Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional 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) and NO ADVERSE EVENT (No adverse event) in a 15-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 11-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 (Patient received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient 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 (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient 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 (Patient received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion). Patient weight was reported as 24#/12oz. No concomitant medications were reported. Vaccine administration location was reported as LQ. It was reported that, the vaccine underwent temperature excursion one in the freezer and one in the refrigerator. The excursions were picked up by local review of the temperature data logger 2 weeks later after the excursion. The excursion occurred on 07-Aug-2022. The office practice was to take 1 vial from the freezer and to place the vial in the refrigerator when there was a vaccination appointment. Due to the office process of 1 vial taken out of the freezer and placed in the refrigerator some vaccine underwent the excursion in the freezer and the rest of the vaccine excursion happened in the refrigerator. The excursion occurred in refrigerator where the vials were stored in refrigerated storage; maximum or minimum temperatures reached, as applicable (specify temp is in C or F) was positive 14 degrees Celsius and excursion occurred for 3 hours and 5 minutes. On 08-Aug-2022, the vials were moved from freezer to refrigerator. Currently vials were returned to the freezer/refrigerator, maintained at room temperature, administered, or discarded. One vial was impacted. It was stated that, the vials were not punctured until they were used for a patient and then discarded. The proposed desired Use by Date was stated as 18-Aug-2022. No side effects were reported. No treatment medications were reported.