How will the 2009 H1N1 influenza vaccines be monitored for safety?
The CDC and FDA closely monitor the safety of seasonal influenza and other vaccines licensed for use in the United States in cooperation with state and local health departments, healthcare providers, and other partners. The purpose of vaccine safety monitoring is timely identification of clinically significant adverse events following immunization that may be of public health concern. Adverse events, or possible side effects, following immunization may be coincidental to (meaning occurring around the same time but not related to vaccination) or caused by vaccination. The purpose of vaccine safety monitoring is timely identification of clinically significant adverse events following immunization that might be of public health concern. CDC and its partners will use multiple systems to monitor the safety of 2009 H1N1 influenza vaccine. Two of the primary systems that will be used to monitor the safety of these vaccines after they are in widespread use are: the Vaccine Adverse Event Report