chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.  This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient has 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Two negative COVID Test; Negative, notes: Two negative COVID Test; Positive, notes: Tested covid positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 6 (Booster), Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster), Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Single, Unknown manufacturer), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 06Jan2024 to 10Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 14:00 as dose 1, single (Lot number: HG5685) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "osteopaenia" (unspecified if ongoing); "Hashimotos Thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 01Sep2017, stop date: 17Jan2024; METHOTREXATE, start date: 01Jan2020, stop date: 17Jan2024. Past drug history included: Tramadol, reaction(s): "known allergies Tramadol". Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2023, outcome "unknown" and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 30Dec2023 to 04Jan2024.
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 69-year-old male patient 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1; Unknown Manufacturer), for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound on January 18 after testing 3 x negative; Negative, notes: Rebound on January 18 after testing 3 x negative; Negative, notes: Rebound on January 18 after testing 3 x negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 10Jan2024 to 14Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 27.0
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 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose number unknown, single (Lot number: GH9694) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Just tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 08Jan2024 to 13Jan2024.
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.  A 35-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization.  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 vaccination failure, covid-19 which included Paxlovid taken from 05Jan2024 to 10Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Mar2020 (unspecified if ongoing), notes: No - but this was patient's 6th time with Covid since Mar2020. Patient no allergies history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID 19 treatment from 11Jan2024 to 16Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 61.0
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.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 (BOOSTER), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), Unknown Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included received Paxlovid from 14Jan2024 to 18Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 53-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: "Allergies: Penicillin" (unspecified if ongoing); "Obese" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "former smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naltrexone, reaction(s): "Allergies: Naltrexone"; Prednisone, reaction(s): "Allergies: Prednisone". 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 which included received Paxlovid from 09Jan2024 to 14Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug BNT162b2 omi xbb.1.5 and the reported events covid 19, drug ineffective cannot be excluded.
Age: 40.0
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 Physician.  A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "adhd" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "ptsd" (unspecified if ongoing); "solitary kidney" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: Tested negative on day 3 of paxlovid treatment; (Jan2024) Negative, notes: Tested negative on  day 5 of paxlovid treatment; (Jan2024) positive, notes: Covid Ag test positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included received Paxlovid from 11Jan2024 to 16Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug BNT162b2 omi xbb.1.5 and the events vaccination failure and covid 19 cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm and as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID 19 treatment from 05Jan2024 to 09Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 59.0
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 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 at 15:00 as dose 1, 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: "chronic fatigue" (unspecified if ongoing); "Cancer survivor", start date: 2014 (unspecified if ongoing), notes: cancer survivor (10 years); "pine nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin"; Meropenem, reaction(s): "known allergies: Meropenem". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, lot number unknown), reaction(s): "COVID-19 Immunization"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, lot number unknown), reaction(s): "COVID-19 Immunization"; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN, lot number unknown), reaction(s): "COVID-19 Immunization". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2024, outcome "recovered" (16Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2024) positive; (16Jan2024) negative; (17Jan2024) negative; (19Jan2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included received Paxlovid from 09Jan2024 to 14Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included: Paxlovid from 07Jan2024 to 12Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR test positive/ mild sc started 11Jan mild fever cough and rhinorrhea and loss of smell; PCR test positive/ mild sc started 11Jan mild fever cough and rhinorrhea and loss of smell; This is a spontaneous report received from a Nurse.  A 38-year-old female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HT9275) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 10Oct2023 as dose number unknown, single. Vaccination history included: Covid 19 vaccine (Dose Number: 1, manufacturer unknown), for Covid-19 Immunization; Covid 19 vaccine (Dose Number: 2, manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2024, outcome "recovered" and all described as "PCR test positive/ mild sc started 11Jan mild fever cough and rhinorrhea and loss of smell". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2024) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 42.0
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Cot nasal congestion on 19Jan and tested Ag positive; Cot nasal congestion on 19Jan and tested Ag positive; This is a spontaneous report received from a Nurse from product quality group.  A 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 as dose 1, single (Lot number: HF9275) at the age of 42 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 26Oct2023 as ose number unknown, single (Lot number: 944457), in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2024 at 08:00, outcome "unknown" and all described as "Cot nasal congestion on 19Jan and tested Ag positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (nasal swab) on 19Jan2024 was positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna Spikevax; 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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3248), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01May2023 as dose 6 (booster), single (Lot number: 067H22A), in left arm and on 29Sep2023 as dose 7 (booster), single (Lot number: AU3832B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis (quiet)" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Known allergies: Penicillin, crabmeat, quinoa" (unspecified if ongoing); "Known allergies: Penicillin, crabmeat, quinoa" (unspecified if ongoing), notes: Known allergies: Penicillin, crabmeat, quinoa; "Known allergies: Penicillin, crabmeat, quinoa" (unspecified if ongoing), notes: Known allergies: Penicillin, crabmeat, quinoa. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "Moderna Spikevax"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information included anti viral details COVID 19 Treatment with Paxlovid from 11Jan2024 to 16Jan2024.  No follow-up attempts are possible.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 13:00 as dose 1, single (Lot number: HG4629) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: treated, in 2021. Concomitant medication(s) included: ANASTROZOLE, start date: Feb2021. The patient had no known allergy.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "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 vaccination failure, covid-19 with paxlovid from 09Jan2024 to 13Jan2024.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Neurological symptom
Clinical narrative: Patient experienced loss of taste and smell along with significant neurological sequellae; Patient experienced loss of taste and smell along with significant neurological sequellae; Patient experienced loss of taste and smell along with significant neurological sequellae; This is a spontaneous report received from a Pharmacist.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 27May2021 as dose 2, single (Lot number: EW0177) at the age of 42 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0175, Route of Administration: Intramuscular), administration date: 06May2021, when the patient was 42-year-old, for COVID-19 Immunization.  The following information was reported: AGEUSIA (disability), ANOSMIA (disability), NEUROLOGICAL SYMPTOM (disability), outcome "not recovered" and all described as "Patient experienced loss of taste and smell along with significant neurological sequellae". The events "patient experienced loss of taste and smell along with significant neurological sequellae" required physician office visit. Therapeutic measures were taken as a result of ageusia, anosmia, neurological symptom.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug and events ageusia, anosmia, neurological symptom cannot be excluded. 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.
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.  A 35-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vasomotor rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergies: Doxycycline". Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Rash
Clinical narrative: 72 hours after vaccine, burning sensation, redness, and rash around both eye.; 72 hours after vaccine, burning sensation, redness, and rash around both eye.; 72 hours after vaccine, burning sensation, redness, and rash around both eye.; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Jan2024 at 18:00 as dose 1, single (Lot number: Unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to sedatives" (unspecified if ongoing), notes: allergic to sedatives. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]. The following information was reported: BURNING SENSATION (non-serious), ERYTHEMA (non-serious), RASH (non-serious) all with onset 19Jan2024 at 18:30, outcome "recovered" and all described as "72 hours after vaccine, burning sensation, redness, and rash around both eye.". Therapeutic measures were taken as a result of burning sensation, erythema, rash.  Additional information: Patient took 25 mg of Benadryl for treatment. Prior to vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Batch/lot number is not provided, and it cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single at the age of 37 years 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: "Diabetes" (unspecified if ongoing). 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) all with onset 26Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 27Dec2023 to 01Jan2024.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "primary immune disease/common variable immune disease" (unspecified if ongoing); "an autoimmune disease" (unspecified if ongoing); "severe gastroparesis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: didn't make one antibody. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid   Clinical course: Confirms she is at least 18 yrs of age and older. She received Pfizer covid vaccine a couple of years ago. Reports for 6 months after the shot, she experienced 'awful' and 'horrendous' side effects. She couldn't stay awake and she had muscle spasms all over her body. When she got tested for antibodies, she didn't make one antibody from the Pfizer covid vaccine; it was as if she never had the shot.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400020269 same patient and product, different dose and event;
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose #01, #02, #03, #05: Moderna /Dose #4: Pfizer; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2023 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Dec2021 as dose 1, single), in right arm, on 30Dec2021 as dose 2, single), in right arm, on 07Oct2022 as dose 3 (booster), single), in left arm and on 29Dec2023 at 12:00 as dose 5 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "egg sensitive" (unspecified if ongoing); "Tyoe 1 Narcolepsy" (unspecified if ongoing); "Chronic Migraine" (unspecified if ongoing); "Cluster Headaches" (unspecified if ongoing); "POTS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2023 at 13:00, outcome "unknown", described as "Dose #01, #02, #03, #05: Moderna /Dose #4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 4 days after a negative test; Positive, notes: Positive rapid test confirmed. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 07Jan2024 to 13Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got her Covid-19 shot and this year she got the new variant; she got her Covid-19 shot and this year she got the new variant; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 "recovered" and all described as "she got her Covid-19 shot and this year she got the new variant". The events "she got her covid-19 shot and this year she got the new variant" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: she tested negative, and had no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient said that she got her Covid-19 shot and this year she got the new variant and she took Paxlovid from her doctor and she tested negative, and had no symptoms.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 74.0
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 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Jan2024 to 13Jan2024. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2023 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Penicillin allergy" (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 10Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2024) Positive; (Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 10Jan2024 to 15Jan2024. Clinical course: Patient started Paxlovid as soon as he had symptoms and tested positive. Felt better and tested negative five days later.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 63.0
Sex: M
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.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid received from 09Jan2024 to 13Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Dec2023 as dose 1, single at the age of 66 years, 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: Covid-19 vaccine (dose 1, single, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 2, single, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 3 (booster), single, manufacturer unknown), 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received anti-viral COVID 19 treatment with Paxlovid from 06Jan2024 to 10Jan2024.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Nov2023 as dose 1, single (Lot number: HF9300) at the age of 39 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,SINGLE, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2,SINGLE, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER),SINGLE, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER),SINGLE, unknown manufacturer), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure which included Paxlovid received from 09Jan2024 to 13Jan2024. No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 received treatment of Paxlovid; COVID 19 received treatment of Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "celiac" (unspecified if ongoing); "Allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 received treatment of Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jan2024) Negative, notes: Negative for Covid after 6 days (11Jan) then started to feel tired and congested and tested positive again 20Jan; (20Jan2024) Positive, notes: Negative for Covid after 6 days (11Jan) then started to feel tired and congested and tested positive again 20Jan. Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID started on 07Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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 34-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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), 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.
Age: 73.0
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 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HD9876) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 19:30 as dose 1, single (Lot number: HF9275) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Banana" (unspecified if ongoing); "Known allergies: eggplant /chomwe (Korean melon)" (unspecified if ongoing); "Known allergies: pine nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose 4 (booster), single lot no. GH9694 on Arm Left), administration date: 21Sep2022, when the patient was 38-year-old, for COVID-19 immunization; moderna (Dose 3 (booster), single lot no. 027H27B), administration date: 14Dec2021, when the patient was 37-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single lot no. EW0165), administration date: 02May2021, when the patient was 36-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, single lot no. EW0158), administration date: 11Apr2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid administered from 02Jan2024 to 07Jan2024.
Age: 68.0
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.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: penicillin" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.