Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: 13 patients received  an expired vaccine for a booster dose; Vaccine was stored in the refrigerated after 30-day Use By Date, therefore product storage error was captured.; 13 patients received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (13 patients received  an expired vaccine for a booster dose) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerated after 30-day Use By Date, therefore product storage error was captured.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (13 patients received  an expired vaccine for a booster dose) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerated after 30-day Use By Date, therefore product storage error was captured.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (13 patients received  an expired vaccine for a booster dose) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerated after 30-day Use By Date, therefore product storage error was captured.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She  stated  that she received dosages in January with the same lot number, 045L21A that expired on the 20-Jan-2022 and they were put in the freezer and  from 23-Feb-2022 until the 12-May-2022 they administer them to 13 patients, all booster dosages, after they expired. Gave consent to be follow by safety  Number of doses/vials was13 doses out of 12 vials.  The vial was initially stored in the refrigerator on 20-Jan-2022.  Vaccine was administered  from 23-Feb-2022 until the 12-May-2022.  Vial was underwent temperature excursions  Vial was refrigerated condition at the time of the excursion.   Lot number and Expiration Date*: 045L21A5, Jul-2022  Vial temperatures Maximum 44.6°F  minimum  38.8°F reached.  Vial Excursion duration was 3 months.  No,Visual inspection noting any vaccine state change, they are in seal boxes.  Number of vials/doses impacted: 660 doses, and they have now 520  No any previous excursions with the impacted vial(s).  Patient had no allergy medications, food and other products.   Patient ever had COVID + test or diagnosis was reported as unknown.   Vial was underwent temperature excursions.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route,Dose).  No concomitant medication were reported.   No treatment drug were reported.