Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: Bivalent  doses were administered after multiple temperature excursions.; No adverse event; Vial was moved from freezer to refrigerator on 3Oct2022 and administered on 7Nov2022; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent  doses were administered after multiple temperature excursions.), EXPIRED PRODUCT ADMINISTERED (Vial was moved from freezer to refrigerator on 3Oct2022 and administered on 7Nov2022) and NO ADVERSE EVENT (No adverse event) in a 65-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 (Vial was moved from freezer to refrigerator on 3Oct2022 and administered on 7Nov2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent  doses were administered after multiple temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent  doses were administered after multiple temperature excursions.), EXPIRED PRODUCT ADMINISTERED (Vial was moved from freezer to refrigerator on 3Oct2022 and administered on 7Nov2022) 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 (Bivalent  doses were administered after multiple temperature excursions.) and EXPIRED PRODUCT ADMINISTERED (Vial was moved from freezer to refrigerator on 3Oct2022 and administered on 7Nov2022).    Concomitant product use was not provided by the reporter.  The patient administered the bivalent vaccine after it underwent several temperature excursions.  On 05-Nov-2022, 44.86F for 15 min.  On 08-Nov-2022, 35.88F for 15 min  On 09-Nov-2022, 34.62F for 15 min and at 3:37p temp was 35.15F for 15 min.  All the vials were in refrigerated storage at the time of excursion. Total 7 vials were affected, and the size of vial was reported as 2.5 ml.  The vials were moved from freezer to refrigerator on 03-Oct-2022.  No visual changes were noted in the thawed vials.  It was further reported that the vaccine was expired.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-679999, US-MODERNATX, INC.-MOD-2022-680010, US-MODERNATX, INC.-MOD-2022-680023, US-MODERNATX, INC.-MOD-2022-680053, US-MODERNATX, INC.-MOD-2022-680060 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live follow-up received included case narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679999:Same reporter US-MODERNATX, INC.-MOD-2022-680010:Same reporter US-MODERNATX, INC.-MOD-2022-680023:Same reporter US-MODERNATX, INC.-MOD-2022-680053:Same reporter US-MODERNATX, INC.-MOD-2022-680060:Same reporter