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/10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of April 29, 2023; The vials had been moved from our freezer to the refrigerator on 3/31/23.; 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 April 29, 2023), PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23.) 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 April 29, 2023), PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23.) 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 April 29, 2023), PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23.) 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/10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of April 29, 2023) and PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23.).    The case contains 6th of patient out of 10 patients reported by reporter.  Concomitant Medication use information was not provided by reporter.  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 March 2023.  10 Doses were given between 1 May 2023 and 7 May 2023 from these vials.  10 patients who received Moderna Bivalent Covid-19 vaccine between May 1 and May 7 that was past it's use by date of April 29, 2023  Treatment Medication use information was not provided by 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 Follow up received that contains significant information includes vaccine details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723501:Patient no. 1 (Master case)