Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Bivalent dose administered to patient after temperature excursion.; Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes; No adverse event; Bivalent dose administered to patient after temperature excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to patient after temperature excursion.), PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Bivalent dose administered to patient after temperature excursion.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent dose administered to patient after temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to patient after temperature excursion.), PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to patient after temperature excursion.), PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Bivalent dose administered to patient after temperature excursion.) 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)) (Intramuscular), 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 dose administered to patient after temperature excursion.), PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent dose administered to patient after temperature excursion.).    The concomitant medication was not reported by reporter.  It was reported that vaccine underwent a temperature excursion on Friday 21-Oct-2022.Storage condition at the time of the excursion was refrigerated. The vaccine was an individual vial. The size of the vial was 2.5mL. The highest temperature reached was 46.5 F. The excursion duration was 15 minutes. The vials were returned to the refrigerator. The vaccines appeared normal during visual inspection. The Lot numbers and Expiration Dates of the vaccines that underwent temperature excursion were 083B22A, 051D22A and 28-Nov-2022 and 19-Nov-2022 respectively.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-664063, US-MODERNATX, INC.-MOD-2022-664049, US-MODERNATX, INC.-MOD-2022-664054, US-MODERNATX, INC.-MOD-2022-664064, US-MODERNATX, INC.-MOD-2022-664042, US-MODERNATX, INC.-MOD-2022-664056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664064:Same reporter US-MODERNATX, INC.-MOD-2022-664054:Same reporter US-MODERNATX, INC.-MOD-2022-664049:Same reporter US-MODERNATX, INC.-MOD-2022-664063:Same reporter US-MODERNATX, INC.-MOD-2022-664042:Same reporter US-MODERNATX, INC.-MOD-2022-664056:Same reporter