Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.; 1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 vial temperature excursion opened and punctured on 23Jul2021 and 5 doses were administered from it.) to be possibly related.    The medical assistant stated that she had 2 vials that were in freezer and gone temperature excursion due to a power outage on 17-Jul-2021. The fridge and freezer were not in the same unit per the reporter. Initially the reporter said fridge had a temperature excursion but not the freezer as the alarms never went off for the freezer. However, the data logger showed a temperature excursion for the freezer as well. The shipment received for those 2 vials was more than 24 hours and stated that she had them for a while.  Per HCP, the data logger showed alarms went (failure) off for freezer and fridge and was calling for 2 vials that have undergone temperature excursion. 1 vial was kept in the freezer and not used. Storage condition at the time of the excursion: frozen storage. Maximum temperature was 26.6 degrees Fahrenheit while Minimum was (- ) 11.2 degrees Fahrenheit. Total Excursion duration reported was 3 hours and 10 mins, excursion duration was above 46°F (8°C): None. Interim disposition of vials was 1 vial kept in freezer and 1 vial moved to refrigerator. In visual inspection no changes noticed. Pertinent detail reported as no previous excursion, 1 vial was punctured and used after being moved to fridge and thawed and from which 5 doses were administered. Reporter stated that the open vial was discarded after 12 hours and stated that she will quarantine the unopened frozen vial. No concomitant medication information was provided. No treatment medication information was provided.