Age: 82.0
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; Returned vial to the refrigerator after administering, which undergone temperature excursion with 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent dose administered to patient after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to patient after temperature excursion), PRODUCT STORAGE ERROR (Returned vial to the refrigerator after administering, which undergone temperature excursion with highest at 46.5 F for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an 82-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 (Returned vial to the refrigerator after administering, which undergone temperature excursion with highest at 46.5 F for 15 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent dose administered to patient after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to patient after temperature excursion), PRODUCT STORAGE ERROR (Returned vial to the refrigerator after administering, which undergone temperature excursion with highest at 46.5 F for 15 minutes) 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent dose administered to patient after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to patient after temperature excursion) and PRODUCT STORAGE ERROR (Returned vial to the refrigerator after administering, which undergone temperature excursion with highest at 46.5 F for 15 minutes).    The concomitant medication was not reported by reporter. It was reported that vaccine underwent a temperature excursion on Friday 21Oct2022. 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 051D22A,083B22A and 19-Nov2022 and  28-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-2022-664045, US-MODERNATX, INC.-MOD-2022-664042 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664064:Same reporter US-MODERNATX, INC.-MOD-2022-664049:Same reporter US-MODERNATX, INC.-MOD-2022-664045:Same reporter US-MODERNATX, INC.-MOD-2022-664054:Same reporter US-MODERNATX, INC.-MOD-2022-664063:Same reporter US-MODERNATX, INC.-MOD-2022-664042:Same reporter