Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023; no adverse event; 9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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 June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-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 (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023).    No concomitant medication was reported.  Dose was placed into the refrigerator initially on 04-MAY-2023. No treatment information was reported.  The case contains information for patient 1 out of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-729627, US-MODERNATX, INC.-MOD-2023-729629, US-MODERNATX, INC.-MOD-2023-729628, US-MODERNATX, INC.-MOD-2023-729630, US-MODERNATX, INC.-MOD-2023-729631, US-MODERNATX, INC.-MOD-2023-729632, US-MODERNATX, INC.-MOD-2023-729633, US-MODERNATX, INC.-MOD-2023-729634 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729628:Patient 3 US-MODERNATX, INC.-MOD-2023-729629:Patient 6 US-MODERNATX, INC.-MOD-2023-729627:Patient 2 US-MODERNATX, INC.-MOD-2023-729630:Patient 7 US-MODERNATX, INC.-MOD-2023-729631:Patient 4 US-MODERNATX, INC.-MOD-2023-729632:Patient 8 US-MODERNATX, INC.-MOD-2023-729633:Patient 9 US-MODERNATX, INC.-MOD-2023-729634:Patient 5