Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture; No adverse event; patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, 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 16-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial 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 PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture).    No relevant concomitant medications were reported. HCP stated that 2 patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture. Date the vial was initially stored in the refrigerator was on 14 DEC 2022. Vial was first punctured on 15 DEC 2022, 2:00 PM and administered on 16 Dec 2022 at 09:42 AM. The vial haven't undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius = 46 degree to 77 degree Fahrenheit): Approximately 18 hours. No treatment medication reported.