Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (No adverse event) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown whether patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 25-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 25-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-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 (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.).    Information regarding previous vaccination was unknown. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The expiry date was reported as 13-Jun-2023. Individual vial size was unknown. Suspect vaccine dosage text was reported as unknown. Vial did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information about patient 3rd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736471 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736471:Same reporter, Patient 1