Any untoward medical occurrence that:

  • results in death;
  • is life-threatening (NOTE: The term “life-threatening” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe);
  • requires inpatient hospitalisation or prolongation of existing hospitalisation;
  • results in persistent or significant disability/incapacity;
  • is a congenital anomaly/birth defect; or
  • is a medically important event or reaction.