chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Syncope, Vaccination failure
Clinical narrative: Covid test result=Positive; Covid test result=Positive; syncopal episodes; Heart rate began dropping into the 40-50s range; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0169) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Shellfish" (unspecified if ongoing), Known allergies: Sulfa Notes,: sulfa Codiene Percocet Compazine Reglan Shellfish. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPAMAX; LEXAPRO; ROPINIROLE; BUSPAR. Past drug history included: Codiene, reaction(s): "Known allergies"; Percocet, reaction(s): "Known allergies"; Compazine, reaction(s): "Known allergies"; Reglan, reaction(s): "Known allergies", notes: Known allergies: Sulfa Codiene Percocet Compazine Reglan Shellfish. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product=COVID 19, prev dose brand=Pfizer mRNA BNT, prev dose brand unknown=False, prev dose lot number=ER8733, prev dose lot unknown=False, prev dose administration date=05Apr2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 05Apr2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Sep2021, outcome "unknown" and all described as "Covid test result=Positive"; SYNCOPE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "syncopal episodes"; HEART RATE DECREASED (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Heart rate began dropping into the 40-50s range"; FATIGUE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "severe fatigue". The events "syncopal episodes", "heart rate began dropping into the 40-50s range" and "severe fatigue" were evaluated at the physician office visit and emergency room visit. It was unknown if patient had covid prior vaccination. The patient had covid tested post vaccination. The patient underwent the following laboratory tests and procedures: heart rate: (26Apr2021) dropping into the 40- 50s range, notes: Heart rate began dropping into the 40- 50s range; investigation: (unspecified date) unknown results; sars-cov-2 test: (27Sep2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of syncope, heart rate decreased, fatigue as multiple testing in progress.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result=Positive; Covid test result=Positive; syncopal episodes; Heart rate began dropping into the 40-50s range; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0169) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Shellfish" (unspecified if ongoing), Known allergies: Sulfa Notes,: sulfa Codiene Percocet Compazine Reglan Shellfish. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPAMAX; LEXAPRO; ROPINIROLE; BUSPAR. Past drug history included: Codiene, reaction(s): "Known allergies"; Percocet, reaction(s): "Known allergies"; Compazine, reaction(s): "Known allergies"; Reglan, reaction(s): "Known allergies", notes: Known allergies: Sulfa Codiene Percocet Compazine Reglan Shellfish. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product=COVID 19, prev dose brand=Pfizer mRNA BNT, prev dose brand unknown=False, prev dose lot number=ER8733, prev dose lot unknown=False, prev dose administration date=05Apr2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 05Apr2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Sep2021, outcome "unknown" and all described as "Covid test result=Positive"; SYNCOPE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "syncopal episodes"; HEART RATE DECREASED (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Heart rate began dropping into the 40-50s range"; FATIGUE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "severe fatigue". The events "syncopal episodes", "heart rate began dropping into the 40-50s range" and "severe fatigue" were evaluated at the physician office visit and emergency room visit. It was unknown if patient had covid prior vaccination. The patient had covid tested post vaccination. The patient underwent the following laboratory tests and procedures: heart rate: (26Apr2021) dropping into the 40- 50s range, notes: Heart rate began dropping into the 40- 50s range; investigation: (unspecified date) unknown results; sars-cov-2 test: (27Sep2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of syncope, heart rate decreased, fatigue as multiple testing in progress.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID.; I tested positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 (Lot number: EL9264) at the age of 23 years as dose 2, single and administered in arm right, administration date 23Jan2021 (Lot number: EL3249) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Nov2021, outcome "recovering" and all described as "I tested positive for COVID.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive, notes: Nasal Swab (PCR test). Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: The patient had no known allergies. The patient had no vaccine in four weeks and had none other medications in 2 weeks. The patient was tested for covid post vaccination and resulted positive.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Muscular weakness
Clinical narrative: Headache; chest pain; dizziness; leg weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 08:30 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "Headache"; CHEST PAIN (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "chest pain"; DIZZINESS (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "dizziness"; MUSCULAR WEAKNESS (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "leg weakness". The events "headache", "chest pain", "dizziness" and "leg weakness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, chest pain, dizziness, muscular weakness.  Additional information: The reporter considering the events as non serious. Facility where the most recent COVID-19 vaccine was administered was School or Student Health Clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient received treatment for the events with ekg, glucose screen.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Illness, Nasal congestion, Pain
Clinical narrative: sick/ Really Sick; chills; fever; body aches; stuffy nose; Weakness; her arm was a little sore; sleepy; 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 39 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 15Nov2021 18:30 (Lot number: 320308D) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "sick/ Really Sick"; CHILLS (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "chills"; PYREXIA (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "fever"; PAIN (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "body aches"; ASTHENIA (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Weakness"; NASAL CONGESTION (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "stuffy nose"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "not recovered", described as "her arm was a little sore"; SOMNOLENCE (non-serious) with onset 15Nov2021, outcome "not recovered", described as "sleepy". Therapeutic measures were taken as a result of illness, chills, pyrexia, pain, asthenia, nasal congestion, pain in extremity, somnolence. Clinical course: Patient stated that on Monday she was sleepy and her arm was a little sore. On Thursday at 4:00AM she woke up with chills, fever, body aches and stuffy nose - she stated she was really sick and still feels sick and it varies, she feels different everyday. She clarifies by feels really sick she means chills, fever, body aches, and stuffy nose. Treatment received was Tylenol and Theraflu. No family medical history relevant to AE and no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE(s) require a visit to Emergency Room or considering going to the doctors office. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: sick/ Really Sick; chills; fever; body aches; stuffy nose; Weakness; her arm was a little sore; sleepy; 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 39 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 15Nov2021 18:30 (Lot number: 320308D) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "sick/ Really Sick"; CHILLS (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "chills"; PYREXIA (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "fever"; PAIN (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "body aches"; ASTHENIA (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Weakness"; NASAL CONGESTION (life threatening) with onset 18Nov2021 04:00, outcome "not recovered", described as "stuffy nose"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "not recovered", described as "her arm was a little sore"; SOMNOLENCE (non-serious) with onset 15Nov2021, outcome "not recovered", described as "sleepy". Therapeutic measures were taken as a result of illness, chills, pyrexia, pain, asthenia, nasal congestion, pain in extremity, somnolence. Clinical course: Patient stated that on Monday she was sleepy and her arm was a little sore. On Thursday at 4:00AM she woke up with chills, fever, body aches and stuffy nose - she stated she was really sick and still feels sick and it varies, she feels different everyday. She clarifies by feels really sick she means chills, fever, body aches, and stuffy nose. Treatment received was Tylenol and Theraflu. No family medical history relevant to AE and no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE(s) require a visit to Emergency Room or considering going to the doctors office. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: experienced vertigo after both first and second doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "meniere disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "experienced vertigo after both first and second doses". It was unknown if therapeutic measures were taken as a result of vertigo.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Feeling abnormal
Clinical narrative: The patient experienced COVID-19; The patient experienced COVID-19; Felt like allergies; Felt like allergies; Lost taste, smell eight to nine days; Lost taste, smell eight to nine days; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157790-00.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; risankizumab (SKYRIZI), first regimen subcutaneous (Batch/Lot number: unknown) at 150 mg and second regimen subcutaneous (Batch/Lot number: unknown) at 75 mg (75 mg (1 in 1 once)) for psoriasis. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2021, outcome "recovered" (2021) and all described as "The patient experienced COVID-19"; FEELING ABNORMAL (non-serious), HYPERSENSITIVITY (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Felt like allergies"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Lost taste, smell eight to nine days". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Apr2021) positive. The action taken for risankizumab was temporarily withdrawn.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter assess the causality for the events COVID-19 and Feeling abnormal as possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the  reported events 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
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity, SARS-CoV-2 test
Clinical narrative: The patient experienced COVID-19; The patient experienced COVID-19; Felt like allergies; Felt like allergies; Lost taste, smell eight to nine days; Lost taste, smell eight to nine days; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157790-00.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; risankizumab (SKYRIZI), first regimen subcutaneous (Batch/Lot number: unknown) at 150 mg and second regimen subcutaneous (Batch/Lot number: unknown) at 75 mg (75 mg (1 in 1 once)) for psoriasis. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2021, outcome "recovered" (2021) and all described as "The patient experienced COVID-19"; FEELING ABNORMAL (non-serious), HYPERSENSITIVITY (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Felt like allergies"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Lost taste, smell eight to nine days". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Apr2021) positive. The action taken for risankizumab was temporarily withdrawn.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter assess the causality for the events COVID-19 and Feeling abnormal as possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the  reported events 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 10:00 (Lot number: EW0217) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "Anxiety" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: IMITREX. The following information was reported: HEADACHE (non-serious) with onset 18Aug2021 08:00, outcome "recovered with sequelae", described as "Severe headache". The event "severe headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional Information: It is reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient had diagnosed with COVID-19. Treatment received for the adverse event with Prescription pain relief and steroids, sleep study. Since the vaccination, patient had not been tested for COVID-19. The patient had no known allergies as reported.  Follow-Up (29NOV2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Diabetes mellitus, Drug ineffective, Irritable bowel syndrome
Clinical narrative: Diabetes; Even after Covid-19 vaccination got covid; Even after covid-19 vaccination got COVID; Even after covid-19 vaccination got COVID, dose 1 on 15Feb2021, Dose 2 on 08Mar2021; Irritable bowel syndrome; Arthritis; Possible injection reaction/few hours after injection fingers went into stiffness where could not even move them; This is a Solicited report from a non-interventional based on the information received by Pfizer from AbbVie manufacture number (21K-163-4160088-00) and (21K-163-4160088-00) . A contactable 56-year-old female consumer patient reported for herself that:  A 56-years-old female patient received first dose of bnt162b2 (BNT162B2,formulation: Solution for injection, Batch/Lot number: unknown), via intramuscular route of administration on 15Feb2021 at the age of 56 years as DOSE 1,SINGLE for covid-19 immunization and on 08Mar2021 ,at the age of 56 years she received second dose of bnt162b2 (BNT162B2,formulation: Solution for injection, Batch/Lot number: unknown), via intramuscular route of administration, as DOSE 2,SINGLE for covid-19 immunization. And ADALIMUMAB(HUMIRA), Solution for injection in pre-filled pen from an unknown date and ongoing, dose description: CF, for Moderate to severe ulcerative colitis. The patient's relevant medical history and concomitant medications were not reported. It was reported that on an unspecified date in 2021, patient experienced Irritable bowel syndrome, Even after Covid-19 vaccination got covid, vaccination failure (Vaccine response impaired) ,Diabetes, Arthritis, Possible injection reaction/few hours after injection fingers went into stiffness where could not even move them and drug ineffective.The patient underwent lab tests and procedures which included SARS-CoV-2 test result positive. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of the events Irritable bowel syndrome, Even after Covid-19 vaccination got covid, Diabetes, Arthritis, were reported as not recovered and for events Possible injection reaction/few hours after injection fingers went into stiffness where could not even move them and vaccination failure(Vaccine response impaired) and drug ineffective were reported as unknown.  Causality as per the reporter: Not reported.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Diabetes; Even after Covid-19 vaccination got covid; Even after covid-19 vaccination got COVID; Even after covid-19 vaccination got COVID, dose 1 on 15Feb2021, Dose 2 on 08Mar2021; Irritable bowel syndrome; Arthritis; Possible injection reaction/few hours after injection fingers went into stiffness where could not even move them; This is a Solicited report from a non-interventional based on the information received by Pfizer from AbbVie manufacture number (21K-163-4160088-00) and (21K-163-4160088-00) . A contactable 56-year-old female consumer patient reported for herself that:  A 56-years-old female patient received first dose of bnt162b2 (BNT162B2,formulation: Solution for injection, Batch/Lot number: unknown), via intramuscular route of administration on 15Feb2021 at the age of 56 years as DOSE 1,SINGLE for covid-19 immunization and on 08Mar2021 ,at the age of 56 years she received second dose of bnt162b2 (BNT162B2,formulation: Solution for injection, Batch/Lot number: unknown), via intramuscular route of administration, as DOSE 2,SINGLE for covid-19 immunization. And ADALIMUMAB(HUMIRA), Solution for injection in pre-filled pen from an unknown date and ongoing, dose description: CF, for Moderate to severe ulcerative colitis. The patient's relevant medical history and concomitant medications were not reported. It was reported that on an unspecified date in 2021, patient experienced Irritable bowel syndrome, Even after Covid-19 vaccination got covid, vaccination failure (Vaccine response impaired) ,Diabetes, Arthritis, Possible injection reaction/few hours after injection fingers went into stiffness where could not even move them and drug ineffective.The patient underwent lab tests and procedures which included SARS-CoV-2 test result positive. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of the events Irritable bowel syndrome, Even after Covid-19 vaccination got covid, Diabetes, Arthritis, were reported as not recovered and for events Possible injection reaction/few hours after injection fingers went into stiffness where could not even move them and vaccination failure(Vaccine response impaired) and drug ineffective were reported as unknown.  Causality as per the reporter: Not reported.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac flutter, Heart rate, SARS-CoV-2 antibody test
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient(herself). Other Case identifier(s): 21K-163-4157183-00 (AbbVie).  A 69-year-old female patient received bnt162b2 (BNT162B2, Solution for injection,Batch/Lot number: unknown), intramuscular route as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation; ibrutinib (IMBRUVICA), oral since Jan2020 (ongoing) (Batch/Lot number: unknown) at 420 mg for chronic lymphocytic leukaemia. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. NO KNOWN ALLERGIES . The following information was reported: CARDIAC FLUTTER (medically significant) with onset Oct2021, outcome "unknown", described as "Heart Flutter"; BLOOD PRESSURE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "Blood Pressure Shoot Up".The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Oct2021) shoot up; heart rate: (Oct2021) 136 bpm; sars-cov-2 antibody test: (unspecified date) negative. The action taken for ibrutinib was dosage not changed.  The reporter considered "heart flutter" and "blood pressure shoot up" not associated to bnt162b2.   Additional information:It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of heart flutter, blood pressure shoot up and had third covid  Pfizer vaccine as she didn't have antibodies was not provided.   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 between the reported events and 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac flutter, Heart rate, Immunisation
Clinical narrative: had third covid Pfizer vaccine; COVID-19 antibody test negative; Heart flutter; Blood pressure shoot up; MC-2015-135  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157183-00 (AbbVie).  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; ibrutinib (IMBRUVICA), oral since Jan2021 (ongoing) (Batch/Lot number: unknown) at 420 mg for chronic lymphocytic leukaemia. Relevant medical history included: "Cll" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Route of Admin:1)Intra-muscular), for COVID-19 Immunization; Bnt162b2 (Second dose, Route of Admin:2)Intra-muscular), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "had third covid Pfizer vaccine"; CARDIAC FLUTTER (medically significant) with onset Oct2021, outcome "unknown", described as "Heart flutter"; BLOOD PRESSURE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "Blood pressure shoot up". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Oct2021) shoot up; heart rate: (Oct2021) 136 bpm; sars-cov-2 antibody test: (unspecified date) negative. The action taken for ibrutinib was dosage not changed.The reporter considered "had third covid pfizer vaccine" not related to COVID-19 antibody test negative .The reporter causality for the events Cardiac flutter, Blood pressure increased, COVID-19 antibody test negative was not reported for the co-suspect IMBRUVICA.  Additional information: The patient did not have antibodies with imbruvica (ibrutinib). The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 available in narrative the reported  events of  Booster, Antibody test negative  cardiac flutter and BP increased are assessed as related to suspected vaccine BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: had third covid Pfizer vaccine; COVID-19 antibody test negative; Heart flutter; Blood pressure shoot up; MC-2015-135  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157183-00 (AbbVie).  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; ibrutinib (IMBRUVICA), oral since Jan2021 (ongoing) (Batch/Lot number: unknown) at 420 mg for chronic lymphocytic leukaemia. Relevant medical history included: "Cll" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Route of Admin:1)Intra-muscular), for COVID-19 Immunization; Bnt162b2 (Second dose, Route of Admin:2)Intra-muscular), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "had third covid Pfizer vaccine"; CARDIAC FLUTTER (medically significant) with onset Oct2021, outcome "unknown", described as "Heart flutter"; BLOOD PRESSURE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "Blood pressure shoot up". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Oct2021) shoot up; heart rate: (Oct2021) 136 bpm; sars-cov-2 antibody test: (unspecified date) negative. The action taken for ibrutinib was dosage not changed.The reporter considered "had third covid pfizer vaccine" not related to COVID-19 antibody test negative .The reporter causality for the events Cardiac flutter, Blood pressure increased, COVID-19 antibody test negative was not reported for the co-suspect IMBRUVICA.  Additional information: The patient did not have antibodies with imbruvica (ibrutinib). The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 available in narrative the reported  events of  Booster, Antibody test negative  cardiac flutter and BP increased are assessed as related to suspected vaccine BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Rheumatoid arthritis
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 21K-163-3850576-00.  A 70 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral since 01Jun2020 (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day. Relevant medical history included: "epilepsy" (unspecified if ongoing); "sulfa antibiotics allergy" (unspecified if ongoing); "headache" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; CELECOXIB taken for arthritis; CEPHALEXINE; HYDROMORPHON AL; ONDANSETRON ODT; TRIAZOLAM; NP THYROID. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 10Nov2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness aggravated"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain aggravated"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache". The action taken for upadacitinib was dosage not changed.  Clinical Course: 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 couple of flares of dizziness with mild pain un-known onset, couple of flares of dizziness with mild pain unknown onset, headache and rheumatoid arthritis flare ups on and off was not provided.  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 between the event Rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Fatigue, Irritability, Self-injurious ideation
Clinical narrative: Extreme fatigue; self-injurious behavior; aggressive; extremely irritable for 7 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 15:00 (Lot number: UNKNOWN) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "DMDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "ASD" (unspecified if ongoing); "allergies: Artificial dye" (unspecified if ongoing), notes: known allergies: Artificial dye. Concomitant medication(s) included: ZOLOFT; LITHIUM OROTATE; RITALIN; INTUNIV; MAGNESIUM. The following information was reported: FATIGUE (non-serious) with onset 10Nov2021 15:00, outcome "recovering", described as "Extreme fatigue"; SELF-INJURIOUS IDEATION (non-serious) with onset 10Nov2021 15:00, outcome "recovering", described as "self-injurious behavior"; AGGRESSION (non-serious) with onset 10Nov2021 15:00, outcome "recovering", described as "aggressive"; IRRITABILITY (non-serious) with onset 10Nov2021 15:00, outcome "recovered" (Nov2021), described as "extremely irritable for 7 days". Therapeutic measures were taken as a result of fatigue, self-injurious ideation, aggression, irritability with Magnesium, Epsom Salt bath, Pure Body detox.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. Patient reported very difficult days at school and home. The pediatric vax contains tromethamine/tromethamine hydrochloride. Patient read that it could interact with stimulant medications, lithium and should not be given to people with dye allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; Headache; stuffy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Apr2021 (Lot number: EP6955) at the age of 22 years as dose 2, single and intramuscular, administered in arm left, administration date 25Mar2021 (Lot number: EP6955) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2021, outcome "recovering" and all described as "Positive COVID test"; HEADACHE (non-serious) with onset 17Nov2021, outcome "recovering", described as "Headache"; NASAL CONGESTION (non-serious) with onset 17Nov2021, outcome "recovering", described as "stuffy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive, notes: Nasal Swab. The action taken for bnt162b2 was unknown. Therapeutic measures were not taken as a result of vaccination failure, covid-19, headache, nasal congestion.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Cardiac disorder, Diabetes mellitus, Fibromyalgia, Hypertension
Clinical narrative: diabetic; Comarinty 1st dose- fibromyalgia; Polymyalgia; heart problems; high blood pressure; had issues with her appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "pericarditis", start date: Jan2021 (unspecified if ongoing); "migraine", start date: Jan2021 (ongoing), notes: She is taking everything and still having migraines and polymyalgia.; "polymyalgia", start date: Jan2021 (ongoing), notes: She is taking everything and still having migraines and polymyalgia.; "fibromyalgia", start date: Jan2021 (unspecified if ongoing); "stomach issues", start date: Jan2021 (unspecified if ongoing); "Covid", start date: Jan2021 (unspecified if ongoing), notes: She added in January she had Covid. The patient's concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic"; FIBROMYALGIA (non-serious), outcome "unknown", described as "Comarinty 1st dose- fibromyalgia"; MYALGIA (non-serious), outcome "unknown", described as "Polymyalgia"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; APPETITE DISORDER (non-serious), outcome "unknown", described as "had issues with her appetite". Clinical course: The patient wants to know if there was any other way to help the situation. She was on oxycodone three times a day, on delta 8 gummies. She stated she had spoken to her health care provider and they don't know what to do. She had tried Prednisone and it did nothing. She added, she had diabetes and her sugar was below 50 the whole night, the whole night she was in the red and was even on a steroid.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event diabetes mellitus and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: diabetic; Comarinty 1st dose- fibromyalgia; Polymyalgia; heart problems; high blood pressure; had issues with her appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "pericarditis", start date: Jan2021 (unspecified if ongoing); "migraine", start date: Jan2021 (ongoing), notes: She is taking everything and still having migraines and polymyalgia.; "polymyalgia", start date: Jan2021 (ongoing), notes: She is taking everything and still having migraines and polymyalgia.; "fibromyalgia", start date: Jan2021 (unspecified if ongoing); "stomach issues", start date: Jan2021 (unspecified if ongoing); "Covid", start date: Jan2021 (unspecified if ongoing), notes: She added in January she had Covid. The patient's concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic"; FIBROMYALGIA (non-serious), outcome "unknown", described as "Comarinty 1st dose- fibromyalgia"; MYALGIA (non-serious), outcome "unknown", described as "Polymyalgia"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; APPETITE DISORDER (non-serious), outcome "unknown", described as "had issues with her appetite". Clinical course: The patient wants to know if there was any other way to help the situation. She was on oxycodone three times a day, on delta 8 gummies. She stated she had spoken to her health care provider and they don't know what to do. She had tried Prednisone and it did nothing. She added, she had diabetes and her sugar was below 50 the whole night, the whole night she was in the red and was even on a steroid.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event diabetes mellitus and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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.