Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 11 adult patients received the expired Bivalent booster beyond 30 days; No adverse event; 11 adult patients received the expired Bivalent booster beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) 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 (11 adult patients received the expired Bivalent booster beyond 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) 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 (11 adult patients received the expired Bivalent booster beyond 30 days) and PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days).    This case contains information for the 8 out of 11 adult patients described by the reporter. No concomitant information was reported. 11 adult patients received the expired Bivalent booster beyond 30 days in the refrigerator. At this time reporter does not have the patient information handy and reporter was not sure if any of those patients received any other vaccines at the same time. Vaccine vials were a case of 10pcs and 7 vials from the case were used to administer vaccines from 13JAN2023 thru 22JAN2023. Reporter advised that 11 doses of vaccines were used from the 7 vials. Reporter advised that label on case of vials advised that vials should have been used before 12JAN2023 Reporter advised that NONE of the patients that have received the 11 doses have reported any adverse reactions. it was intact cartons, 2.5 ml, The vial was initially stored in the refrigerator 13DEC2022 and administration of vaccine from 13JAN2023 thru 22JAN2023. Vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient