This chapter addresses questions regarding the safety of vaccines. Any medical product that has a positive effect can have a negative effect; hence, no vaccine is absolutely safe. Before they are licensed, vaccines are tested in tens of thousands of children. These studies are extensive enough to determine whether vaccines cause common or even uncommon side effects, but they are not sufficient to determine whether a vaccine causes a very rare side effect. To test for this, two postlicensure systems were put in place in the late 1980s and early 1990s: the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD). VAERS is a surveillance system codirected by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), which can raise the question of whether a vaccine caused a particular problem. These questions can then be answered by the VSD, a group of large health maintenance organizations (HMOs).
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