Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023; No Adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No Adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     The patient had no known allergies. Previous COVID-19 diagnosis was unknown.  Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (Dose 1) on 26-Dec-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 16-Feb-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 16-Feb-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 administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) had not resolved and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-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 administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023).    No concomitant medications were reported.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received the initial booster dose of Moderna COVID-19 vaccine, Bivalent. Pharmacist reported that they inadvertently gave some vaccines past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023. Individual vials of Bivalent of 2.5 mL vial was initially stored in the refrigerator on 14-Jan-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.