chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
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). 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 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: DEPO-ESTRADIOL, start date: 07Dec2017; PROGESTERONE, start date: 09May2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical information: The patient had COVID-19 in 2022 and received PAXLOVID as treatment from 20Dec2022 until 25Dec2022. It was stated that the patient was negative for consecutive tests each 24 hours apart in Dec2022.   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: 36.0
Sex: F
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). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 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 included: "known allergies: Peanuts" (unspecified if ongoing). If vaccine received: Yes. Other medication in 2 weeks: Yes. Concomitant medication(s) included: LEVOTHYROXINE; ZOLOFT.  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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna dose: 3 15Sep2022/Pfizer dose 2: 15Oct2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 12May2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: LISINOPRIL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12May2022, outcome "unknown", described as "Moderna dose: 3 15Sep2022/Pfizer dose 2: 15Oct2021"; 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; (18Dec2022) Negative, notes: Tested negative on Dec 18Dec, 19Dec, and 26Dec; (19Dec2022) Negative, notes: Tested negative on Dec 18Dec, 19Dec, and 26Dec; (26Dec2022) Negative, notes: Tested negative on Dec 18Dec, 19Dec, and 26Dec; (31Dec2022) Positive, notes: Retested positive on 31Dec. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300003295 Same patient, same product, different event;
Age: 64.0
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 a contactable reporter (Consumer or other non HCP). 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), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Dec2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Allergy to bell peppers" (unspecified if ongoing). There were no concomitant medications. 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 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included PAXLOVID from 22Dec2022 to 26Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 31Mar2022 at 10:00 as dose 4 (booster), single (Lot number: 046L21A), 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: "High cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "heart valve repair", start date: 28Jan2022 (unspecified if ongoing), notes: Other medical history: heart valve repair 28Jan2022. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 as the patient received Paxlovid treatment on 30Dec2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 30-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; 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received paxlovid (Lot number: 1923798A) for COVID 19 treatment from 29Dec2022. No known allergies were reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  COVID 19, drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Age: 44.0
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 45-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: GH9694) 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), 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: "Obesity" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: avocado" (unspecified if ongoing); "Known allergies: banana" (unspecified if ongoing); "Known allergies: strawberry" (unspecified if ongoing); "Known allergies: pumpkin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Covid 19 Treatment; (01Jan2023) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
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 non-contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN. 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; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between the reported events Drug Ineffective, Covid 19 and the suspect drug cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), 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 included: "Lupus (SLE)" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Patient received anti-viral, Paxlovid as covid-19 treatment from 21Dec2022 to 26Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jul2022 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm 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: "Asthma" (unspecified if ongoing); "Pneumonia" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: If vaccine received: Yes. Patient not received other medication in 2 weeks. Patient not had any known allergies. Anti viral details: [{product COVID 19 Treatment, brand Paxlovid , treatment start date was 21Dec2022, treatment stop date was 26Dec2022, indication was Treatment of COVID-19).  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, 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) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 as dose 3 (booster), single (Lot number: FP7138) at the age of 51 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: "Known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benzoyl peroxide, reaction(s): "Known allergies: benzoyl peroxide", notes: Known allergies: benzoyl peroxide. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: This was a report about COVID Treatment. Other medical history included none. Patient received anti-viral product Paxlovid (Pfizer) from 20Dec2022 till 24Dec2022 for treatment of COVID-19. Had reoccurring symptoms started the following Wednesday 28Dec after finishing Paxlovid, received no treatment and was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "drug ineffective", "COVID-19".
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose 1-3: Moderna Vaccine and dose 4 Pfizer; 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 22-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 right arm for covid-19 immunisation; elasomeran (MODERNA 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), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "Lymphocytic colitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "contact dermatitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Dogs" (unspecified if ongoing); "Known allergies: Cats" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). Concomitant medication(s) included: LIALDA; FLUOXETINE; DUPIXENT; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OXYBUTYNIN. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Erethromycin, reaction(s): "Known allergies: Erethromycin"; Tamiflu, reaction(s): "Known allergies: Tamiflu"; Formaldehyde, reaction(s): "Known allergies: Formaldehyde". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "Dose 1-3: Moderna Vaccine and dose 4 Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took a round of Paxlovid after testing positive for covid; Positive, notes: I tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Reported as, patient took a round of Paxlovid after testing positive for covid. Patient symptoms had gone away, but she continued to mask. On the fourth day after finishing the Paxlovid, her symptoms reappeared. She tested positive for Covid again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive test; Covid positive test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 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 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 positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Other medication was received in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Moderna / dose #5 Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EK4176), on 12Feb2021 as dose 2, single (Lot number: EM9809) and on 11Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 60 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 066A21A) and on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: macrodantin, reaction(s): "Drug Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Moderna / dose #5 Moderna"; VACCINATION FAILURE (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: Negative, notes: Two negative daily tests and then a positive; Negative, notes: Two negative daily tests and then a positive; Positive, notes: Two negative daily tests and then a positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 65.0
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). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EP6955), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0217) and on 27Apr2022 as dose 4 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "past mini-stroke" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2022) Negative, notes: Negative antigen test on 30Dec2022; (01Jan2023) Positive, notes: Antigen test positive again on 01Jan2023; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID Treatment).
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Cardiac monitoring, Cardiac stress test, Echocardiogram
Clinical narrative: Heart attack; Hemochromatosis; Enzyme troponin showed up; The initial case was missing the following minimum criteria: specific suspect drug. Upon receipt of follow-up information on 30Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EP6955), as dose 2, single (Lot number: EP7534), as dose 3 (booster), single (Lot number: FF8841) and as dose 4 (booster), single (Lot number: FJ9943) for COVID-19 immunisation; atorvastatin (ATORVASTATIN), (ongoing) (Batch/Lot number: unknown) at 20 mg 1x/day for blood cholesterol abnormal; lisinopril (LISINOPRIL), (ongoing) (Batch/Lot number: unknown) at 20-25 mg, 2x/day for hypertension. The patient's relevant medical history included: "High blood pressure" (ongoing); "Cholesterol" (ongoing); "Heart murmur", start date: 21Dec1956 (ongoing). Concomitant medications included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); NP THYROID (ongoing). The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 04Oct2022, outcome "recovered", described as "Heart attack"; TROPONIN INCREASED (non-serious) with onset 05Oct2022, outcome "recovering", described as "Enzyme troponin showed up"; HAEMOCHROMATOSIS (non-serious), outcome "unknown", described as "Hemochromatosis". The patient was hospitalized for myocardial infarction (start date: 05Oct2022). The events "heart attack" and "enzyme troponin showed up" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: (unspecified date) Unknown results; Blood test: (unspecified date) Unknown results; Cardiac monitoring: (unspecified date) Unknown results; Cardiac stress test: (unspecified date) Unknown results; Echocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging heart: (unspecified date) Unknown results; Troponin: (05Oct2022) Showed up. The action taken for atorvastatin and lisinopril was dosage not changed. Therapeutic measures were taken as a result of myocardial infarction, troponin increased. Clinical course: The patient reported that she recently had a heart attack. She was admitted to emergency on 05Oct2022. The enzyme troponin showed up but subsided around 10AM on 05Oct2022. While there, she was put on Metoprolol and Eliquis. Echocardiogram, angiogram, MRI of her heart, and all kinds of blood work (blood was drawn throughout her stay) were performed. She had a stress test since and was currently wearing a heart monitor. She does have a heart murmur but still no cause. The patient also reported that she does have hemochromatosis (unspecified onset date). Additional information: Lisinopril and Hydrochlorothiazide start date: 20 years, Atorvastatin start date: 10 years, NP Thyroid start date: 4 years prior to the time of the report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I've been totally vaccinated and all kinds of boosters and everything and still got it.; I've been totally vaccinated and all kinds of boosters and everything and still got it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I've been totally vaccinated and all kinds of boosters and everything and still got it.". Clinical course: Patient stated "I forgot I have so much stuff going on and Covid this last year left me clueless...I actually didn't experience it until the summer which was bad because I've always managed to keep myself fine and than I got the 5, 4/5 variant and than I felt better after I initially got sick for like 4 or 5 days and than I stayed feeling bad for like a whole month. So it kind of ruined my whole summer but at least I didn't end up in the hospital or anything and I've been totally vaccinated and all kinds of boosters and everything and still got it. Its fine I'm alive...   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.
Sex: U
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Feeding disorder
Clinical narrative: 20 hrs. long stomachache; unable consume food; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4; Manufacturer unknown), for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 30Dec2022, outcome "recovered" (Dec2022), described as "20 hrs long stomach ache"; FEEDING DISORDER (non-serious) with onset 30Dec2022, outcome "recovered" (31Dec2022), described as "unable consume food".  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: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Got COVID". Clinical course: The patient received his booster shot and had "a bit of a reaction to it, more significant than the previous boosters". The patient got COVID during a cruise in Sep, but did not notice any changes in heart rhythm while sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Coma, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Coma; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "recovering"; COMA (medically significant), outcome "recovering". Therapeutic measures were taken as a result of guillain-barre syndrome, coma. Clinical course: The patient regretfully reported that he/she received the Pfizer COVID vaccine almost one and a half years prior to the time of the report while working in the [country]. The patient developed GBS, which left him/her in a coma and paralyzed both hands and legs. The patient had only made a minor recovery after extensive medical treatments. As a result, the patient stated that he/she need to file a lawsuit against Pfizer for concealing these types of side effects from vaccine recipients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Thrombosis
Clinical narrative: severe myocarditis; blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed with unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE NUMBER UNNOWN (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 immunization. The following information was reported: MYOCARDITIS (death, medically significant), outcome "fatal", described as "severe myocarditis"; THROMBOSIS (death, medically significant), outcome "fatal", described as "blood clots". The patient date of death was unknown. Reported cause of death: "severe myocarditis", "blood clots". It was not reported if an autopsy was performed. Clinical course: the patient's father in law died of severe myocarditis and blood clots 1 month after receiving his 2nd Pfizer covid booster shot. The patient was a recovered cancer patient who had a perfectly clean bill of health and was just examined prior and had a heart that was in perfect shape.   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.; Reported Cause(s) of Death: severe myocarditis; blood clots
Sex: F
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: paralyzed; Initial information was received on 31-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves an unknown age of female patient who experienced paralyzed after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (lot number, formulation, strength, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a serious event of paralyzed (paralysis) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (paralyzed).  At time of reporting, the outcome was Unknown for the event paralyzed.  Seriousness Criteria : This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2023: This case involves an unknown age of female patient who experienced paralyzed after receiving influenza vaccine. Further information regarding past medical history, concurrent condition, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Influenza
Clinical narrative: had the worst flu ever going on my second week of coughing; had the worst flu ever going on my second week of coughing; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who had the worst flu ever going on his/ her second week of coughing after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, expiry date, form: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had the worst flu ever going on my second week of coughing (cough) (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (had the worst flu ever going on my second week of coughing).  At time of reporting, the outcome was Unknown for both the events (cough, influenza).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu shot and still got the flu; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-Health Care Professional.  This case involves Adult and unknown gender patient who experienced I got the flu shot and still got the flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (with dose, strength, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious I got the flu shot and still got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got a flu shot still got it; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.   This case involves an patient of unknown age and gender who received a flu shot still got it.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, Expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination..  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 31-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves an adult patient of who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got my flue shot and today I have the flu; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date: not reported) via unknown route in unknown administration site (form, strength: unknown) for prophylactic vaccination.  On 31-DEC-2022 the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "I got my flue shot and today I have the flu".  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got a flu shot and still got influenza; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult and unknown gender patient who got a flu shot and still got influenza after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient got a flu shot and still got influenza (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly "Got a flu shot and still got Influenza"   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: sick for more than 2 weeks.; I have flu type A; Initial information received on 02-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who reported been sick for more than 2 weeks and i have flu type a after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site.  On an unknown date the patient reported been sick for more than 2 weeks (illness) and I have flu type A (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 02-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of an unknown age and gender who experienced flu after receiving vaccine influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.