Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry; No adverse event; 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry) 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 09-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry) 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 (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry).    No concomitant medications was reported. Nurse reported that 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine after 11-FEB-2023. The case involved was combination of first dose and some 2nd primary doses.  The Intact Carton vial size was unknown. Date the vial was initially stored in the refrigerator were 1 vial on 16-FEB-2023; 1 vial on 02-MAR-2023 and 1 vial on 09-MAR-2023. Date(s) of administration of vaccine were 1 Patient on 16-FEB-2023; 2 Patients on 02-MAR-2023; 3 Patients on 09-MAR-2023. The vial did not undergo any temperature excursions. No treatment drug details was reported. This case contains information for the 6th patient out of 6 child patients as described by the reporter.   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-2023-715545 (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-2023-715545:Patient 2