Sex: U
Vaccine: 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; The vials should have been discarded on 11-Feb-2023, 8 doses were given after 11-Feb-2023. Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vials should have been discarded on 11-Feb-2023, 8 doses were given after 11-Feb-2023. 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.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     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 (The vials should have been discarded on 11-Feb-2023, 8 doses were given after 11-Feb-2023. 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 (The vials should have been discarded on 11-Feb-2023, 8 doses were given after 11-Feb-2023. 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 (The vials should have been discarded on 11-Feb-2023, 8 doses were given after 11-Feb-2023. 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).    Concomitant medication was not provided  Nurse reported that vaccine was bivalent vaccine and vial size was unknown. The vial was initially stored in refrigerator on 12-Jan-2023 and 8 doses were administered on 14-Feb-2023,15-Feb-2023, 22-Feb-2023, 28-Feb-2023 . The vial did not undergo any temperature excursion.  Treatment information was not provided.   This case contains information for the 8th 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-2023-713732, US-MODERNATX, INC.-MOD-2023-713733, US-MODERNATX, INC.-MOD-2023-713734, US-MODERNATX, INC.-MOD-2023-713735 (E2B 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-2023-713732:4 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