The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... The Vaccine Adverse Event Reporting System (VAERS) Results Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type COVID19 6-17 Naeusa, abdominal pain, tiredness, general body ABDOMINAL PAIN PFIZER\BIONTECH VACCINE 1210954-1 years aches (COVID19) 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 COVID19 6-17 to a local hospital and the transferred to another ABDOMINAL PAIN UPPER PFIZER\BIONTECH VACCINE 1071409-1 years hospital for higher level of care. Pediatric cardiology (COVID19) 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. Dizziness and nausea 10 minutes after injection, COVID19 6-17 continued to wax and wane over approx 90 minutes. ABNORMAL BEHAVIOUR PFIZER\BIONTECH VACCINE 0912103-1 years No vitals taken. Patient ambulated back to work at (COVID19) 1800. "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 COVID19 11pm and stayed till 3am. Her hearing loss happened ACOUSTIC STIMULATION 6-17 PFIZER\BIONTECH VACCINE 0935956-1 in her left ear and lasted for 5 days and started to TESTS years (COVID19) 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%." Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation COVID19 ACUTE RESPIRATORY 6-17 with very limited air entry and hypoxemia. Patient PFIZER\BIONTECH VACCINE 0921641-1 FAILURE years received Benadryl, steroids, epinephrine, and Duoneb (COVID19) without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported. 2 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 nothing serious, and she was encouraged to report to 1-2 ALLERGY TO VACCINE PFIZER\BIONTECH VACCINE 0921052-1 Pfizer, she didn't know if this is significant, or years (COVID19) 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 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 COVID19 VACCINE (EUA) (LOT # ER8729, exp 7/31/2021) IM 6-17 ALLERGY TO VACCINE PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During years (COVID19) 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 3 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 losing hair rapidly after about 6 to 7 days. She was 6-17 ALOPECIA PFIZER\BIONTECH VACCINE 1175802-1 started on large dose of prednisone 100mg per day years (COVID19) 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. COVID19 Systemic: Anaphylaxis-Medium, Systemic: Rash 6-17 ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other- years (COVID19) wheezing, shortness of breath, coughing-Medium 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 COVID19 6-17 any other vaccines within four weeks prior to the ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 1165996-1 years vaccination. The patient experienced multi-phase (COVID19) 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. Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine COVID19 site 20min after symptom onset with significant 6-17 ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved years (COVID19) 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. 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 COVID19 VACCINE (EUA) (LOT # ER8729, exp 7/31/2021) IM 6-17 ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During years (COVID19) 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 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 COVID19 date (Batch/Lot number was not reported) as SINGLE 6-17 ANAPHYLACTIC SHOCK PFIZER\BIONTECH VACCINE 1165997-1 DOSE for covid-19 immunization. The patient medical years (COVID19) 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. 4 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 at 11:00 and a diagnosis of anaphylactoid reaction on 6-17 ANAPHYLACTOID REACTION PFIZER\BIONTECH VACCINE 1114461-1 27Jan2021 at 10:30, which were considered as life years (COVID19) 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 5 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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. 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 COVID19 3/22/2021 for biopsy and hemodynamic assessment, ANTI-HLA ANTIBODY TEST 6-17 PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction. POSITIVE years (COVID19) 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. COVID19 Flushing, sweating, anxious, tingling in ears, nausea, 6-17 ANXIETY PFIZER\BIONTECH VACCINE 1080286-1 blurry vision. Vitals within normal limits. Patient years (COVID19) stabilized. 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 COVID19 6-17 better for the duration. BP initially 141/89 while ANXIETY PFIZER\BIONTECH VACCINE 1171412-1 years sitting with HR at 75. Pt laid down with feet propped (COVID19) 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. COVID19 Arm soreness Fatigue Appendicitis (unclear if directly <6 APPENDICITIS PFIZER\BIONTECH VACCINE 0952106-1 related to vaccine but need to report to determine if months (COVID19) increased risk due to vaccine) COVID19 6-11 ARTHRALGIA PFIZER\BIONTECH VACCINE 0968464-1 Headache,chills,muscle/joint pain months (COVID19) COVID19 Within one hour of vaccine, pain at sight of injection. 3-5 ARTHRALGIA PFIZER\BIONTECH VACCINE 1074334-1 Within three hours of receiving vaccine, body aches, years (COVID19) joint aches. Within 8 hours of vaccine, headache. COVID19 Extreme arm pain alternating with numbness and 6-17 ARTHRALGIA PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist, years (COVID19) chills, low grade fever (100.5), fatigue Pt is an 17 year old male who presents with a history of left shoulder pain since 3/25. He has recently been COVID19 6-17 vaccinated for SARS Co-V2 (First dose on March 5th ARTHRALGIA PFIZER\BIONTECH VACCINE 1148292-1 years with second dose on March 27). He is currently (COVID19) hospitalized for elevated troponin and working up for myocarditis. 6 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Patient described rapid onset sweating and flushing. Said he felt light headed as well. Gave Benadryl 25 COVID19 6-17 mg with continued observation for 30 minutes and he ASTHENIA PFIZER\BIONTECH VACCINE 0942502-1 years said he felt mostly better, but still tired and weak. (COVID19) Followed up next day and his mother said he was doing better. Patient felt dizziness, weakness, and a fast heartbeat COVID19 6-17 immediately after receiving injection. Patient was ASTHENIA PFIZER\BIONTECH VACCINE 1069293-1 years observed by EMS onsite and then went to ED for visit. (COVID19) Patient discharged from ED with no issues. Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / COVID19 6-17 Lethargy-Mild, Systemic: Fainting / Unresponsive- ASTHENIA PFIZER\BIONTECH VACCINE 1241599-1 years Severe, Systemic: Headache-Mild, Systemic: (COVID19) Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia- Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild 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 COVID19 3/22/2021 for biopsy and hemodynamic assessment, ATRIOVENTRICULAR BLOCK 6-17 PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction. FIRST DEGREE years (COVID19) 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. COVID19 Red round bump under his left armpit that is painful 6-17 AXILLARY PAIN PFIZER\BIONTECH VACCINE 0950793-1 to the touch Currently using Ibuprofen and ice packs years (COVID19) to help COVID19 Initial reaction sore arm, off balance, tingling in arm, <6 BALANCE DISORDER PFIZER\BIONTECH VACCINE 0918673-1 around 2 hours later lower extremities painful - body months (COVID19) aches COVID19 6-11 BALANCE DISORDER PFIZER\BIONTECH VACCINE 0918683-1 Persistant symptoms of perception off and off-balance months (COVID19) 7 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 BASAL GANGLIA 6-17 setting of patient's complex cardiac history. However, PFIZER\BIONTECH VACCINE 1227884-1 INFARCTION years cannot rule out other causes of infarct. Left (L) sided (COVID19) 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. Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin. She COVID19 has a history of Truncus Arteriosus s/p repair and has 6-17 BASAL GANGLIA STROKE PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue. years (COVID19) 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. Fever of 103 F, received Tylenol, then developed COVID19 BASOPHIL PERCENTAGE 6-17 tonic-clonic seizure activity for about 20 minutes PFIZER\BIONTECH VACCINE 1096709-1 DECREASED years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) 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 COVID19 3/22/2021 for biopsy and hemodynamic assessment, 6-17 BIOPSY HEART ABNORMAL PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction. years (COVID19) 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. 8 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 the next 2-3 weeks and developed dark black scabs. 6-17 BIOPSY SKIN PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was years (COVID19) 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. Fever of 103 F, received Tylenol, then developed COVID19 6-17 tonic-clonic seizure activity for about 20 minutes BLOOD CALCIUM NORMAL PFIZER\BIONTECH VACCINE 1096709-1 years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) Fever of 103 F, received Tylenol, then developed COVID19 6-17 tonic-clonic seizure activity for about 20 minutes BLOOD CHLORIDE NORMAL PFIZER\BIONTECH VACCINE 1096709-1 years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) 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 BLOOD CREATINE COVID19 6-17 to a local hospital and the transferred to another PHOSPHOKINASE MB PFIZER\BIONTECH VACCINE 1071409-1 years hospital for higher level of care. Pediatric cardiology INCREASED (COVID19) 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. Fever of 103 F, received Tylenol, then developed COVID19 BLOOD CREATININE 6-17 tonic-clonic seizure activity for about 20 minutes PFIZER\BIONTECH VACCINE 1096709-1 NORMAL years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) 9 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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. COVID19 Prior to vaccination, the patient was not diagnosed 6-17 BLOOD CULTURE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the years (COVID19) 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. 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 COVID19 time were normal while rectal temps remained low. 6-17 BLOOD CULTURE NEGATIVE PFIZER\BIONTECH VACCINE 1064049-1 Infectious work up negative (blood, urine cultures years (COVID19) 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 Fever of 103 F, received Tylenol, then developed COVID19 BLOOD GLUCOSE 6-17 tonic-clonic seizure activity for about 20 minutes PFIZER\BIONTECH VACCINE 1096709-1 INCREASED years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) Patient felt lightheaded and confused. He laid down COVID19 and rested for about 5 minutes. The EMT took vitals 6-17 BLOOD GLUCOSE NORMAL PFIZER\BIONTECH VACCINE 0963612-1 and they improved with rest. The patient was years (COVID19) transported by ambulance to Hospital for additional observation because they are a minor. 10 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 6-17 3 hours away to get the vaccine and wanted to know BLOOD GLUCOSE NORMAL PFIZER\BIONTECH VACCINE 0995255-1 years that if because he experienced this after the first dose (COVID19) 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. Fever of 103 F, received Tylenol, then developed COVID19 6-17 tonic-clonic seizure activity for about 20 minutes BLOOD LACTIC ACID PFIZER\BIONTECH VACCINE 1096709-1 years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) Fever of 103 F, received Tylenol, then developed COVID19 BLOOD POTASSIUM 6-17 tonic-clonic seizure activity for about 20 minutes PFIZER\BIONTECH VACCINE 1096709-1 NORMAL years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) 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, COVID19 temp, 96.2 temporal, 62HR, 100 %spo2, 116/60 Bp. BLOOD PRESSURE 6-17 PFIZER\BIONTECH VACCINE 1241721-1 116/60. 5:32 Pt awake enough, stable to be observed MEASUREMENT years (COVID19) 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. Fever of 103 F, received Tylenol, then developed COVID19 6-17 tonic-clonic seizure activity for about 20 minutes BLOOD SODIUM NORMAL PFIZER\BIONTECH VACCINE 1096709-1 years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) Approximately 20 hours after vaccination patient felt faint, lost all color and fainted. She was in and out of COVID19 responsiveness. Patient was transported to the ER. 6-17 BLOOD TEST PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after years (COVID19) observation. According to patient's mom the EKG and lab work were unremarkable. Patient has fully recovered. 11 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 6-17 hours after. Headache was bad and continued on BLOOD TEST PFIZER\BIONTECH VACCINE 1040554-1 years 05Feb2021 (reported today). Also, still feel nausious (COVID19) 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 anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional 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. About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. COVID19 6-17 While waiting at Urgent Care for 30 minutes, her BLOOD TEST PFIZER\BIONTECH VACCINE 1172466-1 years face, tongue, and throat became swollen, hives (COVID19) developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home. 12 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type "Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the patient's father) from the Pfizer-sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the Right Arm (also reported as: right shoulder) on 23Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) at 16-years-old as a single dose for COVID-19 immunisation. Medical history included heart valve operation from an unknown date and unknown if ongoing (Mechanical heart valves). Concomitant medications included an unspecified medication, taken for an unspecified indication from an unspecified date to an unspecified date, which was reported as: ""Yes she is taking other medication."" On 29Mar2021, the patient experienced stroke and severe allergic reaction (medically significant). The clinical course was reported as follows: On behalf of his 16-year-old daughter, the patient's father reported that she had the first dose administer in the right shoulder on 23Mar2021. On 29Mar2021, the patient had a stroke. The patient's father stated, ""our lives have changed, completely."" The patient's father reported that his daughter was receiving medical care ever since then; and was also being treated by a physician. The patient's father was asking about compensation from COVID19 Pfizer regarding his daughter's severe adverse event 6-17 BLOOD TEST PFIZER\BIONTECH VACCINE 1266007-1 (AE) that occurred after the first dose of vaccine. The years (COVID19) patient's father reported that the case had been submitted by the (Name) healthcare team ""to the FDA and to Pfizer, and I haven't heard back from either."" The patient's father mentioned in passing, that he ""could call (Name) and have this all over the news"" but that he ""wants to be responsible"" and doesn't want to do that. The patient's father stated the concern, ""Well my concern I am not sure that medical profession is what I really need to do, my concern is that my daughter took the Pfizer COVID vaccine on 23Mar2021 in (Name) in vaccination location. On 29Mar2021, 6 days later, she had a stroke, and that she is receiving a medical care ever since then , now my question is like I said probably for maybe for correlated relation type of person define as well as for it there is a compensation for adverse reaction to COVID vaccination being that this was only thing that was introduce in her system as far as doing that time the vaccination shot."" The patient underwent lab tests and procedures which included blood test: ""that's for 4/2 out of normal"" on an unknown date; also reported: ""Yes that's been ongoing as far as giving blood. That's for 4/2 out of normal"". Therapeutic measures were not taken and was reported as ""no she isn't taking anything for it."" The clinical outcome of the events, stroke and severe allergic reaction, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411875 Pfizer" Blood clot in right calf. Noticed pain and knot in calf on Sunday 3/14/2021. It worsened over the next few COVID19 days. Went to Urgent care on 3/18 and they sent us 6-17 BLOOD TEST ABNORMAL PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it years (COVID19) was a clot identified as deep vein thrombosis, and started a treatment of blood thinner and pain medication. Fever of 103 F, received Tylenol, then developed COVID19 6-17 tonic-clonic seizure activity for about 20 minutes BLOOD UREA NORMAL PFIZER\BIONTECH VACCINE 1096709-1 years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) 13 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type temperature 101; vaccine was administered to 7-year-old son; This is a spontaneous report from a Pfizer sponsored program, received from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports. A 7-year-old male patient received BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 12Jan2021 at a single dose for Covid-19 immunization. Medical history included respiratory distress (at birth had persistent respiratory distress requiring oxygen for 10-12 days), Febrile seizure in Jan2017, and pneumonia in Jan2017. The patient's COVID19 concomitant medications were not reported. A mother 6-17 BODY TEMPERATURE PFIZER\BIONTECH VACCINE 0976811-1 went to get vaccinated for Covid-19. She took her years (COVID19) kids ages 7 and 15. The kids were also vaccinated. The vaccine was administered to the 7-year-old son on 12Jan2021. Her son (patient) had a temperature of 101 on 13Jan2021. The mother was concerned because the vaccine was not recommended for his age. She was wondering if he should be in the ER. The reporter does not know if the child still has a fever. She said that the vaccination providers went ahead and gave the vaccine to the children as well even if they were not scheduled to get them. Outcome of the event was unknown. Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021041926 Same reporter, product, and event, different patient Rapid pulse 121-133; fever 101.3; chills; dizzy; body aches; This is a spontaneous report from a contactable consumer (parent). A 17-years-old male patient received bnt162b2 (BNT162B2, lot number=EM9709) second dose, vaccination location of left arm, via an unspecified route of administration on 14Feb2021 17:15 at SINGLE DOSE for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical COVID19 6-17 vaccine included first dose of BNT162B2 on BODY TEMPERATURE PFIZER\BIONTECH VACCINE 1070696-1 years 24Jan2021 16:00 (lot number=EL9261; vaccine (COVID19) location=Left arm). The patient experienced rapid pulse 121-133, fever 101.3, chills, dizzy and body aches, all on 15Feb2021 14:30 with outcome of recovering. No treatment received for events. The patient underwent lab tests which included body temperature: 101.3 on 15Feb2021, heart rate: 121-133 on 15Feb2021. The events reported as non- serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. 14 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the COVID19 6-17 ER on 17March2021 for headache with blurry vision. BODY TEMPERATURE PFIZER\BIONTECH VACCINE 1135577-1 years Patient reported symptoms for 1 day prior. Also had (COVID19) persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile. 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. 15 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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. COVID19 Prior to vaccination, the patient was not diagnosed 6-17 BODY TEMPERATURE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the years (COVID19) 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. Vaccination occurred on 1/12 at 13:00. A few hours after the vaccination, I experienced muscle pain in the vaccinated arm. 1/13: I had trouble sleeping; left arm was in immense pain. 07:00: experiencing arm soreness, muscle pain, nausea, hot flashes; temperature = 99.5 08:20: experiencing arm soreness, muscle pain, hot flashes, chills, sensitivity to light; temperature = 100.6. Took 650mg acetaminophen. 09:00: experiencing arm soreness, muscle pain, sensitivity to light; temperature = 100.8 10:30: experiencing arm soreness, muscle pain; temperature = 99.2 11:15: experiencing arm soreness, muscle pain; temperature = 99.0 12:20: experiencing arm soreness, muscle pain; temperature COVID19 = 98.0 Extremely fatigued; took nap (13:00-17:00) BODY TEMPERATURE 6-17 PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain, INCREASED years (COVID19) headache; temperature = 99.3 18:00: experiencing arm soreness, muscle pain, headache; temperature = 99.2. Took 650mg acetaminophen. 19:00: experiencing arm soreness, muscle pain, headache; temperature = 100.8 20:00: experiencing arm soreness, muscle pain; temperature = 98.3 21:00: experiencing arm soreness, muscle pain; temperature = 100.6 21:30: experiencing arm soreness, muscle pain; temperature = 99.2 22:20: experiencing arm soreness, muscle pain; temperature = 100.1. Took 400mg Ibuprofen. 1/14: 07:00: woke up experiencing pain at the injection site, neck pain, headache. These events continued throughout the day. No temperature over 99.5. 18:30: Took 650mg acetaminophen for headache. 16 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the COVID19 6-17 ER on 17March2021 for headache with blurry vision. C-REACTIVE PROTEIN PFIZER\BIONTECH VACCINE 1135577-1 years Patient reported symptoms for 1 day prior. Also had (COVID19) persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile. 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. 17 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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. COVID19 Prior to vaccination, the patient was not diagnosed 6-17 C-REACTIVE PROTEIN PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the years (COVID19) 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. Fever of 103 F, received Tylenol, then developed COVID19 C-REACTIVE PROTEIN 6-17 tonic-clonic seizure activity for about 20 minutes PFIZER\BIONTECH VACCINE 1096709-1 INCREASED years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) one day of fever found to have elevated inflammatory markers, LV dysfunction (now resolved), elevated COVID19 troponin and ST elevation in EKG concerning for C-REACTIVE PROTEIN 6-17 PFIZER\BIONTECH VACCINE 1127200-1 myopericarditis. Admitted to hospital. No documented INCREASED years (COVID19) fever in hospital, no rash, no GI symptoms, no other criteria met for MIS-C. Unclear etiology of myopericaraditis. Fever of 103 F, received Tylenol, then developed COVID19 6-17 tonic-clonic seizure activity for about 20 minutes CARBON DIOXIDE NORMAL PFIZER\BIONTECH VACCINE 1096709-1 years (received 10mg intranasal midazolam and 0.5mg (COVID19) buccal clonazepam while awaiting EMS) 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 COVID19 3/22/2021 for biopsy and hemodynamic assessment, 6-17 CARDIAC ARREST PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction. years (COVID19) 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. 18 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type COVID19 6-17 Patient reported difficulty breathing and chest pain; CARDIAC ARREST PFIZER\BIONTECH VACCINE 1199455-1 years suffered cardiac arrest and death (COVID19) Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. COVID19 Patient placed on ECMO and imaging revealed 6-17 CARDIAC ARREST PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology years (COVID19) of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21. 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 COVID19 3/22/2021 for biopsy and hemodynamic assessment, 6-17 CARDIAC DYSFUNCTION PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction. years (COVID19) 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. COVID19 6-17 CARDIAC FAILURE PFIZER\BIONTECH VACCINE 1242573-1 Heart failure years (COVID19) Pt is an 17 year old male who presents with a history of left shoulder pain since 3/25. He has recently been COVID19 CARDIOVASCULAR 6-17 vaccinated for SARS Co-V2 (First dose on March 5th PFIZER\BIONTECH VACCINE 1148292-1 EVALUATION years with second dose on March 27). He is currently (COVID19) hospitalized for elevated troponin and working up for myocarditis. Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin. She COVID19 has a history of Truncus Arteriosus s/p repair and has CEREBRAL 6-17 PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue. MICROHAEMORRHAGE years (COVID19) 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. Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin. She COVID19 has a history of Truncus Arteriosus s/p repair and has CEREBROVASCULAR 6-17 PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue. ACCIDENT years (COVID19) 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. 19 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type "Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the patient's father) from the Pfizer-sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the Right Arm (also reported as: right shoulder) on 23Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) at 16-years-old as a single dose for COVID-19 immunisation. Medical history included heart valve operation from an unknown date and unknown if ongoing (Mechanical heart valves). Concomitant medications included an unspecified medication, taken for an unspecified indication from an unspecified date to an unspecified date, which was reported as: ""Yes she is taking other medication."" On 29Mar2021, the patient experienced stroke and severe allergic reaction (medically significant). The clinical course was reported as follows: On behalf of his 16-year-old daughter, the patient's father reported that she had the first dose administer in the right shoulder on 23Mar2021. On 29Mar2021, the patient had a stroke. The patient's father stated, ""our lives have changed, completely."" The patient's father reported that his daughter was receiving medical care ever since then; and was also being treated by a physician. The patient's father was asking about compensation from COVID19 Pfizer regarding his daughter's severe adverse event CEREBROVASCULAR 6-17 PFIZER\BIONTECH VACCINE 1266007-1 (AE) that occurred after the first dose of vaccine. The ACCIDENT years (COVID19) patient's father reported that the case had been submitted by the (Name) healthcare team ""to the FDA and to Pfizer, and I haven't heard back from either."" The patient's father mentioned in passing, that he ""could call (Name) and have this all over the news"" but that he ""wants to be responsible"" and doesn't want to do that. The patient's father stated the concern, ""Well my concern I am not sure that medical profession is what I really need to do, my concern is that my daughter took the Pfizer COVID vaccine on 23Mar2021 in (Name) in vaccination location. On 29Mar2021, 6 days later, she had a stroke, and that she is receiving a medical care ever since then , now my question is like I said probably for maybe for correlated relation type of person define as well as for it there is a compensation for adverse reaction to COVID vaccination being that this was only thing that was introduce in her system as far as doing that time the vaccination shot."" The patient underwent lab tests and procedures which included blood test: ""that's for 4/2 out of normal"" on an unknown date; also reported: ""Yes that's been ongoing as far as giving blood. That's for 4/2 out of normal"". Therapeutic measures were not taken and was reported as ""no she isn't taking anything for it."" The clinical outcome of the events, stroke and severe allergic reaction, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411875 Pfizer" COVID19 1-2 CHEST DISCOMFORT PFIZER\BIONTECH VACCINE 0939839-1 warm sensation chest area years (COVID19) 20 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type "Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours COVID19 6-17 later woke up from sleep with this chest tightness as CHEST DISCOMFORT PFIZER\BIONTECH VACCINE 0930353-1 years well as achyness and headache. áShe states that she (COVID19) had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non- compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed ""mild LV non compaction at the apex"" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms." Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / COVID19 6-17 Lethargy-Mild, Systemic: Fainting / Unresponsive- CHEST DISCOMFORT PFIZER\BIONTECH VACCINE 1241599-1 years Severe, Systemic: Headache-Mild, Systemic: (COVID19) Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia- Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild 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 COVID19 6-17 to a local hospital and the transferred to another CHEST PAIN PFIZER\BIONTECH VACCINE 1071409-1 years hospital for higher level of care. Pediatric cardiology (COVID19) 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. Chest pain developed 3 days following vaccine administration. Presented to ED the morning of 4/11/2021, and was found to have diffuse ST elevation on ECG, and troponin level of 0.52. Received dose of aspirin, and then was transferred to Hospital for treatment and monitoring of pericarditis the afternoon of 4/11. Echo at Hospital with good LV COVID19 function. Repeat EKG demonstrated ST elevation 6-17 CHEST PAIN PFIZER\BIONTECH VACCINE 1197826-1 again, and he was started on ibuprofen 600 mg every years (COVID19) 6 hours. Chest pain recurred in the evening of 4/11, but resolved some time after administration of ibuprofen. Troponin level upon arrival to Hospital were 3.92 at 17:11 on 4/11, then rose 8.68 at 23:42 on 4/11 at the time of his worsening chest pain. Chest pain still resolved by morning of 4/12, and troponin level downtrended to 5.87 at 6:22 on 4/12. Diagnosis consistent with myopericarditis. COVID19 6-17 Patient reported difficulty breathing and chest pain; CHEST PAIN PFIZER\BIONTECH VACCINE 1199455-1 years suffered cardiac arrest and death (COVID19) 21 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / COVID19 6-17 Lethargy-Mild, Systemic: Fainting / Unresponsive- CHEST PAIN PFIZER\BIONTECH VACCINE 1241599-1 years Severe, Systemic: Headache-Mild, Systemic: (COVID19) Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia- Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild COVID19 6-17 Shortness of breath, fatigue, tachycardia - persisting CHEST X-RAY NORMAL PFIZER\BIONTECH VACCINE 1013212-1 years since vaccination (COVID19) COVID19 6-11 CHILLS PFIZER\BIONTECH VACCINE 0968464-1 Headache,chills,muscle/joint pain months (COVID19) COVID19 Myalgia, CoughWheeze, chills, sore throat, fatigue Did 1-2 CHILLS PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for years (COVID19) symptoms to subside. 22 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Around 4:00 pm on 4/12/2021 I began to feel a slight headache and my side effects worsened that evening. I lost my appetite due to the muscle pain, aches, fatigue, and chills that I felt. After taking a nap, I did not feel rested but instead restless. Because of the chills, I put on joggers and a sweatshirt, then proceeded to try and read a book while sitting under a blanket. I was unable to concentrate or focus on my book because of the chills, so I instead watched television. By 9:00 pm, I tried to go to sleep and took my last remaining dose of Tylenol. The aches and chills had only gotten worse and I was still dressed in joggers and sweatshirt as I tried to fall asleep underneath two blankets and quilt. All night long I tossed and turned because of the shivers, aches, and chills. I was unable to sleep for more than 45 to 60 minutes at a time before I woke up again. This happened repeatedly all night and it was very painful. On 4/13/2021 around 8:00 am, I got out of bed with continued shivers, aches, pain, fatigue, headache, and chills. I suffered from these symptoms all day long. Around 3:00 pm I tried to eat spaghetti with meatballs and steamed vegetables, but the spaghetti tasted like cardboard and I was only able to eat come of the vegetable mix. All day long I kept drinking water to stay hydrated and spent most of my time switching from my couch to my bed with restlessness, aches, shivers, and chills. The chills started to subside around 2:00 am on 4/14/2021 after I took a hot shower for about 15 to 20 minutes. Still dressed in joggers and a sweatshirt, this time I tried to sleep COVID19 under two blankets, but the shivers and chills kept 3-5 CHILLS PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021 years (COVID19) around 10:00 am, I finally felt well enough to be able to drive to a store to by ibuprofen. When I got home, I took some and was finally able to take a nap and get some rest. I felt much better after my nap, was able to eat, and go for a small walk. This was my Pfizer second shot and it is worth mentioning that I live alone with no friends or family and I am an COVID-19. I had nobody to call and ask for help or to take care of me. I had to deal with the additional psychological trauma of not being able to ask anyone for help as I worried how long the adverse effects would last. I did not call my doctor because the last time I went in to see him, the facility charged me $170 for a 20-minute appointment and decided to take more than two months to let me know that I still owed $119. Everyone at the CDC and other agencies have failed those of us who live alone, especially public health officials, who did absolutely nothing to prepare to help and support people like me during this pandemic. Your ideals of individualism are bad public health policy for those of us who are alone, have nobody to turn do, and do all the right things by wearing masks, getting vaccinated, and staying six feet away from everybody. Yet, we are the ones who suffer the most and have to struggle with adverse effects of pandemic trauma, depression, and other mental health issues in addition to loss of taste and smell. I have not enjoyed food in over six months. It sure would be nice if for the next pandemic you also put together a plan for people who live alone and have nobody to turn to for help because you've failed us in this pandemic. COVID19 Extreme arm pain alternating with numbness and 6-17 CHILLS PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist, years (COVID19) chills, low grade fever (100.5), fatigue COVID19 DEVELOPED HEADACHE, FEVER, CHILLS, BODY 6-17 CHILLS PFIZER\BIONTECH VACCINE 0920541-1 ACHES, NAUSEA. RESOLVED BY MORNING OF years (COVID19) 12/31/20 COVID19 Late at night patient began having chills and extreme 6-17 CHILLS PFIZER\BIONTECH VACCINE 0924171-1 muscle pain all over her body, sore throat, nausea, years (COVID19) extreme fatigue. She also had a fever of 102. COVID19 30 mins after IM injection: Left arm tingling 45 mins 6-17 CHILLS PFIZER\BIONTECH VACCINE 0951087-1 after IM injection: Left arm, Left shoulder, Left upper years (COVID19) back tingling, Headache, chills, fatigue COVID19 6-17 CHILLS PFIZER\BIONTECH VACCINE 0957769-1 body aches, nausea, vomiting, and chills years (COVID19) COVID19 6-17 DEVELOPED BODY ACHES, FEVER, HEADACHE, AND CHILLS PFIZER\BIONTECH VACCINE 0974439-1 years CHILLS (COVID19) 23 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 the next 2-3 weeks and developed dark black scabs. 6-17 CHILLS PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was years (COVID19) 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. "The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours later with vaccine side effects the family was prepared for, including headache, chills, nausea, vomiting and fatigue. This all resolved within 48 COVID19 6-17 hours. Approximately one week later, the child woke CHILLS PFIZER\BIONTECH VACCINE 1058308-1 years up again in the night with severe chills in the middle (COVID19) of the night. It was a sudden onset following a week of feeling well. She had to sit in a warm/hot shower for an hour to get warm. She described it as ""freezing to death."" She has never experienced anything like this before." Rapid pulse 121-133; fever 101.3; chills; dizzy; body aches; This is a spontaneous report from a contactable consumer (parent). A 17-years-old male patient received bnt162b2 (BNT162B2, lot number=EM9709) second dose, vaccination location of left arm, via an unspecified route of administration on 14Feb2021 17:15 at SINGLE DOSE for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical COVID19 6-17 vaccine included first dose of BNT162B2 on CHILLS PFIZER\BIONTECH VACCINE 1070696-1 years 24Jan2021 16:00 (lot number=EL9261; vaccine (COVID19) location=Left arm). The patient experienced rapid pulse 121-133, fever 101.3, chills, dizzy and body aches, all on 15Feb2021 14:30 with outcome of recovering. No treatment received for events. The patient underwent lab tests which included body temperature: 101.3 on 15Feb2021, heart rate: 121-133 on 15Feb2021. The events reported as non- serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. Chills; body aches; This is a spontaneous report from a contactable consumer (patient parent). A 17-year- old (17-year-old age at vaccination) female patient received second dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 27Jan2021 01:00 PM at single dose in left arm for COVID-19 immunization at clinic. Medical history was none. The patient was not pregnant at time of vaccination. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the COVID19 6-17 patient was not diagnosed with COVID-19. No CHILLS PFIZER\BIONTECH VACCINE 1100277-1 years Allergies to medications, food, or other products. (COVID19) Concomitant medication was not reported. The patient previously took (at age 17-year-old) first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E1014D) on 06Jan2021 in left arm for COVID-19 immunization. The patient experienced chills, body aches on 28Jan2021 01:15 AM. No treatment received for the adverse events. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number for 2nd dose has been requested. 24 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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. COVID19 Prior to vaccination, the patient was not diagnosed 6-17 CHILLS PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the years (COVID19) 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. Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) on 17Mar2021 at COVID19 6-17 14:15 in the left arm for covid-19 immunisation. The CHILLS PFIZER\BIONTECH VACCINE 1269727-1 years patient's medical history was not reported. There (COVID19) were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected. 25 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 3/22/2021 for biopsy and hemodynamic assessment, COMPLEMENT FIXATION 6-17 PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction. TEST POSITIVE years (COVID19) 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. COVID19 death by suicide Narrative: death by suicide; 1-2 COMPLETED SUICIDE PFIZER\BIONTECH VACCINE 0958443-1 12/26/20, self inflicted gun shot wound; found years (COVID19) deceased by family member COVID19 6-17 COMPLETED SUICIDE PFIZER\BIONTECH VACCINE 1243487-1 Patient Committed Suicide with a firearm. years (COVID19) COVID19 Arm soreness Fatigue Appendicitis (unclear if directly COMPUTERISED <6 PFIZER\BIONTECH VACCINE 0952106-1 related to vaccine but need to report to determine if TOMOGRAM months (COVID19) increased risk due to vaccine) Diagnosed w/ severe pneumomediastinum involving COVID19 COMPUTERISED 6-17 base of neck and right upper extremity. PFIZER\BIONTECH VACCINE 1193717-1 TOMOGRAM years Emphysematous changes in the airway and vascular (COVID19) structures of the neck. Severe, debilitating fatigue to the point of not being able to stay awake for more than a couple of hours a COVID19 day. This continues, although minimally improved, 1 COMPUTERISED 6-17 PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache- TOMOGRAM HEAD years (COVID19) daily, continues 1 month out Dizziness Thrombophlebitis Initial low-grade fever and arm soreness resolved within 2 days 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 COVID19 losing hair rapidly after about 6 to 7 days. She was 6-17 CONDITION AGGRAVATED PFIZER\BIONTECH VACCINE 1175802-1 started on large dose of prednisone 100mg per day years (COVID19) 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. Patient felt lightheaded and confused. He laid down COVID19 and rested for about 5 minutes. The EMT took vitals 6-17 CONFUSIONAL STATE PFIZER\BIONTECH VACCINE 0963612-1 and they improved with rest. The patient was years (COVID19) transported by ambulance to Hospital for additional observation because they are a minor. Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / COVID19 6-17 Lethargy-Mild, Systemic: Fainting / Unresponsive- CONFUSIONAL STATE PFIZER\BIONTECH VACCINE 1241599-1 years Severe, Systemic: Headache-Mild, Systemic: (COVID19) Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia- Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild "Entered observation @ 1935. Mother stated to this nurse @ 1950, that daughter felt ""light-headed"". Water was given. @ 1954, patient started to gag. Went to restroom. @ 1958, she was walked with this nurse and others to ""bed"" that's located in COVID19 6-17 vaccination clinic. Mother explained to this nurse and COOLING THERAPY PFIZER\BIONTECH VACCINE 0927167-1 years others that her daughter shows s/s of these (COVID19) symptoms upon each vaccination. Lightheadedness and nausea lasted for about 10-15 minutes. Cold compress was applied to help relieve s/s from vaccine. States she felt better around 2005. Left observation @ 2005, showed no s/s of distress." COVID19 Myalgia, CoughWheeze, chills, sore throat, fatigue Did 1-2 COUGH PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for years (COVID19) symptoms to subside. COVID19 Systemic: Anaphylaxis-Medium, Systemic: Rash 6-17 COUGH PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other- years (COVID19) wheezing, shortness of breath, coughing-Medium 26 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine COVID19 site 20min after symptom onset with significant 6-17 COUGH PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved years (COVID19) 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. Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation COVID19 6-17 with very limited air entry and hypoxemia. Patient COVID-19 PFIZER\BIONTECH VACCINE 0921641-1 years received Benadryl, steroids, epinephrine, and Duoneb (COVID19) without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported. 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. COVID19 Prior to vaccination, the patient was not diagnosed 6-17 COVID-19 PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the years (COVID19) 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. 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 COVID19 time were normal while rectal temps remained low. 6-17 CULTURE URINE NEGATIVE PFIZER\BIONTECH VACCINE 1064049-1 Infectious work up negative (blood, urine cultures years (COVID19) 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 27 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type "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 COVID19 11pm and stayed till 3am. Her hearing loss happened 6-17 DEAFNESS PFIZER\BIONTECH VACCINE 0935956-1 in her left ear and lasted for 5 days and started to years (COVID19) 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%." Patient received second dose of Pfizer vaccine on March 17, 2020 while at work. March 18, 2020 her 5 month old breastfed infant developed a rash and within 24 hours was inconsolable, refusing to eat, and COVID19 developed a fever. Patient brought baby to local ER <6 DEATH PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis months (COVID19) revealed elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP. No known allergies. No new exposures aside from the mother's vaccination the previous day. COVID19 death by suicide Narrative: death by suicide; 1-2 DEATH PFIZER\BIONTECH VACCINE 0958443-1 12/26/20, self inflicted gun shot wound; found years (COVID19) deceased by family member she was going to die/dies after vaccine; 2-year-old patient; This is a spontaneous report from a non- contactable consumer via a Pfizer-sponsored program. A 2-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 2-years-old via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical COVID19 history and concomitant medications were not 1-2 DEATH PFIZER\BIONTECH VACCINE 1255745-1 reported. It was reported that the 2-year-old dies years (COVID19) after vaccine on 03Mar2021. Reported on VAERS. Look for the researchers to exclude her from the study, probably claiming her death had nothing to do with the shot, she was going to die that day, five days after vaccination anyway. That's how they roll. The patient died on 03Mar2021. The outcome of the event was fatal. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.; Reported Cause(s) of Death: she was going to die COVID19 6-17 Patient reported difficulty breathing and chest pain; DEATH PFIZER\BIONTECH VACCINE 1199455-1 years suffered cardiac arrest and death (COVID19) Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. COVID19 Patient placed on ECMO and imaging revealed 6-17 DEATH PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology years (COVID19) of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21. COVID19 6-17 DEATH PFIZER\BIONTECH VACCINE 1242573-1 Heart failure years (COVID19) 28 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Around 4:00 pm on 4/12/2021 I began to feel a slight headache and my side effects worsened that evening. I lost my appetite due to the muscle pain, aches, fatigue, and chills that I felt. After taking a nap, I did not feel rested but instead restless. Because of the chills, I put on joggers and a sweatshirt, then proceeded to try and read a book while sitting under a blanket. I was unable to concentrate or focus on my book because of the chills, so I instead watched television. By 9:00 pm, I tried to go to sleep and took my last remaining dose of Tylenol. The aches and chills had only gotten worse and I was still dressed in joggers and sweatshirt as I tried to fall asleep underneath two blankets and quilt. All night long I tossed and turned because of the shivers, aches, and chills. I was unable to sleep for more than 45 to 60 minutes at a time before I woke up again. This happened repeatedly all night and it was very painful. On 4/13/2021 around 8:00 am, I got out of bed with continued shivers, aches, pain, fatigue, headache, and chills. I suffered from these symptoms all day long. Around 3:00 pm I tried to eat spaghetti with meatballs and steamed vegetables, but the spaghetti tasted like cardboard and I was only able to eat come of the vegetable mix. All day long I kept drinking water to stay hydrated and spent most of my time switching from my couch to my bed with restlessness, aches, shivers, and chills. The chills started to subside around 2:00 am on 4/14/2021 after I took a hot shower for about 15 to 20 minutes. Still dressed in joggers and a sweatshirt, this time I tried to sleep COVID19 under two blankets, but the shivers and chills kept 3-5 DECREASED APPETITE PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021 years (COVID19) around 10:00 am, I finally felt well enough to be able to drive to a store to by ibuprofen. When I got home, I took some and was finally able to take a nap and get some rest. I felt much better after my nap, was able to eat, and go for a small walk. This was my Pfizer second shot and it is worth mentioning that I live alone with no friends or family and I am an COVID-19. I had nobody to call and ask for help or to take care of me. I had to deal with the additional psychological trauma of not being able to ask anyone for help as I worried how long the adverse effects would last. I did not call my doctor because the last time I went in to see him, the facility charged me $170 for a 20-minute appointment and decided to take more than two months to let me know that I still owed $119. Everyone at the CDC and other agencies have failed those of us who live alone, especially public health officials, who did absolutely nothing to prepare to help and support people like me during this pandemic. Your ideals of individualism are bad public health policy for those of us who are alone, have nobody to turn do, and do all the right things by wearing masks, getting vaccinated, and staying six feet away from everybody. Yet, we are the ones who suffer the most and have to struggle with adverse effects of pandemic trauma, depression, and other mental health issues in addition to loss of taste and smell. I have not enjoyed food in over six months. It sure would be nice if for the next pandemic you also put together a plan for people who live alone and have nobody to turn to for help because you've failed us in this pandemic. Blood clot in right calf. Noticed pain and knot in calf on Sunday 3/14/2021. It worsened over the next few COVID19 days. Went to Urgent care on 3/18 and they sent us 6-17 DEEP VEIN THROMBOSIS PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it years (COVID19) was a clot identified as deep vein thrombosis, and started a treatment of blood thinner and pain medication. 29 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0158), intramuscular, administered in left arm on 09Apr2021 16:30 as single dose for COVID-19 immunization. Medical history included 3 weeks of urticaria prior to vaccination. The patient has had no COVID history COVID19 prior vaccination. The patient has not been tested for 6-17 DIARRHOEA PFIZER\BIONTECH VACCINE 1255191-1 COVID post vaccination. Concomitant medications years (COVID19) included fish oil; diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC); ibuprofen (MOTRIN), and an unspecified multivitamin. The patient previously took Amoxicillin and experienced drug allergies. After vaccine, the patient became very red, had dizziness, vomiting and diarrhea and hypotension on 09Apr2021. The events resulted in an emergency room/department or urgent care visit and hospitalization for 1 day. Treatment included epi, Benadryl, steroids, Pepcid, and fluid boluses. The outcome of the events was not resolved. passing out; Vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:45 (Batch/Lot Number: Ew0161) at 17-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The COVID19 6-17 patient's medical history was reported as none (no DIARRHOEA PFIZER\BIONTECH VACCINE 1266009-1 years known allergies). The patient did not have COVID (COVID19) prior to the vaccination. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 14Apr2021 at 13:15, the patient experienced passing out (medically significant), vomiting (non-serious), and diarrhea (non-serious). The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination. Patient received second dose of Pfizer vaccine on March 17, 2020 while at work. March 18, 2020 her 5 month old breastfed infant developed a rash and within 24 hours was inconsolable, refusing to eat, and COVID19 developed a fever. Patient brought baby to local ER <6 DIET REFUSAL PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis months (COVID19) revealed elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP. No known allergies. No new exposures aside from the mother's vaccination the previous day. 30 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type "Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours COVID19 6-17 later woke up from sleep with this chest tightness as DISCOMFORT PFIZER\BIONTECH VACCINE 0930353-1 years well as achyness and headache. áShe states that she (COVID19) had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non- compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed ""mild LV non compaction at the apex"" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms." 05:02PM MOM STATES PT 'FEELS NAUSEA AND HEADACHE'. (PT HAS DIFFICULTY DESCRIBING HOW HE FEELS). PT ALERT, PINK,W/D, RESP REG WITH EASE. 05:06PM COOL CLOTH PLACED ON BACK OF NECK, TUMS GIVEN PO, LIQUID BENADRYL 25MG GIVEN PO. 05:20PM 'FEELS A LITTLE BETTER, LESS NAUSEA.' NOW HAS RT CLAVICLE PAIN. ALERT, PINK, W/D, RESP WITH EASE. 05:30PM STILL C/O COVID19 HEADACHE, NAUSEA AND RT CLAVICLE PAIN. 6-17 DISCOMFORT PFIZER\BIONTECH VACCINE 1054615-1 05:55PM TO EXIT PER W/C TO BE DRIVEN HOME PER years (COVID19) MOM. NO ACUTE DISTRESS NOTED. ALERT, PINK, W/D, RESP WITH EASE. 2-25-21 10AM TC- MOM STATES SHE GAVE PT LIQUID TYLENOL LAST NIGHT FOR DISCOMFORT. STATES HE DOES FEEL BETTER TODAY BUT STILL HAS HEADACHE AND RT CLAVICLE PAIN- NO NAUSEA. SHE STATES SHE DID KEEP HIM HOME FROM SCHOOL TODAY. HE HAS HIS REG APPT WITH HIS PCP ON 3-1-21 AND WILL ASK ABOUT HIM GETTING DOSE #2. 31 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Around 4:00 pm on 4/12/2021 I began to feel a slight headache and my side effects worsened that evening. I lost my appetite due to the muscle pain, aches, fatigue, and chills that I felt. After taking a nap, I did not feel rested but instead restless. Because of the chills, I put on joggers and a sweatshirt, then proceeded to try and read a book while sitting under a blanket. I was unable to concentrate or focus on my book because of the chills, so I instead watched television. By 9:00 pm, I tried to go to sleep and took my last remaining dose of Tylenol. The aches and chills had only gotten worse and I was still dressed in joggers and sweatshirt as I tried to fall asleep underneath two blankets and quilt. All night long I tossed and turned because of the shivers, aches, and chills. I was unable to sleep for more than 45 to 60 minutes at a time before I woke up again. This happened repeatedly all night and it was very painful. On 4/13/2021 around 8:00 am, I got out of bed with continued shivers, aches, pain, fatigue, headache, and chills. I suffered from these symptoms all day long. Around 3:00 pm I tried to eat spaghetti with meatballs and steamed vegetables, but the spaghetti tasted like cardboard and I was only able to eat come of the vegetable mix. All day long I kept drinking water to stay hydrated and spent most of my time switching from my couch to my bed with restlessness, aches, shivers, and chills. The chills started to subside around 2:00 am on 4/14/2021 after I took a hot shower for about 15 to 20 minutes. Still dressed in joggers and a sweatshirt, this time I tried to sleep COVID19 under two blankets, but the shivers and chills kept DISTURBANCE IN 3-5 PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021 ATTENTION years (COVID19) around 10:00 am, I finally felt well enough to be able to drive to a store to by ibuprofen. When I got home, I took some and was finally able to take a nap and get some rest. I felt much better after my nap, was able to eat, and go for a small walk. This was my Pfizer second shot and it is worth mentioning that I live alone with no friends or family and I am an COVID-19. I had nobody to call and ask for help or to take care of me. I had to deal with the additional psychological trauma of not being able to ask anyone for help as I worried how long the adverse effects would last. I did not call my doctor because the last time I went in to see him, the facility charged me $170 for a 20-minute appointment and decided to take more than two months to let me know that I still owed $119. Everyone at the CDC and other agencies have failed those of us who live alone, especially public health officials, who did absolutely nothing to prepare to help and support people like me during this pandemic. Your ideals of individualism are bad public health policy for those of us who are alone, have nobody to turn do, and do all the right things by wearing masks, getting vaccinated, and staying six feet away from everybody. Yet, we are the ones who suffer the most and have to struggle with adverse effects of pandemic trauma, depression, and other mental health issues in addition to loss of taste and smell. I have not enjoyed food in over six months. It sure would be nice if for the next pandemic you also put together a plan for people who live alone and have nobody to turn to for help because you've failed us in this pandemic. Sitting post vaccine, started to feel light headed. EE COVID19 6-11 was given an ice pack, had sit down in floor. DIZZINESS PFIZER\BIONTECH VACCINE 0906846-1 months Prolonged monitoring, no additional side effect. EE (COVID19) returned to work. Dizziness and nausea 10 minutes after injection, COVID19 6-17 continued to wax and wane over approx 90 minutes. DIZZINESS PFIZER\BIONTECH VACCINE 0912103-1 years No vitals taken. Patient ambulated back to work at (COVID19) 1800. 32 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type "Entered observation @ 1935. Mother stated to this nurse @ 1950, that daughter felt ""light-headed"". Water was given. @ 1954, patient started to gag. Went to restroom. @ 1958, she was walked with this nurse and others to ""bed"" that's located in COVID19 6-17 vaccination clinic. Mother explained to this nurse and DIZZINESS PFIZER\BIONTECH VACCINE 0927167-1 years others that her daughter shows s/s of these (COVID19) symptoms upon each vaccination. Lightheadedness and nausea lasted for about 10-15 minutes. Cold compress was applied to help relieve s/s from vaccine. States she felt better around 2005. Left observation @ 2005, showed no s/s of distress." Patient described rapid onset sweating and flushing. Said he felt light headed as well. Gave Benadryl 25 COVID19 6-17 mg with continued observation for 30 minutes and he DIZZINESS PFIZER\BIONTECH VACCINE 0942502-1 years said he felt mostly better, but still tired and weak. (COVID19) Followed up next day and his mother said he was doing better. Patient felt lightheaded and confused. He laid down COVID19 and rested for about 5 minutes. The EMT took vitals 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 0963612-1 and they improved with rest. The patient was years (COVID19) transported by ambulance to Hospital for additional observation because they are a minor. COVID19 nausea, vomiting, sensitivity to light, hearing was 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 0971606-1 muffled, a bit of dizzines. She vomited 3 times. in a years (COVID19) span of 30 minutes. Approximately 20 hours after vaccination patient felt faint, lost all color and fainted. She was in and out of COVID19 responsiveness. Patient was transported to the ER. 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after years (COVID19) observation. According to patient's mom the EKG and lab work were unremarkable. Patient has fully recovered. 33 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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 COVID19 6-17 hours after. Headache was bad and continued on DIZZINESS PFIZER\BIONTECH VACCINE 1040554-1 years 05Feb2021 (reported today). Also, still feel nausious (COVID19) 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 anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional 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. """Pfizer-Bio-Tech COVID-19 Vaccine EUA"" : Individual received the Pfizer Covid-19 vaccine. She began to feel dizzy and flushed at 1:00 pm. Her vitals were 82/46, 22, 68, 98% RA at1:00 pm. We applied ice to back of neck. B/P 72/42,20, 76 P, 98 % RA. COVID19 1:20 pm. Individual report that he had not drink any 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1049830-1 fluids and only had a few bites to eat. Patient years (COVID19) swallowing intact. She was given bottle of water. 1:46 pm vitals were 82/54, 100% SATS, 81, 14. Individual stated she felt better and was not longer dizzy. 1:55 pm vitals 79/54. 14, 78, 98% RA. Individual went home with family with no noted distress." COVID19 Felt light headed, ringing in her ears, c/o nauseated. 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1052856-1 BP 110/68 Pulse 68. Removing Jacket. Offered water. years (COVID19) Offered oxygen but refused. Patient felt dizziness, weakness, and a fast heartbeat COVID19 6-17 immediately after receiving injection. Patient was DIZZINESS PFIZER\BIONTECH VACCINE 1069293-1 years observed by EMS onsite and then went to ED for visit. (COVID19) Patient discharged from ED with no issues. 34 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Rapid pulse 121-133; fever 101.3; chills; dizzy; body aches; This is a spontaneous report from a contactable consumer (parent). A 17-years-old male patient received bnt162b2 (BNT162B2, lot number=EM9709) second dose, vaccination location of left arm, via an unspecified route of administration on 14Feb2021 17:15 at SINGLE DOSE for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical COVID19 6-17 vaccine included first dose of BNT162B2 on DIZZINESS PFIZER\BIONTECH VACCINE 1070696-1 years 24Jan2021 16:00 (lot number=EL9261; vaccine (COVID19) location=Left arm). The patient experienced rapid pulse 121-133, fever 101.3, chills, dizzy and body aches, all on 15Feb2021 14:30 with outcome of recovering. No treatment received for events. The patient underwent lab tests which included body temperature: 101.3 on 15Feb2021, heart rate: 121-133 on 15Feb2021. The events reported as non- serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. 17 yo F in post vac are reports nausea, dizziness, headache 4 mins after vaccination. Denies other s/s, speaks clear and complete. No respiratory distress COVID19 6-17 noted. Two set of vitals taken, WNLs. . Monitored for DIZZINESS PFIZER\BIONTECH VACCINE 1073873-1 years 30 mins, s/s continued and have increased, post vac (COVID19) nurse recommended medical attention. Mom declined EMS transport. Mom stated she would take pt to a local urgent care. My daughter became very dizzy, pale, and hot (sweating through her clothing) almost passing out after receiving her first dose . Paramedics were COVID19 called, vitals taken, and she was taken to an 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1074203-1 observation area. She started to feel a bit better after years (COVID19) about 15 minutes. She was observed by paramedics and a nurse for another 30 mins and we were able to leave and go home. At home she was exhausted the remainder of the night. Patient started to feel strange within 1 minute of receiving the vaccine. Within 5 minutes of receiving the vaccine, patient felt very faint, dizzy, nauseous, tingly, lost feeling in lower body, blurry vision, and started shaking. EMS was called at vaccination site. EMS arrived about 5 minutes later and took patient's COVID19 blood pressure. First reading was 102/70, second 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1075055-1 reading a few minutes later was 108/76. By that years (COVID19) time, patient could sit up and was alert and oriented. Patient never lost consciousness. Patient was not taken to the ER. Patient remained on-site for another 45 minutes until symptoms resolved enough that she felt it was safe to leave. Patient has not had a reaction to vaccines or other medical treatment in the past. Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient (not pregnant) received the second dose bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 29Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. The COVID19 6-17 patient's medical history and concomitant DIZZINESS PFIZER\BIONTECH VACCINE 1076730-1 years medications were not reported. She had her first dose (COVID19) of bnt162b2 on 08Jan2021 in the left arm. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 17:00, the patient had deadache, fever, dizziness and fatigue. No treatment was reported. The outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. 35 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type seizure like symptoms; Dizziness; lethargy; fatigue; This is a spontaneous report from a contactable pharmacist. A 16-year-old male patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was EN6205. Medical history and concomitant medications were unknown. On 02Mar2021 at 12:00, the patient experienced Dizziness, seizure like symptoms, lethargy, fatigue. It was unknown if the patient was treated due to the events. The patient recovered from the events in Mar2021. It was unknown if the patient COVID19 had COVID prior vaccination; it was unknown if the 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1115268-1 patient was tested for COVID post vaccination.; years (COVID19) Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizure 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. About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. COVID19 6-17 While waiting at Urgent Care for 30 minutes, her DIZZINESS PFIZER\BIONTECH VACCINE 1172466-1 years face, tongue, and throat became swollen, hives (COVID19) developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home. Severe, debilitating fatigue to the point of not being able to stay awake for more than a couple of hours a COVID19 day. This continues, although minimally improved, 1 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache- years (COVID19) daily, continues 1 month out Dizziness Thrombophlebitis Initial low-grade fever and arm soreness resolved within 2 days COVID19 6-17 Systemic: Dizziness / Lightheadness-Mild, Systemic: DIZZINESS PFIZER\BIONTECH VACCINE 1236341-1 years Fainting / Unresponsive-Mild (COVID19) COVID19 6-17 Systemic: Dizziness / Lightheadness-Mild, Systemic: DIZZINESS PFIZER\BIONTECH VACCINE 1241577-1 years Seizure-Mild (COVID19) Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / COVID19 6-17 Lethargy-Mild, Systemic: Fainting / Unresponsive- DIZZINESS PFIZER\BIONTECH VACCINE 1241599-1 years Severe, Systemic: Headache-Mild, Systemic: (COVID19) Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia- Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild 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, COVID19 temp, 96.2 temporal, 62HR, 100 %spo2, 116/60 Bp. 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1241721-1 116/60. 5:32 Pt awake enough, stable to be observed years (COVID19) 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. 36 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0158), intramuscular, administered in left arm on 09Apr2021 16:30 as single dose for COVID-19 immunization. Medical history included 3 weeks of urticaria prior to vaccination. The patient has had no COVID history COVID19 prior vaccination. The patient has not been tested for 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1255191-1 COVID post vaccination. Concomitant medications years (COVID19) included fish oil; diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC); ibuprofen (MOTRIN), and an unspecified multivitamin. The patient previously took Amoxicillin and experienced drug allergies. After vaccine, the patient became very red, had dizziness, vomiting and diarrhea and hypotension on 09Apr2021. The events resulted in an emergency room/department or urgent care visit and hospitalization for 1 day. Treatment included epi, Benadryl, steroids, Pepcid, and fluid boluses. The outcome of the events was not resolved. was sweating profusely and breathing heavy then he passed out; was sweating profusely and breathing heavy then he passed out; was sweating profusely and breathing heavy then he passed out; he started getting dizzy; felt nauseated; This is a spontaneous report from a contactable consumer (patient's parent). A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 11Apr2021 14:30 (Lot Number: EW0150) (age at vaccination: 16-year-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no. No COVID prior COVID19 vaccination, no COVID tested post vaccination, no 6-17 DIZZINESS PFIZER\BIONTECH VACCINE 1269700-1 Known allergies. There were no concomitant years (COVID19) medications (no other vaccine in four weeks and no other medications in two weeks). Right after the patient was administered the vaccine, he started getting dizzy and felt nauseated, was sweating profusely and breathing heavy then he passed out. They were in the car so the nurse reclined his chair. He passed out and then woke up and then passed out (twice) -They gave him water and gum to chew and remained laying flat. After about 20 or so minutes he felt better and nurse checked his pulse and heart rate during the ordeal. The adverse events start date was reported as 11Apr2021 14:30. No treatment received for the events. The outcome of the events was recovered. 37 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type 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. COVID19 Prior to vaccination, the patient was not diagnosed 6-17 DRUG INEFFECTIVE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the years (COVID19) 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. 38 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the COVID19 6-17 ER on 17March2021 for headache with blurry vision. DRUG SCREEN PFIZER\BIONTECH VACCINE 1135577-1 years Patient reported symptoms for 1 day prior. Also had (COVID19) persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile. 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. COVID19 metallic taste immediately; last for several hours-- 1-2 DYSGEUSIA PFIZER\BIONTECH VACCINE 0971259-1 resolved. swelling/tenderness anterior neck/most years (COVID19) likely lymphadenopathy Narrative: phone call bilateral numbness cheeks and jaw, difficulty swallowing Narrative: College med student received COVID19 1-2 COVID vaccine 30mins later had numbness in both DYSPHAGIA PFIZER\BIONTECH VACCINE 0940015-1 years cheeks and jaw, 40mins after vaccine he had (COVID19) difficulty swallowing. No SOB, No resp distress, no noticeable swelling of tongue About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. COVID19 6-17 While waiting at Urgent Care for 30 minutes, her DYSPHAGIA PFIZER\BIONTECH VACCINE 1172466-1 years face, tongue, and throat became swollen, hives (COVID19) developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home. 39 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type "Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours COVID19 6-17 later woke up from sleep with this chest tightness as DYSPNOEA PFIZER\BIONTECH VACCINE 0930353-1 years well as achyness and headache. áShe states that she (COVID19) had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non- compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed ""mild LV non compaction at the apex"" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms." COVID19 Systemic: Anaphylaxis-Medium, Systemic: Rash 6-17 DYSPNOEA PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other- years (COVID19) wheezing, shortness of breath, coughing-Medium COVID19 6-17 Shortness of breath, fatigue, tachycardia - persisting DYSPNOEA PFIZER\BIONTECH VACCINE 1013212-1 years since vaccination (COVID19) Dad says 5-10 minutes after vaccine patient started COVID19 having symptoms. Patient said it felt like she couldn't 6-17 DYSPNOEA PFIZER\BIONTECH VACCINE 1049139-1 breathe, like her throat was closing off. Patient years (COVID19) walked with staff member to EMS ambulance ~50 feet away. COVID19 6-17 Patient complained of shortness of breath, heart DYSPNOEA PFIZER\BIONTECH VACCINE 1053095-1 years racing. EMS cleared and released to home. (COVID19) Patient was normal and little nervous before vaccination. After receiving vaccinations about 2 minutes patient stated he could get up and was shaking. He was pale and sweating. Pharmacist Rima COVID19 left the room to get another pharmacist. Patient mom 6-17 DYSPNOEA PFIZER\BIONTECH VACCINE 1055411-1 reported she saw him passing out and eyes rolling. years (COVID19) Patient was conscious after and had difficulty breathing but return to normal after a few minutes. We gave him a ice pack and called 911 to be ready on hand but was not dispatched. Patient rested in the room and left on their own. About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. COVID19 6-17 While waiting at Urgent Care for 30 minutes, her DYSPNOEA PFIZER\BIONTECH VACCINE 1172466-1 years face, tongue, and throat became swollen, hives (COVID19) developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home. Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine COVID19 site 20min after symptom onset with significant 6-17 DYSPNOEA PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved years (COVID19) 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. 40 of 149 13/05/2021, 09:56 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446... Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Manufacturer Type COVID19 6-17 Patient reported difficulty breathing and chest pain; DYSPNOEA PFIZER\BIONTECH VACCINE 1199455-1 years suffered cardiac arrest and death (COVID19) Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / COVID19 6-17 Lethargy-Mild, Systemic: Fainting / Unresponsive- DYSPNOEA PFIZER\BIONTECH VACCINE 1241599-1 years Severe, Systemic: Headache-Mild, Systemic: (COVID19) Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia- Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild Patient was normal and little nervous before vaccination. After receiving vaccinations about 2 minutes patient stated he could get up and was shaking. He was pale and sweating. Pharmacist Rima COVID19 left the room to get another pharmacist. Patient mom 6-17 DYSSTASIA PFIZER\BIONTECH VACCINE 1055411-1 reported she saw him passing out and eyes rolling. years (COVID19) Patient was conscious after and had difficulty breathing but return to normal after a few minutes. We gave him a ice pack and called 911 to be ready on hand but was not dispatched. Patient rested in the room and left on their own. "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 COVID19 11pm and stayed till 3am. Her hearing loss happened 6-17 EAR DISCOMFORT PFIZER\BIONTECH VACCINE 0935956-1 in her left ear and lasted for 5 days and started to years (COVID19) 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%." "The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours later with vaccine side effects the family was prepared for, including headache, chills, nausea, vomiting and fatigue. This all resolved within 48 COVID19 6-17 hours. Approximately one week later, the child woke EAR PAIN PFIZER\BIONTECH VACCINE 1058308-1 years up again in the night with severe chills in the middle (COVID19) of the night. It was a sudden onset following a week of feeling well. She had to sit in a warm/hot shower for an hour to get warm. She described it as ""freezing to death."" She has never experienced anything like this before." 41 of 149 13/05/2021, 09:56
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