What Happens When Rare, Adverse Events are Detected?
• VAERS reports of life-threatening events, hospitalization and/or extended hospital stay, life-threatening illnesses, disability and all reports of death, are followed up individually by a health professional. • Based on careful review, analysis and further investigation of spontaneous reports, FDA can initiate various regulatory actions such as changing vaccine labels or packaging, initiating scientific investigations, distributing safety alerts, inspecting manufacturers facilities and records, or withdrawing the vaccine from the market.li> • The National Vaccine Injury Compensation Program (VICP) is a Federal program that helps children who may have experienced rare, serious vaccine side effects. For details about this program, call (800) 338-2382. CDC, National Immunization Program: http://www.cdc.gov/nip FDA, Center for Biologics Evaluation and Research: http://www.fda.
