Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours; No Adverse Event; Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours; Moderna bi-valent Vaccine was administered as first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours), WRONG PRODUCT ADMINISTERED (Moderna bi-valent Vaccine was administered as first dose), PRODUCT STORAGE ERROR (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours) and NO ADVERSE EVENT (No Adverse Event) in a 20-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours) and WRONG PRODUCT ADMINISTERED (Moderna bi-valent Vaccine was administered as first dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours), WRONG PRODUCT ADMINISTERED (Moderna bi-valent Vaccine was administered as first dose), PRODUCT STORAGE ERROR (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours), WRONG PRODUCT ADMINISTERED (Moderna bi-valent Vaccine was administered as first dose) and PRODUCT STORAGE ERROR (Vial initially punctured on 22-Jun-2023 22JUN2023 Unknown afternoon time (No longer has the vial) and administered on 23-Jun-2023 at 10:52 A.M, vial was administered more than 12 hours post puncture. Vial was stored in refrigerator for about 20 hours).    Concomitant product use was not provided by the reporter.  It was unknown when vial was initially stored in the refrigerator. Post puncture vial was in fridge. Individual Vial in open Carton Vial size was 2.5 ml. Vial did not undergo any temperature excursions. Via was not exposed at room temperature. Vial was exposed to room temperature less than 24 hours. Time of the vaccination was reported as 10:52 A.M. Expiry date was reported as 03-Oct-2023.  Treatment information was not provided.