Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event) in an elderly 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. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 31-May-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 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) 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 (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023).    Concomitant product use was not provided by the reporter.  Pharmacist was calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine, initially located in the freezer, thawed, and injected on 31-May-2023.  Dose administered after 30-day use by date or after manufacturer date of expiry products. The vial did not undergo any temperature excursions.  Moderna vaccines was still effective.   Pharmacist called Moderna regarding expiry date of 19-May-2023. Moderna did lot check and stated it was still effective. There has been no adverse reaction for patients. All booster doses. All patients qualified age greater-than 65 or immune compromised.  Treatment information was not provided.  This case contains information for the 4th patient out of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:(patient 3 out of 20)