Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.; Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022; No adverse event; dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions/ dose of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions/ dose of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.), PRODUCT TEMPERATURE EXCURSION ISSUE (dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.), PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 69-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 (dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions/ dose of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.), PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions/ dose of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.), PRODUCT TEMPERATURE EXCURSION ISSUE (dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.), PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022) 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 of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions/ dose of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired.), PRODUCT TEMPERATURE EXCURSION ISSUE (dose of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions.) and PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022).    Concomitant products were not reported.  It was reported that vial size was 2.5ml and storage condition at the time of excursion was refrigerated. The temperature excursions happened on 05-Nov-2022 44.86F for 15 mins, 08-Nov-2022 35.88F for 15 mins and 09-Nov-2022 34.62F for 15 min at 3.37p temperature was 35.15F for 15mins. 0n 03-Oct-2022 the vial was moved from freezer to refrigerator. Vials was discarded, visual inspection had no visual changes.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679887 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live Significant follow up events and Case narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679887:same reporter