Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: Dose of Moderna Covid-19 Vaccine, Bivalent was administered after multiple temperature excursions; No adverse event; Dose of Moderna Covid-19 Vaccine, bivalent was administered after multiple temperature excursion and 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 was administered after multiple temperature excursion and Bivalent were administered after vaccine was expired.), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine, Bivalent was administered after multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 66-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 an unknown date, 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 was administered after multiple temperature excursion and 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 was administered after multiple temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine, bivalent was administered after multiple temperature excursion and Bivalent were administered after vaccine was expired.), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine, Bivalent was 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 EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine, bivalent was administered after multiple temperature excursion and Bivalent were administered after vaccine was expired.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine, Bivalent was administered after multiple temperature excursions).    Case included information of patient 3 out of 6 patients.  Concomitant product use was not provided by the reporter.  It was reported that storage condition at the time of excursion was refrigerated storage. Total 7 vials were involved and vial size was 2.5 ml. Visual is inspection of vaccine was thawed with no visual changes.  On 07-Nov-2022, total 6 doses of Moderna COVID-19 Vaccine, Bivalent were administered after multiple temperature excursions and after vaccine was expired.  Temperature excursion occurred on 05-Nov-2022 at 44.86 degree Fahrenheit for 15 minutes, on 08-Nov-2022 at 35.88 degree Fahrenheit for 15 minute, on 09-Nov-2022 at 34.62  degree Fahrenheit for 15 minute and on the same day at 3:37 P.M at 35.15 degree Fahrenheit for 15 minute.  Vaccine moved from freezer to refrigerator on 03-Oct-2022. Vaccine were discarded.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-679887 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live follow-up received. Case narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679887:same reporter