Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022), PRODUCT STORAGE ERROR (more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination. No medical history reported by reporter. Patient did not have allergies to medications, food and other products. Unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health condition. No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. On 07-Jul-2022 at 12:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 15-Aug-2022 at 9:36 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 25 microgram. On 15-Aug-2022 at 9:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022), PRODUCT STORAGE ERROR (more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14 AUG 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose-07-Jul-2022/ 2nd Dose-15-Aug-2022) and PRODUCT STORAGE ERROR (more than 30 days in the refrigerator). No Concomitant medications were provided. Patient race was reported as "private". Vial was initially stored in the refrigerator on 14JUL 2022 and vial did not undergo any temperature excursions. That vial had spent more than 30 days in the refrigerator and the 30 day BUD was 14 AUG 2022. No reported symptoms. No additional doses, medications, or treatments had been administered at that time. Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2022: Follow up received contains significant information included patient demographics and suspect product details were added.