Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date and time vial was first punctured 30-May-2023 at 09:36 AM 7. Date and time of administration of vaccine 31-May-2023 around 7:45 AM Total amount of time the vial was exposed to room temperature range (8 degree to 25 degrees Celsius or 46 degrees; No adverse event; a child was given a dose that was beyond the time the vial needed to be discarded after it was punctured/Dose administered >12/24 hours post puncture; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a child was given a dose that was beyond the time the vial needed to be discarded after it was punctured/Dose administered >12/24 hours post puncture), PRODUCT STORAGE ERROR (Date and time vial was first punctured 30-May-2023 at 09:36 AM 7. Date and time of administration of vaccine 31-May-2023 around 7:45 AM Total amount of time the vial was exposed to room temperature range (8 degree to 25 degrees Celsius or 46 degrees) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included KINRIX and PROQUAD for an unknown indication.    On 31-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 31-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a child was given a dose that was beyond the time the vial needed to be discarded after it was punctured/Dose administered >12/24 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time vial was first punctured 30-May-2023 at 09:36 AM 7. Date and time of administration of vaccine 31-May-2023 around 7:45 AM Total amount of time the vial was exposed to room temperature range (8 degree to 25 degrees Celsius or 46 degrees) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a child was given a dose that was beyond the time the vial needed to be discarded after it was punctured/Dose administered >12/24 hours post puncture), PRODUCT STORAGE ERROR (Date and time vial was first punctured 30-May-2023 at 09:36 AM 7. Date and time of administration of vaccine 31-May-2023 around 7:45 AM Total amount of time the vial was exposed to room temperature range (8 degree to 25 degrees Celsius or 46 degrees) 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 child was given a dose that was beyond the time the vial needed to be discarded after it was punctured/Dose administered >12/24 hours post puncture) and PRODUCT STORAGE ERROR (Date and time vial was first punctured 30-May-2023 at 09:36 AM 7. Date and time of administration of vaccine 31-May-2023 around 7:45 AM Total amount of time the vial was exposed to room temperature range (8 degree to 25 degrees Celsius or 46 degrees).    Date the vial was initially stored in the refrigerator 26-May-2023. Individual vials or unbroken cartons were 4 and vial size was 2.5 ml. Date and time of administration of vaccine 31-May-2023 around 7:45 AM.  Treatment information was not provided.