Information about GARDASIL 9

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GARDASIL 9 helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, and anal cancer and genital warts in both males and females. 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 girls to get routine cervical cancer screenings later in life. GARDASIL 9 does not treat cancer or genital warts. GARDASIL 9 may be given as 2 or 3 shots. For persons 9 through... GARDASIL 9 helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in...


Safety Information for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)Safety Information for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

SAFETY AND SIDE EFFECTS

Safety Information for GARDASIL 9

The safety of a vaccine is an important part of its story

Itʼs 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 youʼll find information about the safety of GARDASIL 9.

What should my childʼs doctor or health care professional know before giving GARDASIL 9?

Make sure to tell your childʼs 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 childʼs 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?

What are the most common side effects ofGARDASIL 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 childʼs 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 childʼs 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 (Human Papillomavirus 9-valent Vaccine, Recombinant)?

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.


 

Important Safety Information

 

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Anyone who is allergic to the ingredients of GARDASIL 9 or GARDASIL, including those severely allergic to yeast, should not receive the vaccine. GARDASIL 9 was not studied in women who knew they were pregnant.

The side effects include pain, swelling, redness, itching, bruising, bleeding, and a lump where your child got the shot, headache, fever, nausea, and dizziness.