Age: 0.5
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 20-Jun-2023 at 1:00 P.M, vail was administered on 21-Jun-2023 at 10:42 P.M, Via was stored on room temperature.; No adverse event; They provided two infant vaccines past the expired time.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They provided two infant vaccines past the expired time.), PRODUCT STORAGE ERROR (Vial was first punctured on 20-Jun-2023 at 1:00 P.M, vail was administered on 21-Jun-2023 at 10:42 P.M, Via was stored on room temperature.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Jun-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 (They provided two infant vaccines past the expired time.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 20-Jun-2023 at 1:00 P.M, vail was administered on 21-Jun-2023 at 10:42 P.M, Via was stored on room temperature.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They provided two infant vaccines past the expired time.), PRODUCT STORAGE ERROR (Vial was first punctured on 20-Jun-2023 at 1:00 P.M, vail was administered on 21-Jun-2023 at 10:42 P.M, Via was stored on room temperature.) 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 (They provided two infant vaccines past the expired time.) and PRODUCT STORAGE ERROR (Vial was first punctured on 20-Jun-2023 at 1:00 P.M, vail was administered on 21-Jun-2023 at 10:42 P.M, Via was stored on room temperature.).    Concomitant product use was not provided by the reporter.  It was reported that the vaccines were reconstituted and then left out. It was the Moderna bivalent with blue cap. It was reconstituted with the sterile diluent, and everything was fine up until they were administered. The MA had grabbed an old vial that was left on the counter. Then the nurse confirmed that the product was Moderna bivalent vaccine. She clarified that it was not reconstituted. Via was initially stored in the refrigerator on 15-Jun-2023. Vial did not undergo any temperature excursion. Unsure total amount of vial was exposed to room temperature range (8 degree to 25-degree Celsius equals to 46 degrees to 77-degree Fahrenheit) and not reported (reported as no response) if the vial was exposed to room temperature for more than 24 hours or not.  Treatment information was not provided.  This case contains information about patient 1st out of 2 infant patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730175.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730175:Patient 2