Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered dose of the bivalent vaccine to patient after the 30 day beyond use date and initially moved from the freezer to the refrigerator on 29-Sep-2022; No adverse event; administered dose of the bivalent vaccine to patient after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose of the bivalent vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (administered dose of the bivalent vaccine to patient after the 30 day beyond use date and initially moved from the freezer to the refrigerator on 29-Sep-2022) 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. 027E22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: DTAP on 25-Mar-2013, Seasonal influenza (Seasonal influenza) on 23-Jan-2017, Seasonal influenza (Seasonal influenza) on 11-Dec-2017, Seasonal influenza on 12-Dec-2018, Zoster (Zoster) on 06-Dec-2019, Seasonal influenza (Seasonal influenza) on 06-Dec-2019, Zoster (Zoster) on 26-Jul-2020, Seasonal influenza (Seasonal influenza) on 24-Oct-2020, Seasonal influenza (Seasonal influenza) on 06-Dec-2021 and Seasonal influenza (Seasonal influenza) on 30-Oct-2022. Past adverse reactions to the above products included No adverse event with DTAP, Seasonal influenza, Seasonal influenza, Seasonal influenza, Seasonal influenza, Seasonal influenza, Seasonal influenza, Seasonal influenza, Zoster and Zoster. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 30-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose of the bivalent vaccine to patient after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered dose of the bivalent vaccine to patient after the 30 day beyond use date and initially moved from the freezer to the refrigerator on 29-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered dose of the bivalent vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (administered dose of the bivalent vaccine to patient after the 30 day beyond use date and initially moved from the freezer to the refrigerator on 29-Sep-2022) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered dose of the bivalent vaccine to patient after the 30 day beyond use date) and PRODUCT STORAGE ERROR (administered dose of the bivalent vaccine to patient after the 30 day beyond use date and initially moved from the freezer to the refrigerator on 29-Sep-2022).    It was reported that patient had received Moderna vaccine on 20-Mar-2021 (dose 1), 17-Apr-2021 (dose 2) and 22-Nov-2021 (dose 3).  The vaccine was contained in individual vials within broken carton.  The vial was initially stored in the refrigerator on 29-Sep-2022.  The size of the vial was 2.5 ml.  The vial was initially stored in refrigerator on 29-Sep-2022.  The vial did not undergo any temperature excursions.  The medication error was discovered on 31-Oct-2022.  It was reported that the patient had no reported adverse events or symptoms, and no additional doses, medications or treatments were administered to the patient.