Age: 63.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 19-Apr-2023 and administered on 25-apr-2023 and stored in fridge post puncture.; No adverse event; Bivalent Vaccine that was punctured 19Apr2023 and administered on 25Apr2023 to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25Apr2023 to patient), PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and administered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old 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. AS7072B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-Apr-2023, 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 25-Apr-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 (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25Apr2023 to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and administered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25Apr2023 to patient), PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and administered on 25-apr-2023 and stored in fridge post puncture.) 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 (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25Apr2023 to patient) and PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and administered on 25-apr-2023 and stored in fridge post puncture.).    The vial was first punctured on 19-Apr-2023 and administered on 25-apr-2023 and stored in fridge post puncture. No concomitant medications was reported. It was individual vial, size of the vial was 2.5 ml.  The vial was initially stored in refrigerator on 19-Apr-2023. The vaccine was administered on 25-Apr-2023 at approximately 2.25 pm and 4.19 pm. The vial was stored in fridge post puncture. The vial did not undergone any temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was less than 10 minutes. No treatment drug details was reported. This case contain information of 1st patient out of 2 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721460 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721460:Patient 2