Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: No adverse event; vial was first punctured: 2/2/2023,administration of vaccine: 2/3/2023/ vial exposed to room temperature for >24 hours: YES; Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator; Vaccine was stored at room temperature for 31 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was first punctured: 2/2/2023,administration of vaccine: 2/3/2023/ vial exposed to room temperature for >24 hours: YES), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator), PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Feb-2023 at 3:00 PM, 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 01-Feb-2023 at 7:00 AM, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours). On 03-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator). On 03-Feb-2023 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was first punctured: 2/2/2023,administration of vaccine: 2/3/2023/ vial exposed to room temperature for >24 hours: YES). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial was first punctured: 2/2/2023,administration of vaccine: 2/3/2023/ vial exposed to room temperature for >24 hours: YES), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator), PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours) 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 (vial was first punctured: 2/2/2023,administration of vaccine: 2/3/2023/ vial exposed to room temperature for &gt;24 hours: YES), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator) and PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours).    No concomitant medication information was provided.  It was reported that patient was administer with vaccine 31 hrs after removed from refrigerator (recommended time is 12hr).  No treatment medications were provided. Date(s) and time(S) vial was first punctured was 2 Feb 2023 at 10:21. The vial stored at room temperature post puncture. the vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was approx. ~28.5 hours It was unknown if the vial exposed to room temperature for >24 hours   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2023: Significant Follow up appended: New event added