Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 24-Jul-2023; No adverse event; 4 doses was given after the beyond used by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses was given after the beyond used by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 24-Jul-2023) and NO ADVERSE EVENT (No adverse event) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:HCP stated patient medical history is Unknown.  Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 1) on 14-Jan-2021, COVID-19 Vaccine (3rd dose lot number 939903) on 26-Oct-2021, COVID-19 Vaccine (4th dose lot number is 059A22A) on 07-Jun-2022, COVID-19 Vaccine (Dose 2) and COVID-19 Vaccine (Dose 5). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine, COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 24-Jul-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 24-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 (4 doses was given after the beyond used by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 24-Jul-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses was given after the beyond used by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 24-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 (4 doses was given after the beyond used by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 24-Jul-2023).    Concomitant medication details not reported by the reporter. It was reported that 4 doses was given after the beyond used by date. The BUD  was reported as 22-Jul-2023. 1 Intact carton Remaining vials has been discarded. Vial size was 2.5 ml. Vial did not undergo any temperature excursions. The expiry date was reported as 14-Oct-2023. Dosage text was reported as Unknown Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734896, US-MODERNATX, INC.-MOD-2023-734913, US-MODERNATX, INC.-MOD-2023-734932 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734896:Same Reporter US-MODERNATX, INC.-MOD-2023-734913:Same reporter US-MODERNATX, INC.-MOD-2023-734932:Same Reporter