Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was punctured on 25-May-2023 and was exposed to room temperature for 23 hours and 53 minutes; No adverse event; A patient received a dose administered 12 hours post puncture. Vial was punctured on 25-May-2023 around 11:50 AM and a dose was administered from that vial on 26-May-2023 at 11:43AM; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received a dose administered 12 hours post puncture. Vial was punctured on 25-May-2023 around 11:50 AM and a dose was administered from that vial on 26-May-2023 at 11:43AM), PRODUCT STORAGE ERROR (The vial was punctured on 25-May-2023 and was exposed to room temperature for 23 hours and 53 minutes) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067h22a) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine.     On 26-May-2023 at 11:43 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-May-2023 at 11:43 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 (A patient received a dose administered 12 hours post puncture. Vial was punctured on 25-May-2023 around 11:50 AM and a dose was administered from that vial on 26-May-2023 at 11:43AM). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was punctured on 25-May-2023 and was exposed to room temperature for 23 hours and 53 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received a dose administered 12 hours post puncture. Vial was punctured on 25-May-2023 around 11:50 AM and a dose was administered from that vial on 26-May-2023 at 11:43AM), PRODUCT STORAGE ERROR (The vial was punctured on 25-May-2023 and was exposed to room temperature for 23 hours and 53 minutes) 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 (A patient received a dose administered 12 hours post puncture. Vial was punctured on 25-May-2023 around 11:50 AM and a dose was administered from that vial on 26-May-2023 at 11:43AM) and PRODUCT STORAGE ERROR (The vial was punctured on 25-May-2023 and was exposed to room temperature for 23 hours and 53 minutes).    Concomitant drugs were not reported.  It was reported that the blue cap vial of 2.5 ml size was initially stored in refrigerator on 16-May-2023 and post puncture was stored at room temperature of 75 to 76 degree F for 23 hours and 53 minutes.  The vial was not exposed to temperature excursion.  Treatment medications were not provided.