Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered on 01-May-2023.; No adverse event; 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 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 (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered on 01-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 01-May-2023, 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 01-May-2023, 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). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered on 01-May-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 (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered on 01-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 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 (The vials had been moved from our freezer to the refrigerator on 3/31/23 and administered on 01-May-2023.).    No concomitant medications were reported.  It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine.  The vaccine coordinator advised us to reach out to your office to see if the affected patients would need to repeat their dose in the future or if the vaccine stability had been tested out longer than the 30 days currently recommended. The remaining vials have been quarantined and salvaged out of our inventory.  No treatment medications were 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 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)