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From Everything.Sucks

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

An Adverse event can lead to health problems and medical negligence, according to a post published by psnet.ahrq.gov

"Case 4: A middle-aged man had rectal bleeding. The patient's physician completed only a limited sigmoidoscopy, which was negative. The patient had continued rectal bleeding but was reassured by the physician. Twenty-two months later, after a 14-kg (30 lb) weight loss, he was admitted to a hospital for evaluation. He was found to have colon cancer with metastases to the liver. The physicians who reviewed his medical record judged that proper diagnostic management might have discovered cancer when it was still curable. They attributed the advanced disease to substandard medical care. The event was considered adverse and due to negligence."

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