Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received a vaccine that under went a temperature excursion; No adverse event; Patient received a vaccine that underwent a temperature excursion; 1st dose administered on 29-Jun-2022; 2nd dose administered on 13-Aug-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 29-Jun-2022; 2nd dose administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 29-Jun-2022; 2nd dose administered on 13-Aug-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient 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 (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 29-Jun-2022; 2nd dose administered on 13-Aug-2022) 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 (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 29-Jun-2022; 2nd dose administered on 13-Aug-2022).    Patients weight was reported as 37.2. Vaccine 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 under went 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.