Age: 83.0
Sex: F
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; 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.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (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.), 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 83-year-old female 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.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     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 (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.). 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 (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.), 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 (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 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 receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Individual vial size was unknown. Suspect vaccine dosage text was reported as unknown. Via did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information about patient 2nd 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