OBJECTIVES: To evaluate the safety of trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to evaluate the risk of medically attended events (MAEs) in a subcohort of children who had multiple annual doses of TIV over their lifetimes. DESIGN: Self-controlled screening study. SETTING: Seven US managed care organizations from October 1, 2002, to March 31, 2006. PARTICIPANTS: Children aged 24 to 59 months who received at least 1 TIV dose (66 283 children and 91 692 TIV doses). EXPOSURE: Vaccination with TIV. MAIN OUTCOME MEASURES: Medically attended events in inpatient and emergency department settings in one of the following risk windows: 0 to 2, 1 to 14, or 1 to 42 days after vaccination. All MAEs that met the screening criteria of incidence rate ratios (IRRs) exceeding 1.0 and P