Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture; No adverse event; Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022 at 2:30 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture) 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 (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Administered the dose from a vial that was punctured 24 hours ago/doses administered more than 12 hours post puncture).    No concomitant medications were reported. The 2.5 ml vial was initially stored in the refrigerator on 06-Oct-2022 at 10:56 AM. The date and time at which vial was first punctured was on 09-Oct-2022 at 10 am.. The vaccine was administered on 10-Oct-2022 at 2:30 PM. The vaccine was administered more than 12 hours post puncture. The vial was stored in the fridge post puncture, and it had not undergone any temperature excursions. The total amount of time the vial was exposed to room  temperature range (8 to 25 degree C equals to 46 to 77 degree F) was 30 minutes out of the fridge. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658089 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658089:MOD-2022-658089 (RR patient)