Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: It was unknown when the vial was initially stored in the refrigerator but the caller stated that most likely the vials were stored in the fridge during more than 1 month.; No adverse event; Moderna COVID-19 Vaccine Bivalent dose was administered after the expiration date/The vials expired on 23-MAY-2023 and the dose was administered on 20-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent dose was administered after the expiration date/The vials expired on 23-MAY-2023 and the dose was administered on 20-JUN-2023), PRODUCT STORAGE ERROR (It was unknown when the vial was initially stored in the refrigerator but the caller stated that most likely the vials were stored in the fridge during more than 1 month. ) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Overweight.    On 20-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jun-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 (Moderna COVID-19 Vaccine Bivalent dose was administered after the expiration date/The vials expired on 23-MAY-2023 and the dose was administered on 20-JUN-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (It was unknown when the vial was initially stored in the refrigerator but the caller stated that most likely the vials were stored in the fridge during more than 1 month. ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent dose was administered after the expiration date/The vials expired on 23-MAY-2023 and the dose was administered on 20-JUN-2023), PRODUCT STORAGE ERROR (It was unknown when the vial was initially stored in the refrigerator but the caller stated that most likely the vials were stored in the fridge during more than 1 month. ) 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 (Moderna COVID-19 Vaccine Bivalent dose was administered after the expiration date/The vials expired on 23-MAY-2023 and the dose was administered on 20-JUN-2023) and PRODUCT STORAGE ERROR (It was unknown when the vial was initially stored in the refrigerator but the caller stated that most likely the vials were stored in the fridge during more than 1 month. ).    It was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date. The vials expired on 23-MAY-2023. No Adverse  events were reported. Dose administered after 30-day Use By Date or after Manufacturer. Vial size was 2.5 mL.. It was unknown when the vial was initially stored in the refrigerator but the caller stated that most likely the vials were stored in the fridge during more than 1 month.  The vial undergo any temperature excursions. No treatment medication was reported.  This case contains information about patient 2nd out of 2 patients.; Sender's Comments:  PR-MODERNATX, INC.-MOD-2023-730087:patient 1