GARDASIL

It’s no surprise that you want to know more about the safety of GARDASIL before being vaccinated. The safety of a vaccine is an important part of its story. That’s why Merck and the Centers for Disease Control and Prevention (CDC) are committed to monitoring the safety of GARDASIL on an ongoing basis.

What are the possible GARDASIL side effects?
The most common GARDASIL side effects are:

• pain, swelling, itching, bruising, and redness at the injection site
• headache
• fever
• nausea
• dizziness
• vomiting
• fainting

Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity.

Tell your health care professional if you have any of the following problems because these may be signs of an allergic reaction:

• difficulty breathing
• wheezing (bronchospasm)
• hives
• rash

Tell your health care professional if you have:

• swollen glands (neck, armpit, or groin)
• joint pain
• unusual tiredness or weakness
• generally feeling unwell
• leg pain
• shortness of breath
• chest pain
• aching muscles
• muscle weakness
• seizure
• bad stomach ache

Contact your health care professional right away if you get any symptoms that concern you, even several months after getting the vaccine.

For a more complete list of GARDASIL side effects, ask your doctor or health care professional.

Could I get HPV or any disease caused by HPV from GARDASIL?
No. You cannot get HPV or any disease caused by HPV from GARDASIL. That's because there is no live virus in the vaccine.

Instead, GARDASIL contains a protein that helps the body's immune system produce antibodies against HPV—without causing an infection.

For more information on GARDASIL, talk to your doctor or health care professional.

Who should not get GARDASIL?
You should not get GARDASIL if you have, or have had:

• an allergic reaction after getting a dose of GARDASIL.
• a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate 80.

What should I tell my health care provider before getting GARDASIL?
Tell your health care provider if you:

• are pregnant or planning to get pregnant. GARDASIL is not recommended for use in pregnant women.
• have immune problems, like HIV infection, cancer, or you take medicines that affect your immune system.
• have a fever over 100°F (37.8°C).
• had an allergic reaction to another dose of GARDASIL.
• take any medicines, even those you can buy over the counter.

Your doctor or health care professional will help you decide if you should get the vaccine.

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IMPORTANT INFORMATION ABOUT GARDASIL

GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. GARDASIL is for girls and young women ages 9 to 26.

GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts. GARDASIL will not protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL is given as 3 injections over 6 months.

SELECT SAFETY INFORMATION

Anyone who is allergic to the ingredients of GARDASIL, including those severely allergic to yeast, should not receive the vaccine. GARDASIL is not for women who are pregnant.

The side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity. Only a doctor or health care professional can decide if GARDASIL is right for you or your daughter.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Read the Patient Product Information or the Prescribing Information for GARDASIL.