Table 5 Classification of adverse event severity

Mild: asymptomatic or mild symptom, requiring self-care only (e.g. ice/heat, over-the-counter analgesic)

Moderate: limiting age-appropriate activities of daily living (e.g. work, school) OR sought care from a medical doctor

Serious: results in death OR is a life-threatening AE OR an AE resulting in inpatient hospitalization or prolongation of existing hospitalization for more than 24 h, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect