Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; temperature excursions have been administered to patient; temperature excursion that had occurred in a refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 45-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.     No Medical History information was reported.   On 15-Sep-2022 at 4:46 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator). On 15-Sep-2022 at 4:46 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions 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)) (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 (temperature excursion that had occurred in a refrigerator) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient).    Concomitant medication was not reported.  It was unknown if the patient had ever tested or been diagnosed with COVID-19.  The patient received 3 primary doses of Moderna vaccine intramuscular in deltoid.  Vaccine 4th dose reported as 0.5 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158: