Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours; No adverse event; Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours), PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022 at 1:00 PM, 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 12-Oct-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours), PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) 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 more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) and PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours).    No concomitant medications were reported.  The vial size was reported as 2.5 mL and was an individual vial.  The vial was first punctured on 15-Sep-2022 at an unknown time.  The vial was initially stored in refrigerator post puncture on 15-Sep-2022.  The vial did not undergo any temperature excursions.  The total amount of time during the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was 27 days.  No treatment medications were reported.   Reporter did not allow further contact