Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture / Post puncture the vial stored in refrigerated condition; No adverse event; The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture), PRODUCT STORAGE ERROR (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture / Post puncture the vial stored in refrigerated condition) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2023 at 10:20 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jul-2023 at 10:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture / Post puncture the vial stored in refrigerated condition) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture), PRODUCT STORAGE ERROR (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture / Post puncture the vial stored in refrigerated condition) 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 (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture) and PRODUCT STORAGE ERROR (The vial was punctual the day before around 9:40 AM 0n 07/12/2023. The vaccine was administered on 07/13/23 at 10:20 AM / The patient(s) received expired dose > 12 hours after puncture / Post puncture the vial stored in refrigerated condition).    Concomitant Medication use information was not provided by reporter.  The vial was punctual the day before around 9:40 AM 0n 07/12/2023. No side effects were reported by the patient. The vaccine was administered on 07/13/23 at 10:20 AM. The patient(s) received expired dose > 12 hours after puncture.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Individual vials or intact cartons the 1 dose vial size was reported as 2.5mL.   Date the vial was initially stored in the refrigerator was reported as 22 June 2023.   Date(s)and time(s) vial was first punctured was on 12 July 2023 at 9:40AM.  Post puncture the vial stored in refrigerated condition. The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2023: Follow up received that contains non significant information includes updated narrative. On 17-Jul-2023: Follow up received that contains significant information includes added expiry date of vaccine and updated narrative.