Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 10 doses of bivalentvaccine 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; 10 doses of bivalentvaccine 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; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 doses of bivalentvaccine 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), EXPIRED PRODUCT ADMINISTERED (10 doses of bivalentvaccine 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 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 PRODUCT STORAGE ERROR (10 doses of bivalentvaccine 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), EXPIRED PRODUCT ADMINISTERED (10 doses of bivalentvaccine 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 NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (10 doses of bivalentvaccine 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), EXPIRED PRODUCT ADMINISTERED (10 doses of bivalentvaccine 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 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 PRODUCT STORAGE ERROR (10 doses of bivalentvaccine 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 EXPIRED PRODUCT ADMINISTERED (10 doses of bivalentvaccine 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).    No relevant concomitant medications were reported. 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 these vials. No treatment medication reported.   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: Vaccine information reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723501:Patient no. 1 (Master case)