Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) 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 (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD. Total 42 dose was administered after 30-day Use By Date. The Bivalent 6m-5y vial of 0.4 mL (Lot number: 216K22A) was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb2-023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 8th of 42 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient 1)