definiens: or means any un toward medical occurrence that at any dose : results in death, is life - threatening, requires inpatient h ospitalization or prolongation of existing hospital ization, results in persistent or significant disability / incapacity or, is a congenital anomaly / birth defect . Medical a nd scientific judgment should be exercised in deciding whether ex pedited reporting is appropriate in other situation s, such as important medical events that may not be immediatel y life - threatening or result in death or hospitaliz ation but may jeopardize the patient or may require intervent ion to prevent one of the other outcomes listed in the definition above . These should also usually be cons idered serious . Examples of such events are intensi ve treatment in an emergency room or at home for aller gic bronchospasm ; blood dyscrasias or convulsions t hat do not result in hospitalization ; or development of dr ug dependency or drug abuse or transmission of an i nfectious agent via a medicinal product