chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19-2
Symptoms: Histoplasmosis
Clinical narrative: had histoplasmosis a while back, said it was like fungus in the lungs; This spontaneous case was reported by a consumer and describes the occurrence of HISTOPLASMOSIS (had histoplasmosis a while back, said it was like fungus in the lungs) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included AFib (prior to vaccine).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HISTOPLASMOSIS (had histoplasmosis a while back, said it was like fungus in the lungs) (seriousness criterion medically significant). At the time of the report, HISTOPLASMOSIS (had histoplasmosis a while back, said it was like fungus in the lungs) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Patient received Spikevax as first dose. No treatment drug was reported. Company comment This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the serious (due to medically significant) unexpected, event of Histoplasmosis, which occurred on an unknown date and with unknown latency in the context of receiving the first dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine. It was reported that patient had histoplasmosis a while back, said it was like fungus in the lungs. No further information was disclosed. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Live significant Follow-up : Medical history and first dose details added.
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022).    No concomitant medications were reported.  The patient and the Nurse Practitioner did not wish to report any additional information. Patient did not even want to report the Adverse Event at all.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717576:
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: no adverse event; Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.; Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.), PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,) and NO ADVERSE EVENT (no adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Mar-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,). On 27-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.), PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Due to freezer issue on March 8th,2023, vaccine went possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Reporting Lot 010H22A Bivalent, Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes. ,).    No concomitant medications were reported. Patient did not report any reactions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717499 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717499:Same reporter ,Daughter case
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes; No adverse event; possible temperature excursion, patients received this vaccine; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes).    No concomitant drug was reported. It was reported that bivalent, due to freezer issue on 08-Mar-2023, possible temperature excursion, lowest Temperature -22.2 degree Celsius, High -13.6 degree Celsius, for over 10 minutes. Two patients received that vaccine. The patient received first bivalent dose. No reactions reported. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717480:Same reporter, mother case
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccine 4 weeks prior to COVID-19 vaccine.     On 28-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that the individual adult bivalent vial of 2.5 ml size was not exposed to temperature excursion. It was unknown when the vial was initially stored in refrigerator.  Treatment medications were not provided.  This case was reported for adult patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-717526 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717526:Patient 1 out of 2 adult patients
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 adult patients received expired Bivalent Booster of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 adult patients received expired Bivalent Booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 adult patients received expired Bivalent Booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 adult patients received expired Bivalent Booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 adult patients received expired Bivalent Booster of Moderna COVID-19 vaccine).    No concomitant drug was reported. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Individual vials of 2.5 ml was initially stored in the refrigerator. It was reported that vial did not undergo any temperature excursions. Dose administered after manufacturer date of expiry. No treatment drug was reported. This case contains information for the 1st of 2 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717543 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717543:Patient 2 out of 2 adult patients
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Doses were administered after temperature excursion in the refrigerator; Doses were administered after temperature excursion in the refrigerator; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator), PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was Unknown if patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator), PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator), PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator) and PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator).    No concomitant medications were reported.  Batch/lot number for suspect product was reported as 215K22A, AS7171B.  Excursion happened at less than 2C from 9:41 am to 10:23 am. Minimum temperature reached was 1.1C. Less than 2C from 17:43 to 18:04, minimum temperature reached was 1.8C. No treatment details were reported.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the fridge on 24-Jan-2023/Vaccine administered on 27-Feb-2023; no adverse event; Moderna Bivalent vaccine was administered after 30-day Use By Date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24-Jan-2023/Vaccine administered on 27-Feb-2023) and NO ADVERSE EVENT (no adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24-Jan-2023/Vaccine administered on 27-Feb-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24-Jan-2023/Vaccine administered on 27-Feb-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24-Jan-2023/Vaccine administered on 27-Feb-2023).    No concomitant medications were reported.  Vaccine was stored in the fridge on 24-Jan-2023.   Patient did not report any side effects.  No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023; No adverse event; Moderna Bivalent vaccine was administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day use by date), PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day use by date), PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient did not report any side effects. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023; no adverse event; a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023) and NO ADVERSE EVENT (no adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023).    Concomitant medication details not reported by the reporter. Vaccine was stored in the fridge on 24-Jan-2023. Treatment details was not reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023; no adverse event; Moderna Bivalent vaccine was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023) and NO ADVERSE EVENT (no adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023).    No concomitant medications was provided. No treatment medications was provided.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the fridge on 24Jan2023; no adverse event; Moderna Bivalent vaccine was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023) and NO ADVERSE EVENT (no adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023).    No concomitant medications were reported. No treatment details were reported. It was reported that patient had not reported any side effects post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity
Clinical narrative: He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure abnormal.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced PAIN IN EXTREMITY (He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days). On 27-Sep-2022, PAIN IN EXTREMITY (He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Patient experienced numbness and arm pain on the day of the vaccination.  On March 27th patient called the pharmacy and complained of numbness and pain that she felt radiated down to her legs when she woke up that morning.  At the time of conversation around 1pm she said the symptoms are starting to fade and is not as bad as it was that morning.  Pharmacist advised her to call her doctor and report the ADR so she can be checked if necessary.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Fatigue, Headache, Herpes zoster
Clinical narrative: Within a week developed large cold sore (shingles) on forehead and outer lower eye lid (both left side of face) Both calves, ankles,feet swelled up massively which lasted about 8/9 days. Tired headache lymph nodes in neck, groin, armpit and behind knees
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymph node pain, Lymphadenopathy, Oral herpes, Pain
Clinical narrative: Within a week developed large cold sore (shingles) on forehead and outer lower eye lid (both left side of face) Both calves, ankles,feet swelled up massively which lasted about 8/9 days. Tired headache lymph nodes in neck, groin, armpit and behind knees
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, X-ray limb
Clinical narrative: Within a week developed large cold sore (shingles) on forehead and outer lower eye lid (both left side of face) Both calves, ankles,feet swelled up massively which lasted about 8/9 days. Tired headache lymph nodes in neck, groin, armpit and behind knees
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 02:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Investigation, Pain in extremity, X-ray
Clinical narrative: The first one  go like my arm was going to fall off for 2 week the pain was unbelievable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 1, single (Lot number: FM0773) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lung disease" (unspecified if ongoing); "Thyroid disease" (unspecified if ongoing), notes: I take stuff like that because I have thyroid disease. Concomitant medication(s) included: CALCIUM & VITAMIN D [CALCIUM LACTATE;CALCIUM PHOSPHATE;COLECALCIFEROL] oral taken for thyroid disorder. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The first one  go like my arm was going to fall off for 2 week the pain was unbelievable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional notes: Calcium With Vitamin D: Calcium 600mg a day with vitamin D, Once a day, Tablet, By mouth. Patient had both doses of vaccine administered at the Right arm. Patient stated, she believe so, the first one go like my arm was going to fall off for 2 week the pain was unbelievable, second shot, she got sick. Two weeks of pain, throbbing pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135606 same reporter/patient/product, different dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; DOSE: 1, 2, 3; Brand: Pfizer/ DOSE: 4; Brand: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: en6203), in left arm, on 11Mar2021 as dose 2, single (Lot number: en6208), in left arm and on 21Sep2021 as dose 3 (booster), single (Lot number: 3013-8a), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2023 as dose 4 (booster), single (Lot number: as71718), in left arm for covid-19 immunisation. The patient's relevant medical history included: "gout" (unspecified if ongoing); "asthma history" (not ongoing); "Known allergies: tetracycline" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: morphine"; Ceclor, reaction(s): "Known allergies: ceclor". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jan2023, outcome "not recovered", described as "DOSE: 1, 2, 3; Brand: Pfizer/ DOSE: 4; Brand: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment paxlovid from 17Mar2023 to 22Mar2023.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body height, Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: got COVID-19 after getting his series of two COVID-19 shots/patient had been exposed to COVID-19 after taking the COVID-19 Vaccines/still positive for COVID-19 antibodies; got COVID-19 after getting his series of two COVID-19 shots/patient had been exposed to COVID-19 after taking the COVID-19 Vaccines/still positive for COVID-19 antibodies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dementia", start date: 2020 (unspecified if ongoing), notes: Diagnosed 3 years ago; "High cholesterol" (unspecified if ongoing), notes: Diagnosed when he was between 53-55 years of age; "Had places of skin cancer removed off of his body" (unspecified if ongoing), notes: it was several times in the last 5-10 years. There were no Family Medical History Relevant to Adverse Events.The patient's concomitant medications were not reported. There were no prior Vaccinations within 4 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19 after getting his series of two COVID-19 shots/patient had been exposed to COVID-19 after taking the COVID-19 Vaccines/still positive for COVID-19 antibodies". It was reported that patient got COVID-19 after getting his series of two COVID-19 shots, which were manufactured by Pfizer. Patient has been testing for COVID-19 antibodies as recent as 2 months ago in Jan2023 and still positive for COVID-19 antibodies. Patient's doctor, advised since patient is testing positive for both antibodies, there is no reason for patient to get a booster at this time. That way, he could get a booster if needed. Then states, that's over 18 months ago. Caller did not specify what was over 18 months ago. Caller stating patient didn't test positive for COVID-19, it showed in his blood work. Patient's doctor said at some point, patient had been exposed to COVID-19 after taking the shots. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) showed exposure to COVID-19; Body height: (unspecified date) Either 5ft-8in or 5fr-9in; SARS-CoV-2 antibody test: (unspecified date) Positive, notes: still positive for COVID-19 antibodies; (Jan2023) Positive, notes: testing for COVID-19 antibodies as recent as 2 months ago in Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135810 Same reporter/drug/AE, different patient.;
Age: 76.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8732), on 20Apr2021 as dose 2, single (Lot number: EW0161), on 27Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "controlled high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "venous insufficiency" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "treated ocular melanoma" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; headache; body ache; fatigue; more severe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 30Aug2021 at 15:00 as dose 3 (booster), single (Lot number: EW0187) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Irregular/ rapid heart beat" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL oral taken for heart rate irregular, start date: 2000 (ongoing); ATORVASTATIN oral taken for blood cholesterol increased, start date: 2000 (ongoing). Vaccination history included: BNT162b2 (Dose 1, single, Date: 18Mar2021, Time: 2:30 PM, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 18Mar2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Time: 3:00 pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EM8729, After dose 2 of the vaccine, I had headache, body aches, fatigue for about 4-6 hours upon waking the next morning.), administration date: 08Apr2021, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Headache", "fatigue", "Body ache". The following information was reported: NAUSEA (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body ache"; FATIGUE (non-serious), outcome "recovered"; CONDITION AGGRAVATED (non-serious), outcome "recovered", described as "more severe".  Additional information: It was reported, the patient had headache, body aches for about 4-6 hours after dose 2 upon waking the next morning. It was reported. After dose 3 of the vaccine, I had the same as above plus nausea. The symptoms were a bit more severe and lasted 8-10 hours. I felt that these reactions meant my body building immunity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300058266 same reporter/pt, different dose/event;US-PFIZER INC-202300033779 Same patient, same product, different event (Dose 1,2,3,4) (LOE case);
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Thankful to Pfizer for the COVID vaccines and boosters/He received all of his Pfizer COVID vaccines, and still got COVID; Thankful to Pfizer for the COVID vaccines and boosters/He received all of his Pfizer COVID vaccines, and still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 "Thankful to Pfizer for the COVID vaccines and boosters/He received all of his Pfizer COVID vaccines, and still got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: He was only positive for COVID for 5 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received. Clinical course: he was only positive for COVID for 5 days. Caller declined report for her husband. She was very thankful to Pfizer for the COVID vaccines and boosters. Her and her husband did all of the Pfizer COVID vaccines. He received all of his Pfizer COVID vaccines, and still got COVID and had to take Paxlovid.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Type I diabetes" (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 included Paxlovid from 17Mar2023 to 21Mar2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.