Sex: U
Vaccine: COVID19-2, 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/10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of 29-Apr-2023; 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; 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/10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of 29-Apr-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/10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of 29-Apr-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/10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of 29-Apr-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (10 doses of bivalent vaccine were given from vials beyond their recommended use date/10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of 29-Apr-2023).    The case was for the patient number 2 out of 10 patients.  No concomitant medications were reported.   It was reported that 10 doses of bivalent vaccine were given from vials beyond their recommended use date. The vials had been moved from our freezer to the refrigerator on 31-Mar-2023. 10 Doses were given between 01-May-2023 and 07-May-2023 from the vials that was past it's use by date of 29-Apr-2023. The lot number was 027E22A and the vaccine expiration date was 18-May-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723501 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2023: Live-Significant follow-up appended: Narrative update.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723501:Patient no. 1 (Master case)