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 13-Dec-2022 and administered between 13-Jan-2023 and 22-Jan-2023; No adverse event; 11 adult patients received the expired Bivalent booster beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Dec-2022 and administered between 13-Jan-2023 and 22-Jan-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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 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. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Dec-2022 and administered between 13-Jan-2023 and 22-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Dec-2022 and administered between 13-Jan-2023 and 22-Jan-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 (11 adult patients received the expired Bivalent booster beyond 30 days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Dec-2022 and administered between 13-Jan-2023 and 22-Jan-2023).    No concomitant product was reported.  It was reported that 11 adult patients received the expired Bivalent booster beyond 30 days in the refrigerator. Vaccine vials were a case of 10 pieces and 7 vials from the case were used to administer vaccines from 13-Jan-2023 to 22-Jan-2023. Pharmacist advised that 11 doses of vaccines were used from the 7 vials. Pharmacist advised that label on case of vials advised that vials should have been used before 12-Jan-2023. She confirmed that none of the patients that received the 11 doses had reported any adverse reactions. Bivalent Lot number: lot 042H22A with expiration date 07-Jun-2023. Vials were in intact cartons of size 2.5 ml. The vial was initially stored in the refrigerator on 13-Dec-2022. The vial did not undergo any temperature excursions.  No treatment information was reported.  This case contains information for the 4th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient