Quadrivalent HPV Vaccine: Postlicensure Safety Data and Marketing Controversies

Postlicensure safety surveillance can reveal previously undetected adverse events. Investigators from the CDC and FDA summarized voluntary reports to the U.S. Vaccine Adverse Event Reporting System (VAERS) from June 2006 (when the quadrivalent human papillomavirus [qHPV] vaccine was first marketed in the U.S.) through December 2008. The VAERS received >12,000 adverse event reports, 772 of which noted serious adverse events (AEs). AE rates per 100,000 vaccine doses were 8.2 for syncope, 7.5 for local reactions, 6.8 for dizziness, 5.0 for nausea, 4.1 for headache, 3.1 for hypersensitivity reactions, 2.6 for urticaria, 0.2 for venous thromboembolic events (VTEs), and 0.1 for anaphylaxis and death. With the exception of syncope and VTEs (which …