Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initial stored in refrigerator on 21-Nov-2022, pulled from the fridge on 23Nov2022 at 10:30AM, it was uncapped and administration on 25-Nov-2022; No adverse event; Dose administered after exposure to room temperature greater than 24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature greater than 24 hours), PRODUCT STORAGE ERROR (The vial was initial stored in refrigerator on 21-Nov-2022, pulled from the fridge on 23Nov2022 at 10:30AM, it was uncapped and administration on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, 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-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature greater than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initial stored in refrigerator on 21-Nov-2022, pulled from the fridge on 23Nov2022 at 10:30AM, it was uncapped and administration on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature greater than 24 hours), PRODUCT STORAGE ERROR (The vial was initial stored in refrigerator on 21-Nov-2022, pulled from the fridge on 23Nov2022 at 10:30AM, it was uncapped and administration on 25-Nov-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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature greater than 24 hours) and PRODUCT STORAGE ERROR (The vial was initial stored in refrigerator on 21-Nov-2022, pulled from the fridge on 23Nov2022 at 10:30AM, it was uncapped and administration on 25-Nov-2022).    The concomitant medication was not reported by reporter. It was reported that the Medical Assistant had a lot of Moderna that was pulled from the fridge on 23-Nov-2022 at 10:30AM. Reporter said it was uncapped and used on 25-Nov-2022 on 3 patients (Administration times: 10:30AM, 10:46AM and 3:45 PM). The reporter wanted to know if the doses need to be repeated. One individual vial used with vial size 2.5 mL. On 21-Nov-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The total 48 hours amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F). The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-679111, US-MODERNATX, INC.-MOD-2022-679116 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679111:Same reporter US-MODERNATX, INC.-MOD-2022-679116:Same reporter