Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: No adverse event; Inappropriate age at vaccine administration; Patient received a vaccine that underwent a temperature excursion; Patient received a vaccine that underwent a temperature excursion; 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 underwent a temperature excursion), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event) in a 5-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion). On 16-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On an unknown date, the patient experienced 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 underwent a temperature excursion), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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 underwent a temperature excursion) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration).    The patient had a weight of 16 (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.