Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product storage error
Clinical narrative: Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures; Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053022A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, 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 STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) 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 STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures).    No concomitant medications were reported. HCP stated that the vaccines were stored in the freezer, they keep a log of temperatures morning and evening, have had no prior or current temperature excursions, no alarm and no power outages. Treatment information was not provided.  This case contains information for the 14 of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-687867 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687867:Master