chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Headache, Immunisation, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Booster; Headache; Generalized aching; Diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Available). The reporter is the patient. Other Case identifier(s): 21K-163-4072856-00 (AbbVie).  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant) with onset 06Jan2022, outcome "recovering", described as "Rheumatoid arthritis flare up"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Generalized aching"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Diarrhea". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of rheumatoid arthritis flare up, headaches, body aches and diarrhea was not provided.   The reporter's assessment of the causal relationship of the event with the suspect product 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, a causal association between reported events rheumatoid arthritis, headache, pain, diarrhoea, and the suspect 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous lupus erythematosus, Fatigue, Musculoskeletal discomfort
Clinical narrative: Thinks COVID-19 Vaccine triggered her lupus; bother her shoulder, but not as bad; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 Given at afternoon (Lot number: ER8733) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Subacute Discoid Lupus" (unspecified if ongoing), notes: It is lupus of the skin, not systemic, Diagnosed at least ten years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Batch/lot number: EN6199, injected into the left arm), administration date: 11Mar2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (Dose: 1, Batch/lot number: EN6199, injected into the left arm), administration date: 11Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "nausea feeling", "The shoulder, where it was given on the left side, it swelled all the way up into her neck", "lymph nodes on that side of the body were inflamed", "It hurt form her shoulder to her elbow"; Measles vaccine (When 4-5 years old), for Measles, reaction(s): "she contracted Measles". The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant) with onset 2021, outcome "unknown", described as "Thinks COVID-19 Vaccine triggered her lupus"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "bother her shoulder, but not as bad"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tiredness". The event "thinks covid-19 vaccine triggered her lupus" was evaluated at the physician office visit.  Reporter is a social worker. She had to go to the doctor because of this specific reason and was instruction by the CDC representative to contact Pfizer for reimbursement. She went right back in and got a second dose COVID-19 Vaccine. Tiredness got her again, but not as bad. Second dose COVID-19 Vaccine did bother her shoulder, but not as bad. The nurse injected the vaccine on the same left arm as the first dose. It did flare up a little, but not nearly as bad as it was with the first dose COVID-19 Vaccine. She didn't have to go back to the doctors. The patient thinks COVID-19 Vaccine triggered her lupus.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200063461 Same patient and drug, different doses and similar events
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous lupus erythematosus, Immunisation, Nausea
Clinical narrative: Thinks COVID-19 Vaccine triggered her lupus; It is lupus of the skin, not systemic.; Had a little nausea, but not as bad.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Dec2021 (Lot number: FF2590) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Subacute Discoid Lupus", start date: 2012 (unspecified if ongoing), notes: lupus of the skin, not systemic. , Thinks the COVID-19 Vaccine triggered her lupus. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Batch/lot number: EN6199    , Dosage text: unknown dose amount; injected into the left arm; , Date of administration: 11Mar2021), administration date: 11Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Tiredness", "The shoulder, where it was given on the left side, it swelled all the way up into her neck", "All of her lymph nodes on that side of the body were inflamed", "It hurt form her shoulder to her elbow."; Bnt162b2 (Dose: 1, Batch/lot number: EN6199    , Dosage text: unknown dose amount; injected into the left arm; , Date of administration: 11Mar2021), administration date: 11Mar2021, when the patient was 57 years old, for Covid-19 immunisation, reaction(s): "nausea feeling"; Bnt162b2 (COVID-19 Vaccine: Second Dose: , Manufacturer: Pfizer, Date: 01Apr2021, NDC/EXP: Unknown, LOT: ER8733, Dose: Unknown, Route: injected to left arm, Second dose COVID-19 Vaccine did bother her shoulder, but not as bad), administration date: 01Apr2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Second dose COVID-19 Vaccine did bother her shoulder, but not as bad"; Measles vaccine (When caller was 4-5 years old, she received the Measles vaccine. After vaccination, she contracted Measles NDC/LOT/EXP unknown), reaction(s): "she contracted Measles". The following information was reported: IMMUNISATION (medically significant) with onset 03Dec2021, outcome "unknown", described as "booster"; CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Thinks COVID-19 Vaccine triggered her lupus; It is lupus of the skin, not systemic."; NAUSEA (non-serious), outcome "unknown", described as "Had a little nausea, but not as bad.". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200063460 Same patient and drug, different event separated in time;US-PFIZER INC-202200063385 Same patient and drug, different event separated in time
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Paralysis, SARS-CoV-2 antibody test
Clinical narrative: hyperventilation; half of her body was paralyzed/left side of patient body was paralyzed; This is a spontaneous report received from two contactable reporters (Consumers) from medical information team for a Pfizer sponsored program. The reporters are the patient and patient's daughter. Other Case identifier(s): US-PFIZER INC-202200065168.  A 41 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Apr2021 09:15 (Lot number: EW0171) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Family Medical History included the patient's grandfather had a reaction to a vaccine, but it was amoxicillin. But he died. There were no concomitant medications. No vaccines administered on same date of the Pfizer Suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: HYPERVENTILATION (medically significant) with onset 19Apr2021 09:20, outcome "recovered" (2021), described as "hyperventilation"; PARALYSIS (medically significant) with onset 19Apr2021 09:20, outcome "recovered" (20Apr2021), described as "half of her body was paralyzed/left side of patient body was paralyzed". The events "hyperventilation" and "half of her body was paralyzed/left side of patient body was paralyzed" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (Apr2021) less. Therapeutic measures were taken as a result of hyperventilation, paralysis. Clinical course: On 19Apr2021, the patient received the Pfizer vaccine and 5 minutes later half of her body was paralyzed. (withheld) called an ambulance and administered her Benadryl. The ambulance took the caller to the emergency room and then sent her home 2 hours later. Patient diagnosis was hyperventilation. Further details reported that 5 minutes after the vaccine the left side of patient body was paralyzed, she couldn't move it and she couldn't feel it. That lasted the whole first day and then half of the second day. It didn't go away until 20Apr2021. Patient was calling to find out if she can get another dose of the vaccine if she would have a similar result as the first dose. Also it was mentioned that the patient was participating in a study on how many antibodies were in her system. The last study showed that she had less now so she was concerned. The doctor told the patient that there was a risk and that she should not get a second dose of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had Covid; had 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 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included miscarriages on an unspecified date, noted as had two previous miscarriages and had a lot of trouble getting pregnant from an unspecified date. The patient's concomitant medications were not reported. The patient had COVID on 25Oct2021. The clinical outcome of had COVID was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Immunisation, Palpitations
Clinical narrative: dull heart ache; palpitations; Pfizer Booster Dose; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 10Jan2022, outcome "unknown", described as "Pfizer Booster Dose"; ANGINA PECTORIS (medically significant) with onset 11Jan2022, outcome "not recovered", described as "dull heart ache"; PALPITATIONS (non-serious) with onset 11Jan2022, outcome "not recovered", described as "palpitations". Clinical details: the patient had been having palpitations with a dull heart ache since 11Jan2022. These episodes came every 5-10 minutes and getting progressively worse.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Bone cancer
Clinical narrative: bone cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (BNT162B2) (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: BONE CANCER (medically significant, life threatening), outcome "unknown", described as "bone cancer". The consumer was reported for her sister. The patient just about died and now she has bone cancer after receiving her first injection. She was in remission for 9 years and she's gonna lose her sister. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots over his whole body and died; This is a spontaneous report received from a non-contactable consumer or other non hcp from medical information team.  A male 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: THROMBOSIS (death, medically significant), outcome "fatal", described as "blood clots over his whole body and died". The patient date of death was unknown. The reported cause of death was thrombosis. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: blood clots over his whole body and died
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster dose; Positive COVID test; Positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: shortly after booster dose.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Concussion, Headache, Hyperacusis, Immunisation
Clinical narrative: Fainted; Vomited; 102 degree Fever; Concussion resulting from fainting; head pounding; sensitivity to light and noise; sensitivity to light and noise; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 18:30 (Lot number: FJ1611) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfonamides" (unspecified if ongoing). Patient didn't have other medial history and didn't have covid prior vaccination. Concomitant medication(s) included: ACIDOPHILUS; MAGNESIUM GLYCINATE; MONOLAURIN [GLYCERINE MONOLAURATE]. Patient received other vaccine in four weeks. Past drug history included: Azithromycin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 2, lot number: EW0170, administration time: 03:30, location: Left arm), administration date: 24Apr2021, when the patient was 26 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, lot number: EW0150, administration time: 02:00, location: Left arm), administration date: 03Apr2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 23Dec2021 18:30, outcome "unknown", described as "Booster"; SYNCOPE (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Fainted"; VOMITING (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Vomited"; PYREXIA (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "102 degree Fever"; CONCUSSION (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Concussion resulting from fainting"; HEADACHE (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "head pounding"; PHOTOPHOBIA (hospitalization), HYPERACUSIS (hospitalization) all with onset 25Dec2021 04:00, outcome "recovering" and all described as "sensitivity to light and noise". The patient was hospitalized for immunisation, syncope, vomiting, pyrexia, concussion, headache, photophobia, hyperacusis (hospitalization duration: 1 day(s)). The events "fainted", "vomited", "102 degree fever", "concussion resulting from fainting", "head pounding", "sensitivity to light and noise" and "sensitivity to light and noise" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of syncope, vomiting, pyrexia, concussion, headache, photophobia, hyperacusis, which included Physical Therapy, Magnesium recommended (400mg). Vomiting and fever recurred one week after vaccine. The patient underwent the following laboratory tests and procedures: body temperature: (25Dec2021) 102 degree fever; sars-cov-2 test: (06Jan2022) negative, notes: Nasal Swab.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, SARS-CoV-2 test, Syncope, Vomiting
Clinical narrative: Fainted; Vomited; 102 degree Fever; Concussion resulting from fainting; head pounding; sensitivity to light and noise; sensitivity to light and noise; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 18:30 (Lot number: FJ1611) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfonamides" (unspecified if ongoing). Patient didn't have other medial history and didn't have covid prior vaccination. Concomitant medication(s) included: ACIDOPHILUS; MAGNESIUM GLYCINATE; MONOLAURIN [GLYCERINE MONOLAURATE]. Patient received other vaccine in four weeks. Past drug history included: Azithromycin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 2, lot number: EW0170, administration time: 03:30, location: Left arm), administration date: 24Apr2021, when the patient was 26 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, lot number: EW0150, administration time: 02:00, location: Left arm), administration date: 03Apr2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 23Dec2021 18:30, outcome "unknown", described as "Booster"; SYNCOPE (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Fainted"; VOMITING (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Vomited"; PYREXIA (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "102 degree Fever"; CONCUSSION (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Concussion resulting from fainting"; HEADACHE (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "head pounding"; PHOTOPHOBIA (hospitalization), HYPERACUSIS (hospitalization) all with onset 25Dec2021 04:00, outcome "recovering" and all described as "sensitivity to light and noise". The patient was hospitalized for immunisation, syncope, vomiting, pyrexia, concussion, headache, photophobia, hyperacusis (hospitalization duration: 1 day(s)). The events "fainted", "vomited", "102 degree fever", "concussion resulting from fainting", "head pounding", "sensitivity to light and noise" and "sensitivity to light and noise" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of syncope, vomiting, pyrexia, concussion, headache, photophobia, hyperacusis, which included Physical Therapy, Magnesium recommended (400mg). Vomiting and fever recurred one week after vaccine. The patient underwent the following laboratory tests and procedures: body temperature: (25Dec2021) 102 degree fever; sars-cov-2 test: (06Jan2022) negative, notes: Nasal Swab.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Hot flush
Clinical narrative: fainting; Chest pain; shortness of breath; blurred vision; dizzy; Haven't been able to work with all this; left arm pain; weakness; hot/flush; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Nov2021 11:00 (Lot number: 32030bd) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "covid " (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LEVOTHYROXINE; OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID] and anodizing. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 17:30, outcome "not recovered", described as "fainting"; CHEST PAIN (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "left arm pain"; ASTHENIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "weakness"; HOT FLUSH (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "hot/flush"; DIZZINESS (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "dizzy"; VISION BLURRED (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "blurred vision"; MYALGIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "muscle pain"; IMPAIRED WORK ABILITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Haven't been able to work with all this". The events "fainting", "chest pain", "shortness of breath", "left arm pain", "weakness", "hot/flush", "dizzy", "blurred vision", "muscle pain" and "haven't been able to work with all this" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were not taken as a result of syncope, chest pain, dyspnoea, pain in extremity, asthenia, hot flush, dizziness, vision blurred, myalgia, impaired work ability.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Myalgia, Pain in extremity, SARS-CoV-2 test, Syncope
Clinical narrative: fainting; Chest pain; shortness of breath; blurred vision; dizzy; Haven't been able to work with all this; left arm pain; weakness; hot/flush; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Nov2021 11:00 (Lot number: 32030bd) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "covid " (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LEVOTHYROXINE; OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID] and anodizing. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 17:30, outcome "not recovered", described as "fainting"; CHEST PAIN (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "left arm pain"; ASTHENIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "weakness"; HOT FLUSH (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "hot/flush"; DIZZINESS (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "dizzy"; VISION BLURRED (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "blurred vision"; MYALGIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "muscle pain"; IMPAIRED WORK ABILITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Haven't been able to work with all this". The events "fainting", "chest pain", "shortness of breath", "left arm pain", "weakness", "hot/flush", "dizzy", "blurred vision", "muscle pain" and "haven't been able to work with all this" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were not taken as a result of syncope, chest pain, dyspnoea, pain in extremity, asthenia, hot flush, dizziness, vision blurred, myalgia, impaired work ability.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: fainting; Chest pain; shortness of breath; blurred vision; dizzy; Haven't been able to work with all this; left arm pain; weakness; hot/flush; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Nov2021 11:00 (Lot number: 32030bd) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "covid " (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LEVOTHYROXINE; OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID] and anodizing. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 17:30, outcome "not recovered", described as "fainting"; CHEST PAIN (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "left arm pain"; ASTHENIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "weakness"; HOT FLUSH (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "hot/flush"; DIZZINESS (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "dizzy"; VISION BLURRED (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "blurred vision"; MYALGIA (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "muscle pain"; IMPAIRED WORK ABILITY (non-serious) with onset 18Nov2021 17:30, outcome "not recovered", described as "Haven't been able to work with all this". The events "fainting", "chest pain", "shortness of breath", "left arm pain", "weakness", "hot/flush", "dizzy", "blurred vision", "muscle pain" and "haven't been able to work with all this" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were not taken as a result of syncope, chest pain, dyspnoea, pain in extremity, asthenia, hot flush, dizziness, vision blurred, myalgia, impaired work ability.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Headache, Oropharyngeal pain
Clinical narrative: low grade fever; cough; headache; sore throat; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from a sales representative.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2, single and administration date 07Nov2021 (Batch/Lot number: unknown) 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: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "tested positive for Covid-19"; PYREXIA (medically significant), outcome "unknown", described as "low grade fever"; COUGH (medically significant), outcome "unknown", described as "cough"; HEADACHE (medically significant), outcome "unknown", described as "headache"; OROPHARYNGEAL PAIN (medically significant), outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) low grade; sars-cov-2 test: (12Jan2022) positive. Description of Event: patient was vaccinated with his first dose on 07Nov2021 and completed the series on 28Nov2021. He has tested positive for Covid-19 on 12Jan2022 His symptoms include low grade fever, cough, headache and sore throat.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: low grade fever; cough; headache; sore throat; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from a sales representative.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2, single and administration date 07Nov2021 (Batch/Lot number: unknown) 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: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "tested positive for Covid-19"; PYREXIA (medically significant), outcome "unknown", described as "low grade fever"; COUGH (medically significant), outcome "unknown", described as "cough"; HEADACHE (medically significant), outcome "unknown", described as "headache"; OROPHARYNGEAL PAIN (medically significant), outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) low grade; sars-cov-2 test: (12Jan2022) positive. Description of Event: patient was vaccinated with his first dose on 07Nov2021 and completed the series on 28Nov2021. He has tested positive for Covid-19 on 12Jan2022 His symptoms include low grade fever, cough, headache and sore throat.  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
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had COVID five different times. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "covid". The patient has had the vaccine and been hospitalized for COVID. Patient was sick again with Covid right now. Every time got a booster patient got sicker and the problems got worse and more immediate.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Multisystem inflammatory syndrome in children, Suspected COVID-19
Clinical narrative: got the Covid vaccine and then he got COVID; got the Covid vaccine and then he got COVID; multiple system inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 8 year-old male 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: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "got the Covid vaccine and then he got COVID"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown", described as "multiple system inflammation". Clinical course: While providing information for report caller stated her eight year old great grandson had to be put in withheld because he was having multiple system inflammation and all his systems were trying to shut down. Caller states her great grandson got COVID anyway and they put him at withheld. He was there for a little over a week. He was in bad shape withheld. Caller clarified that her great grandson got the Covid vaccine and then he got COVID. Several family friends have had the Covid vaccine and all have had Covid after it, not omicron or delta variant, the original.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have omicron; have omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have omicron". The patient reported that vacine omicron or pills for omicron, he/she had omicron.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: fully vaccinated and boosted 22Oct2021, all Pfizer, and just recovered from Covid (probably omicron).; fully vaccinated and boosted 22Oct2021, all Pfizer, and just recovered from Covid (probably omicron).; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (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: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "fully vaccinated and boosted 22Oct2021, all Pfizer, and just recovered from Covid (probably omicron).". It almost certainly mitigated his symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Systemic lupus erythematosus
Clinical narrative: Covid-19 Vaccine booster; Lupus; Felt incredibly sick after the booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (Covid-19 Vaccine booster) (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: Covid-19 vaccine (Dose:1,MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose:2,MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Covid-19 Vaccine booster"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus"; ILLNESS (non-serious), outcome "unknown", described as "Felt incredibly sick after the booster". Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (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: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. Clinical course: She had mild symptoms. Runny nose, congestion, headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pulmonary thrombosis, Thrombosis
Clinical narrative: booster; blood clots in her whole body; clots from her toes to her lungs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clots in her whole body"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "clots from her toes to her lungs". The events "blood clots in her whole body" and "clots from her toes to her lungs" were evaluated at the physician office visit. The clinical course was reported as follows: The caller was calling on behalf of her friend (patient) who took the first and second dose and the booster shot as well, and ended up with blood clots through her whole body. Caller said she is wondering, because it was not only her friend, she is wondering why some people get blood clots and die from getting the vaccine, she was talking about a lot of people, she looked it up. She said there is an expiration on the LOT she got this shot, and she wanted to know how is there going to be expiration on what she got. She said her friend got two shots, and then got the booster, and there are people getting blood clots that are dying or in the hospital, and she wanted to know why some who get the vaccine get blood clots and then some who get the booster have blood clots in their whole body. She said she didn't know why they are still administrating these vaccines, why people who are susceptible to getting blood clots, why should they have been getting these vaccines? She said her girl friend had clots from her toes to her lungs, and her doctor said it was from the vaccine. She said Pfizer shouldn't be allowing the vaccines to be given.   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, Colitis, Drug ineffective, Fall, Migraine
Clinical narrative: caught covid; caught covid; had a bad fall; colitio; migraines / awful migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: had not have one in twenty years. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caught covid"; FALL (medically significant), outcome "unknown", described as "had a bad fall"; COLITIS (medically significant), outcome "unknown", described as "colitio"; MIGRAINE (non-serious), outcome "unknown", described as "migraines / awful migraines". The event "colitio" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of colitis. Detail course was reported as the patient had on shot of Pfizer vaccine, did not have 2nd shot. The patient caught covid and had a bad fall and colitio, had emergency surgery. The patient had covid 3 times. The patient used to get migraines and had not have one in twenty years, after the 2nd and 3rd covid outbreak patient had awful migraines.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Throat swelled up; This is a spontaneous report received from a contactable consumer or other non hcp.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 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: PHARYNGEAL SWELLING (death), outcome "fatal", described as "Throat swelled up". Caller stated her first cousin died right after. Clarified that her cousin lived two weeks after, but they had to put her in hospice the day after she got the COVID vaccination. Her throat swelled up to the point it killed her. The patient date of death was unknown. The reported cause of death was throat swelled up. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Throat swelled up
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash, Throat irritation, Urticaria
Clinical narrative: itchy throat; tingly lips; hives; rash over entire body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2020 (Lot number: el1284) at the age of 41 years as dose 1, single for covid-19 immunisation. There was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT IRRITATION (medically significant) with onset 29Dec2020, outcome "recovered", described as "itchy throat"; PARAESTHESIA ORAL (medically significant) with onset 29Dec2020, outcome "recovered", described as "tingly lips"; URTICARIA (medically significant) with onset 29Dec2020, outcome "recovered", described as "hives"; RASH (medically significant) with onset 29Dec2020, outcome "recovered", described as "rash over entire body". Therapeutic measures were taken as a result of throat irritation, paraesthesia oral, urticaria, rash. The treatment included Benadryl.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (BNT162B2) to the events of throat irritation, paraesthesia oral, urticaria, rash 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.