Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old.; No adverse event; Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old), PRODUCT STORAGE ERROR (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1214B) for COVID-19 prophylaxis.     Patient had never been diagnosed with/ tested positive for COVID-19. She had no chronic or long-standing health conditions.  Concomitant products included PEDIARIX, HIB VACCINE CONJ (TET TOX) (HIBERIX), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 09-Dec-2022 at 10:32 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Dec-2022 at 10:32 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old), PRODUCT STORAGE ERROR (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old) and PRODUCT STORAGE ERROR (Doses was administered on 09-Dec-2022 at 10:00AM, punctured on 08-Dec-2022 at 1:00 PM . First dose for patient aged was under 5 years old.).    It was reported that vial was initially thawed on 08-Dec-2022 and vial was  first punctured on 08-Dec-2022  at 1PM . Vial size was mentioned as 2.5 ml. The vial was initially stored in refrigerator on 08-Dec-2022. Vial was stored in room temperature post puncture. Vial exposed to room temperature for twenty one hours post puncture and room temperature range was in between 8 degree Celsius to 25 degree Celsius / 46 degree Fahrenheit to 77 degree Fahrenheit. Vial did not go any temperature excursions. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2022: Live significant follow-up appended consists of patient identifier added. On 15-Dec-2022: Vaccine information updated.