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You are here: Home / NEWS . . . . . . . . / Vaccine Adverse Events / Endocrine System / Cervical Cancer HPV / FDA recognizes that Gardasil needs a label change

FDA recognizes that Gardasil needs a label change

April 16, 2011 By Jonathan Leave a Comment

VIHC
Vaccine Injury Help Center

April 15, 2011

“Gardasil is the only human papillomavirus (HPV) vaccine that helps protect against 4 types of HPV. In girls and young women ages 9 to 26, Gardasil helps protect against 2 types of HPV that cause about 75% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. In boys and young men ages 9 to 26, Gardasil helps protect against 90% of genital warts cases. Gardasil also helps protect girls and young women ages 9 to 26 against 70% of vaginal cancer cases and up to 50% of vulvar cancer cases. Gardasil may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. Gardasil does not prevent all types of cervical cancer, so it’s important for women to continue routine cervical cancer screenings. Gardasil does not treat cancer or genital warts. Gardasil is given as 3 injections over 6 months,” according to gardasil.com.

Sounds good, right? Well there are some risks that you need to be aware of before you allow yourself or your loved one to be vaccinated with Gardasil. And the Food and Drug Administration believes that it is important enough that they have recently made changes to the warning label.

On June 9, 2009 FDA approved a revised label for Gardasil. In the new label, information pertaining to syncope is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccinations.

The American Heart Association describes syncope as temporary loss of consciousness and posture, described as “fainting” or “passing out.” It’s usually related to temporary insufficient blood flow to the brain. It most often occurs when the blood pressure is too low (hypotension) and the heart doesn’t pump a normal supply of oxygen to the brain.

It may be caused by emotional stress, pain, pooling of blood in the legs due to sudden changes in body position, overheating, dehydration, heavy sweating or exhaustion. And it may be a side effect of some medicines.

Read Full Article…

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Filed Under: Cervical Cancer HPV, Gardasil / Silgard Injuries, Vaccine Science Tagged With: Cervical Cancer HPV, Gardasil, HPV vaccine, immunizations, Vaccine Adverse Reactions

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HPV Vaccine VAERS Reports

Description 12/14/2019  TOTAL
Disabled 3,092
Deaths 523
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Abnormal Smear 695
Cervical Cancer 186
Infertility 52
Life-threatening 1,001
Emergency Room 15,419
Hospitalized 6,448
Extended Hosp. Stay 304
Serious 9,497
Total Adverse Events 64,270

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