Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023; No adverse event; expired vaccine being accidently administered/administered 1 day past the post thaw expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date), PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-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. 047D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date), PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023) 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 (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date) and PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023).    No concomitant product was reported. It was reported that affected vaccine was Spikevax Moderna 6mo-5yr royal blue cap purple label with lot number 047D22A and expiry date 08-Mar-2023 on vial. 1 vial was affected. This lot number did not undergo any previous temperature excursion. The unopened vial was initially stored in the refrigerator post thawing on 13-Jan-2023. It was first punctured on 13-Feb-2023. Vaccine was drawn up into the syringe, wherein 3 were doses withdrawn and administered on 13-Feb-2023 wherein from 1-3pm, 3 were doses administered. The vial/syringe was stored at room temperature once punctured. It was not returned into fridge. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius) was 2 hours. No treatment information was reported.  This case contains information for the 1st of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712032, US-MODERNATX, INC.-MOD-2023-712033 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712032:Patient 2 out of 3 Patients (child) US-MODERNATX, INC.-MOD-2023-712033:Patient 3 out of 3 Patients (child)