chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Drug Interaction; tested positive for Covid-19/Received 1st adult Pfizer Covid-19 Vaccine on 19Nov2021 and tested positive to Covid two days later; jitters in the body/Experiencing like severe jatter in whole body; rapid heart rate/I am not cold and I have no fever, not cold with rapid heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: EW0191) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 22Nov2021, outcome "unknown", described as "tested positive for Covid-19/Received 1st adult Pfizer Covid-19 Vaccine on 19Nov2021 and tested positive to Covid two days later"; DRUG INTERACTION (non-serious), outcome "unknown", described as "Drug Interaction"; FEELING JITTERY (non-serious) with onset Nov2021, outcome "unknown", described as "jitters in the body/Experiencing like severe jatter in whole body"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "rapid heart rate/I am not cold and I have no fever, not cold with rapid heart rate". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) rapid heart rate; (Nov2021) increased; sars-cov-2 test: (22Nov2021) positive, notes: she tested positive to Covid on 22Nov2021. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient took her first dose of the Pfizer BioNTech Covid-19 vaccine and two days later patient tested positive for Covid-19. Patient states on 24Nov2021 she received an infusion of two products being bamlanivimab and etesevimab for treatment. After the infusion, patient experience severe jitters in the whole body and a rapid heart rate. Patient stated that she was not cold and she had no fever, not cold with rapid heart rate. Patient also takes cholesterol medication (atorvastatin) and D-tab blocker (lisinopril). Patient would like to know if the jitter in her body and the rapid heart rate were caused by the infusion or the Covid-19 vaccine she received and if there is any drug interaction with atorvastatin, lisinopril and the Covid-19 vaccine. She also wanted to know if there be any chance that might be causing her jatter because it seems like every time, she took that and she got jatter, or possible the Infusion as well. Patient states that due to the infusion she received on 24Nov2021, she was advised to wait 90 days to receive her second dose.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Glycosylated haemoglobin increased, Illness, Sinus disorder
Clinical narrative: sinus started acting up; elevated A1C; first 24 hours after the vaccine she was feeling sick; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Nov2021 14:00 (Lot number: FF2593) at the age of 54 years as dose 2, singe for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "obesity" (unspecified if ongoing); "prediabetic" (unspecified if ongoing), notes: her numbers were at a 6 for several years. There were no concomitant medications. Past drug history included: Benadryl. Vaccination history included: Comirnaty (first dose, Batch/lot number: FH8027), administration date: 08Nov2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "Elevated A1C", "COVID arm", "Sick for like 3 weeks", "Knot in her arm for 3 weeks", "Swelling", "Fever". The following information was reported: GLYCOSYLATED HAEMOGLOBIN INCREASED (medically significant) with onset 2021, outcome "unknown", described as "elevated A1C"; ILLNESS (medically significant) with onset 2021, outcome "recovering", described as "first 24 hours after the vaccine she was feeling sick"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus started acting up". The events "elevated a1c" and "first 24 hours after the vaccine she was feeling sick" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; glycosylated haemoglobin increased: (2021) elevated.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immunodeficiency, Injection site paraesthesia, Product use issue
Clinical narrative: history of her and her husband being slightly immunocompromised; history of her and her husband being slightly immunocompromised; felt heat at the injection site; felt mild, warm tingling sensation at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (COMIRNATY), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd Dose, Caller states that after the second dose of vaccine, she felt nausea, tiredness similar to feeling under the weather like she was catching a cold or the beginning of a flu.), for Covid-19 immunization, reaction(s): "tiredness", "cold", "Nausea"; Bnt162b2 (1st Dose, Caller states the second vaccine had stronger effects than the first one.), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "history of her and her husband being slightly immunocompromised"; FEELING HOT (non-serious), outcome "unknown", described as "felt heat at the injection site"; INJECTION SITE PARAESTHESIA (non-serious), outcome "unknown", described as "felt mild, warm tingling sensation at the injection site".  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-202101706095 same reporter/drug/AE with different patient
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered
Clinical narrative: bad mood; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4144750-00.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOOD ALTERED (medically significant) with onset 2021, outcome "unknown", described as "bad mood". The action taken for bnt162b2 was unknown; for adalimumab was dosage not changed.   Additional information:PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 2021, patient was in bad mood after Pfizer COVID vaccine injections. It was unknown if she was enrolled in a COVID 19 Vaccine Trial.   Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of LEFT KNEE REPLACEMENT SURGERY and BAD MOOD with HUMIRA(ADALIMUMAB) was no reasonable possibility.   Product-Reaction level Seq.No. : 1 Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB), UNKNOWN  Causality  Bad mood (Mood altered) Action(s) taken with drug : Dose Not Changed Causality as per reporter (Drug/Vaccine) : No reasonable possibility Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility Dechallenge : N/A  Product-Reaction level Seq.No. : 2 PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN)  Causality  Bad mood (Mood altered) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Not Related Dechallenge : N/A  Did event abate after stopping drug? NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Limited information precludes a comprehensive causality assessment of event ,however due to possible temporal association the causal role of BNT162B2 Vaccine is assessed as related.Case will be reviewed further on receipt of FU information  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: Atrial fibrillation
Clinical narrative: A-fib; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A-fib". Additional Information: Caller (Doctor) stated she is calling for her neighbor (female, unknow age) who received the Pfizer covid vaccine and in September she experienced A-fib. Her doctor told her that this could be related to Pfizer covid vaccine she received. Caller wanted to know about any reports of A-Fib with the vaccine. She stated she told the patient that her doctor needs to "work up" the patient to find out potential causes of the A-fib.   The lot number for bnt162b2 was not provided and will be requested during follow up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation with the suspect drug Comirnaty cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Joint swelling, Pain, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4120129-00 (AbbVie). A 57-year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Route: Intramuscular), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "recovered" (2021), described as "Rheumatoid arthritis flare up"; ILLNESS (non-serious), outcome "recovered", described as "Sickness"; PAIN (non-serious), outcome "unknown", described as "Pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Hand swelling"; JOINT SWELLING (non-serious), outcome "unknown", described as "Joint swelling". The action taken for adalimumab was unknown. Causality: Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) Causality as per reporter for the event's rheumatoid arthritis flare up, Sickness, pain, hand swelling, and joint swelling were Reasonable possibility. Causality for suspect: Pfizer BioNTech covid-19 vaccine (tozinameran) Causality as per reporter for the event's rheumatoid arthritis flare up, Sickness, pain, hand swelling, and joint swelling were possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2 cannot be ruled out. 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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: Was unknowingly asymptomatic COVID positive at time of Pfizer booster. / COVID symptoms became moderate severe; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; booster injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: 2122FJ1611) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 039A21A), for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 048A21A), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 22Nov2021, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna"; IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "booster injection"; COVID-19 (non-serious) with onset 24Nov2021, outcome "recovering", described as "Was unknowingly asymptomatic COVID positive at time of Pfizer booster. / COVID symptoms became moderate severe". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive. Therapeutic measures were not taken as a result of covid-19.  Additional information :No other vaccine in four weeks. Patient was unknowingly asymptomatic COVID positive at time of Pfizer booster. After booster injection,COVID symptoms became moderate -severe and have lasted 7+ days. No covid prior vaccination. Patient was covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: 38 year old female received the Pfizer-BioNTech Covid-19 Vaccine and subsequently developed DVT.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 38-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome recovered (2021), described as 38-year-old female received the Pfizer-BioNTech Covid-19 Vaccine and subsequently developed DVT.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Deep vein thrombosis cannot be established. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: had all 3 doses he was 95 years old and died of covid; had all 3 doses he was 95 years old and died of covid; had all 3 doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95 year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "had all 3 doses he was 95 years old and died of covid"; IMMUNISATION (death, medically significant), outcome "fatal", described as "had all 3 doses". The patient date of death was unknown. The reported cause of death was drug ineffective, covid-19. The reporters best friend he was vaccinated with the covid vaccine, The reporter was unsure who made the patient's covid vaccine.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Reported Cause(s) of Death: had all 3 doses he was 95 years old and died of covid; had all 3 doses he was 95 years old and died of covid
Sex: M
Vaccine: COVID19
Symptoms: Appetite disorder, Arthralgia, Bedridden, Depressed mood, Gastric disorder
Clinical narrative: stomach problems; couldn't eat; It's hard to open up, and then it hurts; It's hard to open up, and then it hurts; feels "grabbing in my right side, the cancer is getting bigger"; "my mind is going on me",; has trouble remembering things; joint pain comes and goes; unable to get out of bed for 2 or 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2021-098111 (RA).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral, administration date 31Jul2021 (Lot number: 1391898) as 8 mg, daily for hepatic cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach problems"; APPETITE DISORDER (non-serious), outcome "unknown", described as "couldn't eat"; DEPRESSED MOOD (non-serious), PAIN (non-serious), outcome "unknown" and all described as "It's hard to open up, and then it hurts"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "feels "grabbing in my right side, the cancer is getting bigger"; "my mind is going on me","; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "has trouble remembering things"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain comes and goes"; BEDRIDDEN (non-serious), outcome "unknown", described as "unable to get out of bed for 2 or 3 days". The action taken for lenvatinib mesilate was unknown.  Additional information: Was the event considered a drug interaction: No, Was dose of the product reduced due to event: No, Was the product discontinued due to event: No. Clinical Course: Patient reported "joint pain comes and goes, I'm fine right now. Sometimes I can't even roll out of bed"; missed appointments due to being "unable to get out of bed for 2 or 3 days"; unable to bend left pointer finger. "It's hard to open up, and then it hurts"; "stomach problems after getting the COVID shot, couldn't eat, would throw it back up, better now"; feels "grabbing in my right side, the cancer is getting bigger"; "my mind is going on me", has trouble remembering things.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Pain, Thinking abnormal
Clinical narrative: stomach problems; couldn't eat; It's hard to open up, and then it hurts; It's hard to open up, and then it hurts; feels "grabbing in my right side, the cancer is getting bigger"; "my mind is going on me",; has trouble remembering things; joint pain comes and goes; unable to get out of bed for 2 or 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2021-098111 (RA).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral, administration date 31Jul2021 (Lot number: 1391898) as 8 mg, daily for hepatic cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach problems"; APPETITE DISORDER (non-serious), outcome "unknown", described as "couldn't eat"; DEPRESSED MOOD (non-serious), PAIN (non-serious), outcome "unknown" and all described as "It's hard to open up, and then it hurts"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "feels "grabbing in my right side, the cancer is getting bigger"; "my mind is going on me","; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "has trouble remembering things"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain comes and goes"; BEDRIDDEN (non-serious), outcome "unknown", described as "unable to get out of bed for 2 or 3 days". The action taken for lenvatinib mesilate was unknown.  Additional information: Was the event considered a drug interaction: No, Was dose of the product reduced due to event: No, Was the product discontinued due to event: No. Clinical Course: Patient reported "joint pain comes and goes, I'm fine right now. Sometimes I can't even roll out of bed"; missed appointments due to being "unable to get out of bed for 2 or 3 days"; unable to bend left pointer finger. "It's hard to open up, and then it hurts"; "stomach problems after getting the COVID shot, couldn't eat, would throw it back up, better now"; feels "grabbing in my right side, the cancer is getting bigger"; "my mind is going on me", has trouble remembering things.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". Reporter had a query as they already had the first 2 doses and his wife had cancer and 2 operations, they both would like to get the 3rd dose specifically the Comirnaty vaccine, the fully approved one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis B
Clinical narrative: Hepatitis B; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEPATITIS B (medically significant), outcome "unknown", described as "Hepatitis B". Caller wants to have information about the Paxlovid. He mentioned that he had Hepatitis B. Paxlovid is not an active product. He is inquiring for Paxlovid indication of use for those people who had a history of Hepatitis B. He added that he already got the Covid-19 vaccine but he did not mention the brand of the vaccine. He also requested to be anonymous. No information gathered. Provided PMI contact number and hours of operation. Call got disconnected while connecting the call to PMI. Unable to gather the first and second dose date. No transfer was made. Submitted Manual AE form since the caller mentioned that he had Hepatitis B but it was not mentioned if this happened before or after receiving the Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pericarditis
Clinical narrative: pericarditis; A fibrillation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2016-020714 (RA).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA) (Batch/Lot number: unknown) at 20 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for covid-19 immunisation. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A fibrillation". The action taken for lenvatinib mesilate was unknown.  Clinical course: Patient mentioned that his thyroglobulin increased after missing 2 doses of Lenvima. He also said that in 2018 he was on Lenvima and had to decrease the dose due to bad side effects.  Pfizer is a marketing authorization holder of bnt162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of bnt162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was positive for covid/vaccinated 100%; was positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "was positive for covid/vaccinated 100%"; COVID-19 (medically significant), outcome "unknown", described as "was positive for covid". It was further reported that the person the caller was working with. The patient had the Pfizer covid vaccine. The patient had the same symptoms the caller had. The patient does not have any medicine that she was taking and the caller told her she needs to be seen by a doctor. The patient is vaccinated 100% because they had to get vaccinated for work. The patient was positive at work. They have 10 flight attendants and only 2 got positive. The patient was working with the caller and the customers did not have their masks on someone was sick on that plane. The patient was positive for covid too. The patient had the Pfizer covid vaccine. The patient is vaccinated 100% because they had to get vaccinated for work. The patient was positive at work. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: she was positive for covid. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Antinuclear antibody, Antinuclear antibody increased
Clinical narrative: Severe Alopecia requiring steroid injection; Elevated ANA; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Dec2020 (Lot number: EH9899) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: ALOPECIA (medically significant) with onset 31Dec2020, outcome "recovering", described as "Severe Alopecia requiring steroid injection"; ANTINUCLEAR ANTIBODY INCREASED (non-serious) with onset 31Dec2020, outcome "recovering", described as "Elevated ANA". The events "severe alopecia requiring steroid injection" and "elevated ana" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antinuclear antibody: (31Dec2020) elevated. Therapeutic measures were taken as a result of alopecia, antinuclear antibody increased. It was reported that patient received treatment with Steroid injection every 4 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received other medications within 2 weeks of vaccination. The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event Alopecia and the 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.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Myocarditis, SARS-CoV-2 test
Clinical narrative: Chest pains that led to a Minor heart attack; Chest pains that led to a Minor heart attack; shortness of breaths; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 12:00 (Lot number: FC3180) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination, no known allergies.  Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA6780, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 21Jul2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (hospitalization, life threatening), MYOCARDIAL INFARCTION (hospitalization, life threatening) all with onset 24Oct2021 03:00, outcome "recovered with sequelae" and all described as "Chest pains that led to a Minor heart attack"; DYSPNOEA (hospitalization, life threatening) with onset 24Oct2021 03:00, outcome "recovered with sequelae", described as "shortness of breaths"; MYOCARDITIS (hospitalization, life threatening) with onset 24Oct2021 03:00, outcome "recovered with sequelae", described as "myocarditis". The patient was hospitalized for chest pain, myocardial infarction, dyspnoea, myocarditis (hospitalization duration: 3 day(s)). The events "chest pains that led to a minor heart attack", "chest pains that led to a minor heart attack", "shortness of breaths" and "myocarditis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Oct2021) negative. Therapeutic measures were taken as a result of chest pain, myocardial infarction, dyspnoea, myocarditis included Heparin drip, blood pressure medication, aspirin.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Haemorrhage, Rash pruritic
Clinical narrative: antibody thing are low; developed a itchy rash from her neck down to her calves; bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 (Lot number: EW0198, Expiration Date: Sep2021) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The patient has been on unspecified medicines for a long time. Vaccination history included: Bnt162b2 (1st dose; Lot number: EW0181, Expiration date: Aug2021), administration date: 21Jun2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "bleeding"; RASH PRURITIC (non-serious) with onset 15Jul2021, outcome "not recovered", described as "developed a itchy rash from her neck down to her calves"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "antibody thing are low". . The patient broke out all over and has had the rash almost five months. The event "developed a itchy rash from her neck down to her calves" was evaluated at the physician office visit. Her doctor, dermatologist and allergist tried to treat it and it doesn't go away. The patient underwent the following laboratory tests and procedures: antibody test: (2021) low. Therapeutic measures were taken as a result of rash pruritic.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Headache
Clinical narrative: infected with Covid after receiving her two dose series Of Pfizer bioNTech COVID-19 vaccine; infected with Covid after receiving her two dose series Of Pfizer bioNTech COVID-19 vaccine; Fatigue; Cough; Stuffy nose; Headache; This is a spontaneous report received from non-contactable reporter (nurse) from a sales representative. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant), outcome "unknown" and all described as "infected with Covid after receiving her two dose series Of Pfizer bioNTech COVID-19 vaccine"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; COUGH (non-serious), outcome "unknown", described as "Cough"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Stuffy nose"; and HEADACHE (non-serious), outcome "unknown", described as "Headache". Clinical course: The time from last dose was unknown. She was not able to get her booster prior to the infection  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events Drug ineffective, Covid-19  and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: infected with Covid after receiving her two dose series Of Pfizer bioNTech COVID-19 vaccine; infected with Covid after receiving her two dose series Of Pfizer bioNTech COVID-19 vaccine; Fatigue; Cough; Stuffy nose; Headache; This is a spontaneous report received from non-contactable reporter (nurse) from a sales representative. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant), outcome "unknown" and all described as "infected with Covid after receiving her two dose series Of Pfizer bioNTech COVID-19 vaccine"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; COUGH (non-serious), outcome "unknown", described as "Cough"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Stuffy nose"; and HEADACHE (non-serious), outcome "unknown", described as "Headache". Clinical course: The time from last dose was unknown. She was not able to get her booster prior to the infection  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events Drug ineffective, Covid-19  and the suspect drug BNT162B2 cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Arthritis flare up; Dose 1: Moderna, Dose 2: Moderna, Dose: 3: Pfizer; Dose 1: Moderna, Dose 2: Moderna, Dose: 3: Pfizer; Dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 15:00 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: ARTHRITIS (disability) with onset 30Nov2021 15:00, outcome "not recovered", described as "Arthritis flare up"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 30Nov2021 15:00, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna, Dose: 3: Pfizer"; IMMUNISATION (non-serious) with onset 30Nov2021 15:00, outcome "unknown", described as "Dose received 3". Therapeutic measures were not taken as a result of arthritis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Ageusia, Antibody test, Blood test, Depression
Clinical narrative: Loss of taste; depression from the miscarriage; I had a miscarriage of 6 weeks old; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 6 weeks pregnant at the event onset. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (Pfizer COVID Vaccine with my daughter's dad, we got the number 2 series), for Covid-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 17Jul2021, outcome "unknown", described as "I had a miscarriage of 6 weeks old"; AGEUSIA (non-serious), outcome "unknown", described as "Loss of taste"; DEPRESSION (non-serious), outcome "unknown", described as "depression from the miscarriage". The pregnancy resulted in spontaneous abortion (17Jul2021). The patient underwent the following laboratory tests and procedures: antibody test: (13Nov2021) unknown result; blood test: (13Nov2021) unknown result.  Additional information: Consumer stated, she doesn't had a lot number. She got 2 vaccinations from (Name). That was in a 2 series, she threw away that card, they have it on (Name) on computer. Reason for no lot number was unspecified for Flu Vaccine, Consumer stated, "No, it was just the pharmacy." Additional Context: This was the first case out of the 2 cases. When confirmed the name of the vaccine as Pfizer COVID-19 vaccine, consumer stated, "Yeah, she got the vaccination, Pfizer COVID Vaccine with my daughter's dad, we got the number 2 series and then she had a miscarriage of 6 weeks old on 17Jul2021 and then she and her daughter's dad had been losing out taste. Question asked if they are going to get that back. She had all paperwork and stuff. They are off eventually the vaccination so we can taste again. They are losing our taste from the Pfizer vaccination. Question asked when will the taste come back to our mouth, she and her daughter's dad. In response to further probing, consumer stated, "if you going to send me a package on the mail. So, consumer can send the information on the miscarriage that we I had from it" Other medical conditions: Consumer stated, "No, just a loss of taste. I just want to get it back, loss of taste and the depression from the miscarriage." Prior vaccination (4 Weeks): Consumer stated, "Flu vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Immunisation
Clinical narrative: Heart pain for long time; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old male patient received BNT162B2, administered in arm left, administration date 30Nov2021 20:00 (Lot number: FJ8757) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. No known allergies and other medical history. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other medications the patient received within 2 weeks of vaccination. The patient previously received BNT162B2 (Batch/Lot No: EL3248) administered in arm left on 07Jan2021 at 04:00 PM, as dose 1; and BNT162B2 (Batch/Lot No: EL9265) administered in arm right on 28Jan2021 at 06:00 PM as dose 2; both at 29 years old for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 02Dec2021 12:00, outcome "not recovered", described as "Heart pain for long time". Therapeutic measures were not taken as a result of angina pectoris. Since the vaccination, it's unknown if the patient has been tested for COVID-19.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Sinus disorder
Clinical narrative: when she took the 1st dose of the vaccine she lost hearing in her left ear for three days and felt stopped up; she had sinus problems and everything; This is a spontaneous report received from contactable nurse. The reporter is the patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 10Nov2021 14:00 (Lot number: FF2593, Expiration Date: 30Mar2022) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 2021, outcome "recovered" (2021), described as "when she took the 1st dose of the vaccine she lost hearing in her left ear for three days and felt stopped up", she did not know when the hearing loss began and felt like her ear was stopped up like a cotton ball was there but she did not loose hearing and was not able to being able to hear like if you are flying on a plane the pressure changes and it felt like that; she did not know when the hearing issue began but it was just a few days after the 1st dose of the vaccine and was not ongoing but lasted like 3 days. She took a nasal congestion tablet and Flonase and with blowing her nose those products did not work and she could not hear from her left ear and it was stopped up; she had never woken up not able to hear out of one ear and, SINUS DISORDER (non-serious) with onset 2021, outcome "unknown", described as "she had sinus problems and everything". Therapeutic measures were taken as a result of deafness unilateral, sinus disorder. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event deafness unilateral and BNT162B2.  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.