Side effects and safety of the Gardasil vaccine

HPV (human papilloma virus) is the most common sexually transmitted infection (STI) among people in the United States. Millions of Americans are infected with HPV. Fortunately, vaccination with the Gardasil-9 vaccine can help provide protection against HPV infection. 

Yes, both the 9-valent HPV vaccine (Gardasil 9) and quadrivalent HPV vaccine (Gardasil) have favorable safety, based on findings from many vaccine safety monitoring systems and more than 160 studies with adults and children. Both vaccines have been researched and monitored for over 15 years and deemed safe in populations approved for use.

Because HPV infection usually occurs after first sexual activity, HPV vaccination is routinely recommended for children ages 11 or 12, although the vaccine can be given starting at age 9. Catch-up HPV vaccination is recommended for people through age 26 who are not adequately vaccinated.

Although you don’t need a pregnancy test to be vaccinated and there is no evidence of harm to the fetus from the vaccine, if you are pregnant, you should delay HPV vaccination until after your pregnancy. You can receive the HPV vaccine if you are breastfeeding.

Most sexually active adults have likely already been exposed to HPV, so vaccine effectiveness is lower in older age groups. HPV vaccines do not treat existing HPV infections. HPV vaccination is not recommended for adults older than 26 unless you weren’t adequately vaccinated originally or are at risk for new infection. Talk with your provider if this is a concern. HPV vaccines are not approved for use in adults over age 45.

Vaccines, like any medicine, can have side effects. The most common side effects of Gardasil vaccine are usually mild and may include fever, headache and a sore arm from the shot.

Although rare, some people have fainted after getting the HPV vaccine. To help prevent this from happening, a person should sit or lie down during vaccination and stay in that position for about 15 minutes afterward.

On very rare occasions, severe (anaphylactic) allergic reactions may occur after receiving any vaccination or medication. This is why most people are monitored for a certain period of time after they get a shot. Symptoms of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness and weakness. If such reactions occur, contact emergency services immediately. People with an allergy to yeast or any other component of the vaccine should not receive the HPV vaccine.

All studies to date show that no deaths have been linked to any HPV vaccine, including Gardasil or Gardasil-9. The vaccine safety surveillance system, which is overseen by the CDC and the FDA, received seven reports of death following Gardasil-9 from December 1, 2014, through December 31, 2017. During this time, about 29 million doses had been distributed in the United States. After careful review of every reported death, CDC concluded that these extremely rare occurrences were not causally linked to the HPV vaccine. Further, the Advisory Committee on Immunization Practices reviewed clinical trials of any licensed HPV vaccine published during January 1, 2006, thru October 18, 2018, and found few serious adverse events and no vaccine-related deaths.

Published January 2021. Reviewed and clinically updated by Julie McDaniel, MSN, RN, CRNI, January 2023.