Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered; No adverse event; Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered), EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Jul-2022 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered), EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered).    Concomitant medication list was not provided. It was reported that dose was administered more than 12(US)/24(CA) hours post puncture. Number of doses per vial was 1 vial. Date the vial was initially stored in the refrigerator was unknown, Date and time vial was first punctured was unknown. The vial was stored post puncture in the refrigerator. The vial underwent temperature excursions, total amount of time the vial was exposed to room temperature range was 70 hours. Storage condition at the time of the excursion was room temperature. The patient had not previously experienced this event. The event had not caused patient to seek medical care. Treatment information was not provided.