Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was taken out of refrigerator on 07-Apr-2023 at 08:20 and was administered to patient on 10-Apr-2023 which was exposed to room temperature; No adverse event; A medical assistant reports that they had bivalent vaccine exposed to room temperatures more than 24 hours which was administered to patient on 10-Apr-2023.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A medical assistant reports that they had bivalent vaccine exposed to room temperatures more than 24 hours which was administered to patient on 10-Apr-2023), PRODUCT STORAGE ERROR (The vial was taken out of refrigerator on 07-Apr-2023 at 08:20 and was administered to patient on 10-Apr-2023 which was exposed to room temperature) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 18-Mar-2021, Moderna COVID-19 Vaccine (Dose 2) on 16-Apr-2021 and MODERNA COVID-19 VACCINE (1st booster dose lot number 011D21A) on 05-Dec-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Hypertension.    On 10-Apr-2023 at 9:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Apr-2023 at 9:00 AM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (A medical assistant reports that they had bivalent vaccine exposed to room temperatures more than 24 hours which was administered to patient on 10-Apr-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was taken out of refrigerator on 07-Apr-2023 at 08:20 and was administered to patient on 10-Apr-2023 which was exposed to room temperature) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A medical assistant reports that they had bivalent vaccine exposed to room temperatures more than 24 hours which was administered to patient on 10-Apr-2023.), PRODUCT STORAGE ERROR (The vial was taken out of refrigerator on 07-Apr-2023 at 08:20 and was administered to patient on 10-Apr-2023 which was exposed to room temperature) 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 (A medical assistant reports that they had bivalent vaccine exposed to room temperatures more than 24 hours which was administered to patient on 10-Apr-2023.) and PRODUCT STORAGE ERROR (The vial was taken out of refrigerator on 07-Apr-2023 at 08:20 and was administered to patient on 10-Apr-2023 which was exposed to room temperature).    Concomitant drugs were not reported.  It was reported that no adverse events were reported by patient so far.   Treatment medications were not provided.  This case was reported for patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2023-719687 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719687:same reporter