chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Atrial fibrillation, Body temperature increased, Chills, Dyskinesia
Clinical narrative: At about 9:00 PM, six hours after receiving the vaccine, my sense of well-being shifted dramatically, and I immediately went to bed. For the next three hours, my entire body constantly shook, with every muscle in my torso shaking explosively. For much of the time, AFIB was experienced and didn't end until about noon today. I did not have tachycardia.   If the phenomenon can be called chills, it is the worse occurrence I've ever experienced. I became weak and, several times, couldn't muster the strength to get out of bed, and when I did had trouble standing. Headache accompanied the experience. The picture in my mind was of being rolled about ferociously in a large metal drum. Surprisingly, the seemingly non-stop muscle convulsing did not precipitate a cold sweat. My skin was hot but seemed relatively dry.   My temperature rose four degrees from the 97.9 recorded before our medical visit and still has not settled to my average level. In addition, I drank 36 ounces of water over 8 hours and voided less than eight during that time. Testing for COVID this morning returned a negative result.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Dysstasia, Headache, Mobility decreased, Parosmia, SARS-CoV-2 test negative
Clinical narrative: At about 9:00 PM, six hours after receiving the vaccine, my sense of well-being shifted dramatically, and I immediately went to bed. For the next three hours, my entire body constantly shook, with every muscle in my torso shaking explosively. For much of the time, AFIB was experienced and didn't end until about noon today. I did not have tachycardia.   If the phenomenon can be called chills, it is the worse occurrence I've ever experienced. I became weak and, several times, couldn't muster the strength to get out of bed, and when I did had trouble standing. Headache accompanied the experience. The picture in my mind was of being rolled about ferociously in a large metal drum. Surprisingly, the seemingly non-stop muscle convulsing did not precipitate a cold sweat. My skin was hot but seemed relatively dry.   My temperature rose four degrees from the 97.9 recorded before our medical visit and still has not settled to my average level. In addition, I drank 36 ounces of water over 8 hours and voided less than eight during that time. Testing for COVID this morning returned a negative result.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Tachycardia, Tremor
Clinical narrative: At about 9:00 PM, six hours after receiving the vaccine, my sense of well-being shifted dramatically, and I immediately went to bed. For the next three hours, my entire body constantly shook, with every muscle in my torso shaking explosively. For much of the time, AFIB was experienced and didn't end until about noon today. I did not have tachycardia.   If the phenomenon can be called chills, it is the worse occurrence I've ever experienced. I became weak and, several times, couldn't muster the strength to get out of bed, and when I did had trouble standing. Headache accompanied the experience. The picture in my mind was of being rolled about ferociously in a large metal drum. Surprisingly, the seemingly non-stop muscle convulsing did not precipitate a cold sweat. My skin was hot but seemed relatively dry.   My temperature rose four degrees from the 97.9 recorded before our medical visit and still has not settled to my average level. In addition, I drank 36 ounces of water over 8 hours and voided less than eight during that time. Testing for COVID this morning returned a negative result.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received moderna booster after the cdc changed guidelines to new  moderna bivalent booster
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast feeding, Confusional state, Dizziness, Feeling cold, Headache
Clinical narrative: I woke up at 4 am to pump breastmilk. I experienced chills, achy muscles and night sweats up to that point. After pumping, I became extremely light headed with muffled hearing, black vision spots, and proceeded to collapse.  I was momentarily confused. I lied down in bed with my feet elevated and experienced ringing in the ears and headache. After 10 minutes, my symptoms had improved, with chills and sweating remaining. By morning, all symptoms had resolved.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoacusis, Myalgia, Night sweats, Syncope, Tinnitus
Clinical narrative: I woke up at 4 am to pump breastmilk. I experienced chills, achy muscles and night sweats up to that point. After pumping, I became extremely light headed with muffled hearing, black vision spots, and proceeded to collapse.  I was momentarily confused. I lied down in bed with my feet elevated and experienced ringing in the ears and headache. After 10 minutes, my symptoms had improved, with chills and sweating remaining. By morning, all symptoms had resolved.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Visual impairment
Clinical narrative: I woke up at 4 am to pump breastmilk. I experienced chills, achy muscles and night sweats up to that point. After pumping, I became extremely light headed with muffled hearing, black vision spots, and proceeded to collapse.  I was momentarily confused. I lied down in bed with my feet elevated and experienced ringing in the ears and headache. After 10 minutes, my symptoms had improved, with chills and sweating remaining. By morning, all symptoms had resolved.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: body aches, chills, nausea, stomach ache , headache
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea
Clinical narrative: Muscle aches all over. Slight nausea.  Extremely sore at injection site.
Sex: U
Vaccine: COVID19
Symptoms: Imaging procedure, Magnetic resonance imaging, Myopericarditis, Ultrasound scan
Clinical narrative: Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Imaging procedure: Unknown Results; Magnetic resonance imaging: Unknown Results; Ultrasound scan: Normal in reported cases.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202201126704 Same article/ drug/event and different patient.;US-PFIZER INC-202201126706 Same article/ drug/event and different patient;US-PFIZER INC-202201126705 Same article/ drug/event and different patient;US-PFIZER INC-202201126707 Same article/ drug/event and different patient;US-PFIZER INC-202201126708 Same article/ drug/event and different patient;US-PFIZER INC-202201126709 Same article/ drug/event and different patient;US-PFIZER INC-202201126710 Same article/ drug/event and different patient;US-PFIZER INC-202201126711 Same article/ drug/event and different patient;US-PFIZER INC-202201126706 Same article/ drug/event and different patient.;US-PFIZER INC-202201126704 Same article/ drug/event and different patient.;US-PFIZER INC-202201126710 Same article/ drug/event and different patient;US-PFIZER INC-202201126711 Same article/ drug/event and different patient;US-PFIZER INC-202201126705 Same article/ drug/event and different patient.;
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash
Clinical narrative: a rash around the vaccine injection site; body fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4711618.  A 37-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years for COVID-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing); "Pain usually in lower half of body" (ongoing); "Muscle spasms" (ongoing); "Difficulty walking" (ongoing); "Balance Issues" (ongoing); "Allergy to sulfa based drugs" (ongoing); "Use of a cane" (ongoing); "Use of a walker" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "a rash around the vaccine injection site"; FATIGUE (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "body fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocarditis; This is a literature report.  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. 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: MYOCARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: Enhancement, notes: Enhancement (subepicardial; basal inferolateral and inferior walls, mid-ventricular, antro/inferolateral, and apical lateral wall); Echocardiogram: NR.; Sender's Comments: Based on available information, and plausible temporal association, the causal association between the event myocarditis and the suspect drug bnt162b2 cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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: Chest X-ray, Computerised tomogram thorax, Echocardiogram, Ejection fraction, Electrocardiogram
Clinical narrative: Covid-19 Vaccine-Associated Pericarditis; This is a literature report.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Chronic kidney disease" (ongoing); "Hyperlipidemia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Covid-19 Vaccine-Associated Pericarditis". The patient underwent the following laboratory tests and procedures: Chest X-ray: Bilateral pleural effusion and atelectasis; Computerised tomogram thorax: Cardiomegaly with bilateral pericardial effusion, notes: and pleural effusion; Echocardiogram: tricuspid regurgitation (mild to moderate), notes: LVEF: 55-60%,; Ejection fraction: 55-60 %; Electrocardiogram: Ectopic atrial rhythm, Lt. ventricular, notes: hypertension, prolonged QTc; Electrocardiogram QT interval: prolonged.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram QT interval, Pericarditis
Clinical narrative: Covid-19 Vaccine-Associated Pericarditis; This is a literature report.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Chronic kidney disease" (ongoing); "Hyperlipidemia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Covid-19 Vaccine-Associated Pericarditis". The patient underwent the following laboratory tests and procedures: Chest X-ray: Bilateral pleural effusion and atelectasis; Computerised tomogram thorax: Cardiomegaly with bilateral pericardial effusion, notes: and pleural effusion; Echocardiogram: tricuspid regurgitation (mild to moderate), notes: LVEF: 55-60%,; Ejection fraction: 55-60 %; Electrocardiogram: Ectopic atrial rhythm, Lt. ventricular, notes: hypertension, prolonged QTc; Electrocardiogram QT interval: prolonged.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Angiogram, Chest X-ray, Echocardiogram, Ejection fraction
Clinical narrative: COVID-19 mRNA Vaccine-Associated Myocarditis; This is a literature report.  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccination (Dose 1, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "COVID-19 mRNA Vaccine-Associated Myocarditis". The patient underwent the following laboratory tests and procedures: Angiocardiogram: normal; Angiogram: normal; Chest X-ray: normal; Echocardiogram: Normal; Ejection fraction: 55 %.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: COVID-19 mRNA Vaccine-Associated Myocarditis; This is a literature report.  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccination (Dose 1, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "COVID-19 mRNA Vaccine-Associated Myocarditis". The patient underwent the following laboratory tests and procedures: Angiocardiogram: normal; Angiogram: normal; Chest X-ray: normal; Echocardiogram: Normal; Ejection fraction: 55 %.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram
Clinical narrative: lymphodenopathy under my right arm / right axillary lymph node is still enlarge; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), administration date: Mar2021, for COVID-19 Immunization; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "lymphodenopathy under my right arm / right axillary lymph node is still enlarge". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had both COVID-19 vaccine in Mar/Apr2021 in addition to the booster in late Dec2021 and since then, patient had been struggling with lymphadenopathy under the right arm, same arm patient received the vaccine. Patient did a memogram in Jun2022, it was okay. It had been 8 months since the booster and the right axillary lymph node was still enlarged. Patient did some research but not much studies or reports had been covered except there were some reports from Japan with similar symptoms and condition.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This week I got COVID; This week I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" and all described as "This week I got COVID". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional Information: Patient took 2 Pfizer COVID vaccine shots in Feb2021 then 2 boosters later. Patient was taking Paxlovid and doing better.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Clinical information: The reporter (patient) stated, I had a heart attack about two weeks after my first shot. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US189517_OS (Novartis). A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Loss of control of legs
Clinical narrative: when I got the second vaccine I lost the use of my legs for 20 minutes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: LOSS OF CONTROL OF LEGS (medically significant), outcome "unknown", described as "when I got the second vaccine I lost the use of my legs for 20 minutes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted Covid-19; Contracted Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient had 2 primary doses of Pfizer BioNTech vaccines and 1 booster dose. Contracted COVID-19 and took Paxlovid then experienced viral rebound after Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201135572 same drug/ event, different patient;
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease
Clinical narrative: Crohn's disease flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4309603-00.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Daily dose: 1) First Dose (1 in 1 Once), Route of administration : Intramuscular), administration date: 02Nov2020, when the patient was 30-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 2, SINGLE, Daily dose: 2)Second Dose (1 in 1 Once), Route of administration : Intramuscular), administration date: 20Dec2020, when the patient was 30-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease flare up". The action taken for adalimumab was unknown.  Clinical Information: In 2021, the patient experienced COVID. Causality as per reporter (Humira): The reporter's causality for the event Crohn's Disease Flare up was not provided. Causality as per reporter (BNT162B2): The reporter's causality for the event Crohn's Disease Flare up was Not Reported.  The reporter's assessment of the causal relationship of "Crohn's disease flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 information provided and plausible temporal association, the causality between BNT162B2 and the event crohn's disease cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4526974-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown), on 16Aug2021 as dose 2, single (Batch/Lot number: unknown) and on 12Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1160031), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for upadacitinib was unknown.  Clinical course: The reporter considered "rheumatoid arthritis flare up" not related to BNT162b2. Rheumatoid arthritis flare up, out come not recovered/not resolved. Solicited report from the USA by a consumer of an adult female with an event of  non-serious rheumatoid arthritis flare ups periodically/got flare ups when took  covid booster shot with Rinvoq (Upadacitinib). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flare ups periodically/got flare ups when took covid booster shot. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of Rheumatoid arthritis flare ups periodically/got flare ups when took covid booster shot was not provided. The reporter's causality with event and Rinvoq (Upadacitinib) was not reported.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4528096-00 (Agency).  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (cf), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 14Aug2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to BNT162b2.  Clinical course: On 14Aug2022, the patient experienced COVID-19. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Primary reporter contact for lot number information was not available. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of COVID-19 was not provided. Causality as per reporter (Drug/Vaccine) was not reported. Causality as per reporter (Drug/Vaccine) was possible. Did reaction abate after stopping drug was N/A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events  Drug ineffective and suspected Covid 19 cannot be completely excluded.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19/ Fatigue and sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4210732-00 (Agency).  A 57-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), since 01May2021 (ongoing) (Lot number: 1163675), subcutaneous for psoriasis. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "recovered", described as "Covid-19"; SUSPECTED COVID-19 (medically significant) with onset Jun2022, outcome "recovered", described as "Covid-19/ Fatigue and sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. The action taken for risankizumab was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug level, Drug level decreased, Haematochezia, Pyrexia
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4526929-00. A 12-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 1, single (Batch/Lot number: unknown), in Nov2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "Bloody stool"; DRUG LEVEL DECREASED (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever". The patient underwent the following laboratory tests and procedures: Drug level: Humira levels were on the low end of normal, notes: Humira levels were on the low end of normal. The action taken for adalimumab was unknown and BNT162b2 was not applicable. The reporter's assessment of the causal relationship of "bloody stool" and "drug level decreased" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "fever" related to BNT162b2. Clinical course: Solicited report by a consumer of an adolescent male with events of non-serious Humira levels were on the low end of normal, Bloody Stools and Fever with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Humira levels were on the low end of normal, Bloody Stools and Fever. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if she was enrolled in a Covid 19 vaccine trial. Primary reporters contact for lot number information was unsuccessful. Follow-up attempts are completed. No further information is expected. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events bloody stool, drug level decreased and fever Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: taken the shots and they got my arm in pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "taken the shots and they got my arm in pain".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Dyspnoea
Clinical narrative: difficulty breathing; skin allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003102 (Novavax).  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "recovered", described as "difficulty breathing"; DERMATITIS ALLERGIC (non-serious), outcome "recovered", described as "skin allergies".  Additional information: It was reported that the symptoms lasted for a week.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abortion spontaneous, Malignant melanoma
Clinical narrative: Miscarriage; melanoma; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4527037-00.  A 51-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Pregnant" (unspecified if ongoing); "Melanoma" (unspecified if ongoing), notes: She had Melanoma; "miscarriages" (unspecified if ongoing), notes: In past she had miscarriages. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: Unknown, Route of administration: Intra-muscular), administration date: 03Feb2021, when the patient was 51-year-old, for COVID-19 vaccination, reaction(s): "Panic attacks". The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "Miscarriage"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "melanoma". The pregnancy resulted in spontaneous abortion. The action taken for adalimumab was unknown. The fetus was exposed to maternal use of Humira in utero. The mother experienced melanoma and miscarriages.It was unknown if she was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful. Causality for Humira (Adalimumab), for the event Miscarriage Causality as per reporter was Not Reported and Causality as per manufacturer was No reasonable possibility and for the event Melanoma Causality as per reporter was Probable, reasonable possibility and Causality as per manufacturer was Not assessable.   The reporter's assessment of the causal relationship of "miscarriage" and "melanoma" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events  miscarriage", "melanoma"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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 83-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 82 years, in arm, via needle route (as reported), for covid-19 immunisation. The patient's relevant medical history included: "Former smoker : No" (unspecified if ongoing), notes: Is the Patient a smoker/Former smoker : No. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Site of injection: Arm, Route: Needle (as reported), Batch/ Lot number: K63249), administration date: 21Jan2021, when the patient was 81-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Site of injection: Arm, Route: Needle (as reported), Batch/ Lot number: EL9262), administration date: 11Feb2021, when the patient was 81-year-old, for Covid-19 immunization. The following information was reported: BREAST CANCER (medically significant) with onset 05Jan2022, outcome "unknown", described as "Breast Cancer -History of after 3rd Pfizer-BioNTech Covid 19 Shot". Clinical information: The patient received dose 4 of BNT162b2 on 12Apr2022 and experienced COVID-19 on 02Aug2022. During follow-up, the reporter answered following questions: Does the patient have a positive test for SARS-CoV2 reported as No. Dose the patient has SARS-CoV2 antibodies at diagnosis reported as No. Was/ Is the patient hospitalized reported as No. Was/ Is the patient admitted to an Intensive Care Unit reported as No. Is the patient still hospitalized reported as No. If discharged, did the patient have SARS-CoV2 antibodies at hospital discharge reported as No. Did the patient display signs at rest indicative of severe systemic illness reported as No. Did the patient require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation reported as No. Please provide information on any new or worsened symptoms/ signs during the Covid-19 illness experienced (including date of onset/ worsening): Multiorgan failure reported as No. Tachypnea: No. Hypoxemia: No. Covid-pneumonia: No. Respiratory failure: No. Other: Yes, Details: the patient stated, I did not have Covid. Cardiovascular: No. Heart failure: No. Cardiogenic shock: No. Acute myocardial infarction: No. Arrhythmia: No. Myocarditis: No. Other: No. Gastrointestinal/ Hepatic: No. Does the patient have a history of any of the following reported as Cancer (Breast (05Jan2022)). Did the patient provide information to you regarding the reported adverse event(s) with the use of the product reported as Yes. If yes above, do you considered the Pfizer product had a causal effect to the adverse event reported as Yes.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown).; reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown).; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "recovering" and all described as "reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he tested positive for covid/coronavirus (date unknown). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: patient reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown). off xeljanz xr for month of Jul. unable to determine change in arthritis symptoms due to being sick with covid/coronavirus. date unknown as to when patient resumed xeljanz xr and/or if change in symptoms after resuming. reports feeling better. still has lingering productive cough. no additional information/details or dates were provided by the patient.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy thyroid gland, Constipation, Muscle spasms
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 01Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ectopic pregnancy", start date: 1974 (unspecified if ongoing); "Fibroid removal", start date: 1980 (unspecified if ongoing), notes: Fibroid removal; "Fibroid removal", start date: 1984 (unspecified if ongoing), notes: Fibroid removal. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Time: 02:00 PM, Anatomical site of injection: Left arm, Route of injection: Intramuscular), administration date: 17Feb2021, for COVID-19 Immunization; BNT162b2 (Dose: 02, Time: 02:30 PM, Anatomical site of injection: Left arm, Route of injection: Intramuscular), administration date: 10Mar2021, for COVID-19 Immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 2022, outcome "recovering", described as "Lower back spasm"; CONSTIPATION (non-serious), outcome "unknown". The event "lower back spasm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.