Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) 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. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-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 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No concomitant medications were reported. Dose was administered on 01-Dec-2022 from lot number 021H22A, best use by date of 26-Nov-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-685131, US-MODERNATX, INC.-MOD-2022-685132, US-MODERNATX, INC.-MOD-2022-685133, US-MODERNATX, INC.-MOD-2022-685126, US-MODERNATX, INC.-MOD-2022-685135, US-MODERNATX, INC.-MOD-2022-685136, US-MODERNATX, INC.-MOD-2022-685137, US-MODERNATX, INC.-MOD-2022-685138, US-MODERNATX, INC.-MOD-2022-685139, US-MODERNATX, INC.-MOD-2022-685140, US-MODERNATX, INC.-MOD-2022-685142, US-MODERNATX, INC.-MOD-2022-685141 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685135:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685136:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685137:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685138:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685139:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685140:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685142:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685133:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685132:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685131:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685126:Original Case : MOD-2022-685126 US-MODERNATX, INC.-MOD-2022-685141:Samer Reporter