Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients received a vaccine that under went a temperature excursion; No adverse event; patients received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion).    Patient's weight was reported as 29. Vaccine administration site was reported as LQ. Concomitant medication list was not provided.  It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion. The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08-Aug-2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18-Aug-2022. Number of vials/ per doses impacted was 1 vial.  The excursion occurred on 07-Aug-2022.  The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided.