Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 15-APR-2023; No adverse event; Pharmacist Calling to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist Calling to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 15-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Apr-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 15-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist Calling to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 15-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist Calling to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 15-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist Calling to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 15-APR-2023).    No concomitant medications were provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30 day use by date.  The vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 13 Mar 2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 3rd of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115, US-MODERNATX, INC.-MOD-2023-721131, US-MODERNATX, INC.-MOD-2023-721158, US-MODERNATX, INC.-MOD-2023-721163, US-MODERNATX, INC.-MOD-2023-721171, US-MODERNATX, INC.-MOD-2023-721173, US-MODERNATX, INC.-MOD-2023-721187, US-MODERNATX, INC.-MOD-2023-721188, US-MODERNATX, INC.-MOD-2023-721190 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Significant Live follow up appended : Patient information updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Patient 1 US-MODERNATX, INC.-MOD-2023-721131:Patient 2 US-MODERNATX, INC.-MOD-2023-721158:Patient 4 US-MODERNATX, INC.-MOD-2023-721163:Patient 5 US-MODERNATX, INC.-MOD-2023-721171:Patient 6 US-MODERNATX, INC.-MOD-2023-721173:Patient 7 US-MODERNATX, INC.-MOD-2023-721187:Patient 8 US-MODERNATX, INC.-MOD-2023-721188:Patient 9