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 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), 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 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 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), 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 NO ADVERSE EVENT (no adverse event). At the time of the report, 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), 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 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 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 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).    This case is for 10th patient out of 10 patients. 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 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2023: Live follow-up include vaccine details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723501:Patient no. 1 (Master case)