Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023; No adverse event; vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023), PRODUCT STORAGE ERROR (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023) 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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 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. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023), PRODUCT STORAGE ERROR (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-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 (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023) and PRODUCT STORAGE ERROR (vaccines that were administered past 30 days beyond use date/vial was initially stored in the refrigerator 13-Dec-2022 and vial was used 13-JAN-2023 through 22-JAN-2023).    Concomitant product use was not provided by the reporter. Patient  received additional booster  dose. It was reported that Vaccine vials were a case of 10 pcs and 7 vials from the case were used to administer vaccines from 13-JAN-2023 through 22-JAN-2023. Vials were initially stored in the refrigerator 13-Dec-2022 Reporter also advised that 11 doses of vaccines were used from the 7 vials and vials should have been used before 12-JAN-2023. Individual vial size was 2.5 ml. Vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient, 5th adult  patient case out of 11 adult patient's