Age: 90.0
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 on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.; No adverse event; Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.) and NO ADVERSE EVENT (No adverse event) in a 90-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067h22a) for COVID-19 prophylaxis.   No Medical History information was reported.    On 14-Apr-2023 at 8:15 AM, 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 14-Apr-2023 at 8:15 AM, 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 COVID19 bivalent vaccine dose was administered after 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.) 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 COVID19 bivalent vaccine dose was administered after 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.).    No concomitant medications were reported.  Vial size was 5 mL. Post puncture the vial was on room temperature until 3 pm 13-Apr-2023 then the vaccine was put in a syringe in a fridge until administration of the dose on the 14-Apr-2023 8:15 AM. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 4 hours.  No treatment information was provided.