Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023; no adverse event; Dose administered after 30-day Use By Date and BUD date was 28-Jan-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and BUD date was 28-Jan-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023) and NO ADVERSE EVENT (no adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Feb-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. On 10-Feb-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 administered after 30-day Use By Date and BUD date was 28-Jan-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-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 and BUD date was 28-Jan-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-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 BUD date was 28-Jan-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023).    No concomitant medications was reported.  Dosage text of the suspect was reported as unknown. It was reported that 7 doses were administered and the size of the vial was 2.5ml. The vial was initially stored in the refrigerator on 29-Dec-2022. Vaccine was administered to 2 patients on 31-Jan-2023, 2 patients on 02-Feb-2023 and 3 patients on 10-Feb-2023. The vial did not underwent any temperature excursion and the BUD date was 28-Jan-2023.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712785, US-MODERNATX, INC.-MOD-2023-712771, US-MODERNATX, INC.-MOD-2023-712773, US-MODERNATX, INC.-MOD-2023-712777, US-MODERNATX, INC.-MOD-2023-712783, US-MODERNATX, INC.-MOD-2023-712812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712785:Same reporter US-MODERNATX, INC.-MOD-2023-712771: US-MODERNATX, INC.-MOD-2023-712777: US-MODERNATX, INC.-MOD-2023-712783: US-MODERNATX, INC.-MOD-2023-712812: US-MODERNATX, INC.-MOD-2023-712773:Same reporter