Pfizer

Sore arm on 3/20/2021. No other symptoms/signs. Presented for routine heart transplant follow up visit 3/22/2021 and was found to have new decreased cardiac function by echo, new 1st degree heart block by ECG, and new gallop. Patient taken to cath lab 3/22/2021 for biopsy and hemodynamic assessment, but he had V fib arrest with anesthesia induction. After initiation of CPR, patient was placed on ECMO. Biopsy shows ACR 2R (moderate cellular rejection) and pAMR 2 (moderate antibody-mediated rejection). Labs show new donor specific, complement-fixing Antibody against the cardiac allograft. Patient is in ICU being treated for acute rejection.

Patient received vaccine around 745 am on 4/22/21. He did not have any side effects or concerns until 4/23/21 at approximately 9:30 am when he had what Mom describes as a grand mal seizure while at school. Patient was reportedly sitting in his chair at school. He stretched his arms above his head then fell onto the floor with full body convulsions for just under 1 minute. Patient vomited about 20 minutes later. Our office was informed by mother around 10:30 am. Patient at home and sleeping. Advised Mom to take patient to local ED for further evaluation and monitoring.

Physician assistant at Patient's pediatrician office call pharmacy and informed us that patient had a grand mal seizure after yesterday's vaccine and was being sent to the ER at Hospital.

Patient received his first dose and fainted in the chair immediately after, when he saw a drop of blood trickle down his arm. Patient regained consciousness right after. Patient was monitored closely in observation and left the vaccination site in stable condition.

Patient developed significant thrombocytopenia 3 days after vaccination (platelet count 35,000). Other counts normal, no clinical bleeding. Lab was ordered as part of a work up for persistent abdominal pain (which was present before the vaccine)

Patient is a previously healthy 16 year-old M presenting with acute onset chest pain, shortness of breath, nausea, vomiting, malaise, fever and myalgia to ED on 5/6/2021 at 20:44. He started experiencing symptoms on 5/6/2021 morning a t06:07 AM. He received his second dose of Pfizer COVID-19 vaccine on 5/4/2021 10:: AM. In the ED, CBC, CMP and UA was within normal limits. EKG at 20:46 and again at 21:14 showed ST segment elevation in inferolateral leads with possible myocardial injury, ischemia or pericarditis. Troponin 0 hour was 835 and at 2 hours 1674. Patient was admitted to the PICU for further evaluation and management. Echo on 5/6/2021 showed normal LV systolic function with SF 31% . Cardiac MRI on 5/7 showed contrast enhancement of inferolateral wall consistent with myo-pericarditis with small pericardial effusion. Troponins were trended every 12 hours and plateaued in the 1800's on 5/8/2021. Patient was diagnosed with acute myo-pericarditis. Respiratory viral PCR and COVID-19 PCR on 05/06/2021 were negative. Thyroid studies were normal. ANA titer is pending. Viral serology for HbsAg was negative and HIV was non-reactive. Results for additional viral serologies for Coxsackie viruses, EBV, CMV and HHV6 are awaited. Patient was treated with NSAIDs and Colchicine. IVIG was not given based on clinical judgement. Pediatric Cardiology was involved in patient's care and clinical decision making. Patient remained hemodynamically stable on room air throughout his PICU course. He was discharged on 5/9/2021 with Pediatric Cardiology outpatient follow up in 2-3 weeks. He will continue Ibuprofen 600 mg every hours and Famotidine 20 mg 2 times daily until his follow up.

Pt came to ER with nausea, vomiting, difficulty breathing. Pt was coughing up blood O2 sat 90 room air initially then down to low 80's. Put on high flow 10 L nasal cannula. Diagnosis hypoxia, dyspnea at rest, pericarditis, elevated troponin 35. Transferred to second hospital. Update from them : likely myopericarditis with cardiogenic shock, respiratory failure, diffuse ST elevation on EKG, on Inotropes

HPI: Patient is a 16-year-old male who was upgraded to our emergency department after blood work showed a significant thrombocytopenia. Please see walk-in clinic provider NP for presenting history and physical exam. Patient reports to me development of sore throat as well as blood from the throat last Thursday. Patient also began to notice development of bruising to his legs without any injury approximately a week ago. Denies any pain. Denies any blood in the urine or stool. No other medical complaints at this time. Chief Complaint Patient presents with ? Sore Throat was seen a few weeks ago for ear infection, also had sore throat at that time that never went away. School nurse wanted him swabbed for strep and covid PCR ? Bleeding/Bruising has large bruising to right leg for about a week, no injury. also states bruise to upper left thigh and right shoulder and scattered small bruises. School nurse wants his platelets checked. Denies pain. States mild bleeding in gums and states notices blood in back of throat ROS: See HPI above. All other 12 review systems negative otherwise specified in HPI above. ROS PMH: Past Medical History Past Medical History: Diagnosis Date ? Asthma ? GI symptoms 10/2018 with pharyngitis ? Headache ? Strep throat ? Tonsillar and adenoid hypertrophy nasal scope Past Surgical History Past Surgical History: Procedure Laterality Date ? COLONOSCOPY 12/07/2018 with biopsies ? ESOPHAGOGASTRODUODENOSCOPY 12/07/2018 with biopsies ? TONSILLECTOMY & ADENOIDECTOMY 2011 Family History Family History Problem Relation Age of Onset ? Hypertension Father ? Diabetes Mellitus Father Social History Tobacco Use ? Smoking status: Never Smoker ? Smokeless tobacco: Never Used ? Tobacco comment: no second hand smoke exposure Substance Use Topics ? Alcohol use: No Allergies: No Known Allergies Meds: No current facility-administered medications on file prior to encounter. Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? albuterol HFA 108 (90 Base) MCG/ACT inhaler Inhale 2 puffs every 4 hours as needed. 1 inhaler 1 ? Aspirin-Acetaminophen-Caffeine (EXCEDRIN PO) ? acetaminophen (TYLENOL) 325 MG tablet Take 975 mg by mouth every 6 hours as needed for Pain. ? naproxen (NAPROSYN) 220 MG tablet Take 440 mg by mouth twice daily - with breakfast and supper. Physical Exam: Blood pressure (!) 148/93, pulse 107, temperature 98.6 °F (37 °C), resp. rate 20, height 6' 5" (1.956 m), weight (!) 348 lb 8 oz (158.1 kg), SpO2 96 %. O2 flow: Physical Exam Constitutional: He is well-developed, well-nourished, and in no distress. No distress. HENT: Head: Normocephalic. Right Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Oropharynx is clear and moist. No oropharyngeal exudate. Mild erythema in the posterior pharynx with some bleeding. No posterior pharynx edema. Eyes: Conjunctivae are normal. Right eye exhibits no discharge. Left eye exhibits no discharge. No scleral icterus. Cardiovascular: Exam reveals no gallop and no friction rub. No murmur heard. Pulmonary/Chest: Effort normal. No stridor. No respiratory distress. He has no wheezes. He has no rales. Abdominal: Soft. Left upper quadrant tenderness. Musculoskeletal: General: No tenderness, deformity or edema. Cervical back: Normal range of motion. Neurological: He is alert. Gait normal. GCS score is 15. Skin: Skin is warm. He is not diaphoretic. Multiple baseball to softball size bruises to the bilateral lower extremities worse on the right than left. Mild petechiae. Psychiatric: Mood, memory, affect and judgment normal. Diagnostics: Results for orders placed or performed during the hospital encounter of 05/10/21 CBC WITH DIFFERENTIAL Result Value Ref Range White Blood Cells 7.72 4.0 - 13.0 K/uL Red Blood Cells 3.48 (L) 4.15 - 5.30 M/uL Hemoglobin 10.8 (L) 11.8 - 15.4 g/dL Hematocrit 30.5 (L) 35.5 - 46.5 % MCV 87.7 77 - 94 fL MCH 31.0 25.0 - 32.3 pg MCHC 35.4 31.9 - 35.9 g/dL RDW 16.2 (H) 11.5 - 14.8 % Platelet Count 9 (LL) 160 - 424 K/uL MPV 11.4 (H) 6.8 - 10.5 fL Neutrophil % Pending % Lymphocyte % Pending % Monocyte % Pending % Eosinophil % Pending % Basophil % Pending % Absolute Neutrophils Pending 1.6 - 7.5 K/uL Absolute Lymphocytes Pending 1.2 - 4.9 K/uL Absolute Monocytes Pending 0.1 - 0.9 K/uL Absolute Eosinophils Pending 0.0 - 0.6 K/uL Absolute Basophils Pending 0.0 - 0.2 K/uL COMPREHENSIVE METABOLIC PANEL Result Value Ref Range Sodium 138 133 - 144 mEq/L Potassium 4.4 3.5 - 5.0 mEq/L Chloride 101 95 - 107 mEq/L Carbon Dioxide 22 22 - 32 mEq/L Anion Gap 15 6 - 15 mEq/L BUN 14 8 - 24 mg/dL Creatinine 0.81 0.69 - 1.20 mg/dL Glomerular Filt Rate NOT CALCULATED due to age less than 18 years. mL/min Glucose 110 (H) 70 - 100 mg/dL Albumin 4.9 3.5 - 5.2 g/dL Calcium 10.0 8.6 - 10.4 mg/dL AST 23 11 - 41 IU/L ALT 28 (H) 0 - 19 IU/L Alkaline Phosphatase 142 90 - 366 IU/L Bilirubin, Total 0.4 <1.5 mg/dL Total Protein 7.7 5.9 - 7.8 g/dL Globulin 2.8 1.8 - 3.7 g/dL A:G Ratio 1.8 1.2 - 2.7 PROTHROMBIN TIME Result Value Ref Range Prothrombin Time 18.4 (H) 12.0 - 14.6 sec INR 1.5 (H) 0.9 - 1.1 PTT, PARTIAL THROMBOPLASTIN Result Value Ref Range PTT 32 23 - 36 sec CRITICAL VALUE HEME Result Value Ref Range Critical Value ED Course: Patient was upgraded to the emergency department after he was noted to have significant thrombocytopenia. Patient is pleasant he has no active complaints other than some throat irritation bleeding in the throat and bruising that was nontraumatic to the legs. My physical examination reveals multiple rather large bruises to the bilateral lower extremities up to softball size worse on the right than left. Patient had some mild left upper quadrant discomfort. Very minimal bleeding in the posterior pharynx. I personally reviewed the labs and CBC revealed an anemia at 10.830.5 hemoglobin hematocrit respectively. Most notably a 9000 thrombocytopenia. CMP essentially unremarkable. INR 1.5 PTT normal. I added on Lyme disease and tick-borne illness as well as a Monospot type and screen. Patient did receive his 1st visor vaccine for COVID-19 on April 29, 2021. IV was established in the emergency department in consultation made to Pediatric Oncology. I spoke with pediatric oncology in regards to patient's history and present illness. He does agree that the patient should in fact be transferred under the pediatric care but recommended under the general hospitalist service. He did not advise to proceed with any active treatment in our emergency department such as gamma globulin, platelets or steroids. Awaited call back from pediatric hospitalist and spoke with Dr. She has agreed to accept the patient in transfer. Patient and family are comfortable disposition plan no further questions at this time. Impression: 1. ITP Disposition: Transfer ED on 5/10/2021 Revision History Detailed Report Note shared with patient Note filed date Mon May 10, 2021 12:24 PM

patient developed dizziness about 5 hours after vaccine and began sweating profusely. initial blood pressure was quite low in the 77/46 however subsequent reading was 108/76 and patient exhibited no other signs of anaphylaxis. paramedics were called in case reaction became more severe but patient recovered and was back to baseline within 15 minutes or so. no intervention given.

Thrombocytopenia. Had sore throat and intermittent fevers, as part of evaluation PCP obtained CBC with differential that showed leukopenia and thrombocytopenia. No bleeding or bruising, no petechiae.

elevated cardiac enzymes; left ventricular damage; This is a spontaneous report from a contactable pharmacist. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, at single for covid-19 immunisation (At the age of 16-years). Medical history was none. The patient's concomitant medications were not reported. On unspecified date, the patient was with elevated cardiac enzymes and left ventricular damage followed by a dose of product. Physicians indicate it was directly correlated and the reported was asking for specific information on this topic as to reported tissue damage especially with the EUA update age range. The patient underwent lab tests and procedures which included cardiac enzymes with results elevated on unspecified date. Outcome for all the events was unknown. Information about batch number and lot number is requested. Further information has been expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of elevated cardiac enzymes,left ventricular damage. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

"The patient presented with symptoms of pericarditis and palpitations. Evaluation revealed elevated troponin levels consistent with myocardial injury, ST elevation on ECG (consistent with pericardial inflammation) and short episodes of non-sustained ventricular tachycardia that were not hemodynamically significant. Echocardiography revealed normal anatomy and normal ventricular / valvular function with no pericardial effusion. He was observed in hospital on telemetry for 24 hours and transitioned to outpatient care with exercise restrictions as well as oral non-steroidal anti-inflammatory and colchicine therapy. Clinical diagnosis was peri-/myocarditis without ventricular dysfunction."

Syncopal episode with loss of consciousness and fall with left head injury 2 minutes after vaccine administration. First Aid was administered immediately to stop the bleeding. Patient was awake and alert and declined further medical assistance. Pharmacist monitored for 30 more minutes before patient was able to walk away on their own.

Patient is a 16yo girl admitted on 5/19 with sepsis secondary to myocarditis and pneumonia, s/p IVIG, after presenting with fever, myalgia, sore throat, hypotension, elevated troponin, elevated CRP, and leukocytosis with left shift. Sore throat has been present for about a week and fevers began on 5/17 with a Tmax of 103. On 5/18, she began developing shortness of breath and upon evaluation by the PCP on 5/19, she was admitted. During initial workup on 5/19 upon admission, hospitalist was high concerned as she developed hypotension of 91/48 on 5/20 at 08:35am. CT of chest on 5/20 showed patchy consolidation of the posterior lower lobes bilaterally. At that point, I was contacted and recommended broadening regimen to clindamycin , ceftriaxone, and azithromycin. Upon transfer to Hospital, further serologies were collected which showed leukocytosis with left shift, highly elevated CRP, elevated troponin, elevated IL-6, elevated ferritin, negative Covid abs test, negative RVP, and negative Covid PCR. IVIG (2grams/kg) started on 5/20 at 22:57. Cardio and ID on board and all regular myocarditis infectious workup has been collected. ID consulted for workup and management. Of note, patient received the Covid vaccine on 5/1/21

have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; This is a spontaneous report from a contactable Physician. A 16-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm left on 12May2021 10:15 (Batch/Lot Number: EW0167) as single dose at the age of 16-year-old for COVID-19 immunisation, administered ad hospital. Medical history included acne with no medications. The patient's concomitant medications were not reported. patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 21Apr202110:15 (Batch/Lot Number: ER8735) as single dose at the age of 16-year-old for COVID-19 immunisation. No past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis, 36 hours of left chest pain radiates to left arm on 13May2021. The course of events was as follows: Previously healthy 16 year old male complaining of 36 hours of left chest pain radiates to left arm. Had Pfizer vaccine dose #2 about one day prior to chest pain onset. Found to have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis. Admitted to the Pediatric ICU for further management on 15May2021 7:00AM. The patient was hospitalized for the events, considered life threatening. Since the vaccination, the patient has been tested for COVID-19: Sars-cov-2 test: negative on 15May2021 Nasal Swab. Therapeutic measures were taken as a result of events, treatment in process. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Suspect pericarditis, elevated CRP, very very slight pericardial effusion, classic story, few EKG findings

5/15/2021 1120: EW0182 1st dose QMC -BVC Pt c/o itching to throat, chest tightness immediately. Mother gave benadryl at 1207. Epi pen at 1235. Pt taken to ED by mother. Pt rec'd prednisone, famotidine after observation and dx of anaphylaxis to Pfizer Covid 19 vaccine.

Prodrome of headache and gastric upset over 2 days following second dose. Then felt fine. Found the following day dead in bed. Autopsy pending

Presented to urgent care on 5/28 with complaints of sore throat, Headache, body aches and fever for 103, slight cough, denies chest pain or SOB. Had a neg rapid strep. Diagnosed with viral illness 5/30 presented to the ED with chest pain, cough, wheezing and SOB. Also had diarrhea and low abdominal pain. Was hypotensive and bradycardia. Received 2 bolus of Lactated Ringers . EKG with ST segment elevation. Concern for MISC. Transferred to hospital. 5/30 at the hospital he had another bolus of fluid, continued bradycardia admitted to the ICU for potential for hypotension during IVIG for suspected MISC, worsening ST elevation on EKG. TTE unremarkable. Started on IVIG, anakinra, lovenox and solumedrol. Monitored on telemetry. EKGs consistent with myopericarditis. discharged home on prednisone on 6/4 with a long taper, has follow up with rheumatology and cardiology. Stool enterovirus positive culture positive. He had previously been diagnosed with COVID-19 in November 2020

16 year old male with no PMH who presented with chest pain. Initially on 6/10-6/11 had expected myalgias and headaches post vaccination similar to dose #1, but later 6/11 developed chest pain that made it impossible for him to sleep. It was waxing and waning but continued through 6/12 which after discussion with PMD ultimately led to referral into our facility for further evaluation. Received a dose of ibuprofen with marked symptomatic relief. No further medications given during his time, his chest pain had resolved after that ibuprofen dose and was at clinical baseline until discharge on 6/15. Prolonged hospital course was to arrange for cardiac MRI to be done for comparison. Otherwise had serial labs (documented below) which had trended in the right direction.

Pain in the back of patient's right calf started after a flight on 6/2/2021. We ended up in the ER on 6/7/2021. There he was diagnosed per ultrasound with DVT or having a blood clot in a vein in his right calf. He was prescribed Eliquis and counseled to follow up with his physician at home. Patient met with our family physician on 6/9/2021, the day we arrived home to follow-up. After receiving the medical records Dr. advised us to file this report. We understand that blood clots can happen on flights, but Dr. felt that this event was such an anomally for patient that it merited further reporting. Patient is a completely healthy 16 year old male who is an extremely active athlete who participates in basketball, track, cross-country and other physical activities daily. For him to develop a blood clot after a 4 hour flight is an exceptional, unexpected event. Dr. long term plan is to keep patient on Eliquis for 6 months, then take him off of the medicine and then run more blood tests after 2 weeks to fully investigate the incident.

Chest pain, shortness of breath, severe myocarditis, rhabdomyolysis developed 2 days after his second shot.

My son died, while taking his math class on Zoom. We are waiting for the autopsy because the doctors did not find anything. He was a healthy boy, he had a good academic index, he wanted to be a civil engineer. He was the best thing in my life.

Myocarditis with onset 7/12, worse on 7/13 and admitted to hospital to Cardiology service. Had non-sustained ventricular tachycardia and was transferred to the cardiac ICU on 7/14 morning and placed on a lidocaine drip. He had no further arrhythmia, and lidocaine was stopped and transferred out of CICU on 7/15.

Clot and bleed in brain causing stroke; Clot and bleed in brain causing stroke; Clot and bleed in brain causing stroke; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old male patient received BNT162B2 (Lot Number: EW0186), dose 2 via an unspecified route of administration, administered in arm left on 20May2021 11:30 as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). No known allergies. Concomitant medication included paracetamol (TYLENOL). The patient previously received first dose of BNT162B2 (lot number: ER8735) in left arm on 29Apr2021 17:15 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced clot and bleed in brain causing stroke on 06Jul2021 17:00. The events were reported as serious due to hospitalization. Events resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Treatment received for the adverse events: Current hospitalization in PICU, rehabilitation, and pending further follow up actions. Prior to vaccination, was the patient diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 06Jul2021. The outcome of events was recovering.

After my son received his 2nd Dose of the Pfizer on the scheduled date at approx.10:45 am, we went home and were just relaxing and at approx 1:54 pm. My son in a panic yelled for me to come into the bathroom and he showed me his urine and it was bright red with clots (Gross Hematuria). I know the time because as soon as I saw it I took a picture (of which I still have on my phone). I proceeded to access how he was feeling and after he said he felt okay just scared-no pain or anything, I called his Pediatrician whose office instructed me to take him to the ER and that is what I did. He was not rough housing, there was no trauma and again no pain. This has never happened before.

Anaphylactic Reaction. Throat began closing up, difficulty breathing, dizzy, disoriented. Received several treatments of Epinephrine, Streroids, Benadryl, and Ativan. Put on Oxygen. He is now on Benadryl every 6 hours for the next 3 days and been told to carry around an Epi-pen in case he has more adverse reactions. Follow-up with his primary care is scheduled for tomorrow 3/19/21.

Approximately 15 minutes after vaccination, recipient developed tightness in throat. Taken into ambulance by EMTs. Seen by doctor at 20 minutes post vaccine. Patient developed stridor and shortness of breath. Treated for anaphylaxis- IM epinephrine x2, IV dexamethasone, 250 mL normal saline bolus. Transported to emergency department by EMS.

multi-phase anaphylaxis/several anaphylactic reactions; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program. A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 17Mar2021 at 12:45 (at the age of 17-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to sticking plaster (adhesive) and diabetes type 1. Family history included allergies to some antibiotics in the mother. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced multi-phase anaphylaxis/several anaphylactic reactions in Mar2021, which caused hospitalization and was reported as an important medical event and life-threatening. The clinical course was reported as follows: The patient had multi-phase anaphylaxis following his first dose of vaccination. He went to three different hospitals and was in the pediatric intensive care unit (PICU) at the time of reporting. The patient was heavily sedated, intubated, and on a ventilator for 3 days. The clinical outcome of multi-phase anaphylaxis/several anaphylactic reactions was unknown. Follow-up attempts are completed. No further information expected.

severe reaction to the vaccine had a anaphylactic shock had 2 more the next day; This is a spontaneous report received from a contactable consumer. A 17-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history includes diabetic (reported as Takes diabetic med humaran). It was reported that the patient experienced severe reaction to the vaccine had an anaphylactic shock had 2 more the next day. It was added that very sedated fighting it so he dont die. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Blood clot in right calf. Noticed pain and knot in calf on Sunday 3/14/2021. It worsened over the next few days. Went to Urgent care on 3/18 and they sent us straight to ER for Ultrasound. In hospital they found it was a clot identified as deep vein thrombosis, and started a treatment of blood thinner and pain medication.

17-year-old male who presents with 8 days of headache. He received his first dose of the Pfizer vaccine on 4/21. He felt like he had the flu after getting the vaccine and developed right-sided neck pain and a temperature to 100. The patient did endorse being elbowed in the neck playing basketball during this time as well, as he played in a basketball tournament in right after this. He got his Covid vaccine in his right deltoid. He saw his pediatrician on 4/26 and a CT scan of his neck with IV contrast was done and this showed significant diffuse right-sided deep spatial neck edema and right-sided adenopathy. The pediatrician discussed the findings with ENT who recommended augmentin and a medrol dosepak. The patient developed a headache several days after this and went to urgent care for evaluation. There was concern that the augmentin and steroids had caused the headache, so the steroids were stopped and he was switched to keflex on 4/30. He was given phenergan and toradol at Urgent Care and discharged home. His mom notes that several days ago he had fevers of 101-104. He has not had a fever for several days now. His headache continued and he felt unwell at basketball practice so he returned to urgent care on 5/4. A CT scan of his head was done which showed right sigmoid and transverse sinus thrombosis as well as thrombophlebitis of the right IJ. He was sent to ED for further management at that time. In the ED, the patient was hemodynamically stable and well-appearing. The CTs were overread by our radiologists here. The patient had some labs done at the outside urgent care but PT/PTT/INR and a CRP were drawn here, which were unremarkable. A Covid PCR is negative. Neurosurgery, neurology, and hematology were consulted. Neurology recommended heparin and a hypercoagulable workup and hematology agreed with this plan. The patient was admitted to the ICU for neuro checks and monitoring during initiation of heparin.

Patient was recently admitted to the hospital with heart failure due to rejection. The medication that has been administer to him has caused too many side effects and negative reactions. I was told to report it.

17yo otherwise healthy male presents to clinic for worsening cough, runny nose congestion, and sweats starting 4 days ago. He received the COVID vaccine 5 days ago in the afternoon and initially had what he expected to be normal side effects from the vaccine that evening. Symptoms included body aches, runny nose and general malaise. However, over the last few days he has felt worse and developed more congestion, cough, and sweating. He did improve a little bit 2 days ago but then started to feel worse yesterday and had a worsening cough that is resulting in some chest tightness. Cough is productive sounding. Mom describes it as barking. No appreciable wheezing but he sounds hoarse. He has some SOB after coughing repeatedly. He states it simply feels like it is hard to breathe for 10-20minutes after a coughing attack but then it resolves. He developed sweating yesterday as well. He states he will just start sweating for no reason. No measured fever. No chills. Today he has dried skin and cracked lips from blowing/wiping his nose all the time. No fevers. No vomiting. No diarrhea. No numbness/tingling. No redness/swelling at injection site. No rashes. No HA. EXPOSURE: No one at home is sick, No known exposures prior to vaccine CHRONIC: None, no hx of asthma or allergies, hx of eczema. PCP: None UTD on imms. Vitals: Wt 163.4, HR 60, RR 18, Temp 97.8, O2 sat % 98 Past Results: Examination: GENERAL APPEARANCE: alert, no acute distress, non-toxic, mildly diaphoretic, talking and cooperating throughout exam, sitting comfortably on exam bed, able to talk in complete sentences. HEAD: no visible lesions or abnormalities. EYES: no eye, eyelid, or orbital abnormalities identified. EARS: BILATERAL TMs pearly gray without erythema, effusion, or purulence; EAC with normal amount of cerumen bilaterally, no mastoid erythema or tenderness. NOSE: patent nares, congested, clear rhinorrhea. MOUTH/THROAT: moist mucous membranes, uvula midline, mild pharyngeal erythema without tonsillar exudate, no soft palate lesions, no trismus, no soft palate swelling or erythema, no difficulty swallowing or drooling. NECK: supple, non-tender, FROM. CHEST: normal shape, good expansion, no visible lesions/abnormalities, no tenderness, no retractions, no grunting, no stridor. HEART: no murmur, RRR. LUNGS: clear to auscultation, prior to administration of inhaler, diffuse wheezing and rhonchi throughout, post inhaler, improved air movement with focal rales in RIGHT poseterior middle lung field around T5. ABDOMEN: soft, no tenderness, no masses palpated, normoactive bowel sounds, non-distended. NEURO: alert, non-focal exam. SKIN: warm, dry without rash, petechiae, or purpura. Pneumonia of right middle lobe due to infectious organism Start Albuterol (Eqv-Proventil HFA) aerosol, 90 mcg/inh, 2 puff(s), inhaled, every 6 hours, 30 day(s), 1 Start amoxicillin tablet, 500 mg, 2 tab(s), orally, 3 times a day, 10 day(s), 60 Imaging:XR CHEST 2 VIEWS PA AND LAT Notes: History and exam are consistent with Community Acquired Pneumonia. CXR final read indicates RIGHT middle lobe bronchopneumonia. Suspect that pneumonia is unrelated to COVID vaccine. Pneumonia is an inflammation of the lungs caused by infection. Antibiotics are used to treat bacterial pneumonia. Other medications may help improve breathing and relieve symptoms in bacterial and viral pneumonia. Start and complete entire course of antibiotics. Increase fluids and restas much as possible. Patient informed to return if not improved or go to ER if worsening sympmtoms, SOB, or increased chest pain. Should be rechecked in 2-3 days by PCP. Discussed side effects and risks of medications with the patient. Patient expressed understanding and a willingness to participate in the plan. Patient left the UC in a stable condition with all questions answered at this time. Cough Imaging:XR CHEST 2 VIEWS PA AND LAT Notes: Discussed cough in clinic. Will plan to treat with albuterol PRN cough/wheezing every 4-6hrs and Stiolto Respimat 2 inhalations QD after discussion with Dr. First dose of Stiolto given in clinic with improvement in symptoms and improved aeration. Focal findings now appreciable. Discussed close follow-up and when to return to clinic. Will report symptoms to VAERS. All questions and concerns answered and addressed.

After 1st shot; Patient developed multiple blood clots (lungs and legs) about 10-11 days afterwards. All tests for cause of clots were inconclusive. Patient received his second dose and with in 48 hours was hospitalized for appendicitis. If it was a reaction after just one shot, I would normally think it was a coincidence. With him have severe reactions after both shots, it seems very suspicious!

COVID-19, mRNA, LNP-S, PF (PFIZER-BIONTECH) 5/19/2021 (17 Y) , 4/28/2021 (17 Y) Severe chest pain, Requiring hospitalization for pain management and MI/Myocarditis therapy.

Patient presented with one week of back, right leg and right groin pain. Right lower extremity swelling and was diagnosed with deep vein thrombosis from right popliteal vein into IVC involving a renal vein. He is on anticoagulation currently and going for catheter-directed thrombolysis today. Patient has been in hospital two days and hospitalization is ongoing at the time of this report.

Patient received 2nd Pfizer COVID vaccine on 5/21/21. He had fever and headache for about 24-36 hours, which he had also had after the first dose of the vaccine. On 5/23, he woke up with constant substernal chest pain, which worsened with exertion and deep inspiration. The pain increased throughout the day. In the ED, he was found to have elevated troponin ,CK-MB, elevated CPK, and elevated liver enzymes. EKG was concerning for ST elevation initially. Bedside echocardiogram showed low-normal function, normal coronaries, trace effusion, and no evidence of RV strain. Troponin and NT pro BNP were increased upon admission to our facility. Repeat ECHO showed borderline global hypokinesis of the LV with an LVEF of 51%. He received IVIG on 5/24/21 and also was started on ketorolac on 5/24/21. Troponin and CK were trending downwards at the time of this submission.

Patient hospitalized for overdose. Patient found to have potential myocarditis. Patient overdosed on antihistamines loratadine and doxylamine. Found to have rhabdomyolysis. CK levels have been trending downward. Patient found to have elevated troponin and ECHO showed decreased EF raising concern for myocarditis. Also with EKG changes. Patient is asymptomatic without chest pain or palpitations. Cannot differentiate cause of myocarditis, can be due to over dose and related to rhabdomyolysis or other causes.

Patient began with substernal chest pain 8 out of 10. Patient was taken to emergency room. At the outside hospital patient was given Motrin with improvement of pain. Patient's troponin at outside was 34.5. CK-MB was 41.6. CK was 523. CBC was unremarkable. Sed rate was 15. CRP 1.46. Patient had chest x-ray that showed no acute process. EKG at outside hospital shows sinus rhythm with occasional PVC. Mild diffuse settle ST elevation and no PR depression. Upon arrival to the floor patient had no significant pain. On telemetry patient was found to have an episode of nonsustained ventricular tachycardia. Patient denies recent cough, congestion or fevers. Patient does have 2 parents and a dog at home. Of note patient got first dose of pfizer Sars-Covid-19 vaccine on April 14. Second dose of Pfizer vaccine was given on May 14. Initial troponin i-STAT presentation was 11.03. Patient also experiencing nausea and vomiting on 5/20.

First shot received on 4/3/21, and second received on 4/24/21. Symptoms of cold, tingling, and numb left toes and left foot noticed about 2 weeks after 2nd Pfizer dose. Went to ER and blood clots were found in arteries in left knee and ankle, and clots in the vein in left calf. Four procedures performed by Intervention Radiology (IR) at Hospital on 5/25/21, and was treated with Heparin and TPA. Released from hospital with clot remaining in left calf vein and is taking Eliquis. Continuing treatment with hematologist post release from hospital.

elevated Troponins, CK, CK MB, EKG showed ST segment elevation, trivial effusion, normal coronaries, and low to normal function; elevated Troponins, CK, CK MB, EKG showed ST segment elevation, trivial effusion, normal coronaries, and low to normal function; elevated Troponins, CK, CK MB, EKG showed ST segment elevation, trivial effusion, normal coronaries, and low to normal function; elevated Troponins, CK, CK MB, EKG showed ST segment elevation, trivial effusion, normal coronaries, and low to normal function; elevated Troponins, CK, CK MB, EKG showed ST segment elevation, trivial effusion, normal coronaries, and low to normal function; Myocardial Injury; sudden chest pain that woke him up and got worse; This is a spontaneous report from a contactable physician. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21May2021 (Lot Number: EW0618) (at the age of 17 years old) as 2nd dose, single dose for COVID-19 immunisation. Medical history allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity from an unknown date. The patient's concomitant medications were not reported. No reported family medical history relevant to adverse events (AE), no reported cardiac arrhythmias, myocardial infarction (MI) under 50, no early deaths, nor any pertinent history. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0619) on Apr2021 for COVID-19 immunization. The patient experienced myocardial injury on 23May2021, 2 days after he received his second Covid vaccine with possible association. It was stated that the patient came in to the emergency room (ER) about 28 hours after his second vaccine with sudden chest pain that woke him up and got worse. Further stated that the patient was seen at an outside emergency department (ED) and had elevated troponins, creatine kinase (CK), creatine kinase-MB (CK MB), electrocardiogram (EKG) showed ST segment elevation, Echo showed trivial effusion, normal coronaries, and low to normal function. It was reported that he was admitted for monitoring due to potentially decompensating. Stated that he was consulted because of the association with the vaccine, and viral testing was done; the patient was tested for enterovirus, adenovirus, cytomegalovirus (CMV), epstein-barr virus (EBV), and parvovirus, all were negative. Treatment received was intravenous immune globulin (IVIG), pain medication and general support. States that the patient did receive IVIG while he was there, a one time dose, because the cardiologist was concerned with the way his troponins were trending, no decompensation. Further stated that the patient did not receive any pressors at any point and that the patient was still in the hospital but he was being transferred to the floor and they were trending labs, but he was not on any pressors or anything and he seemed like he has been doing well. There were no additional vaccines administered on same date of the Pfizer suspect. Chest pain and myocardial injury required a visit to Emergency Room on 23May2021. No prior vaccinations (within 4 weeks). No or unknown AE following prior vaccinations. As per the reporter all events seriousness criteria reported as medically significant, hospitalization. The patient was hospitalized from 24May2021 and ongoing at the time of the report (also reported as 2 days and counting). The outcome of all the events was recovering.; Sender's Comments: Based solely on chronological connection to the vaccine causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Myocarditis with chest pain and ST segment elevation. Elevated troponin. Runs of ventricular tachycardia. Hospitalization to pediatric cardiac intensive care unit. Presented to ED 6/9 and currently in the intensive care unit.

Patient presented with myopericarditis. Woke up at 230 am with vomiting and then developed chest pain. Came to ED immediately. ECG showed widespread ST elevations. Troponin at 25, peaked at 44, now downtrending. Admitted to cardiology, had run of Vtach and then admitted to PICU on Day 2.

I gave the Pfizer vaccine first dose to patient and consulted patient waiting in the store for 15minutes and told him common side effects. After 10 minutes sitting down, his mom notified us the patient fell on the floor. He hurt his right eye brown and caused bleeding and we called 911 . I took the patient sat on the chair in the lobby and tried to clean his opened wound on the eye brown. We gave him drink some water and he felt tired and light dizziness.After 20 minutes, 911 came and checked his pulse, oxygen, and clean his wound. After 30 minutes, patient felt okay and no longer having dizziness and he refused to go to Emergency. He still had pain from hurting eye brown.

History of prior COVID19 infection in March 2021, mild symptoms. Vaccine #1 on 5/14/21, Vaccine #2 on 6/11/21. Acute onset chest pain/pressure on 6/13/21 in the early morning. Chest pain slowly improved throughout the day. Treated with NSAIDs and colchicine due to concern for myopericarditis.

Symptoms: (05/01/21) Woke up with sore throat. Shortly developed stabbing chest pain that got progressively worse. Treatment: (05/01/21) taken to ED, was given morphine for pain. EKG showed STEMI. Troponin levels were in the 20s . Was also given 325mg of Aspirin. Troponin levels finally decreased to ~6 on day three (05/03/21). He was discharged that same afternoon on 5/3.

presented to the hospital 6/14/2021 with chest pain and troponin leak (peak of 14.9 after 2nd Pfizer vaccination (6/11/2021) with ST elevation on EKG and ventricular ectopy with non-sustained ventricular tachycardia, PVCs. treated for suspected myocarditis. remains hospitalized

c/o "feeling sick for a week"; treated at clinic Saturday, 6/19, for UTI and prescribed antibiotics; c/o generalized muscle pain/aches since 6/16/2004; positive for diarrhea and fever. Received an EKG, labs, and chest Xray. Diagnosis of Obstructive jaundice and SIRS. Transferred to higher level of care with specialty in house.

Patient with 1 day of chest pain, leading to ER visit that same day and admission to hospital with concern for myocarditis. Currently admitted to hospital awaiting further workup.

Two day after his 1st covid-19 vaccine, he experienced CP and fever and was taken to ER where a bedside US showed possible pericardial effusion. He was hospitalized overnight and an ECHO showed mild pericardial effusion. He was otherwise well, sent home on 10 day course of scheduled ibuprofen with f/u with cardiology in 2 weeks. When I saw him 9 days later he was asymptomatic.

History of Present Illness 17-year-old male who denies any major medical problems presents to the ER concern for chest pain. The patient states that he stayed up all night and he woke up this morning around 12:30 p.m., around 1 hour prior to arrival and he was having a tightness in his chest. The tightness is constant, seems to go down his left arm. He has never had this happen before. He received his Pfizer vaccination for COVID-19 on Friday of last week and he feels like he has had some aches since that time. He has been taking Motrin for this and this morning he also took Motrin but there is no significant relief. He has no significant shortness of breath, no nausea vomiting, no diaphoresis. I spoke with him privately and he denies any history of cocaine abuse. Per his mother he has healthy, no major medical problems. He has not recently had any other concerns or recent review systems. No history of having blood clots or DVTs. Medical Decision Making: History examination as above. Patient presents our concern for tightness in his chest with some radiation to his left arm over the past 1 hour. His EKG does show J-point elevation but he has no risk factors, he is hemodynamically stable well-appearing on examination. He has no shortness of breath, nausea, diaphoresis. Differential includes myopericarditis, early repolarization. Feel that the likelihood of STEMI, ACS is low. Will obtain a troponin as a part of his workup, chest x-ray for evaluation of cardiac silhouette size, bedside ultrasound. I do not suspect that he has a PE. He has no tachycardia tachypnea hypoxia. No external findings of suggest a DVT on examination. I do not suspect that he has cardiac tamponade, CHF, pulmonary process such as pneumothorax, pneumonia based on his history. Do not suspect a GI etiology. Will monitor closely here in the ER and re-evaluate. Time 2:30 p.m.. The patient's troponin is elevated at 7. I consult with Cardiology and I spoke with Dr- we reviewed the patient's EKG, his presentation, his history. He feels this is secondary to myocarditis from likely the COVID-19 vaccination. I have added a viral PCR as well as a part of his workup. He does not recommend activation the cath lab, he does not feel this is a STEMI. I do agree based on the history and the patient's appears this time. He recommended a formal echocardiogram as well. -I spoke with the ultrasound technician at bedside and there is no evidence of wall motion abnormality. This is consistent with my examination. -given the patient's elevated troponin we do not have capabilities of caring for him here. Not have Pediatric Cardiology, we do not have a PICU if the patient's condition were to worsen. There for the patient requires transfer to tertiary center. -will consult with another hospital for transfer. Time 3:22 p.m.. I spoke with Dr, he accepts for transfer. No recommendations for medications at this time. The patient is chest pain-free, hemodynamically stable. Spoke with the ultrasound technician there is no evidence of cardiac wall abnormality, pending official interpretation with our cardiologist. -asked for emergent transfer because I do not want the pain to be waiting here in the ER with possible worsening condition, worsening troponin elevation without cardiology consultation at a pediatric specific hospital. I do not want him to have the chance of deteriorating at this facility and therefore I do feel that he warrants emergent transfer as opposed to routine where he could wait here in the ER for hours. I do feel that benefits outweigh the risk and I spoke with the patient and his family about this and they agree. Critical Care: 55 minutes. Emergent evaluation on presentation given his EKG showing STEMI per computer interpretation. Time spent for multiple re-evaluations, discussion with Cardiology and outside hospital consultants, time spent with documentation. Time spent with family. Complex medical decision making. Serious life threatening disease process. Potential for death and increased morbidity. Exclusive of procedure time.

Immediately after administration, he started taking deep breaths and holding his chest with chest pain. He then lay down on the exam table and symptoms improved in a few minutes. 14 days later, on 6/17/2021, he developed severe muscle pain and was hospitalized two days later on 6/19/2021 for rhabdomyolysis. Discharged 6/22/2021 from Medical Center. He is an active athlete, plays alot of basketball and lifts weights. This was his first episode of rhabdomyolysis.

Approximately 11 days after receiving my first dose, I began feeling dull pain in my left calf. By Saturday, 4/17, the pain was severe enough to warrant a trip to the emergency room. After receiving an ultrasound of my leg, two blood clots were found in my left calf. One fully occluded a vein and another partially occluded a different vein.

Developed two blood clots in my left calf; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the right arm on 05Apr2021 at 10:00 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. Medical history included ADD (attention deficit hyperactivity disorder). Concomitant medication included mirtazapine (AVANZA). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient developed two blood clots in my left calf on 13Apr2021 at 14:00 which resulted in emergency room/department or urgent care visit. Treatment for the event blood clots included rivaroxaban (XARELTO). The outcome of the event blood clots was recovering. The patient was not tested for Covid post vaccination. Information on the lot/batch number has been requested.

18M with no PMH s/p pfizer vaccination dose 2 on 5/4/21 who presented with chest pain. He initially had chest pain the day prior to admission with pain in his back and down his left arm. This improved with Tylenol and resolved prior to bed. On the morning of 5/6 the chest pain returned and was so severe it woke him from sleep. He was difficult for him to characterize, but he said it was all over his chest, sometimes sharp and pressure-like, most severe in mid substernal region and was so substantial that he had difficulty speaking properly. He feels that the pain is most severe when lying flat and is best managed when he is resting at a 45 degree angle. Patient was at ED he was found to have an initial ECG with ST depressions in aVR and elevations in II, aVF, and V2 through V6 raising suspicion for pericarditis/myocarditis. Initial troponin was elevated at 4.35 as well. Cardiology Dr. was contacted by ED physician, case discussed, and EKGs reviewed and felt this was more likely pericarditis, but not STEMI. Of note, he reports a family history significant for his mother having a?hole in her heart.?He was given Toradol with improvement in his pain and upon arrival to hospital his chest pain was markedly improved. He was noted to have troponins peaking at 39.415 that down trended and an elevated CRP of 4.8 on admission. D-dimer was 0.26. Covid PCR was negative. He was evaluated by cardiology again here who upon review of his ECG and cardiac enzymes as well as presentation was consistent with pericarditis. Echocardiogram showed normal LV systolic function with trace posterior pericardial effusion and telemetry was monitored without any arrhythmias. He was started on low-dose beta-blockers, aspirin 650 mg 3 times a day, and colchicine 0.6 mg every 12 hours for 2 doses followed by 0.6 mg daily. He is planned to continue this for approximately 3 months and will need to follow-up with cardiology in 1 to 2 weeks for repeat monitoring and management with plan to taper off aspirin once his CRP normalizes. Later that night, he even had a similar episode of sudden onset chest pain for which she received IV Toradol with minimal relief and oral Tylenol with relief of symptoms after that. No telemetry abnormalities were recorded at that time. ECG the following day showed improving ST changes and troponin of 26.328 with CRP 4.2. He had no further symptoms for over 24 hours and is responding well to treatment. He is advised to take Tylenol as needed in addition to the above-mentioned medicines should he have any recurrent chest pain.

He had chest pains and could not breath after 48 hours, rushed to the ER. Stayed in the hospital for 4 days. He had a heart attack and was diagnosed with acute idiopathic myocarditis.

Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: Patient lost conciousness a few minutes after dose was given. Patient was unresponsive for approximately 2 minutes. Neck felt tight, difficulty breathing, was not alert/oriented when finally awoken. Patient was given 1 shot of epi 0.3 due to a temporary interuption in breathing that lasted seconds. By the time paramedics arrived, he was becoming more alert. Was taken to the ER and discharged.

pericarditis; a large pericardial effusion; This is a spontaneous report from a contactable physician. An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 18 years old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter explained the only probable trigger to the 18-year-old male patient developing pericarditis and a large pericardial effusion was the receipt of the first dose of BNT162B2, 2-3 weeks before the diagnosis. The reporter added he read through the CDC website, about increased cases of myocarditis and pericarditis after getting the second dose of BNT162B2. The reporter asked if the second dose was contraindicated after such adverse reaction to the first dose. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of Pericarditis and Pericardial Effusion and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees and Investigators, as appropriate.

Blood Clot/DVT Pain and swelling in lower extremity following left elbow reconstruction with contralateral gracilis autograft.

At 2-8-21 at approximately 1:00pm I recieved my 2nd shot. At 5:00am on 2-9-21, I woke up experiencing an extreme headache, nausea, body aches, and severe chest pain. I checked my heartrate with a PulseOximeter and found it to be elevated at 105-115. I called out of work and rested in bed for the day. On 2-10-21 most of my symptoms had subsided however the chest pain persisted through 2-11-21. On 2-11-21 at 2:00pm, I visited the Urgent Care. While there, the provider ran an ECG, Chest X-Ray, and bloodwork. Test results showed Troponin levels in my blood had reached critical levels of 7.72ng/ml. I was immediately transported to the ER at the Hospital, where upon arrival they did an EKG and bloodwork. I was then admitted and seen by a cardiologist, who ordered an CT Angiogram, more bloodwork, and an Echocardiogram. After I was admitted, my mother contact the nurses station to check on me and asked what was wrong. She was then told the hospital was treating me for an NSTEMI and Myocarditis. This resulted in a 3 day hospital stay where the results of the tests showed there was nothing wrong with my heart other than the increased Troponin levels. It should be noted that I have had ZERO previous cardiac issues, or any other significant health issues. I was discharged from the hospital with lower but still elevated Troponin levels, and told to follow up with my primary care doctor. I had no health issues and felt fine until I had my second dose of the Covid-19 vaccine. I have copies of my hospital records detailing all of this.

Pt reports generalized body aches, fatigue, fever 3/26, one day after receiving vaccine. Evaluated at ED 3/28, received Ketorolac and was discharged. While in parking lot, patient experienced blurring of vision, lightheadedness, nausea, SOB, and left-sided chest pain with return for re-evaluation. Pt treated for possible allergic reaction and concurrent EKG and blood work showed elevated troponin and transient ST elevation. Cardiology consulted and evaluated patient to have severe acute onset systolic heart failure, cardiogenic shock with pulmonary edema, Idiopathic fulminant myocarditis with myonecrosis, and hypoxic respiratory failure. Placed on furosemide, supplemental oxygen, and pending MRI.

Anaphylaxis. Turned gray, diaphoretic, blurred vision, difficulty hearing. Blood pressure quickly dropped to 66/31. Perfusion was 5 seconds. Received EpiPen (0.3mg Epinephrine) x1. BP better but slow to return to baseline. To Emergency Room for 4 hours observation. While in ED, received IV Benadryl and IV Zofran. Condition improved by the end of 4 hour observation so discharged with an EpiPen.

patient developed anaphylactic symptoms, hypotensive, dizziness, facial paleness. Epi-pen and 1 liter NS administered. Patient brought to ED, medicated with diphenhydramine and ondansetron. sent home from ED after approx 4 hours.

heart failure; heart attack; fluid in his lungs; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Right on 25Mar2021 (received at the age of 19-years-old) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included ongoing seasonal allergies and cardiac murmur he had as an infant. When probing medical history, the consumer reported that as an infant, her son, had a heart murmur. Her son saw a heart specialist in (State) who did an ultrasound/sonogram of her son's heart. The specialist said the heart murmur was fine and nothing needed to be done. She also adds that for family medical history, she and her husband don't have any early onset heart issues in either side of their families. She also reported that her son has horrible seasonal allergies. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; triamcinolone acetonide (NASACORT) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. The reporter stated that her son (patient) had a heart attack (26Mar2021) after receiving the first dose of bnt162b2. The patient also experienced heart failure on 28Mar2021 and had fluid in his lungs on Mar2021. She called regarding the COVID-19 vaccine on behalf of her 19-year-old son who received his first vaccine on 25Mar2021. Her son received his first Covid 19 vaccine at a PRIVACY where he attends college. On Friday, 26Mar2021, he was feeling crummy, on Saturday, 27Mar2021, he was feeling crummy. On Saturday night, 27Mar2021, her son started texting her around 11:30PM saying he had pain in his left shoulder and left arm. He had already taken 2 Advil and it wasn't helping with the pain, her son asked if he could take a third Advil. The reporter told her son he could take a third Advil because it had been an hour and a half since he had taken the first two Advil. The texts from her son continued. He was getting no relief. He took a hot shower and tried self-massage and warm compresses. He ended up throwing up and he said he felt a little better. Her son tried to lay down and couldn't get any relief from his pain. The pain was tremendous in his left shoulder and arm. Her son told his mother, he thinks he needs to go to the emergency department. His mother is two hours away from him and told him to call 911. Her son had a friend take him to the emergency department instead of calling 911. Her son went to PRIVACY. While at the emergency department, the doctor thought that her son's pain was muscular. Her son received an injection of Toradol. Her son was discharged from the emergency room and went back out to his friend who had brought him to the hospital. Her son and his friend didn't even make it out of the emergency department parking lot when her son suddenly couldn't see anything. His eyes were wide open and all he could see was black. His ears started ringing. Her son went back into the emergency department. Her son received Benadryl and an Epi-pen thinking maybe he was allergic to the Toradol and having a reaction to the Toradol. Her son had blood work, an EKG, and vital signs done in the emergency department on 28Mar2021. His blood work were over 3000 which the reporter reports, indicates a heart attack. The emergency room doctor did not think the Toradol would have pushed his Troponin levels that high. With her son complaining to her about the pain in his left shoulder radiating into his left arm and throwing up, those are signs of a heart attack. Her son was maybe playing off the seriousness of the pain he was experiencing. It was agreed at that point it might be her son's heart. She was about 18 minutes away from the hospital when she received a call from the hospitalist, the doctor taking care of her son. And that doctor tells her that her son is not doing well and is not responding to treatment of the bag of saline fluids. The doctor is trying to get her son's blood pressure and heart rate back up. The doctor was afraid he might have to air flight him to the PRIVACY hospital. She told the doctor she is 18 minutes away and asked if he can wait that long or does she have to turn around and drive the opposite direction to the PRIVACY. At this point her son was having a COVID-19 viral test in case he needs to be transported to the other hospital. The doctor tells her that her son can wait the 18 minutes until she gets to the hospital. She arrived at the hospital and wanted to see her son, her son is on high flow oxygen and she has to gown and glove up to be in his room for fear of Covid particles since he's on the high flow oxygen. His COVID-19 viral test results have not come back at this time. Her son was admitted to the hospital for heart failure. He was in the hospital for 5 days. He was admitted in the wee hours of the morning on 28Mar2021. During the time he was in the hospital he had chest x-rays and he was given Lasix to get the fluid off his lungs. His white blood cells were way up so he was given an antibiotic. He had an MRI, Chest X-rays, and a Heart Catheterization through his wrist that would indicate that he had blocked arteries in his heart. He had no blocked arteries. The heart catheterization revealed an artery going into his 4th heart chamber was slow to open and close. The cardiologist prescribed Metoprolol for six months with monitoring. The cardiologist feels the Metoprolol will repair his artery and get his blood pressure and heart rate numbers where they need to be. He was admitted to the hospital at around 3:00AM on 28Mar2021 and was discharged on 01Apr2021. Her son's COVID-19 viral test came back negative, but his COVID-19 antibody test showed that he did have COVID-19 antibodies. The doctor didn't know if that meant that her son had a previously undiagnosed case of the COVID-19 virus or if he developed COVID-19 antibodies that soon after he received the Covid 19 vaccine. She reported when her son was discharged, he was feeling better, but still had residual fluid at the bottom of his lungs. Her son did have to go for a chest x-ray on Tuesday, 06Apr2021, after he was discharged, to make sure the fluid was making its way out of his body. When he was discharged from the hospital, he had some shortness of breath and he was tired and weak feeling. The pain in his left arm began before he was admitted to the hospital. The shortness of breath started during his hospital admission. At this point in time she would say her son has improved. The Metoprolol he was prescribed by the cardiologist is one half of a 25mg tablet once at nighttime. She stated that she does not have any information on how low her son's blood pressure and heart rate were during his time in the hospital. Therapeutic measures were taken as a result of the adverse events. Outcome of the events was recovering.

difficulty breathing; chest pain; environmental pneumonia; low grade fever/ fever 104.3; chills/ chill were high; body ache; bumps that hurt on in front of his legs; erythema nodosum; hilar lymphadenopathy; This is a spontaneous report from a contactable consumer (patient himself). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Unknown) via an unspecified route of administration, administered in left arm, on 01Apr2021 at 11:15 (at the age of 19 years old) as 1st dose, single dose, for COVID-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 06 to 08April2021 (as reported), the patient began with low grade fever, chills, body ache. Then on, 14Apr2021, the patient began to complain about chest pain went to the hospital. The patient was told that he had environmental pneumonia on right lung, and he was given with antibiotics. On 17Apr2021, the patient went to the emergency room as fever was 104.3 and chill were high, and he had difficulty breathing. The patient was admitted and transferred to a Hospital where he was given with antibiotics, azithromycin (ZITHROMAX) and intravenous fluids; he was discharge on 21Apr2021. Later that night, the patient noticed bumps that hurt on in front of his legs and went to the doctor. It was indicated that the patient had erythema nodosum and was prescribed with prednisone 2x a day for 5 days. The patient took an X-ray that showed he had hilar lymphadenopathy and will go see a pulmonary specialist. He was also told to take the 2nd dose of the vaccine; 2nd dose was taken on 28Apr2021. The patient underwent laboratory test for COVID-19 (nasal swab) on 12Apr2021, 15Apr2021 and 17Apr2021 which all showed negative results. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The adverse events: erythema nodosum, hair lymphadenopathy and pain in leg have resulted to doctor or other healthcare professional office/clinic visit; while for the other adverse events have resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not recovered.

Acute myocarditis. Presented with palpitations. He had wide complex tachycardia (diagnosed as fasicular ventricular tachycardia). Required cardioversion. Started on metoprolol. Hospitalized two days. Send home with LifeVest.

19-year-old male no past medical history brought in by father with complaint of shortness of breath, chest discomfort, palpitations, tachycardia x2 days. Symptoms began 1 day after vaccination. EKG revealed diffuse ST elevations, machine read as *ACUTE MI*. Patient was given 325 mg ASA, placed on O2, and transferred to ER via 911. Patient was hospitalized overnight for observation. Troponins were elevated at 13. Patient had full cardiology work-up and cath lab that did not reveal any arthrosclerosis or underlying heart disease. Diagnosed with myocarditis, discharged on metoprolol and aspirin. Has pending follow-up with cardiology, currently still with mild symptoms.

Petechia/Bruising began within a week, July 14, 2021 labwork showed a platelet count of 7,000. Admitted to hospital through ER on July 15. ITP is likely diagnosis. No other contributing factors (No other illnesses, medication, health problems, etc)

He had no side effects immediately after the shot. About 2 weeks after the shot, he had a grand mal/tonic clonic seizure. It was the first seizure he'd had in about 10 or 11 years. (He never ran fever.)

Immune Thrombocytopenia (ITP) diagnosis with very low platelets. Bruising and petecchae started to develop several weeks after second Pfizer covid vaccine.

headaches; fatigue; bruising all over body; undetectable platelets; Immune thrombocytopenia; petechiae; Arm pain at site; This is a spontaneous report received from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 28Apr2021 (Lot Number: ER8735) at the age of 19 years old, at single dose for covid-19 immunisation. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient experienced arm pain at site in 2021, headaches in May2021, fatigue in May2021, bruising all over body in May2021, undetectable platelets in 2021, immune thrombocytopenia in 2021, petechiae in 2021. Arm pain at site, mid-May: headaches, fatigue, bruising all over body. Hospitalized with undetectable platelets and Immune thrombocytopenia and petechiae. The patient was hospitalized for all events for 3 days. All 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 underwent lab tests and procedures which included Nasal Swab: negative on 23Jun2021. The outcome of the all events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

had absence seizure within 5 hours of vaccination, the next day he started to have more myoclonic twitches. On April 27th morning he started having severe involuntary head shaking like "no" severe along with arms flailing causing shoulder dislocations, with arms flailing also accidentally punched own nose. The head shaking lasted all day through bed time despite normal doses of clonazepam 1mg given. At 1:15 a.m. had a tonic clonic seizure which was different than his "usual" ones. This morning he just woke up at 0715 and has started with the head/shoulder twitches. Yesterday his gait was much more unsteady than usual as well. Our entire family had the vaccine same day and we all only had mild side effects, brother and sister also have complex medical. Thank you for all you do.

Pt developed CP, SOA about 60 hours after vaccine administration went to campus health center and eventually ER where he was diagnosed with bilateral PEs.

1 day after the 2nd shot in the Pfizer COVID vaccine series he began to develop substernal pressure like chest pain . Patient was admitted into the hospital for 2 days (4/27-4/29) for this substernal chest pain. A CTPE, EKG, and CXR were ordered that were unrevealing as to the etiology of the chest pain. Troponins were elevated on admission with a slightly decreased delta (515->479). An ECHO was ordered that showed a LVEF of 35-40% with moderate global hypokinesis of the left ventricle, right ventricles moderately dilated, and no pericardial effusion. A Cardiac MRI was then ordered to determine etiology that showed subepicardial late gadolinium enhancement of the basal inferior and mid-inferior and inferoseptal wall consistent with acute myocarditis. Additionally, a small pericardial effusion without signs of inflammation, calcification, or cardiac tamponade physiology. Patient was then D/C on 4/29 after the cardiac MRI with no medical therapy with the recommendation to not partake in physical activity for one month. Will have follow up with cardiology clinic in 1 month and will participate in cardiac rehab.

presented to the ER with complaints of abdominal pain. Found to have a ruptured appendix with intra-abdominal abscess, UTI, acute hypoxic respiratory failure related to bilateral aspiration pneumonia, and sepsis. Principal Problem: Perforated appendix POA: Unknown Active Problems: Sepsis (CMS/HCC) (HCC) POA: Yes

Initial presentation Patient was in his usual state of good health until 4/19 when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. He awoke the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. The next day he began to experience gross hematuria and presented to the ED with a temperature of 98.9, blood pressure of 100/69mmHg, heart rate of 110bpm, respiratory rate of 18 breaths per minute and an O2 saturation of 97% on room air. On examination, patient was ill-appearing with diffuse pustules on his face, chest and back, periorbital edema, and leukoplakia of the tongue and buccal mucosa. His abdomen was soft and tender to palpation in the suprapubic area and at both costovertebral angles. Hospital course In the ED the patient was found to have a metabolic acidosis of pH 7.33 with an anion gap of 16, lactate 2.6, neutrophilic leukocytosis (22k), acute renal insufficiency with a BUN of 45 and creatinine 3.81 (baseline is 0.76). The patient?s urine demonstrated packed RBCs and 5-10 WBCs. He was admitted to the medicine service for further management. On the medicine floor he was initially found to have rhabdomyolysis (CK 584), worsening renal failure (Creatinine 8), follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. CT A/P without contrast showed increased attenuation of renal pelves and ureters consistent with hemorrhage, but no renal stones or hydronephrosis was seen. The patient was treated with pulse dose 500mg IV Methylprednisilone for 3 days and then transitioned to 60mg Prednisone. The patient?s pustular rash and oral leukoplakia greatly improved while on pulse dose steroids, but his kidney function continued to decline (Creatinine rising from 8 to 11), and the patient?s bilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. Bilateral hearing loss prompted an MRI of the brain which identified several punctate infarcts across multiple vascular territories in bilateral cortices and left cerebellum. The patient?s kidney function has continued to decline, with progressive hyperkalemia and hemodialysis was begun.

Acute onset chest pain began 4/11/2021, he took NSAIDS and tried to sleep. The following day, 4/12/21 the chest pain was still present. He was admitted to hospital and diagnosed with acute myo-pericarditis. He was treated with Colchicine with improvement in his symptoms.

I got out of my truck and collapsed; I had a grand mal seizure, seizing for 5 plus minutes; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; I leaned forward slamming on the gas colliding with another vehicle.; I don't remember starting my vehicle; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533), via an unspecified route of administration at the age of 20-year-old at arm left on 21Apr2021 22:30 at single dose for COVID-19 immunization. Medical history included epilepsy, haven't had a seizure until now for 2 years. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications included Men's Multivitamin GNC and fish oil received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The was leaving he apartment complex to go to school after work around 7am 23Apr2021, the patient didn't remember starting he vehicle, but he leaned forward slamming on the gas colliding with another vehicle. he got out of his truck and collapsed, he had a grand mal seizure, seizing for 5 plus minutes, having to go to the emergency room, he slammed his head repeatedly on the concrete during the seizure leaving his head bleeding and cuts all over he. He was now unable to drive for 6 months and need to get an MRI an EEG and be put on medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for one day for events. Facility where the most recent COVID-19 vaccine was administered in workplace clinic. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was received treatment for all events. The outcome of events was unknown. Follow-up attempts are needed. Further information is expected.

Patient developed pleuritic chest pain. Presented to ER and had CT angiogram to eval for pulmonary embolism. Unfortunately, study was suboptimal but showed possible subsegmental PE vs mixing defect and consolidation in lingula consistent with pneumonia vs pulmonary infarct from PE. Scan initially read as more likely pneumonia but patient without consistent symptoms and re-read as concerning for pulmonary embolism. Patient otherwise healthy without other risk factors for PE. Repeat CTA 2 weeks later with better quality without e/o PE and improving but not resolved opacity in lingula. LE dopplers 3 wks after onset w/o DVT. Hypercoaguable labs pending.

pain; heart attack; couldn't talk, the pain was so hard; pain in his left arm; Indigestion; chest pain; small temperature that was one degree higher than before; wiped out tired-extremely exhausted and tired; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in right arm on 13May2021 at 11:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is very strict on his health. The patient is a vegetarian, he is very health conscious. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID vaccine. The patient previously received the first dose of bnt162b2 on Apr2021 for COVID-19 immunization and experienced tenderness at the shot site and was very tired. On the morning of 14May2021, the patient had a small temperature that was one degree higher than before and the patient was wiped out tired-extremely exhausted and tired. Then the patient started experiencing chest pain within days of the second dose. The patient woke up on 15May2021 with chest pain that was persistent through 18May2021. On 19May2021, the chest pain got worse. The reporter thought the patient had indigestion so she gave the patient Tylenol, Pepcid, and clear soda and the patient felt a little better. On 20May2021, the patient was clutching his chest and had pain in his left arm. The patient couldn't talk, the pain was so hard. The patient went to the emergency room at 12:00 and the healthcare team said that the patient was experiencing a heart attack (reported time of heart attack was 10:00). The patient was not admitted to the hospital. They said the chemical that the large muscle in the heart makes, it was elevated which was how they determined it was a heart attack. These lab numbers were drawn every three hours and they came down but never went away. The patient had two Troponin draws and they were both elevated. They also did an EKG on the patient which showed a heart attack. The patient was told to see a cardiologist and was sent home. The reporter is watching the patient and the patient is still in a little bit of pain but not as much. The patient went to his primary care provider on the day of the report and the doctor doesn't see this as a displaced issue. The doctor does not know what would cause this in the heart. The patient is to see the cardiologist on Tuesday, 25May2021. The reporter is unsure if this is related to the vaccine but it was almost a week after the patient's second dose. The outcome of the event small temperature that was one degree higher than before was recovering and the outcome of the event wiped out tired-extremely exhausted and tired was not recovered. The outcome of the other events was unknown. Information on the lot/batch number has been requested

On Friday patient woke up with severe chest pain. He had to be taken to the emergency room. His troponin levels were above 1300 which indicated a heart attack so they admitted him to the hospital overnight. However, the blood work indicated an infection and Ibuprofen was the only medicine that helped with the pain. While at the hospital a series of tests were done to find out what was going on. Once the patient was stable enough he left the hospital and he is now undergoing more tests and getting his medical records transferred to the doctors here. We are still in the process of finding out the exact issue and will hopefully get some answers soon.

Patient was admitted with neurologic complaints (arm numbness and tingling) and chest pain/tightness. Was found to be hypertensive, thrombocytopenic and in AKI. Was evaluated for mutltiple problems but found to have aTTP. Patient received plasma exchange, high-dose steroids, rituximab and caplacizumab. AKI resolved, neurologic complication resolved and thrombocytopenia resolved. Patient was discharge 6.21.21 with prescription for caplacizumab.

HPI: The patient is a very pleasant healthy 21 y/o male with no sig PMH, he received the second dose of Pfizer's vaccine on the 15 th, he had some retrosternal sharp chest pain which was worse with breathing about 2 days ago which got better, but last night he started having more chest pain radiating to his lower jaw, he presented to the ER where his troponin came elevated, he has no fever chills no SOB no other complaints. His chest pain resolved with no recurrence, his EKG was normal. No h/o heart issues or chest pain in the past.

Rhabdomyolysis (CK > 22.000); Elevated LFTs; This is a spontaneous report from a contactable physician. A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 21-year-old on 24Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was School or Clinic. Medical history included asthma. Concomitant medication included ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported. The patient experienced rhabdomyolysis (CK > 22.000) (hospitalization) on 24Apr2021, elevated LFTs (hospitalization) on 24Apr2021. The patient underwent lab tests and procedures which included blood creatine phosphokinase: > 22.000 on 24Apr2021, liver function test: elevated on 24Apr2021, SARS-CoV-2 test: negative on 25Apr2021 (Nasal Swab). Therapeutic measures were taken as a result of rhabdomyolysis (CK > 22.000), elevated LFTs. The outcome of events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rhabdomyolysis and Elevated LFTs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.

Patient is a 21 y.o. male with no past medical history who got his second dose of COVID (Pfizer) vaccine on Saturday presented with chest pain since Sunday. Patient says that he was in his USOH until yesterday when he started having substernal chest pain which was getting worse with inspiration but also with specific movements. He does have pain even at rest sometimes but he thinks that it's exacerbating by breathing. Had some nausea/vomiting as well. Denies other symptoms. Not really sob or leg swelling. In the ER, his Trop I was 10.7 and his WBC was 12.2. His EKG was NSR with short PR and STE I, II, III, AVF, V4-V6 Patient is a 21 y.o. male with no past medical history who got his second dose of COVID (Pfizer) vaccine on Saturday presented with chest pain since Sunday with some pleuritic characteristics. He was found to have a very elevated trop I to 10.7, leukocytosis to 12.2 and STE in I, II, III, AVF, V4-V6. His POCUS in the ER was without significant pericardial effusion and probably normal EF. Differential at this point includes pericarditis vs myopericarditis (there are some myocarditis cases reported in Israel post Pfizer vaccination, predominantly in young male patients) vs less likely ACS. Will need admission and further work up and treatment -Admission to Cardiology -NPO in case team tomorrow decides to proceed to LHC -Full echo and cardiac MRI tomorrow -Telemetry monitoring -Repeat EKG q4h overnight -send CRP, ESR -trend Trop to peak -would not start heparin gtt at this point -Please start tonight ASA 650 TID + Colchicine 0.6 mg BID 21-year-old man admitted with signs and symptoms of acute myo-pericarditis or in the setting of recent COVID-19 vaccination. He apparently had the findings are vaccine 2 days ago and developed pleuritic chest pain. His ECG shows pathognomonic changes for pericarditis in the is a small troponin elevation. He has no past medical history or exertional symptoms to suggest CAD. Bedside echocardiogram showed preserved left ventricular systolic function. He was admitted and placed on aspirin and colchicine. A cardiac MRI today showed evidence of myopericarditis. He had 3 beats of nonsustained VT on tele.

Patient had a seizure about 40 seconds after receiving the COVID19 (Pfizer) vaccine. He urinated, and became cyanotic, not breathing and faint pulse. CPR as initiated and 911 called. Patient regained consciousness after 30 compressions and was taken to the hospital after ambulance arrived.

Mycocarditis. The patient was hospitalized for severe chest pain on the evening of May 26. His chest pain resolved in 12 hours without specific treatment and he was discharged on May 27th. Follow up (by phone) 1 week later (June 3), he reports doing well with no residual symptoms. He is back at work.

Patient reported history of fainting with previous vaccinations. Patient received 1st dose of Pfizer vaccination and was screened a couple of minutes after administration and patient said he felt fine. Patient stood up and walked to the waiting chair where the patient fell and hit his head causing bleeding and patient appeared to shake but came out and was responsive immediately. Provided first aid, gave patient paper towel, to wipe off blood and provided ice pack and bandages and suggested immediate medical care. The patient looked pale and was sweating after fainting. Offered to call 911 but patient declined and Store management assisted and filed report.

A patient with no past medical history presenting with chest pain and troponin leak 2 days following Pfizer COVID-19 vaccination. LHC was negative. Work up and imaging was consistent with Myocarditis. Echocardiogram was consistent with mildly reduced systolic function. The patient was discharged with pain and anti-inflammatory medications. Additionally, the patient had several runs of non-sustained Ventricular tachycardia and was tachycardic for which Beta-blocker was started.

Patient was sitting in the chair and then fell onto the floor head first causing him to bump his head and also hit his nose. He appeared to have a bump on his forehead and his was bleeding.

patient admitted for chest pain and code MI. elevated troponin with normal coronary, 0.5-1 mm ST elevation in inferior leads and V5 when troponin was positive at 0.5. MD stated patient is diagnosed with myocarditis.

Tiny "bumps" covering both arms, both legs below the knee, collarbone area, back, and shoulders. Bumps are extremely itchy. I have unknowingly itched my arms until the bumps begin to bleed. Best described as hundreds of small mosquito bites.

Seven days after received Dose 1 of Pfizer Covid-19 vaccine, right arm was swollen and uncomfortable, the next day was purple. He want to urgent care center who thought he had "Covid arm" and was put on prednisone. Arm worsened, so he went to ER in middle of night on 5/4/21. He was given shot of Lovenox and sent home to return in am for ultrasound. Ultrasound next morning showed right subclavian vein DVT. He was put on Eliquis and told to follow up with hematologist. He is working on getting appointment with a hematologist before flying home, where he will do further work up with hematologist there.

Bleeding; Shortness of breath; Chest pain; Fever of 102; Viral myocarditis; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration assuming left arm, at age 22 years, on 05May2021 (Batch/Lot Number: EW0153) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history was reported as no. Concomitant medications were not reported. Patient historically took first dose of BNT162B2 at age 22 years on 14Apr2021 for COVID-19 immunization. Reporter's son unfortunately appeared was hospitalized for adverse reaction (bleeding) and the physician told reporter to report this. Patient had has viral myocarditis of heart on an unspecified date on May2021 after he got his second dose on 05May2021. On 06May2021, patient started having symptoms of shortness of breath, chest pain and fever of 102 (unit: unknown) after the second dose, so he went to emergency room. Then on Friday , 07May2021, he ended up with bleeding, so admission date is 07May2021 and he is still in the hospital at the time of reporting, they don't know how long. Patient also underwent lab test and procedure that includes laboratory test on May2021, 2 weeks before, patient was fine until the second dose. The outcome of the events was unknown.

Patient is a 22 y.o. male with PMH of obesity who presented to ED on 5/22 with c/o chest pain 3 days after receiving his second dose of Pfizer COVID-19 vaccine. Trop elevated to 12.7 and ECG with diffuse ST segment elevation consistent with pericarditis. He had an episode of NSVT. Trop peak 29. Patient was started on ASA + colchicine and metoprolol. TTE revealed LVEF 49% with multiple segmental abnormalities. Due to concern for worsening arrhythmia and possible need for myocardial biopsy patient was transferred to BMMC on 5/23. Cardiology was consulted and cardiac MRI was performed. No further arrhythmias noted on telemetry monitoring. Cardiac MRI revealed LVEF 57% RVEF 53%, no vasodilator induced perfusion defect, delayed enhancement MRI is abnormal, epicardial enhancement of distal anterior and anterolateral walls with small pericardial effusion, consistent with perimyocarditis. Patient chest pain resolved and he denied other associated symptoms.Ttroponin level down to 5, VSS. Medically stable for discharge with no strenuous activities until inflammatory biomarkers normalize and close f/u with cardiology in 1 week. New medications: - ASA 650mg TID for 7 days followed by ASA 325mg daily - Colchicine 0.6mg BID for at least 3 months - Metoprolol succinate 25mg daily Follow up with cardiology clinic in 1 week with CRP, ESR, and troponin

On Friday night, April 16,2021, after working all day for his job, Pt told his roomates that he wasn't feeling well, was throwing up, had the chills and was going to lay down. When the roomates didn't see him Monday morning, April 19, 2021, they went into his room and found him unresponsive. The medical examiner ruled death due to cancer which appears incorrect considering the evidence.

Approximately two weeks after receiving the second dose I began to notice abdominal pain that worsened when breathing or laying down. The pain became more severe over the course of the next few days that I admitted myself to the emergency room of the Hospital. A CT scan showed a pulmonary embolism located in my lower right-hand lung, which would have killed me if left untreated. I was admitted to the hospital and treated for pain and given intravenous blood thinners for 3-4 days. I was discharged with orders to follow up with a pulmonologist, cardiologist, and PCP. I was unable to schedule visits with the specialists due to financial constraints. After leaving the hospital my condition began to improve and has continued to improve since. As I understand it, the tissue in my lung may never heal and as a result i suffer diminished lung capacity.

Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.

Patient presented with a no health hx except for hives to PCN as a child and "passed out" with a childhood vaccine x 7 years ago. Vaccine given without incident, doctor present to distract patient while I gave vaccine. 3-5 min post vaccine patient c/o of nausea and trash can provided. Patient became silent while talking, head fell forward and clonic tonic posturing noted in upper extremities. Called to doctor and patient lowered to floor and placed in recovery position, MSE lasted approximately 30 seconds, EMS called. Post seizure: Patient very pale and diaphoretic, oriented to person quickly, no signs of facial swelling, resp distress or symptoms of a severe allergic reaction. B/P 134/50 HR 80 and regular, patient at this time shares that he had a MSE 3 or 4 years ago with friends. States came around after eating and drinking. States he did not share this information with his health care provider. Patient was AA&O x3 but with dismissed LOC from pre-vaccine state. 1200-EMS arrived, B/P 110/7, glucose 88/EMS, attempted to sit patient up/EMS, became dizzy and pale. Lowered to recovery position and waited for second team. Attempted to sit patient up again when second team arrived and again he became pale and dizzy. 1212- patient consented to be transported to hospital at this time/EMS.

Grand Mal seizure. 55 hours post vaccine. Lasted 15 minutes and required emergency rescue medication Nayzilam. He has seizure disorder but his seizures are well controlled. Typically only has one post op brain surgery or due to illness/infection. Has less than 10 in his life. Phoned one of his physicians to report the seizure and discuss situation. Was told to just watch for other symptoms or side effects. He recovered from seizure and rescue med. Notified two other doctors of the event the next work day.

1/11/21 COVID Pfizer vaccine #1 = no issues (given at Clinic = screening form marked all no but had a 30 min watch post vaccine 1/29/21 Covid Pfizer vaccine #2 EL0261 left arm at Clinic, 2/20/2021: medical sent to local ER on 2/20 for 2 day c/o worsening left hand/forearm numbness, coldness, discoloration to left hand and pain (purple appearance). Was seen at clinic with negative DVT r/o US, nl imaging and labs. 2/21 sent to ER c/o UE pain and weakness x 5 days (woke up with bicep pain that progressed to numbness, tingling, swelling and discoloration of hand (cyanosis pallor and cold LUE x 3 days). Severity is moderate. Quality dull pain. Currently invo 1/11/21 COVID Pfizer vaccine #1 = no issues (given at Clinic = screening form marked all no but had a 30 min watch post vaccine 1/29/21 Covid Pfizer vaccine #2 EL0261 left arm at Clinic - no c/o reported 2/20/2021: medical sent to local ER on 2/20 for 2 day c/o worsening left hand/forearm numbness, coldness, discoloration to left hand and pain (purple appearance). Was seen at clinic with negative DVT r/o US, nl imaging and labs. 2/21 sent to ER c/o UE pain and weakness x 5 days (woke up with bicep pain that progressed to numbness, tingling, swelling and discoloration of hand (cyanosis pallor and cold LUE x 3 days). Severity is moderate. Quality dull pain. Currently involves entire left arm (arm, elbow forearm wrist hand).. Did have some swelling and motor loss, NO CP, SOB or sensory loss, no redness, no injury, no fever, chills, ha, depression sore throat, cough, rash, lymphadenopathy, abd pain, GI distress, no trauma or recent illnesses. 2/21: admitted clinic w/rhabdomyolysis: no preceding workouts, increased activity on ship, back sleeper, no alcohol, no trauma,. nsp: skin intact, no erythema. Mild edema to upper arm around triceps. Mild purple discoloration to dorsum of hand. Palp: TTP about triceps. TTP anterior shoulder. TTP biceps. Able to palpate triceps tendon and biceps tendon. NTTP throughout the rest of hand and forearm. Hand is cooler relative to contralateral side. NTTP cervical spine. ROM: Full passive ROM of the shoulder and elbow with pain. No micromotion pain with any joint in the upper extremity. Painless cervical spine ROM. Motor: 3/5 strength to OP/FPL/2nd FDP, EIP/EPL, 1st and 2nd DIO. 3/5 deltoid, biceps, triceps, wrist extensors, wrist flexors. Sens: Decreased sensation throughout entirety of forearm and hand distal to the elbow. Above the elbow, sensation is intact. Vasc: 2+ radial pulse, symmetric to contralateral side. BCR <3 sec. Hand is cooler than contralateral side. Lab: CRP <5, ESR 4, CK 31,924, PT 14, INR 1.1, D-dimer 0.46, AST 610, ALT 186, Cr 0.94, WBC 6.3 Imaging: Radiographs of the chest, shoulder, elbow, wrist, and hand demonstrate no fracture. The shoulder is well located. CTA starting at the heart demonstrate no vascular abnormalities. Assessment: unlikely that he has compartment syndrome or a cervical spine pathology. His exam does not localize to one specific innervation or muscle group. His paresthesias and diffuse 3/5 weakness on exam may be related to parsonage turner syndrome (post viral neuritis) versus edema. While he does have a cool hand and mild/moderate edema on exam, his CTA is normal and his exam is very reassuring that this is not compartment syndrome. He likely has rhabdomyolysis based on upper arm swelling in the setting of CK of 31924. Discharge 2/22/2021: He received a total of 3 liters of IV fluids and was encouraged to drink large amounts of water. Repeat CK levels showed to be down trending as were his AST and ALT enzymes. Plain radiographs of his left arm and shoulder were unremarkable as was CT angiography of his chest. Electrolytes and renal lab work was within normal limits throughout the hospitalization.On the day of discharge, he was tolerating a PO diet, ambulating without difficulty, and hemodynamically stable. LUE w/ minimal swelling, no erythema. TTP over L triceps belly, No TTP over the distal LUE. Somewhat decreased sensation to light touch over distal LUE. 2+ radial pulses b/l. LUE ROM somewhat limited 2/2 pain, but intact. ---- to f/u with HCP in 2 weeks, sooner if worse (medical officer) CK 2/22/21 was down to 14653

23 year old male with a history of 31 allergic reactions, Mast cell activation syndrome, Addisons disease, and POTS, developed anaphylactic reaction after receiving first Pfizer COVID-19 vaccine. Patient took 50 mg benadryl 30 minutes before arriving at vaccine clinic in anticipation of possible reaction per physician's recommendation. Per pt he asked multiple physicians regarding receiving the covid vaccine and was given the permission to proceed. Also took 20mg hydrocortisone in the morning, then 10mg this afternoon for Addison's disease. 1603 - Pt received 1st dose of Pzifer covid-19 vaccine and during the first 5 minutes of observation complained of feeling itchy and wheezing, light headed, nauseous. 1608 - 0.3mg epi given at - self administered right thigh. 1613 - 90 mg of hydrocortisone (solu-cortef), patient's own medication, given by RN through pt's PICC line RUE; line was flushed with NS before and after and cleaned with alcohol swab. 1615 - Self-administered 4 mg Zofran (patient's own medication) at 1615 into the RUE PICC; cleaned with alcohol swab. 1615- Second 0.3mg of epi given- self administered left thigh. 1617 - Fire department arrived. 1621- pt complains of itchiness still but wheezing is reduced. BP 118/83 at 4:25 PM, normal O2 sat and pulse, normal respiratory rate. 1626 - patient placed in gurney, escorted out by Fire Dept en route to Hospital Physician assistant and five other RN were with the patient and his mother.

Approximately 7-10 days or so after receiving the first dose of the pfizer Covid vaccine I started to develop this red, nodule-like, painful "rash" on both of my forearms. Not only the left arm where the vaccine was administered. This did not go away after a couple of days, and I was instructed by a physician to being taking Benadryl. This appeared to alleviate the symptoms (no visible red nodules anymore) 4-5 days prior to my second dose, so I stopped the medication and presumed it was done. Then, within 4-5 hours of receiving my second Pfizer covid vaccine, I broke out into the same red, painful, nodule-like "rash" along both of my forearms. This time was worse than the previous reaction. I was instructed to take Allegra at the time by a physician, which I did for approximately 4 weeks. This seemed to get rid of the symptoms I was experiencing, and I could not visualize the nodules on my forearms anymore. However, after approximately 2 weeks, I noticed a painful and swollen vein in my right forearm, opposite arm to the one I received the vaccine in. I did not think much of it at the time, since I had no other associated symptoms. Then, over the next couple of weeks, it appeared to become more swollen and painful. Also, I saw another swollen vein near my knee. On April 6, I had labs drawn and CBC, CMP, TSH, and ESR came back normal, but the CRP was elevated. Thus, I was instructed to begin aspirin 325mg, which I took for 4 days beginning April 8th and ending April 12th. On April 13th, an official ultrasound confirmed a DVT in my right popliteal vein, a superficial thrombus in my proximal great saphenous vein, and a superficial thrombus in my right forearm where the pain originated from weeks prior. The initial presumption at this time is that the clots are vaccine-related, but could be linked to an underlying blood disorder that was triggered by the vaccine. Blood hyper coagulation labs have not yet come back. I was initiated on Eliquis starting April 12th for the DVT.

Nodule on both forearm; swelling along veins and they became painful; swelling along veins and they became painful; 2 superficial venous thromboses, one in my arm and another in my leg; 2 superficial venous thromboses, one in my arm and another in my leg; Deep vein thrombosis leg; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 25Jan2021 (Lot Number: EL3247), as single dose, for COVID-19 immunisation. Patient was vaccinated in the hospital. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not have COVID-19 prior to vaccination. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL0142) on 04Jan2021 at 11:30 AM in left arm and experienced nodule on extremity and vaccination site nodule. The patient experienced deep vein thrombosis leg (medically significant, life threatening) in 2021 with outcome of not recovered, nodule on both forearm (life threatening) on 25Jan2021 with outcome of not recovered, swelling along veins and they became painful (life threatening) in 2021 with outcome of not recovered, swelling along veins and they became painful (life threatening) in 2021 with outcome of not recovered, 2 superficial venous thromboses, one in arm and another in leg (life threatening) in 2021 with outcome of not recovered. It was reported that within hours from second dose the nodules reappeared. At this time, patient was told to take Allegra and did so for 4 weeks. A month later, patient began to see some swelling along his veins and they became painful. This developed into a DVT, deep venous thrombosis, in leg and 2 superficial venous thromboses, one in arm and another in leg. all the events required physician office visit. None of the events occurred at vaccination site, but physician believed they were triggered by receiving the vaccine. Treatment of Eliquis was initiated the day before report. Patient was not tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.

Patient noticed some SOB and chest tightness the evening after receiving the Pfizer COVID vaccine. A few days later his symptoms worsened to chest pain. He went to the ED and was further transferred to the hospital where he was found to have myocarditis. He is being treated with colchicine and lisinopril.

the patient was sitting in our observation area for the recommended 15 minutes. he fainted and fell face forward out of his chair at the 10 minute mark. my pharmacy technician and I ran out of the pharmacy to help the patient while another technician called 911. we rolled him to his side and he was breathing but pale. we removed his mask and noticed his head was bleeding. we put pressure on the would and stayed with the patient until the paramedics arrived

Patient collapsed onto floor from standing about 5 minutes after his injection. Was unresponsive for about 1 minute then came to. Head laceration with light bleeding to the back of his head. 911 was called immediately and patient was transported to a hospital ED.

Received first dose of Pfizer on 3/1. Felt tired for few days and was fine. Started having neck and back pain and then extreme heart burn, pain down left arm, trouble breathing etc. Admitted into hospital on 3/20/21 with Triponin Level at 1.8 and Blood Platelets level at 20,000. Fever and resting heart rate of 135 BPM. Extreme heart burn and pain down left arm. Triponin level rose to 4.5. Platelet levels did not increase. After multiple blood tests to make sure they were correct Cardiologist and Hematoligist diagnosed as Myopericarditis and ITP blood disorder. Spent 4 days in hospital on heavy Decadron dose for ITP and levels improved. Myopericarditis being treated with Colchicine and Metoprolol. Was discharged from hospital on 3/24 and monitored at home. ITP levels still fluctuating and Myocarditis and Pericarditis are still being treated. No previous history of any heart or blood problems and no family history. 23 year old healthy male with no previous health conditions.

Acute STEMI presentation with chest pain and ST elevations inferior/posteriorly. Taken to cath lab emergently and chest pain resolved, ST segments cleared immediately upon injection of contrast into L coronary system. Cardiology and ID suspected arterial embolism had been present and was dislodged/dissolved by contrast injection.

He did not told me about any symptoms. He just died the next day of the vaccine. Still today doesn?t know why he died. He appeared to be in good health.

Pt. developed arm site pain, fever chills and muscle aches day after 2nd dose, 05/14/2021 symptoms resolved by night time. He awoke on 5/15/2021 with waxing and waning chest pain/ burning and chest pressure, seemed too improve but by 5 AM on 5/16/21 was more intense and he presented to E.D. where EKG showed diffuse ST elevations and PR interval depressions. Troponin was elevated at 0.494, increased in next hour to 0.569 and patient was admitted. TTecho showed normal E.F. of 60-65%, nl valves and trace pericardial effusion. CXR was negative for pulmonary infiltrates, (no Hx of Covid Dx) P.E. showed no conjunctivitis, no rashes, all else also WNL

Client reported to both nurses hx of multiple episodes of syncope with needles. Client was hydrated and offered to lay down prior to administration of vaccine severally. Client refused offer to lay down post vaccination prior to vaccine administration. Client experienced syncopal episode immediately after administration of vaccine. Client was eased to ground by staff. Legs were elevated on chair. Client displayed seizure like movements lasting 30 secs. Tonic-clonic, jerky movements observed. Eye rolled to back of head observed. LOC checked and client was AOx3. VS#1 BP: 122/82,O2: 100%; P: 84. VS#2 BP: 129/78, P: 94, O2: 100%. EKG: Sinus Tach, no blocks.

onset of right knee pain on 5/24, followed by left knee pain on 5/26. DVT of left lower extremity diagnosed 5/27

Patients father said his son began throwing up 2 days after injection. They took him to the ER and patient was given some medication to stop emesis. Two days later patient was still throwing up and the ER told him to give the medication a couple more days to work. The father said the throwing up was not constant and patient was able to eat and keep it down. The emesis was reported as dark brown mucous with no food particles in it. Patient was reported to throw up everyday until his death on day 9.

Two weeks after the second vaccine shot, patient had a seizure while sleeping. It was a grand mal seizure that lasted for three minutes. Afterwards he was lethargic and does not remember the events

Presented with chest pain starting 1d after 2nd vaccine and worsening 3 d post vaccine. Found to have nstemi with troponin 11, normal echo, normal heart cath, negative urine drug screen.

I have been discharged from the hospital with pericarditis; Went into walk in on 10May, and was rushed to ER due to heart issue. ER states I possibly had a heart attack; The Sunday following 2nd dose, woke up with severe chest pains; This is a spontaneous report from a contactable consumer (patient). A 24-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 06May2021 18:30 (Lot Number: ew0171) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history was none. The patient was healthy. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication(s) included ibuprofen. The patient took the first dose of bnt162b2 on 15Apr2021 07:00 PM (Lot number EW0153) in left arm for COVID-19 immunisation. On 09May2021 03:30 AM, the patient woke up with severe chest pains. Went into walk in on 10May, and was rushed to ER due to heart issue. ER stated he possibly had a heart attack, and now he had been discharged from the hospital with pericarditis. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalized for two days. Multiple treatments administered. The patient had covid test type post vaccination nasal swab on 10May2021 with negative result. The outcome was unknown.

Myopericarditis, 3 Days after Vaccination, elevated troponin/NSTEMI, chest pain Treated with high dose ASA/Colchicine per cardiology

Woke up with chest pains when breathing, overall tightness with sharp pain in the right pectoral as well as neck pain. Waited a week and then went to an urgent care for symptoms and they sent me to ED. After evaluation I was admitted for more testing and started on treatment. Discharged on 6/10 taking ibuprofen and colchicine with outpatient follow-up on 6/17/2021.

Myo-pericarditis. Hospitalized for 3 days from severe chest pain. Hospital tests came back with troponin levels at heart attack severity.

Patient found to have large pericardial effusion without tamponade. He is now status post sub-xiphoid pericardial window with subsequent drainage of effusions. Pericardial pathology showed hemorrhagic pericardial tissue with marked acute and chronic inflammation and adherent fibrin consistent with fibrinous pericarditis. Patient endorses improved symptoms post-operatively, remains afebrile, and is without leukocytosis. Minimal residual pain is likely secondary to his recently removed chest tube. Medical team plans to discharge patient today.

diagnosed with heart failure; Cardiomyopathy; there's inflammation within his heart as well as reduced ejection fraction; there's inflammation within his heart as well as reduced ejection fraction; chest pain; palpitations; rapid heart beat; This is a spontaneous report received from a consumer (patient) A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular arm left on 26Apr2021 (Batch/Lot Number: EW0170) as single dose (at the age of 24) for covid-19 immunisation. The patient medical history was none. Patient states he had no prior medical history or cardiovascular issues. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient experienced cardiomyopathy on May2021, diagnosed with heart failure on an unspecified date, there's inflammation within his heart as well as reduced ejection fraction on an unspecified date, chest pain on 02May2021, palpitations on 02May2021, rapid heart beat on 02May2021, there's inflammation within his heart as well as reduced ejection fraction on an unspecified date. Patient went to a specialist that Monday, a private practice, and after a good range of medical tests, he was diagnosed with cardiomyopathy and was admitted. The patient was hospitalized for cardiomyopathy and heart failure from 04May2021 to 06May2021. Patient states he was hospitalized 5 days later and diagnosed with cardiomyopathy and he was diagnosed with heart failure after he received the Pfizer vaccine after a good range of tests and MRI's, it seems there's inflammation within his heart as well as a reduced ejection fraction. Patient states it happened immediately after being vaccinated and since then have been taking cardiovascular medications everyday. Patient states he had a regular MRI heart with and without contrast in May2021. Patient states they said there was decent range of dysfunction. Patient states it's super detailed, so he thinks he would rather Pfizer get in touch with the doctor. Patient states the report is 2 pages long, but what he knows for certain is it was cardiomyopathy for sure. Patient states he also got a PET MRI heart in Jun2021 as well. Patient states his doctors said it can't be confirmed 100% but they have a reason to believe it could have been from the vaccine. Patient states he needs an answer from Pfizer and he's not the first person that's probably called in, he needs someone to hear him on this. Patient states he doesn't want to contact the media. Patient states he needs an answer, this has ruined his life essentially. Patient states he knows it's not specifically the call handler or Pfizer, but this is taking a lot for him and if someone can get back to him on this that would be great. Patient states he is a 24 year old, able-bodied guy, who's very healthy and it all started right after getting vaccinated. The outcome of cardiomyopathy, chest pain, palpitations, rapid heart beat was recovering, of the other events was unknown. No follow-up attempts are possible. No further information is expected

Has multiple blood clots; He had been feeling different for about a week since he got the second shot.; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in upper right arm on 19Jun2021 at 12:00 (at the age of 24 years) as dose 2, single for covid-19 immunisation. The patient had no medical history and family medical history relevant to adverse events. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number was not reported) via an unspecified route of administration, in left arm on 29May2021 as dose 1, single for covid-19 immunisation. Patient had no additional vaccines administered on same date of the pfizer suspect and no prior vaccinations within 4 weeks. The reporter wanted to inform that the patient had a bad reaction to the Pfizer vaccine. On an unspecified date in 2021 patient experienced had multiple blood clots, he had been feeling different for about a week since he got the second shot. The patient was hospitalized for has multiple blood clots from 15Jul2021 to still in hospital. The blood clots were persisting and was not dissolving. On 18Jul2021 patient underwent lab tests which included CT scans, ultrasounds abdomen, and blood work waiting on results. Therapeutic measures were taken as a result of has multiple blood clots (thrombosis) includes treatment with IV Heparin. The outcome for event multiple blood clots was not recovered, and for feeling different for about a week it was unknown. Information about Lot/Batch number has been requested.

Patient, "Starting just hours after the vaccine I felt exhausted. I slept for a long time and woke up the following day with the standard arm pain but I also had extreme fatigue and a headache as well as a productive cough. That lasted for over 48 hours. On the third day I had fatigue, cough, body aches and a headache. I received a rapid covid test on the 31st that was negative and the nurse practitioner said that she believed that I was either having a bad reaction to the vaccine or bronchitis or pneumonia. Last night I had all of the same symptoms as days prior as well as tightness in my chest and a obvious upper respiratory infection."

25yo M with no sig PMHx or FMHx for ACS presents with 4 days of viral symptoms: f/s/c/myalgia/fatigue/HA that progressed to include CP for last 3 days. Classic positional CP, dull pressure, worse lying flat, better leaning forward, feels every heart contraction. Work up consistent with Acute Pericarditis and treated outpatient with Ibuprofen and Colchicine. symptoms worsened and he was evaluated and admitted overnight hospital for observation due to elevated troponin and STE on EKG. Pt stable and discharged next day.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient reported a shell fish allergy that produces similar reactions. Patient has not taken Benadryl before and dose not own an Epi-pen.

Vomiting Fever Pneumonia due to COVID-19 virus Sepsis Acute respiratory insufficiency -Continue supplemental oxygen as needed to maintain spO2 over 90% -Patient completed remdesivir as well as a convalescent plasma. -Patient will complete 5 more days of oral dexamethasone. oral Decadron.

Pt is a 25M with PMH of GERD, ADHD, obesity who presented to the ED on 5/11 for chest pain. That morning he had noticed increased substernal chest pressure associated with palpitations, nausea, diaphoresis, and left arm tingling. He notes that early last year he was very sick and though he had COVID but confirmatory testing was not available at that time. After recovering from the illness he noted that he had occasionally episodes of chest pressure and palpitations. However yesterday was the worst his symptoms have ever been. He did receive his 2nd COVID vaccine this past Saturday and experienced fatigue, nausea, weakness. In the ED patient has HD stable, afebrile, saturating well on RA. Labs were notable for troponin of 5.2 which trend down to 3.1. ESR WNL, CRP elevated 2.4. EKG showed normal sinus rhythm with signs suggestive of possible pericarditis. CXR negative. CTA showed no pulmonary embolism, enlarged and prominent left axillary lymph nodes, nonspecific, cholelithiasis. Patient admitted for NSTEMI. Enlarged axillary lymph nodes likely reactive in the setting of recent COVID vaccine. Cardiology consulted. Patient underwent cardiac cath which was unremarkable. Cardiology recommends short course NSAIDs for possible pericarditis, however EKG changes unimpressive per cardiology. Discharged home on ibuprofen 400 mg TID for 5 days. Advise follow up with PCP within 1 week.

throat fell really tight. They told him was throat was closing up.; Anaphylaxis/anaphylactic shock/severe allergic reaction; Swelling of the throat/throat was swelling; Trouble breathing; Itchy throat; Said that his throat felt really thirsty.; He is very upset./He is pretty devastated.; His throat started to do it again.; They said maybe it was something he ate or maybe sinuses; This is spontaneous report from contactable consumer (patient) and contactable consumer (patient's mother). A 25-year-old male patient received the first dose for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No. EWO187) at single dose for COVID-19 immunization on 19May2021 at 12:00 or 13:00. Relevant history included Diabetes, obesity, endocrine abnormalities, genetic/chromosomal abnormalities, respiratory illness, compromised immune status and Allergies. The patient had Allergies to non-steroidal anti-inflammatory drugs that can induce anaphylactic shock, severe reaction, swelling of face and throat. Relevant concomitant drug was unknown. No history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect If applicable. No Vaccines were Administered prior vaccinations (within 4 weeks). Family Medical History was none. About 3-5 minutes after being administered the Vaccine, the patient immediately developed anaphylactic shock. He was transported via ambulance to the Emergency Room on 19May2021 where he verified he was admitted to the hospital Emergency room for about 5-6 hours and discharged from the hospital the same day, 19May2021. He was told not to get any additional doses. He was still having swelling of the throat and went back to the ER today and was given a steroid prednisone 40mg a day for 5 days. He was advised to take benadryl also. He said he didn't get any IVs or anything. He had a past medical history of anaphylactic reaction to NSAIDS. He has been advised not to get the second dose. The patient stated the anaphylactic shock occurred with trouble breathing, throat was swelling and itchy throat. He did go into ER, they told him to just keep drinking fluids, that there was nothing else they could really do. When he was seen in the emergency room they gave him Benadryl and a steroid: Prednisone for now which he is on for the next couple of days. He was told that after 2 days or something, that after getting injected that he wouldn't have any symptoms-but he is still having those pretty severe symptoms of anaphylactic shock. Initial onset of anaphylactic shock was about 3-5 minutes after Pfizer Covid Vaccine shot was administered. Within 10-15 minutes he had swelling of tongue and throat and difficulty breathing. They called an ambulance, the ambulance took him to the Hospital emergency room where he was admitted and discharged that same date on 19May2021 after about 5-6 hours; he reported discharge time was around 16:40. They told him to come back if he had any issues that occurred over next couple of days or worsening or causing problems; to call back the nurses line. He was on a lot of Benadryl, a lot of antihistamines. When he gets off the antihistamines almost all the allergic reactions of the anaphylactic shock reoccur. This morning, 21May2021, he didn't take any Bendaryl before bed, and this morning when he woke up he was alright. After being at work like 30 minutes he felt the itchiness; scratchy throat; swelling of tongue; a little swelling of the throat; difficulty breathing. He took Benadryl and called the hotline who told him to call the Emergency room, he called the emergency room and went there. He talked to them this morning because he went to work and had issues breathing. He called and they told him to come in asap, so he went in to the emergency room; they gave him Benadryl and told him there was nothing else they could do other than him taking the steroid: Prednisone. The patient was in the hospital 3 days and will be day 4 tomorrow. He was trying to figure out how long this will last. They told him to talk to his doctor. They basically told him they were not responsible. The patient's mother reported that her son received the shot Wed 19May2021. Does not know if the Walgreen's reported this. He left there in an ambulance within 10 minutes of getting the shot. They took him to the emergency room and he got mixed information. He went back again today. They blew him off and told him maybe it was something he ate. She assumed that an allergic reaction would be about 24 hours but this is day 3. She is scared he may be taking too much Benadryl. He said he felt like he needed something to drink. Said that his throat felt really thirsty. He went back inside since his throat fell really tight. They told him was throat was closing up. They saw that his throat was swollen and they called the paramedics. Within 15 minutes they came and brought him to the emergency room. Nobody had given him Epi. They were going to give it to him an Epi pen but he wanted to wait for the paramedics. He was freaking out. The paramedics showed up and they were unable to give him Epi, stating he didn't have hives. He only received Benadryl. They he had to have to give him extra Benadryl because whatever they gave him in the IV because the first didn't work and his throat was still closing up. It made him feel like a drug addict asking for Benadryl. She was not sure if they gave him Benadryl in the ambulance, knows that it was given in the emergency room. The Benadryl may have been started in the ambulance but she is not sure. They did give him oxygen in the ambulance. Clarified he was in the ER over 4 hours, but was not admitted to the hospital. They gave him steroids but forgot to send him home with steroids. He had to call to find out about getting them and they told him they forgot to send the prescription in. He was late starting the next dose of steroids. He went back to the ER today, day 3. He didn't feel too bad today and went to work. After exerting a little energy and moving around, his throat started to do it again. He didn't have Benadryl on him. He left work because he thought it was going to close up again the day he got the shot. Once he calmed down, he took Benadryl. He called the hospital to ask if this was normal. He was told that it is not normal and was told that if he still felt bad, to come to the hospital. They said maybe it was something he ate or maybe sinuses. He spoke to one of the doctors. They had never shown him how to use an ePi pen. He does not know how long this will last. He gets scared. Treatment: Has only been taking Benadryl. He started the steroids yesterday and today. They had given him Benadryl today in the ER and he is home now. The patient visited to the Emergency room twice, first time by ambulance, confirmed he was not admitted. He was pretty devastated. The outcome of events was unknown.

After the shot I felt fine. Four days later I was sent home, I had respiratory issues. I developed pneumonia in my lungs