Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; 1st dose administered on 25-Jun-22 and 2nd dose administered on 13-Aug-22; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 25-Jun-22 and 2nd dose administered on 13-Aug-22) and NO ADVERSE EVENT (No adverse event) in a 2-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 25-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 (Received a vaccine that underwent a temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 25-Jun-22 and 2nd dose administered on 13-Aug-22). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 25-Jun-22 and 2nd dose administered on 13-Aug-22) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 25-Jun-22 and 2nd dose administered on 13-Aug-22).    Weight of the patient was reported as 31# (unit not specified).  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was  with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported by reporter.