HPV (Human Papillomavirus) vaccine - what you need to know [Gardasil®-9]

All content below is taken in its entirety from the CDC HPV (Human Papillomavirus) Gardasil-9 Vaccine Information Statement (VIS): www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil-9.html.

CDC review information for HPV Gardasil-9 VIS:

  • Page last reviewed: March 31, 2016
  • Page last updated: March 31, 2016
  • Issue date of VIS: March 31, 2016

Content source: National Center for Immunization and Respiratory Diseases

WHY GET VACCINATED?

Gardasil-9 prevents human papillomavirus (HPV) types that cause many cancers, including:

  • Cervical cancer in females
  • Vaginal and vulvar cancers in females, and
  • Anal cancer in females and males,
  • Throat cancer in females and males
  • Penile cancer in males

In addition, Gardasil-9 prevents HPV types that cause genital warts in both females and males.

In the U.S., about 12,000 women get cervical cancer every year, and about 4,000 women die from it. Gardasil-9 can prevent most of these cases of cervical cancer.

Vaccination is not a substitute for cervical cancer screening. This vaccine does not protect against all HPV types that can cause cervical cancer. Women should get regular pap tests.

HPV infection usually comes from sexual contact, and most people will become infected at some point in their life. About 14 million Americans, including teens, get infected every year. Most infections will go away and not cause serious problems. But thousands of women and men get cancer and diseases from HPV.

HPV VACCINE 

Gardasil-9 is an FDA-approved HPV vaccine. It is recommended for both males and females. It is routinely given at 11 or 12 years of age, but it may be given beginning at age 9 years through age 26 years.

Three doses of Gardasil-9 are recommended, with the second dose given 1 to 2 months after the first dose, and the third dose given 6 months after the first dose.

SOME PEOPLE SHOULD NOT GET THIS VACCINE

  • Anyone who has had a severe, life-threatening allergic reaction to a dose of HPV vaccine should not get another dose.
  • Anyone who has a severe (life threatening) allergy to any component of HPV vaccine should not get the vaccine. Tell your doctor if you have any severe allergies that you know of, including a severe allergy to yeast.
  • HPV vaccine is not recommended for pregnant women. If you learn that you were pregnant when you were vaccinated, there is no reason to expect any problems for you or your baby. Any woman who learns she was pregnant when she got the Gardasil-9 vaccine is encouraged to contact the manufacturer's registry for HPV vaccination during pregnancy at 1-800-986-8999. Women who are breastfeeding may be vaccinated.
  • If you have a mild illness, such as a cold, you can probably get the vaccine today. If you are moderately or severely ill, you should probably wait until you recover. Your doctor can advise you.

RISKS OF A VACCINE REACTION 

With any medicine, including vaccines, there is a chance of side effects. These are usually mild and go away on their own, but serious reactions are also possible.

Most people who get HPV vaccine do not have any serious problems with it.

Mild or moderate problems following Gardasil-9

Reactions in the arm where the shot was given:

  • Soreness (about 9 people in 10)
  • Redness or swelling (about 1 person in 3)

Fever:

  • Mild (100°F or 37.8°C ) (about 1 person in 10)
  • Moderate (102°F or 38.9°C) (about 1 person in 65)

Other problems:

  • Headache (about 1 person in 3)

Problems that could happen after any injected vaccine:

  • People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
  • Some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
  • Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.

As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

The safety of vaccines is always being monitored. For more information, visit: www.cdc.gov/vaccinesafety/.

WHAT IF THERE IS A SERIOUS REACTION?

What should I look for?

Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.

Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would usually start a few minutes to a few hours after the vaccination.

What should I do?

If you think it is a severe allergic reaction or other emergency that can't wait, call 9-1-1 or get to the nearest hospital. Otherwise, call your doctor.

Afterward, the reaction should be reported to the "Vaccine Adverse Event Reporting System" (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS does not give medical advice.

THE NATIONAL VACCINE INJURY COMPENSATION PROGRAM

The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.

Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation. There is a time limit to file a claim for compensation.

HOW CAN I LEARN MORE?

Ask your health care provider. He or she can give you the vaccine package insert or suggest other sources of information.

  • Call your local or state health department.

Contact the Centers for Disease Control and Prevention (CDC):

  • Call 1-800-232-4636 (1-800-CDC-INFO) or
  • Visit CDC's web site at www.cdc.gov/hpv

Information