chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand=Pfizer / BioNTech/vaccine brand other=Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06May2023 at 16:00 as dose 4 (booster), single (Lot number: GJ326P) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Dec2021 as dose 3 (booster), single (Lot number: 041J21A), in right 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: "Kidney stone", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: MACUHEALTH, start date: 01Jan2022, stop date: 16Sep2023; LIFEPAK NANO, start date: 01Jan2022, stop date: 16Sep2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand=Pfizer / BioNTech/vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Known allergies was reported as NKMA. Stage 0 melanoma removed in Feb2023.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2, bnt162b2 omi ba.4-5  in this patient cannot be completely excluded.
Age: 59.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2 NOS), on 11Sep2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Sep2023) Positive, notes: positive test 2 days after completing final dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: M
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). The reporter is the patient.  A 30-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 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: "Allergy: Sulfa medications" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Fatty Liver" (unspecified if ongoing); "Obesity" (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 Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". 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 included PAXLOVID from 06Sep2023 to 10Sep2023.   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: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had Covid; I had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old patient received 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 (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "I had Covid". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 11 day(s)). The event "i had covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient on the Paxlovid (Treatment).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 26Apr2021 as dose 2, single (Lot number: ER8736), in left arm, on 21Dec2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FJ5683), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "gout" (unspecified if ongoing); "ADD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Sep2023.
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 60 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: Fm9992) 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: "Allergy: latex" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; VAGIFEM. 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: Patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 07Sep2023 to 12 Sep2023
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 07Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 02Oct2022 as dose 4 (booster), single (Lot number: 062F22A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "overweight" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2022, outcome "recovered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Sep2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) negative. Therapeutic measures were taken as a result of drug ineffective COVID-19 which included as PAXLOVID as prescribed from 30Aug2023 until 04Sep2023.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
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 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 6 (booster) , single (Batch/Lot number: unknown) at the age of 49 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), 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. The patient had no relevant medical history. No known allergies. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment of COVID-19 included Paxlovid from 06Sep2023 to 10Sep2023. 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
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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), in Apr2023 as dose 6 (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), 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. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "restless legs syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asparagus, reaction(s): "Drug Allergy: Asparagus". 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. The patient used Paxlovid as treatment from 04Sep2023 to 09Sep2023.   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: 35.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 03Sep2023 to 07Sep2023.  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 the information currently available, a lack of efficacy with bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded
Age: 72.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: Qj5342) at the age of 72 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: Fm0698) 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 had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  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 including Paxlovid from 06Sep2023 to 11Sep2023.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 3 Moderna, Dose 4 BNT16B2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:00 as dose 4 (booster), single (Lot number: G49694) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: 030L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: 001A21A), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PMDD" (unspecified if ongoing); "Known allergies: Citalopram and benzocaine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022 at 14:00, outcome "unknown", described as "Dose 3 Moderna, Dose 4 BNT16B2"; 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 which included Paxlovid received from 30Aug2023 to 03Sep2023.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.The patient had no known allergies. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid from 28Aug2023 to 01Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: 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 39-year-old male patient received bnt162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergies. 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. COVID-19 Treatment included Paxlovid from 08Sep2023 to 12Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 46-year-old female patient (not pregnant) 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'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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 14Sep2023.  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: 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).  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 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's relevant medical history included: "Taking blood pressure medication ongoing" (ongoing). The patient has no known allergies. The patient took concomitant medications. 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: (11Sep2023) positive, notes: Tested positive morning after completing five days of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID rebound; COVID rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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: "shiitake mushrooms" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16Sep2023, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID rebound". 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.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 cannot be fully excluded.
Age: 53.0
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) (Nurse). 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 22Sep2022 as dose 5 (booster), single (Lot number: GJ6739) 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), 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: "hypothyroidism" (unspecified if ongoing); "htn" (unspecified if ongoing); "IDDM" (unspecified if ongoing). Known allergies reported as none. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included COVID 19 Treatment from 07Sep2023 to 11Sep2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 50.0
Sex: F
Vaccine: 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 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), in Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  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 including Paxlovid from 11Sep2023 to 16Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 44.0
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 45-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 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: "IBS" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing); "Barrett's esophagus" (unspecified if ongoing); "Bipolar II" (unspecified if ongoing); "arthritis" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2023) Positive, notes: positive home test beginning on 14Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19 (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.
Age: 65.0
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 contactable reporter(s) (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), on 11Aug2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 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), as dose 4 (booster), single (Batch/Lot number: unknown) and 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. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". 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. COVID-19 Treatment included Paxlovid from 07Sep2023 to 11Sep2023. 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: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: gotten COVID; gotten COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) 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) 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), outcome "unknown" and all described as "gotten COVID". The event "gotten covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had been vaccinated and have been, have had the extra shots, the patient had three of those, but looks like the patient still caught it. So, patient went to the doctor and the doctor gave the patient Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy heart, C-reactive protein, Ejection fraction, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: acute myocarditis 2 days after 1st dose; This is a literature report from License Party for the following literature source(s).  A 40-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SARS-CoV-2 infection" (unspecified if ongoing), notes: without need for hospitalization. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "acute myocarditis 2 days after 1st dose". The patient underwent the following laboratory tests and procedures: Biopsy heart: no active myocarditis; C-reactive protein: 9.5; Ejection fraction: 47 %, notes: generalized hypokinesia; Electrocardiogram: Diffuse ST-segment elevation, notes: with depression in aVR, V1; Magnetic resonance imaging: Edema delayed enhancement, pericardial effusion; SARS-CoV-2 test: negative; Troponin: 102; 520. Therapeutic measures were taken as a result of myocarditis.  Clinical course: The patient had previously been infected by SARS-CoV-2 without need for hospitalization. The patient hospitalized with chest pain and who were diagnosed with myocarditis by laboratory and cardiac magnetic resonance imaging 2 days after 1st dose of BNT162b2. The chest pain was most commonly described as constant, nonpositional, and nonpleuritic, consistent with acute myocarditis mainly without pericardial involvement. Troponin values were elevated and appeared to peak the day after admission, whereas had no eosinophilia. The patient was tested and negative for SARS-CoV-2. Cardiac magnetic resonance imaging revealed patchy delayed gadolinium enhancement consistent with myocarditis in patient. The patient had resolution of his chest pain, was discharged from the hospital in stable condition, and were alive with preserved left ventricular ejection fraction at last contact. The patient was hemodynamically stable; endomyocardial biopsy found no active myocarditis. Therapeutic measures included prednisone and colchicine.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test, Troponin
Clinical narrative: acute myocarditis 2 days after 1st dose; This is a literature report from License Party for the following literature source(s).  A 40-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SARS-CoV-2 infection" (unspecified if ongoing), notes: without need for hospitalization. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "acute myocarditis 2 days after 1st dose". The patient underwent the following laboratory tests and procedures: Biopsy heart: no active myocarditis; C-reactive protein: 9.5; Ejection fraction: 47 %, notes: generalized hypokinesia; Electrocardiogram: Diffuse ST-segment elevation, notes: with depression in aVR, V1; Magnetic resonance imaging: Edema delayed enhancement, pericardial effusion; SARS-CoV-2 test: negative; Troponin: 102; 520. Therapeutic measures were taken as a result of myocarditis.  Clinical course: The patient had previously been infected by SARS-CoV-2 without need for hospitalization. The patient hospitalized with chest pain and who were diagnosed with myocarditis by laboratory and cardiac magnetic resonance imaging 2 days after 1st dose of BNT162b2. The chest pain was most commonly described as constant, nonpositional, and nonpleuritic, consistent with acute myocarditis mainly without pericardial involvement. Troponin values were elevated and appeared to peak the day after admission, whereas had no eosinophilia. The patient was tested and negative for SARS-CoV-2. Cardiac magnetic resonance imaging revealed patchy delayed gadolinium enhancement consistent with myocarditis in patient. The patient had resolution of his chest pain, was discharged from the hospital in stable condition, and were alive with preserved left ventricular ejection fraction at last contact. The patient was hemodynamically stable; endomyocardial biopsy found no active myocarditis. Therapeutic measures included prednisone and colchicine.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: Get pneumonia; Get pneumonia; 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 pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 13Nov2013 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Get pneumonia". Clinical course: The patient had 2 pneumonia shots which the patient think would go back to about 10 years before. The patient had a Prevnar on 13Nov2013. Ironically back in April of this year (Apr2023) the patient did get pneumonia.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: severe brain bleed which left me disabled and crippled; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in Dec2021 as dose number unknown (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: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: ER2613), administration date: 25Mar2021, for covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EW0175), administration date: 11Aug2021, for covid-19 immunisation. The following information was reported: CEREBRAL HAEMORRHAGE (disability, medically significant), outcome "unknown", described as "severe brain bleed which left me disabled and crippled". Severe brain bleed which left patient disabled and crippled- lost medical practice and career plus any ability to perform any physical activity or have a job. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (CEREBRAL HAEMORRHAGE) and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300257445 Same patient/vaccine, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: they both got COVID; they both got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "they both got COVID". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: U
Vaccine: UNK
Symptoms: Animal bite, Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Imovax prescribed with off label diagnosis W55.81XA Bitten by other mammals with no adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 24-year-old and unknown gender patient who experienced intentional off label prescription by hcp: IPV (VERO) [Imovax] prescribed with off label diagnosis, bitten by other mammals with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the intentional off label prescription by hcp:  IPV (VERO) [Imovax] suspension for injection at dose 1ml via subcutaneous route was prescribed with off label diagnosis: bitten by other mammals (Animal bite) with no adverse event (off label use) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: Patient given Menquafi at 11 year and again at 12 year with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was given Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] at 11 year and again at 12 year with no reported adverse event.  The patient's past vaccination(s) included MENQUADFI on 13-SEP-2022 with At 11 years of age. The patient's past medical history, medical treatment(s) and family history were not provided.   On 08-Sep-2023, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection at 11 years and again at 12 years (lot U7673AB, with unknown strength, dose, expiry date) via unknown route in unknown administration site as prophylactic vaccination.  On 13-Sep-2022 and 08-Sep-2023, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine at 11 years and again at 12 years with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Deafness unilateral
Clinical narrative: deaf in left ear; Initial information received on 12-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient).  This case involves an unknown age and unknown gender patient who experienced deaf in left ear after receiving vaccines COVID-19 vaccine and Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2022, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer and COVID-19 vaccine not produced by Sanofi Pasteur with unknown strength, formulation, dose, frequency, batch number & expiry date via unknown route in unknown administration site for prophylactic vaccination and COVID-19 Immunisation respectively.  Information on batch number was requested.  Reportedly Patient claims flu vaccine left her deaf in one ear last year.  Will definitely get flu shot as I always have for years, but not with COVID vaccine together. Left me deaf in left ear last November (deafness unilateral)(onset date :unknown date in Nov-2022 ,unknown latency)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.  Seriousness Criteria: Medically Significant.; Sender's Comments: Sanofi Company Comment dated 19-Sep-2023: This case involves an unknown age and unknown gender patient who experienced deaf in left ear after receiving vaccines COVID-19 vaccine and Influenza Vaccine. Further information regarding past medical history, concurrent condition(s), time to onset, concomitant medication(s), allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cold sweat, Immediate post-injection reaction, Influenza, Pain
Clinical narrative: cold sweats; body aches like someone hit me head to toe; got the flu; Initial information received on 13-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who experienced cold sweats, body aches like someone hit me head to toe and 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 formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient developed cold sweats (cold sweat), body aches like someone hit me head to toe (pain) and got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, Product name was not provided. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine.  I only got the flu once in my life and it was immediately after getting the vaccine. I was soooooo cold sweats and body aches like someone hit me head to toe  for 3 days.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events cold sweats, body aches like someone hit me head to toe, got the flu.  At time of reporting, the outcome was Unknown for the event cold sweats, body aches like someone hit me head to toe and got the flu.