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Are Girls Fainting from Gardasil?

Jan 4, 2008 | Parker Waichman LLP

The Gardasil vaccine is proving to be such a painful injection that some young girls might  actually be fainting when they receive it.  The stories of Gardasil-induced fainting are just the latest side effects being reported in relation to the controversial cervical cancer vaccine.

During its first year of use, reports of girls fainting from vaccinations rose sharply.  While other shots tend to hurt only at the moment of the needle stick, patients around the country are reporting that Gardasil stings and burns while the vaccine itself enters the body.  Officials at Merck & Co., which makes Gardasil, acknowledge the sting. They attribute it partly to the virus-like particles in the shot. Pre-marketing studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles.  Merck insists this Gardasil vaccine pain is short-lived, however, some patients have reported discomfort while driving with or sleeping on the injected arm for up to a day after receiving Gardasil.

Since Gardasil came on the market in 2006, there has also been a rise in reports of vaccine-associated fainting in girls. From 2002-2004 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, according to the Centers for Disease Control (CDC).  US health officials, however, are quick to point out that there has been no definitive proof that Gardasil is causing the fainting spells.

Still, fainting is not the only side effect reported in regards to Gardasil.  Since its approval, the Vaccine Adverse Event Reporting System has received 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil.  In several instances, blood clots were reported to have occurred after the administration of Gardasil. Other side effects including paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Of the 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.

As of now, there is no way to know exactly how - or if - Gardasil played a role in the onset of these side effects.    A thorough safety review is the only way to determine if Gardasil is truly safe.  But so far, the Food & Drug Administration is refusing to revisit the vaccine.

Following its approval, the CDC recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck's heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.


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