Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 20-Jun-2023, vaccine was expired on 20-Jul-2023, vaccine was administered on 03-Aug-2023.; No adverse event; A vaccine expired on 20-Jul-2023 and was then administered to a patient, a 5-year-old patient received expired Bivalent Blue Cap Moderna COVID-19 vaccine (0.25 ml) on 03-Aug-2023, Dose administered after 30-day Use By Date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vaccine expired on 20-Jul-2023 and was then administered to a patient, a 5-year-old patient received expired Bivalent Blue Cap Moderna COVID-19 vaccine (0.25 ml) on 03-Aug-2023, Dose administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 20-Jun-2023, vaccine was expired on 20-Jul-2023, vaccine was administered on 03-Aug-2023.) and NO ADVERSE EVENT (No adverse event) in a 5-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 information was reported.    On 03-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 03-Aug-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 vaccine expired on 20-Jul-2023 and was then administered to a patient, a 5-year-old patient received expired Bivalent Blue Cap Moderna COVID-19 vaccine (0.25 ml) on 03-Aug-2023, Dose administered after 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 20-Jun-2023, vaccine was expired on 20-Jul-2023, vaccine was administered on 03-Aug-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A vaccine expired on 20-Jul-2023 and was then administered to a patient, a 5-year-old patient received expired Bivalent Blue Cap Moderna COVID-19 vaccine (0.25 ml) on 03-Aug-2023, Dose administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 20-Jun-2023, vaccine was expired on 20-Jul-2023, vaccine was administered on 03-Aug-2023.) 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 vaccine expired on 20-Jul-2023 and was then administered to a patient, a 5-year-old patient received expired Bivalent Blue Cap Moderna COVID-19 vaccine (0.25 ml) on 03-Aug-2023, Dose administered after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 20-Jun-2023, vaccine was expired on 20-Jul-2023, vaccine was administered on 03-Aug-2023.).    Concomitant product use was not provided by the reporter.  Individual vial size was 2.5 ml. Manufacturer expiry date was 13-Oct-2023. Suspect vaccine dosage text was reported as unknown. It was reported that not sure which dose it was in the schedule. Vial did not undergo any temperature excursions.  Treatment information was not provided.