User:Fxmastermind/sandbox1

go edit your own stuff

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Hey, you long time wikipedia editing mofos, there are way too many rules, regulations and hoops to jump through to just get to this point. And I'm a really smart mofo.

article started March 17 2008 1:51 EST

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Safety

In February 2009, the Health Ministry of Spain suspended use of one batch of Gardasil after health authorities in the Valencia region reported that two girls had become ill after receiving the injection. European regulators said the cervical cancer vaccine was safe and did not make two Spanish girls ill.

The sudden deaths of two UK girls, in 2008, followed the deaths of three U.S. females, ages 12, 19 and 22, who died days after receiving Gardasil was administered. The U.S. Food and Drug Administration recently reported that 28 women miscarried after receiving the vaccine.

According to the Centers for Disease Control, the vaccine was tested in over 11,000 women and girls (ages 9 to 26). The Food and Drug Administration and Centers for Disease Control say that the vaccine has only minor side effects, such as soreness around the injection area. The FDA and CDC consider the vaccine to be safe. It does not contain mercury, thiomersal or live virus or dead virus, only virus-like particles, which cannot reproduce in the human body. Merck, the manufacturer of Gardasil, will continue to test women who have received the vaccine to determine the vaccine's efficacy over the period of a lifetime.

Fainting is more common among adolescents receiving the Gardasil vaccine than in other kinds of vaccinations. Patients should remain seated for 15 minutes after they receive the HPV vaccine. There have been reports that the shot is more painful than other common vaccines, and the manufacturer Merck partly attributes this to the virus-like particles within the vaccine. General side effects of the shot may include joint and muscle pain, fatigue, physical weakness and general malaise.

As of 30 June 2008, out of over 16 million doses of Gardasil distributed in the United States, there have been 9,749 reports to the Vaccine Adverse Event Reporting System (VAERS) following Gardasil vaccination. Gardasil has less than half the average percentage of serious reports. These are anecdotal reports, and "it is important to note that a report to VAERS does not mean there is a connection between the vaccine and the event. It means the event took place following vaccination." The FDA and CDC said that with millions of vaccinations “by chance alone some serious adverse effects and deaths” will occur in the time period following vaccination, but have nothing to do with the vaccine. Although at least 20 women who received the Gardasil vaccine have died, there is no evidence that deaths or serious outcomes were connected to the shot. Where information was available, the cause of death was explained by other factors. Likewise, although a small number of cases of Guillain-Barré Syndrome (GBS) have been reported following vaccination with Gardasil., there is no evidence linking GBS to the vaccine.

The FDA and CDC monitor events to see if there are patterns, or more serious events than would be expected from chance alone.