Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial moved from the freezer to the refrigerator on 21-Jun-2022 and first dose was administered on 27-Jul-2022, second dose administered on 25-AUG-2022; No adverse event; Doses administered after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vial moved from the freezer to the refrigerator on 21-Jun-2022 and first dose was administered on 27-Jul-2022, second dose administered on 25-AUG-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male 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 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial moved from the freezer to the refrigerator on 21-Jun-2022 and first dose was administered on 27-Jul-2022, second dose administered on 25-AUG-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vial moved from the freezer to the refrigerator on 21-Jun-2022 and first dose was administered on 27-Jul-2022, second dose administered on 25-AUG-2022) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vial moved from the freezer to the refrigerator on 21-Jun-2022 and first dose was administered on 27-Jul-2022, second dose administered on 25-AUG-2022).    No concomitant medication information was provided. The vial size was reported as 2.5 ml. It was reported that Lot AS1414B was moved from the freezer to the refrigerator on 21-Jun-2022. It was reported that the vial did not undergo temperature excursions. They had multiple doses administered after the 30 days beyond use date. None of patients reported experiencing any symptoms after receiving those doses.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654159, US-MODERNATX, INC.-MOD-2022-654157, US-MODERNATX, INC.-MOD-2022-654166, US-MODERNATX, INC.-MOD-2022-654167, US-MODERNATX, INC.-MOD-2022-654171 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654159:Patient 2 (same reporter) US-MODERNATX, INC.-MOD-2022-654157:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-654166:Patient 4 (same reporter) US-MODERNATX, INC.-MOD-2022-654167:Patient 5 (same reporter) US-MODERNATX, INC.-MOD-2022-654171:Patient 6(same reporter)