Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-2023; No adverse event; Beyond Use Date bivalent vaccine administered / Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Beyond Use Date bivalent vaccine administered / Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-2023) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-May-2023 at 10:00 AM, 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 08-May-2023 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Beyond Use Date bivalent vaccine administered / Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Beyond Use Date bivalent vaccine administered / Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-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 (Beyond Use Date bivalent vaccine administered / Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-2023).    No concomitant medication were reported.  Patient took 1st dose of Moderna vaccine on 27 October 2021 and the dose was 100mcg, 2nd dose on 26 April 2022 and the dose was 100 mcg and the 3rd dose taken on 14 November 2022 dose was given as 50mcg.  A patient was administered Bivalent outside of use date due to removal from freezer to refrigerator on 02/02/2023 it was removed from the freezer and placed in the refrigerator. temperature: stored in the refrigerator was at 41 degree F.  Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry   Bivalent BA.4-5 having blue cap gray border   Individual vials were used, and the vial size was 2.5 ml.  Date the vial was initially stored in the refrigerator was reported as 02 February 2023.   The vial did not undergo any temperature excursions.  It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  It was unknown that the patient had chronic or long-standing health  conditions.  It was unknown that the patient taken prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being  at time of vaccination and/or at the time of the adverse event.  No treatment medication were reported.   This case was linked to MOD-2023-725188, MOD-2023-723380 (Patient Link).