An adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information.
Any event that is not expected, in accordance with the label (USPI in the US and SmPC in Europe), is considered an unexpected event. Importantly, if an event is listed in the label, but occurs at a higher severity or with a worse outcome than the event listed in the label, is also considered unexpected. For investigational medicinal products, an unexpected adverse reaction is an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. the investigator’s brochure for an unauthorised investigational product or the summary of product characteristics for an authorised product).
