21 with the following diagnoses listed below. J18.9 - Pneumonia, unspecified organism U07.1 - COVID-19

Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respiratory failure Pneumonia due to COVID-19 virus Received plasma therapy remdesivir dexamethasone?changed to oral Decadron upon discharge

Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemia, and smoking who presented to the ED yesterday morning with 1 day history of chest pain. Patient described the CP as moderate aching in the substernal area that did not radiate. The pain was intermittent, with each episode lasting 1-2 minutes. The CP was associated with LUE numbness and SOB on exertion. The chest pain and LUE numbness have now resolved. Patient also reports a three week history of RUE swelling. The swelling gradually worsened and is now associated with pain and proximal RUE bruising. RUE pain is rated 5/10. In the ED, patient was found to have NSTEMI and small right lower lobe segmental pulmonary artery embolus. Venous Doppler was positive for occlusive thrombosis in the R subclavian, basilic, and cephalic veins. Patient was started on IV heparin. Patient is scheduled for cardiac cath today. Hematology is consulted regarding PE and RUE DVT. Patient denies personal or family history of blood clots or recent travel. Reports receiving COVID vaccine in LUE approximately three weeks ago. Also admits to being more sedentary recently due to being unemployed. Denies nausea, vomiting, bleeding, bowel changes, fever, or chills. Significant PE findings: RUE edema, firm and tender to palpation, ecchymosis on proximal RUE, distal sensation and active ROM intact

TIA with aphasia/right hand weakness- fully recovered. On 5/7/21, took a nap after work, when he woke at 6:45PM, realized he couldn't read - knew it was words, but seemed jumbled, so went to talk to his wife but he was speaking jumbled words. He could understand her speaking and hear himself, just couldn't respond in words. Wife called 911, by the time EMS arrived sx were resolving. When EMS arrived, he was evaluated and found that his right hand was slightly tingly/tired. ABCD2 score of 5 for HTN BP>140/90, speech disturbance , weakness, sx <60 min.

Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.

On May 9th I began to experience severe pain in my back extending down my left side. The pain was severe enough to prevent sleeping that night. The pain continued throughout May 10th becoming worse with deep breaths or any type of internal strain (cough, sneeze, etc). That evening, I took two Tylenol and later two Ibuprofen and was able to sleep. The pain persisted for the next week, slowly improving but not fully going away. On May 15th I conducted a telemedicine appointment and was advised to go to either Urgent Care or the ER. I chose the ER at Hospital. A D-Dimer test showed elevated results and a CT scan was ordered. The CT revealed blood clots in my right lung, specifically "Subpleural conslidation in the posterior basilar segment the right lower lobe is present, compatible with pulmonary infarct. Question additional pulmonary infarct in the lateral basilar segment the lower right lobe. Probable atelectasis in the left lung base." MD prescribed Eliquis @ 10mg 2x daily and I was discharged with a referral to .

Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after post-vaccination 15 minute observation period patient experienced loss of conscioussness and a fall from standing. Patient transported by ambulance to emergency department alert and oriented with stable vital signs reporting headache. Patient found to have moderate right subarachnoid hemorrhage, extensive facial and mandibular fractures, bilateral nasal fractures, and right ribs six and seven fractures. Patient determined not to be a candidate for surgery and admitted for pain control, antibiotics, and monitoring. Discharged medically stable on antibiotics with neurology and oral maxillofacial surgery follow-up in place.

diagnosed with a Deep Vein Thrombosis since the clot was in his vein/Arm starting swelling specifically in his wrist and forearm; This is a spontaneous report initially directly from a contactable consumer (the patient), and then received from a Pfizer sponsored program. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164) via an unspecified route of administration, administered in left shoulder on 20Apr2021 at age of 48-year-old at singe dose for COVID-19 immunization. The patient had no medical history (including any illness at time of vaccination). No family medical history relevant to AE(s). The patient did not receive any concomitant medications (reported as "the patient did not receive other products"). No relevant tests. No prior vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration in his left shoulder on 30Mar2021 at age of 48-year-old for COVID-19 immunization and experienced no adverse event. Caller stated he was calling about the COVID 19 vaccine. Caller stated he got the second dose about 3 weeks ago and about 10 days or 11 days after the second dose (01May2021) his arm starting swelling specifically in his wrist and forearm. Caller stated he went to the emergency room and there was a blood clot found in his left arm. Caller stated he was diagnosed with a deep vein thrombosis since the clot was in his vein. Caller stated everything was going better but the emergency room doctor told him he should probably report this to Pfizer to let Pfizer know. Caller clarified that he was released from the emergency room and was never admitted to the hospital. Treatment received for the event included blood thinner. The event required a visit to emergency room, and the caller stated he went to physician office today. The outcome of the event was recovering.

Patient was admitted 5/24/21 ~2-3 weeks after his 2nd dose of pfizer vaccine. Stated that he had had shortness of breath and chest pain that started a few days after vaccine that never really got better. He was found to have pericardial effusion and pleural effusion of unclear etiology. Did not have evidence of myocarditis on EKG or imaging, but findings suspicious for pericarditis.

Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for about 45 minutes. Then irregular heart beat and significantly high blood pressure (over 190). Stent put in.

About 14 days after the first vaccine dose ( Pfizer) patient presented to the ER with severe chest pain. He was sent home after labs, EKG and CT chest were reported as normal. He was told that he had a hiatal hernia. One week later he was found by his wife expired in his bedroom late morning. Patient had no medical problems such as hypertension and never smoked. He was very active and played sports such as pickle ball.

Patient had no reaction at time of vaccination; was monitored for 15 minutes prior to leaving clinic. This nurse was notified today by ER Physician that the patient came into the ER around 8pm (on the night of the same day that he received his vaccine in the early morning hours) with c/o shortness of breath. It was reported that the patient had taken nebulizer treatments at home with no relief. Symptoms began around 5:30pm. Patient ambulated into ER at time of visit but during the visit became unresponsive. Patient was intubated and coded with time of death called at 9:52pm. Patient has history of asthma.

This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at around 9:00 to 10:00 (at the age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. The patient had no medical history. The patient had no family medical history relevant to adverse event. There were no concomitant medications. The patient had no other products. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). It was reported that, the patient was calling about the Pfizer covid vaccine. Unfortunately, he had a heart attack in Apr 2021. It turns out the day before his heart attack, he received the first dose of the covid vaccine. He had a heart attack on Saturday, 10Apr2021 at around 16:30 to 17:00. He was sitting down eating dinner and had a heart attack. The patient required emergency room and physician office. He was hospitalized for the heart attack on 10Apr2021. His cardiologist suggested that he call to report this to Pfizer. His cardiologist told him that he has cardiac ectasia, which may have been exacerbated by the first dose of the covid vaccine. He actually feels good now. He feels good and was not getting worse. He was not cleared for physical activity from his cardiologist, so he cannot work out yet. He was starting to put weight back on. Whenever he left the hospital, he was 211 pounds. Now he was 215 pounds. It may be water weight; may his sodium be high. But he was starting to increase in weight. His wife was older. He has a 92-year-old mother-in-law with health issues that lives downstairs. He runs basketball training and was around a lot of kids. He has no idea he had any heart conditions. His wife had gotten the COVID-19 vaccine, and his wife let him know that he was getting it too. The patient had no relevant test done. The patient was remained in the hospital for 6 days and discharged on 15Apr2021. The outcome of the event heart attack was recovered on an unspecified date in 2021. The outcome of the events Weight increased and cardiac ectasia was unknown. Follow up needed, further information was requested.

get in to the hospital due to my heart, AFib; Shortly after, his heart rate went up/Heart beat jumped so fast, sudden rapid heartbeat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 48-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 13:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. Patient received the first dose on 14Mar2021 at the age of 47years old. The patient medical history was not reported. The patient's concomitant medications were not reported. Shortly (about an hour) after vaccination, his heart rate went up to 190 bpm and into atrial fibrillation. Heart beat jumped so fast, sudden rapid heartbeat. Caller sought medical care via emergency department, and went to doctor couple of times specially to heart doctor to make sure things are good. Patient was hospitalization for event Atrial fibrillation. Patient had Echocardiogram and PET scan on unknown date with result unknown. Outcome of events was unknown. Follow up needed, further information was requested.

Two months after receiving my second dose of the Pfizer COVID19 vaccine, I suffered a stroke. Symptoms included vision loss, complete left-side paralysis, loss of cognition, and loss of consciousness. Within ~15 minutes of the event, I was transported by ambulance to the nearest hospital and provided care. Within 3 hours of the event, I received tPA (Tissue Plasminogen Activator), and recovered fully.

48 year-old man referred for admission from outpatient echo appointment after finding of large pericardial effusion. Patient's history includes iron-deficiency anemia from hiatal hernia and season allergies. Was in usual state of health until received second Pfizer mRNA Covid-19 vaccine 5/18/21. A few days later developed cough, 'brain fog,' dyspnea. Had remote outpt visit and treated with abx for sinusitis. Covid test was negative 5/28/21. Symptoms worsened and developed swelling of legs and abdomen, worse exertional dyspnea and had to sleep sitting up due to orthopnea. Began on lasix 20 PO BID as outpt with significant improvement in swelling and other symptoms over past week - thinks he lost 20 lbs. Still feels more bloated than usual. Had outpt echo as part of eval and sent to ED. Denies chest pain, palpitations, dizziness. Brain fog is improving. Mildly constipated. No black or bloody stools. No abd pain. PERICARDIAL EFFUSION (6/15/2021) Assessment: echo Large pericardial effusion noted mostly post and no echo evidence of tamponade. Smaller in size. no need for pericardiocentesis Discharge home on lasix 20 mg daily Net neg 5.4 L chest xray looks improved unbale to get thoracentesis due to not enough fluid Vitals stable

Although it has been four months since I received the vaccine, I wonder if there is a connection. On 7/7/2021 I went to the emergency room with chest pain. They were able to rule out a heart attack, and with a CT scan discovered I had an acute pulmonary embolism in the lower lobe of my left lung. There is no explanation for where the blood clot came from as I am healthy and active, have had no recent surgeries, no evidence of blood clots elsewhere in the body, and no long trips that could explain the development of a blood clot. I am undergoing lots of tests but so far no underlying health condition has been discovered that would explain how a blood clot got into my lung. Treatment = Xarelto (blood thinner).

Allergic reaction that occurred 7 days after receiving the first vaccination. Treated for anaphylactic shock at local ER and released. Anaphylactic shock returned within 24 hours causing second visit to the ER. I was then transported to hospital for ICU admission. Body broke out with hives rash for several days followed by severe joint swelling. Remained in ICU 3 days and was released to see Allergist.

swollen left calf that was DVT, deep vein thrombosis; This is a spontaneous report from a contactable Other Health Professional. A 49-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. Patient had no known allergy. No COVID prior vaccination. No COVID tested post vaccination. Historical vaccine included 1st dose of bnt162b2 (lot: EK5730) via intramuscular on 23Dec2020 at 15:30 at single dose on left arm for COVID-19 immunisation. Concomitant medication included levothyroxine and atorvastatin. 1 week after receiving the 2nd dose, patient woke up with a swollen left calf. Ultrasound the same day (19Jan2021) showed that was DVT, deep vein thrombosis. Patient started taking apixaban (ELIQUIS) (blood thinner) the same day. Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was resolving. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could function but nothing seemed 'clear' or 'sharp', 1/7/2021 fatigue, arm sore. The 'fog' was worse; 1/8 fog was really bad; forgetting conversations. 1/9 2:45 in morning. Went to bathroom. Walking, about 1/2 way there, felt like a 'spike' and instant HA. I went to bathroom, door closed, I got sick/vomiting. The shiver, shakes, and fever spiked. I bent down to throw up and I cant relieve. I fell into the wall, pushed self to stand up. Was back in bedroom, laying on floor and passed out. Wife woke me, I was bleeding. Don't know how long I was on the floor. BP144/78, 133 blood sugar, O2 was 98%, temp 98.1. 3:45 I decided to go to hospital, EKG, CT scan, Xray, etc. 'Just fainted' *PCP stated it was due to shot / vaccine. **busted lip, ER bill ***2nd vaccine; minor side affects (slight HA, )

bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fingers and the feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249, expiration date not reported) via unspecified route of administration in the arm right on 21Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. The patient previously took iodine and experienced drug allergy; also received first dose of bnt162b2 (Lot number: EJ1685) via unspecified route of administration in right arm on 30Dec2020 14:00 for COVID-19 immunization. Facility type vaccine: clinic. It was reported that on 23Jan2021, couple of days after the second shot, patient experienced skin on hands and the bottom of my feet started to peel off and bleeding and very painful in the fingers and the feet. The events resulted in both: Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if treatment received for the events. Outcome of all events was recovering.; Sender's Comments: Based on plausible temporal relationship and known drug profile, a contributory role of the suspect BNT162B2 cannot be excluded in the development of bleeding, skin exfoliation and pain in extremity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

SEVERE ITP PLATELET TRANSFUSION, IVIG X 2, PULSE DEX X4 DAY RITUXIMAB, PREDNISONE, PROMACTA SPLENECTOMY 3/8/21

I went into atrial fibrillation/flutter within hours after the shot. I was totally fine and in sinus rhythm prior to the shot.

With no previous heart issues. Heightened hear rate started on evening after the vaccine, topped out at a resting heart rate of over 160bpm. Went to primary health care physician, he did EKG, then ordered me to Emergency Room. Was diagnosed with Atrial Fibrillation with RVR, prescribed Apixban (Eliquis) 5mg oral tablet, 1 tab 2 times a day, prescribed Metoprolol (metrolrolol succinate 50mg extended relese) 50mg 1 cap per day. Given diltiaZEM 10mg via IV push while at the hospital. Continue to have increased heart rate and have not returned to a normal sinus rhythm as of 3/23. Scheduled for follow-up with EP on 4/9 to review heart rhythms.

Thrombocytopenia (CMS/HCC) Hypomagnesemia Alcohol abuse Alcoholic hepatitis Hyponatremia Renal insufficiency Symptomatic anemia

Blood clot; Unable to use arm at all; This is a spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in arm left, on 09Mar2021 02:15 AM, as single dose for COVID-19 immunization. Patient's medical history included Fibromyalgia. Concomitant medications were not reported. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient did not receive other vaccine in four weeks of vaccination. On an unknown date in Mar2021, patient had Blood clot and patient was unable to use arm at all. Patient resulted in Emergency room/department or urgent care, Disability or permanent damage in Mar2021. Patient did not receive treatment for adverse events. Seriousness of the events reported as hospitalization and disability. Outcome of the events was not recovered. Information about lot/batch number has been requested.

Atrial Fibrillation / diagnosed with Atrial Fibrillation with RVR; heart rate heightened (topped out at a resting heart rate of over 160 bpm)/ up to 160 (high /bpm)/ continued to have increased; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 20Mar2021 18:15 (batch/lot number: ER2613 and expiry date unknown) at 49 years old at a SINGLE DOSE for COVID-19 immunization. The patient was vaccinated at the Hospital. The patient's medical history included obesity from an unknown date and unknown if ongoing. Patient had no previous heart issues and had no known allergies. There were no concomitant medications or other medications in two weeks of vaccination. The patient did not receive other vaccination within 4 weeks prior to the BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 21Mar2021, 12:00 am, patient went into atrial fibrillation with a high heart rate up to 160 bpm. It was reported that the heightened heart rate started on evening after the vaccine (on 20Mar2021), it topped out at a resting heart rate of over 160 bpm. Patient went to a primary health care physician, he did EKG (results unknown), then ordered patient to Emergency Room (Hospital name). The patient was diagnosed with Atrial Fibrillation with RVR. The patient was prescribed Apixaban (Eliquis) 5 mg oral tablet, 1 tab 2 times a day and Metoprolol (metoprolol succinate 50 mg extended release) 50 mg 1 cap per day. Patient was also given Diltiazem 10 mg via IV push while at the hospital. It was reported that patient continued to have increased heart rate and have not returned to a normal sinus rhythm as of 23Mar2021. The patient underwent lab tests and procedures which included EKG: unknown result on Mar2021; heart rate: heightened (topped out at a resting heart rate of over 160 bpm ) on 20Mar2021, up to 160 (high /bpm) on 21Mar2021 and heart rate: continued to have increased on 23Mar2021; and sinus rhythm: have not returned to normal on 23Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and patient was hospitalized for one day. The outcome of the events was not recovered.

He had been experiencing chest discomfort after eating and activity for a month, that resolved with rest. Family history of ischemic heart disease. Pt is a smoker, HTN and dyslipidemia. I was just informed a patient received the Pfizer vaccine yesterday @ 1129. Arrived to ER @1700 with a STEMI. He went for a heart cath yesterday and CABG this morning. Per the cath report his LAD was occluded. I believe he was more aware of his symptoms after receiving the vaccine and that is why he finally came in.

Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain placed in head and multiple CT scans and MRI exams while there. Discharged with home PT and neurologist follow ups. Experiencing left side weakness and head fogginess still.

Swelling left leg. Femoral vein DVT identified on ultrasound on April 5, 2021 (partially occluded clot). hematologist switched me from Eliquis to starter pack of Xarelto.

Heart attack and death; This is a spontaneous report from a contactable Nurse. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ej1685) intramuscular in left arm on 18Dec2020 at 11:00 AM at single dose for COVID-19 immunisation. Medical history was none, no known allergies. No other concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced heart attack at 05:30 pm on 06Apr2021 and the event caused patient death. No treatment for the event. Autopsy results was available. Autopsy remarks: heart attack. No COVID prior vaccination, no COVID tested post vaccination. The patient died on 06Apr2021. An autopsy was performed and the reported cause of death was heart attack.; Sender's Comments: Myocardial infarction occurred 3 months and 19 days after BNT162B2 vaccine administration. The event is considered unrelated to suspect drug being rather an incidental occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Heart attack and death; Autopsy-determined Cause(s) of Death: Heart attack

DVT left lower extremity; Bilateral Pulmonary Emboli; first dose: 23Feb2021; second dose: 16Mar2021; first dose: 23Feb2021; second dose: 16Mar2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199 and expiration date not provided) intramuscular, administered in the left arm on 16Mar2021 13:30 as a single dose for COVID-19 immunization. The patient has no relevant medical history. Family history included diabetes (mother). The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200 and expiration date not provided) Injected intramuscularly in left upper arm on 23Feb2021, 13:30 for COVID-19 immunization and experienced DVT symptoms, soft tissue injury, muscle pull and ankle strain. The patient experienced DVT left lower extremity and bilateral pulmonary emboli on 23Apr2021. The patient called regarding the Pfizer COVID vaccine. He had adverse events to report. He has a DVT on his left calf, which he later clarified was left lower extremity. He is currently on double dose of apixaban (ELIQUIS) since Friday. He finally went and got it looked at. He is still being treated and will be seeing a hematologist. He stated that DVT symptoms occurred after first dose and was undiagnosed. He treated it as soft tissue injury and thought it was a muscle pull and ankle strain. Eliquis was started on 23Apr2021 and dose is 5 mg. He is taking two tablets twice daily for 7 days and then 1, 5mg tablet bid (twice a day) as well. No emergency room or physician's office required but Urgent care facility was visited on 23Apr2021. During this visit, they did Lab work, D Dimer results 1590 on 23Apr2021; Venous Doppler resulted in positive DVT in Left Lower Extremity. Chest CT resulted in positive peripheral defects in small branches of the lower lobes bilaterally, left greater than right, consistent with Pulmonary Emboli. Left sided pleural effusion and left basillary infiltrate, possibly atelectasis or developing infarct. Few pleural based nodular densities at right lung base, again atelectasis versus developing infarcts. The rest just states what was normal. Eliquis was prescribed on 23Apr2021, 5 mg two tablets twice daily for 7 days, then regular dose times 7 days. He is to report to hematologist on 29Apr2021. The outcome of the events deep vein thrombosis and pulmonary embolism was unknown. The reporter assessed the events as serious (life-threatening).; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events DVT of legs and Pulmonary embolism 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.

DVT symptoms occurred after first dose and was undiagnosed; soft tissue injury; muscle pull and ankle strain; muscle pull and ankle strain; This is a spontaneous report from a contactable nurse. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 23Feb2021 at 13:30 (Batch/Lot Number: EN6200) at a single dose for COVID-19 immunization. Medical history included a family history of diabetes - his mother had diabetes. The patient's concomitant medications were not reported. DVT symptoms occurred in Feb2021 after the first dose and was undiagnosed. He treated it as soft tissue injury and thought it was a muscle pull and ankle strain. The outcome of the events was unknown. Information on the batch/lot number has been requested.

He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.

have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6 (lbs) pounds/Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight; falling; felt super strong; dizziness; failed all the tests for motor skills for his arms and legs; Fell and hit elbow and 3 ribs on left side; Fell and hit head; Sensory nerves are all gone; Fatigue; scabs; delusional; tore tendons in between ribs; They are tender(ribs); hurting all over; Cannot walk or lift anything; chest pain; his arm was sore a little; Left arm injection site pain; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 03Feb2021 (batch/lot number and expiration date not reported) at the age of 49 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, vascular disease, bilateral stents placement, cataracts since he was born. Concomitant medication included gabapentin taken for an unspecified indication from an unspecified start date and ongoing. On 04Feb2021, the patient experienced left arm injection site pain. The patient experienced dizziness, falling, and couldn't go to work on unspecified date. He was treated by his (MD) physician, was given a CT scan, echocardiogram, and found to have some clots. He stated he has a history of vascular disease and had bilateral stents placed a year ago. He was placed back on an aspirin/Plavix regimen and referred to a neurologist because he has no motor skills anymore. He stated he failed all the tests for motor skills for his arms and legs. He was advised not to take the second dose of the vaccine and was diagnosed with neuropathy and autoimmune disorder (caller does not specify which disorder). He reported being positive for Covid-19 in Dec2020. He wanted to know what else he can do for his symptoms and is offering to be tested by Pfizer for treatment. The symptoms come in really hard seven days later. He actually had to go to the (ER) emergency and they worked on him and a whole string of doctors. He went to the emergency room and something was going on and wanted him to go to a family practitioner. They sent him to vascular, neurological and now they want to send him to a research center. It was a whole week after receiving vaccine before he began having symptoms. With the neuropathy and autoimmune, he cannot work like he did. He can hardly walk. Unspecified autoimmune was diagnosed last week. He can't remember the name of it. They told him not to take second one because the first one did what it did to him. It hurt a little and it was quick. The next day (04Feb2021), he said his arm was sore a little. He is only taking 4 medications and they looked it up. He did not think they were relevant. He was disoriented and fell and hit his head a couple of times. They ran an MRI on his head trying to figure that part out. That was done last week. He doesn't know the date and said it may have been on Friday. Results were good. The date he was disoriented was Wednesday 03Feb2021, when he took the shot. He has been disoriented and has been that way ever since. They kept him for 15 minutes to make sure no one passed out. He has been disoriented since then. He could not think clearly, and he could not do his job. He tore tendons in between ribs. He first thought he actually broke his ribs, but did not. There were two different falls. He cannot feel feet or anything. His motor skills are OK but when they did neuropathy test, they put needles in and shocked him to make his motor fire. His reflexes were really bad. He fell and hit elbow to keep from falling on face and twisted going down hitting 3-4 ribs on left side. It has been over 3 weeks now for his ribs. They are tender but they are not like the initial blow. It feels like they are healing. He fell and hit head a week ago. He was unsure of the exact date. He did not go to the emergency room with this one because the bed caught him. He fell and hit his head. All he has left is scabs. He cannot walk or lift anything (11Feb2021). That next Wednesday, he got ready to go to work and was so delusional and could not go in. He slept from 5:30 all that day and all that night. Then Thursday, he gets up and goes to work and goes slower, just to see what happened on Wednesday. He had fatigue and was disoriented. He did not provide start date or outcome for fatigue. He walked in and said either call an ambulance or he would go home. He went home and that was the last day of work. He then stated he laid in the car for 30 minutes and he said he is going to the emergency room. He went straight there that day. He had stents put in lower part of his body a year before. The neuropathy and the autoimmune kicked in 7 days later after the shot. The reason he went to the ER is because he thought it was his stent. He had bilateral, 4 of them. He was having chest pain and hurting all over on 11Feb2021. He thought he was having a heart attack. He was seen in the emergency room and released. It depends on how far he goes, how the chest pain worsens. Right now, he is ok, but when he gets up and moves around, it does the same thing. Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight. He was about 200 something and was kind of built and now is skin and bones. He lost 6 (lbs) pounds within a week and is eating like crazy. Sensory nerves are all gone. If hit with a baseball bat and he would not feel it. It came on slowly almost that he did not know it was happening. That is why they want to send him to Privacy for a research center and he does not want to go. He never had this happen before. ER or physician's office required: 1st date was on Thursday, 11Feb2021, when he went to Privacy. He was having chest pain and hurting all over. He thought he was having a heart attack. He was released. The patient stated he wanted to change the information he had provided since he was not in his right mind since he had taken the wrong medication dose than the doctor had given him. He stated the medication dosage he wanted to change was for Amiripyin. He stated he wanted to say he told the representative the symptoms he had experienced was enhanced which they were yesterday because he was trying to fight everything and stay awake. COVID 19 vaccine: he stated the doctor did not want him to take the second dose of the vaccine. He stated one of the symptoms he had experienced after the vaccine that he wanted to change the outcome for is the neuropathy. He stated he is back to where he used to be and yesterday it was bad he could hardly walk or talk. He stated also the other symptoms he wanted to change the outcome for is the autoimmune. The patient has not recovered from neuropathy, autoimmune disorder, disoriented, can't walk or lift anything, chest pain, and sensory nerves all gone; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.

Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No risk factors for DVT. Unknown lot number for vaccine. Not done at my faciluty

Post vaccine #2 on 5/18 he developed hives, shortness of breath and reportedly did not feel with fatigue. Symptoms worsened and he was admitted to ICU on May 21st via the ED for multiorgan failure including respiratory failure with R pneumonia, Shock, Renal failure, Disseminated intravascular coagulation, shock liver failure requiring invasive vent support and treatment for septic shock including vasopressor support and antibiotic therapy. He was started on CRRT on the 22nd. His INR continues to rise and Hb dropping consistent with worsening DIC. Blood cultures are positive for MRSA. He will likely die from progressive septic shock and MSOF.

Serious chest pains began 5 days post receiving 2nd vaccine. 3 days later ended up in hospital with massive heart attack.

Irregular heartbeat started shortly after the vaccine and continued from then until now and is still occurring. Comes with occasional fatigue and several episodes of afib

Patient presented to the ED and was subsequently hospitalized for Acute CVA (cerebrovascular accident) within 6 weeks of receiving COVID vaccination.

Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.

Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw they were solid red; inflamed; hands swelled up; itchy; sore; sore where injected the Testosterone into left arm.; sore where injected the Testosterone into left arm.; This is a spontaneous report from a contactable consumer (patient). An 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 16:45 (Lot Number: EW0182; Expiration Date: 31Aug2021) as 1st 0.3 ml single dose at the age of 49-years-old for covid-19 immunisation; testosterone cipionate, via an unspecified route of administration from 2020 (Lot Number: 88945; Expiration Date: 30Sep2021) and ongoing, at 150 mg, 2x/week (150 mg injection bi weekly ) for gonads, low testosterone. The patient medical history included low testosterone, gastrooesophageal reflux disease, COVID in the past (He did not know initially he had it, he had lost of taste and smell). Concomitant medication included dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. None prior vaccinations (within 4 weeks). No family medical history relevant to AEs. No additional vaccines administered on same date of the pfizer suspect. The patient experienced anaphylactic reaction (medically significant) on 17May2021. Time of onset (24-hour clock): Roughly 18:00. Usually he took the testosterone in the morning, but he forgot. He was wrapping up the day, took the testosterone and by 18:02 he was on the ground, cold. The patient got his vaccination last Tuesday (11May2021). He was also on testosterone for gonadism. He usually administered the vaccine in his shoulders. He took the testosterone bi-weekly. On Monday he administered it his left shoulder and on Thursday it is in his right shoulder. After getting the vaccine he administered testosterone in his right shoulder on Thursday and had no issues. The patient mentioned everyone else who got the COVID Vaccine he knows had sore arm, nausea, but he did not have any of that. On Monday (17May2021) he injected his testosterone into the same arm/location, left arm, where he got the COVID vaccine and had an anaphylactic reaction. He contacted his doctor and went to the emergency room. The patient confirmed he felt like he had recovered completely from the anaphylactic reaction. Caller clarified the anaphylactic reaction. He did the testosterone injection in the same spot he had the COVID injection. Within 5 minutes it was like his skin was on fire. He was sweating, had stomach cramps, and was throwing up. Once he stopped throwing up he looked at his arms and saw they were solid red. They were all inflamed. His legs were inflamed. His hands swelled up. They were red. He had to take his wedding ring off. He was itchy. It was like he was on fire. He was sore, and sore where injected the Testosterone into left arm. He confirmed he had no problems swallowing or breathing. Based on the symptoms he was experiencing he realized these were things listed to be aware of when getting the COVID shot and to seek medical attention for. He went to the ER and they verified it was an anaphylactic reaction. Treatment included: He was given an Epi-Pen. It made him feel like off, like he had too much coffee or something. he was also given Benadryl and some Anti-Inflammatory to calm his body down. Investigations: He had blood drawn at the ER. However, he does not know if was actually tested. He was informed when the nurse drew blood it would be up to the doctor, but he has no knowledge if anything was done. Action taken of testosterone cypionate was dose not changed. Outcome of the events was recovered on 17May2021.

Acute ischemic stroke; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 08:00 (at age 49-years-old) (Batch/Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation. The first dose was received on 13Apr2021 (lot number: ER8735) on the left arm at age 49-years-old. Medical history included high cholesterol and penicillin allergy. Concomitant medication included rosuvastatin. No other vaccine was received within 2 weeks of vaccination. The patient experienced acute ischemic stroke which started afternoon of 05May2021 13:00. Patient visited ER on 06May2021 at 07:00 and was hospitalized for stroke from 06May2021 to 07May2021. He started physical therapy to rebuild strength and coordination in left arm and leg. Treatment atorvastatin 40,aspirin 81,Hydrochlorothiazide 25 was given. Patient was not diagnosed with covid prior to vaccination and has been tested on 06May2021 (nasal swab): negative. Outcome of the event was recovering.

Hositalized for Stroke on May 5, 2021. Patient dismissed from hospital May 12, 2021. Under continuing treatment to reduce blood clots.

Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic reaction; Eczema; This is spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL3249), via an unspecified route of administration on 21Jan2021 on the right arm at 02:00 pm as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EJ1685), via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced bleeding, was losing skin on hands and feet, losing finger and toenails. The patient also had excessive pain, and also had a allergic reaction. Caller stated that he had an allergic reaction to the vaccine in January and was still having these side effects. The patient visited emergency room and physician office due to the events. The case was assessed as serious (medically significant). Patient's lab tests and Investigation results on an unknown date on Biopsy of skin on hands and feet revealed Eczema. Lot of blood work (uknown) done. The patient did not receive any treatment for the events. The outcome of the events was not resolved. Follow-up attempts needed. Additional information has been requested.

This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: ED6955), dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 15:10 as 1st dose single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.Reporter stated on 03Apr2021 her husband had his first shot and on 28Apr2021 he had the second shot, then on 07May2021 he had a massive heart attack husband was hospitalized for three days and has not recovered completely also her husband is 49 years old with no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. Reporter stated her husband is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are trying to adjust his blood pressure medication as it is a little low at this time and trying to see what will happen. Reporter stated they do not know what this was caused, had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack, couple of days after the second dose of the vaccine it stopped, and her husband was getting better each day and was not taking naps as often, slight pain where the shot was given in his arm: Reporter stated this was just a couple of days after the first dose and then it happened again after the second dose on 28Apr2021 but stopped a couple days after. On 7May2021,The patient experienced massive heart attack, high blood pressure was unknown, Diabetes, High cholesterol not recovered, extremely tired, achy and slight pain where the shot was given in his arm was resolved. Follow-up attempts are needed. Additional information has been requested.

Massive heart attack; Diabetes; High blood pressure; High cholesterol; Achy; Fever; slight pain where the shot was given; after the second one he was very tired; he was sweating; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 at 10:15 (at the age of 49-years-old male) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Vaccine was not administered at military facility. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient had no other vaccine prior this vaccinations within 4 weeks. Patient had no medical history including any illness at time of vaccination. No family medical history relevant to AE. The patient had received dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 at 15:10, for covid-19 immunisation and experienced diabetes and extreme tiredness. 07May2021, the patient experienced massive heart attack, diabetes, high blood pressure, high cholesterol, on 28Apr2021 slight pain where the shot was given, achy and fever, on an unspecified date "after the second one he was very tired" and "he was sweating ". The patient was hospitalized for massive heart attack from 07May2021 to 09May2021. Reporter (patient's wife) stated her husband had no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Fever was overnight and did break in the morning all for the COVID vaccine. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. The patient is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are tying to adjust his blood pressure medication as it is a little low at this time and trying to see what might happen. Reporter stated they do not know what diabetes was caused from. The patient had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack. The event caused emergency room visit. Reporter stated her husband went to the cardiologist the week after and he just went to the endocrinologist yesterday for diabetes. Reporter stated extremely tired started immediately after the second vaccination. The patient after the second one he was very tired and he went to lay down and she noticed he was sweating because he had a temperature. A couple of days after the second dose of the vaccine it stopped and her husband was getting better each day and was not taking naps as often. Patient was given a lot of water and refueled and he slept through the night. He experienced slight pain where the shot was given in his arm but that was nothing that alarmed them. It stopped a couple days after. The reporter wanted feedback. The reporter has seen on the news how there are issues and heart issues and is there any feedback or any other contact she needs to make. NDC Number and expiry date was unknown. The patient underwent lab tests and procedures which included blood test: on May2021. He still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack. Treatment was given for the event hypertension. outcome of the event heart attack, pain, fever, vaccination site pain was recovered. Blood pressure high, High cholesterol ,Diabetes was not recovered. Outcome of the event fatigue and sweating was recovered on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.

Since vaccination patient has been treated in office for swollen lymph nodes, shingles and DVT right lower extremity

49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aortic dissection, pericarditis, myocarditis. On arrival, patient appeared critically ill with cool, clammy skin, diaphoretic, complaining of chest pain. Patient initially able to answer simple questions, however quickly became unconscious, witnessed having tonic colonic seizure activity. Patient given 2 mg of lorazepam which aborted the seizure, however he remained unresponsive. IV fluids were started, and patient remained hypotensive after 3 L of fluids. Bedside cardiac ultrasound was performed which showed a large pericardial effusion with tamponade physiology. We continued fluid resuscitation and patient was intubated, while stat Cardiology consult was called. Patient suffered a cardiac arrest shortly after intubation. Cardiology performed emergent pericardiocentesis at the bedside which showed hemopericardium with output of greater than 500 mL of blood. ROSC was achieved following pericardiocentesis, and we continued resuscitative measures. Emergent arterial line and central venous lines were placed. Patient began to have profuse bleeding from all orifices, and massive transfusion protocol was initiated. Patient was stabilized enough to be taken to CT scanner which showed an extensive aortic dissection extending into the RCA, abdominal aorta, brachiocephalic artery, common carotids, and into the abdominopelvic vasculature. Cardiac and vascular surgery were consulted stat, and the decision was made to take the patient emergently to the OR. We were informed shortly after that the patient had expired en route to the operating room and they were unable to obtain ROSC. Final impression: type A aortic dissection, cardiac tamponade. Second dose of mRNA vaccine (unknown if Pfizer or Moderna) received two days prior to event.

AFTER 2-3 WEEKS AFTER THE SECOND DOSE, STARTED FATIGUE, SOB, COUGHING CAME TO SEE ME, HAD CHF , REFERRED TO A CARDIOLOGIST DR, MD, WHERE HE HAD ECHO DONE WITH NML CHF AND SEVERE LVH. HE HAD A COVID TEST NEGATIVE.

04/17/2021 Chronic cough, especially at night. I am a former smoker. I went to doctor and had x-rays. Was diagnosed with pneumonia.

Intense abdominal pain that required hospitalization from Sunday, May 16, 2021 until Friday, May 28, 2021 due to portal vein thrombosis as well as other abdominal blood clots. No clots were found in extremities and no genetic reason for occurrence. Patient left hospital with Xarelto medication for thrombosis treatment. Patient is still under medical care by hematologist and primary care physician to date for treatment of the blood clots.

pneumonia; valley fever; diabetes; shortness of breath/difficulty breathing; body aches; headache; got sick; hadn't been well enough; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-years, via an unspecified route of administration, administered in right arm on 23Apr2021 at 02:11 at single dose for COVID-19 immunisation. Medical history included he and his family did have the COVID-19 virus in Nov2020 (with the COVID-19 virus in Nov2020 his fever had reached 103 degrees Fahrenheit). Concomitant medications were not reported. He was calling about the vaccine. He was scheduled for his second dose on 14May2021 but between his first and second dose, he developed pneumonia. He reported he and his family did have the COVID-19 virus in Nov2020. He was the only one that got sick after receiving the vaccine. He didn't know if it was coincidental or happenstance. He had been taking medication and hadn't been well enough to get his second dose. His primary care doctor and the doctor he saw at the urgent care both told him not to get the second dose until he was well. Now several weeks had passed and he wanted to know if he was ok to get the second one or will he have to restart and get the first vaccine again. The type of pneumonia that he had was called Valley Fever. He had been told it was because of the dry climate. He did have a chest x-ray and that was who the doctor knew he had pneumonia. He also had a blood test to confirm that he had the Valley Fever. He also had a COVID-19 virus test and that was negative. He actually thought he had the COVID-19 virus for a second time. The symptoms were exactly like the COVID-19 virus. He had a low grade fever, body chills, body aches, a cough developed and a really intense headache. He went to the urgent care with those symptoms and tested him and found out he did have the Valley Fever, a type of pneumonia. The doctor ordered the blood test to confirm the Valley Fever. His fever didn't get as high this time like it did when he had the COVID-19 virus. This time with the Valley Fever his fever was about 100 degrees Fahrenheit. He definitely had body aches, chills, shortness of breath and difficulty breathing. Since Nov2020 when he had COVID-19 he can say his lung capacity wasn't what it used to be pre COVID-19 virus. He was just able to go out and walk his dog and felt like he was breathing normally. Then he received the first dose and a week and a half later he got sick with the Valley Fever. He would like to get the second COVID-19 vaccine but wanted to know if he had to start the process over. He didn't take any medications and considers himself healthy. He would like to add that when he went for his follow up for the Valley Fever he had a complete blood work and urinalysis and interestingly enough his numbers came back that now he was in the diabetic range. He didn't know if it was related to the COVID-19 vaccine or not but thought that he should add it. He wasn't prescribed any medications for the diabetes he was told to change his diet. His blood sugar came back normally and his doctor told him when people have diabetes their blood sugar gets out of whack. He was going to change his diet for the next couple months. He went to the urgent care on 14May2021 with his symptoms, that was the same day he was supposed to get the second COVID-19 vaccine. He was asking if he was outside the window and need to start over or just need to get another shot. He said that he wants to get the vaccine. The events shortness of breath, difficulty breathing result in physician office. Outcome of the events was unknown. Information about lot/batch number has been requested.

At the beginning of April I stated having arrhythmia so I went to a cardiologist. The cardiologist said it was just PVC's. On May 29th I suffered a heart attack. I had stent put in. I now take aspirin, brilinta, lostartin, atorvastatin, metoprolol. I still have an arrhythmia as I recover from my heart attack.

arm pain from the moment he received tie injection. Hands and fingers went numb. was told arthritis in shoulder. Went to Er on the 20th of july and a CT scan was done . Had stroke on the 21st . two blood clots were found

Sudden onset of chest pain, EKG proven acute myocardial infarction with fresh thrombus in right coronary requiring cardiac cath and stenting

Rhabdomyolysis, CPK 5070 U/L (normal range <308 U/L) on Feb 3, 2021. Diffuse sore muscles after extreme work out on both 1/30 & 1/31.

Pt received vaccine on Friday, March 19th. On Monday, March 23rd, t was hiking with boy scout troop, became short of breath, collapsed and went into full arrest. BLS done on scene, transported to local ER where pt was pronounced dead.

he started feeling sick day after vaccine with flu like symptoms, seen in ED 5 days after vaccination, diagnosed with COVID19, About 1 week after that, he was found dead at home on his couch.

2 days after 1st shot I felt extreme fatigue and shortness of breath for several days. Got tested for COVID with negative results. Went to hospital on 16th of February and was admitted due to heart condition and recent heart attack. I told them my next vaccine was due on the 18th and they gave it to me while I was admitted. Within 24 hours I had another heart attack. I was sent to another hospital for an Angiogram where they expected to find blockage and prepared to install a stint. They found no blockage. There is no medical explination.

Patient presented to ED with two day history of hives over body. Received treatment for anaphylaxis in ED including Epi-Pen, Pepcid, Benadryl, and Solumedrol. Patient initially hypotensive.

A perfectly healthy guy, who did not change anything else in his life, got the first vaccination, and 12 days later had a blood clot in his right lung. Went to ER, was diagnosed, and spent 3 days in the hospital. Serious. Doctors so far has no explanation for why this happened.

developed chest pain and shortness of breath 12 hours after vaccination and went to ED and hospitalized with PE and DVT and now on xarelto

Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches, elevated heart rate, uncontrollable body spasms, loss of appetite

Severe anaphylactic shock Hives, Rash, etc.. Started 3/29/2021 lasting until 4/15/2021 Still feeling off

Within a couple of hours of second Pfizer shot I experienced symptoms of Atrial Fib and sought treatment at the local healthcare facility. After 13 hours of treatment my heart ?coveted ? and was released for the hospital. I received meds and tests to make the conversation happen

pulmonary embolism; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ep7534), via an unspecified route of administration, administered in right arm on 16Mar2021 15:00 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included verapamil. The patient previously took lisinopril and experienced allergies. The patient received first dose of bnt162b2 on 23Feb2021, 13:00 for Covid-19 immunization. On 19Mar2021, the patient started having challenges with shortness of breath. On 31Mar2021, after the challenge continued to grow he was checked into the hospital and was diagnosed with pulmonary embolism. Despite no travel nor history of family blood clots, nor was he was genetically dispositioned. The events resulted in emergency room/department or urgent care. Therapy for the events included Blood thinner. The patient had no other vaccine in 4 weeks, and no Covid prior vaccination. The patient was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab was negative on 31Mar2021. Outcome of events was recovering.

Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/brown dots all over my lower legs and arms followed by black and blue bruises on legs and arms. Went to ER seven days after first noticed symptoms. Was admitted to ICU with platelet level near 2,000. Complete blood workup was done and everything was eliminated except Immune Thrombocytopenic Purpura (ITP). I was treated intravenously with immunoglobulin and steroids. On 4/21/21 I was released from the hospital with my platelet level near 49,000. Following up with hematologist on 4/26/21 for further testing and evaluation.

Patient presented to ED for c/o SOB 4/17/21. He was diagnosed with PE. Also for completion, patient did have shoulder surgery 6 weeks ago without complication.

I received the Pfizer vaccine on 21 December 2021. On December 27 I developed a fever, cough and was diagnosed with Covid-19. About 14 days later I started to get a rash on hands and feet with burning sensation. I was evaluated and diagnosed with Covid toes. About 1 week later I developed a fever and was evaluated and diagnosed with pneumonia, pulmonary embolism, and a DVT. I continue to get worse to include arthritis in hands, wrists, feet and ankles. I was admitted to the hospital with worsening pneumonia, reactive arthritis and a rash on elbows, knees, hands and feet. I was in the hospital for about 5 days. I have been evaluated by rheumatology, pulmonary and dermatology since. The ongoing theory is I have a reactive arthritis from COVID and may have developed psoriasis/psoriatic arthritis.

8 days post vaccine patient developed rash on left arm that spread to b/l arms and legs. Over the next few days developed increased fatigue, severe joint pain, fever and worsening rash. Was seen in ER on 4/23/2021. Extensive work up showed increased CRP, Eosinophilia, increased LFTs, increased WBC. Skin biopsy was taken and revealed Superficial and deep perivascular and interstitial dermatitis, histiocyte-predominant and with eosinophils. ANA was positive 1:640, Ferritin was elevated. The patient was admitted. . Patient had CT scan of the chest on 4/28/2021 which showed bilateral pulmonary embolism and possible mass in the right side of the liver. Patient was started on anticoagulation. Next day, patient had severe abdominal pain with pain in the right lower quadrant. He as found to have Ogilivie's Syndrome with colon ischemia and peritonitis. Now s/p resection with septic shock. The patient is in the ICU and intubated.

Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in left arm on 19Apr2021 16:00 (Lot Number: ER8731) 2ND DOSE, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EP6955) on 29Mar2021 01:00 PM in the left arm for COVID-19 immunization and experienced stroke like event/seizure. The patient had stroke like event/seizure following first and second injections. The patient also had brain inflammation. Events onset date reported as 22Apr2021 11:00. The events were reported as serious due to hospitalization in Apr2021 for 5 days. Events resulted in doctor or other healthcare professional office/clinic visit and a visit to emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 since the vaccination. Outcome of events was unknown. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Apr2021. No treatment received for the events. Further information has been requested.

seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown Information on Lot/Batch number was available. Additional information has been requested.

nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines; blurred vision in right eye that comes and goes; ringing in his left ear; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Fullness in face; Body aches; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; feeling dizziness/had to stop driving; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (may have been in morning) (Batch/Lot Number: Unknown; Pfizer COVID-19 vaccine) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 50 years old. The patient's medical history and concomitant medications were not reported. History and Investigations: Doesn't take any medications. Has no medical conditions, unless age was considered a medical condition. Historical vaccine included first dose of COVID-19 Vaccine reported as on Third Friday in Feb2021 (First dose: between 1430-1530), and experienced AEs: Brain fog; Headache: Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. Dizziness: Had to stop a couple times while driving home from vaccine facility. Aches and pains. All symptoms from the first dose went away within 3-4 days. Caller would say patient recovered completely from symptoms associated with first dose. The patient experienced nurse stated it could possibly be blood clots on an unspecified date with outcome of unknown, patient is afraid he is going to have a stroke or scared he had one after the covid-19 vaccines on an unspecified date with outcome of unknown, brain fog: at times he can't do the simplest things. he will look at the clock on the wall and says he knows what it is, but can't find the words to say. cannot carry on a conversation intelligently on 12Apr2021 with outcome of not recovered, headache all over the back of his head/affecting his balance. in back of head, moves around, sometimes the front on 12Apr2021 with outcome of not recovered, feeling dizziness/had to stop driving on 12Apr2021 with outcome of not recovered, blurred vision in right eye that comes and goes on an unspecified date with outcome of not recovered, ringing in his left ear on an unspecified date with outcome of not recovered, fullness in face on 12Apr2021 with outcome of not recovered, body aches on 12Apr2021 with outcome of not recovered, very fatigued throughout the day, sleeping a lot/tired and sleeps a lot on an unspecified date with outcome of not recovered, date received first dose: third friday in feb2021/received second dose on 12apr2021, six weeks after first dose on an unspecified date with outcome of unknown. Patient was caller's husband. Had both doses and had the same problem. His experience is very bad with the second dose and has had it for a month. Within a day after the first dose, had brain fog, headache, and dizziness where he had to stop driving a couple times. This went away within a few days. Patient and caller were concerned about the second dose. They spoke with patient's doctor and the local Health Department, both said it couldn't be from the vaccine. Patient was advised to get the second dose. Had the same symptoms with second dose, but occurred within an hour of received second dose. Symptoms have continued. Also experiencing blurred vision in right eye that comes and goes. Patient had an appointment with his doctor this week, but the doctor basically didn't look at him. Doctor advised patient to see a neurologist. Another nurse stated it could possibly be blood clots. Caller is trying to find help. Caller wanted to add with the second dose, patient experienced ringing in his left ear, fullness in his face, and headache all over the back of his head. Was feeling dizziness after second dose and had to stop driving. Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines. If the COVID-19 Vaccines woke up some other health issues, patient wants to get it taken care of. Received second dose on 12Apr2021, six weeks after first dose. Got second dose at a different location. Second dose COVID-19 Vaccine AEs: Started experiencing symptoms within an hour. Headache: Affecting his balance. In back of head, moves around, sometimes the front. Comes and goes. Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently. Dizziness. Blurred vision in right eye: Doesn't know if this started on 12Apr2021 or a couple days after. States as the day goes on and he gets tired, it will worsen. It comes and goes. Ringing in left ear: Began on 12Apr2021 or a few days after. Fullness in face: Stated this comes and goes, but has stayed the same. Documented as provided. Body aches: Comes and goes. Seems to worsen as the day goes on. Very fatigued throughout the day, sleeping a lot: He's tired and sleeps a lot. It was hard for him to get out of bed. Caller stated patient's symptoms worse as the days goes on. Patient never experienced pain at the injection site. Guesses patient received COVID-19 vaccines in his left arm because the county was doing a dive-thru clinic. Since he didn't get out of his car, she believed patient would have received the vaccines in the left arm. The events REQUIRE A VISIT TO Physician office: Doctor doesn't think anything is wrong. ER: Not yet. Is considering going to the ER today. PRIOR VACCINCATIONS WTIHIN 4 WEEKS was None. RELEVANT TESTS: None. Events Clot blood and stroke considered medically significant. Follow up attempts are needed. Information of Lot/Batch number has been requested.

I63.9 - CVA (cerebral vascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC

Pneumonia, unspecified organism Non-ST elevation (NSTEMI) myocardial infarction Gastrointestinal hemorrhage, unspecified Thrombocytopenia, unspecified

Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood leaving my arms and legs, began to feel feint. Laid down on ground with legs elevated. Began shaking. Called 911. Was taken to the hospital by ambulance. Once at hospital, felt arms and legs were numb. After a period of time going through testing at the ER, feeling returned to all but left leg. Stayed overnight, went home on 5/6/2021. Strength returned to left left over the next several days. Since 5/6/2021. Have been dealing with increasing debilitating anxiety, as well as photosensitivity, insomnia, and other related issues since returning home.

Reports onset of "return of Covid symptoms" almost immediately (fever, chills, diarrhea, shortness of breath, loss of taste and smell, jaundice). Followed by extreme symptoms as of May 7th including fever above 104 degrees Fahrenheit. Pt first seen by medical professional on May 11. Patient was hospitalized May 15 and remained hospitalized until June 1 and was treated for multiple infections and sepsis during hospital stay.

Patient died 04/06/2021 Covid vaccine #1 Pfizer 03/16/2021 Lot #EN6207 Covid Vaccine #2 Pfizer 03/19/2021 Lot # N/A

DVT Blood clot left popliteal vein. Pt is healthy adult male road cyclist. No other risk factors for DVT blood clot.

stroke; This is a spontaneous report from a contactable consumer (patient self). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm Left in Apr2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 50-year-old) for COVID-19 immunisation. The administration time was 10:00 AM. Medical history included arthritis and gastrooesophageal reflux disease (GERD). Concomitant medications included ASA; celecoxib; esomeprazole sodium (NEXIUM). The patient previously received BNT162B2 dose 1 in Mar2021 at the age of 50-year-old for COVID-19 Immunization. There was no other vaccine in four weeks. The patient did not have Covid prior vaccination. No known allergies. The patient suffered a stroke on 23Jun2021, with very little to other known risk factors which resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized in Jun2021 for 2 days. Treatment received inluced hospitalization, multiple tests, and new Rxs. Outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pulmonary Embolism Requiring hospital stay; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 2021 (also reported as Mar2021) at 50 years old as dose 2, single for COVID-19 immunization. Medical history included blood pressure abnormal, atrial flutter, heartburn, and penicillin allergy from an unknown date. Concomitant medications included ciclosporin (CYCLOSPORIN) taken for an unspecified indication, start and stop date were not reported. Other concomitant medications include unspecified blood pressure meds, and atrial flutter meds. The patient previously received the first dose of bnt162b2 (lot number: EW0169) on 16Apr2021 at 50 years old for COVID-19 immunization. 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 and has not been tested for COVID-19 since the vaccination. On 11Jun2021 16:00 the patient experienced pulmonary embolism requiring hospital stay. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit and was considered by the reporter as serious for requiring hospitalization for 4 days and life-threatening illness (immediate risk of death from the event). The patient was given an unspecified blood thinner as treatment. The outcome of the event was recovered with sequelae (lasting effects). Information on the lot/batch number has been requested.

Patient presented to the ED with NSTEMI on 4/20/2021. Patient hospitalized on 4/27/2021 for heart failure, nonischemic cardiomopathy and elevated troponin due to type 2 myocardial infarction.

Nose bleed started on 2/1/21 that would not stop for 2 days. Labs checked - Platelets dropped from baseline of 210 to "4" - sent to hospital on 2/2/21, required ICU Admission with dx of unspecified ITP. There are no other changes of medications or regimen prior to incident. Hospital notes also suspect from COVID vaccine as otherwise unexplained. Has not fully recovered, still in ICU.

At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially bleeding and unconscious and was brought by EMS to the hospital. Upon arrival at the hospital he had a temperature of 40 C. He was found to have 2 small left temporal hemmorhagic contusions on CT scan. He had a seizure during the hospitalization. He was initially treated for HSV encephalitis but it is not clear if that was confirmed. The hospital team may not have known of the recent vaccination. He improved during the hospitalization, but remained with a very unsteady gait. He could not return to the group home. He was transferred to a rehab facility to receive PT on 02/16/2021. He remains at rehab. Prior to the fall, on the 3rd day after vaccination, on 2/8/21 at about 10 am, the patient coughed and had a small blood on the inside of his face mask while at his day program. He was seen by his PCP and had no abnormal findings. He had a CBC, BMP and CXR and all were unremarkable.

suspected pulmonary embolism; shock; cardiac arrest; This is a spontaneous report from a non-contactable consumer (patient's wife). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 04Mar2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced a suspected pulmonary embolism on Monday 08Mar2021 at 11:30 AM. Embolism led to shock and cardiac arrest. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received unspecified treatment for the events. The patient died on 08Mar2021 at 11:30 AM. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: suspected pulmonary embolism; shock; cardiac arrest

Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness over his whole right side denies any chest pain no tingling no trauma no incontinenc

After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morning 01/09/2021 . I was stroked out taken to er. Still I have weakness on left , hearing loss, loss taste, even I drink water taste bitter. Loss smell. I am doing physical and speech therapy. Still not recovered.

Pulmonary embolism. SOB; Left upper extremity dialysis graft occlusion necessitating balloon and stent; This is a spontaneous report from a contactable physician. A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in arm right on 25Feb2021 at single dose for COVID-19 immunisation. Medical history included end stage renal disease (ESRD) on HD due to hypertension (HTN), and morbid obesity. The patient was allergic to Levaquin, NSAIDs. Concomitant medications included acetylsalicylic acid (ASPIRIN), atorvastatin, clonazepam, dutasteride, escitalopram, metoprolol, nifedipine, sevelamer, torsemide, cetirizine hydrochloride (ZINE). On 25Feb2021, the patient had left upper extremity dialysis graft occlusion necessitating balloon and stent on the day of the vaccine administration. Pulmonary embolism developed 3 weeks after the first vaccine dose (Mar2021). No leg swelling, no long-distance travel, no immobilization or other cause of pulmonary embolism identified. No cough or fever. Shortness of breath (SOB) developed the day before the Pulmonary embolism (PE) was diagnosed (Mar2021). AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 2 days, received Heparin drip followed by Xarelto as treatment. Events outcome was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided the company cannot completely exclude a contributory role of BNT162b2 administration in the development of the reported 'complication associated with device and pulmonary embolism', with SOB as initial sign and symptom associated with pulmonary embolism. The impacts 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 left arm . Tension in arms and shoulders. Shortness of breath. On 3/19/2021 I was diagnosed with pulmonary embolisms in both lungs and right leg

Currently, developed 3 blood clots in right arm 4 days after receiving the vaccination. First was noticed on the morning of April 6, the second in the evening of April 6, and the third was noticed on the morning of April 7. First one has appearance of cellulitis located on the forearm. Doctor issued treatment for cellulitis on April 6. Reddish/purple skin colored with grey edges in a circle. Second clot is below the skin with slight bulge closer to the elbow than the first. The third indication is in the upper arm above the elbow on inside of arm. Appearance marked by 2 curved lines similar to varicose veins just below where the clot is bulging the skin. No discoloration of the 2nd and 3rd indications of clot.

I received the vaccine at 12:15 PM. I was a little tired but generally fine the rest of the day. I woke up at 2:30 and didn?t feel well. I got up to go to the bathroom. I started getting the chills and feeling dizzy. I passed out. My wife found me passed out on the ground and bleeding. I needed six stitches in my head and have a black eye as well as other facial lacerations. I have no recollection of anything until my wife woke me. I have never passed out in my life prior to this.

Pt received dose of vaccine on Sunday. Had business trip on Thursday. After flight became short of breath and had discomfort in the chest. Worsening on trip back

Chest pain Acute kidney failure, unspecified DOE (dyspnea on exertion) Hypoxia Bilateral pleural effusion Chronic obstructive pulmonary disease, unspecified COPD type Chronic kidney disease, unspecified CKD stage Acute on chronic heart failure with preserved ejection fraction

Cryptogenic stroke. Experienced garbled speech for a period of less than one minute. Symptoms resolved on their own. Went to ER and had an MRI showing three spots for affected tissue.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient hospitalized for blood clot (called pharmacy @ 835pm on 4/15/21). Asked by hospital to contact pharmacy. Patient called from personal phone number.

Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date. The patient died on 02Apr2021. An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain

Week after vaccine developed shortness of breath and pain breathing. Trip to ER and admitted to hospital. Diagnosed with Pulmonary Embolism. Blood clots both lungs.

he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old. Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering. Information on the lot number has been requested.

BRIEF OVERVIEW: Bilateral PE Discharge Provider: MD Primary Care Provider at Discharge: NP Admission Date: 4/26/2021 Discharge Date: 4/26/2021 Active Hospital Problems (Diagnosis Date Noted) ? Pulmonary embolism without acute cor pulmonale, unspecified chronicity, unspecified pulmonary embolism type (HCC) 04/26/2021 Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: Patient is a 51 y.o. male with a past medical history of psoriasis, environmental allergies who presents today with sudden shortness of breath, left side pleuritic chest pain 7/10, worsened with deep inspiration. No recent travel, no family history, no history of malignancies, no immobilization or surgeries. He had his 2nd dose of Pfizer COVID vaccine on April 1. He does not have a history of COVID-19 infection, and COVID-19 PCR test was negative in ER. His blood pressure is a little high at 170 6/83 mm, pulse 76 per minute saturating 96% on room air, troponin less than 6, BNP 16, WBC 12.3,, EKG without any significant ST T-wave changes. CT angiogram of the chest shows nonocclusive thrombi in almost all the lobes, there is no saddle embolus noted. There is no evidence of right heart strain. Echo: The technical quality of the exam was limited due to suboptimal acoustic windows. The left ventricle is normal in size. There is normal left ventricular wall thickness. The left ventricular ejection fraction is 60%. Regional wall motion abnormalities cannot be excluded due to limited visualization. The right ventricular size, thickness, and function are normal. No significant valvular pathology identified with Doppler examination. There was insufficient tricuspid regurgitation envelope detected to calculate right ventricular systolic pressure. Injection of contrast documented no interatrial shunt. There is no comparison study available. He was started on Heparin gtt. And admitted for observation. He required no supplemental oxygen. He was discharged later pm on Eliquis 10 mg bid for 7 days, than 5 mg bid for 3 months. I am questioning did he had COVID-19 vaccine related bilateral PE. His hypercoagulable profile is pending. He has no sign of malignancy, no new symptoms, no weight loss. He had normal colonoscopy 2 yrs ago. He should follow up with his PCP. He was given work excuse from 4/26-5/3/21. She shouldn't take non steroidal anti-inflammatory (Ibuprofen (Motrin), Naproxen, Naprosyn, Voltaren, Relafen ... meds because of blood thinner Eliquis. He can take Tylenol 500 mg 1-2 tabs 3-4x a day as needed. He was also prescribed Lidoderm patch. For HTN he was started on DASH diet and Norvasc 5 mg daily. He should follow up with PCP next week. Also he was instructed to quit smoking.

Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side weakness. EMS evaluated the patient on-site. The patient was hypertensive (197/129) with a FSBG of 95mg/dL. During stroke assessment, the patient had new onset facial palsy/droop and need speech abnormality which signaled a stroke alert. 12-lead EKG was unremarkable. EMS transported the patient to Emergency Department. In the ED, the patient presented with a headache, chest heaviness, and slurred speech, but no aphasia. NIH stroke scale was 0. Patient remained hypertensive (170/109). Labs, tests, and imaging did not indicate rtPA administration. ED physician administered 0.4mg SL Nitroglycerin, 10mg IV Hydralazine, and 325mg PO Aspirin prior to admission for suspected Transient Ischemic Attack. Upon admission, differential was TIA vs. CVA vs. ACS. Admitting physician ordered HbA1C, lipid panel, MRI brain, CTA head/neck, 2D echo, and neurology consult. Throughout course of admission, patient had recurring midsternal chest pain that was relieved with Nitroglycerin. Imaging ruled out CVA. Given elevated TGs and Cholesterol, patient was started on Atorvastatin 40mg PO. Suspected TIA and ACS. Neurology consult reviewed the labs and imaging, and stated the episodes of stuttering are most commonly associated with anxiety or stress reaction. Neuro did not recommend any further workup unless this happened again unprovoked. Patient was discharged after a 3-day admission with diagnosis of cerebrovascular disease, unspecified. The patient was prescribed 81mg PO Aspirin, 20mg PO Lisinopril, and 40mg PO Atorvastatin.

DVT developed in Right Calf approx 24 hours after the vaccine administration; This is a spontaneous report from a contactable physician. This Physician reported for a 51-year-old male patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney stone from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any vaccine in four weeks. Patient did not receive any vaccine in four weeks. The patient developed DVT in right calf approximately 24 hours after the vaccine administration on 12Mar2021 with outcome of recovering. Therapeutic measures were taken as a result of event included Xarelto. Patient was not tested for covid post vaccination. Information on the lot/batch number has been requested.; 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 DVT 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.

Tinitus in left ear as of 4/13/21. And disgnosed with a blod clot in right calf symptom of clot felt on 4/17/21

I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where several clots were found; Two days after my vaccine I began having severe pain in my right leg in the calf area and pain in my chest when I took a deep breath or coughed. Over the weekend it got worse and worse, on Tuesday th; Pain in my chest; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14Apr2021 13:00 (Batch/Lot Number: Ew0153) (at the age of 51 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included duloxetine; trazodone; pregabalin (LYRICA); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); and meloxicam, all taken for an unspecified indication, start and stop date were not reported. The patient previously took vancomycin and daptomycin and experienced drug allergy to these medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021 09:00, two days after the vaccine, the patient began having severe pain in his right leg in the calf area and pain in his chest when he took a deep breath or coughed. Over the weekend, it got worse and worse, on Tuesday 20Apr2021, the patient had an ultrasound done on his leg where a blood clot was found. He had a chest computerized tomography (CT) performed where several clots were found. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment included blood thinners. No COVID prior vaccination and not COVID tested post vaccination. The case was assessed as non-serious by the reporter. The outcome of the event was not recovered.

Patient with no family or personal cardiac ischemic history, appropriate diet. Prior evaluation 6 years prior showed 10% stenosis. Performs regular cardiovascular exercise (Peloton). No smoking or drug or alcohol history. Normal lipids before and after event. Normal lipid subfractions (MRI advanced profile). Pfizer Vaccine Dose #1 received 12/31/2020. First mild angina episode 1/17/2021. Pfizer Vaccine Dose #2 received 1/21/2021. Increasing angina developed 1/22/2021 through 1/27/2021. Normal echocardiogram 1/27/2021. NSTEMI occurred 1/28/2021 at 3:30am necessitating Emergency room visit, Catheterization demonstrating a new 95% LAD stenosis and stent placed. Patient subsequent developed questionable dysautonomia (tachycardia and insomnia of unknown etiology). Currently in recovery.

N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia

dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat anything; Wheezing; migraine; Light, hacking cough; Fever/ 103.9 degrees; Chills; No more than 2-3 hours of sleep per night for 5 nights; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered on left arm on 14Apr2021 10:45 (Batch/Lot number was not reported) at age of 51 years as single dose. The patient medical history and concomitant medications was reported as none. Historical v for covid-19 immunisation accine included the first dose of BNT162B2 administered on left arm on 24Mar2021 at age of 51 years for covid-19 immunisation and experienced no issues. Patient reported that after the second dose of the Covid-19 vaccine, he had a fever for 8 days and was diagnosed with pneumonia on 21Apr2021. Patient reported that he was tested for both Covid-19, Influenza A, and Influenza B twice on 19Apr2021 and 21Apr2021 and tested negative for Covid-19 and influenza both times. Patient reported that he had no pre-conditions and that he was feeling great the night before he received the second dose of the Covid-19 vaccine, 13Apr2021. Patient reported that he was planning to go to work following the second dose of the Covid-19 vaccine on 14Apr2021. He began running a low-grade fever (102 degrees) on 14Apr2021 after receiving the Covid-19 vaccine and then his temperature flared up to 103.5 degrees on 15Apr2021. Fever: He received the second dose of the Covid-19 vaccine at 10:45 on 14Apr2021 and about 2:00 in afternoon on 14Apr2021 was the first fever that was significant. The last fever he had on 21Apr2021, his temperature was 103.9. He was put on antibiotics for pneumonia. He contacted the on-call nurse for his company. The on-call nurse advised him to see a doctor on Saturday, 17Apr2021.He went to the doctor on Monday, 19Apr2021. The doctor only ran a Covid-19 swab for testing and a flu swab. His doctor did not do blood work and stated that the patientwas experiencing an ill effect of the Covid-19 vaccine and sent the patient home. He went back to the doctor on Wednesday, 21Apr2021. When he went back to the doctor, the staff performed a chest X-ray and ran 4 different blood works to see what the patient had. The second Covid-19 test that he received on 22Apr2021 was performed with both the rapid test and the test that was sent off. Both Covid-19 tests came back negative. SARS test on 22Apr2021 was negative. 508-3 High Sensitivity CRP: One of his numbers that was parts per liter, 3 is considered to be high risk and he had 300 (300+) of whatever it was on 21Apr2021. He went back to the physician and was given another steroid shot an additional prescription. He had been back to the doctor 3 times since then. Fever: His fever was 103 consistently after 15Apr2021. 508-3 High sensitivity CRP: This value showed abnormal. The results said that relative risk was greater than 1 mg/liter and high was greater than 3. 1000 CBC with auto differential on 21Apr2021: The abnormal results were red blood cells measured at 4.38; hematocrit measured at 13.82; MCHC measured at 36.4; Neutrophils measured at 84; Lymphocytes measured at 12; and absolute Lymphocytes measured at 0.57. He wore a Garmin and that it recorded that he received no more than 2-3 hours of sleep per night for 5 nights. He didn't know anything about pneumonia previously and that he had specifically told his physician's office everything about what he was experiencing. He told his physician about the wheezing in his chest (on 17Apr2021), cough (on 16Apr2021), fever, and chills (on 14Apr2021). His physician told him it was a normal reaction to the Covid-19 vaccine and sent him home on 19Apr2021. He then consulted Google and started to realize that his side effect were very atypical. Wheezing: When he breathed really light, the crackling would continue. If he breathed shallow, the wheezing was audible but if he breathed deeply, it was not. The pneumonia was in the left side of his chest. He was still being treated for the pneumonia. He has his last dose of medication tomorrow, 27Apr2021, and that he was also being released to go back to work tomorrow. Cough: He had a little cough that would then go away. The cough began late Friday, 16Apr2021. It was interesting because it wasn't a main part of the illness. The cough was just kind of a hacking cough every once in awhile. The cough was not continuous like go and go and go and stop. The cough came, went away for awhile, then came again.The cough being worse was relative. He was coughing more than he did on Wednesday 21Apr2021, Thursday 22Apr2021, and Friday 23Apr2021. The cough was consistent more so at night when he laid down. He would probably say that it was a different feel towards the cough but it was still a cough. The cough was still the same volume but not the same effect. Headache (on 18Apr2021): He had been waking up with headaches in the morning and going to bed with them at night. On Wednesday, 21Apr2021, the headache was due to dehydration from the fever and night sweats. Once he got away from the dehydration headaches, the headache got better but he had woken up with a headache the last few days and had a headache at bedtime a few nights in a row. The headache was usually a frontal headache and this morning, 26Apr2021, the headache was toward the back of his head. The headaches last a few hours until he started moving around. On Saturday, 17Apr2021 he experienced a migraine that would not go away. He didn't usually get migraines. The migraine lasted hours if not for a day and that the headache was something furious. Sunday 18Apr2021 was pretty much the same thing with the headache. Because of the massive fever, he couldn't eat anything at all (17Apr2021). The headache was mostly due to low blood sugar and dehydration. Appetite: His appetite improved after his second doctor's appointment on 21Apr2021. The second provider was a lot more straightforward and advised the patient that he needed to start taking care of himself and trying to force himself to eat. He forced himself to eat on 21Apr2021 and by Thursday 22Apr2021, he had a full appetite and was craving food again. Shortness of breath (Apr2021): Patient reported that the shortness of breath was just from being fatigued. Patient reported that he got out of breath from going up and down the stairs. He was unsure when the shortness of breath began because he was moving very little, but that he noticed the shortness of breath on Monday, 19Apr2021 when he got up to go to the doctor.On Friday 16Apr2021 and Saturday 17Apr2021, he had a really good break.On Friday 16Apr2021 from 9 AM to 1 PM, he had no fever and it was like the sun was coming out, then the fever hit really hard. The same thing happened on Saturday, 17Apr2021, but the fever free period lasted maybe a little longer. His fever returned and that the afternoon of Saturday 17Apr2021 was the worst he had been the entire time. On 13Apr2021 to get away from arm soreness, he did a few laps in the pool. On 13Apr2021 he had a new best time on the 100 in freestyle in the pool and that he felt really strong going into 14Apr2021 to get his second dose of the Covid-19 vaccine. There was nothing that would have indicated that he had anything going on before getting the second dose of the Covid-19 vaccine. Up until Saturday, 17Apr2021, he had only been taking Motrin and just taking 2 tablets. He had no break in between fevers and chills and was not able to get ahead of the fever with the Motrin. There was a long stretch where the Motrin wasn't working and his temperature didn't get below 100 for several days. He tried to cycle acetaminophen in beginning Saturday 17Apr2021 to try to get the acetaminophen in between the Motrin doses. When he went back to the doctor on 21Apr2021, the provider told him that he could take 3 to 4 Motrin tablets at a time but not to exceed 4 doses per day. He never took more than 3 tablets. Motrin was generic ibuprofen. Night sweats (on 21Apr2021): The last couple of nights have been the same. He had a fan on to keep a little cooler and that it was 61 degrees outside and he felt the night sweats. He had a buckwheat mat that was cool that he put on the floor to stay cooler with the night sweats. Come Thursday, 22Apr2021, he said we're done with this and he couldn't sleep from it (Apr2021). Last night, 25Apr2021, he knew that he had night sweats because he was sweating at night and the temperature in the room was 64 degrees. AEs did not require a visit to Emergency Room. AEs required a visit to Physician Office for fever, wheezing, cough, shortness of breath, chills. Outcome of events was unknown.

ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Principal problem Discharge Summary (Physician Assistant) ? ? Internal Medicine Cosigned by: MD at 2/27/2021 4:06 PM Discharge Summary Hospitalist Medicine Admission Date: 2/23/2021 Length of Stay: 0 Days Discharge Date: 2/25/2021 Admission Diagnosis Hospital Problems POA * (Principal) Costochondritis Yes COVID-19 Yes Problem List Resolved POA Resolved Problems Atypical chest pain 2/25/2021 Yes SIRS (systemic inflammatory response syndrome) (CMS/HCC) 2/25/2021 Yes Hyponatremia 2/25/2021 Yes Dehydration 2/25/2021 Yes Home Or Self Care CODE STATUS: Full Code Active Issues Requiring Follow-up Test Results Pending at Discharge Pending Labs Order Current Status Blood culture x 2 SETS Preliminary result Blood culture x 2 SETS Preliminary result Hospital Course Hospital Course: Please refer to the admitting providers H&P for full history. Patient is a 51-year-old male with a PMHx significant for hemochromatosis, sarcoidosis and morbid obesity who initially presented to the ED for evaluation of chest pain, cough and shortness of breath. On presentation, vitals were mostly unremarkable other than some mild tachycardia and tachypnea. Patient was able to maintain adequate oxygenation on room air but was placed on supplemental oxygen for comfort. Blood work was mostly unremarkable. ABG was not particularly concerning. Troponin was negative x3. Patient underwent chest CTA which showed basilar atelectasis bilaterally and scattered groundglass opacities and scattered borderline size hilar and mediastinal lymph nodes consistent with patient's known sarcoidosis. Patient was treated with supportive care and monitored overnight. He was able to maintain sufficient oxygen levels. On the time my evaluation, patient continues to complain of bilateral rib pain worse with deep breaths consistent with costochondritis. I discussed with the patient that he will need to continue to take NSAIDs on a scheduled basis to help with his discomfort. Additionally I offered to prescribe cough medicine. I discussed possibly discharging the patient on steroids however he states that he makes a point to avoid taking steroids due to his history of hemochromatosis. At this point, patient no longer requires care in the hospital and can be discharged home. Patient is agreeable with the plan and all questions have been answered appropriately.

fever , cough, tiredness , body aches Office Visit 4/30/2021 Urgent Care CRNP Family Medicine COVID-19 Dx Cough Reason for Visit Progress Notes (Nurse Practitioner) ? ? Family Medicine ? ? Encounter Date: 4/30/2021 ? ? Signed Expand AllCollapse All History Chief Complaint Patient presents with ? Cough Lingering fatigue, fever Positive Covid test 4-26-21 Patient is a 51 y.o. male HPI Patient is a 51-year-old male who presents with continued Covid symptoms. Patient was diagnosed on April 26. He is currently on day 9 of symptoms. Patient continues to have low-grade fevers. Wife and patient would like the cough is worse. He has been taking over-the-counter medications with minimal relief. He denies history of pneumonia or asthma. Symptoms started suddenly and have been persistent. Tmax at home = 100.4 F Admits to nasal congestion, rhinorrhea, sinus pressure, nonproductive cough Denies ear pain, sore throat The cough is worse at nighttime. Admits to occasional mild chest tightness.

On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: "Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home. Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00. MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition: deceased."

a DVT in his left calf after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 18:15 (Batch/Lot Number: ER8735) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) on 01Apr2021 16:00 at the age of 51-years-old in Left arm for covid-19 immunization and experienced a superficial blood clot in his left calf. The patient experienced a deep vein thrombosis (DVT) in his left calf after the second vaccine on 16Apr2021 6:30 PM. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the events included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.

had a superficial blood clot in my left calf between the first and second vaccines; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 16:00 (Batch/Lot Number: ER8733) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a superficial blood clot in his left calf between the first and second vaccines on 16Apr2021. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the event included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.

Exactly 5 days after the second dose of the Pfizer covid-19 vaccine, I suffered an ischemic stroke. There was a blood clot in my brain that was broken up after tPA was administered about 2 hours after the symptoms of the stroke set in. To date (May 30) I have had many tests, including 2 MRIs, CT scans, TEE, heart monitoring etc. So far, it has been called a "cryptogenic stroke" because there is no cause. The only thing different was the vaccine I received 5 days before the stroke.

thought it might be a heart attack; Sharp pain in center of chest. Noticed mild pain first; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Apr2021 09:30 (Batch/Lot Number: ew0167) (at the age of 51 years old) as 2nd dose, single dose for COVID-19 immunization. Medical history included T1 diabetic. Concomitant medications included insulin lispro (HUMALOG) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient received the first dose of BNT162B2 in left arm on 02Apr2021 09:30 (lot: er8734) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 22:30, the patient experienced sharp pain in center of chest. Patient noticed mild pain first, he considered going to hospital at peak, thought it might be a heart attack. Patient didn't have any other symptoms and it subsided so he didn't think to do anything. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on unspecified date in Apr2021.

June 15 - Right side lower rear rib cage pain. June 17 - Lightheaded. June 20 - shortness of breath and weakness. Symptoms progressively get worse and increase in intensity. June 26 - go to Emergency Room. CT scan with contrast revealed a blood clot in each lung of moderate size and several small clots. Diagnosis was pulmonary embolism. Put on Heparin and admitted to hospital. Administered Heparin for 2 and 1/2 days. Upon discharge (June 29) was prescribed Eliquis.

Household contacts had covid 4/15/21 (PCR+) when pt had cough/fatigue. He got 1st Pfizer dose 5/11/21. 5/24 he develops abdl pain, nausea, vomitting; seen in ED 5/28 w/ WBC cnt 17k CRP 197 but neg CT abdomen. Our ED on 5/31—hypotensive, temp 101.8, pulse 130s, COVID PCR neg, CXR normal. Despite fluids, needed pressors. Next day, still on pressors, new CHF, pulmonary opacities on XR, Echo with severe biventricular hypokinesis(EF 20%). Inflamm markers elevated: WBC 19k , 92% polys, hgb 11, plts 73k, CRP 334 mg/L, COVID spike Ab 1568, COVID NP index 233. Rx with IVIg for MIS x 1 dose, steroids, rapidly improved. On 6/11, 6/24 EF 60%, inflamm markers, CBC normalized. Now well, off steroids. MIS likely due to vac

Patient suffered a Heart Attack 13 days after receiving his second covid vaccine. The heart attack was unknown and presented as the flu at the time. 9 days later he had a second event that finally drove him to the hospital. A bout 3 days after entering the hospital he suffered a dual hemispherical stroke. NOTE: this report is being filed by me as POA as requested by his family.

Expected symptoms ended within about 24 hours from the shot. But 48 hours after the shot there was massive nerve pain in the (left) shoulder of the shot, the pain radiated throughout deltoid, chest, shoulder, neck on the left side. This nerve pain lasted for about 36 hours and then dissipated (I know it was nerve pain because years ago i experienced something similar in the other shoulder for unrelated reasons). But the shoulder was very sore and weak for 2 full weeks, during which i saw an orthopedist who diagnosed bursitis caused by SIRVA. For weeks afterwards the shoulder felt like it returned to normal . However in the first 2 weeks of June my whole left arm began getting sore and tired. In midjune i noticed that my shoulder was atrophying and the front deltoid was not activating (my biceps was doing all the work). Orthopedist ordered an EMG (June 29), which confirmed axillary nerve damage to anterior deltoid. I?ve been doing physical therapy since mid June and as of today July 25th it is beginning to recover but it could take months to a year and may never fully recover.

Diagnosed day after 2nd shot with opthalmic artery thrombus causing vision loss/change in left eye. I did get shot series on 12/22/2020 #1 and 1/10/2021 and was diagnosed with Covid-19 on 12/13/2020. My internist MD did not feel the vaccine caused the thrombus /Stroke but I wanted to report it as it was associated with the vaccine administration (symptoms of vision loss within 24 hours of the vaccine #2 administration).

At first I started to feel tired and achy. A couple days later a cough came and fatigue got worse. It was mostly body aches, chills, sore throat, stuffy nose/congestion and a cough. I got released to go back to work on Jan 26 and I worked all day and that night I woke up with serve shortness of breathe and a temp a 103. I went to the ER and had pneumonia. I tested positive on Jan.11 for Covid, I tested on Jan. 4 and it was negative. I still have not went back to work.

2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am in good health and do not have multiple risk factors for CVA. While the scans showed evidence of a CVA, no underlying cause has yet to be determined.

*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 AM, patient began to experience dizziness and shortness of breath. Per witnesses, he then began to have seizure activity followed by cardiac arrest. He was treated with CPR and 1 shock from the AED, which resulted in spontaneous return of circulation. He was awake and confused after return of pulse and sent to Hospital Emergency Room. This event occurred 19 days post first vaccine. He was scheduled to get his second dose on 2/12/2021, but did not receive it due to event.

white blood cell count was very high; death; This is a spontaneous report from a contactable consumer (ex-spouse) via medical information team. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 at a single dose (at the age of 52-years-old) for COVID-19 immunisation. Medical history included back pain: At some point before the vaccine was administered, he had a telehealth visit for reported back pain. Concomitant medications were not reported. The patient died on 05Mar2021 at his home. The patient received the first dose of COVID vaccine at a hospital on 02Mar2021. The patient was a fairly healthy active 52-year-old. At some point before the vaccine was administered, he had a telehealth visit for reported back pain. He was instructed to get blood work/labs done. A letter was received the day of his death that states his white blood cell count was very high and with it a recommendation that he seek medical attention. She (ex-spouse) reports the autopsy results won't be complete for a few months. The cause of death is unknown. The outcome of white blood cell count was very high was unknown. Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Death

On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced severe calf pain while playing soccer. Over the next 2 weeks I experienced vascular claudication in that leg and was eventually diagnosed with arterial thrombus in Left tibioperoneal, anterior tibial/dorsalis pedis and posterior tibial arteries. I do not have any known predisposing conditions for arterial thrombus and no history of thromboembolic disease.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Additional Details: Patient had shortness of breath, chest tightness and throat swelling (uncomfortable feeling described by patient). Paramedics took the patient with them. Patient came to the pharmacy 3 hrs later and informed us that he was doing okay and his breathing was better.

heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Patient presented 4/3 stating received Pfizer COVID-19 vaccine on Monday and began having sympoms about Wednesday. Developed fever by Thursday and cough/nausea/vomiting by Friday. Cough ongoing and feels like he should have production but is not able sputum out. The pain is chest is described as not being able to fully expand his lungs when he tries to inhale. Patient presented 4/6-DOA

anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious, - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired.

I do not know if there is any correlation to the vaccine or not. Probably not, but i thought best to report it in case others have had similar medical issues coincidentally with getting the shot. One week after the shot I was hospitalized with a Pericardial Effusion and required a Pericardiocentesis procedure.

tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority. Information on the lot/batch number has been requested.

On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021; He tested positive for Covid19 on 30Mar2021; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in arm left on 19Mar2021 (at the age of 52-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid19 on 30Mar2021. On 31Mar2021, the patient suffered a stroke and was admitted to the hospital until 2Apr2021. He was scheduled for second dose and he got COVID, so would like to know the protocol and ins and outs and steps for that. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Mar2021. The patient did not receive any treatment for the events. The clinical outcome of the On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021 and He tested positive for Covid19 on 30Mar2021 were unknown. No follow up attempts are possible.

52 yo male received first dose of Pfizer vaccine on 3/20 at outside institution. The next morning, pt experienced uncontrollable tremors and twitching and presented to the ED. In the ED, patient had generalized tonic-clonic seizure that lasted for about 1-3 minutes. CT head scan was unremarkable. Neurology started pt on Keppra 500 mg BID and plan for MRI and routine EEG. The next morning, pt felt back to baseline and was alert and oriented. Patient has a history of HIV and stroke with residual right-sided weakness. He has no history of seizure nor reactions to vaccines. Physician advised patient that he should not receive second dose of vaccine.

At approximately 10AM CDT on 13 March 2021, I started having upper left-side chest pain. The pain increased as the day progressed. By 4PM CDT, the pain was bad enough that co-workers insisted I go to the hospital for evaluation. At approximately 4:30PM CDT, a co-worker drove me to the hospital. I was admitted at 5:16 PM CDT on 13 March 2021 to Medical Center, to treat multiple, bi-lateral pulmonary embolism. While still in the emergency room, I was injected with a blood thinner. I was released from the hospital on 15 March 2021, with a prescription for APIXABAN (Eliquis), which I am required to take for 6-months. I was directed to see my primary care physician within 3-weeks of being discharged.

Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the left calf leg. Cramp like pain in the left calf with blue-ish/purple color in the ankle and left foot. Foot and leg was cold to the touch with extraordinarily strong migraines. Person leads healthy lifestyle and is physically and athletically fit. I was given Gemtesa to treat the clots, 150mg x2 a day for 7 days then to 75mgx2 a day for an unknown period. First dose on 3/24/ 2021 Pfizer Lot#EN6205 Second Dose ON 04/14/2021 LOT#EW0161 10:30AM

Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the left calf leg. Cramp like pain in the left calf with blue-ish/purple color in the ankle and left foot. Foot and leg was cold to the touch with extraordinarily strong migraines. Person leads healthy lifestyle and is physically and athletically fit. I was given Gemtesa to treat the clots, 150mg x2 a day for 7 days then to 75mgx2 a day for an unknown period. First dose on 3/24/ 2021 Pfizer Lot#EN6205 Second Dose ON 04/14/2021 LOT#EW0161 10:30AM.

Swollen red left arm. Diagnosed with blood clots in all his veins in left arm and spent 4 days in hospital on blood thinners and had 2 surgeries to remove them

pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swelling. He was sent to ER, where he was diagnosed with DVT

Patient stated he didn't feel well 2 days after receiving the vaccine and he went to hospital next day. He was diagnosed for blood clot in lung, treated in the hospital and discharged home. Patient stated the doctor was not sure what has caused the blood clot in lung.

Chest pain started two days after 2nd vaccine. CT scan of the chest showed nonocclusive subsegmental pulmonary embolism. Started on heparin infusion initially and transitioned to Xarelto.

headaches, stiffness, dizzyness, fatigue, loss of appetite pnuemonia including a stay in hospital- antibiotics x 3 types, oxygen, steroids

Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.

The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He received the first dose of the Pfizer Vaccine on March 26, 2021. On March 27, 2021 at approximately 7:30 PM, the patient suddenly became unable to speak clearly and walk normally. The ambulance was called at approximately 7:45 PM. The patient was evaluated and placed in the ambulance by approximately 8:15 PM. He stopped breathing in the ambulance. He was resuscitated and placed on a ventilator at some point. After evaluation at the hospital, it was found that he had suffered a pontine hemorrhage. He was kept alive until his heart stopped on March 29, 2021.

signs of a transient ischemic attack; lost control of the left side of the face and possibly of the left side of his body; lost control of the left side of the face and possibly of the left side of his body; elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; weakness; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08May2021 at 15:30 (at the age of 52 years old) (Batch/Lot number: EW0176, Expiration date was unknown) as the 2nd dose, single for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: ER8730, Expiration date was unknown) on 17Apr2021 at 2:30 PM (at the age of 52 years old) for COVID-19 immunization. The vaccine was not administered at the military facility. Relevant medical history included ongoing high cholesterol, ongoing high low density lipoproteins (LDLs), ongoing high triglycerides, and patient might have borderline diabetes, possibly prediabetic, but the reporter was not quite sure. The patient had family history of heart problems. The patient was taking unspecified concomitant medications, but the reporter did not know the medications that the patient was taking. It was also reported that the patient was not completely compliant with his medications. The patient had no additional vaccines administered on the same date of the Pfizer suspect. Prior to vaccinations (within 4 weeks), the patient had no other vaccinations and there were no adverse events (AEs) following prior vaccinations. The reporter stated that in the morning at the time of the report on 13May2021, about 5 days after the second COVID-19 vaccine, the patient had signs of a transient ischemic attack; he lost control of the left side of the face and possibly of the left side of his body; he had elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; and he experienced weakness, but was able to move around. At the time of the report, the patient was on his way to the emergency room (ER). The event "loss of control of left side of face" did require a visit to the emergency room. It was further reported that the patient had signs of a transient ischemic attack and loss of control of the left side of his face and maybe the left side of his body, but the reporter was not sure; he also had some weakness and this episode lasted about an hour during which time the patient's blood pressure was 180/100. After the hour, his blood pressure came down to about 140/100. The patient was able to move around and on the way to the emergency department. No further information was available regarding the patient's visit to the emergency room at the time of the report. The reporter was asking for information on transient ischemic attacks and the Covid 19 vaccine and if there were reports of strokes as well. The reporter stated his family called several doctor friends and doctor relatives and based on the patient's symptoms, it seemed likely that he had a transient ischemic attack. The outcome of the events was unknown.

04/23/2021 13:00 Cardiac arrest from ventricular fibrillation. Collapsed, had immediate bystander CPR and EMS arrived quickly. His initial rhythm was VF. 5 shocks were delivered as well as 2 rounds of epinephrine and 2 boluses of amiodarone. ROSC was achieved

Massive heart attack. He was in Icu with a ECCMO and Impella machine. The highest life support was going to get a heart transplant but hes life ended with a stroke while under sedation for 5 days

? 5/21/21: Pulmonary Embolism o Presented with chest pain, abdominal pain, breathing problems o CT showed pulmonary embolism o Stable for outpatient anticoagulation. Started on 10 mg Eliquis BID x 7 days and then 5 mg BID thereafter.

Heavy clotting issues in my left kidney through my bladder which is causing urinary issues; Urinating large blood clots; Hemorrhaging blood clots/ bleeding; This is spontaneous report from a contactable consumer, the patient. A 52-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 21May2021 10:10 (reported as 10:10 EST) (at the age of 52-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22May2021, the patient called to report an adverse reaction to 1st dose of vaccine, and currently in the emergency room (ER) at the hospital, in a bed with heavy clotting issues in his left kidney through his bladder which was causing urinary issues, literally urinating large blood clots. He currently had a catheter in, they have done blood work and CT scan, but no results provided. The patient had no issues with anything with prostate or kidney but hemorrhaging blood clots. The patient was not yet admitted to the hospital, just in the ER somewhere around 10:00 in the morning. The patient had a follow up and still at home had a catheter and still he was bleeding and follow up tomorrow with Urology department at 10:00; had full blood work follow up tomorrow and had a CT scan. Everything came back as normal as far as his organs go. The patient added, "I would appreciate it if someone would call me with some professional advice what I should do about this whether I need to take the second dose. I need some clarification on what is going on with this and then I need to have a discussion on whether I should take the second dose or not." The outcome of the event was not recovered, at the time of this report. The seriousness of the events was unspecified by the reporter. There is a medical information request included Caller (male, age 52 years)- his question was the first and 2nd dose the same. Tomorrow he should have the full make up back and causes of this from the doctor. It has been a rather traumatic event which he thought was going to be nothing." Due date of second dose. Response included: As noted in the Fact Sheet for Recipients, the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They refer him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knows your health situation and has access to information that can better help inform this decision. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine." and from VR-As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with doctor/healthcare provider about what he had experienced/were experiencing. Information on Lot/Batch number has been requested.

3-4 weeks after his second Pfizer covid 19 vaccination, patient developed a spontaneous DVT in his right peroneal vein. He was treated with Eliquis (current still taking this) and his pain has resolved. He will be seeing a hematologist.

After receiving the vaccine I had the soreness in my arm and a small fever of 99. Over the course of the next few weeks I was experiencing severe eye pain which caused me to start losing site in my right eye and also microclots in my eyes, my eye doctor stated that the vaccine was not the cause of my conditions with my eye. But other than the soreness of my arm where the vaccine was administered and a slight fever I really didn't have any other problems.

Had clots in his lungs / blood clots; Stroke; He received his first dose on 27Feb2021 and second dose on 26Apr2021; This is a spontaneous report from a contactable consumer(patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 at his 52-year-old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He previously received his first dose BNT162B2 for Covid-19 immunization on 27Feb2021 at his 52-year-old. The patient experienced stroke on 07May2021 with outcome of unknown , had clots in his lungs/blood clots on an unspecified date with outcome of unknown. The clinical course was reported as follows: After her received his second dose of the Pfizer COVID-19 vaccine he ended up with a stroke. He had clots in his lungs and one broke off and gave him the stroke. He was just looking to see if there have any information about long term events occurring with blood clots, like is this a one time event or is there a potential for it to keep happening now that he had the vaccine in his system. He received his first dose on 27Feb2021 and second dose on 26Apr2021 and had stoke on 07May2021. He had a stroke after Pfizer shot, now coincidentally he had no other health issues. He did not know if it was related to vaccine COVID may not have been. He was healthy 52 year old male, no medicines no nothing headed with the stroke, they developed a blood clot in his lung ended up with the stroke. Information about batch/ lot number has been requested.

24 hours: Chills and mild tachycardia (HR 111) 48 hours: Continued mild tachycardia (HR 105-117), tmax 100.2,chilles, headache and bodyaches 72 hours: tmax 102.4, tachycardic (HR 141), hypotensive (low SBP 73), sepsis trigger from MEWS 7 at 0545 on 6/21, procalcitonin increased to 111.66 ng/mL right upper quadrant pain. Blood cultures drawn. 96 hours: ongoing hypotension, lactic acid increased to 4.0. Admit to hospital for pressor support. Suspected cholecystitis w/drain placement. Blood cultures drawn at 72 hours showing GNR. Eventually confirmed as Klebsiella oxytoca

Patient reported deceased to public health today. Date of death: 7/15/2021. Sister of patient reports that case reported chest pain while at home walking on his treadmill, he then had to lie down and sister asked him if he was having pain and wanted ambulance called. Reports that patient declined 911 call. Sister then reports that patient had what looked like a seizure, but then went completely unresponsive, so she initiated CPR and called 911. Reports that CPR and 911 response was not successful and patient passed away.

Bilateral pulmonary embolisms; DVT in right leg from groin to behind knee; This is a spontaneous report from a contactable consumer or other non health care professional (Patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 08:00 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 18Mar2021 (Batch/Lot Number: ER8729) as DOSE 2, SINGLE for covid-19 immunization at Hospital.. The patient past Medical history included Migraine and treated with topimax. Concomitant medication included topiramate (Topimax) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 09Apr2021, at 19:00, the patient experienced Bilateral pulmonary embolisms and DVT in right leg from groin to behind knee. The patient visited Doctor or other healthcare professional office/clinic visit and went to emergency room and Hospitalized for 5 days. The patient underwent lab tests which included: On 31Mar2021 sars-cov-2 test Result: Negative (Nasal Swab mako PCR). On 17Apr2021 Nasal Swab: Result: Negative and on 30Apr2021 Nasal Swab: Result: Negative. The patient treated with Heparin IV, Díaz CT, ultrasounds, echo, endo and colo. The event outcome was recovering.

Developed noticeable DVT in the right leg with left leg also having a clot.; Developed noticeable DVT in the right leg with left leg also having a clot.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0168, Expiration Date: Aug2021) via an unspecified route of administration, administered in left arm on 03May2021 (age at vaccination was 52 years) as dose 2, single for COVID-19 immunization. The patient did not have any relevant medical history and concurrent conditions. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533, Expiration Date: Jul2021) via an unspecified route of administration, administered in left arm on 05Apr2021 at 16:00 pm (age at vaccination was 52 years) as dose 1, single for COVID-19 immunization. The patient previously took Sulfa drugs and experienced known allergies to it. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17May2021, the patient developed noticeable DVT in the right leg with left leg also having a clot. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with blood thinners for the adverse events. The device date was reported as 06Jul2021. The events were reported as serious (disabling/Incapacitating). The outcome of the events at the time of last observation was not resolved. Follow-up actions are completed. Further information has been requested.

Patient presented to the ED on 6/2/2021 for covid-19 infection. On 6/9/2021 patient presented to the ED and was subsequently hospitalized for pneumonia due to covid-19 virus. On 6/16/2021 patient presented to the ED with STEMI and was subsequently hospitalized. These visits are within 6 weeks of receiving first dose of covid vaccination.

Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks old.; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; Didn't feel well for 2 weeks; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunization. Other medical history was none before the covid shot, was healthy and now he lost his business and no income. Not known allergies. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced had 4 strokes/my girlfriend took me to the hospital to find out i suffered 4 strokes. 2 were 2 weeks old, few hours after 1st shot severe headache and vomiting/didn't feel well for 2 weeks till i got the severe vomiting and headache again, didn't feel well for 2 weeks, the next day didn't know anything, couldn't speak, shaking, weakness all on 01May2021. The events were serious per hospitalization, disability. The patient was hospitalized for these events. Had 4 strokes, few hours after 1st shot severe headache and vomiting. Didn't think too much about it since they said 50 + men don't get reactions. Didn't feel well for 2 weeks till he got the severe vomiting and headache again, and the next day didn't know anything, couldn't speak, shaking, weakness. His girlfriend took him to the hospital to find out he suffered 4 strokes. 2 were 2 weeks old. Backing it up till 01May2021 when he has the first covid shot. Therapeutic measures were taken as a result of events (Treatment for strokes). The adverse event result in doctor or other healthcare professional office/clinic visit and a visit to Emergency room/department or urgent care. Duration of Hospitalization was 5 days. Hospitalization was not Prolonged. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was resolved with sequelae.

Atrial fibrillation, onset of palpitations 13-14 hours after vaccination, managed with diltiazem with resolution.

Onset of hemmoragic oral bullae after eating very hot cheese toast 1-20-2021 Widely scattered petechiae lower and upper extremeties 1-21-2021 Extensive petechaie lower extremities and a few on trunk face 1-22-2021 CBC in ER showed severe thrombocytomenia with platelets less than 2000 1-22-2021 Admitteed and treated with Decadron 40 mg IV, and IVIG infusions once daily Jan. 23rd and 24th 2021 Hepatiitis pannel negative EBV negative, COVID Nasopharengeal negative, splenic U/S upper limit of normal but unchanged on comparison with old imaging. With treatment platlets increased to 65,000, Discharged from hospital. IVIG discontinued Oral decadron 40mg will continue for 2 days with CBC hematology f/u in 36 hours

Headache the next morning after receiving vaccine that hasn?t gone away, fluid in left lung, blood clots in right lung and leg.

as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine the fever spiked as high as 103 and fatigue continued. four days later a rash developed on his back, and a dry cough developed. He also is experiencing and continues to experience some numbness/tingling in his legs and arms. Two Saturdays following the vaccine he went to the ER and was diagnosed with pneumonia in both lungs. However, a fourth covid test was given and it was negative like the previous three tests.

Within a week after receiving the first round of vaccine I have developed two blood clots in my left leg.; This is a spontaneous report from a contactable consumer (patient) A 53-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 21Jan2021 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient didn't have medical history or concomitant medications. On an unspecified date in Jan2021 within a week after receiving vaccine patient developed two blood clots in his left leg. As treatment patient was currently on blood thinners. At the time of the reporting event outcome was unknown.

Following vaccination, patient felt achy and mildly feverish. During the night, he got up to use the restroom and felt palpitations and lightheadedness, which persisted during the morning. A colleague at work evaluated the patient's pulse, noting it to be irregular and fast, so patient went to the ED for evaluation. EKG was performed and patient was found to be in new onset atrial fibrillation. Patient was given fluid boluses, 10mg IV diltiazem, and a diltiazem infusion, during which the patient converted to normal sinus rhythm. After stabilization, he was discharged with new prescriptions for metoprolol tartrate 25mg BID and apixaban 5mg BID, to follow up with cardiology.

Patient had 1st dose of pfizer and 45-60 minutes later had anaphylaxis in which an epipen was administered. Patient was taken via ambulance to The hospital

He has a bad /slow heart, he had a heart attach after 1st dose. He doesn't feel it's related to the vaccine. It was the heart attack was why he missed his 4 week window. He called the Dept. of Health and they said he needed to start the series over. I explained the series is now complete.

Thrombocytopenia; Blood clots in brain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 13:00 (Batch/Lot Number: EN6206) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Mar2021, patient developed thrombocytopenia and was brought to emergency room/department or urgent care leading to admission, surgery was performed (mechanical thrombectomy) on 30Mar2021 at 10am to address blood clots in the brain. Patient was currently in ICU until he fully recovered. Patient was hospitalized in Mar2021 for 2 days. The events were reported as life-threatening and have caused disability. Outcome of the events was unknown. Information on lot/batch number has been available. Additional information has been requested.

4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOSIS LEFT LOWER EXTREMITY. 4/4/2021: SEVERE SHORTNESS OF BREATH, SQUEAD WAS CALLED AND HE WAS TAKEN TO HOSPITAL ER WHERE HE WAS FOUND TO HAVE BILATERAL PULMONARY EMBOLISM

Received the first shot of Pfizer Covid Vaccine at 10:00 AM on 3/21/21. Aside from some drowsiness I felt fine the entire day. Then that night I woke up at 2:30 AM with severe pain in my right knee. I was unable to bend the knee or walk for the next 36 hours. After that the pain transitioned to the back of my calf muscle for the next few days. The pain then went back to my knee for a day and then returned to the back of my calf muscle. On 3/30/21 I saw my primary care physician who then sent me to get an ultrasound which determined that the pain in my knee and calf were caused by blood clots (DVT). I was then prescribed Eliquis 5 mg blood thinners.

Patient received 1st COVID vaccine on 3/17. On 3/24, he experience pleuritic chest pain and was admitted to the hospital for pericarditis confirmed by EKG. During this hospitalization, he was incidentally found to have left main stenosis 60-70% on the LHC, requiring PCI. Patient did not have an acute MI - hence Dressler Syndrome was thought to be less likely. He was discharged after a week on 3/30/21 with colchicine and other cardioprotective medications. He received his 2nd vaccine on 4/7/21. On 4/14/21, patient was readmitted for pleuritic chest pain attributed to recurrent pericarditis.

stroke; Brain bleed; Brain blood clot; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program named Corporate (Pfizer) Social Media Platforms. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:15 as single dose for covid-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced brain blood clot on 25Mar2021 08:00 , stroke and brain bleed on an unspecified date. The patient was hospitalized for brain blood clot, stroke, brain bleed for 7 days. Therapeutic measures were taken as a result of brain blood clot, stroke, brain bleed included Ventillator. The patient died on 02Apr2021. An autopsy was not performed. The outcome of events was fatal. No other vaccine in four weeks; No covid prior vaccination. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain blood clot; stroke; Brain bleed

One week after injection woke up with a blood clot in left calf. No history of clots. No injury or muscle strain, etc. Just happened out of no where.

Blood clots in right leg below knee; he passed out from pain; pain in his right knee; he couldn't bend his knee at all; knee was swollen; couldn't walk/limping around; his knee more stiff; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6206), via an unspecified route of administration, administered in the right arm on 21Mar2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included ongoing Factor V Leiden heterozygous, allergies to mushrooms from an unknown date and unknown if ongoing and a torn meniscus in his right knee and he had surgery 3 to 4 years ago. The patient's concomitant medications were not reported. The patient previously took Cephalexin and Percocet and experienced allergies. The patient did not have COVID prior to vaccination and has not been tested post vaccination. On 22Mar2021 at night around 2:30AM, the patient woke up and started walking to the bathroom and he passed out from pain. He had pain in his right knee. He thought he had torn his knee again. He had surgery 3 or 4 years ago for a torn meniscus in his right knee and he thought he had torn his meniscus again. He passed out, his wife found him and he went back to bed. In the morning, his knee was still very very sore, he couldn't bend his knee at all. He took an Advil between 6:30AM and 8:00AM. He hadn't taken any medications prior to the COVID-19 vaccine. His knee was swollen but the pain was manageable. He couldn't walk, he was on crutches for about 24 hours then the swelling started coming down and he put a brace on his knee. He could then walk without the crutches but it was still painful. The next day he had pain in the back of his knee. He thought the pain was caused because he had put the brace on and had been using the crutches. Like he had made his knee more stiff from not using it. He was limping around and the pain was bearable. At that point, the pain was maybe a 4 on a scale of 1-10 where his pain had been a 9 on a scale of 1-10. He took another Advil and he realized the pain in the back of his knee wasn't going away. He went to see his family doctor and his doctor was able to get him in that same day for an ultrasound. The ultrasound showed 2 blood clots behind his right knee. The patient had blood clots in right leg below knee. The week of the report, he got an appointment with a hematologist. The hematologist reviewed his case and the doctor isn't 100% sure the blood clots were from the Pfizer COVID-19 vaccine but the doctor isn't ruling it out either because it happened within 24 hours of receiving his first COVID-19 dose. He hadn't done anything strenuous before getting the COVID-19 vaccine, nothing that he thinks would have caused the blood clots. He would like to add, what he thinks is relevant, is that he is positive for Factor V. He reports he has one copy and Factor V only impacts about 3% of the population. The hematologist thought that he might be prone to developing blood clots. The hematologist reports that he has had patients who have had the COVID-19 virus who have developed blood clots. Maybe it's possible that the COVID-19 antibodies were trying to build up his immune system to COVID-19 and it created something similar to having the COVID-19 virus. If he is predisposed to blood clots then the COVID-19 vaccine may have precipitated the blood clots. His second COVID-19 vaccine is scheduled for Sunday, 11Apr2021. He had talked to both his family doctor and his hematologist and they both thought he should be ok in getting the second COVID-19 vaccine. He was prescribed blood thinners. If the second COVID-19 vaccine caused more blood clots the blood thinners would help him. He was asking if there is any additional information or guidance on receiving the second COVID-19 vaccine after his reaction. The pharmacist told him that the COVID-19 vaccine trials were all done in the left arm. He received his vaccine in his right arm and his right knee was affected. If he gets the second COVID-19 vaccine he's getting it in his left arm. He was prescribed Eliquis 5mg take one tablet twice daily. The outcome of the event blood clots in right leg below knee was recovering while the outcome of the other events was unknown.

Patient develop swelling in right leg. Doppler was preformed and DVT was discovered. Patient was placed on Eliquis.

5-6 Blood clots, blood clots were present; heart attack; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 12:00 on left arm at single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included high blood pressure, high cholesterol. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC). Historical Vaccine included first dose of BNT162B2 on 08Mar2021 12:00 on left arm for COVID-19 immunization. The patient experienced 5-6 Blood clots, had heart attack and blood clots were present on 14Apr2021 13:00. The events were resulted in Emergency Room Visit, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included Stent. The outcome of the events were resolving. Information on Lot/Batch number has been requested.

3/12/21 had few minutes of speaking incorrect words which led to eval for TIA 3/17/21 had dopplers of carotid with unequal blood velocities 3/24/21 covid vaccine #1 4/15/21 covid vaccine #2 4/21/21 CTA chest to look for cause of carotid velocities being different and pulmonary emboli were found

Developed RLE pain and swelling on Friday. Progressed over the weekend. Evaluated on Tuesday. Found to have distal DVT. Started on anticoagulation.

DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous report received from a contactable healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (lot number: EL9261), intramuscularly in left arm on 03Feb2021 13:00 at single dose for COVID-19 immunisation. Medical history included gout. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL0142), intramuscularly in left arm on 06Jan2021 13:00 for COVID-19 immunisation. The patient experienced deep vein thrombosis (DVT) causing muscle cramps, chest pain, fever, etc 2-3 weeks after the second dose on 24Feb2021 12:00. Patient did not receive any treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved.; Sender's Comments: Considering a positive temporal association, a causal relationship between the event deep vein thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Shortness of breath; pericardial effusion requiring drainage/fluid around the heart that made the heart beat super fast to pump up blood; inflammation of the heart sac; fluid overload on the lung; fluid around the heart that made the heart beat super fast to pump up blood; This is spontaneous report from a contactable consumer (patient) reported for himself. A 53-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in left upper arm at 53 years old on 20Mar2021 08:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure from 2018, he says he has had this for roughly 3 years. Concomitant medication included amlodipine at 5mg once a day for high blood pressure from an unspecified start date in 2018 and ongoing, he says he has been taking this for a few years, maybe 3 years. No additional vaccines were administered on Same Date of the Pfizer Suspect or within 4 weeks. He was not sick at the time of vaccination previously. The patient was calling about the Pfizer COVID vaccine. He says he is just trying to get answers because what he experienced was very alarming to him. He got the vaccine at 8:00 in the morning. He says a student did it, she took a long time, she was very timid. He says she was being supervised by an RN. He experienced shortness of breath on 07Apr2021, he says it was in the morning that the shortness of breath started, because he did make an appointment to go the the COVID test, he got the COVID test around noon that same day. He says he was diagnosed with pericardial effusion requiring drainage and inflammation of the heart sac. He says he had fluid overload on the lungs that required IV diuretics. He says the symptoms started after the vaccine, and these symptoms were what was causing the shortness of breath. He says the fluid around the heart made the heart beat super fast to pump up blood. He says the fluid triggered the shortness of breath. He says when they removed fluid the breathing got easier but then it settled into the lungs. He says Tuesday he dropped off the cliff, Tuesday or Wednesday night, one of them, for two nights he was on oxygen, they gave him a diuretic for the lungs, after 12 hours he started feeling better, continued to get better and better after they moved the fluid from the lungs with Lasix through the IV. He says he doesn't fit the profile of someone who would develop these issues, he has no history, no cancer, no autoimmune disorders. He says they say well maybe it is the virus but the doctors currently have no specific answers for the caller. He says they told him that someone having this would be the profile of an IV drug user. He says he never uses drugs, he does not fit a profile like this. He says he wants to be fully vaccinated. He says the timing is suspicious with the vaccine shot. He says it is 50/50 on the doctor's opinions, half say to get the shot, the other half say don't do it. He says they say the second shot is worse. He says he is confused as to what to do, that he understands this is a big experiment, he wants the vaccine but not at the cost of another visit to the hospital. He says he was at the hospital on oxygen, he couldn't get out of bed for a day. He says the doctor said there was a study in (Withheld), the caller says he did a lot of research in the hospital for 6 days, that says the demographic is younger but it is heart issues with men for the heart with the Pfizer vaccine. He says they are studying it. He says a couple of doctors referred to that, the ones that say don't get the shot, not yet. He says he can't pinpoint it exactly. He says it could have been a fluke but the timing is very suspicious. He says that because of some of the side effects, his week in hospital, he was concerned for his life, he wants to be fully vaccinated but not at the cost of going though this or cost of killing him. He says he does not want to go through this again, he will not get vaccinated unless he is comfortable. He asks should he switch to (Withheld), is that a safer bet, (Withheld), should he just skip it all together or not. He says he knows they are a different type of vaccine. He says they had to remove fluid form his pericardial sac, he had 2 days of draining, they drained a liter from around the heart so it could beat normal again. He says apparently some of the fluid went to the lungs so he needed oxygen. He says this all happened Tuesday morning, he came back home yesterday, he looks pretty good. He says he just wants to do the vaccine and asks should he take the second one or not. He would like to get any information. He says the fluid in his heart was starting to build up on 05Apr2021 or 06Apr2021, he started getting symptoms that come and go. He says he was admitted to the hospital on 19Apr2021 and his procedure was on 20Apr2021 so his shortness of breath resolved the day after the procedure. He says he was hospitalized from 19Apr2021 to 25Apr2021. After reporting shortness of breath he says that was it, basically. He says he went to the nurse treatment center on 19Apr2021 because he thought it might be COVID but this event landed him in the hospital. The events required a visit to emergency room, he said he went to the emergency room on 19Apr2021 and a doctor told him he might not make it. The patient said he was scared and he didn't know why the doctor would have said that to him. He said he did not have an appointment date to physician office yet, he was waiting to get a call back. Relevant Tests included: Rapid COVID test, Date 07Apr2021 Result negative, Date 15Apr2021 Result negative, Date 19Apr2021 at Patient First Result negative, Date 19Apr2021 at the hospital on admittance, Result negative. Standard COVID test, Date 19Apr2021 Result negative, Date 15Apr2021 Result negative. He says at the hospital there was a lot of tests done on his heart and lungs, nothing was coming back scary, they were coming back as perhaps viral markers. The outcome of shortness of breath was recovered on 21Apr2021, of other events was unknown.

possible thrombosis reaction; Unexpected bruising near injection site.; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; minimal pain/stiffness following the shot; minimal pain/stiffness following the shot; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 53-year-old via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (Lot Number: EW0153) at 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included famotidine (PEPCID AC). The patient previously took flu shot in Oct2020, prilosec [omeprazole magnesium] for seasonal allergy and experienced drug hypersensitivity. The patient experienced unexpected bruising near injection site. Bruise was the size of the bandaid, approximately 1" x 2". Bruising had persisted for more than a week now. The patient had never experienced bruising like this with other vaccines. He would like to rule out possible thrombosis reaction before second shot. He did not have bruising at any other locations other than the injection site. Bruise was purple and red splotches and has now progressed to mostly yellow. He believed the discoloration was a reaction to the vaccine and not the result of the needle. The shot itself was painful but patient felt minimal pain/stiffness following the shot. The event start date was on 20Apr2021. No treatment was received. The outcome was unknown.

4 days later suffered Acute Myocardial Infarction involving the left anterior descending (LAD) coronary artery

Heart Attack, burning from center of chest expanding to back like a dagger and outwards 1 stent placed to stop it 2 more stents the next day preventative Now attending cardiac rehab New meds prescribed

Started experiencing shortness of breath and coughing on May 27, 2021. Noticed shortness of breath as walking up hill. Breathing issues continues to get worse over time. Went to urgent care doctor on June 4th. They said my oxygen level was low and could hear wheezing in chest. They did a chest x-ray and thought I might have pneumonia. Gave me antibiotics. Recommended to see primary care doctor. Went to HCF on 6/7/2021. Saw FNP. She did blood work. Scheduled me for a cat scan on 6/8. Blood tests indicated d-dimer level was high. Cat scan showed pulmonary embolisms in both lungs. Went to hospital.

Seriousness: Does not really know what it is, it could be thrombosis; Caller has experienced redness/redness in thumb and finger tips; tingling/tingling in left hand; decrease sensation in his finger tips/numbness and decreased sensation in left hand; He is still experiencing all of these and has gotten worse; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: EW0183) in the morning between 10:00 and 11:00 am as single dose for covid-19 immunisation at the age of 53-year-old. Medical history included an open reduction internal fixation, surgery on his right clavicle 5 years ago, which is what made him want to get the vaccine. Concomitant drugs included Multivitamin, Vitamin A and Vitamin D. The patient had an exam in December and all of the test results were normal. On 16May or 17May2021, the patient has experienced redness in thumb and fingertips, numbness, and decreased sensation in left hand, tingling in left hand. Symptoms have been ongoing for 10 days; it has progressively gotten worse. It was reported that the symptoms started 2 days after getting the vaccine on 13May2021, was 16May2021 or 17May2021. He takes multi vitamins and minerals and thought it may be related to that. He takes high doses of Vitamin A and Vitamin D. He actually thought it was due to the Vitamin A and Vitamin D. He stopped the vitamins for a few days. Treatment included: Thought maybe, apart from the vitamins, it may be because he was washing his hands so much that it may be from that. He used Aveno lotion to try and lubricate them. The outcome of event Thrombosis was unknown, outcome of other events was not recovered. The reported considered the events were related to the vaccine as it was the left finger tips, especially the thumb, compared to the right. That's why he thinks it is related to the vaccine. The clinical course was reported as: The redness was first, then the tingling. He doesn't remember the exact day. The numbness and decreased sensation were afterward. He is still experiencing all of these and has gotten worse. The thumb on the left hand looks pink and wrinkled. When comparing the right see the difference tell they are different. Seriousness: Does not really know what it is, it could be thrombosis. The redness in the thumb and finger tips is in the right as well but is not as bad as in the left. Follow attempts needed. Further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported event of thrombosis. 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. Ischemic and Hypertensive Heart Disease. No signs. Active and athletic middle age man. Was riding bicycle on a trail, stopped pedaling and dropped dead. Died instantly. CPR was performed. No vitals upon arrival.

I can feel a clot in arm making it very painful; My left arm has been in pain; I cannot use my left arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:00 (Lot Number: EW0172) as single dose for covid-19 immunisation at 53 years old. The patient medical history was not reported. Concomitant medication(s) included lisinopril (unknown manufacturer, 5 mg) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) on 27Mar2021 at 10:00 in left arm when 53 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced can feel a clot in arm making it very painful (thrombosis) (medically significant), his left arm has been in pain (pain in extremity) (non-serious) and cannot use his left arm (mobility decreased) (non-serious) on 23Apr2021 with outcome of not recovered. The patient reported that his left arm has been in pain since the time of injection and now he can feel a clot in arm making it very painful and he cannot use his left arm. The patient was not treated for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on Lot/Batch number was available. Additional information has been requested.

he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away

54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis, and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per EMS, the patient called because he was having constant, diffuse abdominal pain x 1 day that radiated to his chest. On scene, the patient had a witnessed arrest with EMS starting CPR. He was given 3 rounds of epi without ROSC. Pt had no associated shockable rhythm. Of note, pt's wife, had noted pt had received covid vaccine the prior day.

1. Within 24 hrs post vaccination 1/5/2021 severe headache, malaise symptoms. 2. 1/8/2021 onset of severe back pain. 3. 1/13/2021 severe back pain continued, unrelieved by NSAIDS and Acetaminophen. 4. 1/14/2021 non-traumatic rhabdomyolysis possibly due to COVID-19 vaccine diagnosis. Diagnosis was made in hospital Emergency Department.

Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD and EMS arrived, resident pronounced at 12:51am.

9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache requiring taking Tylenol alternate with Advil every three hours. I tested for COVID-19 (PCR) and it was negative. Fever continued. On day 6, I went to urgent care center and was tested again with PCR for SAR-CoV-2 virus. The result was again negative. On day 7, I started coughing so I went to Hospital ER and was admitted. Chest X-ray and CT scan of chests showed pneumonia. The COVID-19 PCR test was again done and was negative. Respiratory panel PCR was negative. Mycoplasma titer was negative. I was given steroid and fever improved. I continued to cough until now (1/30/2021)

24 hours post vaccine develoved T 100.1, headache, light sensitivity, reports headache worsened, blurred vision - went to Emergency Services at Hospital, admitted. Reports diagnosis of CVA. Reports headache has improved, continues with blurred vision

1/15: Pfizer vaccine dose 1 administered 1/16: Fever, chills 1/22: Sore throat, coughing w/white phlegm, taking Tylenol and Mucinex. Fever and chills from 1/16 subsided. Had telehealth consultation with PA. Per her notes, patient said he gets these symptoms annually, requested for an antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms do not subside. 1/23: COVID test administered 1/25: Reported positive for COVID 1/26: Telehealth session w/PA: she informed patient of his positive test, advised to quarantine and seek medical help at hospital if symptoms worsen. Patient reported that his sore throat mostly subsided but is still coughing at night. Said that the pharmacy didn't receive the prescription order for the antibiotic, so this was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed. Death certificate issued by state says cause of death: COVID. Autopsy was not performed. Buried on 2/9/21.

Rapid Atrial Fibrillation occured 12 hours after first injection of Pfizer vaccine. I had no prior history of any cardiac events.

14 hours after vaccination patient experienced signs and symptoms of a stroke: aphasia, left arm weakness, clumsy, could not text. Called 911

This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male patient (height: 193cm, weight: 99.79kg) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6207) via an unspecified route of administration at right upper arm on 18Mar2021 18:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included blood pressure, teeth cleaned (Shortly before the shot, went to the dentist to have teeth cleaned. Directly from Dentist went to pharmacy. Went to pharmacy's Drive Thru to pick up a little antibiotic from the dentist. It was 4 capsules of Amoxicillin. He was supposed to take the Amoxicillin before the dentist office visit, but he forgot to do that. Therefore, soon as he left the dentist office he went to pharmacy to pick it up so he could take it. While he was there, was offered the COVID 19 vaccine and that it was the last shot). Concomitant medications included atenolol tablet from 2016 (been taking for 5 years) and ongoing for blood pressure, and ascorbic acid/ cyanocobalamin/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine mononitrate (ONE-A-DAY). No additional vaccines administered on same date. No history of all previously immunizations. No prior vaccincations wtihin 4 weeks. He got the shot Thursday and by Sunday, many different side effects were coming in. He has had side effects from the COVID VACCINE, but initially he does not want to file report, just thinks that everyone needs to get the shot. He does not have complaints. He is wondering how long the side effects will last, and when they go away. States that he is being treated as he has gone to the doctor's. Also states that he made an appointment with the doctor and almost went to the emergency room a couple of times. Right after the shot, he was getting in the car and his right leg started hurting (on 18Mar2021). It didn't go away for a couple of days. It went away but then noticed his shoes started feeling funny. He wasn't looking at his feet, put his shoes on they felt tight. Then he started to look at feet more. Below his knees, his legs are swollen. Swelling started within 2 to 3 days after the vaccine. The swelling is really severe when standing. Everybody at work has seen how sick he is and his legs. Swelling in the legs has him concerned, thinking maybe it's a blood clot. He was given medicine and would like to see it go away. He keeps his legs up. He has other side effects (all in Mar2021) and is having flu like symptoms. He basically has the flu. He has never had the flu shot. This is the first flu shot (He referred to the COVID vaccine as the flu shot as documented. However, confirmed suspect product as Pfizer covid vaccine) he has had that he knows of. He is questioning if he should get the second shot. He feels a little dizzy. Quick questions get him confused and that it comes and goes. Lungs felt full, gasping for air: not now but, since the doctor gave him antibiotics (unspecified injections, he was given 2 shots at the doctor's office, one in each arm), his lungs felt full. At times he was gasping for air. It went away but thought he was going to die. Now when he gets winded, it feels like he has a dry cough. Gets winded easily. The doctor ordered him an inhaler, Symbicort, but it was very expensive, so he did not get it at that time. He never picked it up because it was too much money. The fluid is not there anymore and he does not feel like he needs this as does not feel like it needs to be cleared. He is having wheezing. He can now take deeper breaths. Fatigue: initially, that he was feeling tired within 1 or 2 days, but he did not recall the next day feeling that way (later stated it was within 2-3 days he started to feel tired). He is still tired. Unable to clarify time frame of fatigue further. He feels bloated and full. Hasn't really eaten but feels real full and bloated. Hot and cold flashes started occurring about the same time as the other symptoms. He had these last evening. He does not get the flu very often and doesn't take the Flu shot. This is the closest thing he can remember having a pretty good episode with the flu. He was also given prescriptions for 2 new medications: Triamterene 37.5mg daily, for leg swelling; Clindamycin, 300mg, twice a day, an antibiotic. The odd thing is that it seems like his eyes are big, like really, really big, like they are really open. It is like big eye balls. States that he is just sick and his body is reacting to getting better. He has not been to work in the last 3 days. States that he is fine, just worried about work. Patient asked for personal advice about going back to work. The outcome of "his right leg started hurting" was recovered; outcome of "below his knees, his legs are swollen/ swelling in the legs/ put his shoes on they felt tight" and Fatigue/feeling tired was not recovered; outcome of other events was unknown.

I went to the ER on 4/17/21. Had Pulmonary Embolism in both lungs. I was in the hospital 3 days. I have no personal history of blood clots and no family history of blood clots. Now I must be on blood thinners the rest of my life, because the science does not know? I understand from the doctors that 4 out of 1,000,000 cases are happening with the Pfizer vaccine. Why is this information not being released to the public? I almost died from the Pfizer vaccine and am not permanently disabled by it.

Felt something in my leg like a cramp / did a scan of my leg and found the clot; dizzy; nearly passed out; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 at 16:30 at single dose in right arm for COVID-19 immunisation at the age of 54-year-old. Lot number was ER8732. Medical history included Human papilloma virus (HPV) positive tonsil cancer, ankylosing spondylitis, tinnitus, neuropathy, decreased memory from chemo and radiation. The patient did not have Covid prior to vaccination. Concomitant medications were unknown. The patient felt something in leg like a cramp for a week since 06Apr2021 before ER visit. On 06Apr2021, the patient got dizzy at home nearly passed out, and he went to ER. On 14Apr2021, Doctor did a scan of leg and found the clot. The patient was hospitalized due to the events and they were considered life-threatening. The patient was treated with heparin and ELIQUIS. On 14Apr2021, Rapid Covid test was negative. The patient was recovering from the events.

Patient is a lovely 54 year old- year old male initially seen 4/5/2021, kindly referred by Dr. History of COVID pneumonia in 4/2020 which was complicated by ARF and shingles, Ramsay Hunt Syndrome, with subsequent post-herpetic pain on right side of scalp.He recently received his COVID-19 Pfizer vaccine 3/20/2021 11 days prior to presentation to the hospital with shortness of breath, worsening dypnea on exertion which started 2 days after vaccine. Before this he was biking twice a week, and swimming nearly daily. He did report any medical problems before COVID, was on no meds. 3/31/2021-CT PE protocol showed multiple bilateral PEs without right heart strain. Pulmonary Vasculature: Bilateral filling defects consistent with pulmonary emboli are visualized involving the following: Distal right main pulmonary artery extending to the right lower lobar, segmental, and subsegmental branches, right middle lobar, segmental, and subsegmental branches and proximal right upper lobe artery. Left lower lobar, segmental, and subsegmental arteries. The right heart is not dilated.COVID/flu swab neg, trop x2 neg, BNP wnl. - Started on therapeutic lovenox then plan to transition on discharge to PO xarelto 15 mg bid x21 days then continue with xarelto 20 mg daily. He was seen by Dr. and referred to me for follow up. He had US 4/5/2021- which showed Right Lower Extremity: There is acute thrombus of the femoral proximal vein.Right Lower Extremity: There is no evidence of deep or superficial venous thrombosis in the common femoral, popliteal, posterior tibial, peroneal, GSV and SSV veins. Left Lower Extremity: There is no evidence of deep or superficial venous thrombosis.' 4/5/2021: Initial hematology visit Currently does not have any pain in legs, swelling. Reports that he still is not back to 100%, he got on peloton yesterday and was only able to go 5-6 miles at a slower pace. Denies fevers, chills, sweats. He has some intermittent pain where his previous zoster scalp lesions were. He has been undergoing facial PT. Thrombophilia workup sent which was grossly negative.

Pt with H/O long-standing ITP, APLABs, VTEs, admitted with exacerbation of ITP and immune neutropenia after first dose of Pfizer COVID-19 vaccine.

approximately 1 weeks post vaccine patient suffered vision loss and was diagnosed with ischemic stroke

Received first dose on 1/4/21 and second dose on 1/25/21. 4/28/21 reported having leg pain and was seen by primary care where it was determined he had a blood clot and was placed on blood thinners.

Acute respiratory failure with hypoxia Pneumonia due to COVID-19 virus Patient was treated with Covid medications including convalescent plasma, remdesivir and dexamethasone. Patient is able to wean off oxygen, currently requiring a minimal amount of oxygen support with exertion. Patient will complete antibiotic course

Patient presented to ED with chest tightness on 4/20/21 54YO male with PMH significant for CAD s/p PCI to RCA x2 (2003, 2005), chronic HBV, GI bleed, H. pylori gastritis presented to the hospital with chest tightness. Patient had just finished working out for about 45 minutes when he noted tightness across his lower chest/epigastric region. Found to be in V tach upon arrival and underwent electrical cardioversion with relief of symptoms. Patient was aspirin loaded and started on heparin and lidocaine drips. He underwent cardiac cath which did not show any hemodynamically significant stenosis. Also underwent cardiac MRI which demonstrated a non-viable transmural infarct of the inferior wall. Etiology of VT was thought to be scar mediated from prior MI. Patient underwent uncomplicated ICD placement and was started on metoprolol. ICD interrogation POD 1 was unremarkable. Patient discharged in stable condition with close follow up with PCP, Cardiology, and EP. Patient with unchanged coronaries and unchanged ejection fraction. Patient received Covid-19 Pfizer vaccine IM on 3/27 (left deltioid - LOT ER8733) and 4/17 (left deltioid - LOT EW0170).

The expected side effects on the day after the second shot of headache, muscle aches, chills, fever. On May 5, 2021, patient suffered a stroke. Could not control right arm, could not speak. Called 911, taken to ER, and checked into hospital.

Patient began to feel short of breath on May 7th. May 10th seen by doctor and diagnosed with new onset atrial fibrillation.

I felt tired the evening of the shot. The next morning I had fever and chills, body aches everywhere, severe headache, extreme fatigue, and very upset stomach. By the second day following the vaccination I have a very bloated stomach and extreme pain. These symptoms continued with the stomach and headache becoming worse. Entered the Emergency Room the evening of May 7th and admitted into the Hospital.

Aches, fluish symptoms, muscle aches, fever (100ish), significant brain fog (confusion, no concentration-still continues), regional shoulder pain, massive headache-several days, significant heart/chest pain upper left quadrant both first and second shot. Went into Atrial fibrillation 4-5 days after first shot. Massive emotional swings from ecstasy to rage and depression starting day after shot and continuing.

I awoke with distorted vision in my Left eye.; a stroke; visual impairment; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), via an unspecified route of administration, administered in arm left on 19 Jan 2021 at 19:00 (Batch/Lot Number: EL3302) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]), rosuvastatin, metoprolol, and ezetimibe (ZETIA), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EL1284) in the left arm on 29Dec2020 07:00 PM for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. He was not diagnosed with COVID-19 prior vaccination. It was reported that the patient awoke with distorted vision in his left eye. He went to the emergency room and was diagnosed with a stroke. He was subsequently transferred to the (hospital name) Level 1 Stroke Center. He continued to have visual impairment. The events started on 30Apr2021 07:00 AM. The patient was hospitalized for 5 days. The events was reported serious life-threatening, hospitalization and disabling/incapacitating. Therapeutic measures were taken as a result of the events with TPA. He had been tested for COVID-19 since the vaccination through rapid test (nasal swab) on 01May2021 with negative result. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Son came into Health Dept this morning to report that his father began throwing up and having diarrhea Saturday morning(05/15/2021) which progressed through the day. States did not want to go to the Hospital but wanted to wait to see his MD at the Dialysis center on Monday (05/17/2021). On Sunday(05/16/2021) nausea and vomiting and diarrhea was worse and now with cough noted. States was washing his hands and fainted, EMS was called and he died that morning.

Fever and chills Myalgia Viral syndrome ED to Hosp-Admission Discharged 4/18/2021 - 4/22/2021 (4 days) Hospital MD Last attending ? Treatment team Acute respiratory failure with hypoxia (CMS/HCC) Principal problem Presenting Problem/History of Present Illness/Reason for Admission Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course This pleasant 54-year-old gentleman with history of hypertension came in with increasing shortness of breath and hypoxia secondary to Covid pneumonia resulting in hypoxic respiratory failure and diffuse pulmonary infiltrates. Patient was hospitalized for management of severe sepsis secondary to Covid pneumonia resulting in acute hypoxic respiratory failure. Patient was also treated for possible secondary bacterial pneumonia given duration of Covid symptoms prior to coming into hospital. Patient made nice recovery and was able to wean off from high flow oxygen down to 2 L with exertion. Patient overall made nice recovery hence he was discharged home. Patient was noted to have rising D-dimers despite clinical improvement in Covid infection. He is at high risk for developing DVTs hence he was recommended to use Xarelto 10 mg daily for 1 month to prevent any risk of DVTs. Patient voiced understanding of this. In he was discharged home with home health care. His readmission potential is low to moderate.

Date 04/30/2021 Onset of symptom at approximately 1:30pm: developed slurred speech. Lost of strength started to left lower extremity and weakness and followed up to left upper extremity with lost of strength and weakness. Symptoms lasted approximately 3 minutes, and was taken to Hospital with an admitting diagnosis of Transit Ischemic Attack.

Blood clot R upper leg. 4/24 left lower leg deep tissue pain x 1 week. R lower leg pain 5/10 or 12 x 1 week. Then redness started 5/31 saw Urgent care 6/1 started abx Bactrim DS 6/2 though was lymph node 6/4 increased swelling saw doctor. Clinic sent for US + for blood clot started blood thinners on 6/5

thought was lymph; redness; L leg pain x 1 week. r lower leg pain x 1 week; Blood Clot R upper leg; This is a spontaneous report from a contactable nurse. A 54-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 intramuscular, administered in arm left on 27Mar2021 14:00 (Batch/Lot Number: EP6955) as dose 2, single at the age of 54-year-old for covid-19 immunisation. Patient received first dose (lot number: EN6199) intramuscular in left arm on 05Mar2021, 10:00 am for COVID-19 immunization. No known allergies or other medical history. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. 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 blood clot R (right) upper leg on 24Apr2021 17:00. L (left) leg pain x 1 week. R lower leg pain x 1 week about 10May2021 or 12May2021. Then redness started 31May2021 saw urgent care 01Jun2021 thought was lymph started abx bactrim then on 04Jun2021 to PMD (Withheld) clinic had us + blood clot r upper leg. The adverse event result in Doctor or other healthcare professional office/clinic visit. Event treatment included blood thinners. The outcome of event was recovering.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on temporal association. 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 .

No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11. This continued for two weeks with increasing symptoms of loss of appetite, nausea, abdominal pain, tingling sensation on scalp before going to ER. Visited urgent care on June 16 and bloodwork results indicated elevated white blood cell count and eosinophil count. There was a question as to whether patient had been subjected to a tick bite, so doxycycline was prescribed. After several days, patient returned to urgent care for follow-up bloodwork (June 20th). Results showed WBC and eosinophil count continued to escalate. He went to ER on June 25th and was admitted to the hospital for 5 days. During his visit at Hospital, he was seen by a team of specialists: cardiologist, pulmonologist, hematologist, infectious disease doctor. Multiple tests were run, as the doctors started broad to eliminate certain diagnoses - i.e., bone marrow biopsy, heart cath, CT scans, x-rays, thoracentesis, etc. Patient had fluid around his heart and lungs and was diagnosed with myocarditis. He had no previous heart issues nor family history of heart issues. Test results indicated no abnormal blockage or other issues, other than inflammation and his heart strength was at 27%. I am unable to access his account, as it was disabled after his death. An autopsy is being performed and results are pending; however, the question(s) at large: what was the condition of his heart at the time of his death and was this vaccine-related? Did his myocarditis get worse? Did his heart muscle weaken further and rupture? Please let me know if the autopsy results are needed and where to send them.

Acute CHF with LV thrombus, multiple strokes involving MCA and left cerebellar stroke, aphasia, left-sided paralysis, immobility. Patient was given tPA, clinical symptoms still progressed. In rehab facility now.

Two mild strokes. First on 6/15/21 the second on 7/14/21. Treated consisted of heart monitoring, CT scan, MRI on brain. Prescribed medication, blood pressure meds, and baby Aspirin.

Patient received his second Pfizer vaccination on 1/14 and had no immediate adverse reaction. He states he developed cardiac symptoms and was seen in the ER on 1/16. He was diagnosed with new onset atrial fibrillation. No previous history of atrial fibrillation.

Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of COVID (cough, sore throat, fever, myalgias), on 20 Jan, pt admitted to hospital for worsening symptoms. Pt tested positive for COVID 19. Pt admitted to ICU where pt had complicated hospital course to include ARDS secondary to COVID pneumonia, nonSTEMI, with biventricular heart failure, on multiple pressor, rhabdomyolysis with acute kidney injury, requiring CRRT. Pt was in hospital for 10 days; he passed away on 31 Jan 2021.

2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through

Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: note: pt stated no allergies on form and when asked verbally by immunizer. at the 7 minute mark he began to exhibit weakness and started falling off his chair. seemed like he was going to pass out. his breathing seemed labored. we position pt on floor, rph admin epipen to left outer thigh. 911 called. ems responded. pt felt better after epipen. bp, hr normal. pt taken to er by ems

5pm 03/18/21 Heart palpitation, pulse rate 180, checked fitness watch ECG, showed SVT, Valsalva maneuver, converted to A-FIB/Flutter. 5:30pm ER visit and admission to ICU for Cardioversion. Preload of Amiodarone converted back to Normal Sinus Rhythm prior to cardioversion procedure. Home 03/20/21 Follow-up in 2 weeks with cardiologist.

Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the patient on-site. No signs of stroke. EKG demonstrated NSR, rate 77bpm, no ST elevation. FSBG was 290mg/dl. EMS transported the patient to Hospital Emergency Department. Enroute, the patient became increasingly confused, forgetting their birthday and location. Patient was hypertensive (178/104) and reported a "crushing headache". EMS crew became concerned for stroke. In ED, the patient remained hypertensive (178/93). ED Physician had high suspicion of TIA versus acute reaction to COVID-19 vaccine. Administerd 650mg acetaminophen and 1mg Lorazepam. Admitted patient to critical care unit where patient stated they had developed a sudden-onset diffuse banding-like headache with associated nausea, diaphoresis, blurry vision, and confusion. MRI was negative and patient was transferred from ICU to hospital. Hospital physician believed the symptoms were likely a vagal mediated response or reaction to his COVID vaccination. Patient was discharged on 3/20 with diagnoses of TIA, Acute encephalopathy, Insulin-dependent type 2 diabetes, Essential hypertension, CAD, Unspecified mood disorder, Dyslipidemia, Obesity, and Mild neuro cognitive disorder

55-year-old male with no diagnosed past medical history presents emergency department after cardiac arrest. Per patient's daughter, patient was feeling at baseline today. He got his COVID vaccine at 5 PM this evening. He was running some errands and called his daughter at 8:40 PM. He told his daughter he was not feeling well. She reports he sounded out of breath and sounded as if he was slurring his words. Daughter told him to pull over and she called 911. She met him on the side of the road and he was gasping for air. She arrived at the same time as EMS. Upon arrival of EMS patient was in ventricular fibrillation. He was defibrillated 3 times. He also had one episode of ventricular tachycardia. He was given 300 mg of amiodarone and 3 rounds of epinephrine with had return of spontaneous circulation. King airway was placed and patient was brought to the emergency department.

they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper part of the left calf 2 inches below the knee on the backside; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Batch/Lot Number: En6207) as SINGLE DOSE for covid-19 immunisation. Medical history included Treatable Acid reflex, anxiety and mild depression. Concomitant medications included omeprazole, buspirone and alprazolam for unspecified indication. Patient had the Covid shot on 18Mar2021 at about 3 PM the next morning (on 19Mar2021 06:00) patient woke up with a sore Leg, Upper part of the left calf 2 inches below the knee on the backside. After it did not go away, he went to the doctor then they had a ultrasound done and found out he had a number of clots in that position. Treatment received for the adverse event includes they put patient on a blood thinner. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. Covid test post vaccination done via nasal Swab, They had the results in 15 minutes, covid test result Negative, ultrasound scan: clots in that position on 19Mar2021 found out, had a number of clots in that position. Outcome of the events was recovering.

On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. Reports new headache rated 8/10 that started at 11am 4/8. Hx of stroke 2018 with residual right side symptoms. BP 162/104, HR 80, O2 sat 97% room air at 1740. Sent to a Medical Center ER and admitted with stroke symptoms and new onset diabetes.

Starting slurring speech, right arm went numb and right side of face was not responding. Went to ER and they confirmed he was having a stroke. Continued to have multiple strokes at ER from 8:40pm last one was 1:30am (4 hours after clot buster given). Cause of stroke is still undetermined no clots found, no high blood pressure and no high chlorestrol.

fatigue mild headache shortness of breath chills low grade fever diagnosed with ACUTE PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONATE had two hospital doctors two hematologist two pa-c specialist all suspect pfizer shot . taking eloquis for 90 days

anaphylaxis; This is a spontaneous report from a contactable healthcare professional (patient). A 55-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, administered in left arm on 05Dec2020 11:00 as single dose for COVID-19 immunisation; and amoxicillin, clavulanic acid (AUGMENTIN), via an unspecified route of administration from 18Mar2021 at unspecified dose for an unspecified indication. Medical history included myocardial infarction (MI), coronary artery bypass grafting (CABG), AV Nodal block, and pacemaker. The patient's concomitant medications were not reported. On 18Mar2021 20:00, the patient experienced anaphylaxis. The patient was hospitalized for 2 days on an unspecified date due to the event. The patient reported that he was on augmentin on and off for years and when he got his first vaccine. And on 18Mar2021, he began augmentin again and had anaphylaxis requiring hospitalization. The patient was asking if this was related to the vaccine, but seems to be a possibility. The event resulted in resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The event was treated with epinephrine, steroids, benadryl, and fluids. There was no other vaccine in 4 weeks and patient had not had Covid prior vaccination and was not Covid tested post vaccination. The action taken in response to the event for amoxicillin, clavulanic acid was unknown. Outcome of event was recovered in 2021. Information on batch/lot number was requested.; Sender's Comments: Based on available information, the event anaphylaxis is assessed as unrelated to BNT162B2. The event occurred more than 3 months after the administration of vaccine and can be attributed to augmentin based on provided information, including close temporal relationship and positive rechallenge.

Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient presented to the emergency department with impaired vertical gaze and dizziness. Vital signs within normal ranges except pulse 49 beats per minute. Diagnosed with CVA, administered tPA, admitted to the hospital. Discharged two days later to home in good condition.

Unknown if any immediate reaction. The patient passed away on 3/28/21 approximately 2 weeks from the first dose of the vaccine.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Date of service was 4/2/21 and patient is still currently hospitalized. Diagnosis is acute hypoxemic respiratory failure due to COVID 19.

Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/2. He had expected post-vaccine side effects including headaches, muscle aches, fever/chills, which lasted 2 days. On 4/19, he presented to the ED with 2 days of R sided pleuritic chest pain, dyspnea, and was diagnosed with PE based on CTA. He was started on treatment with apixaban and his symptoms of pleuritic pain and dyspnea have resolved.

Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: EN6198) (age at vaccination: 55-year-old) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nebivolol nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication from 2013 and ongoing; doxycycline (ORACEA) taken for an unspecified indication from Jul2020 and ongoing. Historical vaccine included first dose of bnt162b2 (Batch/Lot number: EC9269) on 02Feb2021 as single dose in Left arm for covid-19 immunisation. The patient had been experiencing pains on and off for about5-6 days after his first slot. Then he read an article (he swear, he was not researching anything online) about a 56 year old man who developed ITP days after receiving Pfizer vaccine. since he had Afib this article worried him. He had no idea what blood clots felt like, but he was having sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach. The doppal came back negative. The doctor suggested symptoms finally disappeared for good about two days after his second dose. The outcome of the events was unknown.

NSTEMI, treated with PCI, DES evidence of multivessel coronary artery disease PCX 100% occluded submitting out of abundance of caution in case vaccine poses risk of clots in coronary artery disease patients

Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could see all of his veins; Head rush; Felt like he was going to spazz out; Sweating; Diarrhea; Headache and pressure at his temples; His ears were ringing; Left arm pain from injection site; Drop foot; Legs went to sleep; Arms were roided out or supercharged/Forearms did not feel like his blood was right; Difficulty/pain breathing in the upper chest; Difficulty/pain breathing in the upper chest; Pretty big at the base of his left index finger, red spot; Pain in the right thumb base/Pain in base of right foot; He felt like he was going to die 5 times; Thought he was having a stroke; Heart rate would go up or be faint; Lost four pounds during this, and gained one back; Stiff right arm/Left thigh was stiff; Thrashing event; Heart rate went up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, expiration date: 28Mar2021) via an unspecified route of administration on left arm 24Mar2021 10:00 at single dose for covid-19 immunization. Medical history included cytomegalovirus from on an unspecified date 2010 and Palpitations. The concomitant medications were not reported. The patient reported, he has gained back a pound and that he is starting on the road to recovery in the last week. Stiff right arm lasted the first and second week. It started the first day of when he got the shot. The next morning, he calls a thrashing event where he felt like his limbs would not work. They did work, but it felt like he needed to move them around. He was thrashing in bed and making the motion with his big joints, then getting into the small joints. It was his arms and legs. Over the course of like an hour, his heart rate went up to like 120. He does not qualify this as racing, but his heartrate is normally 60. This was several times over the course of the first week so it would have been around 04Apr2021 or 03Apr2021. Events occurred 9 days later, which is what he is considering this first week. His left arm was where he got the vaccine, but his right arm was stiff. He felt like he was going to die 5 times. He also had extreme fatigue. He never went to the emergency room. At this time, his glucose was high and his zinc was low. The doctor thinks the extreme fatigue was the antibodies reacted to the cytomegalovirus. He adds that the back of his knees was cramping in the first and second week. In the right arm, he had some small very small bruises. His forearms did not feel like his blood was right. He does not know how to describe it, but he has had metal slivers in his arm in the past and it felt like that, like an infection. He does not know how to describe it. He adds that in his upper right arm inside, he could see all of his veins, like a roadmap. He also had some other things, like his left side of his head rush, like it felt like blood was rushing from the top to left side of his brain. At dinner and meals he had several instances he could barely sit there, he felt like he was going to pass out or spazz out. His limbs felt like they were going to spazz out. In second week, he had several nights where he sweated a lot overnight. The second week into the third week, he did not have the thrashing stuff anymore but for pretty long his heart would go up a notch and/or the heart would be faint. He had diarrhea when he got up. It did not go up to 120, but maybe 80, Headache and pressure at his temples, ears ringing. Left arm pain from injection site. It started with a bang and really hurt. It was really sore and kind of spread into cramping. It was stiff and the source was the injection site. At work, he thought he was having a stroke. His left leg and thigh were stiff and spreading feeling. About 20 minutes after sitting, his legs did not work, and he collapsed. He had Drop foot when his legs got stiff. It took like a week to retrain his arm and leg, like he had a mini stroke. He did therapy for himself and retrained his arm to play guitar. He had a little bit of stiffness in his left arm that comes and goes, stiffness in his left thigh that comes and goes, and his ears are ringing a little bit and it comes and goes. He is not getting second vaccine. He took zinc per his doctor recommendation, but it did not go well. He felt like his arms were roided out or supercharged. He had difficulty/pain breathing in the upper chest, a pretty big at the base of his left index finger red spot like blood collection, and pain in the right thumb base. He had pain in the base of his right foot. Blood tests were in the second week. Glucose was high and he is hypoglycemic. Glucose 117 mg/dl (79-115 normal range), zinc 54 mcg/dl (60-120 normal range), CMV IGG AB >10 u/mL (positive is > or = 0.7 range). The outcome of the events was unknown.

2/4/2021 - Vaccine 2/26/2021 - Left Ankle surgery 4/9/2021 - Left leg swelling 4/22/2021 - Ultrasound found clots in left leg from groin to ankle

Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI. On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.

pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sinus tachycardia, low Sp02, started having a cough. Sepsis secondary to severe right lung necrotizing pneumonia with empyema, hospitalized for 5 days. Discharged with a right chest tube with Pleur-evac. Will require at least 6 weeks of antibiotics.

ED to Hosp-Admission Current 5/8/2021 - present (12 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Date: 5/8/2021 PCP: DC Hospitalist: MD Assessments Chief Complaint Patient presents with o Dizziness o Cough Principal Problem: Acute respiratory failure (CMS/HCC) Active Problems: COVID-19 Plan #Acute hypoxic respiratory failure requiring 50 L of oxygen support to maintain his oxygen saturations, patient came in with a saturations of 58% on room air. This is secondary to Covid pneumonia -Patient will be started on convalescent plasma, remdesivir and dexamethasone. -Reviewed entire plan of care with with him his interpreter at bedside and patient gave consent to receive convalescent plasma. -We will obtain acute inflammatory markers. -I will also obtain a CT scan of chest to rule out pulmonary embolism given severe hypoxia. -Anticipate hospitalization for 5 days given severe acute hypoxic respiratory failure requiring high flow oxygen. #Acute anion gap metabolic acidosis secondary to lactic acidosis secondary to Covid pneumonia resulting in severe hypoxic respiratory failure. -Check procalcitonin to see if patient is developing secondary bacterial infection. -If procalcitonin is elevated will start patient on antibiotics as well. -Use guaifenesin for mucolytic purposes. -Recheck lactic acid with the current management. #Mild hyponatremia: -Secondary to pulmonary infection with a Covid pneumonia. -No acute intervention needed, will continue to monitor. #GERD: -Continue PPI. Critical care time today is 38 minutes. Patient was educated regarding prone positioning and will prescribe a cough medication gave given intractable cough as well. # VTE Prophylaxis: heparin Full Code Diet: Active Orders No diet order for this patient

I developed a pneumonia after receiving the 2nd dose. Symptoms included: fever, chills, sweats, cough, rash, diarrhea shortness of breath.

Developed DVT of right leg five days after vaccine, recognized 5 days later, hospitalized two days, home on Eliquis

Within 24 hours of receiving the second dose of the Pfizer vaccine I went into persistent atrial fibrillation for the first time ever despite having the condition for almost 10 years.

He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confusion obvious symptoms did resolve over 24 hour- he has some residual fatigue and questionable changes post stroke

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department (ED) reporting fatigue, malaise, and anorexia. Patient was hypoxemic (oxygen saturation 90%) and tachycardic (pulse 108 beats per minute). Diagnosed with COVID-19 and acute hypoxemic respiratory failure, admitted to hospital, received remdesivir, steroids, anticoagulation, and oxygen. Patient improved and was discharged two days later medically stable.

Pt called pharmacy on 06/10/2021 to report he suffered a blood clot of unknown etiology on 05/16/2021.

NSTEMI monitored and improved on his own; no surgical intervention needed started on imdur and losartan and discharged home

I had two: First I had swollen glands in the left armpit. Second: My Atrial Fibrillation became very active. Although i have had 3 ablations, I had several episodes of Afib spanning the last few months since my injection of the Covid vaccine.

Patient developed intermittent afib after first dose but was not seen by a physician at that time, the events were recorded on his smart watch. After second dose, patient went into continuous afib with a blood pressure of 200/120 and a pulse around 200. Went to the local emergency room and was put on cardiac meds, had an ecg that confirmed the diagnosis. Was seen by the primary the next morning and put on a different cardiac med. Still no change to the afib.

I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the brain. I went to emergency at hospital with worst headache of my life. After a brain hemorrhage was confirmed by CT-scan, I was rush to hospital were I was treated in the Cerebral critical unit. I suffered through the worst pain of my life for 10 days as the blood from the hemorrhage drained. It 2.5 months later and I am still dealing with the effects of the hemmorhage (headaches, exhaustion, light sensitivity, short term memory loss and speech issues,

On April 27, after my husband took a 2 mile run. He returned and collapse outside of our home. My son and I immediately perform CPR on him. Three week later my husband did from respiratory heart failure - cardiac arrest. He had no complaints about any chest pain ever. We had just visited his doctor that afternoon and gave no report of heart problems or any immediate health issues.

blood clots in right leg; This is a spontaneous report from a Non-contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 03Apr2021 (Batch/Lot number was not reported) at the age of 55-year-old as single dose for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication included etodolac taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots in right leg on 23Apr2021 with outcome of recovered with sequelae on an unknow date. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included apixaban (ELIQUIS). Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

blood clots in greater saphenous vein; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 08:00 at single dose in left arm (at the age of 55-year-old) for COVID-19 immunization. Medical history included covid-19. Concomitant medication included iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 15Apr2021, the patient experienced blood clots in greater saphenous vein. The event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included Eliquis. The outcome of the event was unknown. Information about batch/lot number has been requested.

On June 17 I went to the ER. Based on the symptoms I had a CT scan. I had a Bi-lateral Pulmonary Embolism with a Saddle Embolism. I was put on Heprin. Based on my Troponin numbers there was damage done to the right side of heart. I spend 4 days in the Hospital. I was released on the 21st of June. I have many doctor appointments scheduled including: cardiologist, phlebotomist, and Primary Physician. I have been sent home with Eliquis and will be on it for the foreseeable future. Days in Hospital: 4

Patient is a 55 y.o. yo male presenting to the ED with fatigue, shortness of breath, difficulty breathing and poor appetite per patient's son-in-law. Patient received Covid vaccine on April 25, 2021 and about 3 days later, started to have symptoms that they thought were just postvaccination symptoms. Patient was having decreased appetite, fatigue and generally did not look well. The following week, patient was tested for work and resulted as positive for COVID-19 at that time. He then presented to the ED on May 8th, was admitted initially to the floor but had progressive decompensation of his hypoxemia and was transferred to the ICU on May 12th. He was intubated and subsequently cannulated for VV ECMO due to hypoxia. He remained on the circuit until 6/26/21 when he was successfully decannulated. He was still ventilator dependent and transferred to LTAC on 7/6. I was just asked by one of his care team members yesterday to submit this case to VAERS as he had no risk factors for such severe COVID disease other then his age of 55. He had normal BMI and no PMH. The concern from staff is that his vaccination may have not only failed to protect the patient, but could have boosted the virus's ability to infect cells; this concern is based on original vaccine and spike protein trials published back in 2005.

Patient was admitted for seizures on 5/5/2021 with plan to discharge to a post acute facility. He was negative for COVID-19 at admission. During discharge screening for facility, he was found to be COVID-19 positive. He was asymptomatic for COVID-19 and was discharged to facility on 5/22/2021. On 5/26/2021 he presented to the hospital again and was found to have a pulmonary embolism. He remained admitted until 6/6/2021.

On April 17, 2021, I woke up with an irregular heartbeat that did not go away after taking my as-needed dose of metoprolol 25 mg orally. I experienced feeling like I would pass out and my heart not feeling right. I called 911 which their EKG machine showed I was in atrial fibrillation (I have never had before). I was taken to hospital via ambulance. I converted back to normal sinus rhythm at arrival to the hospital in the ambulance. The cardiac workup did not show anything significant. Followed-up with my cardiologist's office.

I experienced a massive heart attack on 05/07/2020. I was admitted to the ER next door to my office and two stents were placed in an artery that was clogged 60% along with one that had 100% blockage. I stayed in the hospital from Friday to Sunday and was in the ICU for 2 days.

10 after i got my vaccine , i got pneumonia had a temperature of 104 and had blood clots in both my arms and in my lungs. I went to the emergency room i was kept there for a week. they tested me for covid, ct scan and pvc panal. I had an infection in my lungs. took about a month to recover

just started feeling naeous my blood pressure jumped up, i was right down the road from the hospital so i went there, i took baby aspirin to try and get it to go down i had to take another med to get my pressure down, ct scan, 2 mri, mra, blood work

Covid symptoms with 1st shot. Extreem fatigue and chest pain, shortness of breath with 2nd shot. After two trips to the Emergency room I was admitted to the hospital and diagnosed with Pericarditis and a Pericardial effusion. Traeted with steroids, Colchicine and high dose NSAIDS

Pt fully immunized against covid19, presented 7/27/21 in very critical condition with covid19 pneumonia and severe hypoxic respiratory failure.

Sniffles, body aches and pains, nausea, diarrhea, light headed, profuse sweating, headache and increased BP for 7+ days

Patient hospitalized from 7/17- 7/21/21 due to breakthrough infection. Patient fully vaccinated with Pfizer: received dose #1 on 12/21 /20 and dose #2 on 1/11/21. The following is copied from the discharge summary: Hospital Course: a 56 y.o. male with PMHx of HTN who is being admitted for evaluation of COVID. Patient reports that his first started having symptoms about a week ago after returning from vacation. He is vaccinated with pfizer, 2nd dose completed back in 1/2021. COVID 19 infection/ Acute Hypoxemic Respiratory failure - Continue Dexamethasone 6 mg Po daily to complete 5 more days - Completed Remdesivir 5 days - Supplemental oxygen for target saturaion >90% - CRP 6.7, ESR 30, Ferritin 817, D-dimer 494, procalcitonin 0.18 - Telemetry, no arythmias - PRN albuterol as needed - Ambulation oxygenation test done, originally qualified for oxygen but today repeat doing ok at room air. - Cm consulted for home oxygen, awaiting delivery for discharge Elevated Cr - resolved - Cr 0.89 HTN: stable - Continue home lisinopril HLD - Atorvastatin Vitals and labs personally reviewed. Dispo: Discharge Home today with above.

superficial thrombophlebitis; This is a spontaneous report from a contactable nurse on behalf of a doctor and other health care professional via medical information team. A 55-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 in arm on 25Apr2021 (at the age of 55-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma, start and stop date were not reported. It was reported that he has a patient, male with no medical history. The patient got his second Pfizer COVID vaccine on 25Apr2021. The patient came in "yesterday" (03Jul2021) with superficial thrombophlebitis. He has a blood clot in his varicose vein. They did a doppler to rule out a DVT, and it was negative. The doctor was wondering if the patient was supposed to be treated with an anticoagulant. The doctor thought it was related to the vaccine. The patient noticed it "yesterday" and came into the office. The doppler was negative, but he has a positive superficial clot. The patient did come back "today" for follow up. They did not know the seriousness. The patient got the first vaccine on 30Mar2021 (at the age of 55-year-old). She does not know which arms the patient got the vaccine in. The outcome of superficial thrombophlebitis was reported as resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later

amaurosis fugax. Temporarily lost vision in top half of right eye - lasted about 15-20 seconds - blood clot in right eye. No past history of blood clots

My father woke up 16 days after Pfizer medication was injected. According to his story, he briefly exercised, developed extreme chest pain. His significant other was present and took him to the ER and Medical Center. After obtaining EKG, the ER determined he was having an MI. Appropriate medication were initiated, he was stabalized, and transferred by ambulance to hospital. He received 2 stents in the LAD and an angioplasty for a blockage "further down".

second instance of afib; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), at vaccination age of 56-year-old via an unspecified route of administration in the left arm on 06Mar2021 09:00 (Batch/Lot Number: EN6199) as a single dose for covid-19 immunization. Medical history included afib explained (no other issues) from Sep2020 (reported as 6 months prior) to an unspecified date and post first encounter was diagnosed with obstructive sleep apnea (began cpap treatment nightly). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has no known allergies. Concomitant medications included metoprolol and omeprazole magnesium (PRILOSEC). The patient reported that this was only his second instance of afib. The patient reported that the second episode came 11 hours (also reported as 22:00) post vaccine (06Mar2021) and lasted for 10 hours (07Mar2021). The patient did not received treatment. The patient has not been tested post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. The outcome of the event was recovered on 07Mar2021 (reported as 10 hours after onset).

Blood in my urine, kidney pain, shortness of breath. Fast heart beat that went into atrial fib. 145 BEats a minute for 4 hours. Difficulty breathing for 2 weeks following vaccine.

double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.

STROKE. ACCORDING TO PATIENT'S WIFE, HE IS DOING OK. ONLY WAS HOSPITALIZED FOR A FEW DAYS AND WENT HOME. NO RECORDS OF HIS HOSPITALIZATION ARE AT ; HE WENT TO MEDICAL CENTER.

Two weeks after receiving my second dose I began having difficulty breathing. I was diagnosed with bilateral pulmonary embolism. I have no family history of clotting disorders and was perfectly healthy prior to vaccine

The adverse event was a small stroke which occurred after/during a severe headache . There was numbing/tingling and muscle contractions in my left hand followed my face drooping and slurred speech. It was never said that the stroke was caused by the vaccine. It may have been a factor though.

Swelling in left leg around calf and ankle. After a blood test and sonogram a Deep Vein Thrombosis was found in my left leg. Determined "unprovoked" by Dr. after subsequent blood test results came back negative.

04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was Heartburn, took tums and had a little relief 04/02 to 04/05/2021: Same Symptoms throughout those day, had No appetite, increased fatigue. and Tums No longer gave relief. 04/06/2021 6:00 AM: Went to emergency room and had to receive emergency heart surgery as I was diagnosed with blood clogged arteries and had been having a heart attack for the past several days

Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain approximately 3 days after vaccination; patient presented to hospital approximately 3 weeks after these symptoms started. Was started on Xarelto in the hospital.

Bilateral Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), via an unspecified route of administration on 02Feb2021 (at 56-years-old) as single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), on 12Jan2021 (at 56-years-old) for COVID-19 immunization. The patient experienced Bilateral Pulmonary Embolism on 16Feb2021. Facility where the most recent COVID-19 vaccine was administered was at the Workplace clinic. The adverse event resulted Emergency room/department or urgent care. Treatment received for the adverse event was Xarelto 20 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.

Pain in bilateral lower extremities that started after 1st dose of COVID vaccine. US completed on 4/16/21 showed superficial blood clot in right leg. Treatment included: warm compresses, taking ibuprofen 600 mg with food three times daily, and elevation of your right lower extremity. Outcome: unknown.

The day after receiving his 2nd dose of the pfizer vaccine, he developed hemoptysis and R sided chest pain. He came to the ER on 4/21/21 and was found to have extensive bilateral pulmonary embolism with hemorrhage to likely the RML/RLL. He remained hemodynamically stable and did not require supplemental oxygen. He was started on heparin gtt with stable hemoglobin.

ON 4/28 felt intense pain in legs and blurry eyes, slowly went away after taking advil, came back at night, on thursday 4/29 pain continued and had shortness of breath decided to go to urgent care made appt for 4/30 813AM, at Urgent Care symptoms pointed to blood clots was told to go to local imaging company to get sonogram, sonogram showed blood clots in leg told to go to emergency room, went to Hospital and was admitted, confirmed blood clots and put on blood thinner neprin IV, released 5/2 at 1PM, at home now on blood thinner pills 10mg Eliquis

Patient death certificate lists "natural" causes, with the Immediate Cause of Death of Cardiopulmonary Arrest.

Brain hemorrhage; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number En6200) at single dose on 06Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history included hospitalization and vaccine received during existing hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Concomitant drug was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced brain hemorrhage on an unknown date in Apr2021. The event resulted in emergency room/department or urgent care, prolongation of existing hospitalization, disability or permanent damage. The report was reported as serious with seriousness criteria of prolonged hospitalization (hospitalization days were 37 days) and disabling. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Stroke approximately 3 Weeks after 2 dose; This is a spontaneous report from a contactable consumer(patient). A 56-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in APR-2021 at the 56 years old at single dose for COVID-19 immunisation. The medical history included previous heart attack 4 years ago. The concomitant medications included Other medications in two weeks. There was no other vaccine in four weeks. The Historical Vaccine was first dose BNT162B2 in Mar2021 12:00 PM at 56 years old for Covid-19 immunisation. The patient experienced Stroke approximately 3 Weeks after 2 dose on 09May2021 14:30. The patient was Hospitalized due to it from May2021 to May2021(duration 2 days). There was Emergency Room Visit, department or urgent care. There was treatment for this event. The event was assessed as Life-threatening. There was no covid prior vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 09May2021: unknown. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.

Pericarditis: presented to the ED on 5.26.2021 with chest pain x2 days. Has generally felt unwell since his 2nd COVID vaccination on 5.13.2021.

Within a week after first vaccine dose, burning in legs from above the knee to feet. Numbness and tingling in fingers and feet. Symptoms continue. Within a week after second vaccine, onset of bilateral upper quadrant pain, thoracic and flank pain that worsened over time. Unable to lie down due to sharp pain. Reached out to Oncology and PCP offices after symptoms of both vaccines for awareness and guidance. 5/4/21 - Emergency and inpatient visit - diagnosed with bilateral pulmonary emboli.

Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed my the hospital. I have had a CT scan them MRI. I am in ICU. Who is going to pay for my bills since I have no insurance.

Patient received 2nd COVID (Pfizer) vaccine on 5/21/21, with sweats and chills but otherwise no other issues. On 5/26/21, he note left lower extremity edema. This did not resolve with compression hose and went to hospital for a venous doppler revealing a nonocclusive DVT in the left lower extremity politeal and calf veins. He does not smoke, no change in activity, no recent travel by car or air. He is on lenalidomide and takes aspirin 81mg PO QD.

This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation, administered at hospital. Medical history included known allergies to nut, ongoing hospitalisation Vaccine received during existing Hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) at 112mcg, and isosorbide mononitrate (ISOSORBIDE MONONITRATE) at 60mg, both taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccines within 4 weeks prior to BNT162B2. The patient experienced tightens of chest, difficult breathing, light headed, pulmonary embolism on 26Feb2021. The outcome of events was not recovered. The patient was hospitalized for events in 2021 for 21 days. Seriousness criteria for the evens were Life threatening and prolonged hospitalization. The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative in Sep2020. Therapeutic measures were taken as a result of tightens of events. Information on the lot/batch number has been requested.

feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mildly painful -not quite a headache; painful sensations in the lower left leg; a slight discomfort of the arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 11May2021 10:30 (at the age of 56 years old) (Lot Number: EW0182) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure, allergies: contrast dye. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported that there was a slight discomfort of the arm where the shot was administered (11May2021) - not enough to worry about & expected. The next morning (12May2021) he felt painful sensations in the lower left leg - sensations similar to stress fractures and palpations. It subsided and has not returned. About three/four days later (reported as 14May2021 18:00) continuing two weeks leading to the second dose - he felt a constant and migrating thrombosis/palpitations on the right side of his head. It was mildly painful - not quite a headache yet persistent and localized to the RT temporal lobe above the temple & slightly above that region. It became exacerbated by critical thinking when it occurred & persisted for long periods of time. The cognitive effect has become slightly debilitating & stressful. No treatment received. The outcome of the event 'a slight discomfort of the arm where the shot was administered' was unknown, of the event 'painful sensations in the lower left leg' was recovered, of the other events was not recovered.

brain bleed; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program support. This is the first report of 2 reports, for the first dose. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, administered in left upper bicep on 26Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included ongoing diabetes and the patient had it for 10 years or so and was diet controlled, his blood sugars was good. And ongoing supraventricular tachycardia (SVT) for about 4 years and was medication control. And patient was an amputee from an accident many years ago. Concomitant medications included ongoing carvedilol (COREG) taken for SVT. It was reported that the patient had a brain bleed after the first dose that might be but probably wasn't related to the vaccine. Event outcomes was unknown. No follow-up attempts needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021596614 same reporter/patient/drug, different event/dose.

Fever, shortness of breath, chest pain, bloody nose, heart AFIB, lack of sleep, Diarrhea, and nausea.

(Small Pericardial effusion). Acute pain in the chest, esophagus and throat, pain when breathing, fever, severe headache, diarrhea, fatigue. 12 hrs admitted and 3 days later admitted to hospital. Where a pericardiocentesis was performed.

Hemoptysis. On 06/05, a one-time event (old, dark clots) occurred. On 06/06, there were several instances, some older clots, some lighter/fresher blood. Then 4 days of no blood, but "normal" (usual) infected sputum colors (preexisting lung infection; see continuation page). Then on 06/11 beginning @ 7:57am, fresh (light) blood streaks/tinged sputum, which occurred a number of times over the span of approximately 5 hours, until "normal" pale yellow infected sputum was expectorated. Then on 06/12 beginning @ 9:30am, fresh blood again, which again occurred a number of times over the span of about 5 hours until the usual infected colors of sputum were expectorated. Additional information for Item 18: I have a history of MAI/MAC infection and resultant hemoptysis since 2006. However, until the first Pfizer dose, it had been 2 years since the last incident of hemoptysis, which was due, at least in large part, to malnutrition spanning a couple of months, for reasons unrelated to the lungs. I believe my most recent hemoptysis episodes are a result of my immune system being distracted by the Covid-19 vaccine, thus allowing the Mycobacterium avium (and/or other) to more effectively attack my lung tissue. There was no hemoptysis yesterday (06/13), but this has me concerned about the second dose causing additional, possibly worse, problems for my immune system, as it needs to be concentrating on my lung infection full-time; it has been keeping the MAC (and/or other) generally under control, assuming hemoptysis is a good indicator, which my X-rays over the years of monotherapy with Ethambutol suggest is the case. I discontinued Ethambutol on 06/15/2012, with no further hemoptysis until 04/26/2019, and then no hemoptysis until 11 days after the first Pfizer Covid-19 dose. It seems reasonable to conclude that the vaccine led to these latest hemoptysis events and perhaps allowed the preexisting bacterial infection to cause additional lung damage.The physician noted above is my current pulmonologist. I was to have follow-up lung CT scan and lung function tests, but did not do so in 2020 because of Covid-19 concerns. I had planned to see Dr. and my other doctors after being fully-vaccinated, but since lung function tests cannot be performed on patients with active/recent hemoptysis, this may cause an even further delay in my obtaining appropriate diagnostics and treatment.

Patient received his second Pfizer COVID vaccine on 6/4/21. Notes afterward he started with symptoms of a 'chest cold' and was having pain in left rib/lung/chest area. One morning walking at work and was noticing increased phlegm and chest congestion, spit up a wad of blood. Sharp left lung pain with taking a deep breath. Notes after episode, coughed up darker blood a few more times. Went to ER on 6/14/21 - imaging found with pulmonary embolism/blood clot in left lung. Discharged with Eliquis started pack 2 tab BID for 7 days, then 1 tab BID. New patient consult on 6/16/21 with myself, APRN - continuation of blood thinners initiated, referred for hematology consult, and echocardiogram ordered.

Patient reported to hospital with worsening shortness of breath and vertigo, 88% on RA. Sent for x-ray, CT and US. Extensive DVT and sub-massive pulmonary embolism. Initiated on heparin drip. Currently getting consent for TPA administration.

Two days after the shot I was very ill with nausea, bad headache and was very lethargic. Four day later I went to an urgent care for treatment for nausea and the headache. Two days later I was in the emergency room in the Medical Center for treatment of the same symptoms. Eventually the headache got better so I could function but I was very lethargic and had a constant cough for the next 6-7 weeks.

Inflamation - first of the left hand then the right hand, then inflamation of the lungs causing pneumonia, then inflamation in both shoulders and in the left knee and right elbow.

Pt developed DOE one week after first shot. Symptoms worsened gradually. He presented to Hospital 01/23/2021 with Saddle Pulmonary Embolus.

Peripheral vision loss the morning after the first covid vaccine, confusion over the weekend (approximately 4/2/21-4/6/21), Went to hospital Tuesday 4/6/21. Did MRI and determined patient had a stroke. Doctor said event was "fairly new." Patient was hospitalized almost 3 weeks. Doctors called it "embolic shower," said he may have had more than one stroke. They are calling in a stroke of "unknown origin" Patient currently still has short-term memory problems, blindness in right eye, and had to start dialysis treatments when in hospital, is still on dialysis.

Approximately 15 minutes after patient received a Pfizer Covid-19 and Shingrix vaccine, he lost consciousness, but was visibly breathing. I called 911, then patient stopped breathing . He regained consciousness before I could begin CPR. While waiting for EMS, we took 2 BP readings (142/128 & 96/68) and I questioned patient's wife about medical history... she said that he had passed out 3-4 times in the past year. (Pt had not disclosed this on his vaccination Questionnaire)

hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn; had clot arteries based in blood clots; 1 artery was 99% blocked; cold sweats; afraid to eat because he was so bloated/acid reflux; could not hold food down; out of energy; fatigued, totally out of energy; minor chest pain which he thought was indigestion and heart burn; This is a spontaneous report form a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ) on 30Mar2021 for covid-19 immunisation at the age of 56-year-old. Lot number was EP7533. Medical history included diabetes in 2018. Concomitant medications were unknown. Patient received first dose of BNT162B2 on 09Mar2021 for covid-19 immunisation (Lot Number: EN6198 Anatomical Location: Left Arm). On unknown date, electrocardiogram showed shows heart attack. The patient experienced heart attack on 06Apr2021 (treated with surgery, and received 2 stents in his heart), hard time breathing on 11Apr2021, minor chest pain on 02Apr2021 which he thought was indigestion and heart burn on 06Apr2021, had clot arteries based in blood clots, 1 artery was 99% blocked, cold sweats, fatigued and totally out of energy on 06Apr2021, afraid to eat because he was so bloated/acid reflux, vomit on 06Apr2021. The patient was hospitalized for myocardial infarction, dyspnea and chest pain. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.

I experienced a blood clot in my right leg, had surgeries to remove the blood clot and put a stent in. I had excruciating pain in my right leg. I went to the Hospital. I am in recovery from the adverse event.

this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (not where he works). He went home and reported was fine, but tired. Stated his fatigue and onset of shortness of breath began day 1 post vaccine kept him from working. As his symptoms worsened, on day 4 (1/11/2021) he obtained a pulse ox and O2 sats were in the "80's" with normal heart rate. He went to ER on 1/11 1507 with body aches, fatigue, chest discomfort and SOB where he was ultimately admitted with diagnosis of COVID-19 pneumonia. Is on O2 support via NC.

On January 8, I started having a cramping feeling in my right calf. It went on throughout the day without a event. I woke up the next morning, and the crap was worse. I ran some errands and came home and then looked at my calf of my leg and it was twice the size as my other leg. I had four spots of bruising from ankle to knee. I immediately went to the emergency room. I was hospitalized and had bloodwork and an MRI done which showed that I had a DVT and a pulmonary embolus in my right lung. I was hospitalized for two days on blood thinners. I had no shortness of breath or heart problems during this time. I was then released from the hospital on blood thinners which I have to take for the next six months.

I had my first shot of Pfizer vaccine last Friday morning (March 5). In the evening, I felt fatigued. So I went to sleep early. When I got up Saturday morning, I felt dizzy. The dizziness went away in a few minutes. In the next 36 hours, I had the angina feelings - tightness in the left chest and I felt heart be squeezed occasionally. When I stand up and walk, I felt better. Finally Sunday evening (March 7), I took a walk outside and felt symptom free. Maybe the walk helped, maybe the "thrombosis" had run its course before my walk. I have not had the severe angina symptoms since my PCI procedure in Feb 2018. I am sure the recent occurrence is related to the vaccine. Besides reporting the adverse event, I want to get advices whether I should receive the second shot. Thank you!

Patient passed away unrelated to covid vaccine Narrative: The patient had with a history of ischemic cardiomyopathy and multiple PCI's, CABG history of acute renal failure and hypokalemia and decompensated heart failure. Patient received his first dose of Pfizer dose on 2/18. Patient passed away on 3/8 due to cardiac arrest upon arrival to ER. Cause of death is not related to COVID-19 vaccination.

Pt admitted with acute pleuritic CP and dyspnea that started the day after vaccination. Found to have bilateral PE

57yo Male, resident, declared dead 01/11/2021 , following a period of ill health related to diabetic ulcers.

Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the scene where patient was found unresponsive. Patient was transferred to Hospital. Patient was in full cardiac arrest upon arrival. CPR was initiated. Patient deceased. Patient's mother stated the patient had been feeling badly for 2-days, but refused to seek medical treatment.

Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk now; leg pain; This is a spontaneous report received from a contactable consumer (patient's wife). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, on 25Feb2021 (at the age of 57-years-old), at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer stated she's asking on behalf of her husband. He received his first dose of Pfizer-BioNTech COVID-19 Vaccine on 25Feb2021 and had Joint pain and chills after that (on unspecified date in 2021) he was diagnosed with Blood clot (unspecified date in 2021); she stated he had no history of similar health issues and wanted to know if it could be directly linked to this vaccine. The wife further reported that it's dramatically changing his life, he can't even walk now. He had the Covid vaccine on 25Feb2021 and he has no history of blood clots. He developed a leg pain (on unspecified date in 2021) which was odd and they thought that maybe it was some arthritis or something like that. They went to the orthopedist and he was being treated for what the orthopedist thought was a bakers cyst. But then they discovered it was a very large blood clot from his thigh to his calf. They would like to know about this. They have been looking into what he had experienced, and it seems very unusual. It just seems too coincidental that this happened after the Covid vaccine. The emergency room doctor of course shut them down immediately and said that the Covid vaccine never would have done this. But the patient's doctor yesterday said that there are too many unknowns to say for sure that the Covid vaccine didn't cause this. She is not saying that they are against the Covid vaccine, but they are concerned. The patient is on blood thinners now and they just need to know if there is a possible correlation. She had heard on the world news that there is a connection after receiving the (company name) Covid vaccine and now they are shutting this vaccine down in (region name). She saw on the news last night they were asking if there is a correlation with the Pfizer and (company name) Covid vaccines and this. It is very concerning. They have been trying to do research and there is nothing that you can find. The only thing that they did see online was about the doctor that died of a blood disorder in (state name), he had thrombocytopenia. The patient is going to be sent to see a vein doctor. She stated that he has a lot of things ahead of him and he is too young to be dealing with all of this. They are going to be following up with the vein doctor and she would like to have this information when the vein doctor calls later today. The reported adverse events resulted to an emergency room and physician office visit (went to the orthopedist). The patient received corrective treatment as response to the reported events. Outcome of the events was unknown.

Stroke; BNT162B2 (First dose: 28-DEC-2020; second dose: 14Jan2021); BNT162B2 (First dose: 28-DEC-2020; second dose: 14Jan2021); This is a spontaneous report from a contactable other health professional (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 14Jan2021 (at the age of 57 years; as reported) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 28Dec2020 in the 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 not diagnosed with COVID-19 prior to vaccination. The patient had a stroke on 01Feb2021 at 15:00. The event resulted to emergency room/department visit and physician office visit but was not given any treatment (as reported). The patient was hospitalized for stroke for 27 days. The event was considered serious, life threatening, and disabling/incapacitating. Patient's nasal swab test on an unspecified date was negative. The outcome of stroke was not recovered.; Sender's Comments: Based on know n drug profile it is unlikely that the reported cerebrovascular accident was causally related to BNT162B2. This is probably an intercurrent medical condition. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the product and on the conduct of the study are 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.

Pericarditis leading to pericardial effusion; Pericarditis leading to pericardial effusion; This is a spontaneous report from a contactable other hcp (Patient). A 57-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in arm right on 01Mar2021 (Lot Number: EN6201) as single dose for COVID-19 immunisation. Age at vaccination was 57-year-old. Medical history included chronic pancreatitis, gastritis from an unknown date. No Known allergies. No covid prior vaccination. Concomitant medications in two weeks included amlodipine; losartan; trazodone; ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nicotinic acid, pantothenic acid, phosphorus, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, zinc (CENTRUM MEN 50+), all taken for an unspecified indication, start and stop date were not reported. The patient experienced pericarditis leading to pericardial effusion on 05Mar2021 20:30. AE treatment included Pericardiocentesis. AE resulted in: Doctor or other healthcare professional office/clinic visit, 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). The serious criteria for the event was hospitalization, medically significant, life threatening. The patient was hospitalized for 4 days. The patient received bnt162b2, dose 2 Intramuscularly, administered in arm right on 23Mar2021 07:00 AM (Lot Number: EP6955) as single dose for COVID-19 immunisation. Covid tested post vaccination included Nasal Swab Covid19 PCR on 07Mar2021: Negative. The outcome of the event was not recovered.

Blood Clot On Friday, April 9th I started with a pain in my ankle around 4PM. It was getting worst and worst. It got red, swollen and I was unable to walk normal, I started limping. Around 2PM on Saturday, April 10th, I went to the ER and I had my ultrasound done. I have a blood clot. They prescribe me Eliquis; 10 mg twice a day for one week and 5 mg twice a day for two to six months...

Adverse event #1: Flu-like symptoms, severe headache, vision blurriness, lasting roughly 10 days. Adverse event #2: Deep Vein Thrombosis in the left Popliteal vein with moderate associated edema and pain. Required Emergency Room visit, diagnosis, and treatment with Eliquis. This event prevented normal daily work activities for 5 days, after which edema and pain has mostly subsided.

3/29/2021 Pfizer COVID vaccine #1. Reports feeling poorly since that day. 4/3/2021 ED visit for complaint of SOB, fever, body aches. Admitted for sepsis. 4/4 intubated. 4/12 extubated. 4/14 remains hospitalized. Workup negative for infectious cause. Oncologist consulted, does not appear cancer related. MD suspects reaction to vaccine.

Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top of arm to fingers. Notice first sign on Monday morning (04/12/2021) when i awoke from bed around 7:00am.

1. Acute left deep venous thrombosis in the popliteal, posterior tibial, peroneal, one branch of gastrocnemius veins. 2. Acute left superficial venous thrombosis in the great saphenous prox thigh to knee extending tinto a varicose vein at the proximal calf. 1. Pulmonary embolism with large thrombus burden bilaterally, right greater than left ASA/heparin gtt started

small peripheral right lower lobe pulmonary embolism; anaphylaxis; whole body rash and erythema; whole body rash and erythema; This is a spontaneous report received from a contactable physician. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included joint pain and ongoing 45-packs per year smoker. The patient did not have any allergies to medications, food, or other products. Concomitant medications included salbutamol (ALBUTEROL), hydroxyzine (manufacturer unknown) and diclofenac sodium (manufacturer unknown). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The physician reported, "patient had anaphylaxis and whole-body rash and erythema on separate hospitalization (I was not involved for this but reviewed photos and this was reportedly attributed to the vaccine; I'm uncertain if that event was reported). On hospitalization, the patient was with small peripheral right lower lobe pulmonary embolism on a CT PE (CT scan for Pulmonary Embolus). Patient is an active smoker. No other obvious cause." As a result of the adverse events (unspecified), the patient was hospitalized for one day. The start date of the events was on 29Mar2021. The patient was treated with apixaban (for pulmonary embolism). The clinical outcome of "anaphylaxis and whole-body rash and erythema" and "small peripheral right lower lobe pulmonary embolism" was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pulmonary embolism, anaphylactic reaction and associated generalized rash and generalized erythema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after first vaccine.

patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers and toes. bilateral feet numb and tingling. patient admitted to hospital. by morning 4/14 patien resp status declined, ciwa score 15, afib rvr, ams, low bp. septic shock. source unclear.

Pfizer vaccine , 2 doses. Second dose on Friday 4/16. On Saturday had a strong chest pain, spend all day Sunday with upper back pain and chest pain. Monday pain got stronger, Tuesday on and off chest and upper back pain. Went to the hospital and he had suffered a heart attack. No primo medical conditions of anything cardiovascular related. Only medical hx he has is kidney stones. He is currently at the hospital pending catheterization.

DVT's in right calf; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 16Mar2021 02:00 (at 57-years age) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure diagnosed in 2002 and it is under control with medications, ongoing diabetes diagnosed in 2000, neuropathy, allergies. The patient previously took first dose of BNT162B2 for Covid-19 immunization as Covid-19 vaccine first dose. Concomitant medications included metformin taken for diabetes mellitus from 2010 and ongoing at 1000 mg, twice a day; hydroxyzine (HYDROXYZINE) taken for allergies and ongoing at 25 mg, once a day; omeprazole (OMEPRAZOLE) taken for high blood pressure and ongoing at 40 mg, once a day; losartan (LOSARTAN) taken for hypertension and ongoing at 100 mg, once a day; carvedilol (CARVEDILOL) taken for high blood pressure and ongoing at 6.25 mg, twice a day; gabapentin (GABAPENTIN) taken for neuropathy and ongoing at 800 mg, twice a day; trazodone (TRAZODONE) taken for sleep and ongoing at 100 mg, once a day; simvastatin (SIMVASTATIN) at 20 mg, once a day taken for blood cholesterol and ongoing; insulin detemir (LEVEMIR) taken for diabetes mellitus and ongoing at 30 uL, once a day. Patient hopes he was not going to die. States on Saturday 3Apr2021 he went to the ER because he had DVT's in his right calf and they gave him the pneumonia vaccine there and he was under the influence because he was on pain medications. Patient received the pneumonia vaccine on Sunday 04Apr2021. NDC, lot number, or expiry date unknown. Caller states he got the second dose of the Pfizer vaccine today 6Apr2021. patient hopes he was not going to die because he took the two vaccines so close to each other. Patient has had DVT's since 2014 but flared up this Saturday 03Apr2021. States it was under control and it is recovering slowly, blood is flowing, INR is flowing, and it is therapeutic. they gave him a heparin drip to dissolve it in the ER. Patient was admitted to hospital at 12 midnight on 04Apr2021 and got out on 05Apr2021. The outcome of the event was resolving. Information on the lot/batch number has been requested.

Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of leg not getting any better, saw Doctor who ordered Ultra sound of left leg and CT scan of lungs. Extensive DVT clot found in left leg, low density bi lateral pulmonary embolism in both lower lobes of lungs found from CT scan. Hospital stay for 2 days, Heparin given in hospital and now I'm on eliquis blood thinner. Had gotten my second Pfizer shot 3 days before admittance to hospital.

two blood clots in his leg; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 08Feb2021 (Lot Number: EM9810, unknown expiration) and second dose on 02Mar2021 (Lot Number: ENU202, unknown expiration; pending clarification), both received at the age of 57 years old via unspecified route of administration as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter called to report that the patient had a Pfizer vaccine, received second COVID vaccine on 02Mar2021, and couples of weeks ago, a week longer that the patient was diagnosed with two blood clots in his leg. The patient got both of COVID-19 vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose #2 on 4/24/2021. Patient was found down on 4/25/2021 for an unknown amount of time and EMS was called. Patient noted to be seizing on EMS arrival. Blood glucose was noted to be 32 and an amp of D50 was administered. Patient arrested, received CPR (approximately 1 round) and was intubated in the field. His second glucose reading was undetectable and he received a second amp of D50. Patient also received sodium bicarb, calcium, and epinephrine and transported to ED. Patient subsequently transferred to Medical Center. He was treated for septic shock. His mentation remained very poor after pressors weaned off and sedation stopped. He likely had severe brain injury from hypoglycemia and anoxia - poor brainstem reflexed but did have spontaneous breathing - very poor prognosis - patient was extubated for comfort measures and all interventions stopped after family discussion and per their plan.

Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks. Had a full evaluation at Medicine Center. Work up negative and symptoms resolved; atorvastin dose was doubled. He has had some short term memory loss and decrease in neurocognitive function. He had the second dose of the vaccine as scheduled, following which he had a severe unilateral headache but he did not seek care/evaluation.

Soreness to the injection site for 2-3 days. Sudden onset of palpitations 5 days after the vaccine, which lasted 3 days. Diagnosed as Atrial Fibrillation of unknown origin. No previous history or known risk factors.

Fever of 99.9 on 5/3, 99.6 on 5/4, and 100 on 5/5. Patient started on IVF, Zosyn & Vancomycin ABT's IC for Pnuemonia, Nebulizer treatment for COPD, VS every 4 hours x 48 hours.

stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his left arm/couldn't lift his left arm; low blood pressure; his face was numb; his lip was twitching; bad headache; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 21Apr2021 14:00 (Batch/Lot Number: EW0169) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included stroke from 02Feb2020 to 02May2020 (not ongoing). The patient had 3 stroked last year and he was put on ELIQUIS and baby aspirin and a regimen for his strokes. The last one he had was 02May2020 and he has had no problems since then. Last year when he had strokes it wasn't because of his heart it was because of an artery in his brain that went 90 degrees. In Jun2020 they found out that the problem was an artery and that's when the doctor to do the double dose baby aspirin and then everything was fine and he had no episodes at all. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), lot number: P116218, expiration date: Jan2022 taken for stroke from 02Feb2020 to an unspecified stop date; and apixaban (ELIQUIS), lot number: 1796050, expiration date: Sep2023 taken for stroke from 02Feb2020 to an unspecified stop date. The patient had no additional vaccines on the same date as Pfizer vaccine and had no prior vaccine within 4 weeks. The patient had his first shot of the Pfizer COVID vaccine on 21Apr2021 at 14:00 and stated that they made him go wait for 15 minutes in his car. 10 minutes into waiting after the COVID vaccine, he had to call over the EMT because he had stroke like symptoms. On his left side he had face droop, he had a speech slur and he couldn't move his left arm. The patient was transferred to the hospital and was hospitalized. His CT scan was fine, the CT scan with dye was fine, his MRI was fine, and his heart was fine. The patient wanted to know if he should get the second COVID vaccine because of the reaction that he had from the first COVID vaccine. The patient got the COVID vaccine on 21Apr2021 and on 23Apr2021 he was still having a bad headache, brain fog and there was a deficit on his left side. He can't grab and hold something in his left hand and he has a slight deficit on the left side corner of his mouth. The patient was planning on seeing the provider in the first week of May2021. The patient added that he was told to wait 15 minutes and then 10 minutes in he could feel his face was numb and his lip was twitching and he couldn't lift his left arm. He laid on the horn and the EMS came over and they said that he had stroke like symptoms so they transferred him out of his car and into an ambulance where he had vitals taken and he had another episode of stroke like symptoms. They took him into a different ambulance and had another episode in that ambulance when they were on the way to the hospital. He didn't have anything after that except a bad headache and a slight deficit on his left side, according to them, and just a brain fog like when he was trying to figure out how to put things together and he was still having those at the time of the report. The patient was discharged from the hospital on 22Apr2021. The patient stated that his last stroke was on 02May2020 and he has had no headaches since until he had the COVID vaccine on 21Apr2021. According to the doctors and the neurologist at the hospital he could've had a stroke, he could've had low blood pressure from the vaccine or he could've had a multitude of other things but they recommended him to call Pfizer and CDC for the report. While in the hospital, he had a CT scan without contrast, a CT with contrast on 21Apr2021; an MRI without contrast on 21Apr2021; an echocardiogram without dye and with dye on 22Apr2021 and they did another MRI but of his neck on 22Apr2021; all were normal. The patient was hospitalized for stroke like symptoms, on his left side he had face droop, he had a speech slur and he couldn't move his left arm from 21Apr2021. The event stroke like symptoms resolved with sequel on 22Apr2021. The patient recovered from on his left side he had face droop, he had a speech slur, and he couldn't move his left arm on 22Apr2021. The patient has not recovered from bad headache, brain fog. The outcome of his face was numb was unknown, his lip was twitching and low blood pressure was unknown.

DVT and PE, 2 weeks after first vaccine; DVT and PE, 2 weeks after first vaccine; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) at the age of 57-years-old as single dose for covid-19 immunisation. Medical history included hypertension and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; levothyroxine; amlodipine all taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT (deep vein thrombosis) and PE (pulmonary embolism), 2 weeks after first vaccine on 08Apr2021. The patient was hospitalized due to the events for 1 day. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in Apr2021. Information on lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events DVT (deep vein thrombosis) and PE (pulmonary embolism) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 29Mar2021 03:00 (Batch/Lot Number: ER8733) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included pitavastatin calcium taken for an unspecified indication, start and stop date were not reported. The patient experienced heart attack due to blood clot in rca. occurred on 27Apr2021 at 11 pm. The patient was hospitalized for the reported events and was Life threatening (immediate risk of death from the event). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events which includes Emergency Heart Cath and Stent. The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.

Patient was feeling fatigue, unwell the night after getting the vaccine. The next day he stayed home, did not go to work as he was not feeling well. Two days after getting the vaccine, he had trouble breathing, an ambulance was called and he was pronounced deceased hours later. He had a heart attack.

slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability. Information on lot/batch number was available. Additional information has been requested.

This is a solicited report based on the information received by Pfizer (Mfr Report# UNT-2021-005860). A contactable consumer (patient) reported a 57-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Feb2021 as age of 57 years old at 1ST DOSE, SINGLE for COVID-19 immunization. Co-suspect medications included: nifedipine via an unspecified route of administration from an unknown date at an unspecified dose, frequency and for hypertension; methylprednisolone (MEDROL, Tablet) orally from an unknown date at 16mg daily and for lupus; treprostinil diethanolamine (ORENITRAM, Extended release tablet) orally (PO) from 01Aug2019 at unknow dose and frequency; orally from unknown date at 3.875mg, every eight hours (q8h);(Lot: 2101647 and Expiration date:30Jan2022) at 0.25mg unknown frequency; (Lot: 2101648 and Expiration date: 31Jan2022) orally from unknown date at unknow dose and frequency; (Lot: 2101649 and Expiration date: 31Jan2022) orally from unknown date at 2.875mg, 3x/day; (Lot: 2101810 and Expiration date: 31Jan2023) orally from unknown date at 0.125 mg unknown frequency;(Lot: 2101646 and Expiration date: 31Jan2022) orally from unknown date at unknown dose and frequency; orally from unknown date and ongoing at 3mg 3x/day; all for primary pulmonary arterial hypertension. Relevant ongoing medical history included primary pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), calcium deficiency, systemic lupus erythematosus (SLE), obstructive sleep apnea (OSA) on Continuous positive airway pressure (CPAP), hypercalcemia, chronically high peripheral artery disease (PAD), hypertension and multifactorial stable SOB (shortness of breath). Patient's family history included: COVID-19 (brother positive). Concomitant medications included ambrisentan (LETAIRIS), spironolactone (ALDACTONE), calcium citrate, ergocalciferol (CITRACAL + D), apixaban (ELIQUIS), epinephrine (EPIPEN), folic acid (FOLVITE), digoxin (LANOXIN), furosemide (LASIX), escitalopram oxalate (LEXAPRO), famotidine (PEPCID), hydroxychloroquine sulfate (PLAQUENIL), and sildenafil citrate (REVATIO). This is a solicited report received on 31Mar2021 from a consumer via (pharmacy name). Patient began therapy with Orenitram (treprostinil diethanolamine), on 01 Aug 2019 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 0.25mg, 1mg, 2.5mg and 0.125mg and the current dose was reported as 3.875mg, via oral (PO) route, every eight hours (q8h). On 23Mar2021, the patient experienced event COVID-19 and pneumonia (COVID-19 pneumonia, hospitalization, medically significant).On 23Mar2021, 1 year 7 months 23 days after initiating PO Orenitram, the patient was hospitalized due to COVID-19 and pneumonia and discharged on 29 Mar 2021. The patient was on oxygen at the time of reporting. Action taken with PO Orenitram dose for the event of COVID-19 pneumonia was not reported. At the time of reporting, the outcome of the event of COVID-19 pneumonia was unknown.The reporter did not provide causality for the event of COVID-19 pneumonia. Follow-up information was received as solicited report on 15Apr2021 from a consumer via (pharmacy name). On 06Apr2021, the patient had pneumonia (pneumonia, medically significant and hospitalized). Additional lot number and expiration date were added to 2.5 mg concentration of PO Orenitram. On 06Apr2021, 1 year 8 months 6 days after initiating PO Orenitram, the patient was hospitalized due to pneumonia and remained hospitalized at the time of reporting. The patient was also hospitalized in Mar2021 for COVID (previously reported COVID-19 pneumonia). Action taken with PO Orenitram dose for the event of pneumonia was not reported. At the time of reporting, the outcome of the event of pneumonia was unknown. The reporter did not provide causality for the event of pneumonia. Additional spontaneous information was received on 19Apr2021 from a consumer (social worker) via (pharmacy name). Event of pneumonia was omitted and subsumed under COVID-19 pneumonia. Since 06Apr2021, the patient remained hospitalized due to COVID (previously reported COVID-19 pneumonia). Follow-up information was received on 27Apr2021, from a nurse on behalf of the reporting physician via a query response. On 16Apr2021, the patient had acute hypoxemic respiratory failure (AHRF) from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH (acute respiratory failure, hospitalized, medically significant), pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus (pulmonary arterial hypertension, hospitalized and medically significant), AHRF secondary to Flu B and PAH with baseline PAH (influenza, hospitalized), volume overload (fluid overload, hospitalized). On an unreported date in 2021, the patient had fever, temperature 101.1 F (pyrexia). On an unreported date, the patient had worsening MR (mitral regurgitation) (mitral valve incompetence, medically significant), steroid induced diabetes (steroid diabetes, medically significant), lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at thighs (oedema peripheral), weight slowly coming down, weight up 4 lbs (weight fluctuation), rash (rash), diarrhea (diarrhoea), and leg healing (limb discomfort). On 16Apr2021, 1 year 8 months 16 days after initiating PO Orenitram, the patient was hospitalised due to acute hypoxemic respiratory failure (AHRF) from COVID (previously reported COVID-19 pneumonia) and for AHRF secondary to influenza B exacerbating PAH, then transferred to the other hospital with volume overload and diuresis. The patient was presented with volume overload and needed oxygen requirement (none needed at home prior to both hospitalizations). The patient's breathing and oxygen were improved with diuresis. Patient's pulmonary hypertension was treated with steroids as though to be flare due to lupus. Patient was given intravenous (IV) solumedrol (25 mg in AM and 16 mg in PM) as per the discussion with rheumatology and pulmonary hypertension cardiology with improvement in oxygen status. On 24Apr2021, the patient relevant diagnostic and laboratory test included: complete blood count (CBC) WBC (white blood count) 4.79, RBC (Red blood cell count) 3.31, Hgb (hemoglobin) 8.4, Plt (Platelet count) 146. Comprehensive metabolic panel (CMP) Na (sodium) 141, K (potassium) 4.1, Blood urea nitrogen (BUN) 39, Creatinine 1.68, glucose 90. On 25Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.51, RBC 3.24, Hgb 8.2, Plt 159. Na 141, K 4.4, BUN 39, Creatinine 1.59, glucose 117. On 26Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.41, RBC 3.30, hgb 8.3, Plt 159. Na 141, K 4.4, BUN 37, creatinine 1.54, and glucose 90. The patient was discharged on 26Apr2021. Patient's physical exam at the time of discharge showed pulse 65 bpm, respiratory rate 18 per minute, blood pressure (BP) 138/78 mmHg, temperature 36.5 °C and weight was 90.9 kg. The patient was breathing comfortably in no distress on 2 Litre nasal cannula (NC). Minimal crackles appreciated in the morning posteriorly. The patient had 2+ pitting edema, to knees 1+ dependent edema at thighs and edema unchanged but overall leg size decreased. Continues to be pitting but improved on the day of discharge. Patient's discharge diagnosis pulmonary hypertension exacerbation. Patient's diuretics were increased from 40 mg daily to 60 mg daily and may needed more diuretics. Discharge medications included: Protonix (pantoprazole), Demadex (torsemide), Medrol (methylprednisolone), Citracal + d (calcium citrate, ergocalciferol), Lanoxin (digoxin), Epipen (epinephrine), Lexapro (escitalopram oxalate), Folvite (folic acid), Plaquenil (hydroxychloroquine sulfate). Patient's medications of Pepcid, Lasix, and Aldactone were stopped after discharge from the hospital. The patient was instructed to take pantoprazole 40 mg daily while on steroids and when steroids tapered, he had to discontinue it in future and would stop pantoprazole and resume taking home dose of famotidine. Patient was on nifedipine at home and physician thought to be the contributing factor to lower extremity edema so stopped taking the nifedipine in house. It was reported that steroid induced the diabetes. It was reported that the patient needs transesophageal echocardiogram (TEE) due to had worsening MR (mitral regurgitation) but not agreeable at that time. The patient tried ethacrynic acid 50 mg daily but felt it was not making a difference with his weight. The patient went back on the Bumex (bumetanide) on Friday. Patient's weight slowly coming down to see doing good later on Bumex, his rash subsiding and leg was healing. Patient's weight was stable at 155 lbs and had multifactorial stable shortness of breath (SOB). Patient's weight was above baseline and needed more diuretics. Patient had been in touch with his COVID positive brother who was symptomatic and refused to be covid testing quarantining at that time. On 24Feb2021, the patient got his first dose of COVID-19 vaccine and his temperature was 101.1 °F in 2021. The patient would take Tylenol (paracetamol) and monitor if fever persists to 48 hours he would go to the urgent care. Patient was started on Eliquis and felt much better and no longer to had temperatures and diarrhea. On an 21Apr2021, the patient had right heart catheterization which revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, CI 3.52. Patient had chronically high PAD's and could not take metolazone secondary to hypercalcemia and pending admission for colonoscopy with the physician. Patient reminded multiple times by physician for getting a COVID-19 swab. The patient also had increased 4 lb weight in Apr 2021 since discharge from the hospital. Action taken with PO Orenitram dose due to the event of COVID-19 pneumonia was updated to dose decreased and for the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia, diarrhoea and limb discomfort was not reported. Action taken with nifedipine, and Medrol dose for the events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia diarrhoea and limb discomfort was not reported. At the time of reporting, the outcome of the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation was unknown. The outcome of the events of rash and limb discomfort was recovering. The outcome of the events of pyrexia and diarrhoea was recovered on an unreported date in 2021. The reporter did not provide causality for the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia, diarrhoea, and limb discomfort. Case Comment/Senders Comment: The company has assessed the serious adverse events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, and steroid diabetes as not related to Orenitram. The event of COVID-19 pneumonia was related to the ongoing SARS-CoV-2 pandemic, and the event influenza was related to seasonal Influenza B. The event acute respiratory failure was likely related to acute influenza, but was also possibly impacted by pulmonary insult from COVID-19 pneumonia, and underlying lupus associated with PAH. The event pulmonary arterial hypertension was likely an exacerbation of the underlying PAH due to the concurrent infections. The event mitral valve incompetence and fluid overload were likely related to cardiac dysfunction associated with the underlying chronic and progressive PAH. The event steroid diabetes was likely related to co-suspect medication Medrol, which was used as treatment for the lupus, although co-suspect medication nifedipine was possibly contributory to the event in view of its safety profile and as such cannot be excluded. Pfizer is a marketing authorization holder of [Nifedipine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Nifedipine] has submitted the same report to the regulatory authorities. Information on the batch/Lot number has been requested.; Sender's Comments: Based on the temporal association and the known safety profile, a possible contributory role of BNT162B2 to the development of drug ineffective, COVID-19, pneumonia, rash, pyrexia and diarrhoea cannot be excluded. Acute hypoxemic respiratory failure was secondary to COVID-19, therefore was also considered as related to BNT162B2. The other events were considered as due to underlying or intercurrent conditions and unrelated to BNT162B2. Steroid diabetes was considered as related to methylprednisolone and other events were unrelated to methylprednisolone. Oedema peripheral and limb discomfort were considered as related to nifedipine and other events were unrelated to nifedipine. 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.

AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH; COVID-19 and Pneumonia/COVID-19 pneumonia; COVID-19 and Pneumonia/COVID-19 pneumonia; Acute hypoxemic respiratory failure from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH; Pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus; Volume overload; Worsening MR (mitral regurgitation); Steroid induced diabetes; Lower extremity edema, 2+ pitting edema, to knees. 1+ dependent edema at thighs; Weight slowly coming down, weight up 4 lbs; Rash; Diarrhea; leg healing (limb discomfort); Fever, temperature 101.1 F; This is a solicited report received from a non-contactable other health care professional via pharmacy. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 24Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation, nifedipine, oral from an unspecified date at unspecified dose for hypertension, methylprednisolone (MEDROL, tablet), oral from an unspecified date at 16 mg, daily (every evening), and oral from an unspecified date at 1.5 DF, daily for an unspecified indication, and treprostinil diolamin (ORENITRAM), oral from 01Aug2019 at unspecified dose, oral from an unspecified date (Lot Number: 2101647; Expiration Date: 30Jan2022) at 3.875 mg, 3x/day (q8h), oral from an unspecified date (Lot Number: 2101648; Expiration Date: 31Jan2022) at 3 mg, 3x/day (q8h), oral from an unspecified date (Lot Number: 2101649; Expiration Date: 31Jan2022) at 2.875 mg, 3x/day (q8h), oral from an unspecified date (Lot Number: 2101646; Expiration Date: 31Jan2022) at unspecified dose, and oral from an unspecified date (Lot Number: 2101810; Expiration Date: 31Jan2023) at unspecified dose for Primary Pulmonary arterial hypertension. The patient's medical history ongoing Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), ongoing Systemic lupus erythematosus, ongoing Sleep apnoea syndrome (obstructive sleep apnea (OSA) on Continuous positive airway pressure (CPAP)), ongoing Hypercalcaemia, ongoing Peripheral arterial occlusive disease, ongoing Dyspnoea, family history of COVID-19 (Brother positive), ongoing Continuous positive airway pressure, and ongoing Hypertension. The patient's concomitant medications included ambrisentan (LETAIRIS), sildenafil citrate (REVATIO), calcium citrate, ergocalciferol (CITRACAL + D [CALCIUM CITRATE;ERGOCALCIFEROL]), digoxin (LANOXIN), epinephrine (EPIPEN), escitalopram oxalate (LEXAPRO), folic acid (FOLVITE [FOLIC ACID]), hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); all ongoing, famotidine (PEPCID [FAMOTIDINE]) from an unspecified start date to Apr2021, furosemide (LASIX [FUROSEMIDE]) from an unspecified start date to Apr2021, spironolactone (ALDACTONE [SPIRONOLACTONE from an unspecified start date to Apr2021, and apixaban (ELIQUIS). On 23Mar2021, the patient experienced COVID-19 and pneumonia (COVID-19 pneumonia). The patient was hospitalized on 23Mar2021. The patient was on oxygen at the time of reporting. On 06Apr2021, the patient had pneumonia. The patient was hospitalized due to pneumonia and remained hospitalized at the time of reporting. The patient clarified it as COVID-19 pneumonia. Since 06Apr2021, the patient remained hospitalized due to COVID-19 pneumonia. On 16Apr2021, the patient had acute hypoxemic respiratory failure (AHRF) from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH, Pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus, AHRF secondary to Flu B and PAH with baseline PAH, volume overload. The patient was hospitalized due to the events on 16Apr2021 to 26Apr2021. The patient was presented with volume overload and needed oxygen requirement (none needed at home prior to both hospitalizations). The patient's breathing and oxygen were improved with diuresis. The patient was treated with steroids as though to be flare due to lupus. Patient was given intravenous (IV) solumedrol (25 mg in AM and 16 mg in PM) as per the discussion with rheumatology and pulmonary hypertension cardiology with improvement in oxygen status. On 24Apr2021, the patient relevant diagnostic and laboratory test included: WBC (white blood count) 4.79, RBC (Red blood cell count) 3.31, Hgb (hemoglobin) 8.4, Plt (Platelet count) 146. Comprehensive metabolic panel (CMP) Na (sodium) 141, K (potassium) 4.1, Blood urea nitrogen (BUN) 39, Creatinine 1.68, glucose 90. On 25Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.51, RBC 3.24, Hgb 8.2, Plt 159. Na 141, K 4.4, BUN 39, Creatinine 1.59, glucose 117. On 26Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.41, RBC 3.30, hgb 8.3, Plt 159. Na 141, K 4.4, BUN 37, creatinine 1.54, and glucose 90. The patient was discharged on 26Apr2021. Patient's physical exam at the time of discharge showed pulse 65 bpm, respiratory rate 18 per minute, blood pressure (BP) 138/78 mmHg, temperature 36.5 C and weight was 90.9 kg. The patient was breathing comfortably in no distress on 2 Litre nasal cannula (NC). Minimal crackles appreciated in the morning posteriorly. The patient had 2+ pitting edema, to knees 1+ dependent edema at thighs and edema unchanged but overall leg size decreased. Continues to be pitting but improved on the day of discharge. Patient's discharge diagnosis pulmonary hypertension exacerbation. Patient's diuretics were increased from 40 mg daily to 60 mg daily and may needed more diuretics. Discharge medications included: Protonix (pantoprazole), Demadex (torsemide), Medrol (methylprednisolone), Citracal + d (calcium citrate, ergocalciferol), Lanoxin (digoxin), EpiPen (epinephrine), Lexapro (escitalopram oxalate), Folvite (folic acid), Plaquenil (hydroxychloroquine sulfate). Patient's medications of Pepcid, Lasix, and Aldactone were stopped after discharge from the hospital. The patient was instructed to take pantoprazole 40 mg daily while on steroids and when steroids tapered, he had to discontinue it in future and would stop pantoprazole and resume taking home dose of famotidine. Patient was on nifedipine at home and physician thought to be the contributing factor to lower extremity edema so stopped taking the nifedipine in house. It was reported that steroid induced the diabetes. It was reported that the patient needs transesophageal echocardiogram (TEE) due to had worsening MR (mitral regurgitation) but not agreeable at that time. The patient tried ethacrynic acid 50 mg daily but felt it was not making a difference with his weight. The patient went back on the Bumex (bumetanide) on Friday. Patient's weight slowly coming down to see doing good later on Bumex, his rash subsiding and leg was healing. Patient's weight was stable at 155 lbs and had multifactorial stable shortness of breath (SOB). Patient's weight was above baseline and needed more diuretics. Patient had been in touch with his COVID positive brother who was symptomatic and refused to be covid testing quarantining at that time. In 2021, the patient got his first dose of COVID-19 vaccine and his temperature was 101.1 F. The patient would take Tylenol (paracetamol) and monitor if fever persists to 48 hours he would go to the urgent care. Patient was started on Eliquis and felt much better and no longer to had temperatures and diarrhea. On an 21Apr2021, the patient had right heart catheterization which revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, ci 3.52. Patient had chronically high PAD's and could not take metolazone secondary to hypercalcemia and pending admission for colonoscopy with the physician. Patient reminded multiple times by physician for getting a COVID swab. The patient also had increased 4 lb weight since discharge from the hospital. In 2021, the patient experienced had fever, temperature 101.1 F. On an unknown date, the patient experienced had worsening MR (mitral regurgitation), steroid induced diabetes, lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at thighs, weight slowly coming down, weight up 4 lbs, rash, diarrhea, and leg healing (limb discomfort). In 2021, patient weight was up by 4 lbs since discharge from hospital. The action for nifedipine in response to the events was unknown. The action for methylprednisolone in response to the events was unknown. The action for treprostinil diolamin in response to the events was unknown. The outcome of the events COVID-19 pneumonia, drug ineffective, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation was unknown. The outcome of the events rash and limb discomfort was recovering. The outcome of the events pyrexia and diarrhoea was recovered on an unknown date in 2021. Case Comment/Senders Comment: The company has assessed the serious adverse events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, and steroid diabetes as not related to Orenitram. The event of COVID-19 pneumonia was related to the ongoing SARS-CoV-2 pandemic, and the event influenza was related to seasonal Influenza B. The event acute respiratory failure was likely related to acute influenza, but was also possibly impacted by pulmonary insult from COVID-19 pneumonia , and underlying lupus associated with PAH. The event pulmonary arterial hypertension was likely an exacerbation of the underlying PAH due to the concurrent infections. The event mitral valve incompetence and fluid overload were likely related to cardiac dysfunction associated with the underlying chronic and progressive PAH. The event steroid diabetes was likely related to co-suspect medication Medrol, which was used as treatment for the lupus, although co-suspect medication nifedipine was possibly contributory to the event in view of its safety profile and as such cannot be excluded. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, events of COVID-19 pneumonia, Drug ineffective, Fever, Diarrhea could be related to the suspected drug of BNT162B2. All the other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The reported events are considered unlikely related to the suspected drug of Nifedipine. The events of Diabetes steroid-induced is most likely related to co-suspect medication Medrol, which was used as treatment for the lupus. All the other events are considered unlikely related to the suspected drug of Medrol. Medical history of ongoing Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), ongoing Systemic lupus erythematosus, and ongoing Dyspnoea may provide explanations for some of the events (such as Pulmonary arterial hypertension, Volume overload, Mitral regurgitation, and Oedema peripheral). 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.

My father in law suffered a heart attacked on the day he received his second shot. at the time of this he was staying in our house where he wasn't found until two days later when we received a call from his work saying he never showed up or called in to work. The medical examiner told us that prior to the second vaccine in the last few weeks he had suffered some sort of heart issue that damaged his heart, but wasn't big enough for him to notice or think anything of it. The timeline the medical examiner gave us would have been after receiving the first vaccine. He then received his second Vaccine on a Thursday which was the last time anyone heard from him and he didn't show up to work Friday and was found Saturday after we were notified he didn't show up to work and we called 911. The medical examiner said he suffered a heart attack. The medical examiner said they had to write the death date on Saturday because that was when he was found, but the last anyone heard of him was prior to getting the vaccine and then he missed work the very next day(which was Friday).

Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 with chief complaint of fatigue, chest pain, shortness of breath on exertion. Patient reports fatigue of 2 week duration associated with right-sided chest discomfort, dyspnea, and night sweats. He reports approximately 1 week ago onset of pleuritic R-sided, nonradiating chest pain, with provocative factor of cough and palliative factor of lying supine. He additionally reports dyspnea on exertion and at rest and night sweats of 1 wk duration. CT chest angio showed Large Pericardial effusion, moderate Left pleural effusion, mild right pleural effusion, ascites. On 5/24/2021, patient underwent pericardiocentesis with 800cc of reddish fluid drainage, and left thoracocentesis with transudative fluid. Cytology is pending.

Patient presented with SOB for 2 weeks post vaccination along with headache, fatigue/nausea. He was found to have pericardial effusion and bilateral pleural effusions. He had pericardiocentesis with 975ml drained. He had bilateral thoracentesis with 820 ml drained from R lung and 800 ml drained from L lung.

Pt became diaphoretic following1st dose of Pfizer vaccine. Medics placed pt on cardiac monitor. Cardiac rhythm was ST, then pt went into A-fib. VS: BP=184/100, HR= 128, RR= 22, 02 sat= 98% RA. Pt stated he had not taken his BP med today. 911 called and pt transported to hospital. VS at transport: BP= 165/122, HR= 130, RR= 22, 02 Sat= 99%. Cardiac rhythm: A-fibrillation Medics placed an 18G L AC prior to departure.

Presented to ED with complaint of chest pain onset 0800 this morning. He endorse shortness of breath and a cough that has been ongoing for three weeks.Patient even at rest has significant tachypnea usually in the 40s and sometimes even into the 50s breaths per minute. Sepsis present on admission. COVID-19 infection was diagnosed on the eighth of this month, now is negative. Has been on a ceftriaxone and azithromycin. Could be due to multifocal pneumonia and PE. Changed to cefuroxime,7-day course. Leukocytosis could be due to steroids, recommend to repeat CBC in about a week. Multifocal pneumonia: With underlying COVID-19 diagnosed on the eighth, now is negative. Completed azithromycin for 3 days and was on a ceftriaxone, changed to p.o. cefuroxime on antibiotic for suspicion for secondary bacterial infection, will complete the course. Acute bilateral pulmonary emboli: on Xarelto. Echo reviewed. Mild hemoptysis: Could be due to pulmonary emboli, infarcts, remains on anticoagulation. No recurrence. Left lower extremity DVT/SVT: Anticoagulation as above. Transaminitis: Denies use of alcohol, he has some nonspecific complaint on the right sided abdomen but negative Murphy and ultrasound shows normal gallbladder, normal liver, stable.

Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7). Symptoms of chills and miserable feeling increased day 4 on. Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am.

a blook clot; blockage in the Left Anterior Descending artery; symptoms of shortness of breath; This is a spontaneous report from a non-contactable consumer or other non hcp. A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 17:30 (at the age of 57-years-old) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 02Feb2021and experienced cardiac blockage. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 the patient experienced a blook clot, blockage in the left anterior descending artery and symptoms of shortness of breath. The events were reported as serious (life threatening). It was reported that 15Apr2021, emergency trip to ER, blockage in the Left Anterior Descending artery. This blockage was only 40% blocked in Feb2021, and suddenly in April became 99% blocked. Dr suspected a blook clot when symptoms of shortness of breath appeared suddenly. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Blockage in the Left Anterior Descending artery was treated with cardiac stents. The patient underwent lab tests and procedures which included COVID-19 test tested performed on an unspecified date (result not reported). The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021600543 same patient, different vaccine dose/events

Her husband passed away; Sepsis; Shock due to bilateral pulmonary acute disease syndrome; Shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage; misery and feeling horrible; Severe chills; Headache; Shortness of breath; Fever; Fatigue; Diarrhea; Muscle aches; Skin sensitivity and rash; Skin sensitivity and rash; Sore throat; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 22Feb2021 at 10:00 (Lot Number: EN6202) (at the age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included high cholesterol from 2017 to an unknown date, seasonal allergy from an unknown date and unknown if ongoing and arteriosclerosis from 2017 to an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 (Lot Number: EL9264) (at the age of 57-year-old) as single dose for COVID-19 immunisation; the patient previously received ZYRTEC (10mg almost daily) for seasonal allergy, ibuprofen (ADVIL, 200 mg) and TYLENOL both for pain. Caller stated that the patient passed away on 02Mar2021 which was 8 days after the 2nd dose of the Pfizer COVID Vaccine. On 26Feb2021 the patient went to urgent care and then on 01Mar2021 he went to the hospital emergency room (ER). It was reported that an autopsy was performed on 06Mar2021 and the cause of death listed sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage. The manner of death was natural and the lung presentation is highly suggestive of diffuse alveolar damage due to COVID-19 although the patient had several negative tests for COVID. The patient tested negative for influenza AB, negative for valley fever, negative for Legionnaire's disease and was in the hospital for less than 24 hours. The patient went back to urgent care on 28Feb2021 and was feeling miserable and asking for blood tests and urine tests, stated at that time his platelets were low at 122, glucose was high at 105, sodium was low at 134, calcium was low at 8.3, urine was negative and the patient did not get these labs til Monday when he was on the way to the emergency room and it was all different when he got to the hospital. The test for strep was negative, the oxygen was low at 86 percent when he got to the hospital on Monday and they just had to keep increasing his oxygen, stated a culture, no further details provided about the culture. A CTA done on the chest on Monday which was bad and stated the patient was symptomatic and they did not treat him for COVID but had a clinical suspicion for COVID. Adenovirus was not detected, metapneumonia virus was not detected, respiratory syncytial virus was not detected, parainfluenza was not detected, his platelets kept dropping and he had two tests for valley fever which is Cocci IGG and IGM and those were negative, the sodium level on 02Mar2021 was 126, all of these things were low: chloride 92, CO2 18, calcium 7.8, glucose was high at 222, bun was high at 21, creatinine was high at 1.4, EGFR was low at 52, WBC was high at 18.6, RBC was high at 7.39, HGB was 22.6, HCT was 66.4, RDW was high at 15, RDWFD was 45.5, and platelets were low at 61. The patient came into the emergency room those labs were when he was failing completely and on 01Mar2021 was when he arrived in the ER; at that time his WBC were normal, RBC was high at 6.16, HGB was high at 18.5, HCT was high at 54.9, platelets were low at 73, monocytes absolute were high at 0.96, sodium was low at 129, chloride was low at 95, calcium was low at 8.3, glucose was high at 150 and this was 7 days past the Pfizer COVID Vaccine. The patient was negative for strep pneumonia antigen and negative for Legionnaires Urinary antigen. The chest X-ray was done on 26Feb2021 and the patient was in misery and feeling horrible and they sent him home with albuterol and possible antibiotic to start that Monday and he had severe chills, headache, shortness of breath, fever, fatigue, diarrhea, muscle aches, skin sensitivity and rash, sore throat. Chest X-ray says normal; states the albuterol was PROAIR HFA 90mcg and he tested negative for influenza AB and he never got to the antibiotic because they said to wait til Monday and by that time this was an emergency. The patient outcome of sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage was fatal and unknown for the other events. The patient died on 02Mar2021. An autopsy was performed that revealed the cause of death was sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage.; Reported Cause(s) of Death: Sepsis; Autopsy-determined Cause(s) of Death: Shock due to bilateral pulmonary acute disease syndrome; Diffuse alveolar damage

NSTEMI went to cardiac cath and received stent in LAD. Started on prasugrel 10 mg daily, lisinopril 2.5 mg daily, and aspirin 81 mg daily discharged home

After the second dose my chest started to feel very tight at first. Yet, it progressed to my right calf. I was experiencing very severe pain in my right calf. I thought the pain will eventually go away yet it still continued. About three weeks after my second dose, May 24th, I drove myself to a local clinic, and they directed me to the emergency room to get a X-Ray of my right calf. They found a blood clot. The doctors bandaged my calf and prescribed me Xarelto to treat the pain. In addition to the prescription, they directed me to a Vascular doctor to documented the recovery. As of now it is unclear if the blood clot is completely gone, however, my calf is still swollen. In addition to that, my little toe and the heel of my right foot is numb to any sensations.

Patient presented to the ED for closed fraction dislocation of left ankle on 5/30/2021. Patient was hospitalized on 6/8/2021 for hospice/palliative care. Patient hospitalized on 6/9/2021 for open reduction internal fixation left trimalleolar ankle fracture, medial and lateral malleoli with fixation of the syndesmosis. He died on 6/24/2021. These visits are within 6 weeks of receiving COVID vaccination.

blood clotted; had persistent synovitis in all knuckles; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ew0186 and Expiration date: unknown), via an unspecified route of administration, in arm left on 26May2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amitriptyline hydrochloride (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 10 mg and frequency for unknown indication; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took flu shot on an unspecified date in 2017 and experienced synovitis. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 28May2021, since his first Pfizer shot have had persistent synovitis in all knuckles. On an unspecified date in Jun2021, 12 days after first Pfizer shot donated blood and blood clotted in tubes before completion. He had donated about 40 times and that was the first time his blood has clotted. The case was assessed as non-serious. No treatment was received for events. The clinical outcome of had persistent synovitis in all knuckles, blood clotted were not recovered.

About 4 days after second shot, I noticed I had bumps on by back side. They did not itch. I though they were from bike riding - chafing. But they moved around. 10 days after, my lip started to swell pretty badly while I was in a meeting. Got online with doctor was told to go to hospital. Anaphylaxis was the diagnosis. They gave standard care - steroids, antihistamine, pepcid, etc. Issue went away including the bumps on behind. Was told to go my doctor. Went to my doctor. Said dont worry, likely will not come back again. Just a reaction of some type. Next night lip swelled up - other side of mouth. Online doctor said to go emergency room. Back to emergency same treatment - more steroids, pecid, antihistamine. Back to my doctor and he sends me to alergist. I have never had an allergic reaction to anything in my life. Allergist said the reaction is due to the covid shot and making my immune system go crazy. He put me on regimen of pepcid and antihistamine. Seems to work for about a week - but then the hives came back. More swelling of the face (lips, eyes) but none bad enough to go to hospital. Taking meds 3 to 4 times a day (pepcid and antihistamine). Had swelling in the ankle which the doctor said basically hives gone crazy. Then the hives got worse - and itching. Covered most of my body. The hives on the bottom of the feet felt like walking on air pillow packaging material. Dr puts me back on steroids. Go through this process twice with steroids. Dr said we would have to go the route of Xolair. Received first injection three weeks ago. But after shot had bad hives again with itching this time - more steroids. Then things sort of leveled out - still had hives but not a large - and no itching _ thank goodness. But then on 7-2-21 I woke up with severe swelling of the face - and into the throat. Had difficulty swallowing. Back to emergency room again - more shots and Epinephrine. They prescribe more steroids and epi pen just in case because the reaction was so severe. Second shot of Xolair is in one more week - hopefully gets things under control.

Stroke - CVA (cerebral vascular accident) (HCC) on 05/21/2021; 6:00am 10 day Hospital stay, ongoing Rehabilitation / Physical and Occupational Therapy

Confirmed DVT in right calf behind the knee that started on 7/9/21, 2 days after the 2nd vaccine injection.

UNKNOWN COVID-19 vaccine was administered within the community on the same day patient expired. Family might have this information. Was not shared with us.

Intermittently productive cough, dyspnea, body aches, HA, neck pain 3 days after dose. CXR in ED found LLL pneumonia and enlarged heart; given ABX and isolation.

Anaphylaxis tongue swelling and throat soreness Narrative: developed throat pains and tongue swelling 1/6/21 whereas mRNA vaccine Covid 19 Pfizer was given at Hospital. Advised not to taken 2nd dose until etiology of tongue swelling and throat pains identified. His 1/6/2021 covid 19 test (biofire- which include Covid 19 infection and all possible viral etiology was negative.

He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. 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.

Developed upper extremity Deep Vein Thrombosis (DVT) with complete occlusion of the Axillary and SubClavian veins of the right arm. Swelling, redness of the right arm and hand. Pain in the right axilla. Visibly distended veins near the right clavicle, upper arm, forearm and hand. This occurred 2 weeks following 2nd dose of COVID vaccine. Patient has no risk factors or other known causes of DVT.

Immediate local reaction at the injection site. Bleeding of less than 1 cc and raised 2x2 cm bump. Benadryl and symptoms resolved.

Patient received dose 1 and dose 2 of the COVID 19 vaccine, 2/2/21 (Lot EL9265, Pfizer) and 2/24/21 (Lot EN6202, Pfizer), on 2/28/21 patient presented to the Emergency Department at our facility. CBC lab test was abnormal, possible Leukemia, patient transferred to Medical Center for further evaluation and treatment. Patient expired on March 2, 2021.

Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse over the next few minutes making it difficult to swallow. At the same time I felt very fuzzy and numb all over my face and body and very light headed. My arms and legs felt very heavy. The EMT took my blood pressure and told me it was 174/125. My normal BP is 110/60. I have had my BP taken once a month over last 20 years at my monthly pain center appointments. They hooked me up to a 4 lead cardiac monitor and said I had A -Fib. They then hooked me up to a 12 lead ekg monitor and said I didn?t have A-Fib. I have had 3 EKG?s in last year because I was scheduled to have total knee replacement surgery which was rescheduled 2 times and all 3 EKG?s were completely normal. After about 1 hour my symptoms improved to the point where I could go home. I Have had between 20-30 knee procedures over the last 40 years and my reaction to the vaccine felt exactly like I was being put to sleep by sodium pentothal or a very high dose of Versed.

went into AFIB 3/6/21 ....ER and inpatient from 3/6 to 3/9 No previous heart events whatsoever Hospital cardiac nurse said she had recently been made aware of several cases of Pfizer shot leading to AFIB....said she was on a committee

Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and was transported by EMS to ER and admitted. He was tested 3 times for COVID 19 and found to be negative. CT scan was concerning for viral pneumonia and suspected COVID. He was treated and released to home on 3/4/21. Followed by pulmonologist. Received second Pfizer COVID19 vaccine on 3/21/21. On 3/23/21 developed fatigue, weakness, shakiness, nausea and vomiting. had significant decline over the week. Has acute event on 3/27/21 and was pronounced dead at home.

My husband died on Feb 5. 2021. I do not know if the vaccination had any effect but he died of heart attack from Coronary Artery Disease which was unknown.

DVT Lower Right Leg; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 16:15 (lot number: EN6199) as a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with covid prior vaccination. On 13Mar2021, the patient had DVT lower right leg which resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event which included Warfarin/Enoxaparin. The patient has not been covid tested post vaccination. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.

Cardiopulmonary arrest; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscular on 14Mar2021 (12:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hepatitis B. The patient's concomitant medications were not reported. The patient previously took tenofovir. On 14Mar2021 (21:00), the patient had cardiopulmonary arrest. The reported event had resulted into emergency room/department or urgent care visit. The patient was hospitalized from Mar2021 to an unspecified date due to the reported event, and was reported to be life-threatening. The patient was intubated in response to the event. The patient had a negative SARS CoV-2 test both on 14Mar2021 and 15Mar2021. The outcome of the event, cardiopulmonary arrest, was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information provided and a temporal association, a causal relationship between the event cardiopulmonary arrest and BNT162B2 cannot be completely 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.

Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 21Feb2021 14:00 (at the age of 58-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since the vaccination. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications received within 2 weeks of vaccination. On 10Mar2021 at 11:30 AM, the patient experienced massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung). The patient was hospitalized for the events for 4 days. The events were also considered as life-threatening. Therapeutic measures were taken as a result of massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung) which included intravenous anticoagulants and injected anticoagulant. The patient was recovering from the events. Information about the lot/batch number has been requested.

I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointment for the first available time (Friday April 2). On Thursday morning I was having vision problems, high blood pressure, weakness on left side. I was rushed to the hospital administered tPA and was diagnosed with a stroke.

COUMADIN LEVEL 8.0 PLUS. STOPPED TAKING COUMADIN FOR THREE DAYS. TOOK 1 VITAMIN K TAB 400MCG ON 4/9 AND 4/11. ATE LEAFY GREENS FOR 3 DAYS. INR VALUE 4/12 2.4. RED MARKS AND BRUISING AT INJECTION SITE AND ON BOTH FORE-ARMS. NICKED MYSELF SHAVING, TOOK 48 HOURS FOR BLEEDING TO STOP. NO BLOOD IN URINE OR STOOL. JOINTS ACHE REALLY BAD, TAKING 1000MG TYLENOL EVERY 8 HRS, MUSCLES ACHE REALLY BAD, BESIDES TYLENOL, MASSAGING AFFECTED MUSCLES. LOTS AND LOTS OF PAIN

58 year old white male with history of blood clots developed symptoms of leg pain during 4/11 early am . pt received COVID vaccine on 4/8 developed leg pain on 4/11 early am and went to er and was advised he was clotting in leg at point of previous procedure. he was given eliquis and was told to follow up with specialist

Acute DVT of right lower extremity, diagnosed via venous duplex of lower extremity. Presented to Emergency Room on 4/5/21 with right leg swelling.

Pfizer-BioNTech COVID-19 Vaccine EUA Intense pain behind left eye then left side of head while running/exercising. Went to emergency room within an hour had CT scan verifying acute subatachnoid hemorrhage. MRI, Angiogram and Ultrasounds of the head and neck were also performed.

Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing at +20 mins x- voice changed noticably at +30 mins, subsequently lost x- Some heart palpitations and chest tension at +45 mins x- Angiodema of right eye +90 mins

DVT behind the right knee that developed 3-4 days after the vaccination. I then developed a pulmonary embolism on 01/01/2021.

confusion reported by family since the covid vaccine was administered - came to hospital ED 7 days later and multiple acute ischemic strokes were identified. also noted to be hypertensive and diabetic, previously undiagnosed.

The patient had previously been diagnosed with COVID-19 in November 2020, but did no require hospitalization and had recovered. He received his first dose of the Pfizer COVID vaccine on 2/25/2021, and on 3/15/2021, collapsed suddenly at home and was unable to be resuscitated. An autopsy was performed at the request of the family, and a massive pulmonary embolus was found in the main pulmonary artery and extending far into the segmental pulmonary arteries of both lungs.

Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingling. The patient went to bed at 0700 after working third shift with no symptoms and awoke at 1400 with these complaints. Patient was hypertensive at ED presentation. Patient was diagnosed with stroke and admitted to the hospital. Patient received clopidogrel (loaded with aspirin per self at home PTA).

This 58 year old white male hospice patient received the Covid shot on 3/22/21 and died on 4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Patient presented with pleuritic chest pain on 4/12/21 and was diagnosed with multiple pulmonary embolisms. He was treated with heparin drip and discharged on Eliquis.

On or about April 14, 2021 patient yelled out to a friend to come help him. Patient stated that he "could not see or move". The friend called the ambulance and patient was taken to hospital. One of the doctors tending to patient told me patient had several strokes (over 5). These strokes have left him blind and incapacitated. He is still currently at hospital.

DVT in right leg; Swelling in right leg; Discomfort in right leg while walking; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 10Mar2021 at 16:30 (batch/lot number: EN6208) as a single dose for COVID-19 immunisation (wanted the protection). Medical history included deep vein thrombosis (DVT) from Jul2018 and ongoing. No family medical history relevant to the adverse events. Concomitant medication included warfarin taken for maintenance level for history of DVT from Aug2020 and ongoing. The patient experienced DVT in right leg on 02Apr2021, swelling in right leg on 15Mar2021 and discomfort in right leg while walking on 15Mar2021. The patient reported that he had a reaction to the COVID-19 vaccine and he believes that it was directly related to the COVID-19 vaccine. He reported that he has a history of blood clots in his right leg going back to 2018. He reported that his most recent DVT was in Aug2020 and he was cleared in Nov2020. He reported that he received the COVID-19 vaccine on 10Mar2021. He reported that on 15Mar2021, he started to notice his right leg swelling. He reported that he called his physician on 29Mar2021 and that his physician ordered an ultrasound. He reported that he had the ultrasound on 02Apr2021 and a deep vein thrombosis was found again. Swelling in right leg: he reported that the swelling has gone down. He reported that the reason that he mentioned that he has a history of blood clots was because of his warfarin dosage. He reported that he was first diagnosed with a deep vein thrombosis in Jul2018. He reported that he went through that cycle and that his maintenance level of warfarin was maybe 10 or 12 mg of warfarin per day. He reported that he had another deep vein thrombosis in Aug2020, and since Aug2020 he has been on 17 mg of warfarin daily. He reported that the blood level on warfarin maintenance was supposed to be between 2 and 2.5. He reported that now because of the deep vein thrombosis he experienced in Aug2020, his doctor wanted his level to be at 2.5 to 3.5. He stated that he doesn't think that at that blood level for his warfarin that he should have gotten a blood clot. He reported that something compromised or interfered with the warfarin, resulting in a deep vein thrombosis. Discomfort when walking: he reported that it feels like his leg was compressing. He reported that the discomfort seems to have gotten better. He was queried for details of warfarin prescription. He reported that the 10 or 12 mg warfarin tablets that he had been taking when the blood clot was diagnosed in Aug2020 have been consumed and he no longer has the bottle. He reported that he did not have the bottle with him for his current warfarin prescription. He reported that the warfarin was not auto-refilled by the pharmacy. He reported that the warfarin was only prescribed a week or two at a time. Investigations: he reported that since Aug2020 when the deep vein thrombosis returned, he started doing self INR tests at home. He reported that he constantly self-monitors his INR at home and his levels were consistently at 3.0 to 3.1. He reported that he monitors his INR at least once a week, sometimes twice a week depending on how he feels. He reported that sometimes his INR goes over 4 and he can feel it. He reported that his system was a little off when it feels too high so he knows how to adjust. He reported that he last checked his INR today, 15Apr2021, and that it was 4.0. He reported that he typically checks his INR on Wednesday. He reported that he keeps a log of his INR levels. He reported that he did not see his physician on 29Mar2021, but that he called his physician and his physician wrote a prescription for the caller to get an ultrasound. Vaccination facility type was pharmacy. Vaccine was not administered at military facility. The adverse events did not require a visit to the emergency room and physician office. No prior vaccinations (within 4 weeks). He reported that he doesn't usually get vaccines. BNT162B2 second dose (lot number: ER5729) was administered on an unspecified date; anatomical location: left arm. The outcome of the events was recovering.

Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a numbness in right hand, arm, drooping right side of face; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose in right arm on 05Mar2021 14:30 (Lot: EN6199) and second dose in left arm on 26Mar2021 14:30 (Lot: ER8732); both via an unspecified route of administration (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included allergy induced asthma and seasonal allergies. The patient's concomitant medications were not reported. The patient experienced a numbness in right hand, arm, drooping right side of face and slurred speech, it lasted for 1-2 minutes. The patient went to the ER. Suspected TIA. These events started on 11Apr2021 at 10:00. The events resulted in emergency room/department or urgent care. The patient received unspecified treatment for the events. On 10Apr2021, nasal swab was negative. On 11Apr2021, Covid test type post vaccination with unknown results, rapid and nasal swab was negative. It was reported that the patient had MRI, CT, EKG with unknown results on unspecified dates. The outcome of the events was recovering.

Anaphylactic shock; Swelling of throat; hives all over back and arms; swelling of wrists; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 27Mar2021 10:15 (Batch/Lot Number: GR8732) as SINGLE DOSE for COVID-19 immunization at the workplace clinic. Medical history included asthma allergies. Concomitant medications were not reported. On 27Mar2021 13:00, the patient experienced anaphylactic shock with swelling of throat, hives all over back and arms and swelling of wrists. The patient had no COVID-19 prior to vaccination and not tested post vaccination. The patient was treated with antihistamines/steroids and recovered in 2021.

Blood Clot discovered in my leg my Wednesday April 27. Incredible amounts of pain. By May 5 pain caused by unknown bruise on foot on same leg.

I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered. Information on the lot/batch number has been requested.

This 58 year old male received the Covid shot on 3/27/21 and went to the ED on 4/3 /21 with the following diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019

Left upper extremity deep vein thrombosis. Left arm swelling started 5/3/21. Swelling and pain worsened. LUEDVT of the axillary vein confirmed by ultrasound at ER on 5/8/21. Xarelto 15 mg PO BID initiated.

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

There is nonocclusive thrombus in the proximal left femoral vein. There is occlusive thrombus from the mid femur vein to the popliteal and calf veins; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 PM (at age of 58 years old, Lot Number: ER8733) as a single dose for covid-19 immunization. Medical history included hypertension from an unknown date. Concomitant medications included amlodipine, zolpidem, lisinopril. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:00 PM (at age of 58 years old, Lot Number: EN6206) as a single dose for covid-19 immunization. It was reported the patient the left common femoral and great saphenous veins are patent. There was nonocclusive thrombus in the proximal left femoral vein. There was occlusive thrombus from the mid femur vein to the popliteal and calf veins on 22Apr2021 12:00. The patient was hospitalized for 3 days, it was life threatening illness. Treatment received IV heparin. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 29Apr2021. The outcome of event was not recovered.

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

large pericardial effusion with early signs of tamponade physiology; large pericardial effusion with early signs of tamponade physiology; dose 1, 04Mar2021/dose 2, 04Mar2021; dose 1, 04Mar2021/dose 2, 04Mar2021; This is a spontaneous report from a contactable other health care professional. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 04Mar2021 (Lot Number: EN6203) as 1ST DOSE, SINGLE, dose 2, administered in Arm Left on 04Mar2021 (Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included Stage IV colorectal adenocarcinoma, Shellfish (rash), Peanuts (rash) and rash. 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. Concomitant medication(s) included cetuximab; acetylsalicylic acid (ASPIRIN); atorvastatin; cholecalciferol; levothyroxine. The patient experienced large pericardial effusion with early signs of tamponade physiology on 01Apr2021. Malignancy and infection were ruled out by cytology which showed only mesothelial cells; cultures were negative. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Pericardiocentesis treatment received. The patient hospitalized for 6 days. The patient underwent nasal swab COVID test negative on 08May2021. The outcome was recovered.; Sender's Comments: Reported 'large pericardial effusion with early signs of tamponade physiology', occurred 28 days after bnt162b2 vaccination, is considered unrelated to bnt162b2 but more likely an intercurrent medical condition. Patient's underlying malignancy, concurrent medical condition for which levothyroxine was administered, concomitant medication cetuximab may have contributed to reported event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 58-years-old-male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 27Mar2021 10:00 for Covid-19 immunization. Medical history included hypertension, hairy cell leukemia, and high cholesterol. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included simvastatin, lisinopril, doxazosin, and acetylsalicylic acid (ASPIRIN 81mg). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced atrial fibrillation on 14Apr2021 23:45 requiring cardioversion. The event was assessed as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was unknown.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/4/21). Patient was admitted to the hospital on 4/9/21 for acute hypoxic respiratory failure and was ultimately diagnosed with PJP and HIV/AIDS. On 5/20 patient had tested positive for SARS-CoV-2 and received treatment with monoclonal antibody.

Deep vein thrombosis from groin to knee; This is a spontaneous report from a contactable consumer (patient). This 58-years-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 04May2021 at 14:00 (lot EW0171), at the age of 58 years, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on 09Apr2021 at 15:00 (at 58 years of age), lot: EP7533, in left arm. Medical history included COVID-19. Past drug history included allergy to lamotrigine (LAMITRIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 21May2021 the patient deep vein thrombosis from groin to knee. The event required ER visit, Doctor or other healthcare professional office/clinic visit, hospitalization for 6 days and was reported as serious also as life-threatening condition. Treatment received included removed blood clot and blood thinners administration. The event was resolving at the time of report. Since the vaccination, the patient had not been tested for COVID-19.

J18.9 - Left upper lobe pneumonia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia

4/27/2021 nausea, on 4/28/2021 nausea, vomiting, diarrhea, 4/30/2021 chest pain, 5/1/2021 cardiac arrest

Within 90 days of receiving vaccine, (April 02,2021) I experienced Atrial Fibrillation. Heart rate approached 160bpm, and was admitted to the ER. I did get lucky and cardioverted on my own, but now I'm on new heart medications (metoprolol) and have had to adjust my lifestyle.

On April 30, 2021, I received the 2nd dose of the COVID-19 (Pfizer-BioNTech) vaccine which was 3 weeks after receiving the 1st dose. Then on May 3rd, I experienced pronounced shortness-of-breath while at work lifting objects up to 20 lbs and walking short distances of 20 to 40 m on flat ground. Then on May 4th, 2021, I went into a nearby Urgent Care Clinic (UCC) with shortness-of-breath and exertional dyspnea as the main symptoms. At the UCC blood tests were done along with EKG and chest x-ray. Blood tests revealed several results that were not within standard ranges: troponin (1.25 ng/mL), BNP (5130 pg/mL), D-dimer (1320 ng/mL FEU), and C-reactive protein (75.5 mg/L). I was told that I had congestive heart failure and NSTEMI. UCC then directed me to go to the Emergency Department (ED) at a nearby hospital. In the ED, more tests were done: EKG, CT scan chest (no blood clots were found in the lungs), and cardiac ultrasound (estimated ejection fraction 40-45%). That evening I was transferred to the main hospital for further observation and tests. Not much happened on May 5th and I was not seen by a doctor until 5pm. Then early in the morning of May 6th, I experienced chest pain which lasted between 5 and 10 minutes. I was given oral nitroglycerine. My primary care physician (PCP) and a cardiologist elected to move forward with an angiogram. On May 6th, I underwent cardiac catheterization (CC). The CC report states: (a) 2nd Diag lesion is 50% stenosed (b) Mid RCA to Dist RCA lesion is 80% stenosed,(c) RV branch lesion is 80% stenosed, (d) RPDA lesion is 80% stenosed. Likely spontaneous coronary artery dissection of the mid to distal RCA and postal to mid PDA status post PCI with 2 Xience drug-eluting stents. Post-angiogram+angioplasty tests were done, including carotid artery ultrasound (results within normal limits. No hemodynamically significant stenoses) and MRI brain (punctate foci of restricted diffusion in both cerebral hemispheres. Multiple vascular distributions w/o larger territorial infarct suggest emboli). Other blood test results were: antinuclear antibody (ANA) IFA screen (positive), BNP (8631 pg/mL). I was released from the hospital on May 8, 2021. Follow-up care included cardiac rehab therapy and consultations with the cardiologist, PCP, a neurologist and rheumatologist. Incidentally, 12 days after the angiogram and angioplasty, I experienced temporary numbness and loss of movement in my right arm which lasted no more than a minute, indicative of a transient ischemic attack (TIA). Root cause investigations focusing on SCAD and TIA are on-going.

Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold. Tested ecg with Watch and it indicated Atrial Fibrillation. I didn?t believe it and retried several times over the next hours and finally went to ER.

I had major chest pain, and was gasping for air to; I had major chest pain, and was gasping for air to; was in Afib; i struggle getting out of bed to feed myself; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0612), via an unspecified route of administration, administered in arm right on 17Apr2021 (at the age of 58-year-old) at dose number unknown as a single dose for COVID-19 immunisation. Medical history included high blood pressure (other medications the patient received within 2 weeks of vaccination: High blood pressure medication). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 17Apr2021 the patient experienced major chest pain, and was gasping for air to, was in afib, the patient struggled to get out of bed to feed himself. Re-ported Event: patient received the vaccine early morning of 17Apr, and carried on his day, that night is when the symptoms came. The 2 symptoms that later sent patient to the hospital a few days later as patient explained. Patient had major chest pain and was gasping for air to breath. It was getting worse then out of nowhere, it stopped. And about 10 minutes later it hit patient again. This was a never-ending cycle all night long back and forth symptoms of intense chest pain and gasping for any air at all. By morning the symptoms had faded away. Carried on patient day when night came, they symptoms where back, not near intense as the night before, but still severe. This happened for a few more days and then patient went to his Dr, because the breathing was a major problem. Patient went to the Dr and she sent patient to the ER instantly. They ER said patient was in Afib and never had this or any history in the family. This has changed patient life, patient carrier. To this day patient struggle getting out of bed to feed himself. Adverse event result 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 hospitalised for one day. The clinical outcome of the events was not resolved. Follow up attempts are possible. Further information is expected.

Pt. states received Phizer vaccine 06/02/2021 experiencing fatigue, nauseous. 06/10/2021 adverse event of vomiting, aspiration, heart attack, cardiac arrest, coma 4 days, ICU reporting slight brain damage. Discharged 06/18/2021 to Rehabilitation Facility discharged 07/07/2021.

death J18.9 - Pneumonia, unspecified organism K92.2 - Gastrointestinal hemorrhage, unspecified N17.9 - Acute kidney failure, unspecified

Patient presented to the ED and was subsequently hospitalized for Severe sepsis with acute organ dysfunction within 6 weeks of receiving COVID vaccination.

On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down st. On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down stairs as part of my daily activities. The symptoms of shortness of breath only seemed to appear when I was on any form of extended walking activity or physical movements or exercise this would of have been starting around the 17th of January. The right leg pain was masked by the heating rub while the shortness of breath continued for the next few days. On the 19th of January, I went to an Urgent Care Facility at 0800 am to see a Medical professional to discuss my symptoms I was previously experiencing and to figure out why I was having a shortness of breath and the pain in my right leg. The on staff Physician's Assistant had a Nurse conduct a Covid 19 Rapids test (negative) and a second swab was administered and sent to the Lab. Which produced a (negative for Covid 19) on the 20th of January. An Xray was not taken to determine my shortness of breath. The Dr listened to my lungs and heart, though I did let the PA know I had received both Pfizer shots and when they were administered. I was carrying My Shot record for the vaccine with the dates and lot number. He didnt appear to be interested in further diagnosis and made sure I had the paperwork to track the results of my Covid swab sent to the lab. The visit was completed and I was released to go back to work/home. I carried on the symptoms of the shortness of breath from the 19th of January to the 22nd of January monitoring my O2 (oxygen levels) with a pulse oximeter. They ranged from 90-93. On the evening of the 22nd of January I was becoming very uncomfortable with my breathing climbing the stairs in my home and monitored my O2 readings with the oximeter on my finger when walking upstairs and they dropped down to 60-65. My wife drove me to the emergency room at Hospital. I walked into the ER and checked myself in for shortness of breath and leg pain in my right leg. I was admitted into the emergency room and put on 15 litres of oxygen. The emergency room Dr ordered a chest Xray, Cat Scan of my chest and heart and a sonogram of my right leg. The testing results came back with a noted large pulmonary emboli on my lungs/heart area and blood clots throughout my right leg (right lower extremity DVT). Surgery was performed to remove the pulmonary emboli and I was put on a Heprin Drip to thin out my blood for the remaining clots in my chest and my right leg. The attending physician ordered a T.E.E. (transesophageal Echocardiogram) to observe my heart functions. I was told the TEE did not demonstrate any further recommend surgeries. I was administered a test for my cardio and heart functions prior to my discharge on 27 January 2021. I was prescribed Eloquis for maintenance medication to be monitored by followup visits to my cardiologist and Hemotologist within the next few weeks. I have not family or personal history of Blood Clots. I do perform administrative duties as part of my job, which requires sitting and working on a computer. Note however I move around very often during a work day and operate a farm tractor and have an active life style. I have not recently had any extended trips more than 2 hours nor have I flown within the past year or so.

Superficial and deep vein thrombosis was diagnosed on 27th of January. Symptoms had been going on for around 2 weeks.

On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on right side (RUE, RLE) slurred speech, difficulty with finding words. Transported by POV to ED for evaluation of stroke - same sx with onset of parasthesia in right upper arm. Stroke protocol done - received tPA with resolution of symptoms during infusion. Stayed in hospital until protocol completed. Symptoms resolved over the course of the hopsitalization.

Per the patient's spouse and Hospital: The patient received a rapid COVID test at clinic prior to vaccination, which read negative. The patient received vaccination on 2/23/21 and the following day (2/24/21) began to experience breathing difficulties. The patient was admitted to the emergency room at Hospital on 2/26/21 and diagnosed with hypoxic respiratory failure d/t COVID-19 (oxygen saturation < 50%). Patient was intubated on 3/2/21. Per Hospital pharmacist, patient expired on 3/12/21 at 6:40pm.

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately three weeks after this injection, I began to feel a pain in my left leg. I assumed it was a cramp. I then received a second dose (Lot # EN6206) on 3/13/21. Over that weekend the pain in my leg grew worse and the leg began to swell. on 3/15, I went to my primary care physician who said it looked like a blood clot. He sent me to a radiologist for an ultrasound (?) of the leg. After confirming the clot, I went to a local ER. They started me on Eliquis to treat the clot

passed out; i may have had a TIA; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 11:15 (at the age of 59-year-old) at single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies. Concomitant medication included losartan. No other vaccine in four weeks. No COVID prior vaccination. On 19Mar2021 11:15 AM, the patient immediately passed out and was taken by ambulance to hospital. They said that he may have had a TIA (even though the CT scan and MRI were clean). The patient will not get the 2nd vaccine because of his reaction. The adverse events resulted in Emergency room/department or urgent care, Hospitalization. He was hospitalized on 19Mar2021. The patient had nasal swab test on 19Mar2021 with negative result. The patient received treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Reported cause(s) of patient death: Heart failure; chills; fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 59-years-old, via an unspecified route of administration in left arm on 17Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included congestive heart failure, diabetes, and high blood pressure. He has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included olmesartan medoxomil, furosemide, repaglinide, metformin, amlodipine, atorvastatin, carvedilol, hydrochlorothiazide, and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced chills, fever, and heart failure on 18Mar2021. The events resulted in emergency room/department or urgent care, doctor or other healthcare professional office/clinic visit, and hospitalization for 8 days from Mar2021 to Mar2021. He eventually passed away on 31Mar2021. Treatment received for the events was reported as unknown. The patient underwent lab test and procedure which included nasal swab for COVID which was negative on 20Mar2021. The outcome of the events chills and fever were unknown. The patient died on 31Mar2021. The cause of death was heart failure. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart failure

Developed Left lower extremity DVT 24 hours after vaccine; This is a spontaneous report from a non-contactable Physician. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 24Mar2021 (at the age of 59-year-old) at a single dose for COVID-19 immunisation. Relevant medical history included hypertension (HTN), diabetes mellitus (DM) and hyperlipidemia (HLD). The patient did not have history of deep vein thrombosis (DVT) and no other risk factors. The patient was not diagnosed with COVID-19 before vaccination. No relevant concomitant medications were provided. She developed left lower extremity DVT 24 hours after vaccine, on 25Mar2021. The event required emergency room visit. The patient was treated with an anticoagulation therapy. Post vaccination COVID-19 test was not done. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis was most likely due to the patient's underlying hypertension, diabetes mellitus and hyperlipidemia. However a possible contributory role of vaccine BNT162B2 to the event can not be totally excluded. 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.

Aortic valve endocarditis with MSSA, NSTEMI, Atrial fibrillation. Patient will likely require valve replacement

pt had right leg swelling and pain starting on 03-22-21 and presented for medical care on 03-29-21 was found to have elevated d-Dimers and Doppler RLE showed occlusive clot in right peroneal vein and non-occlusive clot in right popliteal vein

On 7 April, approx 9AM, pt. experienced a TIA (Transient Ischemic Attack or Mini-stroke). Siblings became aware by 10:30, and by 11:45 he was at the ER. His speech was extremely restricted and he was barely able to speak a few words. Face was partially asymmetric, but gross and fine motor skills basically unaffected. He could walk and write his name, follow commands to move arm and legs. Underwent multiple tests including CAT scan, when no sign of bleed stroke confirmed. At admittance, Stroke Scale score = 4. By 3PM, speech started to return, and continued to return. Continued tests with EEG, EKG, and TTE, but no source for TIA could be pinpointed. Unable to perform MRI due to embedded medical device. By next morning speech had almost returned to normal. No physical restrictions noted on following day. Discharged 6PM on 8 April. Doctors unable to explain cause and could not comment on whether related to receiving vaccine a week prior. Recovery seems to be complete with no negative lasting effects as of 22 April, 2021.

Caller also had double pneumonia.; both contracted covid, caller tested positive; This is a spontaneous report received from a contactable consumer. A 59-year-old male patient received, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown and expiry date was not provided), via an unspecified route of administration on 18Mar2021, as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not provided. The patient reported that he contracted with covid on 25Mar2021 and had double pneumonia. On 25Mar2021, the patient underwent lab test and found positive with Covid-19. The patient wanted to know if he can take the second dose. Information on the lot/batch number has been requested.

SOB; Sepsis; aspiration pneumonia; This is a spontaneous report based on the information received by Pfizer. A contactable Other HCP reported that a 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration at the age of 59-year-old on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic UTI, and splenectomy for unknown reason, RMS (Rhabdomyosarcoma). Concomitant medication included ocrelizumab (OCREVUS). On 02Apr2021, it was reported that patient experienced: Went into hospital due to SOB (Shortness of breath) on 02Apr2021, died on 07Apr2021 related to aspiration pneumonia on an unspecified date. Patient developed Sepsis as well on an unspecified date. Patient became a DNR on 06Apr2021 then passed on 07Apr2021. The patient was hospitalized for SOB from 02Apr2021 to an unknown date. The patient died on 07Apr2021. It was not reported if an autopsy was performed. The outcome of event aspiration pneumonia was fatal. The outcome of events SOB and Sepsis was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and known drug safety profile, the reported events more likely represented intercurrent illnesses, but not related 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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: aspiration pneumonia

3 days after the first dose I developed a blood clot in my right calf, never had one before, no trauma, i am very active; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first received first dose of bnt162b2 (Pfizer, Formulation: Solution for injection, Lot Number: EP 7534b) via an unspecified route of administration, administered in left arm on 13Mar2021 11:00 at a single dose for covid-19 immunization. Medical history and known allergies were none. Concomitant medication included rivaroxaban (XARELTO). The patient developed a blood clot in his right calf 3 days after the first dose, never had one before, no trauma, he was very active on 16Mar2021 07:00. No covid vaccination was taken prior. No covid tested post vaccination. Blood thinner for the clot was given as the treatment. The outcome of the event was not recovered.

I was notified that patient passed away at Hospital 10:37 am today. Per message to medical office from Coroner, it was reported that patient collapsed this morning while walking his dog. Patient was brought in by ALS complaint of FULL ARREST to Hospital 10:10 am and pronounced at 10:37 am 4/24/2021 by Dr. at Hospital.

This is a spontaneous report from two contactable consumers (one of them is the patient) from a Pfizer sponsored program. A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP534) via an unspecified route of administration, administered in Arm Left, at the age of 59-year-old, on 22Mar2021 08:30, as SINGLE DOSE for covid-19 immunization. Medical history included three strokes, hypertension, diabetes mellitus. The patient had no additional Vaccines Administered on Same Date of the Pfizer Suspect and had no prior vaccinations within the last 4 weeks. Concomitant medications included metformin taken for diabetes mellitus (has been taking for many years) and losartan taken for hypertension since 2018 (has been taking for about 3 years). On 09Apr2021, the patient was feeling bad and went to the hospital. There he was told that he has had three strokes in the past. The patient was told that one of the strokes was about a month ago (Mar2021). He went to the hospital three days ago. He was not admitted and was sent home. He went back again and was sent home. He was started on Plavix two days ago for stroke. The events required emergency room visit. The patient right now is working and travelling and he supposed to have the 2nd dose of the vaccine on 12Apr2021. He wants to know if he can take it late or what possible that he can do. Outcome of was feeling bad was unknown while the event stroke recovered in 2021 with sequelae.

Because patient had a severe adverse reaction to the first injection, he stated to me that he would not be getting the second injection. Two workers (from the mental health day program, he went to before the covid lockdown) both advised him to get the second injection, however, and he complied. After injection he had episodes of difficulty breathing and vomiting for several nights. Soon after that, he started having to go to the emergency room for blood sugars over 500 (prior to injection his diabetes had been controllable at care home). When he went to ER (for high blood sugar) March 18th, his heart stopped and could not be re-started. He died.

Pt had progressive shortness of breath 4-5 days prior to vaccine administration that resulted in hospital admission and ICU transfer for hypoxic respiratory failure (possible secondary to pneumonia, acute HF exacerbation with fluid overload, etc.). Unclear if related to vaccine given patient's underlying comorbidities and progressive nature of the respiratory failure starting even prior to vaccine administration.

E87.6 - Hypokalemia I24.9 - ACS (acute coronary syndrome) (CMS/HCC) I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)

This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732) at the age of 59-years-old, via an unspecified route of administration in left arm on 22Mar2021 at 15:00 at single dose for COVID-19 immunisation. The patient's medical history was reported as none. He has no known allergies and has COVID prior to vaccination. Concomitant medications included metoprolol, rosuvastatin, oxybutynin, and tamsulosin. There were no other vaccines in four weeks and no additional vaccines administered on the same date of the COVID-19 vaccine. The patient reported that he was having some wild effects from the vaccine and did not know what to do. On 26Mar2021 at 15:00, he was having neuropathy like effects. His hands, arms, legs, and feet were experiencing pain and burning sensations, they were burning like nerve damage; he also has a little burning sensation in his nose and cheeks. He has never had this before. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He was also having some weird sensations in his calf muscles, these sensations started within the past week and a half (Apr2021) which prompted physician office visit. The physician placed him on gabapentin 100 mg to start from 12Apr2021, but it was not enough, it was titrated up to 300 mg, three times a day and he is scheduled to see specialist soon. The patient mentioned that this vaccine has ruined his health. He also went to an urgent care center because his leg was bothering him, it was swelling on an unspecified date in 2021; he thought he had a blood clot; they did some kind of test where they looked at the leg and did not find anything. He didn't have a particular question. He would just like to talk to someone to see if this was going on with anyone else, if it will go away, or if this was permanent problem he will have. The patient was not tested for COVID post vaccination. He received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration in left arm on 13Apr2021 at 15:00 at single dose for COVID-19 immunisation. The outcome of the events was not recovered.

4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confirm blot clot in calf; ER gave Norco 5-325 mg for pain; fever of 101; 4/30/2021-still can't put weight on leg and fever of 101.8; 5/1/2021-woke up with no pain; clot still there; 5/3/2021-saw primary doctor for ER follow-up on clot; primary doctor confirmed there is a small clot in deep vein and could take up to 6 months for it to dissolve on its own.

stroke on 5/2 8:45 am hospitalized 5 days no physiologiical explanation. 3/4 of right cerebellum is dead. at onset nausea vomiting vision loss, loss of balance and coordination BP bottomed out low heartrate while sleepiing

Received first vaccine 4/21/21. Within two days started having tightness in chest, but no other adverse reactions, happened a couple times a day. 5/13/21 received second vaccine....had tightness two more times, then 5/14:22 evening had a heart attack....ambulance to Hospital. 99% blockage in LAD. Hospital inserted stent. Spoke with all of the Cardiologists about my concerns as Heart problems ?Do not? run in my family. I have always had excellent blood pressure and low cholesterol....my father is 86 and was a smoker, and never been on blood pressure medication, same with my late Grandfather. I?ve ?never? had any type of chest pains in my life. Also, I am retired military and have had numerous vaccines, with no issues. The hospital cardiologists said that I could report this, but they believe the Heart attack is due to the fact that I smoke....I just don?t believe that....the Heart Attack occurred 36 hours after my second vaccine!!!

pulmonary embolism; Blood Clot; This is a spontaneous report from a contactable consumer (patient). A 59-yearold male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 (Batch/Lot Number: ew0153) as 1st dose, single (at the age of 59 years) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has not had covid-19 prior to vaccination. The patient experienced pulmonary embolism on an unspecified date and blood clot on 22Apr2021 with outcome of not recovered. The patient was hospitalized for blood clot for 2 days. The patient underwent lab tests and procedures which included blood test: negative on 26Apr2021. Therapeutic measures were taken as a result of the events incudes blood thinner. The outcome of the event blood clot was not recovered and unknown outcome for the event pulmonary embolism. The patient was tested negative for Covid-19 on 23Apr2021 (post vaccination). No follow-up attempts are possible; information about batch number already obtained.

Congestive heart failure, in AFIB; Congestive heart failure, in AFIB; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Apr2021 (at the age of 59-years-old) as 1 st dose, single for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The reported Events were congestive heart failure, in AFib on 03May2021, hospitalization not prolonged. The events resulted to emergency room/department or urgent care. Received unspecified treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

blood clots in both lungs along with lung inflammation; blood clots in both lungs along with lung inflammation; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose (reported as dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), via an unspecified route of administration, administered in the right arm on 16Apr2021 at 08:45 AM as single dose for COVID-19 immunisation. Medical history included cholestoral, blood pressure, indigestion. No known allergies. No covid prior vaccination. Concomitant medications included losartan, avoristatin, omezrapole. The patient previously took the first dose (reported as dose 2) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), via an unspecified route of administration, administered in the left arm on 22Mar2021 at 08:45 AM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02May2021 at 16:00, patient experienced blood clots in both lungs along with lung inflammation. Events caused a call to the emergency responders and a 2-day hospital stay from 02May2021 to 04May2021. Events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Lab data included covid test on 02May2021 was negative (Nasal swab). Lots treatment received for the events. The outcome of events was resolved with sequel on unspecified date.

After 2nd shot I went into AFib about 5/6 days later. This lead to a heart attack about 17 days after 2nd covid shot.

Patient developed hemoptysis requiring two hospitalizations with acute hypoxic respiratory failure requiring intubation during his second admission. Hospital stay was complicated by HAP and PIV infiltration while infusing levophed (for hypotension attributed to sedation) resulting in a right forearm scar.

night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and chest. Ultimately Vomiting violently. Could not lie down without the pain returning. 5/19 Day: Had light breakfast and dinner. No vomiting, but could not lie down without same pain. Morning of 5/20: Breakfast of cereal and fruit at 9am. And noon, I experienced pain again, vomiting at noon. Then to Urgent care, then, Emergency Room, then Hospital.

My husband died May 1st, 3 weeks after his last vaccine April 10 . He had a saddle pulmonary emboli. He did not have any symptoms that I knew of prior to May 1st. Entering info for research data.

Unprovoked bilateral pulmonary embolism Impression: multiple bilateral pulmonary emboli and proximol of which are in the right interlobar right middle lobar, right lower lobar and left lobar arteries. there is also multiple bilateral segmental pulmonary emboli. there is no CT evidence of pulmonary arterial hypertension or right sided heart strain however recommend echocardiogram

s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission. Found to be pancytopenic with bone marrow biopsy consistent with MDS. He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock. He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics.

I63.9 - CVA (cerebral vascular accident) I63.9 - Acute ischemic stroke R29.810 - Facial weakness R56.9 - Unspecified convulsions

Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started running a 102 temp with body aches, by 3/29/21 whole arm was sore and that night moved into the chest area. In the middle of the night pain was unbearable and took him to hospital where we were told he was having a heart attack. Transferred him by ambulance to Regional hospital.

I26.99 - Subacute massive pulmonary embolism (CMS/HCC) I26.99 - Other pulmonary embolism without acute cor pulmonale