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Addressing Questions About Gardasil

What non-serious problems have been reported?

  • Syncope (Fainting)
  • Pain at the injection site
  • Headache
  • Nausea
  • Fever

Fainting, which may sometimes cause serious injuries from falling, is common after injections and vaccinations, especially in adolescents. FDA and CDC have reminded health care professionals that women receiving Gardasil should be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine's prescribing information includes this as well.

What are FDA and CDC doing about the concerns?

FDA and CDC take all concerns about vaccine safety seriously, and, as they do with all licensed vaccines, will continue to closely monitor Gardasil's safety.

Because available information indicates that Gardasil continues to be safe and effective, and that its benefits continue to outweigh its risks:

  • CDC has not changed its recommendations for use of Gardasil.
  • FDA has not made any changes to the Warnings or Precautions sections in the vaccine's prescribing information related to safety.

 

How is Gardasil's safety being monitored?

  • FDA and CDC closely monitor the safety of all vaccines through VAERS, which receives unconfirmed reports of possible side effects following the use of vaccines licensed in the United States.
  • Each batch (known as a "lot") of Gardasil is manufactured and tested for quality control according to the requirements of its FDA license. FDA verifies this, as it does with other vaccines, by performing a lot-by-lot batch review process.
  • FDA's review assures the appropriateness of manufacturing processes and confirmation of testing results. It also includes regular unannounced on-site inspections.
  • No batch may be released for distribution until it has successfully completed all testing and review requirements.
  • FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.

CDC also has other systems in place to monitor the safety of all licensed vaccines.

For more information about topics for your health, visit the FDA Consumer Information Center (www.fda.gov/consumer). 

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