– Any untoward event associated with a research study The event does not necessarily have a causal relationship with treatment or study intervention An AE can be any unfavorable and unintended sign, symptom or disease
Any untoward occurrence in a research participant The occurrence need not have a clear causal relationship with the individual's participation in the research; an AE can be any unfavorable and unintended sign, symptom, event or occurrence affecting a participant's physical, mental, social, financial, legal, or psychological well-being An unanticipated AE should be reported to the Committee as soon as possible after it is identified
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 unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product See also serious adverse event
An injury that was caused by medical management and that results in measurable disability (definition courtesy the Quality Interagency Coordination Task Force)
in a clinical trial, an unwanted effect detected in participants The term is used whether or not the effect can be attributed to the vaccine under study
An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e g , headache following spinal tap or intestinal bleeding associated with aspirin therapy)
Any undesirable event that occurs following vaccination An adverse event could be a true vaccine reaction, or just a coincidental event, with further research needed to distinguish between them
Any harm a patient suffers that is caused by factors other than the patient's underlying condition