Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit; Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit; 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/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 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 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/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit). In November 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that total 19 patients received the affected lot of vaccine out of which 3 were males and 16 were females.  2 second doses (both given to female patients) and 17 booster doses were given to the patients.  The healthcare provider mentioned that they always had the freezer between this temperature range from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit. Two vials were used to administer to healthcare provider's office employees. All doses were injected in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  The patient did not experience any adverse events after receiving the vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   This case was linked to MOD-2022-474599, MOD-2022-474544, MOD-2022-479778, MOD-2022-479873, MOD-2022-479908, MOD-2022-479943, MOD-2022-479957, MOD-2022-479962, MOD-2022-479975, MOD-2022-479978, MOD-2022-479984, MOD-2022-479989, MOD-2022-479991, MOD-2022-479993, MOD-2022-479997, MOD-2022-479999, MOD-2022-480005, MOD-2022-480007 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Significant Follow up received: contains updated outcome of the event of product storage error and narrative updated.