chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023.  Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 6th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided. This case was reported for patient 7 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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 (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    Patient did not received any other vaccines in the 4 weeks prior to Covid-19.  No concomitant medications were provided.  The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Health care professional was looking for the availability of the vaccine.  No treatment medication was provided.  This case contains information for the 15th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 16 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 18 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 17th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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 (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 9 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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. 065H22A) 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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 (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    No concomitant medications were provided. The patient had not received any other vaccine 4 weeks prior to COVID-19 vaccine. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 19th out of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 10th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 20 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 2nd of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant administered the vaccine past the BUD (17Feb2023); no adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant administered the vaccine past the BUD (17Feb2023)) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant administered the vaccine past the BUD (17Feb2023)) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant administered the vaccine past the BUD (17Feb2023)) 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 (Medical assistant administered the vaccine past the BUD (17Feb2023)).    It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that the Medical assistant called to report that they administered some vaccine past the BUD (17-Feb-2023) to 20 patients. HCP  was looking for the viability of the vaccine. The vaccine was administered between 13-March-2023 to 05-Jun-2023. The patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was reported. This case contains information for the 3rd of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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 (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    Patient did not received any other vaccines in the 4 weeks prior to Covid-19.  No concomitant medications were provided.  The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Health care professional was looking for the availability of the vaccine.  No treatment medication was provided.  This case contains information for the 12th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:(Master Case of Patient 1 )
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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. 065H22A) 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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 (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 13th out of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case of Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). Patient did not received 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 4th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; no adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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.     Patient did not report any medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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 (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    Patient did not received any other vaccines in the 4 weeks prior to Covid-19.  No concomitant medications were provided.  The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Health care professional was looking for the availability of the vaccine.  No treatment medication was provided.  This case contains information for the 5th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme, Oral herpes
Clinical narrative: herpes-associated erythema multiforme; herpes viral gingivostomatitis; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (herpes-associated erythema multiforme) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included SARS-CoV-2 infection (Recovered).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (herpes-associated erythema multiforme) (seriousness criterion medically significant) and ORAL HERPES (herpes viral gingivostomatitis). At the time of the report, ERYTHEMA MULTIFORME (herpes-associated erythema multiforme) and ORAL HERPES (herpes viral gingivostomatitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.  Company comment: This literature-non-study case report concerns a 40-year-old male patient with medical history of COVID-19 infection, who experienced serious (medically significant) unexpected event of special interest -Erythema multiforme and non serious unexpected event of Oral herpes. Reportedly, the patient developed herpes viral gingivostomatitis and herpes associated erythema multiforme following an unspecified dose of the mRNA-1273 vaccine. Temporal relationship between the reported events and vaccination remained unknown since no dates were provided. At the time of this report, the outcome of the events remained unknown. Recent COVID-19 infection remains a confounder. Case will be re-assessed upon receipt of full text article with more details provided. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid AE was reported 05-Dec-2022 to 18-Dec-2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid AE was reported 05-Dec-2022 to 18-Dec-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2022, the patient experienced COVID-19 (Covid AE was reported 05-Dec-2022 to 18-Dec-2022). On 18-Dec-2022, COVID-19 (Covid AE was reported 05-Dec-2022 to 18-Dec-2022) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.  Vaccination dates were provided as 27-Feb-2021, 20-Mar-2021 and 28-Dec-2021. Reporter did not know which vaccines corresponded to which dates. The patient received one vaccination from Moderna and two vaccinations from Pfizer. It was reported that patient had COVID-19 with previous Pfizer COVID vaccinations. Confirmation via a test was not provided.  Reporter became aware that the patient had Pfizer COVID vaccinations on 07-Apr-2023.  The reporter became aware of the COVID AE on 20-Dec-2022.  No treatment medication information was reported.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; the 1st dose of the bivalent vaccine from the pink cap with a yellow label vial last 04May2023; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (the 1st dose of the bivalent vaccine from the pink cap with a yellow label vial last 04May2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 04-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 04-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (the 1st dose of the bivalent vaccine from the pink cap with a yellow label vial last 04May2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (the 1st dose of the bivalent vaccine from the pink cap with a yellow label vial last 04May2023) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (the 1st dose of the bivalent vaccine from the pink cap with a yellow label vial last 04May2023).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication not reported.  Treatment medication not reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 18-Apr-2023 and was administered to patient on 25-May-2023; No adverse event; Dose of Bivalent was given past the use date 18-May-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of Bivalent was given past the use date 18-May-2023), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 18-Apr-2023 and was administered to patient on 25-May-2023) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 069H22A) for COVID-19 prophylaxis.     It was reported that patient had no allergies. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-May-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 25-May-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 (Dose of Bivalent was given past the use date 18-May-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 18-Apr-2023 and was administered to patient on 25-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of Bivalent was given past the use date 18-May-2023), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 18-Apr-2023 and was administered to patient on 25-May-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 (Dose of Bivalent was given past the use date 18-May-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 18-Apr-2023 and was administered to patient on 25-May-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the vial was not exposed to temperature excursion as to the HCPs knowledge. The bivalent vaccine was administered to three patients on 19-May-2023, 21-May-2023 and 25-May-2023 after use by date of 18-May-2023. No adverse events were reported.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727536, US-MODERNATX, INC.-MOD-2023-727682 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727536:same reporter US-MODERNATX, INC.-MOD-2023-727682:same reporter
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023) 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. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 02-Jun-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 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023).    No concomitant medication information was reported.  Individual vials vial size was reported as 0.4 mL, 0.5 mL, 2.5 mL, or 5.5 mL, 2.5 ml. The vial was initially stored in the refrigerator on 01JUN023 The vial did not undergo any temperature excursions. No treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2023: Live Significant follow up appended.