chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: INCOMPLETE DOSE ADMINISTERED; This spontaneous report received from a health care professional concerned 17 multiple patients. The patient's weight, height, and medical history were not reported. The patients were previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, 1 total administered, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patients had any adverse event after covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 18-FEB-2023) 0.25 ml, 1 total administered, start therapy date was not reported for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported.  On an unspecified date, the patients received an additional half dose, as a booster of the Janssen covid-19 vaccine (incomplete dose administered) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of incomplete dose administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20230426062.
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent 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. 045H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 11-Apr-2023, the patient 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 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 11-Apr-2023, the patient experienced EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent 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 EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine).    No concomitant medications were reported.    It was reported that [patient was administered second bivalent Moderna COVID-19 vaccine at 1:30 on 11-Apr-2023 after a previous dose of the Moderna Bivalent vaccine. No reported symptoms. No additional doses, medications or treatments administered in response.  This case contains information for the 2nd of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719301 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719301:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP advised that her office utilized vaccine vials that expired on 3-30-23. Vaccines were administered on 4-7-23 too 2 patients.).    No concomitant medications were reported. Total 2 patients were administered with the expired dose of vaccine on 07-Apr-2023. One patient received expired vaccine as first dose and other  patient received vaccine as a 2nd primary dose. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719336 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719336:Patient
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 014C21A, 028L20A and 039K20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Allergic reaction to bee sting (Bee allergy).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2022, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Wrong product administered
Clinical narrative: 6-11yr bivalent vaccine was given to elderly patient; Nausea- couldn't get out of bed; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (6-11yr bivalent vaccine was given to elderly patient) and NAUSEA (Nausea- couldn't get out of bed) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017B22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 23-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 23-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (6-11yr bivalent vaccine was given to elderly patient) and NAUSEA (Nausea- couldn't get out of bed). At the time of the report, WRONG PRODUCT ADMINISTERED (6-11yr bivalent vaccine was given to elderly patient) outcome was unknown and NAUSEA (Nausea- couldn't get out of bed) had resolved.        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 medications was provided. No treatment medications was provided. Patient received 1st dose, lot number was 018B221, 2nd dose with lot number was 048B21A.   This case was linked to US-MODERNATX, INC.-MOD-2023-719184 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719184:wife case
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.    In October 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received first 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-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023).    Concomitant drugs were not reported. Treatment medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent 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. 045H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines prior to COVID-19 Vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5). Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).    On 11-Apr-2023 at 1:30 PM, 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 11-Apr-2023, the patient experienced EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent 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 EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 reporting day after a previous dose of the Moderna Bivalent vaccine).    No concomitant information was reported. It was reported that no other symptoms were there and no additional doses medications or treatments administered in response. This case contains information for the 1st patient out of 2 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719304 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719304:2nd patient case
Sex: M
Vaccine: COVID19-2
Symptoms: Encephalopathy
Clinical narrative: started experiencing post vaccination encephalopathy; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALOPATHY (started experiencing post vaccination encephalopathy) 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 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 ENCEPHALOPATHY (started experiencing post vaccination encephalopathy) (seriousness criterion medically significant). At the time of the report, ENCEPHALOPATHY (started experiencing post vaccination encephalopathy) 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 medications were reported.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Encephalopathy, which occurred after an unspecified dose of mRNA-1273.222 vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.          Reporter did not allow further contact
Sex: U
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: They are here and we found out that they both only have 1 primary series on record from 2021.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (They are here and we found out that they both only have 1 primary series on record from 2021.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (They are here and we found out that they both only have 1 primary series on record from 2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (They are here and we found out that they both only have 1 primary series on record from 2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (They are here and we found out that they both only have 1 primary series on record from 2021.).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 1st patient out of 2 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719366 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719366:(Case for Adult Patient 2 )
Sex: U
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; Patient had 1 primary series on record from 2021.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient had 1 primary series on record from 2021.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient had 1 primary series on record from 2021.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient had 1 primary series on record from 2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient had 1 primary series on record from 2021.).    No concomitant information was reported. No treatment information was provided. This case contains information for the 2nd patient out of 2 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719364 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719364:(Case for Adult Patient 1 )
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine stored in the refrigerator; No adverse event; A patient got an expired dose this week; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient got an expired dose this week), PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient got an expired dose this week). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient got an expired dose this week), PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 patient got an expired dose this week) and PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dose administered after manufacturer date of expiry. The vial was initially stored in the refrigerator on 10-Apr-2023. The vial did not undergone any temperature excursions. No side effects reported by patient.  No treatment medications was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters) 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 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters).    No concomitant medications were reported.     Patient noticed that they used bivalent boosters instead of 1 monovalent booster and one bivalent booster. The patient was not sure if he had actually received 2 bivalent boosters or if he was referring to both boosters just as both bivalent boosters because that was the most recent booster he had received or not.  No treatment medications were reported.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Unknowingly administered an expired moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine) and NO ADVERSE EVENT (no adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 31-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine).    No concomitant medication was reported.. Patient had no adverse reactions. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received the expired vaccine in for their Primary Series.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.).    No concomitant medications was reported.  A Female patient received a dose of the Moderna Covid-19 vaccine last week in a clinic. The Pharmacist does not know which dose the patient received the expired vaccine in for their Primary Series.  No treatment medications was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: He died on the 26th; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He died on the 26th) in a male patient of an unknown age 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 an unknown date, 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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 medications were provided. The patient had 4 COVID-19 vaccine vaccinations. No treatment medication was provided.  Company Comment: This is a spontaneous fatal case concerning a male patient of an unknown age with no reported medical history, who experienced the fatal serious, medically significant, unexpected event of Death (reported as he died on the 26th), which occurred on an unknown date and with unknown latency after a dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine, considered as the fourth dose of COVID-19 vaccination schedule. It was reported that the patient had 4 COVID-19 vaccines. However, no information on vaccination schedule nor detailed vaccine product was disclosed. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. 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; Reported Cause(s) of Death: He died on the 26th
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22a) for COVID-19 prophylaxis.     No Medical History information was reported.  On 07-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported.  Total 2 patients were administered with the expired dose of vaccine on 07-Apr-2023. One patient received expired vaccine as first dose and other  patient received vaccine as a 2nd primary dose.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719341 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719341:Patient
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Booster dose of Moderna bivalent were given after the 12 hrs; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) 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 (Booster dose of Moderna bivalent were given after the 12 hrs).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719313 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719313:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Booster dose of Moderna bivalent were given after the 12 hrs; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) 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 (Booster dose of Moderna bivalent were given after the 12 hrs).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719303:Same reporter
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) 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 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 28Mar2023 to 01Apr2023.  Based on investigation result conclusion: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940; lot FF8839, fill lot FF8833, and the bulk formulated drug product FA9148; lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319; lot EM9810, fill lot EM9806, and the formulated drug product lot EM9808 and lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency [Name] concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148519 Same patient/reporter, Different drug/adverse event;
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis/idiopathic; This is a literature report.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 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: MYELITIS TRANSVERSE (medically significant) with onset 22Jan2021, outcome "unknown", described as "Transverse myelitis/idiopathic". Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information provided in this case and considering a plausible drug-event temporal association, there is a reasonable possibility that the reported events are related to the suspect product BNT162b2 (COMIRNATY).  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Myelitis transverse
Clinical narrative: Transverse myelitis/idiopathic; This is a literature report.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 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: MYELITIS TRANSVERSE (medically significant) with onset 22Jan2021, outcome "recovered", described as "Transverse myelitis/idiopathic". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Consistent With transverse myelitis; Magnetic resonance imaging head: showed T2/FLAIR white matter hyperintensities and, notes: global atrophy. Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported events 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. ,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug/event; different patient;
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Pfizer, Dose Number: 5 / Moderna, Dose Number: 1, 2, 3, 4; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. An 83-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 15:30 as dose 5 (booster), single (Lot number: 8J5342) at the age of 82 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 at 14:00 as dose 1, single (Lot number: 004M20A), in left arm, on 27Feb2021 at 13:00 as dose 2, single (Lot number: 023nZurt), in left arm, on 03Sep2021 at 01:00 as dose 3 (booster), single (Lot number: 048F21A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Pfizer, Dose Number: 5 / Moderna, Dose Number: 1, 2, 3, 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative on two successive days for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Mar2023 to 29Mar2023.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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 had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152039 Same reporter/patient, different product/AE.;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Date: 11Sep2022 / Moderna, Date: 13Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Lot number: 036B21A), in left arm, on 07May2021 as dose 2, single (Lot number: 014C21A), in left arm, on 10Dec2021 as dose 3 (booster), single (Lot number: 027H21B), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight/obese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Pfizer, Date: 11Sep2022 / Moderna, Date: 13Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 03Apr2023 to 07Apr2023.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; 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 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 17:00 as dose 4 (booster), single (Lot number: 649694) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Apr2021 at 11:30 as dose 1, single (Lot number: EW0161), in left arm, on 11May2021 at 11:30 as dose 2, single (Lot number: EW0183), in left arm and on 11Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Allergy to sulfa" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE, start date: Feb2022; LISINOPRIL, start date: Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: ; Positive, notes: ; Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152156 Same patient, different product, different event;