Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which does not necessarily have a causal relationship with this treatment. It can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Information that suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, previously unknown or incompletely documented.