chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Infertility female, Malaise
Clinical narrative: We are having a difficult time conceiving; We are not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), 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: INFERTILITY FEMALE (non-serious), outcome "unknown", described as "We are having a difficult time conceiving"; MALAISE (non-serious), outcome "unknown", described as "We are not feeling well". The events "we are having a difficult time conceiving" and "we are not feeling well" required physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300053555 same reporter/drug, similar event, different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Myocardial necrosis marker, SARS-CoV-2 test
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There was no other vaccine in four weeks. Patient had no COVID prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "contracted COVID". The event "contracted covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Myocardial necrosis marker: (2022) Elevated, notes: but no sign of CV event; SARS-CoV-2 test: (Nov2022) Positive. Clinical course: Patient contracted COVID in Summer 2022 and then developed chest pain and scapular pain over course of 3 months post infection. Patient went to ER and had elevated cardiac proteins but no sign of CV event. Cardiology consult described cardiac abnormality attributed COVID & vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300054582 same patient, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Musculoskeletal pain, Myocardial necrosis marker, Myocardial necrosis marker increased
Clinical narrative: Cardiac proteins elevated; chest pain; scapular pain; cardiac abnormality attributed COVID & Vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2022 (unspecified if ongoing), notes: in Summer 2022. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: MYOCARDIAL NECROSIS MARKER INCREASED (medically significant) with onset 2022, outcome "recovered", described as "Cardiac proteins elevated"; CARDIAC DISORDER (non-serious) with onset 2022, outcome "recovered", described as "cardiac abnormality attributed COVID & Vaccine"; CHEST PAIN (non-serious) with onset 2022, outcome "recovered"; MUSCULOSKELETAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "scapular pain". The events "cardiac proteins elevated", "chest pain", "scapular pain" and "cardiac abnormality attributed covid & vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Myocardial necrosis marker: (2022) Elevated, notes: but no sign of CV event. Therapeutic measures were taken as a result of myocardial necrosis marker increased, chest pain, musculoskeletal pain, cardiac disorder. Patient contracted COVID in Summer 2022 and then developed chest pain and scapular pain over course of 3 months post infection. Went to ER and had elevated cardiac proteins but no sign of CV event. Cardiology consult described cardiac abnormality attributed COVID & Vaccine. Aspirin was given for treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300054565 same patient, different dose and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: I am fully vaccinated with 3 pfizer shots and 1 Moderna bivalent booster; 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 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "I am fully vaccinated with 3 pfizer shots and 1 Moderna bivalent booster". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: The patient was fully vaccinated with 3 Pfizer shots and 1 Moderna bivalent booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
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) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "obese" (unspecified if ongoing); "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti-viral product Paxlovid for COVID 19 Treatment from 17Jan2023 till 21Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment: Paxlovid, start date: 25Jan2023; COVID 19 Treatment: Paxlovid, start date: 25Jan2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment: Paxlovid, start date: 25Jan2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Alopecia, Laboratory test
Clinical narrative: hair falling/ her hair has always been full and now it's thin; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 20:00 as DOSE 3 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 27 years old, administered in the left arm for COVID-19 immunization; influenza vaccine inact sag 3v (FLUCELVAX), on 14Oct2022 as DOSE 1, SINGLE (batch/lot number: unknown), administered in the right arm for immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included: METFORMIN. Vaccination history included: BNT162b2 (first dose, at 04:00 PM, via an unspecified route of administration, administered in the left arm, (lot number: EY0584) as DOSE 1, SINGLE), administration date: 29Jun2021, when the patient was 26 years old, for COVID-19 immunization; BNT162b2 (second dose, at 03:00 PM, via an unspecified route of administration, administered in the left arm, (lot number: EW0180) as DOSE 2, SINGLE), administration date: 20Jul2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 06Nov2022 at 14:30, outcome "not recovered", described as "hair falling/ her hair has always been full and now it's thin." The events "hair falling/ her hair has always been full and now it's thin" required physician office visit. The patient underwent the following laboratory tests and procedures: tests: normal. Therapeutic measures were not taken as a result of alopecia.  Additional information: Patient was not diagnosed with COVID prior vaccination and has not tested for COVID post vaccination. Patient has not received any other vaccine in four weeks. The patient noticed her hair falling in 06Nov2021 when she sent her mom a message, because she was worried, and then Dec was worse, and keep falling, a lot. She never had issues with her hair, her hair has always been full and now it's thin. She went to the doctor at the end of Jan2023 to see what this can be, she made all tests and return normal. The doctor asked her if she had COVID, but she had only the shots. Then she reminded and searched about the dates when she took her last COVID shot, and when started to fall. And now looking at the Twitter she saw a lot of people with the same problem. She asked, "By any change that you know how long this will take or all my hair will fall?"
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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: "previous lung cancer" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "known allergies: sulpha" (unspecified if ongoing). The patient took other concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures Paxlovid from 24Jan2023 to 28Jan2023 were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Tested positive for COVID; Treatment of COVID-19/Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), 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: "Obese" (unspecified if ongoing); "HTN (Hypertension)" (unspecified if ongoing), notes: HTN; "anxiety/depression" (unspecified if ongoing), notes: anxiety/depression; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Zoloft, reaction(s): "known allergies: Zoloft". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jan2023, outcome "unknown" and all described as "Treatment of COVID-19/Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jan2023) Positive; (30Jan2023) Negative; (31Jan2023) Negative; (2023) Positive. The patient started Paxlovid as treatment from 24Jan2023 to 29Jan2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna,Vaccine administration date:07Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; FAMOTIDINE; CETIRIZINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Apr2022, outcome "unknown", described as "Vaccine brand other: Moderna,Vaccine administration date:07Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2023) Negative; (03Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about COVID treatment yes, If vaccine received yes, Other medication in 2weeks yes, Product COVID 19 Treatment start date 24Jan2023, stop date 29Jan2023, Device timestamp 03Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: 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) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 16Feb2021 as dose 2, single (Lot number: En6200), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: Ff2588), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: (unspecified date) Positive, notes: COVID 19 Treatment; (2023) Positive, notes: Antigen test never went negative. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Drug ineffective, COVID-19 cannot be excluded
Age: 33.0
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) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 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: "Prediabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive. The patient started Paxlovid as treatment from 25Jan2023 to 29Jan2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna,Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GH3275) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Jan2021 at 14:00 as dose 1, single (Lot number: 025J20-2A), in left arm, on 16Feb2021 at 16:00 as dose 2, single (Lot number: 041L20A), in left arm, on 24Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 050c21A), in left arm and on 16May2022 at 13:00 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022 at 18:00, outcome "unknown", described as "Vaccine brand other=Moderna,Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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 drug ineffective, covid-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 31 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Lot number: EK9231), on 16Jan2021 as dose 2, single (Lot number: EL3247) and on 05Oct2021 as dose 3 (booster), single (Lot number: EW0217) for covid-19 immunisation. The patient's relevant medical history included: "Pregnant" (unspecified if ongoing), notes: Other medical history: Pregnant; "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: 01Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid .; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Vaccination failure , COVID-19  cannot be excluded
Age: 70.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 70 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), 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. Past drug history included: Morphine, reaction(s): "Known allergies: morphine", notes: Known allergies: morphine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jan2023) Positive, notes: COVID 19 Treatment; (29Jan2023) Unknown results, notes: After 5 days had faint and indeterminate rapid test results; (02Feb2023) Positive, notes: Got a clear positive line on rapid test; (03Feb2023) Positive, notes: had very dark red positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-10 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I went from COVID negative to COVID positive; Negative, notes: I went from COVID negative to COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment start/stop date: 25Jan2023/03Feb2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2022 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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 "not recovered" and all described as "Treatment of 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 drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 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: "Asthma" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jun1995, stop date: 04Feb2023; SINGULAIR, start date: 01Jun1995, stop date: 04Feb2023. Other concomitant therapy included unspecified oral birth control.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient started Paxlovid as treatment from 25Jan2023 to 30Jan2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number 1 and Dose Number 2: MODERNA; 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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 031M20A), in left arm, on 10Mar2021 as dose 2, single (Lot number: 003A21A), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: 045L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Byetta, reaction(s): "known allergies: Byetta". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "not recovered", described as "Dose Number 1 and Dose Number 2: MODERNA"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment: Paxlovid.
Age: 65.0
Sex: F
Vaccine: 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 contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 13:45 as dose 5 (booster), single (Lot number: GH9693) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0170), on 18Nov2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: 33036BD (also reported as 330368D)), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing), notes: treated with radioablation, now hypothyroid.; "hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive; (25Jan2023) Negative; (25Jan2023) Negative; (25Jan2023) Positive; (25Jan2023) Positive; (04Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. On the eve of 24Jan2023, the patient had mild sore throat, cough, tight chest sensation, myalgias, no fever. The patient awoke on 25Jan2023, same but worse symptoms and tested twice, both negative for COVID. By 13:30, the patient had LG fever of 99.1, check COVID test and strongly positive pink line, surprised  the patient repeated test and positive. From 25Jan2023 to 30Jan2023, the patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID-19 treatment. The patient had no known allergies.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 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), 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 included: "Migraine" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "depression" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Treatment of COVID-19; Treatment of 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Nov2021 as dose 2, single (Lot number: 014F21A), in left arm and on 15Oct2022 as dose 4 (booster), single (Lot number: 053D22A), in left arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 11Apr2021 as dose 1, single (Lot number: 205A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Probably sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (01Feb2023) Negative, notes: tested negative or almost-negative; (03Feb2023) Positive, notes: Two days later, tested strongly positive and symptoms returned. Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 25Jan2023 to 30Jan2023 (lot number 1923797A) for treatment of COVID-19: after taking the full course of Paxlovid, 5 days x 3 pills x2 per day, she tested negative or almost-negative. Two days later, she tested strongly positive, and symptoms returned.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna: Dose number=3 / Pfizer/BioNTech: Dose number: 2; 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 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 at 11:00 as dose 1, single (Lot number: Ep7533), in left arm and on 18Apr2021 at 12:00 as dose 2, single (Lot number: EE0169), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Apr2022 at 14:00 as dose 4 (booster), single (Lot number: o49L21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2008, stop date: 23Jan2023; LEVOTHYROXINE, start date: 01Jan2008, stop date: 05Feb2023; TRAZODONE, start date: 01Jun2022, stop date: 21Jan2023. Not known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2021 at 13:00, outcome "unknown", described as "Moderna: Dose number=3 / Pfizer/BioNTech: Dose number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) Positive, notes: first ever positive test; (03Feb2023) negative; (05Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Lot number: GLO446) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2021 as dose  2, single (Lot number: EWO150, Expiration Date: Jul2021), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 301258), in left arm and on 05Jun2022 as dose 4 (booster), single (Lot number: FMU173), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Throat cancer", start date: 2017 (unspecified if ongoing), notes: fully recovered, no lymph nodes in left side of neck/chest. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No Known allergies. Patient received Paxlovid for Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: not able to sleep; caller has been having ringing in ears ever since; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: INSOMNIA (non-serious), outcome "unknown", described as "not able to sleep"; TINNITUS (non-serious), outcome "unknown", described as "caller has been having ringing in ears ever since". The event "not able to sleep" required physician office visit. Additional information: The patient was not able to sleep every day throughout the years since having the vaccine. The patient had a lot of issues and a reaction. Had seen all doctors but doctors don't have answers. This made the patient not trust any medications after getting the vaccination. the patient had been having ringing in ears ever since, that was not all, the patient had a lot going on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, Lot: EL3249), administration date: 23Jan2021, when the patient was 75-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (dose 2, single, Lot: EN6201), administration date: 13Feb2021, when the patient was 75-year-old, for COVID-19 IMMUNIZATION. The following information was reported: TINNITUS (non-serious) with onset Oct2021, outcome "not recovered". Additional information: The patient received his 3rd dose of the Pfizer Covid vaccine, which was his first booster dose on 23Oct2021, and 3-5 days later he got tinnitus in both ears. He has spoken to his primary care doctor, and even had another booster dose on 10Jan2023 (Lot: GJ6742). He spoke to a hearing doctor but nobody seemed to care or saying anything about it. He stated the side effects were on the news all the time and a doctor mentioned that tinnitus could be a side effect of the vaccine. He saw the hearing doctor shortly after the tinnitus began and was told that other veterans have complained about it as well. The hearing doctor sent him home with a music machine to use for the tinnitus. The patient clarified that the doctor told him that other people said that they got tinnitus after getting the vaccine, but did not know what manufacturer's product those other patients received. The patient did not have other vaccinations within four weeks prior to the first administration date of the suspect vaccine and did not have family medical history relevant to the adverse event.; Sender's Comments: Linked Report(s) : PFIZER INC-202300056353 Same patient/drug/event, different doses;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jan2023 as dose 4 (booster), single (Lot number: GJ6742) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, Lot: EL3249), administration date: 23Jan2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (dose 2, single, Lot: EN6201), administration date: 13Feb2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (dose 3 (booster), single, Lot: FE3592), administration date: 23Oct2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "Tinnitus". The following information was reported: TINNITUS (non-serious), outcome "not recovered". Additional information: The patient received his 3rd dose of the Pfizer Covid vaccine, which was his first booster dose on 23Oct2021, and 3-5 days later he got tinnitus in both ears. He has spoken to his primary care doctor, and even had another booster dose on 10Jan2023 (Lot: GJ6742). He spoke to a hearing doctor but nobody seemed to care or saying anything about it. He stated the side effects were on the news all the time and a doctor mentioned that tinnitus could be a side effect of the vaccine. He saw the hearing doctor shortly after the tinnitus began and was told that other veterans have complained about it as well. The hearing doctor sent him home with a music machine to use for the tinnitus. The patient clarified that the doctor told him that other people said that they got tinnitus after getting the vaccine but did not know what manufacturer's product those other patients received. The patient did not have other vaccinations within four weeks prior to the first administration date of the suspect vaccine and did not have family medical history relevant to the adverse events; Sender's Comments: Linked Report(s): PFIZER INC-202300056289 Same patient/drug/event, different doses.