Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 10 doses of bivalent vaccine were given from vials beyond their recommended use date: 01may23; The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered from 01-May-2023 to 07-May-2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 doses of bivalent vaccine were given from vials beyond their recommended use date: 01may23), PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered from 01-May-2023 to 07-May-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. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 (10 doses of bivalent vaccine were given from vials beyond their recommended use date: 01may23), PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered from 01-May-2023 to 07-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 doses of bivalent vaccine were given from vials beyond their recommended use date: 01may23), PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered from 01-May-2023 to 07-May-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 (10 doses of bivalent vaccine were given from vials beyond their recommended use date: 01may23) and PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered from 01-May-2023 to 07-May-2023).    Concomitant product use was not provided by the reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Approximately 10 doses of bivalent vaccine were given from vials beyond their recommended use date. The vials had been moved from freezer to the refrigerator on 31-Mar-2023. 10 Doses were given between 1-May-2023 and 7-May-2023 from these vials. The vaccine expiration date was reported as 18-May-2023.  10 patients who received Moderna Bivalent Covid-19 vaccine was past its use by date of 29-Apr-2023. The remaining vials were quarantined and salvaged out of our inventory. Treatment drug was not reported. This case contains information for the 10th of 9 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723501 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2023: Live Significant follow-up information received: Drug administration date and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723501:Patient no. 1 (Master case)