SAFETY AND SIDE EFFECTS

SAFETY INFORMATION FOR GARDASIL 9

THE SAFETY OF A VACCINE IS AN IMPORTANT PART OF ITS STORY.

It’s only natural for parents to have questions about vaccines. You should know that Merck, the manufacturer of GARDASIL 9, and the Centers for Disease Control and Prevention (CDC) monitor the safety of the HPV vaccines. Below you’ll find information about the safety of GARDASIL 9.

WHAT SHOULD MY CHILD’S DOCTOR OR HEALTH CARE PROFESSIONAL KNOW BEFORE GIVING GARDASIL 9?

Make sure to tell your child’s doctor or health care professional if your child:

Has immune problems, like HIV infection, cancer, or if your child takes medicines that affect the immune system

Has a fever over 100°F (37.8°C)

Had an allergic reaction to another dose of GARDASIL 9 or GARDASIL

Takes any medicines, even those you can buy over the counter

Is pregnant or planning to get pregnant

 

WHO SHOULD NOT GET GARDASIL 9?

People should not get GARDASIL 9 if they have or have had an allergic reaction to:

A previous dose of GARDASIL 9 or GARDASIL

Yeast (severe allergic reaction)

Amorphous aluminum hydroxyphosphate sulfate

Polysorbate 80

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

 

WHAT ARE THE MOST COMMON SIDE EFFECTS OF GARDASIL 9?

The most common side effects include pain, swelling, redness, itching, bruising, bleeding, and a lump where your child got the shot, headache, fever, nausea, dizziness, tiredness, diarrhea, abdominal pain, and sore throat. Fainting can happen after getting GARDASIL 9. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask your child to sit or lie down for 15 minutes after your child gets GARDASIL 9. Some people who faint might shake or become stiff. The health care professional may need to treat the person getting GARDASIL 9.

Contact your child’s doctor or health care professional right away if any of these symptoms concern you, even several months after your child gets the vaccine.

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

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.

 
IS IT POSSIBLE TO GET HPV OR ANY DISEASE CAUSED BY HPV FROM GARDASIL 9?

No. It is not possible to get HPV or any disease caused by HPV from GARDASIL 9.

 
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IMPORTANT SAFETY INFORMATION

Anyone who is allergic to the ingredients of GARDASIL 9 or GARDASIL, including those severely allergic to yeast, should not receive the vaccine. The safety of GARDASIL 9 has not been shown in pregnant women.

The side effects include:

  • Pain
  • Swelling
  • Redness
  • Itching
  • Bruising
  • Bleeding
  • A lump where your child got the shot
  • Headache
  • Fever
  • Nausea
  • Dizziness
Fainting can happen after getting GARDASIL 9. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask your child to sit or lie down for 15 minutes after your child gets GARDASIL 9. Some people who faint might shake or become stiff.
Only a doctor or health care professional can decide if GARDASIL 9 is right for your child.

INFORMATION ABOUT GARDASIL 9

GARDASIL 9 helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV.
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV.
GARDASIL 9 helps protect boys and men ages 9 to 26 against anal cancer and genital warts caused by those same HPV types.
GARDASIL 9 may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL 9 does not prevent all types of cervical cancer, so it’s important for women to get routine cervical cancer screenings.
GARDASIL 9 does not treat cancer or genital warts. GARDASIL 9 is given as 3 injections over 6 months.
Please read the Patient Information for GARDASIL 9 and discuss it with your child’s doctor. The physician Prescribing Information also is available.
Having trouble paying for your Merck vaccine? Merck may be able to help. Visit http://www.merck.com/merckhelps.

INFORMATION ABOUT GARDASIL 9

GARDASIL 9 helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV.
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV.
GARDASIL 9 helps protect boys and men ages 9 to 26 against anal cancer and genital warts caused by those same HPV types.
GARDASIL 9 may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL 9 does not prevent all types of cervical cancer, so it’s important for women to get routine cervical cancer screenings.
GARDASIL 9 does not treat cancer or genital warts. GARDASIL 9 is given as 3 injections over 6 months.

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