Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.; No adverse event; 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.; 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.), EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.), POOR QUALITY PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, 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 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.) and POOR QUALITY PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.), EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.), POOR QUALITY PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.), EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.) and POOR QUALITY PRODUCT ADMINISTERED (6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.).    No concomitant information was reported. It was reported that storage condition at the time of the excursion was refrigerated storage and vial size was 2.5 mL. Date the vial moved from freezer to refrigerator on 03Oct2022. It was thawed and no visual changes. Doses were administered post temperature excursion. Temperature reached vaccine was (05Nov2022: 44.86F x 15 min) (08Nov2022: 35.88F x 15 min) (09Nov2022: 34.62F x 15 min & at 3:37p temp was 35.15F x 15 min). No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679887 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679887:same reporter