Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), PRODUCT STORAGE ERROR (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female 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 12-Jul-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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), PRODUCT STORAGE ERROR (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), PRODUCT STORAGE ERROR (Received a vaccine that underwent 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 (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and PRODUCT STORAGE ERROR (Received a vaccine that underwent a temperature excursion). No concomitant medication was reported by reporter. Patient got 1st dose on LQ and 2nd dose on LQ. Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 07-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. 13 frozen stored vials were with lot number AS1412B and expiration date 23-Feb-2023. Maximum or minimum temperatures reached was -3.2 degrees Celsius for 3hr 33min. Those were still stored in freezer. No vaccine was refrozen. Proposed desired used by date was 18-Aug-2022. Some vials had been used on patients punctured and discarded within 12 hours. 5 vials were in the freezer 2 were in the refrigerator. 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. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2022: Live Follow-up was received and patient details, case narrative updated.