Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date; Date the vial was initially stored in the refrigerator was on 10 May 2023.Dose administered after 30-day Use By Date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was on 10 May 2023.Dose administered after 30-day Use By Date) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was on 10 May 2023.Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was on 10 May 2023.Dose administered after 30-day Use By Date) 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 PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was on 10 May 2023.Dose administered after 30-day Use By Date) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event).    No relevant concomitant medications were reported. It was reported that open Carton Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was on 10 May 2023. Dates of administration of vaccine were: 1 patient on 1 0JUN 2023, 3 Patients on 11 JUN 2023, 2 patients on 12 JUN 2023, 1 patient on 15 JUN 2023, 2 patients on 24 JUN 2023. The vial hasn't undergone any temperature excursions. No treatment medication reported.  This case was for the 7th patient out of 9 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732805 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732805:Same report Patient 7