Reports Concerning Gardasil Safety

As of January 2015 there have been 34,340 adverse events following the Gardasil vaccine reported to VAERS, including 4,412 serious adverse events and 196 deaths.

The following 24 -page report from Judicial Watch documents 18 deaths that have occurred following vaccination with GARDASIL.  Eleven of these deaths occurred within one week of receiving the vaccine.
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf
 

Finally, in a CBS news report by Sharyl Attkisson on GARDASIL, Merck and the CDC are quoted stating that GARDASIL “Appears safer than most vaccines” and has “Half the average reported serious adverse events.”

http://articles.mercola.com/sites/articles/archive/2009/02/19/Katie-Couric-Reports-on-Serious-Vaccine-Issues.aspx

If this statement were really true, what does that say about the safety of the other vaccines?
 

Gardasil

GARDASIL – Merck – Product Insert
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

GARDASIL® is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

  • Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical Adenocarcinoma in situ (AIS)
  • Cervical intraepithelial neoplasia (CIN) grade 1
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

  • Anal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminate) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18:

  • Anal intraepithelial neoplasia (AIN) grades 1, 2 and 3.

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (Page 2)

Overall Summary of Adverse Reactions:  Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL.  (Page 4)

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL.  Because vaccinees may develop syncope, sometimes resulting in falling with injury; observation for 15 minutes after administration is recommended.  (Page 3)

Anaphylaxis has been reported following vaccination with GARDASIL. (Page 4)

In the clinical safety studies a saline placebo was actually used.  However, the three groups of subjects were broken down as follows: 15,706 received GARDASIL, 13,023 received AAHS control, and 594 received the saline placebo.

AAHS is Amorphous Aluminum Hydroxyphosphate Sulfate.  Therefore 29,323 subjects received an active substance and 594 received the placebo.  The greater problem is that they did not compare the three groups separately, but compared the GARDASIL group to the AAHS group and the placebo together.

Furthermore, AAHS is the adjuvant (the portion of the vaccine that triggers the immune response) in GARDASIL, so the clinical studies were merely comparing GARDASIL to a toxic portion of itself.

Serious adverse events in this study that were judged by the study investigator to be vaccine related included headache, gastroenteritis, appendicitis, pelvic inflammatory disease, urinary tract infection, pneumonia, pyelonephritis, pulmonary embolism, bronchospasm and asthma.

Clinical studies also found in 2.3% of girls and women who received Gardasil reported an incident condition potentially indicative of a systemic autoimmune disorder after enrolling in the study.  These disorders included arthralgia/arthritis/arthropathy, autoimmune thyroiditis, celiac disease, insulin dependent diabetes mellitus, erythema nodosum, hyperthyroidism, hypothyroidism, inflammatory bowel disease, multiple sclerosis, nephritis, optic neuritis, pigmenation disorder, psoriasis, Raynaud's Phenomenon, rheumatoid arthritis, schleroderma/morphea, Steven-Johnson Syndrome, Systemic Lupus Erythematosus, and uveitis. (Page 9)

 Clinical studies also found in 1.5% of boys and men who received Gardasil reported an incident condition potentially indicative of a systemic autoimmune disorder after enrolling in the study.  These disorders included alopecia areata, ankylosing spondylitis, arthralgia/arthritis/reactive arthritis, autoimmune thrombocytopenia, diabetes mellitus type 1, hyperthyroidism, hypethyroidism, inflammatory bowel disease, myocarditis, proteinuria, psoriasis, skin depigmentation and vitiligo (Page 10)

“GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.” (Page 10)

GARDASIL Ingredients: yeast protein, vitamins, amino acids, mineral salts, carbohydrates, amorphous aluminum hydroxyphosphate sulfate, L-histidine, polysorbate 80, sodium borate
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
 

 
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