Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Monovalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Monovalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 22-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022 at 10:46 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 09-Sep-2022 at 10:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient).    Dose 2 vaccine administered at deltoid region.  Concomitant medication list was not provided. It was reported that refrigeration excursions identified, vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022.state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions reported to their knowledge for any of these patients. Storage condition at the time of the excursion was refrigerated. Individual vials or unbroken cartons were 2 unbroken cartons 20 vials. Vial was moved from freezer to refrigerator on 07-Sep-2022. Vials were not visualized. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  Treatment information was not provided.