Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023; No adverse event; Dose was given after the beyond used by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after the beyond used by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     It was reported that patient medical history was unknown. It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 24-Jul-2023, 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 24-Jul-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 (Dose was given after the beyond used by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after the beyond used by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-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 (Dose was given after the beyond used by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient administered on 14-Jan-2021, 2nd dose unknown, 3rd dose unknown 4th dose lot number was 002M21A administered on 09-Apr-2022 5th dose unknown. The 2.5 ml vial was initially stored in the refrigerator 22-Jun-2023.  The BUD date was reported as 22-Jul-2023. The vial did not underwent any temperature excursions. It was reported that one intact carton and remaining vials had been discarded. No treatment medication was reported. This case is reported for patient 1 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-734896, US-MODERNATX, INC.-MOD-2023-734899, US-MODERNATX, INC.-MOD-2023-734913 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734896:Same Reporter US-MODERNATX, INC.-MOD-2023-734899:Same Reporter US-MODERNATX, INC.-MOD-2023-734913:Same Reporter