Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patients got doses after the 30-day beyond use date; Vial was initially stored in refrigerator on 15-NOV-2022 and first dose was administered on 16-DEC-2022, 28-Dec-2022, 4-Jan-2023,7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-NOV-2022 and first dose was administered on 16-DEC-2022, 28-Dec-2022, 4-Jan-2023,7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023.) 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. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-NOV-2022 and first dose was administered on 16-DEC-2022, 28-Dec-2022, 4-Jan-2023,7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-NOV-2022 and first dose was administered on 16-DEC-2022, 28-Dec-2022, 4-Jan-2023,7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023.) 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 (Patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-NOV-2022 and first dose was administered on 16-DEC-2022, 28-Dec-2022, 4-Jan-2023,7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023.).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  It was reported that the pharmacist had received the vaccine order on 15-Nov-2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquiring the patients need to be re-vaccinated.  The size of the vial was reported as 2.5ml and vial was initially stored in refrigerator on 15Nov2022.  The doses were administered on 16-Dec-2022, 28-Dec-2022, 4-Jan-2023, 7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18- Jan -2023. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment medication information was provided by the reporter.  The case contains the information of 7th out of 14 patients who had received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706920:MASTER  CASE