Pfizer

10 minutes after the second dose, patient developed headache, lightheadedness, dizziness, shortness of breath/anaphylaxis. Transferred to ED, and experienced chest pain, SOB, tightness in throat. Patient was sent to the emergency department. Received 25 mg Benadryl prior to arrival as prophylaxis. Received Combivent in the ED, and symptoms improved. Patient was observed for 4 hours in the ED. Eventually patient was discharged home.

Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EN5318) via an unspecified route of administration on 30Jan2021 12:45 into right arm at a single dose for COVID-19 immunisation. The patient medical history included epilepsy and cerebral palsy and known allergies is to amoxicillin. The patient had a seizure disorder, epilepsy (Lennox Gastaut Syndrome). He has an average of 1 Tonic-Clonic (Grand Mal) and 2 Series of Myoclonic Jerks a day. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications in two weeks included topiramate (TOPAMAX), lamotrigine (LAMICTAL), clobazam (ONFI), glycopyrronium bromide (CUVPOSA), potassium citrate, citric acid, calcium carbonate and colecalciferol (VITAMIN D). Within the first 24 hours(PENDING CLARIFICATION, as reported as 30Jan2021 02:45AM) of receiving the vaccine his seizure activity increased. Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks. The patient received emergency seizure medicine Klonopin. The patient did not test COVID post vaccination. The outcome of the events was recovering.

5 minutes after getting shot, started to feel same effects of Tree nut allergy anaphylaxis. Did not need an EpiPen, but still had trouble breathing for the day.

Had onset of a headache about 2 hours after vaccination on Saturday, 20 March. On Tuesday 23 March, at about 11 AM began having a migraine headache (had a past medical history of migraine headaches as a teenager). About 3:10 PM on Tuesday 23 March, began to have tingling and numbness in right hand (he is right-handed). Taken to ER where he could not remember his name. He was admitted and found to have four infarcts in three lobes of his left hemisphere (parietal, frontal and temporal). CT, MRI and cardiographic exams with contrast revealed a patent foramen ovale. Discharged on 40 mg Lipitor and ASA 81 mg, and referred to UCSF Neurology for followup.

Fainted on April 9, waking to racing heart and shortness of breath. Chest pain and shortness of breath persisted. Visited Emergency Room evening of April 11. Multiple tests revealed diagnosis of pulmonary embolism. Was immediately transferred to hospital early April 12. Received blood thinning treatment and catheter operation. Discharged April 15, with prescription of Eliquis for continued blood thinning.

Thrombocytopenia with Platelet count of 2 with development of petechial rash and spontaneous bleeding from gums noted 3 days after immunization. Patient was evaluated in the Emergency Room and admitted to the hospital requiring IVIG infusion and IV steroids with slow up-trend in platelet count over 4 days of hospitalization prior to discharge with Platelet count of 49.

severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; Pain in my left arm from vaccine started on Wednesday; Wednesday I worked on upper body and arm/chest/back muscle pains began/On Thursday, I worked on legs and severe quad/glute/hip muscle pain began; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:30 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included reported as none. Concomitant Therapy included multivitamin, joint suppliment. The patient was hospitalized with severe rhabdomyolysis a few days after receiving his first dose of the Pfizer vaccine. He received the vaccine Tuesday 23Mar2021 and went to the gym Wednesday 24Mar2021 and Thursday 25Mar2021. Pain in his left arm from vaccine started on Wednesday and additional muscle pain was induced post workout on both days. Wednesday he worked on upper body and arm/chest/back muscle pains began. On Thursday, he worked on legs and severe quad/glute/hip muscle pain began. Saturday (27Mar2021) he began urinating the color of Coca-Cola and could not walk. Sunday (28Mar2021) he was hospitalized with a creatine phosphokinase (CK) level of 209,000 U/L with no preexisting health conditions that would cause his CK levels to be so extreme. Adverse event severe rhabdomyolysis was started on 27Mar2021 09:00 AM and resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 7 days. Therapeutic measures were taken as a result of severe rhabdomyolysis included IV fluids. The outcome of the events was recovered.

Per his parents, patient started feeling nauseous an hour or two after the vaccine and at night around 10pm it worsened where he felt nauseous, had shivers and he vomited in the middle of the night. He then vomited again the next day and continued to not feel well the next couple of days. On 4/20/2021 at around 4:20pm he called his mother, his girlfriend and his mentor that he was not feeling well, was nauseous and dizzy and had shivers and was going to pull over on his car to get something to drink. He then stopped answering his phone and was found dead in his car later on that day. Police is investigating the case.

I'm no longer symptomatic. Very recently, in the last 4 days, I had a COVID test that showed positive; Pneumonia; This is a spontaneous report from a contactable consumer (Patient) reported for self. This 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot: EN6203, Expiration date: unknown) via an unspecified route of administration in left arm on 24Mar2021 at 17:30 at single dose for Covid-19 immunization. Patient relevant medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, (as reported) patient experienced lot of coughing, low energy, fever with sweating then would feel extremely cold, Loss of taste, Hot and intense chills and pneumonia on 02Apr2021. Patient underwent lab test to the hospital and got a CT scan. The patient received cough drops and cough suppressant medication for cough with outcome of recovered. Patient took the antibiotics (Advil) for a week or 5 days for Pneumonia till 09Apr2021 with outcome of recovered. Patient underwent lab test and procedure which included COVID test positive (symptomatic) on 02Apr2021.The outcome of event was recovered. Follow-up (12Apr2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program.

Swelling underneath my left arm pit which may be a possible blood clot; Swelling underneath my left arm pit which may be a possible blood clot; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 08Apr2021 (16:15) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (05:45), the patient had swelling underneath my left armpit which may be a possible blood clot. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

Presented with chest pain and dyspnea. Admitted to the hospital. Initially, the diagnosis was NSTEMI. Further testing showed myocarditis.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe

Chest pain, chest tightness, difficulty breathing, all of which were worse when lying down. Soon developed fever, chills, and night sweats, and eventually tachycardia (resting 160 bpm) with atrial flutter and then atrial fibrillation Original pain was within the week of the vaccine, but the fever came on about a month later and lasted for 2 weeks.

Occipital neuralgia; anaphylaxis; feeling like passing out on and off for the next 2-3 hours; he felt lightheaded; little short of breath; fatigue; he had a lot of posterior lymph pain in the back of his head, for 2 weeks on and off; heaviness at the back of his head left sid; chest tightness; he developed a sensation like he was going to lose control of his mind; This is a spontaneous report from a contactable Other Health Professional, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 08Jan2021 at 13:30 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma exacerbation, GERD, childhood anemia, a retinal tear in the right eye all from unspecified dates and unknown if ongoing. The patient also reported medical history three episodes (June 2019, August 2019 and October2019) of anaphylaxis due to "Exercise Induced Anaphylaxis." Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899) on 21Dec2020 at 13:30 after which he experienced pain at the vaccination site which lasted twenty-four hours. The patient's past product use included adrenaline (EPIPEN), an unspecified corticosteroid and an unspecified antihistamine for past allergic reactions. The vaccine was administered in a hospital. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included ciclosportin (RESTASIS), azelastine (AZELASTINE), mometasone furoate (FLONASE), cetirizine hydrochloride (ZYRTEC) and omeprazole (PROTONIX) all for unknown indications from unknown dates and unknown if ongoing. Within four weeks prior to the vaccination the patient had received unspecified "allergy shots" He received "two shots" (one in each deltoid) on 15Dec2021 and "two shots" (one in each deltoid) on 05Jan2021. The patient reported that fifteen to thirty seconds after the second dose of the COVID-19 vaccination he felt lightheaded and a little short of breath. This lasted about eight minutes and then subsided. Approximately thirty to forty minutes (about 30 minutes after he left the facility) later the symptoms returned. He felt short of breath and he thought he was going to pass out. The symptoms included fatigue, shortness of breath lightheaded and feeling like passing out on and off for the next two to three hours. He stated he has completely recovered. He continued to say that he was feeling fine for three days then he began having bilateral cervical lymph pain greater on the left than right, a lot of posterior lymph pain in the back of his head (for two weeks on and off). These symptoms also resolved on their own. He also experienced ("a couple of days later") a sensation where he thought he was going to lose control of his muscles and lose consciousness. He also developed a sense that the was going to lose control of his mind with heaviness at the back of his head, left side. He went to the Emergency Room (date not provided) and they provided Valium. He also reports an Emergency Room visit on 13Jan2021 during which he underwent a CT scan of the head which was normal and a neuro consult suggesting occipital neuralgia and he was put on muscle relaxers. He also stated that experienced shortness of breath and chest tightness after his allergy shots on 26Jan2021 and he specified that he had never before had these reactions to his allergy shots. After that he had yet another possible allergic reaction after eating pizza on 30Jan which included throat swelling as well. He further stated that on 04Feb he had anaphylaxis vs asthma exacerbation. On the following day he developed a heaviness to his left occipital head with that same feeling of wanting to lose control of his muscles. He never had that before. He started Prilosec about one and one half weeks prior to the reporting date. In follow up the Other HCP reporter/patient answered "Yes" to the following questions (DCA) about symptoms experienced: Bilateral wheeze/bronchospasm, upper airway swelling, increased use of accessory respiratory muscles, dry cough, difficulty breathing (without wheeze or stridor, sensation of throat closure, tachycardia, nausea. These were reported without dates and without context with regard to the events reported initially. These were also reported as not requiring treatment and having recovered on unspecified dates. Lab data included three SARS COV 2 nasal swab tests (14Jan2021, 03Feb2021 and 11Feb2021) all of which were negative. Unspecified treatment was reported for the events anaphylactic reaction and mental impairment. The clinical outcomes of the events Anaphylaxis, loss of consciousness, dizziness, dyspnea, fatigue and lymph node pain were reported as recovered on an unspecified date in 2021. The clinical outcome of mental impairment, heaviness of head, chest tightness and occipital neuralgia were reported as unknown.

I had intense stomach pains, muscle pains for 4 days. Could not get out of bed. Also had a fever. I thought these were regular side effects and eventually got better. Then, about a week later I started getting nose bleeds with blood clots coming out of my nose. These lasted a few more days. This never happened to me before, and must have been a side effect from the vaccine.

On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to be recurence of strain injury, although no history of trauma or obvious trigger. Pain conitnued to worsen and had different characteristics than original strain symptoms. Continued to worsen to point wher eunable to weight bear and swollen, hot and red. Saw orthopedist who refered to vascular surgeon, and on day 13 was officially diagnosed with large DVT extending form tibeal & peroneal, popliteal up to the femoral veins. Has no known clotting defects. Currently under evaluation with hematologist who recommended anticoagulants for remainder of his life.

Patient with known alcoholism, found down and out covered in blood for an unknown period of time. Brought to Healthcare Facility by ambulance for treatment, and planned to transfer. Suspected GI bleed; when flight crew arrived, decided to intubate. Failed first attempt, and patient when into cardiac arrest. Was revived with CPR and 2 doses of epinephrine. Pt also received TXA and 1 unit PRBC, and fluids. Successful second attempt, though BPs remained labile. Pt transferred to ICU and was notified that additional evaluation found bleed had actually occurred proximal GI tract (oral mucosal bleed, not esophageal). Pt also diagnosed prior to transfer with multilobar pneumonitis, ascites secondary to alcohol cirrhosis, hematemesis/meme positive stool, leukocytosis and pancreatitis. Was notified by ICU less than 24 hours later that pt was on vent and stable.

27 year old male with Down's Syndrome and no other past medical history received second COVID-19 vaccine on 4/27/2021. On 4/30/2021 began "feeling poorly" with nausea/vomiting and possible chest discomfort. Originally presented to ED on morning of 4/30 - EKG completed demonstrated diffused ST elevation. Patient was transferred to Medical Center for heart catheterization. Left heart catheterization demonstrated normal coronary arteries and LVEDP of 25. Stat ECHO demonstrated pericardial effusion and concern raised for myopericarditis. Patient subsequently transferred to a different Medical Center for higher level of care. Upon arrival to Medical Center plan was to intubate and take to cath lab for heart biopsy and PA catheter placement. However, upon intubation patient began to decompensate and subsequently developed cardiac arrest. During ACLS, VA ECMO was placed and therapeutic hypothermia was initiated. Following VA ECMO placement patient received IVIG, high dose methylprednisolone (1000 mg), anakinra 100 mg, and broad spectrum antibiotics (vancomycin and Zosyn). Despite these efforts the patient continued to have hemodynamic instability and was on high dose vasopressors (epinephrine, norepinephrine, dopamine, angiotensin II, vasopressin). Patient subsequently suffered another cardiac arrest, briefly regained pulse with high dose vasopressors, but subsequently lost pulse despite best efforts and died on 5/1/2021 at approximately 13:00.

Patient appeared to have 45-60 second seizure following first dose of Pfizer COVID-19 vaccine. Appeared to experience a tonic/clonic seizure. He was sitting in a chair, scheduling an appointment to receive his second COVID-19 vaccine and became unresponsive and stiff. Staff responded, patient was lowered to the floor for safety. Patient was turned on his side to maintain airway. O2 was take 97-99% on RA. Once rigidity had resolved, O2 was applies at 3L NC as a precaution once stiffness resolved. BP was taken, 83/59 and pulse 105 side laying. 5 min later, BP 109/73, pulse 106 supine. EMS was called, patient transferred to ambulance. Patient was alert and oriented.

Patient reported chest pain for 2 days and intermittent jaw pain after receiving his second Pfizer COVID vaccine on 4/22, and presented to the ER on 4/25 with a headache and emesis. An ECHO was performed and LVEF was 45%, and an EKG showed possible ST elevation. Per the Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine study there were no reports of STEMI being an adverse effect. Given the patient's ejection fraction of 45%, there was likely a prior medical condition the patient was unaware of and may have precipitated the STEMI rather than the vaccine . Hospitalized for 2 days and diagnosed with pericarditis.

fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/He had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn; felt like he could not stand and had to go to the floor, struggled to get up; arms were numb; thought he was having a heart attack; left arm weak; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left side of face is swollen; left side of face is swollen was reported as worsened.; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left arm pain; This is a spontaneous report from contactable consumers (patient reported for himself, patient's mother). A 27-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 01May2021 12:00 noon (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. The patient's medical history and concomitant medications were not reported. The patient experienced thought he was having a heart attack(medically significant) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (medically significant) on 03May2021 with outcome of not recovered, fainted (medically significant) on an unspecified date with outcome of unknown, lost consciousness for a couple of seconds (medically significant) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/he had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn (non-serious) on 03May2021 01:00 with outcome of unknown, felt like he could not stand and had to go to the floor, struggled to get up (non-serious) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, arms were numb (non-serious) on 03May2021 01:00 with outcome of recovering, left arm pain (non-serious) on 03May2021 with outcome of not recovered, left arm weak (non-serious) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 01:00 with outcome of not recovered, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 with outcome of not recovered, left side of face is swollen (non-serious) on 03May2021 01:00 with outcome of not recovered , left side of face is swollen was reported as worsened (non-serious) on 03May2021 with outcome of not recovered. The patient underwent lab tests which included computerised tomogram (brain CT): no results, electrocardiogram (EKG): no results, both on unknown date. Reported patient was in pain and his mom and dad didn't know what to do. He had sharp pains. No bruises. He remember lowering myself to fall. He didn't fall. It was a strange thing. When he went to the ER they didn't fine anything. He was still in the same amount of pain. Caller stated her son took the vaccine on Saturday. Thirty six hours later around 1:00am he started getting extremely, burning pains across his back.The patient stated he was coming out of the bathroom and felt like he couldn't stand and he had to go to the floor. He lost consciousness for a couple of seconds. Both arms were numb. He struggled to get up. He sat on the couch and then went upstairs after being in the basement. He had a burning pain that felt like needles on his shoulder, left arm and a little on right side. His skin was sensitive. The back of his neck feels like he has a third degree burn. This morning he went to the hospital. Initially said he fainted but clarified that he was speaking about losing consciousness. He had left arm pain. He thought he was having a hard attack. While at the emergency room today he had labs, a brain CT scan and an EKG. He does not have results to provide. Caller added that his skin was hypersensitive. It was like if he moves the hair on his arm it hurts. His parents noticed he has swelling on the left side of his face. The events require a visit to Emergency Room. No Prior Vaccinations (within 4 weeks). Information on Lot/Batch number was available. Additional information has been requested.

Development of substernal chest pain with elevated troponin 3 days after vaccination. Normal EKG. CT angio w/o evidence of PE.

27-year-old gentleman with history of mild intermittent asthma, anxiety, presented with complaints of fever of 99.8 °F on 5/22/2021 associated to fatigue and body aches and then chest pain, generalized with radiation to left arm since afternoon of 5/23/2021, which got worse on 5/24/2021 and he was admitted for further evaluation with initial troponin of 472. Had an NSTEMI; chest tightness, pain in left arm, lightheadedness, dizziness, presyncope. Discharge diagnosis - probable myocarditis; clinical picture most consistent with viral myocarditis.

Stroke - Blood Clot in M2 Brain Artery Friday, May 21, 2021 - Air lifted from Hospital to Hospital Admitted to Neuroradiology Dept and immediate Thrombectomy to remove blood clot behind left eye via angiogram through the groin via catheter. Proceedure was sucessful in removing 100% blocked artery and he was transfered to Resovery, observation and follow-on diagnostic testing in ICU for 4 days. Discharged May 24, 2021

After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.

Pleuritic chest pain, shortness of breath, subjective fever, and malaise within 24 hours. Symptoms and signs consistent with myopericarditis.

Patient received second dose of COVID vaccine on 03JUN2021 and 2 days later began having pleuritic chest pain and fever which improved with ibuprofen. Chest pain continued to worsen and presented to regional hospital. Started on Colchicine, had elevated troponins. Echocardiogram showing pericardial effusion. Left heart cath at hospital was unremarkable with no evidence of CAD. Still with mild pleuritic chest pain with deep inspiration but none at baseline. The admission diagnosis is myocarditis.

On first day, patient was feeling tired, dizzy and foggy and 18 hours later was found dead on the floor.

Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Rash/Itching/Shakiness on left side, followed by trouble breathing; symptoms lasted 1 day

On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Full ACLS was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was intubated. Patient continued into V. Fib arrest and was shocked multiple times.

Patient received the vaccine around 11 am. He hadn't been feeling well (headache, dizziness) per report and initially called in to work. He then decided to come to work and was found down in a patient bathroom during his shift on our Facility while taking care of a patient (he was a nurse aid). Patient was coded and the team and was transferred to our Facility ED. He expired 3/3 2112

Pulmonary embolisms; lung infarcts in left and right lungs; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL5269), via an unspecified route of administration at site of left arm at 15:00 on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included psoriasis and known allergies: clarithromycin. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date. The patient experienced pulmonary embolisms and lung infarcts in left and right lungs on 11Feb2021. The patient was hospitalized for these events for 2 days. COVID was tested post vaccination (Nasal Swab covid test with negative result on 12Feb2021). No other vaccine received in four weeks. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient received treatment (blood thinners and CT Imaging) for adverse event. No COVID prior vaccination. The outcome of events was recovered in Feb2021.

Patient had 2nd COVID vaccine on 2/21/2021. He started having a temperature on 2/24/2021. Patient then started having trouble breathing. We took him to hospital. He was admitted on 2/25/2021. He steadily declined and was sent to ICU and died on March 1, 2021.

Generalized tonic clonic seizure with post-ictal state, 1 minute after the shot, 2 episodes, each lasting about 15 seconds. -stable vital signs, patient has no prior h/o seizure disorder, no h/o allergies to food, vaccine or meds, -patient was not on any meds at the time. -patient was stabilized and transferred to the ER for further evaluation.

Blurred vision; Face and skin are red; Lips tingling; feeling slightly itchy at the injection site after the vaccine/Itching all over his head, scalp, arms and hands, everything; Hives; Tongue and lip swelling/Tongue was starting to swell; Tongue and lip swelling; Shortness of breath; Tachycardia; Anaphylactic shock/anaphylactic reaction; Still has a rash and is itchy/break out rash and get itchy again; Not really wanting to eat dinner; I got home my arm had swollen/Whole arm and hand were swollen; I started feeling slightly itchy at the injection site after the vaccine; Nausea; This is a spontaneous report received from a contactable consumers and other Health Professional. This is a report combining information from duplicate reports 2021372891 and 2021368246. The current and all subsequent information will be reported under manufacturer report number 2021368246. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; lot number : EP7533), dose 1 intramuscular, administered in Arm Left on 02Apr2021 11:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included Sleep Apnea ongoing; idiopathic hypersomnia ongoing; High blood pressure (They want to treat her husband for high blood pressure but they don't want to do that until after these reactions. She clarifies he was having issues with high blood pressure prior to getting the vaccine); Little overweight. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from 2020 and ongoing 20 mg, 1x/day; modafinil from 2019 ongoing 200 mg, 1x/day for Idiopathic hyposomnia for Sleep apnea. patient got the first dose of the vaccine on Friday and within 30 minutes, went into anaphylactic shock and was taken to the local emergency room after being administered Benadryl and an EpiPen without any kind of changes. He was discharged and then on Sunday night, he went into anaphylactic shock again and was taken back to the ER after once again being administered Benadryl and an EpiPen. Now, he was kind of starting to break out in a rash again. This has thrown them for a loop because most of the time they had heard that more severe reactions come with the second dose. She confirms this was her husband first dose. Her husband had sat at Pharmacy for the required 15 minutes and he was feeling a little itchy around the vaccine site. It was just around the site, so they left. In the 10 minutes to get home, he started itching all over his head, scalp, arms and hands, everything (02Apr2021). they looked at his site and his entire arm was starting to swell and there was a rash that had gone all the way down his arm. her husband whole arm and hand were swollen and his tongue was starting to swell. He was administered liquid Benadryl and the Epi shot, He was brought to the emergency room at the hospital. He went home after going to the ER. Her husband had another anaphylactic reaction last night. He hasn't had any new foods or exposure to anything. states that they did say it was possible to have a relapse but that it was rare. He had presented slightly differently but kind of similar. It started with him feeling nauseated and not really wanting to eat dinner. He went upstairs to shower and he started to get itchy again. So, she administered 50ml of liquid Benadryl to just get it into his system and then about 10 minutes later, it was not really having any effect and his tongue and stuff started tingling. She looked at his tongue and his tongue was starting to swell again. So, that's when she administered the EpiPen and 911 was called. Her husband was brought to the Emergency room again and was discharged a few hours later. They didn't keep him overnight for observation or anything. states he is still experiencing blurred vision, red skin, and chest is still red a little bit at the top, and his face is red. His lips are started to tingle but was not interfering with his breathing yet, shortness of breath, tachycardia 02Apr2021. Caller states that about 1 hour ago, patient took one tablet of Benadryl and was given 20ml liquid Benadryl 15 minutes ago. Tests: X-ray was clear (Negative), blood work came back normal. She just feels like its getting to the point where everything is just being prolonged. When they went to the ER, he was been on Benadryl, EpiPens, they provided him steroids, Oxygen, Prednisone, Pepcid to try and prolong the effects of the Benadryl and it doesn't seem like anything is working. patient started feeling slightly itchy at the injection site after the vaccine. I waited the 15 minutes after the injection without having any serious side effects. By the time I got home, my arm had swollen and developed hives 02Apr2021. received Benadryl and an Epi pen. By that time, the rash and hives had spread throughout my body, and my arm, hand, and tongue had swollen. was having trouble breathing and was taken to the ER. On Sunday evening, had a relapse and it started with nausea. Within 30 minutes, was itchy and my tongue started swelling. Patient had Blurred vision; Face and skin are red; Lips tingling; Not really wanting to eat dinner on 05Apr2021; the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Adderall; Prior to vaccination, the patient diagnosed with COVID-19 was Unknown; Since the vaccination, the patient not tested for COVID19, The patient received treatment for all events except events blurred vision; face and skin are red; tingling lips; appetite lost. The outcome of the events blurred vision; face and skin are red; tingling lips; appetite lost was unknown; rest of the events was not recovered.

Presented on 4/26/2021 to the Medical Center ER with chest pain. CTA showed 1. Examination limited by patient motion artifact. There are likely small bilateral segmental pulmonary emboli. 2. Trace effusions. 3. Mild groundglass interstitial prominence could relate to atypical infectious etiology or edema. 4. Severe colonic distention again demonstrated and is incompletely assessed.

Heart was placed into atrial fibrillation. Heart rate was 200BPM. Lost hearing and sense of balance. Profuse sweating and wheezing.

he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having a hard time to get a sentence out (felt like his motor skills were affected); having a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021. Information about lot/batch number has been requested.

My brother got the Pfizer 5/4 and started getting sick with a cough on the 7th and by the 10th he was getting more and more sick and ye was taken to the ER on the 14th and he started coughing up blood, he was out of it and pale and not able to move much. On 5/15 in the hospital he was having a hard time breathing and they were trying to give him meds to make him better, they gave him antibiotics because his blood work showed infection, and Precedex to help him rest, and he passed away the same day, he was in good health before. They also said his heart rate was 201/123 and the doctors said pulmonary anema. It escalated so quickly.

Patient received vaccine at 7:45 pm on 5/19/2021. Chest pain and rapid heart rate occurred approximately 2 hours post vaccine shot. Patient went to ER. Diagnosis was atrial fibrillation with RVR (CMS/HCC). Medication given: Metroprolol 5mg/5ml injection - ADS override pull (10:41pm), sodium chloride 0.9% bonus 1000mL stopped at 5/20 12:36am. Patient spontaneously came out of atrial fibrillation and was released

Patient presented to hospital 5/22 for acute psychiatric emergency. At the time of admission basic labs where obtained and were significant for platelet count of 4,000 (rest of complete blood count unremarkable). Medications and infectious history reviewed and were unremarkable. He has significant ecchymoses and petechiae on initial physical exam. He was started on treatment for Immune Thrombocytopenic Purpura with dexamethasone and Intravenous IgG with significant improvement in platelet count to over 100K.

3 days after 1st shot Severe joint pain (Similar to RA), muscle pain, Headaches that lasted from 4/9/21 to 5/13/21 when I was taken to the hospital where it was found I had a Venous Stroke. Multiple doses of steroid, and Tylenol until the stroke, then I don?t recall what I was given in the hospital but now I am on 80mg of staton, 81mg of aspirin, 1mg of folic acid

Sunday, January 10 2021 around 1900. Suffered from chest pain. EKG showed STEMI. Chest x-ray showed 20% pneumothorax. Treated with nonrebreather 15L for several hours. Follow-up EKG shows retaining right bundle branch block.

Patient was gone out for a run on 28th May. While running, he collapsed suddenly. Onlookers called 911 and they tried to revive him but he died on the spot. his autopsy result is still pending. He had no history of any illness and had been a healthy individual. He used to exercise regularly. He had received his second dose of vaccine that month on 13th May and had faced expected symptoms like fever and chills that only lasted for 2 days.

I experienced heart failure due to Myocarditis and had to be rushed to the hospital. I was administered IV fluids, blood thinner, and medication to help with the inflammation of my heart. I am currently under the care of a Cardiologist and still have symptoms that need to be treated until further notice.

left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular tachycardia/help keep his heart rate at bay; Loss of balance; extreme numbness and tingling in left hand and foot; tingling in left hand and foot; oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily; Issues finding words and trouble speaking; Issues finding words and trouble speaking; Ejection fraction down to 25%; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other healthcare professional (HCP). A 29-years-old male patient received bnt162b2 (lot number: EJ1685), intramuscular (deltoid left) on 21Dec2020 at 05:30 at 0.3 mL single (first dose) for Covid. Medical history was reported as "none". Concomitant medications were not reported. The patient previously received Flu vaccine in Oct2020 for immunization. The patient is an Occupational Therapist, and he called to report an adverse event that he experienced with the first dose of the COVID Vaccine. He received the vaccine last Monday, 21Dec2020 at 5:30AM before his shift at work, then 20 minutes later, he was having severe stroke like symptoms. He experienced severe left sided weakness, loss of balance, extreme numbness and tingling in his left hand and foot, he had issues finding his words and he couldn't speak, and he had an oral motor impairment where his mouth was weak and not coordinated. The staff at the hospital did a neurological exam on him, and he failed, so he had to go to the emergency room (ER). The patient added that he was already in the hospital when this happened, and the ER doctors suspected that he had a CVA, and they gave him TPA to prevent any permanent brain damage and it worked. The patient then added that due to the shock of this whole event, from everything that happened, it has weakened his heart. Reportedly, he is a healthy 29 year old man, with no preexisting conditions, and he works out, and he has no heart conditions, but he had to get a cardiology follow up a few days after he got the vaccine, because he started going in to Ventricular Tachycardia, which he had never had in his life. So, the doctors at the hospital went ahead and did an Echocardiogram and an EKG, and he was told that his Ejection Fraction is down to 25%. He stated his heart is so weak, that he cannot work right now, but the structure of his heart is fine and has not had any damage. The hospital staff thought that maybe the patient had a chronic heart issue that he just did not know about, and that the stress of this event maybe made it kick into overdrive, but he states that the cardiologist said that was not the case, because the structure of his heart is fine, and the only thing they can see is that the heart is pumping weak. One physician even suggested that due to the shock of the event, he might have Takotsubo Cardiomyopathy, which is a broken heart, but because the structure of his heart is okay, it should be reversible. He stated that he is hoping he will heal up good, because he is young and has no pre-existing conditions. He added that his heart is in such a state right now; he has to wear an external defibrillator. The patient stated that all these happened about 20 minutes after he received the vaccine, and he was admitted to the hospital from 21Dec2020 to 25Dec2020. His neurological symptoms have resolved except that he has a stutter that he did not have before and his mouth is fatigued easily, so he has to slow down when he is eating, but now he can eat regular for the most part. The patient confirmed that he was not specifically prescribed the product; it was administered to him at his place of work, but it was optional. He stated he considered how he is working with COVID patients every day, and given the circumstance, he thought that it would be a best practice for him to get the vaccine. He had not gone to his primary care doctor in a while because he had been fine and healthy, but he called them and found out that his primary care had retired, so he has to find a new one now. Regarding the issues finding words and trouble speaking, he stated that he has improved, but it is still ongoing, he is just stuck in a plateau zone. With the Ventricular Tachycardia, he stated that this is an ongoing issue, as he has to wear the life vest even though he has no need to activate it yet. He did have one minor bought of the VTach, but because he is a therapist, he knows how to take care of it with relaxation techniques, he knows how to manage it. He had one bought of VTach the evening prior, but he was able to get it under control. The doctors have him on medication to help keep his heart rate at bay. He has never had to use medication before and is on the following medications to help keep his heart rate at bay: Metoprolol 25mg one tablet once daily by mouth and Lisinopril 5mg one tablet once daily by mouth. The VTach has improved, it was good enough he was able to discharge home, but it is still a concern. His cardiologist said that, basically his hope, is that once his body recover from the whole shock of everything, then his ejection fraction will heal, and his heart will heal. He again stated that the doctor told him that the structure of his heart is perfectly fine; he has thick walls in his heart, no leaking valves, and the heart was not conducting any abnormal signals. The doctor just said that right now, his heart is super weak and that it is an acute problem. With the Takotsubo Cardiomyopathy, he states that two doctors mentioned this diagnosis, but he confirmed that he was not actually diagnosed with this issue, he was just diagnosed with Ventricular Tachycardia. The outcome of the ejection fraction down to 25% was unknown to the patient at this time as he has not had another EKG or echocardiogram, but the cardiologist told him that the cardiologist expects that this will not be resolved quickly anyway. The patient confirmed that he did not receive any other vaccines on the same day he received the COVID vaccine. The only other vaccine he had this year was the flu vaccine which he got back in Oct2020. He has gone on to his online portal and there are the bloodwork results and all the imaging results on there from his CTs and MRIs, but he did not see the EKG or Echocardiogram results yet. He does not have this pulled up at this time, but he does have access to this stuff and can provide it later, if requested. He is curious about the next steps from here to how his case is processed. He is also curious if this information would help Pfizer make modifications to the vaccine if it is found that a lot of people are having the same reaction as he did. He is also wondering, given his situation, that probably he is not going to get the second dose, for his safety, but he is wondering what percentage of effectiveness the first dose does having just covered. The events left sided weakness, loss of balance, extreme numbness and tingling in left hand and foot resolved on 25Dec2020; severe stroke like symptoms and oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily resolved in 2020. The events ventricular tachycardia/help keep his heart rate at bay and issues finding words and trouble speaking were resolving, stutter had not resolved while the outcome of the events it has weakened his heart, and ejection fraction down to 25% was unknown.; Sender's Comments: The reported information is unclear and does not allowa meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Gum bleeding and thrombocytopenia (platelets 41k) found on lab drawn one week after first dose of vaccine.

left foot toe bruise, petechia in feet and lower legs by the next day. thrombocytopenia diagnosed on CBC collected 3/27/21

My heart went into AFIB from 7:30-9:30. I had to go to the ER and now am on blood pressure medicine. I am 29. This has never happened before.

pt admitted as inpatient with congestive heart failure, myocarditis and non sustained ventricular tachycardia

unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swelling and pain progressively worsening; right leg swelling; This is a spontaneous report from a contactable consumer (patient). A 29 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:00 (Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of BNT162B2 on 29Dec2020 at the age of 29 years old for COVID-19 immunisation. Medical history included pleural effusion w/ thoracentesis x2 (5 years ago), known allergies: penicillin and sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included armodafinil taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the workplace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): negative on 28Jan2021. On 28Jan2021, the patient presented to the ED with right leg swelling and pain progressively worsening over the past week. Subsequently diagnosed with unprovoked right leg DVT and bilateral PEs, admitted overnight and given anticoagulation therapy. Labs ordered and reviewed with hematology consult 1 week later and found to be Factor V Leiden positive (hetereozygous). Treatment plan therapeutic dose of Eliquis twice a day for 1 year, prophylactic dose indefinitely after that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events were reported as life threatening illness as patient was in immediate risk of death from the events. The patient was hospitalized for 1 day. The events was recovering. The events was treated with anticoagulation therapy, pain medicine and stockings.

5/15/21 @1200: Gammaplex IV infusion started 1320: pt rang call bell for assistance, RN entered room to see pt shaking uncontrollably, pt reports that he is not feeling well, infusion stopped, and PIV flushed, VS obtained BP: 95/66 HR: 104 Temp: 100 RR: 24, Anaphylaxis kit retrieved, DON on phone assisting with walking through Anaphylaxis reaction needs/protocol 1325: 25mg (0.5mL) of Diphenhydramine given via SIVP, PIV flushed with 3mL NS post Diphenhydramine SIVP, manual BP taken at this time BP reading of 120/78 but really hard to obtain an accurate BP d/t pt shaking, Temp: 100 RR: 23, pt continues to shake, hands are cold to touch, finger tips are white with no cap refill noted, purple areas noted around pts knuckles at this time, pt reports that his feet feel tingly at this time and possibly his fingers, states that his back has a warm sensation and that he has a light feeling, pt reports feelings of being nauseated, garbage can provided for patient 1340: no improvement noted from 1st Diphenhydramine dose given, 2nd dose of 25mg (0.5mL) Diphenhydramine given via SIVP at this time, 3mL NS flushed post med, Acetaminophen 325mg x2 tabs that was dispensed for pre-med that pt declined to take was administered PO at this time, BP: 110/64 HR: 104 Temp: 101 RR: 23, continued body shakes noted, hands continued to be cold to touch with fingertips being white noted, no cap refill noted, purple areas still noted around knuckles of hands, pt still reports a warm sensation to his back, pt communicating with eyes closed most of the time, face coloring is pale 1345: pt reports that he feels like he is going to vomit at this time, pt vomited x 3 times into garbage can, 500mL Normal Saline bag per Anaphylaxis order begin at this time, rice pack heated and provided to pt for hand warming, hands continue to be cold to touch, pt continues to keep eyes closed, face continues to be pale 1347: pt reports feeling a little better at this time, lungs clear in all lobes bilaterally to auscultation, tachycardia noted via palpitation and auscultation, pt states at this time that his back does not feel as bad, color is starting to return to pt face at this time, hands continue to be cold to touch with white fingertips noted 1350: BP: 114/72 HR: 100 Temp: 101.9 RR: 20, pt breathing has decreased, pt reports that he feels like he is feeling better, pt discussed with me again that his provider stated that there was not enough information on time frame in between getting the COVID vaccine and his infusion, he also went on to report that he also spoke with another provider about getting the COVID vaccine and his infusion and that provider gave him the CDC website for him to read about the recommendations as well, he stated that both his provider and the CDC website stated that there was no recommended interval between the COVID vaccine and IVIG 1358: BP: 118/68 HR: 90 Temp: 101.7 RR: 18, color returned to face at this time, cheeks flushed, hands continue to be cold to touch but color have started to return to fingertips at this time, cap refill noted at 4 seconds, pt reports that he thinks he is feeling better at this time, states he feels that his speech is a little slower than normal, no slur noted, pt eyes are open and pt is alert, improvement in VS noted 1410: BP: 106/64 HR: 96 Temp: 101.7 RR: 18, pt reports feeling much better at this time, pt is holding conversation well and without difficulty, pt denies feelings of nausea, more color return noted to pt fingertips, cap refill noted of 3 seconds, pt reporting feelings of being drowsy at this time, reports that his back feels normal 1420: 500mL NS bag completed, pt reports at this time that he does not wish to restart his IVIG and asks if he can stay in the AIS for a little while because the Benadryl is making him super tired, pt reports that he does not have anyone that could come and drive him home, pt assured that he can stay in the AIS with RN as long as he needs 1445: BP: 104/56 HR: 106 Temp: 101.8 RR: 20, pt resting calmly, eyes were closed upon entering the rm, pt states he feels much better still, denies any new or concern symptoms at this time, states that he is just really tired, fingertip coloring has returned, cap refill less than 3 seconds noted, lungs clear to all lobes bilaterally 1500: pt resting calmly, pt opens eyes upon entrance into pt rm, pt continues to report feeling better just tired, pt denies any needs at this time 1515: no changes noted with pt, continues to rest calmly in recliner in room with eyes closed, opening eyes when rm is entered 1540: pt up to restroom 1545: BP: 104/63 HR: 102 Temp: 101.3 RR: 18, pt reports that he is feeling much better, he reports not feeling as drowsy now and that he feels okay for him to drive home, he denies any new symptoms, pt was encouraged to take Tylenol 2 tabs Q4-6 hours for temperature and body aches for the next 24 hours, pt was educated on contacting provider for further IVIG needs and rescheduling, pt educated on going to the ER if symptoms return, pt also educated on monitoring temperature at home 1550: PIV removed with tip intact noted, pt stabilized, all color has returned to hands, pt holding conversations without difficulty 1555: pt escorted out of AIS

Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; This is a spontaneous report from a contactable consumer reporting for self. A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Apr2021 at 13:30 (Batch/Lot number was not reported) as single dose (at the age of 29 years old) for COVID-19 immunization. There was no other vaccination received in the 4 weeks prior. Medical history included epilepsy since 2012, autism spectrum disorder, respiratory illness in Nov2019 (not caused by the flu but with COVID-like symptoms), high blood cell count (previous treatment). There were no known allergies. Concomitant medication(s) included lamotrigine (LAMICTAL) and escitalopram oxalate (LEXAPRO), both taken for epilepsy, start and stop date were not reported. On 25Apr2021 at 20:30, the patient experienced numerous grand mal seizures, never before experienced, including 2 instances of status epilepticus. The patient has had epilepsy since 2012 and current medication levels were in normal range. There was no treatment received for the adverse event. The events resulted in a Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events grand mal seizures and status epilepticus was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Chief Complaint chest pain History of Present Illness Very pleasant 29-year-old gentleman has lived in the US since 9 years old presents to the emergency room with chest pain. Started around Thursday of last week, has been constant progressively worse sharp and worsened with deep inspiration coughing progressed to the point was so severe that he had to come to the emergency room tonight. He denies fevers or shaking chills or any coryza prodrome. He received the 2 dose Pfizer vaccines February 11 and March 18 and has not had Covid Has been monitoring serially for HIV and this has been negative including this evening In the emergency room was given aspirin initially with concern

2 weeks after last dose, has a 5 liter pleural effusion unexplained by cytology reports. Began treatment for metastatic disease, they now suspect CHF due to enlargement of the heart and recurring pleural effusion

Was seen in urgent care 4/23/21 with shortness of breath, cough, congestion. Was tested for COVID which was negative and given rx for albuterol and Tessalon perles. Had Pfizer vaccine 4/28 and subsequently developed chest discomfort 2 days later, along with shortness of breath, productive cough and sinus congestion. ESR elevated at 15 though CRP was normal at 0.5. Troponin normal. ECG showing diffuse ST elevation. Chest x-ray negative. He was started on indomethacin 25 mg 3 times daily. Seen by cardiology 5/4/21 with ongoing chest discomfort and shortness of breath. He was started on colchicine. BNP, and d-dimer were checked which were normal. CXR normal. He was subsequently admitted 5/9-5/11 with transient left sided numbness. TTE showing normal LV function, no hemodynamically significant valvular abnormalities, normal CVP, and no interatrial communication.

Patient had a left sided segmental and subsegmental pulmonary embolism, severe back pain, dyspnea, tachycardia and tachypnea, started on 6/24.

Per Case Management - patient treated at hospital for "who had a bad MI on the 23rd of June, he is coming off ECMO and remains intubated in the ICU". Cardiologist may be contacted regarding

I was diagnosed with 2 DVT in my left leg on 19Jun2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 20Apr2021 at 18:00 (at age of 29 years old, Lot Number: EW0161) as a single dose for covid-19 immunization. No known allergies and no other medical history. The patient's concomitant medications were not reported. The patient was diagnosed with 2 DVT in left leg on 17Jun2021 at 21:00. The event resulted in Emergency room/department or urgent care. Treatment received, currently on Blood Thinners. 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 event was recovering.

Incidentally discovered thrombocytopenia on CBC performed 5/10/2021 for workup of other symptoms (ongoing fatigue), with platelet count 108. Workup reveals like ITP, with otherwise normal peripheral smear and elevated immature platelet fraction. Platelet counts remained stable on follow up labs in May and again in July 2021. Most recent recheck showed platelet count of 115 on 7/12/2021. Therefore, diagnosis appears to be ITP, that is asymptomatic. Previous platelet count on 1/11/2018 was notably slightly low, at 148. This suggests possible pre-existing ITP. Timing of this lower platelet count does not prove, but suggests possibility that vaccination may have worsened ITP to a new, lower platelet level.

The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue. Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.

Pfizer-BioNTech COVID-19 Vaccine EUA About a day and a half after receiving the 1st dose of the COVID vaccine I had a grand mal seizure. I was sitting on the couch with my family and my sister said I had only fallen asleep for about 20 minutes. I take seizure prevention medication each night prior to bed. I had not taken the medication yet but I was up to date on taking this medication. I had not had a seizure in 6 years since starting my medication. I did not have a fever before or after this seizure. I was generally feeling normal prior to the seizure ,after receiving the vaccine.

On April 17th, approximately 2 weeks after receiving the second shot, I woke up to use the bathroom at which point I passed an extreme amount of blood from my rectum along with what appeared to be remnants of blood clots. I took myself to the hospital who confirmed that hemorrhaging and blood clots had formed behind the site of my old ostomy scar inside of my intestines. I had no other signs of ulcerative colitis when scoped and no active flare, only this clotting that arose specifically after this second vaccine dose.

Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day.

I was immunized with the 2nd dose of the Pfizer COVID-19 vaccines on May 4th, 2021, and on May 5th started experiencing left shoulder pain radiating to the arm, and upon breathing in pain would intensify. On the night of May 5th pain started to increase and decided to report to the hospital. On May 6th I was admitted to the hospital to further identify what was causing the shoulder pain, deferent test were performed with normal result but upon performing CT Scan, it was identify that I had blood clots on the left lung (pulmonary embolism). Upon several questions asked by the health care team, the doctors at the Hospital stated that the main cause of the blood cloths was the 2nd dose of the Pfizer COVID-19 vaccine due to my healthy status and being the only thing that I had completed different in the days prior to the hospitalization. Due to this I was prescribed a 3 month anti coagulant treatment for the embolism.

fainted, seizure (grand mal) for 30 seconds, dyspnea, sweating. came to feeling weak, drank water and started feeling better

I developed a DVT in my left leg on 04/08/21 and had to have an IVC filter placed on 04/13/21. I have had several DVTs since getting the vaccine. I have been hospitalized on 04/08/21 to 04/09/21 and from 04/25/21 to 05/01/2021 with DVT and kidneys not working. Now have long term health complications and permanent damage to right leg.

Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest.

3 days later I was in the hospital with a heart attack. I was in CCU for 3 days. The muscle above my heart was inflamed and caused my heart not to do it?s job. I had tests run on my heart and my body and all conclusions came to the vaccine.

I felt numbness in my right leg, the numbness went up to my right arm and then I started slurring. This happened within a few minutes. I laid down and called a nurse adviser. I was recommended to go to ER, so my wife took me to ER. They did CT scan of my head, then CT scan of my head and neck with contrast, then MRI of my head, then MRI of my head and neck with contrast. It was confirmed that I had an ACUTE ISCHEMIC STROKE. It was decided to perform carotid endarterectomy surgery to remove a clot in the neck carotid artery. The clot was removed.

Pulmonary embolism, right lower lobe, 9 Feb 2021, presenting with right chest pain. No other provoking factors identified. Will be treated with six months of rivaroxaban.

Pulmonary embolism of right lung. Required hospitalization x1 overnight. Was started on enoxaparin inpatient, then transitioned to Eliquis 10mg twice daily with intent to drop down to 5mg daily. Presented to ER on 3/3/21 with chest pain. Patient continues to follow up in clinic.

Abnormal vaginal bleeding started on cycle day 8 after my period had ended. Similar to having a second period all over again. This happened also after my first covid19 shot. Very unusual. Had smear test and pelvic ultrasound and all was clear.

URI, bronchitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation, COVID-19, Other viral illness

Admitted to hospital on 5/3 with difficulty breathing, chest pain, light-headedness/dizziness, tingling in arms, and sloght loss of motor control of hands (clenching into fists uncontrollably). CT scan on 5/5 showed sub-sectional pulmonary emboli in both lungs. Released from hospital on 5/7 with treatment course including blood thinners.

Heart palpitations and atrial fibrillation, starting 5/3/2021 6:45 AM. Resolved by electric cardioversion on 5/3/2021 5:00 PM.

This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt "funny". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine.

Woke that morning very lethargic and hard to arouse. Mom states had been doing very well, exercising and losing weight. States he felt good up until that day. DEATH

Patient experienced chest pain and arm numbness 11 days after receiving vaccine on 6/22/21. He went to ER and a chest CT images revealed a pulmonary embolism. He was discharged on 6/22/21 with a prescription for Eliquis 5mg BID.

Renal infarction, or a blood clot in my right kidney; Renal infarction, or a blood clot in my right kidney; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6206) via an unspecified route of administration in left arm on 17Mar2021 at 12:00 (at age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included patient had known allergies to shell fish. Concomitant medication included vitamins NOS (MULTIVITAMINS), daily. Patient did not receive other vaccine in four weeks of vaccination. Medications received within 2 weeks of vaccination included vitamins NOS (MULTIVITAMINS), daily. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, since and post vaccination. On 22Mar2021 at 08:00, patient experienced renal infarction, or a blood clot in right kidney. On 23Mar2021, patient admitted to the emergency room due to event. Treatment received was blood thinners. Outcome of event was recovered. Follow up attempt is excepted. Further information is requested.

Two days after vaccine I was having trouble breathing, irregular heart beat, congestion, bloating, swelling. Went to hospital and nothing was found in tests. A month and a half later I was having similar symptoms and went to the hospital where they found I was having heart failure. My heart was preforming 10-15%.

Anaphylaxis Please note previous VAERS report of Bell's Palsy 8 days following the first dose and subsequently treated with prednisone and valacyclovir. This neurologic diagnosis was not reported by the patient during the consent process with the COVID19 vaccination center staff. Confirmed following review of the consent form. Documentation from Emergency Department Provider: Patient is serially reassessed following treatment for anaphylaxis. Patient has significant improvement in diffuse erythema and hives within 20 minutes. He has gradual improvement in his sensation of throat swelling. He is observed while in the emergency department serially over 4 hours with no recurrence of symptoms. He does not require any repeat dose of epinephrine and feels at baseline. Discussed my suspicions that patient may have had a reaction to COVID-19 vaccine as he has had no other new medications or exposures that he is aware of. As he will not be receiving another vaccine there is nothing to necessarily stay away from. Make sure he notifies individuals about this for any new vaccine should he receive them. Patient is observed for sufficient time but discussed possibility for biphasic reaction. Recommend he return should he have recurrence of symptoms. Recommend he take EpiPen as prescribed for any throat swelling or progressive shortness of breath. Recommend follow-up with a primary care provider for this visit..

Bilateral lower thigh soreness starting 2 days after vaccine (12/21/20) subsequently developing into severe bilateral lower thigh pain and cramping 3 days after the vaccine (12/22/20) persisting for approximately 2 weeks. Confirmed as rhabdomyolysis with elevated CK on 12/29/20, and saw physician on 1/2/21, with subsequent downtrending CK but elevated on 1/2/21.

Heart swelling (pericarditis) , abnormal EKG showing STEMI initially on Saturday approximately 3 days after 2nd vaccine dose administration.

Pt is a 33 y/o male who presents to the ED with c/o of left le swelling progressing over the last 4 days. Pt has no other c/o. Denies fever, cough, cp, abd pain, n/v/d. Pt has had his first COVID vaccine 1/30. Patient was noted to be tachycardic to the 120's in the ER, after 1L of normal saline still tachycardic to the 110's. Lower extremity doppler was negative for DVT, however PE protocol CTA of the chest was positive for a PE, report follows. Patient was given lovenox and flown to Medical Center for higher level of care.

Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Severe, Additional Details: Approx. 15 minutes after getting his COVID vaccine pt. notifed clinic staff that he was feeling unwell and his heartbeat was irregular. Pt. then started to collapse and after being assisted to the ground had a seizure lasting approx. 10 seconds. After waking back up from seizure pt. had trouble breathing. Clinic staff notified me and I immediately administered 0.3 mg of epinephrine via an auto-injector. 911 was called and Pt. was able to sit back up while he waited for EMS.

I developed atrial fibrillation which is ongoing several months later; This is a spontaneous report from a contactable Physician. A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) on 22Dec2020 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included colitis ulcerative. Concomitant medications included mesalamine. On 31Jan2021 developed atrial fibrillation which is ongoing several months later. Treatment received included metoprolol, sotalol. At the time of the reporting the patient had not yet recovered from the events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt was advised to set down in the waiting area for 15 minutes to be monitored, once in a sitting position patient started convulsing into a grand mal seizure, I immedietly ran to him, started restraining him and holding his head to prevent him from hitting the wall, patient was laid flat and restrained by family members and the nurse practitioner, seizure lasted for les than a minute, and patient started to regain consiousness. called 911

On April 6 a.m. developed fewer-like symptoms with muscle pain typical foe fewer with these symptoms steadily worsening by evening. Night shower at appr. 9 p.m. caused a feeling of spinal nerve pinch followed by acute pain during certain movements and breathing. Following day (Wednesday) spent in bed taking Ibuprophene thinking is just a nerve pinch. Called virtual appointment tele doctor who prescribed Katorolac which I took from Wednesday night to Thursday morning per prescription with no effects. On Thursday evening called tele doctor again and got Ibuprophene 800 mg prescription. It helped for 20-30 min only. Same evening coughed some blood. On Friday kept taking Ibuprophene for very temporary relieve. On Saturday April 10 was admitted to hospital and was hospitalized with blood cloth diagnosis for 4 days.

My husband had an anaphylactic reaction within 30 minutes of receiving the Pfizer vaccine. EMS was called and he was taken by ambulance to the hospital. He was having trouble breathing, felt pressure in his chest, was light headed, started having severe chills and heart rate was elevated above 100 beats per minute. Benadryl was given on the way to the hospital and once at the hospital they gave him Tylenol, Pepcid, toradol and solu-medrol.

I have developed an illness closely resembling pneumonia; This is a spontaneous report received from a contactable consumer (patient). A 32-year-male patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration, administered in Arm Left on 02Apr2021 15:00 (reported as 3:00 PM) (Batch/Lot Number: Unknown, reason=Misplaced/discarded) as SINGLE DOSE for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient had no known allergies, not tested positive post vaccination, no covid prior to vaccination and no other vaccine in four weeks. The patient's concomitant medications were not reported. The patient reported that: "i have developed an illness closely resembling pneumonia " on 04Apr2021. The outcome of the event was not recovered. There was no treatment for the reported events. The event resulted in Emergency room/department or urgent care. Information on the lot/batch number has been requested.

pt says that he started getting a blood clot and his left hand wrist. He had this for 2 days. It disappeared and then the next day he discovered he had another blood clot on his right hand palm. He says it is a bump and he can see the blood clot under the skin. Pt will contact his PCP.

fear of death/doom; I went into a full Anaphylaxis shock; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0150) via an unspecified route of administration, administered in Arm Left, at the age of 32-year-old, on 06Apr2021 09:45, as SINGLE DOSE for covid-19 immunisation. Medical history included allergy to shrimp. The patient was not diagnosed with COVID nor was he tested post vaccine. The patient's concomitant medications were not reported. On 06Apr2021 at 10:00 am, 15 mins after the vaccine, a large hive appeared on his forehead and then 1.5 hours later the patient went into a full Anaphylaxis shock with difficulty breathing, throat closing up, fear of death/doom, tingling sensation in whole body, heart pounding rapidly, chest pain, dizziness. The patient went to the emergency room/ urgent care and was hospitalized for 1 day. Therapeutic measures taken in response to the events included administration of Steroids, antihistamines, and pain killers. Outcome was recovering at the time of the report.

rhabdomyolysis; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated, "These symptoms could be unrelated to the vaccine, but I believe they are worth reporting as they occurred after the vaccination." On 16Apr2021, the patient experienced rhabdomyolysis and currently have ongoing muscle pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and hospitalization for 1 day. The outcome of the events was not recovered. No treatment was given to the patient for the events. Information on the lot/batch number has been requested.

33 year old healthy man presented with seizure to Hospital ER on 5/7/2021. He required intubation. CT scan and MRI of brain showed dural venous sinus thrombosis along the anterior to mid aspects of the sagittal sinus. CBC was normal at presentation with WBC 13.9, HGB 16.1 and PLT 367k. He was admitted on unfractionated heparin. Repeat platelet count on 5/8/2021 was 153k. HIPA was negative. Patient was extubated and continued to improve. He was put on warfarin and sent home. He has some mild personality change in the immediate weeks of discharge. Hypercoagulable workup had normal Prot S & C activity, normal ATIII activity. The Factor V Leiden and Prothrombin Gene were negative. The homocysteine level was elevated at 16.3.

Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient brought in by ambulance to emergency department (ED) for generalized tonic-clonic seizures. Patient experienced first seizure and treated, evaluated, and released from ED at another facility. Patient experienced another seizure at home and brought to this facility. Patient experienced a third seizure in the ED, antiepileptic medication was initiated, patient was admitted then discharged the next day stable on antiepileptic medication and follow-up in place. On subsequent follow-up visit with primary care patient reported no seizures but back pain. Found to have a thoracic compression fracture from seizures prior to hospital admission. On neurology follow-up continues to be seizure-free and compliant with antiepileptic medication. Diagnosed with focal epilepsy and will continue to be followed by outpatient neurology.

Cardiomyopathy Severe Sepsis CHEST X-RAY MEASURE OF CARDIAC SAMPL & PRESSURE, L HEART, PERC APPROACH FLUOROSCOPY OF LEFT HEART USING LOW OSMOLAR CONTRAST FLUOROSCOPY OF MULT COR ART USING L OSM CONTRAST

Patient died we think on March 27th although he wasn't found until March 28th. We are waiting for the histology report on his cardiac tissue samples. We are suspecting myocarditis.

Severe Right sided chest pain, right sided muscle spasms and difficulty breathing two weeks after vaccine was administered Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively improved over days. Was discharged after 6 days on admission. Was discharged on oral anticoagulant (Rivaroxaban aka xarelto)

10 hours after receiving injection, spontaneously began feeling cold, shivering to rigors, rapid heart rate increased respiratory rate, lips and nail bed dusky, T37C. Took to ER, Temp 101 F and experienced a grandmal seizure, lasting approximately 1 minute of vigrous movement. froathing and flaying . Temp up to 103F. tachycardia and SOB, PO2 in 90's blood pressure low 78/45 88/50 after 3 liters of fluid up to 100/50. Chest Xray, EKG, multiple labs blood and one urine text.

Pt is currently hospitalized under my care with new onset thrombocytopenia, with platelets at 19,000. He has abdominal pain, nausea and vomiting, and diaphoresis with chills. No symptomatic bleeding at this time. Did admit to nose bleed a few days prior to admission.

At 09pm experienced a severe fever. (the type i experienced with Sepsis) No other symptoms. It was a debilitating fever with chills and severe shaking. I took acetaminophen with some crackers and plenty of water at 10pm. Fever broke by 01am. I followed with a more water and ibuprofen and fell asleep around 02am. Following morning, I feel pretty good, slightly tired but other wise normal. I have had no gastrointestinal or noticeable issues before or following. The episode was near the point of going to ER. It was something utterly unexpected and I've never experienced a fever with no cause.

Morning of April 4, pt experienced a full aching in his right side (front, below shoulder, above ribs). This went away after a few hours. Around 1 am EDT on April 7, the pain returned, slowly subsiding over the course of 12 hours. Between 6-7 pm EDT on April 7, a new more intense pain started in his mid-back, right side accompanied by shortness of breathe. We took him to the ER where he was diagnosed with three pulmonary emboli. He was given blood thinner tablets and send home with prescriptions for more thinners and pain medications. 1.5 days later, his pain has not subsided. He is also protein s deficient and has fact v leiden (homozygous).

Healthy male, no substance use, no symptoms reported made plans to go hiking with a friend the following Sunday (4/18/21) on 4/16/2021 in afternoon. This was last known contact, patient stopped responding to phone after text and was found deceased in home on 4/22/2021, appearing to have passed away in sleep, likely 4/16/2021 in evening.

Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED "He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole." ED called time of death on patient 04/18/2021 at 05:14AM.

Blood clot in right lung; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204; Expiration date was not reported) on the right arm on 26Mar2021 (18:45) as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 31Mar2021, the patient had blood clot in the right lung. The event resulted into doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care, and the patient was hospitalized on an unspecified date in 2021 for two days due to the event. The patient did not receive any treatment for the event. The outcome of the event, 'blood clot in the right lung', was recovered on an unspecified date in 2021 with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination, and had tested negative for COVID-19 nasal swab test on 01Apr2021.

Patient was hospitalized with lower extremity DVT and bilateral pulmonary emboli. He is young and previously very healthy and has no risk factors for venous thromboembolism.

My entire world has unraveled since getting this shot. Been to 4 ERs for systemic inflammation and neurological symptoms. Written off a psycho and about to be committed, but was brilliant. I believe I was given an undiluted dose of Pfizer without diluent, and became psychotic, and furthermore I believe my parents, who also got it, have had their judgement affected as well. They have been a lot less urgent with concern for their welfare of me since the shot. All they do is sleep all the time, wouldn't take me to the ER even when I was having trouble reading and staggering around. I understand I have no credibility here, but please look into this matter seriously, and not just the ravings of a crazy person.

Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021.

Pain in upper part and side by his ribs, into the back; Pain in upper part and side by his ribs, into the back; blood clots in the lungs; Breathing was not normal; It felt like in his back, like the muscles were too tight; This is a spontaneous report from a contactable consumer (patient's mother). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm on 17May2021 (late morning or early afternoon) at age of 33-year-old at single dose for COVID-19 immunization. There was no additional vaccines administered on same date of the Pfizer suspect. Medical history included the patient was diagnosed with COVID-19 in May2021, 15 days before the patient received the vaccine, he was doing very well, it was a light case. There were no concomitant medications. There was no prior vaccinations within 4 weeks. After vaccination, the patient was feeling much better afterwards and felt fine. The patient did not think too much of it. As the day went on, it got worse. The patient had a very serious reaction. The patient had a blood clot in the lungs on 18May2021 and was in the hospital. It was very scary. It was referring to the Pfizer COVID 19 vaccine. The patient received it in (withheld). 15 days before the patient received the vaccine, he did have COVID. The patient's doctor recommended it was ok to go back to work and to have the vaccine. The patient had the vaccine on 17May2021 and by 20May2021, he was in the hospital with blood clots in the lungs. The lung doctor was saying that the blood clot came from the vaccine. The patient had to take blood thinners for 3 months and they are concerned about the long term. The patient was in the hospital for 2 days, in (withheld) from 18May2021 to 20May2021. On 20May2021, the reporter brought the patient home. The patient was in so much pain, reporter took him back in the morning of 21May2021. For event blood clot, it had been 2 weeks. The patient went to work and came home on 18May2021 that day early from work, around 5:00 pm, having pain. The patient called the doctor who said to take paracetamol (TYLENOL) and go to bed. By that evening around 10:00 pm, they ended up taking him to the hospital, where they said he had blood clots. His pain was in the upper part and on the side by his ribs, into the back. The reporter thought at first, it was more to the left but patient was in so much pain, she really could not tell. They said the patient had 2 blood clots, one was on each lung, but they were so small. The pain was so severe. They took the patient to the hospital and he was there 2 days. On 20May2021, they released the patient. When they went to get him on 20May2021, reporter noticed that something was wrong. They gave the patient medication, a prescription pain pill. By the morning of 21May2021, around 06:00, they took him back to the hospital. They did blood work and another CT scan, and said there was no change. When they finally got the patient back into the room, they gave him some type of injection to release the pain. The reporter literally had to call another hospital, who told her to call the nurse supervisor. The reporter was outside calling the nurse supervisor for the emergency room. Then, they said that someone would come out. It had to go that far. After that, when they gave the patient the shot, the pain did subside. When it started to ware off, they gave the patient pain medication. On 22May2021, the doctor called to check on the patient. The reporter was concerned they gave the patient the shot too soon. The doctor said that it would take a while for the medication to take effect. It felt like in his back, like the muscles were too tight and the pain was so bad. The reporter had asked about a muscle relaxer and was initially told to wait until 24May2021 but then ordered a muscle relaxer and it did seem to help some what. On 22May2021, the patient started to feel like there was not any pain and his breathing felt normal. Before that (May2021), the patient's breathing was not normal. It all started happening and could not even explain when. The event blood clots in the lungs required a visit to emergency room for twice, the first time, the patient was admitted to hospital. Treatment included pain medication or muscle relaxers, apixaban (ELIQUIS) after the blood clots. The outcome of blood clots in the lungs and muscles were too tight was unknown, the outcome of rest events was resolved on 22May2021. Information about lot/batch number has been requested.

after I take the vaccine on the night I get high fever for tow days after that I get heart attack or similar I did Cath surgery then MRI after that they find Myocarditis because the vaccine

Pt received his second dose of Pfizer vaccine on 5/06. He has a history of COVID 19 infection in Sept 2020. He Was admitted to our hospital on 6/09 with a massive PE/saddle embolus and RLE dvt resulting in cardiac arrest, pt was resuscitated and remains with anoxic brain injury. No prior history or family history of PE/dvt. Mom did report a knee injury playing golf in the last month prior to presentation and his urine drug screen was positive for cocaine as other etiologies. Has a genetic hypercoag panel pending. Neg for Antiphospholipid ab.

Other diseases of bronchus, not elsewhereclassified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hypertensive heart disease with heart failure Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Heart failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ABG (arterial blood gas) abnormal Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute kidney failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Polycythemia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hyperglycemia, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ARDS (adult respiratory distress syndrome) Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Shock Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Acute respiratory failure Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Aspiration pneumonitis Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Abnormal CXR Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Cardiogenic shock Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Cardiac arrest Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Pulmonary infiltrate Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Aspiration into airway Onset: 17-Apr-202112:23 Abnormal EEG Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Encephalopathy Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Acute thrombosis of right cephalic vein Onset: 19-May-202111:49 Comments: Onset Date: 20210425 Cardiomegaly Onset: 30-Apr-20216:24 Comments: Onset Date: 20210426 Ventricular fibrillation Onset: 29-Apr-20212:21 Comments: Onset Date: 20210427 Coma Onset: 27-Apr-202114:09 Comments: Onset Date: 20210422 Postoperative hemorrhage involving circulatorysystem following circulatory system procedure Onset: 26-Apr-202112:27 Comments: Onset Date: 20210421 Personal history of ECMO Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Presence of ventricular assist device Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Frequent PVCs Onset: 24-Apr-202112:49 Comments: Onset Date: 20210424 Presence of other vascular implants and grafts Onset: 24-Apr-20215:43 Comments: Onset Date: 20210418 Obesity, unspecified Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Body mass index [BMI] 45.0-49.9, adult Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Hyperthermia Onset: 23-Apr-202121:40 Comments: Onset Date: 20210419 Ventricular tachyarrhythmia Onset: 23-Apr-202112:14 Comments: Onset Date: 20210423 This code is used to indicate to the billing staff thatservices have been rendered and the chargeneeds to be coded. Onset: 22-Apr-202113:08 Comments: Onset Date: 20210421 Cardiomyopathy Onset: 22-Apr-202111:48 Comments: Onset Date: 20210422

My adverse event began on 2/5/2021, I started feeling bloated and nauseous and later on in the evening, I found it was difficult to lie flat. This difficulty increased along with some sharp chest pain until I went to the ER 2/7/2021. CT scan was done of the abdomen was clear and chest was full of clots. CPA showed mild clot burden. Ultra sound in both legs showed negative and ECG was clear. Physician stated it looked like something that would have been something they see with COVID infections.

Anaphylactic reaction (throat swelling), sweaty, cold skin, elevated blood pressure (211/137 mmHg) gradual onset within 15 minutes of vaccine administration.

Muscle pain and weakness beginning 2/28/2021, hospitalized 3/2/2021-3/8/2021 for rhabdomyolysis (peak CK = 112,000) and severe transaminitis (ALT and AST in the 2000's). No preceding injury or trauma, no drug or excessive alcohol use. By 3/19/2021 patient still unable to get out of chair without using arms, significant proximal mm weakness. Inflammatory markers elevated and CK and liver enzymes still surprisingly high. Re-hospitalized 3/22/2021. Still in hospital, improving, on date of report (3/23/2021).

34 y.o. male with history of depression admitted to the hospital on 4/23/2021 for chest pain and leg pain found to be due to Deep Vein Thrombosis and bilateral Pulmonary Embolism. Patient started on heparin infusion in the hospital with stabilization of vital signs then transitioned to apixaban at DVT/PE dosing prior to discharge

34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout.

Death. Coroner said collapsed of unknown cause. Autopsy performed. Awaiting final report and toxicology report.

Systemic: Stroke-Severe, Additional Details: pt says he experienced a stroke ~5 hours after receiving the second pfizer shot. pt did not mention experiencing a stroke after the first shot

As a clinical monitor, I was called over to assess a driver slumped over in his seat. He had just received the second dose of the Pfizer vaccine approximately 10 minutes earlier. The passenger (his fiance) said he was acting normal until she heard him grunt and then realized that he was passed out. While attempting to lay flat, I performed a jaw thrust that yielded a stridulous inspiration but was still unresponsive. He did not have a palpable carotid pulse. Paramedics was summoned emergently. Within 30-45 seconds, he awoke but was confused and amnestic to the event. He had no physical complaints and no significant medical or allergy history. I auscultated his larynx (no stridor) and his lungs (CTA). His initial vitals: BP 90/51 HR 61 VR 16 SaO2 100% An electrocardiogram demonstrated a sinus rhythm without ischemic changes or evidence of conduction delay. His glucose was 119. Over the next 30 minutes, he was able to drink two bottles of water and some orange juice. That said, he still said he "felt off." Repeat vital signs: BP 118/62 HR 69 SaO2 100%. The medics advised him to follow up with his doctor, preferably today. His fiance agreed to drive him to an ED near their home for a more thorough evaluation. I provided her my phone number to provide to the ED for any questions. His clinical syndrome was consistent with a syncopal episode associated with orthostatic hypotension. Low suspicion for anaphylaxis.

Emblematic stroke in vision and language centers of brain causing blurred vision and aura as well as facial droop and slurred speach.

Got anaphylaxis 24 hours later; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0164) via an unspecified route of administration administered in left arm on 20Apr2021 at 14:15 (at 34 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included mast cell activation disorder from unspecified date. "Known allergies: with mast cell disorders possible everything and nothing" (as reported). The patient's concomitant medications were not reported. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient got anaphylaxis about 24 hours later, which was considered serious medically significant on 21Apr2021 at 03:00 requiring emergency room visit. The patient reported he had mast cell activation disorder and got anaphylaxis about 24 hours later. The patient suspected to have more than one tryptase alpha/beta 1 (TPSAB1) gene need genetic testing to confirm thus more hemagglutinin receptors that the spike protein attached to. Outcome of the event was unknown.

Myocardial infarction RCA with immediate angioplasty. 100% occlusion. CFX and LAD totally clear. Initial troponin ~5.7 x ULN.

Pt developed rash throughout whole body, with fever and chills. Eventually pt seeked medical attention at ER where pt got prescribed Benadryl and Azithromycin. Wife states pt was diagnosed with pneumonia from vaccine. Two days later pt got prescriptions for prednisone and glipizide

anaphylactic reaction; about to black out/lost consciousness; cold sweats; had a hard time /trouble swallowing; turning pale; his pupils were dilated; This is a spontaneous report from a contactable Pharmacist via Medical Information. This Pharmacist reported for two patients, this is the first of two reports regards to a male patient. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Jun2021 between 10:00 and 11:00 am, maybe around 10:30ish (Batch/Lot Number: EW0178; Expiration Date: Aug2021, NDC number: 59267100002) as 1ST DOSE 0.3ML, SINGLE for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. A pharmacist from pharmacy had 2 patients who received the vaccine and both had a reaction after the dose, within one hour after receiving the dose, and EMS was called. The pharmacist confirmed the first patient had the reaction within 1 hour of receiving the dose. She clarified this person was having cold sweats, about to black out, had a hard time and trouble swallowing and was turning pale, his pupils were dilated. Pharmacist explained they make them sit there for 15 minutes after receiving the vaccine so this reaction happened maybe 3 minutes after he got the shot. The EMS came and he was brought to the hospital. The patient did come back afterwards and he said the doctor didn't know 100 percent what happened, but it might been a slight allergic reaction, not to the point where he lost consciousness, but they did release him. She clarified they checked his vitals and everything and released him. When pharmacist was probed for the event, the pharmacist thought it was an anaphylactic reaction. The events require a visit to Emergency Room, patient was brought by EMS. Not had a visit to Physician Office. Unknown if patient received treatment, the pharmacist wasn't be told that much information. The outcome of events was unknown. Causality: In this case, pharmacist did not think so. She thinks maybe it was anxiety but she wouldn't know.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021646208 same reporter, product, different patient and similar events.

I suffered from acute Idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable consumer (patient). A 34-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 18May2021 10:00 (Batch/Lot Number: EW0177) (at age of 34 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was none. Known allergies was none. 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. Other concomitant medications the patient received within 2 weeks of vaccination included vitamin C gummies. The patient suffered from acute idiopathic thrombocytopenic purpura on 18May2021 19:00. At the end of the 18th, patient noticed spots on arms and legs, about the size of the average mole. Later, gums bled and patient had blood blisters in mouth, from 1 to 3 after rinsing with listerine. The next day, he noticed more spots on feet and lower legs, similar to freckles. By the end of the day, his gums were bleeding unprovoked and he had hematuria. The bleeding continued and he went to the ER the following day and was informed that his platelet count dropped to 0. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Number of days of hospitalization was 3 days. Treatment received for the adverse events included Intravenous Immunoglobulin and steroids. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information on Lot/Batch number is available; Further information has been requested.

Heart attack; he is in the hospital, fully on life support; he has his kidneys and liver are failing; he has his kidneys and liver are failing; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. Medical history included Anxiety, depression. Concomitant medication included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccine within 4 weeks Prior to Vaccine. Reporter stated, is it possible for heart attack to happen 8 days after the vaccine. reporter want to report a reaction, because reporter think it was vaccine reporter wanted to make sure, repoters brother is 34 and he had a heart attack yesterday and he received his vaccine (Confirmed as Pfizer Covid 19 vaccine) 8 days ago, he received his vaccine before his heart attack. Reporter stated, patient has his kidneys and liver are failing, he said they did the lab work really done, he is still waiting to get echo that for his heart. Patient is completely on life support, he still in the hospital. The patient underwent lab tests and procedures which included echoencephalogram: unknown results, Therapeutic measures were taken as a result of heart attack. The outcome for the events he has his kidneys and liver are failing was reported as unknown and for remaining events outcome was reported as not resolved. Information on the lot/batch number has been requested.

After the administration of the vaccine, while waiting for the observation time, I lost consciousness for more than two minutes, I completely fainted and all my muscles contracted until they were rigid. From the symptoms the doctor said it was a tonic-clonic seizure, and that it was a side effect of the vaccine. They told me I turned purple, stopped breathing, and exhaled the remaining air until I stopped breathing for about 30 seconds until then I came back to my senses. The firefighters examined me and all my vital signs were fine so they recommended that I go home and rest.

On Friday I was dianogosed with Bell's Palsy.; On Thursday night i started showing signs of a full-blown stroke; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 34-years-old male patient received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, tch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Right on 11Jun2021 12:00 (at the of 34-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with covid. The patient had no allergies. Since the vaccination, the patient had not been tested for covid 19. The patient previously took BNT162B2(Pfizer covid vaccine, formulation: solution for injection, lot number=EW0168) via unspecified route of administration, administered in Arm right on 19May2021 12:00 as DOSE1, SINGLE for covid 19 immunisation. On 22Jun2021 at 19:00, the patient experienced having issues with his eye. It would look like it was cloudly and he could not blink and eye disorder. On 23Jun2021 , Wednesday, the patient experienced issue with his eye and got worse. On 24Jun2021 Thursday night, the patient started showing signs of a full-blown stroke. On 25Jun2021 Friday, patient was diagnosed with bell's palsy and on Wednesday the issue with eye got worse. The outcome of the events was not recovered. Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected.

RN administered Epi pen at 1059 r/t PT demonstrating difficulty swallowing/anaphylatic reaction. Rapid Response was called. PT stated he was feeling better as demonstrated by breathing and swallowing without difficulty, pulse WNL. PT was taken to the ED by RR Team for further assessment/observation. Was DC'd from ED after reassured that was feeling fine. Solumedrol adn benadryl given in ED. DC'd with epipen, benadryl, prednisone, and famotidine.

Severe muscle soreness in left calf starting on 4-14; continued for several days, leading to ultrasound of the legs on 4/16. Two blood clots were found, one in the left calf, one behind the left knee.

History of Present Illness 34-year-old male with history of end-stage renal disease secondary to lupus nephritis (dx 2018) on MWF dialysis, morbid obesity, CHF with EF 45%, htn, SLE, who presents to the ED for shortness of breath and hemoptysis. Patient states that he has been missing dialysis for around 12 days. He does still make urine around 1/2L daily. He was brought into the ED by his uncle who he lived with. His uncle just got back to town and noticed that Javone had difficult time breathing, thus, brought him to the ED. Patient reports that he also has been having diarrhea, hemoptysis, fever, and shortness of breath for the past 2-3 days. He had Covid vaccination on 5/01 and 5/22. In the ED, he was found to be at 75% oxygen on 10L in the ED, improved to 84% on 15L non-rebreather. He was quickly started on BiPAP. VBG was significant for metabolic acidosis with respiratory compensation pH 7.304, pCO2 27.2, and HCO3 13.1. Labs were notable for Hgb 10.9, K 5.5, Cr 22.3, trop 60, and BNP 7281. Patient was admitted for acute hypoxic respiratory failure suspect secondary to fluid overload 2/2 missed dialysis vs Covid pneumonia.

Acute demyelinating encephalomyelitis; Slurring his speech; Stroke; This is a spontaneous report from a contactable physician. A 35-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in deltoid (unknown if right or left) on 17Dec2020 at 30 ug, single for 'Preventative'. Medical history included hypertension. There were no concomitant medications.(Physician) He is calling about the Pfizer Covid 19 vaccine. States what is going on with the patient may be associated as a side effect. The patient got the vaccine two to three weeks ago, he clarifies the patient received the vaccine on 17Dec2020 and the patient ended up acutely developing (states it is a presumptive diagnosis) Acute demyelinating encephalomyelitis, states it looks like a radiologic diagnosis. The patient is an employee at hospital. When querying seriousness states it is medically significant but could be disabling but he thinks the patient will recover. Reporter seriousness for acute demyelinating encephalomyelitis: Medically significant, Hospitalization. Patient was hospitalized on Sunday and he is still admitted at this time. Dates when patient was in hospital for acute demyelinating encephalomyelitis was from 03Jan2021 to ongoing. Caller thinks the patient was flown to (Place) yesterday. The patient's mother asked the caller if the caller thought the acute demyelinating encephalomyelitis was from the vaccine and the caller responded that he did not think it was from the vaccine. He confirms the patient is still admitted in the hospital and the patient's attending neurologist is doctor. The caller heard about the patient from doctor. When querying covid vaccine dose, the caller states the standard dose is 30 mcg. This was clarified and documented as provided. The patient has not received his second dose yet. He asks if the patient should receive the second dose. He asks a general question if a pregnant patient can be given the Pfizer covid vaccine. He heard the patient had a stroke then the CFO tried to talk to him and the patient was slurring his speech. Caller spoke to the patient's mother this morning and caller told the mother that he would try to find out what is going on with the patient. He asked that the patient get an HIV test even though he does not think the patient is at risk. Vaccination facility type was Hospital. Vaccine administered at military facility was No. None additional vaccines administered on same date of the PFIZER suspect. AE acute demyelinating encephalomyelitis require a visit to Emergency Room, not visit to physician office. Prior Vaccinations (within 4 weeks) was none. He has heard of acute demyelinating encephalomyelitis being associated with vaccines in the past and states that it is rare and usually in kids. States he saw patients that may have had acute demyelinating encephalomyelitis back in the 80s and 90s. Therapeutic measures were taken as a result of acute demyelinating encephalomyelitis (Patient will get steroids tonight pending the review of the x-ray). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported stroke with speech slurred, and the presumptive diagnosis of acute demyelinating encephalomyelitis (looks like a radiologic diagnosis by the reporting physician), was most likely an intercurrent disease, and unlikely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient thought he sat in chair in observation area but he fell on the ground and began to seize. Multiple nurses and EMTs responded and found the patient in tonic-clonic seizure. Pt continued to seize for about 10 seconds and upon exiting the seizure he reported that this happened about 4 years ago The patient repeatedly declined to be transported to the hospital.. He was incontinent and finally he agreed to be transported to a nearby hospital to be checked out.

4 days after vaccination, patient presented with dyspnea and chest pain, was found to have bilateral pulmonary emboli. Was admitted the following day after re-presenting with worsening symptoms and hypoxemic respiratory failure. He was hospitalized one day and then discharged.

DVT blood clot formed in left leg, intense pain started almost 14 days after vaccine. No history of any health concerns with blood clots, healthy 35 year old male who works out and diets. No long drives or sedentary lifestyle.

Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Urinated in the event of fainting-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe

Patient received his 2nd dose of the COVID vaccine (pfizer) on 4/29/21. The next day he developed a fever of 103 F which lasted about 36 hours. He felt achy and generalize malaise and felt sweaty in the evening on 5/1. Presented to ED on 5/2 with chest pain and shortness of breath. Patient given nitro x3, asa, and heparin gtt and transferred for ongoing management of NSTEMI. Family history of CAD; grandfather and all 6 of his brothers died from heart attack

35 year old male without a significant health history, who had his second dose of the Pfizer vaccine 4 days prior to admit on 4/30/2021. Since his second vaccine dose, he started having generalized chest/abdominal aching, chills, body aches, nausea/vomiting. On the day of admission, he awoke with numbness in his right and left upper extremity. In the ED, his ECG showed NSR with anterior and inferior ST elevation. Troponin elevated to 3.99, trended down. Echo normal. Cardiac MRI suggested myocarditis. He was started on colchicine 0.6 mg BID with resolution of his symptoms.

Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient presents to emergency department (ED) reporting sudden onset severe chest pain, emesis, numbness/tingling of arms, and nausea. Initial vital signs: pulse = 90 beats per minute, blood pressure 142/100 mmHg, oxygen saturation 95% on room air. Patient admitted for management of NSTEMI: differential includes myocarditis.

4th day after vaccine. Shortly after waking up in the morning I had a heart attack. Afterwards I entered the ER and stayed overnight for 2 days. I had a series of blood work done. CT scan, Chest X-ray, Angiogram/Hearth Catheterization.

He died. He got the shot then several hours later he was found DEAD in his sleep. We are still awaiting coroners reports.

May 11th had the worse headache of my life. Went to ED. CT scan showed SAH in right frontal/parietal regions. MRA showed multifocal venous sinus thrombosis. Partial thrombosis of superior sagittal. Heparin gtt and sent home on Lovenox BID

According to my wife, 10 minutes post shot I had what appeared to be a mild seizure and lost consciousness for 1-2 minutes. Prior to that happening, I told her I felt light headed. She notified personnel while we were in the 15 min wait holding area and when I regained consciousness two EMTs were checking me out. They took my vitals, asked me questions and had me get out of the car and walk around. I was monitored for several minutes. It was recommended I visit a hospital or urgent care if I continued to feel unwell. My wife & I left the vaccine site and decided on the way home to go to the hospital just to ensure everything was all right. We went back home for about 30-60 minutes. During this time my heart rate continued to remain elevated and it felt like I had adrenaline coursing through my system. I attributed the feeling to recovering from passing out, but it did not dissipate. Upon arrival to the ER I began having trouble trying to breathe and chest pain. During the triage EKG it was discovered I was experiencing atrial fibrillation. I was given treatment, fluids and monitored for several hours before being released. Estimated time from receiving shot to being diagnosed with afib was approximately 2.5-3 hours.

Grand Mal seizure; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 28Apr2021 at 14:00 (lot number: EW0158) at single dose for COVID-19 immunization. The relevant medical history included epilepsy, childhood leukemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), all from unspecified date. Concomitant medications included lamotrigine (LAMICTAL ODT). The patient experienced Grand Mal seizure and heart palpitations on 29Apr2021 at 18:00. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.

started as severe dizziness and weakness, chest pain was hospitalized once I got to the ER because my heart was not working properly, after many test the found my heart was in heart failure with an output of 35% only, was in hospital for 5 days. Doctors couldn't see what caused such a sudden weakness of the heart, they did cardio path and arteries have zero blockage, they did ECO, and a EP Study. My heart now suffers from PVCs or arrhythmia and they are very irregular and frequent. Was given medicine to help the heart and control the PVCs, and discharged with wearing a safety vest, to follow up with the cardio doctors. Followed up with doctors and they have done an MRI which shows scarring of the heart. The doctor has determined that the diagnosis is myocardiatis. There is no proof this direct relation with the vaccine, however symptoms started soon after the vaccine in a healthy young man. Now I still have to go to another electrophysiologist to see what he can do to help alleviate the PVCs and continue to take the medication to see of the heart can improve. I could not work for a month, and still cannot resume normal activities because my heart is to weak to sustain it.

This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 31Mar2021 09:00 (at the age of 35-year-old) (Batch/Lot Number: ER8730) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included hypertension. Concomitant medication included ascorbic acid, beta carotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient previously took bactrim and experienced allergies. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN 6206), administered in left arm on 10Mar2021 at 08:45 AM (at the age of 35-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. On 27Apr2021 at 08:00 AM, the patient experienced bilateral embolisms (blood clots in lungs) and also had blood clot in left leg. Symptoms before diagnosis included dry cough, coughing up blood, chills, fever, body aches, and body pains. The events caused hospitalization. The events resulted 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 COVID-19 test via nasal swab post vaccination which was negative on 29Apr2021 and on 07May2021. Therapeutic measures were taken as a result of bilateral pulmonary embolisms and had blood clot in left leg, chills, and body aches/body pains which included Lovenox injection (blood thinner) and Tylenol for pain. The patient was recovering from all events.

Heart attack (complete blockage in LAD artery). Symptoms began Wednesday 5/12 with elevated heart rate/chest tightness. Went to ER on Friday 5/14 and received two stents via cardiac catheterization.

feels like a blood clot; My right calf has felt strange ever since the second dose and it feels like a blood clot/toes also felt strange/My toes also felt strange for a few weeks but that subsided; a tightness in the leg that doesn't want to go away; This is a spontaneous report received from a contactable consumer. This consumer reported for himself that the 35-year-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:00 (Batch/Lot Number: 6203) as 2nd dose, single for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer COVID 19, Lot number=9265) on 01Feb2021,01:00 PM,in Left arm for covid-19 immunisation. The patient experienced feels like a blood clot on 23Feb2021 with outcome of not recovered , my right calf has felt strange ever since the second dose and it feels like a blood clot/toes also felt strange/my toes also felt strange for a few weeks but that subsided on 23Feb2021 with outcome of not recovered , a tightness in the leg that doesn't want to go away on 23Feb2021 with outcome of not recovered. No treatment received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. The clinical course was reported as follows: My right calf has felt strange ever since the second dose and it feels like a blood clot. There is a tightness in the leg that doesn't want to go away. My toes also felt strange for a few weeks but that subsided. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. Follow up letter has been generated for further information.

About 2 weeks after second dose, experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents.; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 12:45 (Batch/Lot Number: EW0179) as single dose at the age of 35-year-old for COVID-19 immunisation, administered at School. Medical history included pre-diabetic. Patient had not COVID prior vaccination. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT, Inhaler) taken for an unspecified indication, start and stop date were not reported. The patient previously took garlic [allium sativum] and experienced drug hypersensitivity. Vaccine history included bnt162b2 (BNT162B2), dose 1 in right arm on 08Apr2021 02:30 PM (Batch/Lot Number EW0158) for COVID-19 immunisation. No other vaccine in four weeks. About 2 weeks after second dose, on 12May2021 the patient experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The event outcome was recovered with sequelae. The patient was hospitalized for the events for 4 days. The patient underwent lab tests and procedures which included: Sars-cov-2 test (nasal swab): negative on 14May2021. Therapeutic measures were taken as a result of the event, which required cardiac catheterization with two stents.

My first COVID19 Pfizer vaccine shot was on 4/05/21. My second was 3 weeks later on 4/26/21. About 30 hours after my second vaccine on 4/27/21 I started to notice tightness around my lungs/rib cage in the intercostal muscle area. For the next few days the pain increased and I had shortness of breath as well. After a few nights I couldn't lie down to sleep because of this pain so I had to sit upright to sleep. On 5/3/21 I went to the doctor at hospital where I was examined and had a lung X-ray as well as a COVID PCR test (it was negative). The PA diagnosed me with "Pneumonia" and I was given antibiotics (cefuroxime and azithromycin) to take for 6-7 days. I started feeling a little better by 5/6/21 and actually reported here on VAERS with my diagnosis of suspected Pneumonia. On 5/17/21 I had another lung x-ray at hospital and was told my lungs were looking more clear. However, for the next 2 weeks I felt more tired and my poor breathing, a cough with bloody mucus, and more chest/rib cage area pain developed. Despite being a professional runner it became hard to walk up a flight of stairs without breathing really hard and feeling light-headed. On 5/30/21 I woke up with fairly intense chest pain just under my heart. I was taken to the ER at second Hospital and got a CT scan with contrast that showed a bilateral Pulmonary Embolism with infract. An ultra sound of my heart (normal) and blood panels were performed as well as multiple EKGs. I was given a stomach injection of Lovenox also. That afternoon I was transferred to third Hospital. for overnight monitoring with more EKGs and Lovenox injections. Prescribed blood thinner Pradaxa for 3 months with no known cause of clots that caused this Pulmonary Embolism. Kidney test and Heart appeared normal. Still waiting on genetic testing. Lung infract has caused lasting chest pain and my breathing has yet to return back to normal.

blood clots forming in my lungs; Fatigue; Coughing; Pulmonary Embolism; Lower back pain; Experienced intense chest/ribcage and Lower back pain and tightness around lungs about 30 hours after 2nd dose of COVID19 vaccine. Trouble breathing too. Initially diagnosed with Pneumonia a week late; Experienced intense chest/ribcage and Lower back pain and tightness around lungs about 30 hours after 2nd dose of COVID19 vaccine. Trouble breathing too. Initially diagnosed with Pneumonia a week late; Experienced intense chest/ribcage and Lower back pain and tightness around lungs about 30 hours after 2nd dose of COVID19 vaccine. Trouble breathing too. Initially diagnosed with Pneumonia a week late; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Apr2021 11:15 (Lot Number: ER8729, at age of 35 years old) as single dose for COVID-19 immunisation. Medical history included mild asthma, mild allergy to latex. Concomitant medications included albuterol [salbutamol] taken for asthma; cyanocobalamin (VITAMIN B12); vitamin d. The patient previously received first dose of BNT162B2 on 05Apr2021 for COVID-19 immunisation (Brand=Pfizer ER8736; time: 11:15 AM; location: Left arm; Facility type: Hospital). The patient experienced intense chest/ribcage and Lower back pain and tightness around lungs about 30 hours after 2nd dose of COVID19 vaccine in Apr2021. Trouble breathing too. Initially diagnosed with Pneumonia a week later on 03May2021 by chest X-ray. Symptoms did not resolve after antibiotics and fatigue and breathing troubles got worse in May2021. Coughing also became a symptom in May2021. Also, lung pain intensified several weeks later along with chest pain. On 30May2021 was rushed to ER and diagnosed with bilateral Pulmonary Embolism via CT contrast scan. It appeared patient never had Pneumonia, but instead blot clots forming in his lungs on unknown date. It was also reported adverse event start date: 06Apr2021; Adverse event start time: 04:45 PM. Adverse events resulted: in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage] Hospitalization: 1 day. The patient underwent additional lab tests and procedures: COVID test post vaccination: Nasal Swab PCR on 03May2021 result: Negative; Blood test IGG IGM on 01Jun2021 result: Positive. The patient received treatment as Lovenox injections and blood thinner prescription. The outcome of events was recovering.

I'm a registered RN at medical center. I received two doses of Pfizer COVID vaccine. I had no pre-existing medical conditions. After couple weeks I developed sudden onset chest pain. I went to the hospital because I thought I was having a heart attack. I wet through a heart catheterization with no vessel blockages and my EKG was reading NSTEMI. I was hospitalized for a total of two weeks. I was on high doses of anti-inflammatory medication.

Experienced atrial fibrillation beginning in March 19 for approximately 4 days. Symptoms included lightheadedness and mild chest pain. General practitioner confirmed atrial fibrillation on March 22. Symptoms resolved on March 23 without treatment, before visiting a cardiologist.

My previously healthy brother received the Pfizer vaccine (1st dose) and 4 days after he was hospitalized with shortness of breath, heart failure, blood clots in his arm, lungs and leg along with a stroke and many medical conditions kept arising as he was hospitalized. He was in the CICU for a week and a half. Unfortunately, my brother passed away from the Pfizer vaccine. Until his last day the doctors still "didn't know" what was wrong with him. A lot happened during his hospital stay, but this is just a brief statement. They have been keeping his medical records from me. They tested him repeatedly there from covid and he wa salways negative. They had no other explanation to what was happening and all along they wanted it to be COVID-19 and were so quick to say it was not the vaccine.

DX: Myocarditis Onset of S/S 06/02/2021 S/S:Dyspnea on exertion, Fever/chills,Tachypnea Found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation. 35 year old man with medical history notable for likely untreated hypertension and tobacco use disorder who presented with reported fever, confusion, shortness of breath, and facial swelling, initially treated for allergic reaction/angioedema without effect, progressed to respiratory failure, found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation resulting in death. Regarding cardiac picture, patient with abnormal ECG, mildly reduced EF on echo (though could be due to untreated hypertension or to respiratory failure/critical illness), borderline troponin (need to check reference range). ED note initially mentions concern for myocarditis due to vaccine causing heart failure and subsequent respiratory failure, but appears this piece was written prior to MRI showing basilar stroke. Death note has myocarditis listed as a cause of death (among many), though a bit unclear if this was intentionally listed or just reflects a list of all hospital problems. Also had a CT of his head which showed scattered foci of gas within intraorbital soft tissues along with mild proptosis; unclear etiology for this (perhaps a fall with facial injuries prior to arriving at hospital?) Awaiting additional physician notes/imaging reports.

I was having episodes of dyspnea and non productive cough starting from 1/1/2021. On 1/13/2021 I experienced severe dyspnea and had loss of consciousness for 5 seconds and was found down. I was rushed to the hospital and diagnosed with multiple pulmonary embolus (about 9) which was treated with direct TPA via catheterization. I then recovered in the ICU and transitioned to oral anticoagulation and discharged home on 1/15/2021.

Vague onset of malaise, fever, exertional dyspnea, chest pain that progressed approximately 1-2 weeks after the 2nd dose of the Pfizer vaccine. Led to development of pericardial effusion with cardiac tamponade physiology, atrial flutter, and subsegmental pulmonary embolism. Workup of other causes of pericardial effusion (e.g., infection, malignancy, autoimmune), and hypercoagulability were otherwise negative. 2nd dose of vaccine was on 1/4/2021 and pericardial effusion was diagnosed and evacuated on 2/14/2021. Patient hospitalized from 2/14/2021-2/17/2021. Patient is also healthcare provider.

Please reference separately submitted MIS-A form. He had sore throat, high fever, diarrhea, deteriorating in to multisystem failure and apparent acute myocarditis, notably with relative initial sparing of the lungs. He suffered cardiac arrest in radiology after developing aphasia and was transferred to Hospital after cannulation for VA ECMO; he died there 2/8/21.

Received 2nd COVID pfizer vaccine approx 11:15am on 2/18/21. No known reaction from first dose on 1/25/21. Woke up morning of 2/19 and observed extensive petechiae and bloody nose consistent with low platelet count and ITP (immune thrombocytopenic purpura). I was previously diagnosed with ITP and platelet count was 262k confirmed by blood work a couple days before 2nd vaccine. Morning after got blood draw confirming platelets dropped to below 1k. Medical emergency and sent to ER. Admitted and received emergency treatment to increase platelet counts. Ended up requiring splenectomy on 2/22/21. Just discharged from hospital. Multiple medical providers advised me to submit report to VAERS.

Atrial fibrillation; This is a spontaneous report from a contactable consumer (reporting for himself). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204, expiration date: unknown), via an unspecified route of administration in left arm on 11Mar2021 at 12:00 as single dose for COVID-19 immunization. Medical history included gout. The patient's concomitant medications were not reported. On 12Mar2021 at 01:00, the patient experienced atrial fibrillation. The patient stated that it was his first time to have ever had any heart issues. The patient did not received treatment for the event. The outcome of the event was not recovered. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.

I had the 1st shot on Wednesday March 10th. On Sunday the 14th, just before going to bed at about 11pm, I went to pee. The urine was very dark brown. Didn't appear to have any red for blood. The next day I felt like water was being retained and it felt that I couldn't empty the bladder and pee was coming out slower than usual. Late Monday the 15th before bed I peed another dark brown urine and a red blood clot came out. At that point I became very concerned and sent to see the doctor on the 16th. Referred to a kidney specialist for March 31st. Between March 14th to March 29th , somedays I felt like I was retaining water, most days felt like I couldn't empty my bladder with slow flow. With the recent news of the concerns of blood clots with vaccines, I felt that I should report this.

Patient presented to outlying hospital on 3/31 for a 4 day history of nausea, vomiting, and confusion. Blood pressure in the 200s. Admitted for hypertensive urgency, renal failure, encephalopathy. By 4/3, patient was agitated and unable to recognize anyone but his mother. Fever 102.1. Intubated on 4/5 as he continued to worsen and responded only to painful stimuli. Patient transferred on 4/5. MRI demonstrated mutlifocal bilateral cerebral infarcts with vasogenic edema. Small infarct in the left cerebellar hemisphere. All workups so far have been negative. TEE being performed 4/20 to evaluate possible cardiac embolic source. Providers are unsure of etiology of infarcts and edema. Reporting per infectious disease physician's request.

admitted with stroke; He had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2021 (between his 1st & 2nd dose of Pfizer BioNtech).; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number; Unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE, dose 2 via an unspecified route of administration on 21Mar2021 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number; Unknown) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he had symptoms of an illness (perhaps covid like symptoms) starting on 19mar2021 (between his 1st & 2nd dose of pfizer biontech). (illness) on 18Mar2021, admitted with stroke (cerebrovascular accident) (hospitalization) on 08Apr2021. The patient was hospitalized for admitted with stroke (cerebrovascular accident) on 08Apr2021 in ICU currently/still as of 11Apr2021, not yet recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021, sars-cov-2 test: negative on 08Apr2021. Therapeutic measures were taken as a result of admitted with stroke (cerebrovascular accident). A 36 year old brother in law of my friend. He had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2021 (between his 1st & 2nd dose of Pfizer BioNTech). He went ahead and got his 2nd dose on 21March2021. He then went to see his dr in the last week (week of 05Apr2021 I believe) because of not being well. That primary care dr thought the patient had perhaps been exposed to covid between the 1st & 2nd doses (due to symptoms that the dr thought seemed like body's over-reaction to covid) but a covid test was done and it was negative. Then the patient has been admitted to (Hospital name) in (city name) (state name) suffering from a stroke on 08Apr2021. He still has not tested positive for covid (again) but he is in ICU at (Hospital name) with stroke symptoms. This was all related to my by the sister-in-law (my friend (name)). I wanted to report since the 2nd dose Pfizer BioNTech was taken on 21Mar2021 & then in hospital ICU with a stroke (at 36 yrs old) on 08Apr2021. Hospitalized for 4 days in ICU currently/still as of 11Apr2021, not yet recovered, admitted with stroke on 08Apr2021. The outcome of the event for illness was unknown and for stroke was not recovered. Information about Lot/batch number is requested.

Looked like he was in sepsis; thrombus occluding his IMV protruding into part of the SMV; Thrombocytopenia; Bacteremia with E. Coli; Unable to tolerate diet; Abdominal pain; Nausea; Vomiting; Muscle aches; Chills; Fever; This is a spontaneous report from a contactable physician. A 36-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 06Apr2021 at 10:00, at the age of 36 years old, for COVID-19 immunization. The patient's medical history included diverticulitis ongoing since 05Nov2018. Concomitant drugs included escitalopram oxalate (LEXAPRO) ongoing since an unspecified date. There were no other vaccinations 4 weeks prior to receiving BNT162b2. Two days after vaccination, on 08Apr2021, the patient developed nausea, vomiting, muscle aches, chills, and fever. The patient continued to have these symptoms and then developed abdominal pain on 11Apr2021, so the patient went to ER. Nausea, vomiting, muscle aches, chills, fever, and abdominal pain were reported as medically significant events. A CT of the abdomen and pelvis was performed on 11Apr2021, which seemed at that time to reveal only uncomplicated diverticulitis. Therefore, the patient was sent home with oral antibiotics. Then, the patient presented back to ER on 14Apr2021: the patient couldn't tolerate his diet and was experiencing worsening of abdominal pain. Another CT of abdomen and pelvis was therefore done on 14Apr2021, which this time revealed a thrombus occluding his IMV protruding into part of the SMV and the portal vein. In light of this finding, on 14Apr2021 the medical staff retroactively looked at the patient's CT scan from 11Apr2021 and they found that the thrombus was already present but less evident than on 14Apr2021. The patient also looked like he was in sepsis, so the medical team was performing a full septic work-up and the patient was hospitalized on 14Apr2021. The patient was terrified, and the medical staff were ruling out acute mesenteric ischemia. On 14Apr2021, blood work showed thrombocytopenia, and a bacteria blood test showed bacteremia with E. Coli. The event thrombus was reported as serious since medically significant, life threatening, and requiring hospitalization. No information regarding seriousness was provided for thrombocytopenia and bacteremia. Treatment with heparin drip was started (ongoing at the time of the reporting) and the patient improved. However, the reporter stated that at the time of the last reporting, all of the patient's symptoms were ongoing, that all of the patient's symptoms had worsened. At the time of the last reporting the patient was in the ICU. The patient had not recovered from the all reported events. The reporter did not know if the reported events were related to BNT162b2, however she added that diverticulitis could also cause all the patient's side effects. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the thrombosis, sepsis and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including MRI of abdomen and vascular angiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Was admitted via ED 4 days post injection of second dose and was diagnosed with pericarditis and NSTEMI. Since hospitalization a series of symptoms persisted or developed including altered vision, chronic intense headaches which are exacerbated by noise/lights/eyes moving to certain angles, dizziness, severe lethargy, severe intolerance to stress, emotional abnormalities including anxiety and depression, muscular stiffness, flu-like symptoms, vertigo-like symptoms, decreased reaction time, compromised memory recall and articulation fluidity.

Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation.

Grand Mal Seizure 3 days after injection. I was brought to the ER and had tests done. I had a clear EEG, EKG, CAT scan, and MRI. I am now on Keppra.

Thrombosis; Vericose veins; Swollen, bulged nerves around left hand palm and fingers/The same symptoms noticed on right foot; Nerves are in black darkened color and the palm fingers, knuckle areas; the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot.; the palm, fingers, knuckle areas had moderate pain; sensitive to touch; This is a spontaneous report from a contactable consumer(patient). The 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 14:45 (Lot Number: EN6205) as first dose, single for covid-19 immunization. Medical history included none. He had not known allergies to food or medications, no illlness history. Concomitant medications included minerals nos, vitamins nos (CENTRUM A TO ZINC) adutls vitamin, miconazole nitrate (LOTRIMIN AF ANTIFUNGAL) topical cream. The patient experienced one hour after first dose of vaccine shot at left arm shoulder, he saw swollen, bulged nerves around left hand palm and fingers. Nerves were in black darkened color and the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot. The affected areas on both palm, fingers, foot area have dark patch areas with moderate pain. After 32 hours, he saw swollen nerve back of left leg thigh area with deep pain. It was sensitive to touch. It looked like thrombosis or vericose veins not sure about it. He reached out to doctor office and they said to wait for another day to see if he can recover. whereas he still have the darkened black nerve with pain in the affected areas. Events occurred on 24Apr2021 16:00 which was resulted in doctor or other healthcare professional office/clinic visit. There was unknown if treatment received. Outcome of events was not recovered. There was no covid prior vaccination and post vaccination.

PATIENT WAS IMMUNIZED 5/13. PATIENT WAS FOUND DECEASED IN THEIR APARTMENT ON 5/18. FAMILY LAST SAW HIM ON 5/16 WHEN THEY DROPPED HIM OFF AT HIS APARTMENT. MEDICAL EXAMINER HAS NOT YET DETERMINED CAUSE OF DEATH OR EXACT DATE OF DEATH.

1) 4 days following second dose, calf pain developed that did not resolve. After 2 weeks of unresolved calf pain a distal DVT in the right leg was detected by ultrasound at the ED. 2) Within a few days following the second dose, sudden onset hearing loss was detected in the left ear. Accompanied by tinnitus, and aura fullness. There was no vertigo or dizziness episodes

Received first dose on 27May2021/ received second dose on 10Jun2021; he had a massive heart attack; This is a spontaneous report from a contactable consumer (patient parent). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0176, on 10Jun2021 at single dose (at the age of 36-year-old) for COVID-19 immunization. Medical history and concomitant medication were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number : EW0176, on 27May2021 and experienced chest pain. Reporter stated Pfizer drug kill the patient yesterday (28Jun2021). He had a massive heart attack in Jun2021. The outcome of massive heart attack was fatal. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: he had a massive heart attack

Pt.'s mother states that after receiving the 2nd dose of Phizer vaccine the Pt. collapsed 05/26/2021 and passed away. Currently waiting for Autopsy results.

Heart palpitations, PVC's, PAC's, going into A-Fib then cycling into V-Tach. Went to ER and was hospitalized for 5 days. Received multiple EKG's, a stress test with contrast, chest x-rays, and an ECHO; all were unremarkable. Blood work was drawn and also came back as unremarkable. Was placed on Metoprolol and Flecainide to normalize rhythm and maintain heart rate. Was placed on a 30 day halter monitor after being released from the hospital. Several weeks after my hospitalization I started having chest pains and heart palpitations that percussively got worse. I was hospitalized again for 2-3 days and was diagnosed with anxiety and was prescribed Xanax. I continue to have severe anxiety related to my cardiac events. I also continue to have mild/moderate heart palpitations and chest pain.

A couple days later I began experiencing a slight sore arm. Several days later I had a constant headache. Around January 25 I began experiencing non-stop chest pain and on January 27 woke up with severe pain in my arm. I went to the emergency room and was diagnosed with an NSTEMI.

37yo male with no cardiac risk factors had spontaneous dissection of rt coronary artery 5 days post vaccination w associated MI requiring 3 drug eluting stents and "extreme" clot burden on cath requiring tPA.

patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead.

Swollen lymph node right groin started about 6-8 hrs after vaccination. Over next 48 hours below that lymph node down to the right knee increasingly red, swollen rash, pain. ER visit diagnosis Lymphangitis. Treated with IV antibiotics then released 7am 12 March. Treatment with clindamycin(450mg) 3x daily for next 7 days. Rest and elevate leg. 12 hours after treatment began, feeling better not well yet. Swollen lymph node appears to be mostly gone and painful swollen rash has been reduced.

Pt with chest tightness after vaccine with throat itching and fullness. Gave Benadryl IM wth symptoms not getting better with pt looking pale . Gave Epinephrine IM with 911 called . Anaphylaxis like reaction

Received injection at approx. 10:30am. Waited at vaccination site for approx. 30 minutes with no reaction. At approx. 11:10am (40 minutes after injection) I started to feel tightness in my chest and developed moderate wheezing. I immediately took two puffs of my albuterol sulfate HFA inhaler. The wheezing stopped after I used the inhaler. I did not need to use my epi injector but it was definitely anaphylaxis based on prior experience. I did not report this to the vaccination site as I had already left. It is now 12:45pm and I feel fine.

I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon. Saturday at midnight, I woke up in full body sweats and aches. I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours. I took another 2 ibuprofen around 400am. Sunday morning I woke up feeling OK, not great, but OK. Sunday night ? it was very strange ? the full body chills and aches came back. Not as bad as Saturday night, but they returned nevertheless. I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep. Monday I woke up feeling OK again. Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly. This time, I also felt a mild burning in my upper chest and throat. I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain. It felt like burning and a stabbing sensation in my throat and upper chest. I took some ibuprofen, and tried to fall asleep. I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am. At 2:00am I woke up in severe pain again. It was very bad, like an 8 out of a 10. It felt like a burning and stabbing sensation in my lower throat and upper chest. I had my wife call 911, and I was brought to hospital in an ambulance. I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm. I had peak troponin levels of 5, so I basically had a moderate heart attack. I had a cardiac catherization procedure done, as well as a cardiac MRI. The cardiac catherization procedure showed I had no blockages at all in my arteries. The cardiologists diagnosed me with myocarditis. The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system. The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis. It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received.

moderate heart attack; myocarditis; my heart to get inflamed; Monday evening, 22Mar, I started getting pain in my upper chest; getting pain in my upper chest and throat; I had full body chills; I had full body chills and aches; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), , administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Age at vaccination :37 years.The patient received the first dose on 27Feb2021 (Brand Pfizer,Lot number EN6203 , administration time 12:00 PM, Vaccine location Left arm).Medical history included none. There were no concomitant medications.The clinical course was reported as follows: "I received my second covid vaccine shot Saturday at noon, 20Mar. I had full body chills and aches Saturday and Sunday night. Monday evening, 22Mar, I started getting pain in my upper chest and throat. I woke up at 2:00am with severe chest pain. I called # and rode in an ambulance to the hospital. I spent 3 days in the hospital. I was diagnosed with myocarditis. The cardiologist believes my auto immune response to the vaccine attached my heart and caused my heart to get inflamed. I had a moderate heart attack from the vaccine".Th Adeverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event.The patient received treatments for the events (ae treatment medication, cardiac MRI, cardiac catherization).The patient was recovered with sequel from all events.No Covid prior vaccination , No Covid tested post vaccination: Yes (covid test type post vaccination Nasal Swab on 23Mar2021:Negative)

Potential TIA or migraine with aura; Potential TIA or migraine with aura; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 23Mar2021 15:15, as single dose, for COVID-19 immunisation, at a pharmacy. There were no medical history and concomitant medications (no other medications received within 2 weeks of vaccination). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no allergies to medications, food, or other products. On 25Mar2021 at 09:30, the patient experienced transient ischaemic attack (TIA) or migraine with aura which resulted to physician office and emergency room visits, and hospitalization for 1 day (unspecified date). The events were reported as life-threatening illnesses (immediate risk of death from the events). The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. Information on lot/batch number was available. Additional information has been requested.

A few days after the shot, my lower back really started to hurt. So much, that I ended up in the ER thinking it could be kidney stones. ER staff were unable to determine the cause of the pain. Exactly one week after the shot (Tuesday), I start sweating profusely and nearly passing out at work. A day later (Wednesday), my heart rate went through the roof and I was dizzy, out of breath. By Friday night I was in an urgent care clinic with a resting heart rate of 145BPM. (My normal is in the 50s). I was diagnosed with Arterial Fibrillation. I have no history, or family history of heart issues. I run 3-5 days a week....3-10 miles at a time. In the military...very healthy.

Anaphylaxis; drooling; This is a spontaneous report from a non-contactable health care professional. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7533, Expiration date: Not reported), via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had facial/throat swelling after the 15 min waiting period while driving home. No medical treatment, self-resolved with Benadryl at home, Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling). The patient underwent lab tests and procedures which includes patient Vital parameters results included: BP (138/89), HR (81), O2 (96%) at 11:45 am and BP (141/89), HR (68), O2 (97%) at 12:04.. Treatment included: Antihistamines, Epinephrine and IM steroids. Pre-treatment with Benadryl, Pepcid, and Zyrtec. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: The event anaphylaxis and drooling was considered related to suspect drug based on strong temporal association and known safety profile of the 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.

Heart attack; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 (at the age of 37-years-old) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. No COVID prior vaccination. The patient experienced heart attack in 2021. The adverse event resulted in emergency room/department or urgent care, hospitalization in 2021, life-threatening illness (immediate risk of death from the event), disability or permanent damage. No COVID tested post vaccination. The outcome of the event was unknown. Information on lot/batch number has been requested.

NSTEMI and left leg arterial thrombi after first vaccine. In addition, he is in hospital again now after his second vaccine being evaluated for a second NSTEMI.

trouble walking; it was concluded that I had a stroke and the vaccine was likely the main contributor.; the right side of my body was very weak and my balance was off.; the right side of my body was very weak and my balance was off.; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 37 years, on Apr2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included brain tumor from an unknown date and unknown if ongoing. On 09Apr2021, the patient stated, "I am undergoing immunotherapy treatment for a brain tumor. My doctors recommended I take the vaccine 2 weeks following my most recent treatment (administered every 4 weeks). Several hours after receiving the vaccine, the right side of my body was very weak and my balance was off. These symptoms went away by the next morning. 5 days later they came back and progressed. Ultimately, I went to the emergency room having trouble walking, using my right arm and staying balanced. All tests (MRIs, ultrasound, CT scan, extensive bloodwork, and more) proved that there were no apparent causes. Ultimately, it was concluded that I had a stroke and the vaccine was likely the main contributor. I am 37, in shape, and eat extremely well." The patient was hospitalized for the events. The patient underwent lab tests and procedures which included blood test: there were no apparent causes, computerised tomogram: there were no apparent causes, magnetic resonance imaging: there were no apparent causes, sars-cov-2 test: negative on 15Apr2021 and ultrasound scan: there were no apparent causes on an unspecified date. Therapeutic measures (Aspirin prescription, Castor, physical therapy) were taken as a result of the events. The outcome of the events was recovering. Information about Batch/Lot number has been requested.

High fevers, mouth sores (HSV), cough, shortness of breath, headache, fatigue---still ongoing cough and now heart failure--EF is at 40% and grade 1 diastolic dysfunction- 2 chest xrays, CT of chest, 3 covid tests all tests negative--echocardiogram done- 3 different kinds of antibiotics and 2 rounds of steroids, inhaler also, fluids for dehydration-- still out of work

(1) Wed, May 12th - I woke up around 7:30am with pain in my right side near the rib cage/beneath my chest. The pain was also in my upper right shoulder and trap/neck area. (2) Sat, May 15th - in the evening time around 7:30pm I was riding passener seat in a car and started having shortness of breath (constricted breathing) and immense pain in my right side near my rib cage/beneath my chest. The pain felt like the worst muscle spasm I've ever encountered. The pain was gripping and persistent. It was hard to breathe and even harder to utter out a word or two. This intense pain last for 45 minutes until I got home. I admitted myself into the ER around 8:30pm. Around 7 hours later and after a series of multiple tests I was told I have PE-blood clot in my lungs. (3) Sun, May 16th - I was admitted in the hospital around 5:30am. (4) Tue, May 17th - I was discharged around 4:30pm

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: He had blurred vision, sweating a lot and dizzeness

I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day. Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand). The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center. The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine. I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown." Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP

small stroke in the occipital lobe; headaches and partial vision loss due to the stroke; headaches and partial vision loss due to the stroke; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2, via an unspecified route of administration, administered in Right arm (at the age of 37-year-old) on 23Apr2021 09:30 (Lot Number: ER8731) as single dose for covid-19 immunisation. Medical history was none. Concomitant medication included clomiphene [clomifene]; vitamin d [vitamin d nos]; phentermine. He was hospitalized for 3 days. They determined he had a small stroke in the occipital lobe. He currently experiencing headaches and partial vision loss due to the stroke. The events started from 27May2021 10:30. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Received the treatment (Currently undergoing treatment). The outcome of the events was not recovered.

Fatigue, fever, shortness of breath, left sided chest pain. Major pulmonary embolism and right femora vein DVT. Required emergency admission morning of 6/21/2021, EKOS treatment with TPA, 3 night hospital stay so far.

Adverse Event: Sudden cardiac arrest, fatal arrhythmia; Treatment: successful resuscitative efforts; Outcome: AICD placement

E87.1 - Hypo-osmolality and hyponatremia R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction D69.6 - Thrombocytopenia, unspecified J18.9 - Atypical pneumonia

bleeding; sore throat; sickness; raw blisters; joint pain early morning; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a 37-year-old male patient in response to Non-HCP letter sent in cross referenced case that included: A 37-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration in Arm left on 10Mar2021 at 11:13 (Batch/lot number: EN6207) and second dose administered in Arm right on 30Mar2021 at 10:45 AM (Batch/lot number: EP7533) both doses as a single dose for Covid-19 immunisation. Patient's medical history included, a traumatic brain injury on 18Jun1995 at age 11-17 years old treated (4 mo), and at the age of 37 now he has short term memory issues left side spasticity from brain injury and handicapped from an unspecified date and unknown if ongoing. Concomitant medications included ibuprofen, multiple vitamin 1day gummies, Cinnamomum spp. oil, citrus aurantium essential oil, commiphora myrrha oil, eucalyptus spp. essential oil, rosmarinus officinalis essential oil, syzygium aromaticum essential oil (DOTERRA ON GUARD), and Peppermint on guard for unknown indication. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as A6E37. After vaccination, on an unspecified date in 2021, patient experienced joint pain early morning and was hardly ever sick, was shocked at severity of sore throat in evening and actually bleeding. He went to doctor next morning and they though it could be Scarlet fever. After 2 days, it was reported that the symptom does not show the actual bleedings lower back of throat not shown also raw blisters punch like marks. The patient underwent lab test which included culture results as negative on an unspecified date and strep investigation test, results as negative on 02Apr2021 (did strep test looked like scarlet fever; Had no fever). The outcome of events was unknown.

June 14th I had surgery to set broken tibia/fibia. Friday July 16th I began to suffer severe chest pain, shortness of breath, difficulty breathing and tachycardia. Went to a local ER but symptoms decreased as I waited and eventually they sent me home. Mild chest pain, shortness of breath, difficulty breathing, tachycardia and fever lasted until Thursday the 22nd when I saw Dr. He ordered a chest CT and as a result I was diagnosed with pulmonary embolism. I was prescribed Eliquis to help the clots clear.

I am a registered nurse at hospital. On 12/25, seven days after receiving the shot I started to get right lower leg pain and I kept complaining about it till New Years Day. I had no symptoms of a DVT. I triaged on 1/1/21 and the doctors ordered labs/imaging and the results were as followed: D-Dimer biomarker (+) , Ultrasound of the Rt lower leg ( - ) , CTA showed a PE (segmental right upper lobe pulmonary artery consistent with pulmonary embolus). I was discharged on Xarelto and advised to follow up with a hematologist. On 1/5/2021, I went to hematology and they did a whole bunch of labs. I was sent to get a ultrasound of the leg because the pain persist and they found a clot hidden by my soleus. The plan is to continue on the Xarelto for 6 months. Come back in 3 weeks to scan my leg again and get my lab results. On 1/12/2021, I received the 2nd shot of the Pfizer vaccination.

Anaphylactic reaction (flushing, erythema of skin on arms, chest, and neck, tachycardia, diaphoresis, AMS, weakness); received 0.3mcg epi (Epi-pen) in right thigh after being placed on a litter. EMS contacted. Patient improved prior to EMS arrival and was evacuated for further eval and treatment.

Blood clot on lung after experiencing chest pain; This is a spontaneous report from a contactable consumer reported for himself. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 14:00 on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient with confirmed blood clot on lung after experiencing chest pain/chest tightness/left sided, thought that he was having a heart attack, shortness of breath on 03Feb2021, reported as non serious. Emergency room/department or urgent care. Blood thinner received for the events. Outcome of the events was unknown.

Per Dr.'s admit note: "Etiology unclear though favor meningitis/encephalitis given 2 days of viral symptoms, headache, questionable neck pain, and low-grade fever of 100.6. Had first COVID-19 vaccination on 2/13. Cannot exclude paraneoplastic syndrome; possible hilar mass noted on CXR will need further work-up to rule out sarcoid/malignancy. Concern for viral meningitis. No known sick contacts. Another tonic-clonic seizure occurred around 08:00 on 2/24 AM with vomiting; no overt aspiration though certainly high risk given situation."

Pain in left calf leading to development of blood clot above left knee cap near inside of quad; Pain in left calf leading to development of blood clot above left knee cap near inside of quad; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included U/L fasciatomy in same leg with nerve damage, Blood transfusion, previous clot in femoral during recovery, Shellfish (allergy). The patient has not had COVID prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on an unspecified date (lot number: unknown) at 38-years-old. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 16:00, the patient experienced Pain in left calf leading to development of blood clot above left kneecap near inside of quad. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events: Originally treated as cellulitis with doxy. The outcome of the events was recovering. The patient was not tested for COVID post vaccination. Information about Lot/Batch number is requested.

He presented to hospital ED with new onset chest pain. He reports that he woke up this morning nauseous and he vomited after which he has started developing retrosternal chest pressure and some shortness of breath for which he came to the emergency room for assessment. In the emergency room he was given both a GI cocktail and nitropaste with wheeze the symptoms improved. He was transferred to a medical center for higher level of care. At present he is essentially symptoms free. The EKG showed right bundle branch block and all septal myocardial infarction. The right bundle branch block is new compared to his last EKG. The initial troponin was mildly increased at 0.18 and BNP was 118. The renal function is normal with a creatinine of 0.8 and the chest x-ray shows bilateral interstitial opacities which might represent pulmonary edema. He remains admitted

Patient tested positive for COVID on 4/3 or 4/4. Despite this, patient decided to take a road trip since he only had mild symptoms (headache, cough). While he was out of town, his symptoms worsened and he decided to return to home. Patient presented the the ER on 4/13 and was admitted to the hospital for COVID treatment (remdesivir and dexamethasone). He was also found to have a PE and was started on therapeutic Lovenox.

Patient tested positive for COVID on 4/3 or 4/4. Despite this, patient decided to take a road trip to out of state since he only had mild symptoms (headache, cough). While he was in out of state, his symptoms worsened and he decided to return to home state. Patient presented the the ER on 4/13 and was admitted to the hospital for COVID treatment (remdesivir and dexamethasone). He was also found to have a PE and was started on therapeutic Lovenox.

10:00PM Saturday, 4/17/21 Sudden chest pain. Tried to sleep it off, pain lingered all day Sunday 4/18/21. 8:00PM went to local ER with same chest pain, had not gotten better. ER took blood draw, my troponin was 4.6 and doctors thought it was an error since I am 38 years old and otherwise health with no history of chest pain or family history of heat trouble. Second blood draw showed troponin at 5.0 getting worse. They called an ambulance and took me to the hospital nearby. Third blood draw showed 6.0 and I spiked at 10.0 overnight. I had several EKGs, a CT scan, and an angiogram. None of these showed any obstructions or blockages in the heart or blood vessels that could have caused the heart trauma. I had an echocardiogram which showed that my heart is only pumping at 50% which is low for a healthy young person who is a runner. I was diagnosed with myocarditis and with having had a Non-ST Segment Elevation Heart Attack. Again, I have no family history of this, I am otherwise healthy, I do not use drugs and I did not have any trauma to my chest, such as a car accident, that could have caused this. The only explanation is that it was related to the COVID shot, which I had roughly 48 hours before my sudden chest pain

Pulmonary embolism with pulmonary infarction; Pulmonary embolism with pulmonary infarction; This is a spontaneous report from a contactable physician. A 38-year-old male patient received second dose of BNT162B2 (Batch/Lot number was not reported), intramuscular on Apr2021, at 38 years old, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 intramuscular on Mar2021 at 38 years old as single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced pulmonary embolism with pulmonary infarction and patient was hospitalized for 1 day. The events resulted in Emergency room/department or urgent care and Hospitalization. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination and medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Apr2021. Therapeutic measures were taken as a result of pulmonary embolism with pulmonary infarction which included anticoagulation. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate

pneumonia; Extreme weakness; increased coughing; This is a spontaneous report from a contactable consumer (the patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number ER8736), via an unspecified route of administration on 23Apr2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has a known allergy to penicillin. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient reported that she experienced extreme weakness beginning at 9:00 on 24Apr2021 which was still occurring four days later. She experienced increased coughing and was diagnosed by Chest X-ray with pneumonia on 27Apr2021. The events required an Emergency Room visit. The patient experienced pneumonia on 27Apr2021with outcome of recovering, extreme weakness on 24Apr2021 at 09:00 with outcome of recovering and increased coughing on 24Apr2021 at 09:00 with outcome of recovering. The patient underwent lab tests and procedures which included x-ray: pneumonia on 27Apr2021. Therapeutic measures were taken as a result of pneumonia, extreme weakness and increased coughing and included the administration of a "Z-Pack." Additional information has been requested.

Brother felt dizzy and saw double vision with left side body fatigue which was diagnosed as a stroke. He has bleeding in the back of his brain. Went to the ER at Hospital and took a CT Scan and MRI which showed bleeding. Brother had normal blood pressure and everything was fine with him but the stroke happened after a week of his 2nd Covid-19 vaccine dose. He lost strength in his left part of the body and had a speech slur and double vision. He had to wear an eye patch and had a headache. Hospital said no surgery was needed and transfered him to Rehab for rehab. He is currently there getting treatment.

Developed an unprovoked Pulmonary Embolus without evidence of a DVT or any unrelated risk factors for PE.

Chest pain, SOB, DOE Pt presented to hospital - transferred to university hospital - underwent LHC which was clean - Troponin rose to 2.23 - ESR, CRP elevated - active chest pain, EKG w/ diffuse ST elevation - myopericarditis - Cardiac MRI - colchicine/ibuprophen - developed NSVT, required beta blockade

Pt had uneventful 1st Pfizer COVID vaccine on 5/28. 5/31 he presented to our hospital after a V fib cardiac arrest. Pt did well with immediate CPR and cardioversion on the scene but he had no hx of major heart disease. Minor LV dysfunction ( LV 45%). It turned out on that the next day 6/1 pt developed fever and then COVID was checked and was positive. He then developed true covid and was treated. Echo revealed a new dilated CM with reduced EF. I feel his arrest was more likely related to the active covid or his DCM but wanted to report in case given the temporal association

Chest pains while working out since receiving the vaccine. Ultimately, two blood clots were formed and caused a cardiac arrest May 25th, 2021.

Identified PE; Pain moved to right chest; Lower Right Backpain; Breathing difficulty; Off Balance; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose of BNT162B2 (lot number: EW0153), via an unspecified route of administration in arm right on 16Apr2021 12:15 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included vitamin b12 nos (VITAMIN B12) and colecalciferol (D3). On 18Apr2021, the patient went urgent care for breathing difficulty; On 19Apr2021, patient went ER for off balance, dizzy, and breathing difficulty and was prescribed with ibuprofin, meclazine and rest for 8 days; On 07May2021, lower right backpain started (not taken 2nd dose scheduled), on 08May2021, pain moved to right chest; On 09May2021, patient went urgent care-identified PE and admitted to hospital; On 11May2021 discharged; Under blood thinner medication (heprion). Adverse events start date of off balance, dizzy, and breathing difficulty was 18Apr2021 04:00. 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). Patient was hospitalized for 3 days. Covid test post vaccination: Nasal Swab on 09May2021: Negative; Nasal Swab on 09May2021: Negative; Nasal Swab on 19Apr2021: Negative. Outcome of the events was resolving.

Per hospital intake, the patient had ventricular fibrillation cardiac arrest in the field just a few hours after receiving his second Pfizer COVID 19 vaccination. EMS was called, and 20 minutes of CPR were administered, prior to achieving ROSC. Patient was sedated and intubated and taken into Hospital. Cooling protocol was initiated and CT angio did not show any evidence of pulmonary embolism. Patient also underwent cardiac catheterization, which was was negative for clear intracardiac or coronary abnormalities or stenoses. Ultimately, the patient was transferred to medical center for implantation of AICD device. No other obvious source or etiology of arrest, but did think worth reporting given temporal proximity to vaccination.

Patient is a very pleasant 38-year-old male with no significant past medical history other than a BMI of 37 and a past history of COVID-19 infection in February 2021 which was asymptomatic with no sequela after he was required to test after his wife tested positive .he is on no medications prior to arrival, he smokes an occasional cigar and drinks alcohol only occasionally who presented to the emergency room on 6/6/21 With a chief complaint of difficulty breathing, fever, malaise and significant left-sided chest pain that have been ongoing since May 23 slowly worsening. He denied any recent travel any recent illness any recent sick contacts. He denied any illicit drug use over-the-counter supplement use .patient reported he received his first Pfizer Covid vaccine on 5/17/2021 and a few days after began to feel congestion with mild coughing which progressed. He initially thought he may be having allergies and took some Claritin without relief. As the week went on he developed increasing shortness of breath and cough and also developed a fever. He went to the well now urgent care on June 3 and was told he may have pulled a muscle and was sent home. He returned back to our emergency room in the early morning of 6/4 complaining of again of left-sided chest pain radiating into his ribs with associated shortness of breath worse with inspiration associated with coughing but no hemoptysis. At that time he had no complaints of fever or chills. He works at a hardware store and thought perhaps he may have strained himself lifting heavy boxes of flooring. During that ER visit he was hypotensive and tachycardic with respirations of 30. CTA of the chest did not show any pulmonary emboli but showed inflammatory changes in the left side in the lingula consistent with possible acute community-acquired pneumonia. He was given Toradol and morphine and was discharged home on oral antibiotics. His EKG at that time showed sinus tachycardia the ST segments were normal. He was afebrile. He returned back to the emergency room the morning of 6/5 with complaints of worsening left-sided chest pain worsening shortness of breath and worsening fatigue. He reported any movement he develops a cough and he cannot lie flat as he develops significant chest pain which is relieved with sitting up. He had been taking some ibuprofen with minimal improvement. He also reported some nausea and fatigue. He had a fever at home of 102 °F just before coming to the hospital but arrived afebrile. Patient admitted to having COVID-19 infection in February when his wife tested positive. He was asymptomatic other than a headache for 1 day and recovered without any incident. In the ER he was again tachycardic but was afebrile. His blood pressure was 137/81 his O2 sat was 97% on room air. He however was quite tachypneic with respirations of 35 at times at rest. Lab work revealed a white blood cell count of 13.2 with significant elevations of his erythrocyte sedimentation rate and CRP at 75 and 20.8 respectively. Covid testing was negative. Repeat chest imaging reveals a large left pleural effusion and atelectasis with no pulmonary edema. CT scan of the chest revealed no pulmonary emboli but now reveals right middle lobe and bibasilar infiltrates suspicious for an infectious or inflammatory process. EKG revealed sinus tachycardia but no ST changes were apparent. Was clinically dehydrated with an elevated specific gravity positive nitrites but 0-9 white blood cells on urinalysis. Troponin at 0-hour was low -3 1 hour was -3 with no change in his delta. BNP was normal at 14 lactic acid was normal at 1.1. Procalcitonin was normal at 0.60 and lipase was normal at 21 with a normal CMP. He was subsequently admitted to the hospitalist service. In the emergency room he was given Rocephin and azithromycin. The following day his condition worsened with continued fever and increasing shortness of breath. . ESR was worsened from 75 to 82 and cardiac crp now >200. A stat echo was ordered and his case was reviewed with the cardiologist. there was concern for possible myo/pericarditis so pt was started on colchicine and ibuprofen tid and the decision was made to transfer the patient to a larger tertiary care facility. stat echo showed normal ef and no sign pericardial effusion. He was transferred to another hospital where he was followed by cardiology and pulmonology. He ultimately underwent thorocentesis but the fluid reaccumulated so a chest tube/drain was placed. He was treated for a peripneumonic effusion. cultures and cytology were ultimately negative. acid fast bacilli was negative, blood cultures were negative. covid 19 pcr testing was negative x 2. He was discharged home on 6/11/2021 with instructions to continue augmentin bid for 4 more weeks with close follow up with pulmonary and repeat chest x ray in 1 month,

The heart rate was 245; A blood clot in the caller's neck; It was thought he might have lymphoma; Felt like he had a golf ball in his left arm/that little golf ball in his arm started traveling to his whole body- his back, his chest, legs, calves; Sweating; Didn't feel too great; Breathing was off/trouble breathing; Throat was hurting/sore throat; Neck was swollen; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that: A 38-year-old male patient received first dose of BNT162B2 (Solution for injection; Lot number: ER8131 or ER8231 and Expiration date were not reported) via an unspecified route of administration, administered in left arm on 18Apr2021 (at the age of 38-year-old) as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, he went to get the Covid shot through name withheld which Pfizer sponsors and it was done at name withheld. He went there and took the shot. He was told to wait 15 minutes and then left. When he got to car, immediately he felt like he had a golf ball in his left arm. The next couple of days, that little golf ball in his arm started traveling to his whole body. He felt it in his back, his chest, he felt it in his legs. Literally, in the next 3 days, he felt it literally travel through his whole body. He felt it in his calves, it was crazy also mentioned they felt sore or like ball in the arm. He started sweating and didn't feel too great. He thought it was standard side effects and didn't think much of it. A couple of days past by and then Thursday morning, he woke up and his breathing was very off. He clarifies his throat was hurting. He thought it was a sore throat and took some cough medicine and cough drops. Then the next day, it wasn't going away and was still hurting, wasn't getting any better. His breathing was very rough. If he was just standing still like laying down, then felt okay. But if went to move or do something it was very difficult. Again, expecting these symptoms, some people have said these symptoms and he didn't' think much of it. The next morning patient woke up and breathing felt fine. His neck was swollen. He thought maybe he had a sore throat or something. He was taking cough drops to soothe his throat the following day, the throat was still hurting, and it was the same. The patient called the doctor and did a telehealth. The patient told the doctor when he received the first dose Pfizer Covid Vaccine and all his symptoms. The doctor said it is a little unpredictable, nothing the doctor hasn't heard. He went to the doctor office the next day and was hooking to a nebulizer for breathing and prescribed an asthma pump. The doctor thought patient had Lymphoma in the neck. The doctor wanted to go the following day for an ultrasound. He went to the ultrasound and they checked the neck and immediately there were red flags. His heart rate was checked, and the heart rate was 245. The patient was hospitalized from 27Apr2021 to 08May2021. The minute they saw heart rate and started putting intravenous and received treatment to low down heart rate. The heart rate went down to 170 or 165. He had x-rays and a CAT scan done. He had fluids in his heart and fluid in the lung and a blood clot in neck. He had a hole cut open on left side to lungs and the lungs were drained. He went back to the ICU, they ran another CAT scan and X-ray and gave the medication. He does not know if this medication was antibiotics or what the medication was. The CDC received this information because the patient case was so rare. When the CAT scan and X-rays were run again, the fluid is right back up in the lungs. Then he was taken to surgery for the heart. An incision was cut from where itches is to back on the side, a very big incision. The heart was gone into to cut a little piece around the heart. Something was cut out so the heart could drain, and fluid could get out of the heart. While all of this is happening, he wasn't getting any better, was getting worse. The patient health deteriorated, breathing was about 10 percent and was hooked up to a breathing machine. He was sedated at that time and not awake anymore. The machine was keeping him alive. Now, every day for basically five days he was asleep and not knowing what was going on and was tested for Leukemia, cancer, and A to Z every disease you can think of to try to find common ground. Everything came back negative; nothing was wrong with the caller. He was given this or that medication every day and was sedated for about 5 days. Every day of the sedation was getting worse. He was dying and time was ticking. On the 5th day, everything was getting worse. The woman kicked everyone out of the room and went into his mouthpiece on the ventilator that was keeping the alive doing the breathing for the patient. The woman pulled something out of his lung. The woman started pumping him with steroids. What the woman took out of his lung stopped the fluid from going in. The fluid wouldn't fill back up in the lung. Once the woman started giving the steroids, the steroids killed the Pfizer Covid Vaccine. The steroids reversed the Pfizer Covid Vaccine. He was started breathing on his own again. After a couple of hours, the patient finally woke up. The patient is now recovered and has been home the past few weeks on a whole bunch of medication. He is on blood thinners, steroids, and stomach stuff. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Heart attack within 1.5 months of receiving final dose. 38 year old, physically fit patient has excellent cholesterol, blood pressure, and resting heart rate numbers.

I have a blood clot in my left leg that is unprovoked / The clot runs from poplioteal to common iliac.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 12:00 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation at pharmacy or drug Store. The patient medical history included none. Concomitant medications included lamotrigine (LAMICTAL), vortioxetine hydrobromide (TRINTELLIX). Other medications the patient received within 2 weeks of vaccination included Lamictal, Trintellix. The patient historical vaccine included first dose of BNT162B2 via route of administration, administered in left arm on 08Mar2021 05:00PM (at the age of 38-Years-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that, on 21Jun2021 07:00 the patient had a blood clot in his left leg that is unprovoked and he had no underlying conditions. He is male and 38 years old. Blood tests haven't shown the underlying cause and I'm being seen by hemotoligists. The clot runs from poplioteal to common iliac. He was having a thrombectomy on Monday. The patient was hospitalized for I have a blood clot in my left leg that is unprovoked/the clot runs from poplioteal to common iliac for 7 days. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, sars-cov-2 test: negative on 22Jun2021 (Nasal Swab). Therapeutic measures were taken as a result of I have a blood clot in my left leg that is unprovoked/the clot runs from poplioteal to common iliac. Heparin was received as treatment for the adverse event. Will have to have a thrombectomy. The reporter assessed the seriousness as serious. Seriousness criteria caused hospitalization. The outcome of the event was reported as not resolved. Information about batch/Lot number has been requested.

Synopsis of event from ED and attending physician documentation, and pt. interview by this nurse: ...not feeling well for two days with dyspnea on exertion, fatigue, palpitations and mild body aching. Denies any chest pain, shortness of breath at rest or pleuritic pain, noticed lump over anterior right lower leg. Denies hx of leg swelling, calf or thigh pain, no recent travel by air or car. Received first COVID-19 vaccine 7/15/2021. States Friday, 7/16/2021 had 'pins and needles' sensation anterior lower leg then developed lump in that area, painful to touch, slightly reddened. Hx of torn fascia in area per pt. Denies fever, no nausea, vomiting or diarrhea.

Several episodes of facial burning and tingling. Bilateral eye burning. R sided weakness, headache and dizziness. Several episodes from 7/19-7/21. Was determined to have an acute ischemic stroke. Given heparin, phenylephrine, aspirin, clopidogrel, and eventually underwent embolectomy today. Still hospitalized.

During the week he complianed about chest pain, but we didn't pay any attention. On Saturday morning he was ok, went out and when he cema back he laid down. In the afternoon i woke him up and he had a fever of 102.2, blood pressure 157/96, he was shaking and desoriented. I called 911, in the ER he continue like tat. The doctor did some labs and came out negative, everything they did came out negative, he has seazures the next day and was sent to ICU. He was intubated for 4 days. The doctors said that it was a brain infection but all the test results are negative. The doctors at first thought that it was either menigitis or encephalitis, all the test were negative . His final diagnosis was Sepsis, unspecified organism. He still recovering and does not have any recolection of what happened to him.

12/29/2020 2 hr after vaccination patient became hypotensive, decreased oxygen levels was transferred to Hospital currently inpatient at hospital - admitted for cardiac arrest

Anaphylaxis of face, neck and lymph nodes. Noted with pictures Fever Nausea Body aches Oxygen levels into the low 90s Dizziness Fatigue Eyes not staying aligned with each other. Noted in pictures

Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe

received word that the patient passed away on 3/5/2021. Do not know the cause of death, nor where he passed away. He does not have any significant medical history at Health Care Corporation, but did get his first vaccination here on 2/17/2021.

The patient fell down on the floor about less than 5 min after vaccinated (while waiting for the 15min observation period), hit his head on the shelf. After turned him over, his eyes were half closed, unconscious, non-responsive and were not breathing properly. Administered an epi-pen 0.3mg, the patient woke up immediately. Also called 911, EMS came and he was able to get up and walk.

Got a sudden heart attack after developing chest pain/discomfort while walking outside on 3/20 afternoon time. Went to ER and shifted to hospital. Treated with 2 stents in heart. Arteries were found blocked and blood clot was removed.

fatigue/so tired, he can barely can move; silver dollar rash at the injection site; his whole calf was constricted, felt like the muscle was separating inside, compared it to the same feeling of DVT; he is limping today; feeling pain in arm; left arm hurts so bad that he can hardly move it; fever; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient, self-reported). A 39-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER8730; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 24Mar2021 17:00 as SINGLE DOSE for COVID-19 immunization. Medical history included DVT (deep venous thrombosis) 3 years ago in his right calf/DVT of calf from 2019 to an unknown date (Right Calf; DVTs in his calf and had treatment with Eliquis and got off of that, had an ultrasound to check that it was gone); broke his ankle on an unspecified date in 2019; being in a tourniquet too long (DVT (deep venous thrombosis) 3 years ago in his right calf, from being in a tourniquet too long, was in an operation, was treated with ultrasound); normally when something hurts that bad, he has a softball size bruise on his arm, he has lived and had bruises like that before; Operation (DVT (deep venous thrombosis) 3 years ago in his right calf, from being in a tourniquet too long, was in an operation, was treated with ultrasound/rebreak his ankle and put rods and screws in). The patient's concomitant medications were not reported. It was reported that feeling pain in arm on 24Mar2021, fatigue on 25Mar2021, fever on an unknown date in Mar2021, silver dollar rash at the injection site on 25Mar2021. He reported that he had DVT (deep venous thrombosis) 3 years ago in his right calf, from being in a tourniquet too long, was in an operation, was treated with ultrasound. This morning (25Mar2021), his whole calf was constricted, felt like the muscle was separating inside, compared it to the same feeling of DVT that he had those years back. Patient reported that he thought he might be having allergic reaction. He was so tired, he can barely can move, he had a silver dollar size rash on his arm and his arm hurts so bad that he can hardly move it. He stated that this was weird and he has it every now and then, but it is really bad today. He states that 3 years ago he had DVTs in his calf and had treatment with Eliquis and got off of that, had an ultrasound to check that it was gone. He stated that his leg and it hurts so bad. It felt like has phantom clots in the same the muscles are separating again, like the muscle is trying to tear itself in half. Caller asks, the vaccine won't cause blood clots, will it?. Described about Tired, he couldn't get out of bed and he had been laying there for 3 hours this morning. Stated he ate dinner and went to bed. Stated that he works a full time job doing HVAC and goes to school full time so he could've been tired last night and not noticed it, because he is always tired, but today was different. Described about Left Arm Hurts, that it felt like when you play dead arm, that is when a person socks another kid in a certain spot, felt like he was hit with a bat in that spot. Hurt bad and he was surprised how bad it hurt. When he got the injection, he felt nothing. Now he feels like he fell down on his arm. Within a few hours he noticed it and thought it would probably go away. States that he was checking to see if he had a big ole bruise, and that when he noticed the rash. He stated that normally when something hurts that bad, he has a softball size bruise on his arm. States that he has lived an had bruises like that before. Described about Phantom DVT Pain: He stated that his leg started twitching and woke him up. he called it phan-tom DVT, it felt like DVT, like the muscles have memory and start contracting and get so tight like they are tearing each other apart again. Stated that he is limping today (25Mar2021). He stated that it was contracted for 10 minutes and his whole calf was tight. It was his right leg, the same leg as he had 3 blood clots in. He stated that he broke his ankle in 2019 and they left the tourniquet on too long and they had to rebreak his ankle and put rods and screws in and he developed DVTs in his right calf. Stated that it was treated and he had ultrasounds at 3 months, 6 months, and a year and it is all gone and he has had no symptoms since. He stated that it felt like he has 3 blood clots back hardcore with a vengeance. Stated that he had no edema in his foot, it is not full or swelling or trust him he would be running, well not running, but he would be going to the hospital. Patient was not received treatment for the events. Seriousness of the events was reported as Non-serious. Outcome of the events Fever and limping was reported as unknown and outcome of all other events was not recovered.

Suspected Transient Ischemic Attack four days after receiving second dose of Pfizer Covid vaccine, with symptoms including sudden onset, inability to focus eyes, facial numbness on left side, headache, numbness moved around, involved left leg, left arm, left side of face, left side of lips and tongue. Numbness symptoms resolved after approximately thirty minutes; headache remained for approximately 6 hours; fatigue lasted until the following day. No medical care was sought at the time or subsequently.

Patient reports that he was sitting in chair, quite anxious, reporting that he had similar episodes in the past with fainting while aware of hypodermic needles. today, the patient reports that he felt himself beginning to pass out and lowered himself to the floor. Upon reaching the floor the patient sustained a period of unconsciousness for 10 seconds followed by 5 seconds of tonic clonic seizure activity. Patient awoke slightly confused and disoriented. Patient was completely alert and oriented about 30 seconds after event. Patient was brought back to EMS area and evaluated. Vitals signs were assessed and patient refused further medical care and transport to hospital.

Left leg DVT. I am a nephrologist practicing in my area. 10 days or so after receiving Pfizer vaccine I started noticing left leg swelling and some redness. I didn't pay attention to it because I thought this could be a muscle or tendon issues because of my exercise. But the swelling did not go away, however, it decreased overtime with leg elevation, etc but when I checked my leg I found out that I have a DVT. I am a healthy 39 ( when I received the vaccine but I am 40 now). I don't smoke. No family history. I am on a blood thinner now. I need to report this as I think that it is important to be reported. I read in the news that a 40 year-old man was diagnosed with DVT after Pfizer vaccine Please call or email if you need further info

Patient recently diagnosed with DVT and was taking enoxaparin 80mg subq q12h. Presented to ED after receiving vaccination with increased swelling and redness in RLE. worsening of DVT on imaging.

ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE.

Pt had pain in the left calf 10 days after his first vaccine. Pt then went to state on April 2. Pt came back home, the pain was gone. He had his second vaccine on 4/23 of pzifer. After 15 days of getting the second vaccine he felt very short of breath when riding his bicycle. He went to his primary care doctor and he was advised to go into the ER. He was diagnosed with a PE and left leg DVT

Heart went into atrial fibulation completely out of the blue, no prior issues, no family history, no risk factors - the only possible difference was the vaccine (coming from a very pro vaccine family but this needs to be watched)

Passed away from a Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 39 years old, on 11Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included wolff-parkinson-white syndrome from an unknown date to 15Mar2021. The patient was diagnosed with this later in life, but was told he probably had it his entire life it just hadn't caused any issues for him. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously got the flu vaccine for immunization every year with no issues. The patient passed away from a pulmonary embolism on 15Mar2021. The patient was not hospitalized prior to his death. He died from the pulmonary embolism in his sleep. The reporter denied any medications, labs, testing, or treatments for her husband relevant to these events. The patient died on 15Mar2021. There was a private autopsy performed and they said that the Pfizer Covid Vaccine was one of the contributing factors to the patient's death. The autopsy said the vaccine was a contributing factor. The reporter stated she told them since they said it was the pulmonary embolism that killed him, then that's what it should say. The Medical Examiner was saying that the science for the vaccine is so new, they just don't have the data that they need.; Reported Cause(s) of Death: Pulmonary embolism

25 Apr: Heart attack. Treatment: Stent. Cause: Original diagnosis was determined to be a SCAD. Second opinion said it was more heart disease, plaque related.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient reported throat closure about 9 hours after Pfizer COVID injection. He did not seek medical treatment and it resolved. He called it an anaphylactic reaction. I did not administer the second dose of Pfizer vaccine as a precaution. I told him to seek advice from his doctor and if he chooses to get the second dose, he should get it at a medical facility or doctor's office.

Central Retinal Vein Occlusion 1 day after receiving second dose of Pfizer vaccination + Thrombocytopenia

Adverse Event: Pericardial effusion (15 mm). Signs/symptoms were growing chest pain and shortness of breath for 8 days until a CT angiogram revealed the condition. Cardiologist was not able to identify the condition despite, EKG, echocardiogram, and nuclear stress test. ER administered IV steriod, and new cardiologist prescribed Indomethacin and Cochicine. The condition lasted approximately 3 weeks the first time. I am now experiencing a recurrence of the pericarditis/effusion which has been going on for 2 weeks.

Subarachnoid hemorrhage - bleed day 5/24 - rushed to ER and was seen immediately on first CAT scan. Admitted to Neuro ICU for 14 days. Then transferred to rehabilitation hospital and is now going to outpatient PT. Symptoms were extreme headache and then inability to walk. Rushed to ER via ambulance.

DVT; Pulmonary embolism in right lung; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 39-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration, administered in left arm on 02May2021 11:00 (at the age of 39-years-old) (Batch/Lot Number: ER8736, Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hearing aid user. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Batch/Lot Number: EW0162) for covid-19 immunisation. There was no relevant past drug history reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 since the vaccination. On 27Jun2021 08:00, the patient experienced dvt (deep vein thrombosis) and pulmonary embolism in right lung. The patient was hospitalized for 2 days for the reported events. Laboratory tests on 27Jun2021 included sars-cov-2 test: negative (nasal swab). The patient received treatment with blood thinner shots, and eliquis after hospital. Device date was reported as 04Jul2021. The clinical outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

39 Male tested positive 6/4/2021. Vaccinated with Pfizer 12/22/2021 & 1/12/2021. 6/4/2021 hospital admission for tracheo-esophageal fistula (TEF) transfer from hospital. Diminished breathing sounds, minimally conscious. Removed from ventilator support 6/17/2021. Problems at time of death 6/19/2021 - chronic respiratory failure, COVID-19, history of severe TBI, TEF, trach vent/PEG dependent.