Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 14-Nov-2022, on19-Nov-2022, the vial was first punctured and on 20-Nov-2022, the vial was administered; No adverse event; A couple of patients got a dose from a vial that had been punctured and was beyond 12 hrs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured and was beyond 12 hrs), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Nov-2022, on19-Nov-2022, the vial was first punctured and on 20-Nov-2022, the vial was administered) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Nov-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 20-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured and was beyond 12 hrs). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Nov-2022, on19-Nov-2022, the vial was first punctured and on 20-Nov-2022, the vial was administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured and was beyond 12 hrs), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Nov-2022, on19-Nov-2022, the vial was first punctured and on 20-Nov-2022, the vial was administered) 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 (A couple of patients got a dose from a vial that had been punctured and was beyond 12 hrs) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Nov-2022, on19-Nov-2022, the vial was first punctured and on 20-Nov-2022, the vial was administered).    No concomitant medication information was provided.  A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs. Dose administered more than 12 or 24 hours post puncture.  The vial size was 2.5 mL and there were 2 doses.  On 14-Nov-2022, the vial was initially stored in the refrigerator.  On19-Nov-2022, the vial was first punctured. Pharmacist did not know the exact time it was punctured.  The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C to  46° to 77°F). Afternoon or evening time. It was used 10a.  No treatment medication was provided.