Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 06 JUL 2023, vial was first punctured on 14 JUL 2023 3:25PM and vial was exposed to room temperature range was 73 hours after puncture and administration of vaccine on 17 JUL 2023; No adverse event; patient received expired Bivalent 6th dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Bivalent 6th dose), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 06 JUL 2023, vial was first punctured on 14 JUL 2023 3:25PM and vial was exposed to room temperature range was 73 hours after puncture and administration of vaccine on 17 JUL 2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023 at 4:00 PM, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jul-2023 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Bivalent 6th dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 06 JUL 2023, vial was first punctured on 14 JUL 2023 3:25PM and vial was exposed to room temperature range was 73 hours after puncture and administration of vaccine on 17 JUL 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Bivalent 6th dose), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 06 JUL 2023, vial was first punctured on 14 JUL 2023 3:25PM and vial was exposed to room temperature range was 73 hours after puncture and administration of vaccine on 17 JUL 2023) 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 (patient received expired Bivalent 6th dose) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 06 JUL 2023, vial was first punctured on 14 JUL 2023 3:25PM and vial was exposed to room temperature range was 73 hours after puncture and administration of vaccine on 17 JUL 2023).    Concomitant medication not reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Dosage text for suspect product was reported as unknown.  Dose administered more than 12 hours post puncture. Blue Cap and Expiry Date was 14-OCT-2023. Individual vials or intact cartons Vial size 2.5 ml.. The vial stored post puncture at room temperature 64-68F. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C equal to 46° to 77°F) was 73 Hours.  Treatment medication not reported.