Age: 1.83
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 2 Aug 2023 and administration of vaccine on 5 Sep 2023; No adverse event; Dose administered after 30-day Use By Date; Bivalent Booster for infant 6 month to 5-year-old yellow box pink or magenta cap with vial size 0.4 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 2 Aug 2023 and administration of vaccine on 5 Sep 2023), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster for infant 6 month to 5-year-old yellow box pink or magenta cap with vial size 0.4 ml) and NO ADVERSE EVENT (No adverse event) in a 22-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Sep-2023, 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 05-Sep-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster for infant 6 month to 5-year-old yellow box pink or magenta cap with vial size 0.4 ml). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 2 Aug 2023 and administration of vaccine on 5 Sep 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 2 Aug 2023 and administration of vaccine on 5 Sep 2023), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster for infant 6 month to 5-year-old yellow box pink or magenta cap with vial size 0.4 ml) 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 (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 2 Aug 2023 and administration of vaccine on 5 Sep 2023) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster for infant 6 month to 5-year-old yellow box pink or magenta cap with vial size 0.4 ml).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Bivalent Booster for infant 6 month to 5-year-old yellow box pink or magenta cap.  Individual vials or intact cartons was 1 dose and vial size were 0.4ml The vial did not undergo any temperature excursions.  Treatment medication not reported.