Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). In November 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that 10 vials of 15 doses each were stored in a freezer of which the temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit. The reporter stated that they always had the freezer between the 24.3 degree Fahrenheit to 24.7 degree Fahrenheit temperature range. The storage condition at the time of excursion was reported as Frozen storage. The maximum temperature reached was reported as Maximum of 24.7 degree Fahrenheit. Excursion duration was reported as from 09-Nov-2021 to current date (vials have not been removed from freezer). It was reported that the vials are stored in the freezer. The vials had never been thawed. The proposed desired Use by Date was unknown. 10 vials of 15 doses were impacted. It was reported that 2 vials were used and the doses were administered on 23-Nov-2021 and 27-Nov-2021. It was stated that two vial's were used to administer HCP's office employees. It was also reported that all doses were injected intramuscular in deltoid muscle. It was reported that 19 patients were involved of which 3 were males and 16 were females.   It was reported that 2 second doses were given (both given to female patients) and 17 boosters were given.   Administration date was reported 23-Nov-2021 and 27-Nov-2021. Reporter stated that while the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt, they have not had any adverse events.   This case was linked to MOD-2022-474599, MOD-2022-479993 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: I-narrative updated