Age: 83.0
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 the vaccine was administered on 23-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 the vaccine was administered on 23-Jul-2023) and NO ADVERSE EVENT (no adverse event) in an 83-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.     Patient's medical history was Unknown. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 23-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 23-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 the vaccine was administered on 23-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 the vaccine was administered on 23-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 the vaccine was administered on 23-Jul-2023).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. It was reported that patient's 1st dose was unknown, 2nd dose was unknown, 3rd dose was unknown, 4th dose lot number was 060A22A administered on 21-Jun-2022 and 5th dose was unknown. It was reported that 4 doses was given after the beyond used by date. The BUD  was reported as 22-Jul-2023. 1 Intact carton Remaining vials has been discarded. Vial size was 2.5 ml. Vial did not undergo any temperature excursions. The expiry date was reported as 14-Oct-2023. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734899, US-MODERNATX, INC.-MOD-2023-734913, US-MODERNATX, INC.-MOD-2023-734932 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734913:Same reporter US-MODERNATX, INC.-MOD-2023-734899:Same Reporter US-MODERNATX, INC.-MOD-2023-734932:Same Reporter