chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID around the same time, in 2022, after we were vaccinated; Got COVID around the same time, in 2022, after we were vaccinated; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "recovered", described as "Got COVID around the same time, in 2022, after we were vaccinated"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "recovered", described as "got COVID around the same time, in 2022, after we were vaccinated". Clinical course: Caregiver reported: "They all got COVID around the same time, in 2022, after were vaccinated. It was mild." Reporter does not consider event as caused by suspect product(s).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400002758 same reporter, same product, different patient;US-PFIZER INC-202400005826 same reporter, same product, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 2, SINGLE), administration date: 18Apr2023, for COVID-19 immunization; Moderna (DOSE 1, SINGLE), administration date: 18Sep2022, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Lot number: H64629) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Peripheral artery disease" (unspecified if ongoing), notes: Peripheral artery disease; "Known allergies: Cephalosporins" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient took concomitant medications, EFA supplement from 04Apr2018 to 05Jan2024. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol". Vaccination history included: BNT162b2 (Dose Number: 3 , Batch/Lot No: FD8448 , Location of injection: Arm Left), administration date: 21Aug2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 4 , Batch/Lot No: FK9895 , Location of injection: Arm Left), administration date: 06Apr2022, when the patient was 59-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose Number: 5 , Batch/Lot No: GJ6739 , Location of injection: Arm Right), administration date: 16Jan2023, when the patient was 60-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 29Dec2023 to 03Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, 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 (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 27Dec2023 to 02Jan2024. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #4: Pfizer /Dose #5: Novavax; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 13:00 as dose 4 (booster), single (Lot number: GJ665) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Nov2021 at 01:00 as dose 3 (booster), single (Lot number: FJ1611), in left arm for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 06Nov2023 at 14:00 as dose 5 (booster), single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "BBPV" (unspecified if ongoing); "bad taste in the mouth after taking medication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2023 at 14:00, outcome "unknown", described as "Dose #4: Pfizer /Dose #5: Novavax"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative for 2 days; Negative, notes: tested negative for 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID 19 Treatment from  30Dec2023 to 03Jan2024. Covid rebound after 2 days complete Paxlovid. She was tested negative for 2 days after complete her last dose of Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years 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 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 26Dec2023 to 31Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician from product quality group.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Lot number: HG2649), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "MI", start date: 2019 (unspecified if ongoing); "GERD" (unspecified if ongoing); "Meniere's disease" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jun2019; BRILINTA, start date: 13May2019; PANTOPRAZOLE, start date: 01Jul2019. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2023) Positive, notes: Tested COVID Ag positive 24Dec2023.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (dose number unknown, single, in the left arm), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2023) Positive; (26Dec2023) Negative; (31Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors. However, a contributory role of BNT162b2 omi xbb.1.5 to the events Drug Ineffective and Covid-19 cannot be ruled out.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2021 as dose 1, single), in left arm, on 04May2021 as dose 2, single), in left arm and on 29Nov2021 as dose 3 (booster), single), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 22Dec2023 to 27Dec2023.  No follow-up attempts are possible.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid treatment from 19Dec2023 to 23Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: M
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 Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer survivor" (unspecified if ongoing), notes: Prostate cancer survivor. The patient's concomitant medications were not reported. Vaccination history included: moderna vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 13Jan2021, when the patient was 65-year-old, for COVID-19 immunization; moderna vaccine (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 03Feb2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 14Oct2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 4, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 16Apr2022, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 07Sep2022, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 6, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 26Apr2023, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was started as treatment on 26Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19 Treatment; covid-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 10:45 as dose 1, single (Lot number: HH7595) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: johnson and johnson (DOSE 1, SINGLE, vaccine administration time=10:00 AM, vaccine lot number=1805029, vaccine location=Left arm), administration date: 19Mar2021, when the patient was 54-year-old, for Covid-19 Immunization; moderna (DOSE 2 (BOOSTER), SINGLE, vaccine administration time=09:00 AM, vaccine location=Right arm), administration date: 26Oct2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE, vaccine administration time=10:00 AM, vaccine lot number=GJ6665 , vaccine location=Left arm), administration date: 03Oct2022, when the patient was 55-year-old, for Covid-19 Immunization, reaction(s): "Interchange of vaccine products"; moderna (DOSE 4 (BOOSTER), SINGLE, vaccine administration time=10:00 AM, vaccine lot number=056M21A, vaccine location=Left arm), administration date: 13May2023, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on day 5. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28Dec2023 to 02Jan2024. Clinical course: Patient had no known allergies.
Age: 34.0
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 Nurse from product quality group.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 34 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Allergies: Lavender" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 23Aug2018. 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 which included taking PAXLOVID (Lot GK2916 SN 590590068241) on 04Jan2024.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Have retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Septra, reaction(s): "Allergy"; Penicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, 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 which included paxlovid from 22Dec2023 to 26Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
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 Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 as dose 1, single (Lot number: HF9298) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Patient did not have known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2023) Negative. Therapeutic measures including Paxlovid from 27Dec2023 to 31Dec2023 were taken as a result of drug ineffective, covid-19.
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 Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfur" (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 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: M
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 Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (batch/lot number: unknown) at the age of 65 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, 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 Tb from 21Dec2023 to 26Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Lot number: HG4436) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN, start date: 01Jun2023, stop date: 06Jan2024; LEXAPRO, start date: 01Jun2023, stop date: 06Jan2024. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 5, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Positive; (Dec2023) Negative, notes: Then 2 negative tests 48 hrs apart; (Dec2023) Negative, notes: Then 2 negative tests 48 hrs apart. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 12:00 as dose 1, single (Lot number: HH7595) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer/biontech vaccine (Dose 6, At 12:00 PM, lot number: GJ3208, vaccine location: Left arm), administration date: 11May2023, when the patient was 67-year-old, for Covid-19 immunization; pfizer/biontech vaccine (Dose 5, At 12:00 PM, lot number: GJ2524, vaccine location: Left arm), administration date: 19Sep2022, when the patient was 66-year-old, for Covid-19 immunization; pfizer/biontech vaccine (Dose 4, At 12:00 PM, lot number: FK9893, vaccine location: Right arm), administration date: 26Apr2022, when the patient was 66-year-old, for Covid-19 immunization; pfizer/biontech vaccine (Dose 3, At 12:00 PM, lot number: 301308A, vaccine location: Left arm), administration date: 05Oct2021, when the patient was 65-year-old, for Covid-19 immunization; pfizer/biontech vaccine (Dose 2, At 12:00 PM, lot number: EP6955, vaccine location: Left arm), administration date: 29Mar2021, when the patient was 65-year-old, for Covid-19 immunization; pfizer/biontech vaccine (Dose 1, At: 12:00 PM, lot number: EN6199, vaccine location: Left arm), administration date: 07Mar2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures included paxlovid from 19Dec2023 to 24Dec2023 were taken as a result of vaccination failure, covid-19.
Age: 66.0
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 Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2024) Negative, notes: I tested negative 2 and 3 days after Paxlovid; (03Jan2024) Negative, notes: I tested negative 2 and 3 days after Paxlovid; (04Jan2024) Positive, notes: I am now testing positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Paxlovid Treatment start date: 27Dec2023 to 01Jan2024. Case was reported as non-serious.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose Number: 7  Moderna, Dose Number: 6  Pfizer / BioNTech; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 12:00 as dose 6 (booster), single (Lot number: GJ2524) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 at 16:15 as dose 1, single), in left arm, on 25Jan2021 at 15:45 as dose 2, single (Lot number: 030l20A), in left arm, on 27Feb2021 at 16:00 as dose 3 (booster), single (Lot number: 011A21A), in left arm, on 06Dec2021 at 12:00 as dose 4 (booster), single (Lot number: 939909), in left arm, on 05Jul2022 at 12:00 as dose 5 (booster), single (Lot number: 059A22A), in left arm and on 20Oct2023 at 13:00 as dose 7 (booster), single (Lot number: AU3919B) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 7  Moderna, Dose Number: 6  Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment with Paxlovid, treatment start date=20Dec2023, treatment stop date=25Dec2023.
Age: 52.0
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 Consumer or other non HCP from product quality group.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 5 (BOOSTER), Batch/Lot No: GH9694, Location of injection: Arm Left), administration date: 13Sep2022, when the patient was 51-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 4 (BOOSTER), Batch/Lot No: FJ4989, Location of injection: Arm Left), administration date: 27May2022, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 3 (BOOSTER), Batch/Lot No: 320308D, Location of injection: Arm Left), administration date: 29Oct2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 49-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 13Mar2021, when the patient was 49-year-old, for Covid-19 immunization, reaction(s): "COVID-19". 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: (04Jan2024) Negative, notes: I had two negative tests two days (48 hours apart) (on 04Jan and 06Jan2024); (06Jan2024) Negative, notes: I had two negative tests two days (48 hours apart) (on 04Jan and 06Jan2024); (Jan2024) Positive, notes: I again tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 30Dec2023 to 03Jan2024 (Lot number: GK5781).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
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 Consumer or other non HCP from product quality group.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Nov2023 at 16:30 as dose 1, single (Lot number: HG4664) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Penicillin" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Meniere's" (unspecified if ongoing); "intramyocardial bridging" (unspecified if ongoing); "MVP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing), notes: managed with statin drug; "hypogonadism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies". Vaccination history included: BNT162b2 (DOSE 6 (BOOSTER), SINGLE, vaccine administration time=05:00 PM, vaccine lot number=GM1767, vaccine location=Left arm), administration date: 30Jul2023, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, vaccine administration time=12:00 PM, vaccine lot number=GJ3274, vaccine location=Left arm), administration date: 08Jan2023, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, vaccine administration time=04:00 PM, vaccine lot number=FP4554, vaccine location=Left arm), administration date: 16Jul2022, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, vaccine lot number=Fc3183, vaccine lot unknown=False, vaccine location=Left arm), administration date: 29Aug2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, vaccine administration time=09:00 AM, vaccine lot number=EN6204, vaccine location=Right arm), administration date: 21Mar2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE, vaccine administration time=04:00 PM, vaccine lot number=EN6202, vaccine location=Right arm), administration date: 28Feb2021, when the patient was 62-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid (lot number: GY5517) for COVID 19 Treatment from 29Dec2023 to 03Jan2024.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Disease recurrence; Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a Consumer or other non HCP from the health authority. Other Case identifier(s): GB-MHRA-ADR 28382849, GB-MHRA-WEBCOVID-202312070507288360-RTHLP.  A 53-year-old male patient received BNT162b2 (COMIRNATY), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) with onset 01Nov2022, outcome "recovered with sequelae" (18Nov2022); SUSPECTED COVID-19 (hospitalization, medically significant) with onset 01Nov2022, outcome "recovered with sequelae" (18Nov2022); DISEASE RECURRENCE (hospitalization, medically significant) with onset 02Nov2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2023) Yes - Positive COVID-19 test.  Clinical course: Patient was not enrolled in clinical trial and not had symptoms associated with COVID-19. The report did not related to possible myocarditis or pericarditis.  Follow up (05Jan2024): This is a follow up to notify that case 202300441088 was submitted with an incorrect country of primary reporter. 202300441088 will be considered invalid and and corresponding information is re-entered under manufacturer report number 202400007398.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007405 different events, same product, same patient;
Sex: M
Vaccine: COVID19
Symptoms: Scar, Skin erosion
Clinical narrative: Blistering/Blister on hands and feet; rash; red swollen lips; red swollen lips; scarring all over body; raw skin; Kawasaki disease; This is a spontaneous report received from a Consumer or other non HCP from the Regulatory Agency.  A 53-year-old male patient received BNT162b2 (COMIRNATY), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine, for COVID-19 Immunisation, reaction(s): "Fever on and off". The following information was reported: BLISTER (hospitalization) with onset 01Feb2022, 5 days after the suspect product(s) administration, outcome "recovered" (15Mar2022), described as "Blistering/Blister on hands and feet"; RASH (hospitalization) with onset 01Feb2022, 5 days after the suspect product(s) administration, outcome "recovered" (15Mar2022); KAWASAKI'S DISEASE (hospitalization) with onset 2022, outcome "unknown", described as "Kawasaki disease"; SKIN EROSION (hospitalization) with onset 2022, outcome "unknown", described as "raw skin"; LIP ERYTHEMA (hospitalization), LIP SWELLING (hospitalization) all with onset 2022, outcome "unknown" and all described as "red swollen lips"; SCAR (hospitalization) with onset 2022, outcome "unknown", described as "scarring all over body". The patient was hospitalized for blister, rash, lip erythema, lip swelling, scar, skin erosion, kawasaki's disease (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of blister, rash, lip erythema, lip swelling, scar, skin erosion, kawasaki's disease. Clinical course: It was reported that patient presented symptoms very similar to Kawasaki disease. Minor side effects including fever after first shot major ones after second. Blistering on hand and feet the worth, which led to raw skin after the popped. 5 days in hospital. Left scarring all over body. Very major reaction. It was hard to overstate how bad it was. After second vaccine patient had rash and blistering started 5 days after. First symptom was large red swollen lips, blisters worst on hand and feet. He almost had to be treated as a burn victim after the blisters opened up. Worst were feet that each had on big blister covering all of bottom of feet. He was left with severe scarring, especially on bank and stomach. Got his shot very early soon after vaccine was introduced. Patient was not enrolled in clinical trial and not had symptoms associated with COVID-19. The report did not related to possible myocarditis or pericarditis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (05Jan2024): This is a follow up to notify that case 202300442544 was submitted with an incorrect country of primary reporter. 202300442544 will be considered invalid and corresponding information is re-entered under manufacturer report number 202400007405.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007398 different events, same product, same patient;
Age: 36.0
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 Consumer or other non HCP from product quality group.  A 36-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 at 18:00 as dose 1, single (Lot number: HG9497) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Dec2022, stop date: 23Dec2023; ATORVASTATIN, start date: 01Jun2022, stop date: 23Dec2023; FLUOXETINE, start date: 01Dec2022, stop date: 23Dec2023; PHENTERMINE, start date: 01Dec2022, stop date: 23Dec2023. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. 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 from 24Dec2023 to 29Dec2023.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old male patient received BNT162b2 (COMIRNATY), in Apr2021 as dose 2, single (Lot number: ER8733) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: Mar2021, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jul2021, outcome "not recovered", described as "Ringing in the ear". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and have no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Comirnaty in Nov2021, dose 3 (booster), single (lot number FJ1611).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Soreness at injection site; headache; muscle ache; exhausted; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jan2024 as dose 1, single (Lot number: HM7010) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Jan2024 at 21:00, outcome "recovering", described as "Soreness at injection site"; FATIGUE (non-serious) with onset 03Jan2024 at 21:00, outcome "recovering", described as "exhausted"; HEADACHE (non-serious) with onset 03Jan2024 at 21:00, outcome "recovering"; MYALGIA (non-serious) with onset 03Jan2024 at 21:00, outcome "recovering", described as "muscle ache". Therapeutic measures were not taken as a result of vaccination site pain, headache, myalgia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 at 16:00 as dose 1, single (Lot number: 00069-2362-10) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacture Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacture Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacture Unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 with paxlovid from 26Dec2023 to 30Dec2023.