A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
Observational Model: Cohort, Time Perspective: Prospective
Incidence Rate of Syncope
Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
On day of each vaccination
United States: Institutional Review Board