Age: 72.0
Sex: F
Vaccine: 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 14-Apr-2023; No adverse event; Administered expired Moderna Vaccines to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient 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 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 72-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.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-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 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient 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 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient 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 14-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 (Administered expired Moderna Vaccines to patient 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 14-Apr-2023).    No concomitant medications were provided.  Pharmacist was calling to find out about the stability of expired Moderna vaccines as it was administered to several patients after 30-day use by date.  Dose administered after 30-day use by date or after manufacturer date of expiry.  The individual 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 2 nd of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Follow-up received included patient age, gender, initial, date of administration added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Master case US-MODERNATX, INC.-MOD-2023-721147:Patient 2