Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 4-Jun-2023 and was administered on 5-Jun-2023; No adverse event; the dose the patient received on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the dose the patient received on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 4-Jun-2023 and was administered on 5-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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-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. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (the dose the patient received on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 4-Jun-2023 and was administered on 5-Jun-2023) and NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the dose the patient received on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 4-Jun-2023 and was administered on 5-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 (the dose the patient received on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 4-Jun-2023 and was administered on 5-Jun-2023).    No concomitant medication was reported. The doses text of the suspect was reported as Unknown.  It was reported that a facility administered 50 doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired. Lot AS7143C was administered on 5-JUN-2023 to 40 patients. Lot 019H22A was administered on 5-JUN-2023 to 10 patients. The HCP does not have any patient details at this time. No adverse reactions have been reported by any patients. The expiry date for Lot-AS7143C was reported as 11-MAY-2023 and Lot-019H22A was reported as 30-MAY-2023. The vial size was unknown. The vials did not undergo any temperature excursions. No treatment medication was reported.  This case contains information about patient 36th out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)