Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The vaccines have undergone several temperature excursions and have been administered to patients; No adverse event; The vaccines have undergone several temperature excursions and have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccines have undergone several temperature excursions and have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccines have undergone several temperature excursions and have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 49-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 the patient had ever been diagnosed with or tested positive for COVID-19.     On 15-Sep-2022 at 4:34 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Sep-2022 at 4:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The vaccines have undergone several temperature excursions and have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccines have undergone several temperature excursions and have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccines have undergone several temperature excursions and have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccines have undergone several temperature excursions and have been administered to patients) 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 (The vaccines have undergone several temperature excursions and have been administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (The vaccines have undergone several temperature excursions and have been administered to patients).    No concomitant product reported by the reporter. Patient received 0.5 (units unspecified) of Bivalent vaccine in deltoid. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in the units. There were excursions noted. 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 to their knowledge for the patient. No treatment medication reported by the reporter.   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