The Vaccine Adverse Event Reporting System (VAERS) Results Form

The Vaccine Adverse Event Reporting System (VAERS) Results Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description ABDOMINAL PAIN 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1210954-1 Naeusa, abdominal pain, tiredness, general body aches ABDOMINAL PAIN UPPER 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1071409-1 Since receiving his second dose of COVID-19 vaccine (Pfizer) on Sunday 2/21 he has had fever (tmax 103.0 F), headache, and stomach ache. His fever started on 2/21 and had persisted through 2/24. He woke up from a nap on 2/24 in the afternoon at 1600 had onset of severe chest pain. Then reoccurring multiple times throughout the evening. He was taken to a local hospital and the transferred to another hospital for higher level of care. Pediatric cardiology was consulted and treatment was started for suspected atypical pericarditis with colchicine 0.6mg BID and ibuprofen 600mg QID w/ famotidine 40mg QDay. His chest pain resolved the day of admission, even prior to starting treatment. Patient was discharged in clinically stable condition to follow up with pediatric cardiology in 2 weeks as outpatient. ABNORMAL BEHAVIOUR 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0912103-1 Dizziness and nausea 10 minutes after injection, continued to wax and wane over approx 90 minutes. No vitals taken. Patient ambulated back to work at 1800. ACOUSTIC STIMULATION TESTS 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0935956-1 "Patient said she lost her hearing last Thursday (1/7/2021) around 6pm. She said she totally could not hear anything at all and she went to the ER at 11pm and stayed till 3am. Her hearing loss happened in her left ear and lasted for 5 days and started to hear sounds since Sunday and recovered. She described it as ""there was pressure inside the ear"" and she said she also went to her doctor and doctor said she had her hearing back 90% to 96%." ACUTE RESPIRATORY FAILURE 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0921641-1 Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported. The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 2 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description ALLERGY TO VACCINE 1-2 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0921052-1 was nursed by mother who received Pfizer COVID vaccine; one twin who kind of gets allergic reactions to vaccines; body rash; Low grade fever; fussy/ fussiness; This is a spontaneous report from a contactable other health professional (HCP) (patient's mother). This other HCP reported information for both mother and babies (boy girl twins). This is a baby report (girl twin). A 14-month-old female patient received the first dose of BNT162B2 (Lot# EJ1685), via transmammary on 16Dec2020 at single dose for COVID-19 immunization. The patient medical history included like for the 12 month appointment, she got 4 to 5 shots, and got a full body rash and fever for a couple days, but it's hard to say, like she got a flu shots and whatever ones that go with it. There were no concomitant medications. The patient was nursed by mother who received Pfizer COVID vaccine. The patient's mother got her first dose of vaccine, later clarified as the Pfizer COVID vaccine, on 16Dec2020, and she was nursing twins, they are about 14 months now. She had boy girl twins and the patient was shorter than her brother, since she was a girl. She was normal height, in the 50th percentile for age. The patient's mother had no adverse effect, she had normal side effects, and one twin (the girl) who kind of gets allergic reactions to vaccines, like body rash and fever, nothing serious, the other one (the boy) has no issues. Afterwards the twin who gets side effects, was fussy and had a low grade fever, but nothing serious, and she was encouraged to report to Pfizer, she didn't know if this is significant, or anything to worry about with the second dose. The mother stated her daughter was fussy that afternoon, on 16Dec2020, the mother had nursed before she left, say around 10:30 AM, and probably nursed her around 3 PM, afterwards, and the next time she nursed, she was fussy, by early afternoon/evening a couple hours after nursing, The fussiness was just that day and evening, and her daughter has the low grade fever that evening was 16Dec2020. Caller gave her some infant tylenol and it went away, and comforted her, since she got fussy, and it went away that evening. Stated the next morning she gave her the tylenol as well and she was fine. Stated the pediatrician might have that if Pfizer wishes to contact, but she thought maybe after MMR, probably what she had gotten, the problem was she had so many at once, so it's hard to say which ones, like for the 12 month appointment, she got 4 to 5 shots, and got a full body rash and fever for a couple days, but it's hard to say, like she got a flu shots and whatever ones that go with it. Stated it's interesting, the two kids to compare, her son doesn't usually get vaccine reactions, her daughter does, and it's interesting he was completely fine and she was fussy. The outcome of the events low grade fever and fussy/ fussiness was recovered on 16Dec2020. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 baby case (boy twin);US-PFIZER INC-2020518990 maternal case ALLERGY TO VACCINE 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1202766-1 17yr old patient with documented allergies tree nuts (anaphylaxis), peanuts (anaphylaxis), chocolate (anaphylaxis), and shellfish (abdominal pain) presented to clinic for first dose of COVID-19 Pfizer vaccine. No history of previous reactions to any vaccines. RN administered PFIZER COVID-19 VACCINE (EUA) (LOT # ER8729, exp 7/31/2021) IM to patient's left deltoid on 4/12 at 1529. During observation period, patient complained of throat swelling ~ 1545. Patient with noted hives near administration site and flushing on chest which spread to face. Patient given epinephrine 0.3mg IM at 1553. Upon assessment, BP 139/111, HR 103, 100% RA, lungs clear to auscultation bilaterally. Pharynx not visualized due to tongue. Patien The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 3 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description ALOPECIA 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1175802-1 The teen had a history of autoimmune disorder, alopecia areata for the past 2 years. When received the first dose of pfizer COVID vaccine, she started losing hair rapidly after about 6 to 7 days. She was started on large dose of prednisone 100mg per day after 2 weeks to slow down alopecia. However, in the span of 4 days she lost most of her hair. We are wondering if the vaccine could have exacerbated the autoimmune disorder. ANAPHYLACTIC REACTION 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0981762-1 Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium ANAPHYLACTIC REACTION 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1165996-1 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. ANAPHYLACTIC REACTION 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1198675-1 Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives. Patient presented to the emergency department 1.5 hours following onset of anaphylaxis with mild cough and mild pharyngeal swelling for observation. ANAPHYLACTIC REACTION 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1202766-1 17yr old patient with documented allergies tree nuts (anaphylaxis), peanuts (anaphylaxis), chocolate (anaphylaxis), and shellfish (abdominal pain) presented to clinic for first dose of COVID-19 Pfizer vaccine. No history of previous reactions to any vaccines. RN administered PFIZER COVID-19 VACCINE (EUA) (LOT # ER8729, exp 7/31/2021) IM to patient's left deltoid on 4/12 at 1529. During observation period, patient complained of throat swelling ~ 1545. Patient with noted hives near administration site and flushing on chest which spread to face. Patient given epinephrine 0.3mg IM at 1553. Upon assessment, BP 139/111, HR 103, 100% RA, lungs clear to auscultation bilaterally. Pharynx not visualized due to tongue. Patien ANAPHYLACTIC SHOCK 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1165997-1 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. The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 4 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description ANAPHYLACTOID REACTION 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1114461-1 Anaphylactoid reaction; PHASE 1/2/3, PLACEBO- CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject was in the open-label phase of the study when the event occurred. A 17- year-old female subject with a past medical history significant for multiple allergies with anaphylaxis received first dose of blinded therapy (BNT162;PLACEBO) on 20Nov2020 at 17:04 and second dose on 15Dec2020 at 15:16. Per protocol, the participant was unblinded and confirmed to have received placebo and subsequently received third dose of study vaccine (BNT162B2) on 25Jan2021 at 16:50, all via intramuscular route in left deltoid as single doses for COVID-19 immunization. Ongoing medical history included penicillin allergy from 2010, peanut allergy from 2004, legume allergy from 2012, chickpea allergy from 2012, chocolate allergy from 2012, flaxseed allergy from 2016, all with anaphylaxis; pollen allergy from 2007, and asthma and eczema both from 2003. Additional medical history included: tree nuts allergy from 2004 (anaphylaxis). Ongoing concomitant medications included salbutamol sulfate (PROAIR) from 2010 for asthma, epinephrine (AUVI Q) from 2005 for penicillin allergy, peanut allergy, tree nuts allergy, legume allergy, chickpea allergy, flaxseed allergy and chocolate allergy, cetirizine hydrochloride (ZYRTEC) from 2007 for pollen allergy, loratadine (CLARITIN) from 2007 for pollen allergy, and triamcinolone acetonide from 2007 for eczema. There were no concomitant vaccines administered on same date of study vaccine and no prior vaccinations (within 4 weeks prior to the first administration date of study drug). The subject experienced hives left arm on 27Jan2021 at 10:30, shortness of breath 27Jan2021 at 11:00 and a diagnosis of anaphylactoid reaction on 27Jan2021 at 10:30, which were considered as life threatening (the event was considered life- threatening as subject with known anaphylaxis with tree nuts and subject reported similar symptoms). Clinical course was reported as follows: On 27Jan2021 at 10:30 (2 days after receiving BNT162B2 injection on her left arm) the subject started developing hives on her left arm and used her epinephrine pen at 10:54 and shortly after developed shortness of breath at 11:00. The subject did not touch or consume anything new prior to developing the hives on her left arm and the shortness of breath. The subject was not seen by a school nurse and self- administered her epi-pen. The hives resolved at 11:04 and the shortness of breath resolved at 11:24. The subject denied any other symptoms and did not seek further medical attention. There were no relevant tests done. The action taken in response to the events for study vaccine (BNT162B2) was permanently withdrawn (reported as not applicable as per investigator). The subject was not dosed vaccination 4 on 17Feb2021 (Visit 102). Outcome of the events was recovered on 27Jan2021. The investigator reported that there was a reasonable possibility that the event anaphylactoid reaction was related to Dose 3 of the study vaccine (BNT162B2), but not related to dose 1 and dose 2 of blinded therapy (BNT162;PLACEBO), concomitant drugs or clinical trial procedure. Follow-up (27Jan2021 and 03Feb2021): Seriousness life-threatening justification, additional medical history (tree nuts allergy) and clinical course (did not touch or consume anything new before SAE). Follow-up (18Feb2021): New information reported includes: action taken with the blinded study vaccine. Follow-up (02Mar2021): New information reported includes: concomitant medication and action taken with the blinded study vaccine. Follow-up (11Mar2021): New information reported includes: SAE term updated to 'anaphylactoid reaction'. This is a final report for initial notification of a life threatening event. .; Sender's Comments: The event 'anaphylactoid reaction' is unlisted in the protocol's Single Reference The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 5 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description Safety Document (IB). Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 28-FEB-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Anaphylactoid reaction.Review of the database for the PT Anaphylactoid reaction had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 29 non clinical trial cases. The information available in this report is very limited. The Company considers that there is a reasonable possibility that 'anaphylactoid reaction' is related to the study product. There is a plausible, although belated, time relationship between vaccination with BNT162b2 and onset of the event in a subject with a medical history of allergic diathesis; it is worth noting that symptoms resolved rapidly upon self-medication. From the available information for the rationale that led to attribution of a life-threatening seriousness criterion, it may not be justifiable based on past- history of anaphylaxis alone The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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. ANTI-HLA ANTIBODY TEST POSITIVE 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1136945-1 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. ANXIETY 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1080286-1 Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. Patient stabilized. ANXIETY 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1171412-1 Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylaxis in past and was anxious about experiencing it again. Pt moved away from waiting area to be evaluated by RN. RN Assessed pt. Lung sounds clear, Pt denies having difficulty breathing, O2 sat remained 98% or better for the duration. BP initially 141/89 while sitting with HR at 75. Pt laid down with feet propped on chair. Vital signs reevaluated 15 min later: O2 98%, BP 118/89, HR 77. Pt still reports itchy throat but does not have difficulty breathing. Contacted on- call physician, recommended pt be evaluated at ED or urgent care. Pt parent refused ambulance; opted to drive pt to ED for further evaluation. APPENDICITIS < 6 months PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0952106-1 Arm soreness Fatigue Appendicitis (unclear if directly related to vaccine but need to report to determine if increased risk due to vaccine) ARTHRALGIA 6-11 months PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0968464-1 Headache,chills,muscle/joint pain ARTHRALGIA 3-5 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1074334-1 Within one hour of vaccine, pain at sight of injection. Within three hours of receiving vaccine, body aches, joint aches. Within 8 hours of vaccine, headache. ARTHRALGIA 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0907181-1 Extreme arm pain alternating with numbness and tingling, joint pain in shoulder, elbow, and wrist, chills, low grade fever (100.5), fatigue ARTHRALGIA 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1148292-1 Pt is an 17 year old male who presents with a history of left shoulder pain since 3/25. He has recently been vaccinated for SARS Co-V2 (First dose on March 5th with second dose on March 27). He is currently hospitalized for elevated troponin and working up for myocarditis. The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 6 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description ASTHENIA 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0942502-1 Patient described rapid onset sweating and flushing. Said he felt light headed as well. Gave Benadryl 25 mg with continued observation for 30 minutes and he said he felt mostly better, but still tired and weak. Followed up next day and his mother said he was doing better. ASTHENIA 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1069293-1 Patient felt dizziness, weakness, and a fast heartbeat immediately after receiving injection. Patient was observed by EMS onsite and then went to ED for visit. Patient discharged from ED with no issues. ASTHENIA 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1241599-1 Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive- Severe, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia- Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild ATRIOVENTRICULAR BLOCK FIRST DEGREE 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1136945-1 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. AXILLARY PAIN 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0950793-1 Red round bump under his left armpit that is painful to the touch Currently using Ibuprofen and ice packs to help BALANCE DISORDER < 6 months PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0918673-1 Initial reaction sore arm, off balance, tingling in arm, around 2 hours later lower extremities painful - body aches BALANCE DISORDER 6-11 months PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0918683-1 Persistant symptoms of perception off and off-balance The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 7 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description BASAL GANGLIA INFARCTION 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1227884-1 Acute Infarct of R internal capsule and R basal ganglia; Acute Infarct of R internal capsule and R basal ganglia; Left (L) sided motor deficits; L facial droop; This is a spontaneous report from a contactable physician. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included truncus arteriosus (status post (s/p) right ventricle- to-pulmonary artery (RV-PA) conduit and prosthetic aortic valve s/p automatic implantable cardioverter defibrillator (AICD) placement) and arrhythmias. The patient have no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included sotalol taken for arrhythmias and warfarin. The patient was therapeutic on warfarin (INR 2.68) at admission and has been historically very compliant with medication. On 29Mar2021 14:00, the patient experienced acute infarct of right (R) internal capsule and R basal ganglia as diagnosed (dx) on magnetic resonance imagine (MRI), concerning for (C/f) cardio-embolic etiology in the setting of patient's complex cardiac history. However, cannot rule out other causes of infarct. Left (L) sided motor deficits on exam, L facial droop. Transthoracic echocardiogram (TTE) was unchanged from prior. The patient was hospitalized for the events from 29Mar2021 to 05Apr2021. The patient underwent other lab tests and procedures which included COVID-19 nasal swab test was negative on 29Mar2021 and on 30Mar2021. Therapeutic measures were taken as a result of the events and included treatment with anticoagulation. Outcome of the events was recovered with sequel on 2021. The following information on the batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. Consider also possible contributory effects from patient's pre- existing cardiac history. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. BASAL GANGLIA STROKE 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1155731-1 Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin. She has a history of Truncus Arteriosus s/p repair and has been anticoagulated for >10 years without issue. Stroke occurred 1 week after vaccine. She now has L sided motor deficits which are likely permanent. Left arm is flaccid. L leg with poor motor function. BASOPHIL PERCENTAGE DECREASED 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) BIOPSY HEART ABNORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1136945-1 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. The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 8 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description BIOPSY SKIN 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1055003-1 1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day. BLOOD CALCIUM NORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) BLOOD CHLORIDE NORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) BLOOD CREATINE PHOSPHOKINASE MB INCREASED 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1071409-1 Since receiving his second dose of COVID-19 vaccine (Pfizer) on Sunday 2/21 he has had fever (tmax 103.0 F), headache, and stomach ache. His fever started on 2/21 and had persisted through 2/24. He woke up from a nap on 2/24 in the afternoon at 1600 had onset of severe chest pain. Then reoccurring multiple times throughout the evening. He was taken to a local hospital and the transferred to another hospital for higher level of care. Pediatric cardiology was consulted and treatment was started for suspected atypical pericarditis with colchicine 0.6mg BID and ibuprofen 600mg QID w/ famotidine 40mg QDay. His chest pain resolved the day of admission, even prior to starting treatment. Patient was discharged in clinically stable condition to follow up with pediatric cardiology in 2 weeks as outpatient. BLOOD CREATININE NORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 9 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description BLOOD CULTURE 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1224600-1 Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever 101-104 ongoing 8 days after vaccine; rigors; fatigue; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 16- year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8730 and expiry dates were not reported), via unspecified route of administration in left arm on 25Mar2021 at 02:30 PM, as single dose for COVID-19 immunization. The patient's medical history includes occasional migraine and remote pneumonia. The concomitant medication included Multivitamin and Vitamin D. It reported that, on 26Mar2021 the patient experienced Fever 101-104 ongoing 8 days after vaccine, rigors and fatigue. The patient underwent lab test 24 hours post vaccine that was COVID test negative, also negative COVID Ab, increased inflammatory markers CRP, ESR, Ddimer, abnormal CBC and large platelets, mild hemolyzed blood in urine with otherwise negative UA, blood cultures x 2 negative. Vaccination facility: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 (Nasal Swab) and after the vaccination the patient been tested for COVID-19. The patient received ongoing tx with antipyretics, monitoring ongoing as corrective treatment for the adverse event. The outcome of the patient's event drug ineffective and COVID-19 was unknown and other events (fever, rigors, and fatigue) were not recovered. Follow-up (02Apr2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported for her son (Patient). The non-significant information updated. Additional information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. BLOOD CULTURE NEGATIVE 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1064049-1 Overnight 2/27-2/28 had low rectal temperatures to 33.8C. Was also undergoing rectal irrigations and bowel cleanout so unclear if low rectal temps due to this as oral temperatures later obtained at the same time were normal while rectal temps remained low. Infectious work up negative (blood, urine cultures UA; CXR not obtained as no respiratory symptoms). May also be secondary to underlying autonomic instability with neurologic dysfunction though previously has not had hypothermia outside of infections. Temperatures have since normalized BLOOD GLUCOSE INCREASED 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) BLOOD GLUCOSE NORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0963612-1 Patient felt lightheaded and confused. He laid down and rested for about 5 minutes. The EMT took vitals and they improved with rest. The patient was transported by ambulance to Hospital for additional observation because they are a minor. The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 10 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description BLOOD GLUCOSE NORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 0995255-1 He passed out; His blood sugar was 143; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old male patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the right arm on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included hypopituitarism. Concomitant medication included somatropin (NORDITROPIN) taken for hypopituitarism. He passed out (emergency room visit needed) on 17Jan2021, his blood sugar was 143 in Jan2021. Caller stated that her son received his first dose of the Pfizer COVID vaccine on 17Jan2021, stated he passed out. Caller stated they had to drive 3 hours away to get the vaccine and wanted to know that if because he experienced this after the first dose if it would be possible to find somewhere closer to home to get the second vaccine. Caller stated she is in the trial as an adult, that she reached out to her trial coordinator and they told her that they can only administer to persons in the trial. Son feels like maybe there is a drug interaction, caller stated she was not sure about this. Stated after her son passed out, they called an ambulance, states the Medic watched him for about 45 minutes, stated they ran some tests in Jan2021, he did go home that day. His blood sugar was 143 in Jan2021. Heart Rate monitor in Jan2021 she couldn't see so is unsure of the readings. The outcome of the event passed out was recovered on 17Jan2021, of other remain event was unknown. BLOOD LACTIC ACID 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) BLOOD POTASSIUM NORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) BLOOD PRESSURE MEASUREMENT 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1241721-1 5:24pm Pt called staff over and sad he felt faint and then fainted. Parent in car, layed pt back in car, talking to him to help orient him. Vitals obtained, temp, 96.2 temporal, 62HR, 100 %spo2, 116/60 Bp. 116/60. 5:32 Pt awake enough, stable to be observed for another 10 minutes. Pt stated he is fasting ad thats probably why i fainted/ 5:47 pt awake and stable enough to leave. Mother is ok with Pts condition. BLOOD SODIUM NORMAL 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1096709-1 Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS) BLOOD TEST 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1003503-1 Approximately 20 hours after vaccination patient felt faint, lost all color and fainted. She was in and out of responsiveness. Patient was transported to the ER. Patient was treated with fluids and discharged after observation. According to patient's mom the EKG and lab work were unremarkable. Patient has fully recovered. The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... 11 of 149 13/05/2021, 09:56 Symptoms Age Vaccine Manufacturer Vaccine Type VAERS ID Adverse Event Description BLOOD TEST 6-17 years PFIZER\BIONTECH COVID19 VACCINE (COVID19) 1040554-1 Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital an