Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial stored post puncture at room temperature/vial was initially stored in the refrigerator on 16-Sep-2022, in the morning/vial was first punctured on 19-Sep-2022 at 15:15 (3:15pm); No adverse event; administered with bivalent that was past 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with bivalent that was past 12 hours post puncture), PRODUCT STORAGE ERROR (The vial stored post puncture at room temperature/vial was initially stored in the refrigerator on 16-Sep-2022, in the morning/vial was first punctured on 19-Sep-2022 at 15:15 (3:15pm)) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 19-Feb-2021 and Pfizer (Dose 2) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 20-Sep-2022 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 20-Sep-2022 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 (administered with bivalent that was past 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial stored post puncture at room temperature/vial was initially stored in the refrigerator on 16-Sep-2022, in the morning/vial was first punctured on 19-Sep-2022 at 15:15 (3:15pm)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with bivalent that was past 12 hours post puncture), PRODUCT STORAGE ERROR (The vial stored post puncture at room temperature/vial was initially stored in the refrigerator on 16-Sep-2022, in the morning/vial was first punctured on 19-Sep-2022 at 15:15 (3:15pm)) 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 (administered with bivalent that was past 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial stored post puncture at room temperature/vial was initially stored in the refrigerator on 16-Sep-2022, in the morning/vial was first punctured on 19-Sep-2022 at 15:15 (3:15pm)).    No concomitant medications were reported. Vial did not undergo any temperature excursions. Date the vial was initially stored in the refrigerator: 16Sep2022, in the morning Date and time vial was first punctured: 19Sep2022 at 15:15 (3:15pm) Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was approximately 18 hours. Patient received dose 3, Moderna 1st booster on 05Nov2021. Patient received dose 4 as Bivalent 2nd booster. No treatment medications were reported.   This case was linked to MOD-2022-648047 (Patient Link).