Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.; No adverse event; Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 15-Sep-2022 at 3:31 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022 at 3:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.) 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 vaccine has undergone several temperature excursions and may have been administered to patient.) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccine has undergone several temperature excursions and may have been administered to patient.).    Concomitant product use was not provided by the reporter. Patient received dose 4 at deltoid muscle. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Master case