Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023; No adverse event; Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645B) for COVID-19 prophylaxis.     It was unknown whether the patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine or not.  Previously administered products included for COVID-19 immunization: Moderna Covid-19 vaccine (dose 1) on 07-Apr-2021, Moderna Covid-19 vaccine (dose 2) on 05-May-2021 and Moderna Covid-19 vaccine (dose 3) on 27-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.    On 18-Aug-2023, 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 18-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-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 (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023).    No concomitant medication was reported. The vial was first punctured on 18-Aug-2023. The dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial size was 2.5 mL. The vial did not undergo any temperature excursions. No treatment medication was reported.