Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023; No adverse event; the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (the vaccine was administered on day 37 to 2 patients, age group 6-months to 5yrs) and PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was administered to patient on 23-Jun-2023).    Concomitant product use was not provided by the reporter.  Unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Suspect product dosage text was reported as unknown. The intact carton 0.4 ml did not undergo any temperature excursions. Vials were kept between 2-8 C for the entire time. It was reported that vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use, provided the expiration date was not exceeded. Moderna COVID-19 Vaccine, Bivalent should be used 30 days from the date the vaccine was exposed to temperatures above 36°F (2°C). Vials can be used by the end of day on day 30. Expired vaccine or vaccine past the 30-day beyond use date (BUD) will need to be discarded.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730937 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730937:Same reporter