Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date; No adverse event; 7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date) 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 (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date) and PRODUCT STORAGE ERROR (7 Patients have received 8 doses of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date).    Concomitant product use was not provided by the reporter.  For First dose expired product administered was found to be on 22-Aug-2022.  All patients received primary series doses of the 6m-5y presentation of the Moderna COVID-19 vaccine (lot number AS1414B, expiration date unknown). All patients have not reported any symptoms. No patients have received any additional doses, medications, or treatments to the knowledge of the vaccination provider. vials of first dose thaw and refrigeration date was on 22-Jul-2022. vials of second dose thaw and refrigeration date was 09-Aug-2022. Individual vials (3 administrations) size was 2.5 ml. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-650249, US-MODERNATX, INC.-MOD-2022-650252, US-MODERNATX, INC.-MOD-2022-650253, US-MODERNATX, INC.-MOD-2022-650288, US-MODERNATX, INC.-MOD-2022-650293, US-MODERNATX, INC.-MOD-2022-650479 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650249: US-MODERNATX, INC.-MOD-2022-650252: US-MODERNATX, INC.-MOD-2022-650253: US-MODERNATX, INC.-MOD-2022-650288: US-MODERNATX, INC.-MOD-2022-650293: US-MODERNATX, INC.-MOD-2022-650479: