chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; 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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: Er8730), on 15Apr2021 as dose 2, single (Lot number: En5318) and on 22Nov2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Slight asthma when sick" (unspecified if ongoing); "Slight asthma when sick" (unspecified if ongoing) and had no known allergies. The patient took concomitant medications on 01Nov2020 and patient had Prenatal Multivitamin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: It was reported as patient had treatment for COVID 19 with Paxlovid (Anti viral) with treatment start date 06Aug2022 and treatment stop date 10Aug2022. The patient reported that Covid rebounded after taking Paxlovid.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FIASP; LEVOTHYROXINE; INSULIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid from 01Aug2022 to 05Aug2022 for Treatment of COVID-19. Patient had no known allergies. Other medical history: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received "all Pfizer Covid vaccinations" but still got Covid.; received "all Pfizer Covid vaccinations" but still got Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received "all Pfizer Covid vaccinations" but still got Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller states she received "all Pfizer Covid vaccinations" but still got Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment of Paxlovid. Reporter states patient received her last booster in May or Jun, would like to have information on the vaccine currently being developed to address the "4, 2" variant, and when a booster would be recommended with the new vaccine. Patient received "all Pfizer Covid vaccinations" but still got Covid. Reporter seeking information on when she may resume taking amlodipine and lovastatin. patient has not taken either medication while taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 21Apr2021 as dose 2, single (Lot number: ER8736), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FF9843) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BRCA2" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Drug Allergy", notes: known allergies: Penicillin, good, fragrance. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; 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 64-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I experienced rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included tab paxlovid.  Clinical Course- Patient experienced rebound COVID. So far, mild symptoms like a runny nose. Patient should had mistaken it for allergies maybe it is).
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; 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 48-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: thyroid removed" (unspecified if ongoing), notes: Other medical history: thyroid removed. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive, notes: First tested positive 28Jul2022; (04Aug2022) Negative, notes: tested negative 04Aug2022; (09Aug2022) Positive, notes: tested positive again on 09Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient reported that, First tested positive 28Jul2022, tested negative 04Aug2022, tested positive again on 09Aug2022 with paxlovid rebound (symptoms sore throat and runny nose) until 12Aug2022.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 15:00 as dose 1, single (Lot number: EN6206), in right arm, on 24Mar2021 at 15:00 as dose 2, single (Lot number: ER8727), in right arm and on 23Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2588) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) included: PRAVASTATIN TEVA, start date: 01Nov2021, stop date: 31Jul2022; EZETIMIBE ZYDUS, start date: 01Oct2021, stop date: 31Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID 19 treatment from 01Aug2022 to 05Aug2022.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 30Oct2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 07May2022 at 18:30 as dose 4 (booster), single (Lot number: FJ4989) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; VITAMIN D NOS; MELOXICAM; TYLENOL; TYLENOL COLD & SINUS; NAPROXEN SODIUM. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID 19 Treatment from 03Aug2022 to 08Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL3246), on 06Feb2021 as dose 2, single (Lot number: EL3246) and in Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESCITALOPRAM (LEXAPRO), start date: Feb2022; DEXTROAMPHETAMINE SUFATE, start date: Jun2021; TOPIRAMATE, start date: Jun2021; TRAZODONE, start date: Mar2022, stop date: Jul2022; CETIRIZINE HCL, start date: Apr2022; TYLENOL; ADVIL [IBUPROFEN]; ADULT MULTIVITAMIN; VITAMIN D NOS; start date: Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: labs: Unknown Results; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti viral drug PAXLOVID was taken from 30Jul2022 to 03Aug2022 for the treatment of COVID 19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11May2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 25Jun2021 as dose 3 , single (Batch/Lot number: unknown), on 31Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 29Jun2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Aug2022) Positive. The patient received Paxlovid from 06Aug2022 to 11Aug2022 for COVID 19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (unknown if pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for COVID-19 immunisation; COVID-19 vaccine (manufacturer unknown), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "oral cancer 2013", start date: 2013 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; FLOVENT; SINGULAIR; XYZAL; FLONASE ALLERGY RELIEF; PEPCID AC; OMEPRAZOLE. Past drug history included: Lortab, reaction(s): "Known allergies: lortab". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) positive, notes: Rebound Covid. The patient received Paxlovid from 09Aug2022 to 13Aug2022 for COVID 19 treatment.  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, SARS-CoV-2 test
Clinical narrative: Caller is now testing positive for Covid illness 18Aug2022; Caller is now testing positive for Covid illness 18Aug2022; 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 female patient received BNT162b2 (BNT162B2), on 12Jul2022 as dose number unknown (booster), single (Lot number: FJ4991) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "unknown" and all described as "Caller is now testing positive for Covid illness 18Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) positive.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / COVID-19 Treatment 03Aug2022; Pfizer / BioNTech / COVID-19 Treatment 03Aug2022; Rebound Covid; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 14Jan2021 as dose 2, single (Lot number: EK4176), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Jun2012; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS], start date: Sep2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech / COVID-19 Treatment 03Aug2022"; DISEASE RECURRENCE (medically significant), outcome "recovering", described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative and symptoms resolved after course of Paxlovid on day 5; Positive, notes: Return of symptoms and repeat positive antigen test on day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence.  Clinical course: Report about covid treatment: Yes, If vaccine received: Yes, Other medication in 2 weeks: Yes. Rebound Covid. Tested negative and symptoms resolved after course of Paxlovid on day 5. Return of symptoms and repeat positive antigen test on day 10. Remain positive and symptomatic still on day 16 from initial infection (day 6 from rebound start).  No follow-up attempts are possible, no further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and disease recurrence and BNT162B2.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FR9895) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Aug2022) Positive, notes: On day 10 tested positive; (16Aug2022) Negative, notes: day 11 tested negative; (18Aug2022) Positive, notes: Day 13 tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient received vaccine. There was no any other medication received in 2 weeks. Therapeutic measures taken Anti viral details: for COVID 19 Treatment, Brand: Paxlovid Treatment start date: 05Aug2022, Treatment stop date: 09Aug2022, indication Treatment of COVID-19. Took paxlovid as prescribed for five days. On day 10 tested positive, day 11 tested negative, having milder symptoms for next couple of days. Day 13 tested positive, still having mild symptoms. Patient think patient having a rebound reaction.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Apr2022 as dose 4 (booster), single (Lot number: C41J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hemochromatosis" (unspecified if ongoing), notes: Other medical history: hemochromatosis. Concomitant medication(s) included: FENOFIBRATE; ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included patient received other medication in 2 weeks. Patient received treatment Paxlovid, treatment start date: 09Aug2022, treatment stop date: 13Aug2022. No allergies reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Off label use, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; fatigue; Therapy Dates/Duration : 06Aug2021-06Aug2021 - 07Aug2021- 07Aug2021; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4494146-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 06Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 07Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1163895), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious) with onset 07Aug2021, outcome "unknown", described as "Therapy Dates/Duration : 06Aug2021-06Aug2021 - 07Aug2021- 07Aug2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 virus test positive"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "covid-19 virus test positive" and "fatigue" related to BNT162b2. The reporter's assessment of the causal relationship of "therapy dates/duration : 06aug2021-06aug2021 - 07aug2021- 07aug2021" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Clinical course: The reporter's causality for the event(s) of COVID Positive with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of tired was not provided. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective, covid 19, off label use and fatigue with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Fibromyalgia
Clinical narrative: Fibromyalgia; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4505151-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. 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) all with onset 22Jul2022, outcome "recovered" (31Jul2022) and all described as "COVID-19"; FIBROMYALGIA (non-serious), outcome "recovering". The action taken for upadacitinib was unknown. Clinical information: The patient had fibromyalgia and she was experiencing muscles pains. From 22Jul2022 to 31Jul2022, she had covid and went back to normal, covid amplified all the regular symptoms she had and also had a cough. It was unknown if she was enrolled in a Covid-19 Vaccine Trial. The reporter's causality for Rinvoq (Upadacitinib) for the event(s) of Fibromyalgia and Covid was not provided. The reporter's causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran)  for the event(s) of Fibromyalgia and Covid was reported as Possible..  The reporter considered "covid-19" and "fibromyalgia" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 ,Drug ineffective and fibromyalgia.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: we all got COVID; we all got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "we all got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown, notes: we all got COVID.  Clinical course: the patient whole family got the 1st and 2nd dose as soon as it became available. Her husband has a heart condition, so they know it was very important to get the vaccine. They did not get COVID so they thought we were all good and still got the booster as soon as we could. We thought we were definitely good then, but then we all got COVID. The commercial emphasizes the fact that you can never be too careful, and it was our responsibility to ourselves and our community to take action and get the shot. We were all very surprised when we got the test done (we thought we had a common cold). Fortunately, the symptoms were fairly minor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201068097 Same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002851.  A female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, Dose 1), for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown". Therapeutic measures were taken as a result of guillain-barre syndrome.  Additional information: On 03Aug2022, it was reported that a patient started treatment on an unspecified date in Apr2022 with Pfizer-BioNTech COVID-19 Vaccine dose 2 for an unspecified indication. It was reported the patient developed Guillain-Barre Syndrome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002810.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown".  Additional information: On 02Aug2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine at an unspecified date or an unspecified indication. It was reported that, the patient developed tinnitus.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; headache; mild fever; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 59-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "mild fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had never had a serious reaction to any vaccine except the standard symptoms of a sore arm occasionally a headache or a mild fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Kidney infection, Musculoskeletal disorder
Clinical narrative: Kidney infection; Arthritis; hand was not working as well; not walking well; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4501323-00.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Batch/Lot number: unknown) and on 02Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KIDNEY INFECTION (medically significant), outcome "recovered"; ARTHRITIS (non-serious), outcome "unknown"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "hand was not working as well"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "not walking well". The action taken for upadacitinib was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "kidney infection", "arthritis", "hand was not working as well" and "not walking well" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) arthritis was probable, for kidney infection, upper extremity dysfunction, walking difficulty was not reported.  Clinical course: it was reported that on unknown dates, the patient experienced COVID-19 vaccination stirred up arthritis, kidney infection, hand was not working as well and not walking well and RINVOQ was not working very well, and causality was not provided. On an unknown date, kidney infection resolved. Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. The patient had taken COVID-19 vaccination side effects. COVID-19 shot stirred up her arthritis so the physician told her she should not have taken it. She had a kidney infection and stopped RINVOQ for two weeks and resumed. It was unknown if she 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 temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: We just had an otherwise healthy family friend drop dead "suddenly" a few weeks ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "We just had an otherwise healthy family friend drop dead "suddenly" a few weeks ago". The date and cause of death for the patient were unknown. 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: drop dead "suddenly"
Sex: M
Vaccine: DTAP
Symptoms: Headache, Vomiting
Clinical narrative: Initial information received on 10-Aug-2022 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-hcp via MERK. This case involves a male patient  (unknown age) who experienced severe headaches and experienced severe headaches with episodes of vomiting while receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination. On an unknown date, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (strength, dose, formulation, route, lot number not reported) for prophylactic vaccination. On an unknown date the patient developed a non-serious event  severe headaches (headache) and experienced severe headaches with episodes of vomiting (vomiting) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events (vomiting, headache). At time of reporting, the outcome was Unknown for the event vomiting, headache.
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered IPOL after it exceeded the stability data documented in the local labelling  with no reported adverse event; administered IPOL after it exceeded the stability data documented in the local labelling  with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who had administered IPV (VERO) [IPOL] after it exceeded the stability data documented in the local labelling  with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an 19-Jul-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation was unknown, lot U1C572M and expiry date: 17-Jun-2023)) via subcutaneous route in the right deltoid for Immunization.  On an 19-Jul-2022, the patient developed a non-serious administered ipol after it exceeded the stability data documented in the local labelling with no reported adverse event (poor quality product administered) (latency same day) following the administration of IPV (VERO).  On an unknown date, the patient developed a non-serious event of administered ipol after it exceeded the stability data documented in the local labelling with no reported adverse event (product temperature excursion issue)(latency unknown).  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever of 102.6, headache, chills approximately 12 hours after vaccine. Injection site  pain started 5 hours after vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Inflammation, Laboratory test, Palpitations, Peripheral venous disease
Clinical narrative: Chest pain Heart Palpitations/Inflammation  Venous insufficiency in legs
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Syncope
Clinical narrative: Fainted
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness to injection site, parent informed to monitor site and call nurse line if it worsens.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Headache
Clinical narrative: Mild to Severe Headaches. After seeing primary care physician, was given script for CT Head w/o Contrast. CT performed at facility on 8/1/22.  Results normal. Recommendation to follow-up with Neurologist but headaches have since stopped, and I am feeling fine.  No further information to report at this time.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Intermenstrual bleeding, Nausea
Clinical narrative: Fever (>100 F), nausea, body aches, chills, fatigue, breakthrough menstrual bleeding, polyuria and abdominal pain. Fever, fatigue, nausea, body chills/aches started the night of the vaccine and lasted 48 hours. Breakthrough bleeding started after 24 hours and lasted for 1 week. Polyuria started 24 hours after and lasted for 3 days.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Polyuria, Pyrexia
Clinical narrative: Fever (>100 F), nausea, body aches, chills, fatigue, breakthrough menstrual bleeding, polyuria and abdominal pain. Fever, fatigue, nausea, body chills/aches started the night of the vaccine and lasted 48 hours. Breakthrough bleeding started after 24 hours and lasted for 1 week. Polyuria started 24 hours after and lasted for 3 days.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Urticaria
Clinical narrative: PATIENT RECEIVED MENINGITIS, HPV, TDAP VACCINATION TODAY.  FOLLOWING VACCINE PATIENT BECAME DIZZY DEVELOPED A HEADACHE.  VITAL SIGNS INCLUDING BP, PULSE, O2 WITHIN NORMAL LIMITS.  SHE WAS LAID FLAT ON EXAMINIATION TABLE, PROVIDED ICE PACK FOR NECK. PATIENT BEGAN TO DEVELOP URTICARIA OF CHEST AND LEFT NECK, NO SWELLING OF THE MOUTH/TONGUE/DIFFICULTY BREATHING.  PT WAS HYDRATED WITH WATER AND PROVIDED A SAMPLE OF CLARITIN 10 MG PO ONCE FOR HIVES.  PATIENT WAS ALSO ADMINISTERED TYLENOL FOR HEADACHE.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Thirst
Clinical narrative: Chills, body aches, headache, fatigue, extreme thirst.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Product administration error
Clinical narrative: The first attempt at Inradermal administration did not result in a wheal. A second attempt was done by an expert in intradermal administration and was successful.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Postural orthostatic tachycardia syndrome, Tilt table test positive
Clinical narrative: Postural Orthostatic Tachycardia first presented to urgent care with palpitations and elevated heart rate in August 2021
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: No actual adverse reaction. Was suppose to get his second dose of Moderna and was accidently given Pfizer
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgraphia, Injection site pain, Muscle twitching, Tremor
Clinical narrative: MOTHER IS PRESENT WITH PATIENT FOR FOLLOWUP ON HAND AND ARM TWITCHES AT LEAST ONCE A DAY EVERYDAY SINCE COVID VACCINE RECEIVED.  COMPLAINED OF PAIN AT SITE OF INJECTION AND ALSO TWITCHING EPISODE FOR FEW SECONDS, BY THE TIME EXAMINED BY PCP WAS RESOLVED. AFTER THAT SINGLE EPISODE MOM REPORTED STARTED A DAY AFTER INJECTION, THESE TREMBLING/TWITCHING EPISODES ARE MORE FREQUENT AND MORE INTENSE. STARTED 1-2 PER DAY FEW SEC NOW THEY ARE 3-4 A DAY LASTING AT LEAST 1 MIN,INTERFERING CHILD WITH WRITING AT SCHOOL, SINCE EPISODE IS DOMINANT RT HAND.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient called 8/20/2022 to say she developed a few itchy red bumps on right leg. 1 on lower leg behind right knee and 2 or 3 on upper right leg.
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Oral herpes, Oropharyngeal pain, Pain in extremity
Clinical narrative: Just wanted to say I got several lip cold sores and two on my tongue about 30 hr after the vaccine.  I am a physician and I have not history of regular cold sores.   Mild sore throat.  The cold sores were unexpected and this is why I'm reporting them.   Other than that sore arm.
Age: 46.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large bump at injection site, red, itchy, painful, dry, warm
Age: 46.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site warmth
Clinical narrative: Large bump at injection site, red, itchy, painful, dry, warm
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms for a couple weeks.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Significant worsening of psoriasis, which does not respond to usual treatment and continues to today.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Presyncope
Clinical narrative: Patient had a vasovagal episode. VS were performed: 0830 - 129/79, 59, 97.2, no pain; 0850- 126/74,60, no pain. Elevated legs. Patient given water, and juice. Pt recovered without difficulties. ER precautions given. Pt acknowledges and understands. Pt left facility without difficulties.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Electrocardiogram ambulatory, Headache, Heart rate increased, Laboratory test
Clinical narrative: patient began having s/s per mother after her first dose. Began having headaches, dizziness, syncopial episodes and rapid heart rate. SHe subsequently began having panic attacks
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Panic attack, Syncope
Clinical narrative: patient began having s/s per mother after her first dose. Began having headaches, dizziness, syncopial episodes and rapid heart rate. SHe subsequently began having panic attacks
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Magnetic resonance imaging head, Tinnitus
Clinical narrative: I had severe tinnitus 15 years prior from a bad inner ear infection. I habituated to the tinnitus over time to where it was very tolerable. After the COVID-19 vaccine, my tinnitus returned to the severe condition 15 years prior.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Neurological symptom
Clinical narrative: Stroke like symptoms two days after vacation, dx stroke one week later
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Patient experienced bilateral pain in back (midway down, just under bra line)
Age: 25.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: A wheal was not present after the vaccine was administered intradermally. An expert administered the second attempt, a wheal formed, and the attempt was successful.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Quarter sized pink rashy spot around injection site.  Very little soreness. No other reactions.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fall, Heart rate increased
Clinical narrative: The next day after taking the booster dose of the COVID-19 (Pfizer) shot, I woke up around 7:30 am with pain in my abdomen. This then prompted me to go to the bathroom. I had constant loose stools (diarrhea). It made me feel very, very, weak and nauseous. At the same time, my heart rate began to rise rapidly causing me to sweat. I had the sudden urge to throw-up. After fighting this constant feeling for a couple of minutes, I went to my room and notified my sibling I felt like I was about to pass-out. I could not feel the weight of my legs. I began to fall towards my bed.