Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023; No adverse event; Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023) 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 (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the intact carton monovalent 6M-5Y vial of unknown size was administered to patient on 02-Mar-2023. The vial was not exposed to any temperature excursion.  It was also reported that the doses were administered to 6 patients as 1 dose on 16-Feb-2023, 2 doses on 02-Mar-2023 and 3 doses on 09-Mar-2023. The vial was initially stored in refrigerator on 1 vial on 16-Feb-2023, 1 vial on 02-Mar-2023 and 1 vial on 09-Mar-2023. The dose involved combination of first dose and some 2nd primary doses. Treatment medications were not provided.  This case is reported for patient 2 of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-715544, US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715550, US-MODERNATX, INC.-MOD-2023-715551, US-MODERNATX, INC.-MOD-2023-715548 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715544:Patient 01 (Master case) US-MODERNATX, INC.-MOD-2023-715550:Patient 3 US-MODERNATX, INC.-MOD-2023-715549:Patient 4 US-MODERNATX, INC.-MOD-2023-715551:Patient 5 US-MODERNATX, INC.-MOD-2023-715548:Patient 6