Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses; Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond allowed storage and handling guidelines/13 patients received doses) had resolved.            Nurse called and stated that 13 patients received doses from 4 Moderna COVID-19 vaccine vials that were first punctured 12 hours prior to the administration of the vaccine. There were no patient identifiers available to the nurse, so a batch Adverse Event has been filed. No additional side effects have been reported following these administrations. It was also unknown to the nurse at the time of the call if these doses were first or second doses in the administration series of the vaccine. These were the first excursions that these vials were involved in. It was unknown the total amount of time that the vials were exposed to room temperature conditions. It was also unknown to the nurse when the vials were moved from the frozen state to a refrigerated state. The dates and number of doses administered to the patients are listed below: Vial-1- LOT: 006C21A, Exipry: Unknown , Date of first puncture: 11-Jun-2021, Kept in refrigerator after puncture: 36-46 Degrees Fahrenheit, 15-Jun-2021- 2 doses administered to patients, 25-Jun-2021- 2 doses administered to patients. Vial-2 LOT: 006C21A  Exipry: Unknown , Date of first puncture: 13-Jul-2021 Kept in refrigerator after puncture: 36-46 Degrees Fahrenheit, 14-Jul-2021- 2 doses administered to patients, 20-Jul-2021- 2 doses administered to patients. Vial -3- LOT: 006C21A  Exipry: Unknown, Date of first puncture: 28-Jul-2021, Kept in refrigerator after puncture: 36-46 Degrees Fahrenheit, 29-Jul-2021- 1 doses administered to a patient, 30-Jul-2021- 2 doses administered to patients. Vial -4- LOT: 040C21A EXP: Unknown, Date of first puncture: 03-Aug-2021, Kept in refrigerator after puncture: 36-46 Degrees Fahrenheit, 05-Aug-2021: 2 doses administered to patients.  The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.