Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 12-Jan-2023 and administered on Feb-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023 and administered on 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.   No Medical History information was reported.    In February 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In February 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023 and administered on Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023 and administered on 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023 and administered on Feb-2023).    No concomitant medications were provided.  The nurse reported that the vials should had been discarded on 11-Feb-2023 but was confirmed 8 doses were given after 11-Feb-2023. The Moderna COVID-19 vaccine, bivalent (lot number: 065H22A) of an unknown vial size was initially stored in the refrigerator on 12-Jan-2023. The vaccine was administration on 14-Feb-2023, 15-Feb-2023, 22-Feb-2023, 28-Feb-2023.  The vial did not undergo any temperature excursions.  No treatment medication was provided.  This case contains information for the 4th of 8 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713727, US-MODERNATX, INC.-MOD-2023-713729, US-MODERNATX, INC.-MOD-2023-713731, US-MODERNATX, INC.-MOD-2023-713733, US-MODERNATX, INC.-MOD-2023-713734, US-MODERNATX, INC.-MOD-2023-713735, US-MODERNATX, INC.-MOD-2023-713736 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713727:1 of Patient 8 US-MODERNATX, INC.-MOD-2023-713729:2 of Patient 8 US-MODERNATX, INC.-MOD-2023-713731:3 of Patient 8 US-MODERNATX, INC.-MOD-2023-713733:5 of Patient 8 US-MODERNATX, INC.-MOD-2023-713734:6 of Patient 8 US-MODERNATX, INC.-MOD-2023-713735:7 of Patient 8 US-MODERNATX, INC.-MOD-2023-713736:8 of Patient 8