Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, 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 17-Jul-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 1st out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733772, US-MODERNATX, INC.-MOD-2023-733771, US-MODERNATX, INC.-MOD-2023-733779, US-MODERNATX, INC.-MOD-2023-733786, US-MODERNATX, INC.-MOD-2023-733790, US-MODERNATX, INC.-MOD-2023-733796, US-MODERNATX, INC.-MOD-2023-733799, US-MODERNATX, INC.-MOD-2023-733807, US-MODERNATX, INC.-MOD-2023-733810, US-MODERNATX, INC.-MOD-2023-733814, US-MODERNATX, INC.-MOD-2023-733818, US-MODERNATX, INC.-MOD-2023-733820, US-MODERNATX, INC.-MOD-2023-733835, US-MODERNATX, INC.-MOD-2023-733839, US-MODERNATX, INC.-MOD-2023-733841, US-MODERNATX, INC.-MOD-2023-733843, US-MODERNATX, INC.-MOD-2023-733846, US-MODERNATX, INC.-MOD-2023-733848 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733771:Patient 2 US-MODERNATX, INC.-MOD-2023-733843:Patient 17 US-MODERNATX, INC.-MOD-2023-733846:Patient 18 US-MODERNATX, INC.-MOD-2023-733779:Patient 4 US-MODERNATX, INC.-MOD-2023-733841:Patient 16 US-MODERNATX, INC.-MOD-2023-733820:Patient 13 US-MODERNATX, INC.-MOD-2023-733835:Patient 14 US-MODERNATX, INC.-MOD-2023-733839:Patient 15 US-MODERNATX, INC.-MOD-2023-733807:Patient 9 US-MODERNATX, INC.-MOD-2023-733814:Patient 11 US-MODERNATX, INC.-MOD-2023-733848:Patient 19 US-MODERNATX, INC.-MOD-2023-733786:Patient 5 US-MODERNATX, INC.-MOD-2023-733810:Patient 10 US-MODERNATX, INC.-MOD-2023-733796:Patient 7 US-MODERNATX, INC.-MOD-2023-733799:Patient 8 US-MODERNATX, INC.-MOD-2023-733790:Patient 6 US-MODERNATX, INC.-MOD-2023-733818:Patient 12 US-MODERNATX, INC.-MOD-2023-733772:Patient 3