Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; No adverse event; Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male 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.     The patient had no allergies to medications, food, and other products. It was unknown if the patient had been diagnosed with or tested positive for COVID-19.     On 21-Sep-2022 at 12:22 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 12:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may 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 (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Concomitant medication information was not provided.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  No adverse reactions had been reported to the reporter's knowledge for the patient.  No treatment information was provided.