Adverse Event

Usually refers to the consequences of using a pharmaceutical product, medical device or surgical procedure. Serious adverse events might be listed as death, a life-threatening drug experience, inpatient hospitalization, prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, and other important medical events that may jeopardize the patient or subject and may require subsequent corrective medical or surgical intervention to prevent one of the other outcomes listed above.

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