Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong technique in product usage process
Clinical narrative: No adverse event; The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM; administered a dose of the Moderna COVID-19 bivalent vaccine from a pre-filled syringe that was at room temperature for more than 24 hours; The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (administered a dose of the Moderna COVID-19 bivalent vaccine from a pre-filled syringe that was at room temperature for more than 24 hours), EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM) 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. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 03-Dec-2022, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (administered a dose of the Moderna COVID-19 bivalent vaccine from a pre-filled syringe that was at room temperature for more than 24 hours) and EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (administered a dose of the Moderna COVID-19 bivalent vaccine from a pre-filled syringe that was at room temperature for more than 24 hours), EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM) 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 PRODUCT STORAGE ERROR (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (administered a dose of the Moderna COVID-19 bivalent vaccine from a pre-filled syringe that was at room temperature for more than 24 hours) and EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 2DEC2022 at 3:08 PM and the vaccine was administered on 3DEC2022 at 8:10 AM).    No relevant concomitant medications were reported. The patient was administered a dose of the Moderna COVID-19 bivalent vaccine from a pre-filled syringe that was at room temperature for more than 24 hours. The vial was first punctured on 2 DEC 2022 at 3:08 PM and the vaccine was administered on 3 DEC 2022 at 8:10 AM. No treatment medication reported.  The case is for the first patient of two patients involved.   This case was linked to MODERNATX, INC.-MOD-2022-684407 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-684407:Patient 2nd