- results in death
- requires patient hospitalization
- results in persistent or significant disability or incapacity
- is life-threatening
- or is a congenital anomaly/birth defect.
- “Severe” describes the intensity of an event (mild, moderate or severe), the event itself may be of minor medical significance (severe headache) and therefore not “serious”
- “Serious” describes the potential outcome for the patient and is used to define regulatory reporting obligations