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During testing, an aluminum-containing placebo was used. Aluminum can
cause permanent cell damage and is a reactive placebo, unlike most standard
saline placebos. This means that tests of Gardasil may not have given an
accurate picture of safety levels.

Gardasil is marketed as a vaccine that prevents cancer, but it “ . . . has not
been evaluated for the potential to cause carcinogenicity or genotoxicity.”
.....
While Gardasil is the most expensive vaccine ever to be recommended by the
FDA, its long-term effectiveness is unknown and could be as brief as only two
to three years.

Gardasil is not 100% effective against all HPVs. It is designed to protect
against only four strains of HPV, even though there are over thirty strains
including at least fifteen that can cause cancer.

Results VAERS received 12 424 reports of AEFIs following qHPV distribution, a rate of 53.9 reports per 100 000 doses distributed. A total of 772 reports (6.2% of all reports) described serious AEFIs, including 32 reports of death. The reporting rates per 100 000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barré syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease. Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.

http://jama.ama-assn.org/cgi/content/abstract/302/7/750

VAERS receives reports of many events that occur following immunization. Some of these events may occur coincidentally during the time period following vaccination, while others may actually be caused by vaccination. In our analysis of VAERS data, we look for patterns of adverse events that may be plausibly linked to a vaccine. Such patterns of adverse events may require further study.

On August 19, 2009, the Journal of the American Medical Association (JAMA) published an article coauthored by FDA and CDC that reviews the safety data for Gardasil for select adverse events that have been reported to VAERS, from the time period starting from product licensure in June 2006 through December 31, 2008 (JAMA. 2009;302(7):750-757). The article describes 12,424 reports of adverse events following Gardasil vaccination. Of these, 772 were reports of serious events (6.2% of the reports) and the remaining 11,652 (93.8%) were classified as non-serious. During this time period, the manufacturer, Merck and Co., has distributed over 23 million doses of Gardasil in the United States. The information contained in this update is based on the same information contained in the article published in JAMA. FDA will provide a future update to information on the number of reports of adverse events and doses distributed.

The Gardasil safety review assessed the following adverse events: local injection site reactions, syncope, dizziness, and nausea, headaches, hypersensitivity reactions, such as rashes, hives, itching, anaphylaxis, Guillain-Barré syndrome (GBS), transverse myelitis, motor neuron disease, venous thromboembolic events (VTEs), pancreatitis, autoimmune disorders, pregnancy, and deaths. All of these events are included in Gardasil’s labeling. In VAERS, a higher proportion of Gardasil reports were of syncope and VTEs compared with other vaccines. However, none of the adverse events in the safety review, including syncope and VTEs, were reported at rates (number of adverse events/number of doses distributed) greater than expected in a population of this age and gender and with other known contributing factors to these adverse events.

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm

Latest Adverse Event Data

The latest data on adverse events with Gardasil, published in the same issue of the journal, comes from the US Vaccine Adverse Event Reporting System (VAERS). In total, 12,424 adverse events after immunization were reported to in United States between June 2006 and December 2008, during which an estimated 23 million doses had been distributed (with a course of 3 doses per person recommended). This represents a reporting rate of 53.9 reports per 100,000 doses distributed.

Of these, 772 reports (6.2% of the total) were described as serious, including 32 reports of death.

The authors, headed by Barbara Slade, MD, from the CDC, comment that most of the rates of adverse events after immunization were "not greater than the background rates compared with other vaccines," with the exception of syncope and venous thromboembolic events, which were higher for the HPV vaccine.

These 2 events, syncope and thromboembolic events, were also reported for the HPV vaccine at a higher rate during this postlicensure period than they had been in clinical trials before marketing, the authors note.

Syncope or syncope vasovagal was mentioned in 1896 reports, and dizziness was mentioned in 1572 and nausea in 1164 reports. The reporting rate was 8.2 cases per 100,000 doses distributed. The majority (>90% – 95%) of these reports were classified as nonserious, the authors note. However, some of the reports mentioned falls, and some of these led to fractures, concussions, hemorrhages, and lacerations.

Venous thromboembolic events were mentioned in 56 reports, giving a reporting rate of 0.2 cases per 100,000 doses distributed. Of these, 19 cases involved pulmonary embolism, and 4 of these resulted in death.

Other adverse events included local site reactions (reporting rate, 7.5 cases per 100,000 doses distributed), headache (4.1 cases per 100,000 doses distributed), hypersensitivity reactions (3.1 cases per 100,000 doses distributed), urticaria (2.6 cases per 100,000 doses distributed), autoimmune reactions (0.2 cases per 100,000 doses distributed), Guillain-Barré syndrome (0.2 cases per 100,000 doses distributed), anaphylaxis (0.1 cases per 100,000 doses distributed), death (0.1 cases per 100,000 doses distributed), transverse myelitis (0.04 cases per 100,000 doses distributed), pancreatitis (0.04 cases per 100,000 doses distributed), and motor neuron disease (0.009).

http://www.medscape.com/viewarticle/707634?src=mp&spon=16&uac=28013DZ