Health outcomes of interest for evaluation in the Post-Licensure Rapid Immunization Safety Monitoring Program

► The FDA is establishing a new active surveillance program in vaccine safety. ► We systematically developed a list of health outcomes of interest for this program. ► We gathered input from a variety of experts and to form an initial comprehensive list. ► A five-member expert panel and FDA selected 24 outcomes from this list. ► Next steps will include evidence reviews on computerized coding for these outcomes.