Summary of HPV Adverse Event Reports Published in JAMA

Center for Disease Control and Prevention

Vaccine Safety

April 21, 2010

A CDC-FDA report analyzing adverse events following human papillomavirus (HPV) vaccine administration from June 2006 through December 2008 is now published in the Journal of the American Medical Association (JAMA) August 19, 2009 issue, “Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine.”

The study looked for patterns in all adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from when HPV vaccine was first licensed in June 2006 through December 31, 2008. This is the first nationwide published HPV postlicensure study that includes clinical review of medical records associated with reports to VAERS.

The findings were generally not that different from what is seen in the safety reviews of other vaccines recommended for a similar age group, 9 to 26 years old (meningitis and Tdap). Based on the review of available information by FDA and CDC, the HPV vaccine continues to be safe and effective, and its benefits continue to outweigh its risks.

The findings were generally not that different from what is seen in the safety reviews of other vaccines recommended for a similar age group, 9 to 26 years old (meningitis and Tdap). Based on the review of available information by FDA and CDC, the HPV vaccine continues to be safe and effective, and its benefits continue to outweigh its risks.

The study’s main findings include the following:

  • More than 23 million doses were administered nationally since the HPV vaccine was licensed in June 2006. There were a total of 12,424 reports to VAERS of adverse events following HPV vaccination through December 2008.
  • Since the HPV vaccine was approved, the vast majority (94%) of adverse events reported to VAERS after receiving this vaccine have not been serious. An adverse event is considered serious if it is life threatening, or results in death, permanent disability, abnormal conditions at birth, hospitalization or prolonged hospitalization.
  • The most common events reported were:
    • Syncope (or fainting)–common after need injections, especially in pre-teens and teens
    • Local reactions at the site of immunization (pain and redness)
    • Dizziness
    • Nausea
    • Headache
  • Of the 12,424 reports of adverse events, 772 (6% of all reports) described serious adverse events, including 32 reports of deaths.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.