Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022; No adverse event; Bivalent Moderna COVID19 vaccine were given after the beyond use date of 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date of 17Nov2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, 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 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date of 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date of 17Nov2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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 (Bivalent Moderna COVID19 vaccine were given after the beyond use date of 17Nov2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022).    No concomitant medications were reported.  It was reported that total 14 doses of Bivalent vaccines were administered beyond use date. There were Individual vials of size 2.5 ml. The vial was initially stored in the refrigerator on 18-Oct-2022. The vial did not undergo any temperature excursions.  No treatment details were reported.  This case contains information of  the 11 of 14 adult patients described by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2022-675238, US-MODERNATX, INC.-MOD-2022-675258, US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675261, US-MODERNATX, INC.-MOD-2022-675262, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675265, US-MODERNATX, INC.-MOD-2022-675266, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270, US-MODERNATX, INC.-MOD-2022-675271, US-MODERNATX, INC.-MOD-2022-675259 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675238:Patient 1 US-MODERNATX, INC.-MOD-2022-675258:Patient 2 US-MODERNATX, INC.-MOD-2022-675260:Patient 4 US-MODERNATX, INC.-MOD-2022-675261:Patient 5 US-MODERNATX, INC.-MOD-2022-675262:Patient 6 US-MODERNATX, INC.-MOD-2022-675264:Patient 8 US-MODERNATX, INC.-MOD-2022-675265:Patient 9 US-MODERNATX, INC.-MOD-2022-675266:Patient 10 US-MODERNATX, INC.-MOD-2022-675269:Patient 12 US-MODERNATX, INC.-MOD-2022-675270:Patient 13 US-MODERNATX, INC.-MOD-2022-675271:Patient 14