chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Leukopenia
Clinical narrative: flares; flares; This is a spontaneous report from a contactable other hcp and a contactable consumer (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had blood draws every few months. The patient previously took unspecified drug (DRUG, UNSPECIFIED) and experienced adverse event of leukopenia. Patient advised to back off dose to once daily or every other day. Patient also reported COVID vaccine caused flares on an unspecified date. Clinical outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Leukopenia, Condition aggravated) and the BNT162B2 cannot be excluded.  "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cardiac disorder, Diabetes mellitus
Clinical narrative: Diabetes; heart disease; Asthma; This is a spontaneous report received from a contactable nurse (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 intramuscular on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, 0.3 ml single, dose 2 intramuscular on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient asked about the Pfizer Covid 19 booster shot if she could get it 6 months rather than 8 months. She was diagnosed with heart disease, diabetes and asthma on an unspecified date in 2021. Added that she was already done with her two doses of the vaccine last February. The Pfizer BioNTech COVID-19 Vaccine was administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart. A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine. Patient wanted to know if the booster shot had the same dose compared to her first two doses. The clinical outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events diabetes mellitus and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Consumer states that she may have gotten COVID after getting the 1st dose of the Pfizer COVID vaccine.; Consumer states that she may have gotten COVID after getting the 1st dose of the Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced consumer states that she may have gotten covid after getting the 1st dose of the pfizer covid vaccine on an unspecified date in  2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on an unspecified date in 2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: he got a vaccine for covid 19 and got Covid from them; he got a vaccine for covid 19 and got Covid from them; got sick; This is a spontaneous report from a contactable consumer or other non-health professional (reported for nephew) via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced he got a vaccine for covid 19 and got covid from them and got sick. Reporter stated all he hearing was how safe this vaccine was, and now it was getting mandated. It seems like it was going to be forced on us. Maybe nothing sinister. Reporter questioned can Pfizer Guarantee that if he, his wife and two children receive the vaccine there will be no side effects or adverse reactions. He wanted a guarantee that this was not going to kill or harm anyone in my family. It was being forced from the top down. There seems to be a lot of misinformation about the vaccine, how many people have died and how many had taken it repoter questioned. List of lawsuits involving Pfizer, tons of them that Pfizer has had to pay out. A huge list he was looking at. This information, makes it look like there was a lot of corruption, and kick backs. The amount of censorship and a lot of red flags. Reporter asked how does the vaccine work. Reporter stated he was hearing about a lot of side effects from the vaccine. The patient underwent lab tests and procedures which included Covid: got covid on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: One of them can't even use the left side of her face; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced can't even use the left side of her face. Reporter stated that she had friends who had suffered because of this vaccine. They have had major complications. One of them can't even use the left side of her face and the other one lost her baby. She lost her baby. The doctors say that can't prove it was from the vaccine but they say they are pretty darn sure it is because of the vaccine. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attacks; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's cousin). This case is for reporter's first cousin. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. On an unspecified date, the patient had heart attack and was hospitalized. No product quality compliant was reported. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Liver injury, SARS-CoV-2 test negative
Clinical narrative: suspected liver damage; Patterns of diagonal grid-like blood vessels inflammation (similar to livedo reticularis) appeared on left front leg. Faded on its own gradually after two months; elevated level of Alanine Transminase (ALT) at 204 U/L; Aspartate Transaminase (AST) 82 U/L; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in left arm on 18May2021 at 04:30 hours as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On an unspecified date, the patient experienced suspected liver damage, patterns of diagonal grid-like blood vessels inflammation (similar to livedo reticularis) appeared on left front leg. Faded on its own gradually after two months. On 25Jun2021, the patient experienced elevated level of alanine transminase (ALT) at 204 U/L and aspartate transaminase (AST) 82 U/L, 5 weeks after receiving second dose of Pfizer COVID vaccine. No personal history of drinking or other suspected cause could be determined that could attribute to this symptom. The patient underwent lab tests and procedures which included alanine aminotransferase: 204 U/L on 25Jun2021, aspartate aminotransferase: 82 U/L on 25Jun2021, alanine aminotransferase: 67 U/L on an unspecified date in Aug2021 without taking medication, aspartate aminotransferase: 42 U/L on an unspecified date in Aug2021 without taking medication, and RT-PCR: negative on 27May2021. The patient did not receive any other vaccine in four weeks. The patient did not receive any treatment for the adverse events. The patient was recovering from the events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Blood sodium decreased, Heart rate, Heart rate increased, Loss of consciousness
Clinical narrative: Fever 104.7; loss of consciousness; high heart rate; cardiac ischemia; low sodium; This is a spontaneous report from a contactable consumer (patient). An 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 17Aug2021 18:00 as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included pyridostigmine (PYRIDOSTIGMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Pyridostigmine medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever104.7, loss of consciousness, high heart rate, cardiac ischemia, low sodium on 18Aug2021. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included heart rate: high, pyrexia: 104.7, sars-cov-2 test: negative on 28Aug2021 and blood sodium: low, Ct, MRI, ekgs, echocardiogram, blood tests. The patient received treatment for the events with IVs. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial ischaemia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever 104.7; loss of consciousness; high heart rate; cardiac ischemia; low sodium; This is a spontaneous report from a contactable consumer (patient). An 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 17Aug2021 18:00 as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included pyridostigmine (PYRIDOSTIGMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Pyridostigmine medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever104.7, loss of consciousness, high heart rate, cardiac ischemia, low sodium on 18Aug2021. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included heart rate: high, pyrexia: 104.7, sars-cov-2 test: negative on 28Aug2021 and blood sodium: low, Ct, MRI, ekgs, echocardiogram, blood tests. The patient received treatment for the events with IVs. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: heart irregularities; severe tightness in chest; chest pain; shortness of breath; could not move neck much, barely could get out of bed; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021, at 12:00 (at the age of 20-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Past drug included augmentin and had allergy to it. Patient was tested for covid prior and post vaccination. On 18Aug2021, Less than 48 hours after injection patient woke up Wednesday morning and experienced heart irregularities, severe tight-ness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. There they did electrocardiogram and asked the patient to go straight to ER for heart irregularities. The patient underwent lab tests and procedures which included electrocardiogram and results was unknown and sars-cov-2 Nasal Swab test which showed negative results on an unspecified date. Therapeutic measures were taken as a result of heart irregularities and received Medications for heart inflammation, severe tightness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. At the time of this report, the outcome of events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: heart irregularities; severe tightness in chest; chest pain; shortness of breath; could not move neck much, barely could get out of bed; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021, at 12:00 (at the age of 20-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Past drug included augmentin and had allergy to it. Patient was tested for covid prior and post vaccination. On 18Aug2021, Less than 48 hours after injection patient woke up Wednesday morning and experienced heart irregularities, severe tight-ness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. There they did electrocardiogram and asked the patient to go straight to ER for heart irregularities. The patient underwent lab tests and procedures which included electrocardiogram and results was unknown and sars-cov-2 Nasal Swab test which showed negative results on an unspecified date. Therapeutic measures were taken as a result of heart irregularities and received Medications for heart inflammation, severe tightness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. At the time of this report, the outcome of events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Neck pain, Thrombosis
Clinical narrative: blood clots; Long-lasting menstrual cramping (greater than 8 hours & still going); heavy period; cervical discomfort/pain; fatigue; This is a spontaneous report from a non-contactable other health care professional (patient). A non pregnant 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ;  Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. Medical history included penicillin allergy. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient had long-lasting menstrual cramping (greater than 8 hours & still going), heavy period, cervical discomfort/pain, blood clots, fatigue on an unspecified date. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Thrombosis cannot be completely excluded. 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.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diabetes mellitus, Mental status changes, Renal failure, Seizure
Clinical narrative: seizures; stroke; kidney failure; diabetes onset when never had prior; Altered mental status; This is a spontaneous report from a contactable other HCP. A 66-year-old male patient received an unknown dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included high blood pressure. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was unknown. The patient didn't received other vaccine in four weeks. Concomitant medication include regular prescriptions of high blood pressure medication and water pills. On 15Jul2021, the patient experienced altered mental status, seizures, stroke, kidney failure and diabetes onset when never had prior. The events caused in hospitalization 7 days. Treatment was received . The outcome of events was not recovered.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition(hypertension) which is not related to the suspected drug. The case will be reassessed if additional information becomes available.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: lower face felt funny especially right; tingling/numbness around lower face; tingling/numbness around lower face; ER agreed Bell's Palsy mild case; This is a spontaneous report from a contactable consumer (patient). A 51-years-old Non pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administered in arm left on 25Aug2021 at 02:30 PM (age at vaccinattion was 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  No other vaccines were received within four weeks. The patient was not pregnant at the time of vaccination.  Medical history included bell's palsy from 2002 and ongoing, blood clot to eye from 1997 to an unknown date, protein s diagnose from 2010 to an unknown date (Protein S diagnose after DVT Right calf from broken foot), hypothyroidism from 2010 to an unknown date, LPR acid Reflex from 2021 to an unknown date, deep vein thrombosis (DVT) right calf from 2010 to an unknown date (2010 Protein S diagnose after DVT Right calf from broken foot), broken foot from 2010 to an unknown date (2010 Protein S diagnose after DVT Right calf from broken foot). No known allergies were reported. Concomitant medications included omeprazole 20 mg and levothyroxine, liothyronine 45 mg (NP THYROID); both taken for an unspecified indication, start and stop date were not reported. On 25Aug2021 at 02:50 PM, the patient experienced tingling/numbness around lower face which subsided at 03:30 PM. On 26Aug2021 at 05:00 AM, the patient's lower face felt funny especially right. On the same day at 07:20 AM, the patient decided to go to urgent care and was sent to ER. ER agreed Bell's Palsy mild case. Therapeutic measures were taken as a result of the events. Treatment included prescribed steroid (unspecified) but the patient did not take it. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  The outcome of the events tingling/numbness around lower face was recovered and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site; Her arm felt feverish after both vaccines; This is a spontaneous report from a contactable consumer (patient), from a Pfizer Sponsored Program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 (It was the end of Apr or the Middle of May 2021) as dose 1, single for covid-19 immunization and experienced flu symptoms for a week after the first vaccine, sore arm, her arm felt feverish after both vaccines. It was reported that, for the second dose she pain at the injection site. Her arm felt feverish after both vaccines. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119257 same reporter/SD/AE,different patient
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Migraine, Off label use
Clinical narrative: Sudden onset of chronic migraine (30 migraine days/month) beginning 2/20/21. Inpatient hospitalization to manage pain. Currently 20 migraine days/month; received the second dose of BNT162B2 via an unspecified route of administration on 12Jan2021; received the second dose of BNT162B2 via an unspecified route of administration on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on 12Jan2021 (Lot Number: EL8982) at the age of 26-year-old as single dose for COVID-19 immunization. Medical history included Anxiety. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergies included sulfa. The patient didn't received other vaccine in four weeks. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) and escitalopram. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 12Jan2021 (Lot Number: EL3246) at the age of 26-year-old as single dose for COVID-19 immunization. The patient sudden onset of chronic migraine (30 migraine days/month) beginning 20Feb2021. Inpatient hospitalization to manage pain. Currently 20 migraine days/month. migraine treatment with DHE The outcome of migraine was not recovered. The outcome of other events was unknown.; Sender's Comments: Based on current information available, the event migraine mostly represented intercurrent condition in this patient unrelated to Bnt162b2. Given information is too limited for medically meaningful assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis, X-ray
Clinical narrative: blood clots; life threatening blood clots/ had blood clots that were 60% blockage from the brain/ The clot is in her neck was reported as worsened.; minor strokes; This is a spontaneous report from a contactable consumer or other non hcp. An 8 decade elderly (late 70's; unit: not provided) old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration on Feb2021 as dose number unknown, single for covid-19 immunisation. Unable to provide patient's date of birth or current weight. Patient took vaccine as she was elderly, wanted to protect herself from COVID virus, first was avail, and want to be first protected. Reporter unsure if patient had both shots. Medical history included high cholesterol and heart murmur from an unknown date and unknown if ongoing in the past, but caller does not know if it corrected itself in the past. Family Medical History Relevant to AE was none. Prior Vaccinations within 4 weeks was unknown. AE following prior vaccinations was None. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. The patient's concomitant medications were not reported. On unspecified date in Feb2021 the patient experienced blood clots, life threatening blood clots/ had blood clots that were 60% blockage from the brain/ the clot is in her neck was reported as worsened and minor strokes. On unspecified date in Feb2021 the patient underwent lab tests and procedures which included x-ray result with blood clots (60%-80%). The doctor wanted to schedule her for immediate surgery, but they were trying to get her booked and they were all booked up. They said they can put her on a blood thinner medication, but she was already on a blood thinner. They had wanted to switch her from the current blood thinner she was on for another illness (not sure if it's for her age or cholesterol), to another one. Patient was on a blood thinner prior to getting the COVID shot, and she didn't want to switch up the blood thinners. Therapeutic measures were taken. The outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (wife) reporting for patient (Reporters Husband). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Left arm, upper arm on 20Aug2021 (Batch/Lot Number: FC3181, at the age of 49-year-old) as single dose for COVID-19 immunisation. The patient's relevant medical history and concurrent conditions included high blood pressure from an unknown date. Concomitant medication included lisinopril taken for blood pressure high, start and stop date were not reported. There was investigation assessment, prior vaccinations were none. Reporter stated that they received their vaccine on Friday, last Friday and her husband. Well, they took him to the doctor the previous day, on 26Aug2021, he got Bell's palsy, so she had called the pharmacy, they told her to report it to Pfizer too. Treatment for AE included reporter stated that they put him on steroid pack Prednisone. The patient underwent lab tests and procedures which included blood work (blood test): result unknown on Thursday, 26Aug2021 at the doctor's office. The Reporter asked, how did they know if he was supposed to get the second shot and asked whether she supposed to wait for the side effect to clear up. Reporter also asked what she do there. Reporter seriousness for Bell's palsy was unspecified. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Myocarditis, Pain, Pain in extremity
Clinical narrative: MyocarditisHeart Pain, it is getting worse over time paired with chest pains, muscle pains throughout body, arm pains; MyocarditisHeart Pain, it is getting worse over time paired with chest pains, muscle pains throughout body, arm pains; MyocarditisHeart Pain, it is getting worse over time paired with chest pains, muscle pains throughout body, arm pains; MyocarditisHeart Pain, it is getting worse over time paired with chest pains, muscle pains throughout body, arm pains; MyocarditisHeart Pain, it is getting worse over time paired with chest pains, muscle pains throughout body, arm pains; This is a spontaneous report from a contactable consumer. A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: Unknown), via an unspecified route of administration on 25Aug2021 17:00 (age at the time of vaccination was 28 years old as dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. It was reported that no other vaccine in four weeks and no other medications in two weeks. It was reported that covid prior vaccination was no, covid tested post vaccination was no. It was reported that patient had no known allergies. The patient experienced myocarditis heart pain, it was getting worse over time paired with chest pains, muscle pains throughout body, arm pains on 25Aug2021.Therapeuitc measure were taken as no as a result of events. The outcome of events was not recovered.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Decreased appetite, Diabetes mellitus
Clinical narrative: Temperature just read a 101 today; He is sick right now; He got diabetes; He started feeling like flu not the flu but the flu like symptoms; Feeling weak and vomiting; Feeling weak and vomiting; Totally lost his appetite; This is a spontaneous report from a non-contactable consumer or other non-HCP (reporting for boyfriend). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had the shots three weeks ago on an unspecified date in Aug2021. A week ago he started feeling like flu not the flu but the flu like symptoms, reporter had been checking his temperature he was feeling weak and vomiting on an unspecified date in Aug2021, he had all symptoms of flu but no fever but now she was getting worried because now he had totally lost his appetite on an unspecified date in Aug2021 and his temperature just read a 101 today (26Aug2021) and she could not give him to eat or drink anything at all today no matter how hard she tried so, her concern was his second shot is tomorrow is he going to be okay. He got diabetes and she was really worried about him right now. He was sick right now. The outcome of the event he was sick right now was not resolved while that of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Vomiting
Clinical narrative: Temperature just read a 101 today; He is sick right now; He got diabetes; He started feeling like flu not the flu but the flu like symptoms; Feeling weak and vomiting; Feeling weak and vomiting; Totally lost his appetite; This is a spontaneous report from a non-contactable consumer or other non-HCP (reporting for boyfriend). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had the shots three weeks ago on an unspecified date in Aug2021. A week ago he started feeling like flu not the flu but the flu like symptoms, reporter had been checking his temperature he was feeling weak and vomiting on an unspecified date in Aug2021, he had all symptoms of flu but no fever but now she was getting worried because now he had totally lost his appetite on an unspecified date in Aug2021 and his temperature just read a 101 today (26Aug2021) and she could not give him to eat or drink anything at all today no matter how hard she tried so, her concern was his second shot is tomorrow is he going to be okay. He got diabetes and she was really worried about him right now. He was sick right now. The outcome of the event he was sick right now was not resolved while that of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Arm is still sore (from first covid vaccine dose); first covid vaccine dose caused a bleed to the left arm; This is a spontaneous report based on the information received by Pfizer from Sanofi (Mfr. Report#: 2021SA156335). A contactable consumer (patient) reported for a 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 (at the age of 27-year-old) as dose 1, single for COVID-19 vaccination; efmoroctocog alfa (ELOCTATE), via an unspecified route of administration from an unspecified date to an unspecified date, at 4536 iU (intravascular route) and intravenous from an unspecified date to an unspecified date, at 4500 iU (4500 U, IV NOS) for an unspecified indication in the context of COVID 19 crisis. The patient medical history, medical treatments, concomitant medications and family history were not provided. On 29Apr2021 after unknown latency, patient's first covid vaccine dose caused a bleed to the left arm (medically significant) for which patient used 1 dose after calling the hospital, continued from chief complaint on next morning around 5AM. Patient stated the arm was still sore (from first covid vaccine dose) on 30Apr2021 (latency unknown). The action taken in response to the event(s) for efmoroctocog alfa was unknown. The clinical outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Inflammation around the heart .; This is a spontaneous report from Non-contactable consumer female (patient). A 17-year-old female patient (not pregnant at the time of vacciantion) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Aug2021 (at the age of 17 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 26Aug2021 patient experienced inflammation around the heart. Therapeutic measures were taken as a result of inflammation around the heart with Computed tomography (ct), x-ray, electrocardiogram (ecg). The reported event led to patient's prolonged hospitalization on an unspecified date. The reporter considered events as serious. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Malaise, Vaccination site haemorrhage, Wound haemorrhage
Clinical narrative: My nose started to bleed out/after I went to bed around 3:00 AM my nose started to bleed again; After the shot my injection site just started to bleed out a lot; I felt a little off after I received the shot; I noticed a old cut on my finger started to bleed a little; This is a spontaneous report from a contactable consumer (Patient) reporting himself. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3183) via an unspecified route of administration, administered in Arm Left on 28Aug2021 at 13:00 as DOSE 1, SINGLE (at the age of 34-year-old) for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). On 28Aug2021 at 13:30, after the shot injection site just started to bleed out a lot, patient felt a little off after he received the shot. Then about 30 minutes later nose started to bleed out. Patient noticed a old cut on finger started to bleed a little. Then after patient went to bed around 3:00 AM nose started to bleed again. The patient did not received the treatment for events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling on his arm; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Sanofi (manufacturer report number 2021SA156335). A 27-year-old male patient received BNT162B2 (COMIRNATY, Lot unknown, second dose) solution for injection intramuscular in May2021 (at the age of 27-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included efmoroctocog alfa (ELOCTATE) at 4536 iU via intravascular route and 4500 iU. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination in Apr2021 and caused a bleed to the left arm and arm was still sore at site. The patient received Pfizer Covid Vaccine in the second week in May2021; he said he sustained some swelling on his arm on 22May2021 and he infused (efmoroctocog alfa) twice after to treat the swelling. The outcome of the event swelling on his arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test normal, Arrhythmia, Condition aggravated, Diarrhoea, Extra dose administered
Clinical narrative: So I had the booster by Pfizer; So I had the booster by Pfizer; Arrhythmia aggravation; arrhythmia /It is still extremely high; intense heat/got very hot all over; diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on 27Aug2021 (age at vaccination was 84 years) as DOSE 3, SINGLE for COVID-19 immunisation. The patient's medical history included arrhythmia (had no effect on shot one or shot two). The patient's concomitant medications included rivaroxaban (XARELTO) 15 mg for indication blood thinner and metoprolol 25 mg one tablet a day (two medication for her heart and both never affected her heart rate). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date in Jan2021 as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date a DOSE 2, SINGLE; both for COVID-19 immunisation. After the first and second shot, she had no stress, no headache, and had no reaction to shot one or shot two. She had no fatigue also after second shot. The patient stated that, in Aug2021 (from the minute she took the shot) her arrhythmia which she had no problem with shot one or shot two her arrhythmia, her heart rate it was jumped up to a very dangerous level and it continued to the day of reporting. In Aug2021, she had no chills, what she had was intense heat, it was sort of like the closest thing she could describe it as, it was like when women have like they have menopause, a woman got very hot all over specially in the top part of the bottom in the top part of the body; burning up, there were no chills, there was just intense heat and she had diarrhea and nothing else. She did absolutely nothing, had no treatment whatsoever there was nothing what she was going to do with heat. She stated burning up was okay and the fact that her heart, she has to go and see her cardiologist and she do not know what they are going to do about her heart to bring it back down to its normal level. She had been checking heart rate in Aug2021 (for the last three days) and it was been consistently high, it was still extremely high, and it has to be gone back to its normal beat. The patient underwent lab test and procedure on unspecified date in 2021 (three week ago) included antibody test and resulted into antibody was fine. The outcome of events was arrhythmia aggravation was not recovered; intense heat/got very hot all over and diarrhea was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Off label use
Clinical narrative: So I had the booster by Pfizer; So I had the booster by Pfizer; Arrhythmia aggravation; arrhythmia /It is still extremely high; intense heat/got very hot all over; diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on 27Aug2021 (age at vaccination was 84 years) as DOSE 3, SINGLE for COVID-19 immunisation. The patient's medical history included arrhythmia (had no effect on shot one or shot two). The patient's concomitant medications included rivaroxaban (XARELTO) 15 mg for indication blood thinner and metoprolol 25 mg one tablet a day (two medication for her heart and both never affected her heart rate). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date in Jan2021 as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date a DOSE 2, SINGLE; both for COVID-19 immunisation. After the first and second shot, she had no stress, no headache, and had no reaction to shot one or shot two. She had no fatigue also after second shot. The patient stated that, in Aug2021 (from the minute she took the shot) her arrhythmia which she had no problem with shot one or shot two her arrhythmia, her heart rate it was jumped up to a very dangerous level and it continued to the day of reporting. In Aug2021, she had no chills, what she had was intense heat, it was sort of like the closest thing she could describe it as, it was like when women have like they have menopause, a woman got very hot all over specially in the top part of the bottom in the top part of the body; burning up, there were no chills, there was just intense heat and she had diarrhea and nothing else. She did absolutely nothing, had no treatment whatsoever there was nothing what she was going to do with heat. She stated burning up was okay and the fact that her heart, she has to go and see her cardiologist and she do not know what they are going to do about her heart to bring it back down to its normal level. She had been checking heart rate in Aug2021 (for the last three days) and it was been consistently high, it was still extremely high, and it has to be gone back to its normal beat. The patient underwent lab test and procedure on unspecified date in 2021 (three week ago) included antibody test and resulted into antibody was fine. The outcome of events was arrhythmia aggravation was not recovered; intense heat/got very hot all over and diarrhea was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.