chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable consumer or other non-health care professional via Medical Information Team. This consumer reported for a patient (cousin).   A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE  MANUFACTURER UNKNOWN, Formulation: Solution for injection, Batch/Lot Number and Expiration date was 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. The patient experienced heart attack on an unspecified date. The event assessed as serious (hospitalization, medically significant). Caller stated she was concerned about various information she was finding around the FDA approval of the Comirnaty Vaccine. Caller stated her employer was planning on mandating vaccination against Covid-19, but she was concerned because she had two cousins that had heart attacks and another who had a severe allergic reaction with paralysis from the neck down to an unspecified Covid-19 Vaccine. They were hospitalized. The outcome of the event was reported as unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Paralysis
Clinical narrative: paralysis from the neck down; a severe allergic reaction; This is a spontaneous report contactable consumer or other non health care professional. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient experienced severe allergic reaction with paralysis from the neck down. Events resulted in hospitalization on an unspecified date. Reporter concerned about various information she was finding around the FDA approval of the Comirnaty Vaccine and states her employer was planning on mandating vaccination against COVID-19, but she was concerned because she had two cousins that had heart attacks and another (patient), who had a severe allergic reaction with paralysis from the neck down to an unspecified COVID-19 Vaccine, They were hospitalized. The outcome of all the events was unknown.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: Brain filled with blood clots; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. On an unknown date, the patient's brain filled with blood clots. The caller states that she was at a pharmacy with a group of employees and was told by the pharmacist that the BioNTech vaccine was the one that was not FDA approved, and the vaccine that was approved, was not in stock, so she wants to asks, was the approved vaccine on the market yet or not. She clarifies she was calling about the Pfizer BioNtech Covid vaccine and also stated that they also told her that another employee, male, his brain was filled with blood clots, and there were two of them, and they both got the Pfizer vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Bilateral pulmonary embolism; Deep Vein Thrombosis in lower left leg; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Mar2021 09:30 (Lot Number: EN6204) at the age of 68 years old as DOSE 2, SINGLE for covid-19 immunisation. The patient received the first dose of BNT162B2 on 26Feb2021 at 10:00 AM  Lot number EN6200 at Right arm at the age of 68 years old for Covid-19 Immunisation. Medical history included ongoing hypertension from an unknown date. No known Allergies. Concomitant medications included propranolol (PROPRANOLOL); calcium (CALCIUM); krill oil (KRILL OIL) and unspecified multivitamin all taken for an unspecified indication, start and stop date were not reported.  The patient experienced bilateral pulmonary embolism and deep vein thrombosis in lower left leg on 23Jun2021 12:00 with outcome of recovering.  The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 4 days, Life threatening illness (immediate risk of death from the event)]. The patient received tPA and Heparin therapy as treatment. The patient underwent lab tests and procedures which included Nasal Swab: negative on 26Jun2021 Nasal Swab.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority Support received from a non-contactable consumer. The consumer reported same events for two patients (two friends). This is one of the two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient took both doses and passed away on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101123407 Same reporter/suspect product/event, different patients; Reported Cause(s) of Death: took both doses and passed away
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Dyspnoea, Food allergy, Multiple allergies
Clinical narrative: getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine; getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine; getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). This female consumer reported that a 41 years old female (no pregnant) patient received BNT162B2 (lot number=EL3302), at the age of 41-year-old, on 17Apr2021 vaccine location in Left arm at single dose for covid-19 immunization. Medical history was Gastrooesophageal reflux disease (GERD), Arthritis. Known allergies to Peanut, Soya, Sesame. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks included Omeprazole, Desloratadine. Adverse event on 18Apr2021 was getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine. I never had any allergies from peanuts and sesame. Also these came (-) on Food Allergy test done on 23Dec2020 at ENT and Allergy facilities. Event resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment was Nebulization, Prednisone, Breo. Outcome of the event was Not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Drug ineffective, Extra dose administered, Hypersensitivity
Clinical narrative: Came up positive for COVID; Came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; Woozy; I thought I had allergy and all; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number and expiry date were unknown), dose 3 via an unspecified route of administration on an unspecified date in 2021 (Lot Number: EW0175) as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes bnt162b2 dose 1, single in Jan2021 and dose 2, single on 22Jan2021; both doses for covid-19 immunization. Patient got both the Pfizer shots back in January, the last one in January was 22Jan2021. Last week, they had the booster shot and patient took the booster shot on an unknown date in 2021, it was of Pfizer EW0175 patient thinks, it was the booster. The side effect was that, patient was surprised, took that last Saturday and started feeling like woozy like on Tuesday and Wednesday and then thought had allergy and all and patient went to get tested last night and came up positive for COVID on an unknown date in 2021. This was the Pfizer booster that the patient got which was administered last week, last Saturday. The patient underwent lab test which included Covid (sars-cov-2 test) was positive on an unknown date. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test
Clinical narrative: Came up positive for COVID; Came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; Woozy; I thought I had allergy and all; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number and expiry date were unknown), dose 3 via an unspecified route of administration on an unspecified date in 2021 (Lot Number: EW0175) as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes bnt162b2 dose 1, single in Jan2021 and dose 2, single on 22Jan2021; both doses for covid-19 immunization. Patient got both the Pfizer shots back in January, the last one in January was 22Jan2021. Last week, they had the booster shot and patient took the booster shot on an unknown date in 2021, it was of Pfizer EW0175 patient thinks, it was the booster. The side effect was that, patient was surprised, took that last Saturday and started feeling like woozy like on Tuesday and Wednesday and then thought had allergy and all and patient went to get tested last night and came up positive for COVID on an unknown date in 2021. This was the Pfizer booster that the patient got which was administered last week, last Saturday. The patient underwent lab test which included Covid (sars-cov-2 test) was positive on an unknown date. The outcome of the events was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1.; Fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose and first dose of BNT162B2, second dose via an unspecified route of administration in Mar2021, first dose via intramuscular on the left arm on 09Mar2021 at 10:00 AM (Lot Number: EL3247), both at the age of 60-year-old as single dose for COVID-19 immunization. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. known allergies was none. Concomitant medication was not reported. On 25Aug2021 at 02:15 PM, the patient fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1. COVID test (PCR, Nasal Swab) post vaccination on 25Aug2021 and result was positive. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she got her first covid vaccine dose and then got covid; she got her first covid vaccine dose and then got covid; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Reporter was asking how long she has to wait after having covid to receive her second vaccine dose. She got her first covid vaccine dose and then got covid causing her to miss her second dose. Now asking how long she would have to wait to get her second dose after having Covid. The outcome of the event was unknown.  Information about lot/batch number requested.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a contactable consumer (patient) via Pfizer RXPathways. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jan2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient stated that over the past 4-5 weeks from the time of reporting, the patient has been having chest pain with breathing and movement. The patient thought of having some heart issues, so the patient went to PCP (primary care physician), then sent the patient to ER (emergency room), then referred to cardiologist. The cardiologist scheduled the patient for an Echo and Stress Test. Then on 24Aug2021, the pain was worse, so the patient went back to cardiologist. The patient was sent back to ER again and finally the ER diagnosed the patient with pericarditis. The patient had no past cardiac issues or heart related conditions. The outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: Renal Failure; This is a spontaneous report from a contactable consumer.  A 94-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Batch/Lot number was not reported) (at the age of  94-year-old, not pregnant) as single dose for COVID-19 immunisation.  Medical history: none, she was just old. Concomitant medications included temazepam; ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER); ascorbic acid, betacarotene, copper, tocofersolan, zinc (OCUVITE).  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 on 23Feb2021 at 12:00 PM in left arm at the age of 94-year-old for COVID-19 immunization and experienced Renal Failure.  No covid prior vaccination.  No other vaccine in four weeks.  No covid tested post vaccination.  No known allergies.  The patient experienced periodic uncontrollable shaking renal failure.  AE resulted in: Doctor or other healthcare professional office/clinic visit.  No treatment.  The patient died on 18May2021.  An autopsy was not performed.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101102004 same reporter, patient, product, event, different doses and potential; Reported Cause(s) of Death: Renal Failure
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, SARS-CoV-2 test
Clinical narrative: Congestive heart failure; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 24Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient has not been diagnosed with COVID-19 prior to vaccination. Patient was not pregnant and was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccine within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 04Apr2021 in left arm for covid-19 immunisation. The patient experienced congestive heart failure (disability, life threatening) on Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 14Aug2021. Therapeutic measures were taken as a result of the event and included unspecified medication (treatment ongoing).  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, Rash
Clinical narrative: mettallic taste in mouth; mettalic/burning smell; Rash; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) intramuscular on 01Apr2021 at 07:30 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history, family history, and concomitant medications were none. The patient did not receive any prior vaccinations (as reported). On 02Apr2021 at 08:00 the patient experienced rash. The event was reported as non-serious. On unknown dates the patient experienced metallic taste in mouth and metallic/burning smell. The events were reported as serious (persistent/significant disability/incapacity). The patient had a constant burning smell/taste. Sweet foods were okay, but any other foods such as meat and vegetarian tasted like metal and were gross. This change in smell ability could be a serious issue if she would be unable to do her job as a scientist in a chemical lab since she could not determine chemical potency. The patient did not receive any treatment for the events. The outcome of rash was recovered on 30Apr2021. The outcomes of metallic taste and smell were not recovered. It was also reported that the patient received dose 2 of BNT162B2.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100943663 same patient, different dose/events
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received a Positive covid-19 diagnosis after first shot and before the second shot.; Received a Positive covid-19 diagnosis after first shot and before the second shot.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received a positive COVID-19 diagnosis after first shot and before the second shot. Event took place after use of product. Outcome of the events 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: Death
Clinical narrative: who got the vaccine and died three days later; This is a spontaneous report from a non-contactable other hcp. The reporter reported for herself and another patient. This was for another patient. A patient of unspecified age and gender received bnt162b2 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. The patient medical history and concomitant medications were not reported. The patient got the vaccine and died three days later on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.; Reported Cause(s) of Death: who got the vaccine and died three days later
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable consumer. This consumer reported for an adult male patient. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Reason for no lot number of Pfizer COVID-19 Vaccine: complainant hung up abruptly/transfer incomplete. The patient medical and concomitant medication history were reported. Other products, patient history and investigation assessment not provided. The patient experienced died on an unspecified date. It was not reported if an autopsy was performed. Caller was asking why Pfizer not reporting the side effects to VAERS? Caller states that the data on VAERS has stopped counting the fatalities from the Pfizer COVID-19 vaccine and the death count exceeds 12,000. Caller states that the Pfizer COVID-19 vaccine has metals and was asking how was it being passed through the FDA and Pfizer? Normally with other shots, they take years to get approved. FDA only allows, if people die, they did not put it on the market. Caller states that the data on VAERS has stopped counting the fatalities from the Pfizer COVID-19 vaccine and the death count exceeds 12,000. Caller asked if we had COVID, we had the antibodies, why do we have to get the shot.  The lot number was not provided. Information on lot number has been requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101134188 same reporter/drug/event, different patient.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I have lost 3 friends in Spain; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified routed of administration on unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend in Spain. The cause of death was unknown. It was unknown whether an autopsy was done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100059 same reporter/drug/event, different patient; Reported Cause(s) of Death: I have lost 3 friends in Spain
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the sixth of six reports. A patient of an unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot number: EP8573), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the nurse reported that they had 7 to 8 patients positive of COVID-19 and out of which 6 were given Pfizer vaccine and they got infected. The patient tested positive for COVID-19 on an unknown date in 2021. The events were assessed as medically significant. The outcome of the events was reported as unknown.  Investigation Results for Lot Number: EP8573: Conclusion of Previously Completed Investigation : The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up (19Aug2021): New information updated. This is a follow-up spontaneous report received from a Complaint Group. This report included Lot number: EP8573 was updated.   No follow-up attempts are possible. No further information is expected.  Follow-up (01Sep2021): This is a follow-up report to notify that the case 202101065553 and case 202101138804 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202101138804.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Covid 19, Drug ineffective and the suspect drug BNT162B2.,Linked Report(s) : US-PFIZER INC-202101058200 Different patient, same drug/event.
Age: 31.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: intense pain in all my teeth; This is a spontaneous report from a contactable healthcare professional (patient). This 31-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EK9231) via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number EH9899) in the left arm on 30Dec2020 at 08:00 (at 31-years-old) for COVID-19 immunisation. Prior to vaccination the patient did not receive any other vaccines in 4 weeks, had no allergies and was not diagnosed with COVID-19. On 21Jan2021 the patient reported waking up at midnight with intense pain in all their teeth as if chewing on raw sugar mixed with tin foil. No treatment was received for the events. The outcome of the event was recovered on an unspecified date in 2021. Since vaccination the patient had tested positive for COVID on 23Apr2021 via nasal swab.
Age: 31.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: intense pain in all my teeth; This is a spontaneous report from a contactable healthcare professional (patient). This 31-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EK9231) via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number EH9899) in the left arm on 30Dec2020 at 08:00 (at 31-years-old) for COVID-19 immunisation. Prior to vaccination the patient did not receive any other vaccines in 4 weeks, had no allergies and was not diagnosed with COVID-19. On 21Jan2021 the patient reported waking up at midnight with intense pain in all their teeth as if chewing on raw sugar mixed with tin foil. No treatment was received for the events. The outcome of the event was recovered on an unspecified date in 2021. Since vaccination the patient had tested positive for COVID on 23Apr2021 via nasal swab.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only a sore arm after the first dose; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (12Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 37-year-old female consumer (patient) received bnt162b2, dose 1 via an unspecified route of administration, administered in arm left on 24Jan2021 at 12:00 (Batch/Lot Number: EL9262) as single for COVID-19 immunisation in hospital. The patient medical history and concomitant medications were not reported. The patient previously took MMR vaccine and experienced facial swelling and blotches on her face. The patient experienced only a sore arm after the first dose on Jan2021. The patient reported that she had bad reaction to an MMR vaccine in 1999 that resulted in facial swelling and blotches on her face. When she was admitted to the hospital, the MD told her to never receive a flu vaccine because she had "a bad reaction to eggs" in her history. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; temperature (38.6C (101.5F); headaches; This is a spontaneous report from contactable consumer. This 54-year-old female consumer (patient) reported that: A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm left on 09Feb2021 09:30 AM (age at vaccination was 54-year-old), as dose 2, single dose for covid-19 immunisation. The patient had no known allergies. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications in two weeks were vitamins and food supplements. The patient had no other medical history. The patient concomitant medications were not reported. The patient historical vaccine includes received the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 19Jan2021 11:15 AM, as dose 1, single dose for covid-19 immunisation. 12h after the second shot, on 09Feb2021 09:30 AM, patient experienced chills, temperature (38.6c (101.5f) and headaches. The patient underwent lab tests and procedures which included body temperature: 101.5 Fahrenheit on 09Feb2021 temperature (38.6C (101.5F). No treatment received for the events. Outcome of the events was not recovered.  Information on the lot batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain, Parosmia
Clinical narrative: weird smell and taste./ like a chemical bleach smell and taste that feels like it's poison; weird smell and taste./ like a chemical bleach smell and taste that feels like it's poison; soreness within a few hours after the vaccine; This is a spontaneous report from a contactable Nurse. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jan2021 at 08:00 as a dose 1, single for covid-19 immunization. Medical history included High blood pressure and COVID positive in Nov2020. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was hospital; clinic set up in the hospital for workers. No prior vaccinations within 4 weeks. No aes follow prior vaccinations. No family Medical history reported It was reported that after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she experienced a weird smell and taste. It was Like a chemical bleach smell and taste that feels like it's poison on 29Jan2021. She said it was like a chemical bleach smell and taste that feels like it's poison. She said this has been going on for 2 weeks straight since receiving the 1st dose. HCP wants to know if it was still safe for her to receive the 2nd dose of the vaccine if she had this kind of reaction to the 1st dose. Had first COVID-19 Vaccine on 27Jan2021. Due for second dose on 17Feb2021. Two days after first dose, had a weird smell in her nose and a weird taste. Occurring even today. Went to taste soda and still has it. Started after the COVID-19 Vaccine and has been on and off. It is a chemical or bleach smell and taste she was experiencing. Her son is non-verbal and autistic. No further details provided. Scared to get second COVID-19 Vaccine. Known people to only have symptoms for a day or two. Feel like it is almost in her pores. Doesn't know if this is normal or if she needs to get blood work done. She had never known symptoms to last for two weeks straight. Weird smell and taste is off and on. Started with a strong chemical, bleach smell. She could smell other things, but it was a mixture with the chemical smell. It was overpowering. It was all she could smell if she was outside or took a deep breath. Hasn't really tasted food. Went to take a drink of Sierra Mist and had the same taste as what she is smelling. Would try to take a small sip and it felt like it was on her tongue. It threw her off. She could taste the Sierra Mist, but the chemical taste made the soda disgusting. This was all the symptoms she has had. The outcome of event weird smell and taste./ like a chemical bleach smell and taste that feels like it's poison was not recovered and recovered for soreness within a few hours after the vaccine on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine spasm
Clinical narrative: uterine cramps; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 35-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm right on 11Feb2021 14:45 (at the age of 35 years) SINGLE for covid-19 immunization. Medical history included GERD, depression, anxiety, PTSD from 11Feb2021 to an unknown date, food allergy from an unknown date and unknown if ongoing Walnuts and cashews. The patient concomitant medications were not reported. Patient was not priorly did had covid vaccination and was not covid tested post vaccination. Patient took medication Mirena IUD in two weeks before vaccination and no other vaccine in four weeks. On 11Feb2021 14:45 the patient experienced sudden onset of uterine cramps within 10 minutes of receiving the shot. Might not be related but wanted to report anyway. Patient received Advil as Adverse event treatment. The outcome of the event was recovered on unspecified date of 2021.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Tongue disorder
Clinical narrative: bumps on her tongue; bumps on her tongue which are not as painful today; This is a spontaneous report from a contactable consumer (Patient mother). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bumps on her tongue which are not as painful today on 11Feb2021.The outcome of the events was unknown at the time of this report.  No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Accident
Clinical narrative: Accident; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer stated that she was in an accident and needed four stitches and was recommended to receive a tetanus shot. Consumer would like to know if it is okay to receive the tetanus shot after receiving the Pfizer COVID vaccine. The case assessed as serious (medically significant). The consumer stated the event result emergency room visit. Consumer states she is scheduled to receive the second dose of the vaccine on 03Mar2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report from a contactable consumer via Medical Information Team. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 (age at vaccination 67 years) as DOSE 1 SINGLE for covid-19 immunisation. Medical history included a little high blood pressure on an unspecified date. The concomitant medication included either Latranamine or Motropamine for blood pressure (Caller was not sure of the name or spelling). The Historical Vaccine included Flu vaccine on an unspecified date in Aug2020 (It was the super flu shot for seniors). On 11Feb2021 at 6 pm, the patient started vomiting and it lasted all night. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Hypoacusis, Vomiting
Clinical narrative: dizziness; diarrhea; vomiting; I have hard time hearing; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318) via unknown route of administration on 31Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included pressure was a little high not much high but little high. Concomitant medications were not reported. Patient stated she had her first covid vaccine shot 12 days ago and experienced dizziness, diarrhea and vomiting on 11Feb2021. Patient was asking if this was a normal side effect people has experienced when they got the covid vaccine. Patient have hard time hearing on an unknown date in 2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pain
Clinical narrative: She felt aches and pain; She broke out in sweat; Also felt chills last night; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2, dose 2 via an unspecified route of administration on 10Feb2021 as single for COVID-19 immunisation. Medical history included pneumonia. The patient's concomitant medications were not reported. The patient experienced she felt aches and pain, she broke out in sweat and also felt chills last night on 11Feb2021. The patient reported that she got her second dose of the COVID vaccine on Wednesday 10Feb2021. She drank a lot of water and yesterday she felt aches and pain but last night she broke out in sweat. She took her temperature, and it was not really high. Last measure 45 min ago indicated 97 Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 97 Fahrenheit on 12Feb2021. She used a steroid cream and also felt chills last night and she did not feel like that since she had pneumonia. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 35-year-old female consumer (patient) received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 19Jan2021 at 11:30 (Batch/Lot Number: EL3249) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient experienced headache and fatigue on an unspecified date. First dose: headache and fatigue for approximately 3 days. No prior vaccination of COVID. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. This 36-year-old non-pregnant female patient received bnt162b2 (COVID-19-VACCINE, Solution for injection, Lot number: EL9267), via an unknown route of administration on Left arm on 10Feb2021 13:45 (at the age of 36-year-old) at dose 1, single for COVID-19 immunisation. Medical history included Sjogrins. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Feb2021 at 14:00, the patient experienced sore arm. The patient did not receive any treatment for the reported event. Outcome of the event was recovered in 2021. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had the first dose of the pfizer covid 19 vaccine and both experienced arm pain; had the first dose of the pfizer covid 19 vaccine and both experienced arm pain; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unknown age (Age: 72; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization. The patients medical history was not reported. Concomitant medications were not reported. It was reported that that the consumer and his wife had the first dose of the pfizer covid 19 vaccine and both experienced arm pain. Caller stated that his wife takes doxycyline daily. Stated that his wife was due to get a botox injection prior to her second dose of the pfizer covid 19 vaccine. The outcome of the events was unknown.     Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.