Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Unknown number of patients have received bivalent Covid-19 vaccine from this freezer providing that goes through 4 temperature excursions; Moderna Bivalent vaccine have been dispensed that went through this freezer going through 4 temperature excursions per day.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Unknown number of patients have received bivalent Covid-19 vaccine from this freezer providing that goes through 4 temperature excursions), PRODUCT STORAGE ERROR (Moderna Bivalent vaccine have been dispensed that went through this freezer going through 4 temperature excursions per day.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Unknown number of patients have received bivalent Covid-19 vaccine from this freezer providing that goes through 4 temperature excursions), PRODUCT STORAGE ERROR (Moderna Bivalent vaccine have been dispensed that went through this freezer going through 4 temperature excursions per day.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Unknown number of patients have received bivalent Covid-19 vaccine from this freezer providing that goes through 4 temperature excursions), PRODUCT STORAGE ERROR (Moderna Bivalent vaccine have been dispensed that went through this freezer going through 4 temperature excursions per day.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Unknown number of patients have received bivalent Covid-19 vaccine from this freezer providing that goes through 4 temperature excursions) and PRODUCT STORAGE ERROR (Moderna Bivalent vaccine have been dispensed that went through this freezer going through 4 temperature excursions per day.).    No concomitant medications were reported. It was reported as unknown that the patient's receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The caller is a Pharmacy Technician calling from a Pharmacy that distributes Moderna Covid-19 vaccine to multiple clinics. The vaccine is distributed to a Nurse from each clinic at the time vaccine is needed for patient demand.  An unknown number of patients have received Moderna Covid-19 vaccine that goes through 4 temperature excursions per day every day in the manner as described below. The clinic has distributed Moderna monovalent and bivalent Covid-19 vaccine from this freezer providing for 4 temperature excursions per day since they first receive Moderna Covid-19 vaccine on December 22, 2020. Approximately 10,300 Moderna Monovalent and Moderna Bivalent vaccine have been dispensed that went through this freezer going through 4 temperature excursions per day. The freezer that we store our Moderna Covid-19 bivalent vaccine in goes through a cycle that includes a self defrosting cycle where the freezer drops in temperature to minus 10 degrees Celsius. What we do is we date the vaccines in the freezer as if they were in the refrigerator but the vaccine is colder than the 2 to 8 degrees Celsius refrigerator recommendation. This vaccine was given to an unknown number of patients. No additional information is available on these patients. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730857 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730857:Bivalent case