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Gardasil Side Effects

Gardasil, Merck & Co’s cervical cancer vaccine, has been linked to serious side effects, including paralysis and death. Despite growing concerns over the safety of Gardasil, the Food & Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to recommend that Gardasil be given to girls and women ages 9-27. Merck has also continued its heavy-handed efforts to convince state legislatures to make Gardasil vaccination mandatory for young girls.

In July 2008, the CDC announced that the Vaccine Adverse Event Reporting System (VAERS) had received 7,802 reports about side effects following Gardasil administration between June 2006 and April 2008. About 7 percent of these reports involved serious reactions, including paralysis and death. In most cases, the CDC could make no determination as to whether or not Gardasil played a direct role in the reactions.

So far, recipients of Gardasil have reported the following side effects:

• Deaths: As of April 2008, VAERS received 15 reports of death following Gardasil vaccination in the US. The CDC says it has not been able to establish a link between Gardasil and 10 of the deaths. The agency did not have enough information about the remaining five to make any determination.

• Guillain-Barré Syndrome (GBS): GBS is a is an inflammatory disorder of the peripheral nerves that can lead to temporary, yet total paralysis. GBS is a rare disorder, and there are approximately 1 to 2 cases in every 100,000 people per year. According to the CDC, as of April 2008, there were 31 cases of GBS reported after Gardasil administration. At the time of its report, the CDC had confirmed ten of those cases, and said five occurred when Gardasil was administered with another vaccine.

• Paralysis: The families of several young women believe that their partial or total paralysis stemmed from Gardasil. Thirteen-year-old Jenny Tetlock began experiencing muscle weakness about a month after receiving Gardasil. Within 15 months, the California native was almost completely paralyzed. Jenny’s father has conducted a very public campaign to try to determine what role Gardasil played in his daughters condition. The families of two other teenage girls filed suit against Merck in 2008 for their daughters’ partial paralysis following Gardasil administration. In some of the reports to VAERS, paralysis led patients to fall into a coma.

• Anaphylactic shock: Several cases of anaphylactic shock have reportedly occurred within minutes of the administration of Gardasil. Anaphylactic shock is a severe type of allergic reactions that can be life threatening.

• Grand Mal Seizure: In a few cases, patients experienced Grand Mal Seizure immediately after receiving Gardasil. Grand Mal Seizure involves a loss of consciousness and violent muscle contractions.

• Miscarriage: Dozens of miscarriages have occurred following the administration of Gardasil. In all of the cases, the women were not aware that they were pregnant at the time they received Gardasil.

• Blood Clots and Heart Failure: There have been several instances of blood clots and heart failure occurring after Gardasil was administered. In some of these instances, the blood clots were fatal.

After the CDC published the VAERS Gardasil statistics, Merck quickly took steps to defend its vaccine. The company issued a statement saying that there was no indication that Gardasil caused any of the reported side effects. However, many experts countered that without further study, there was no way to determine Gardasil’s relationship to the reports.

In June 2008, Merck and the FDA agreed to change the Gardasil labeling information to reflect some of the mild side effects - nausea, joint and muscle pain, fatigue, physical weakness and general malaise - associated with Gardasil. However, the new information would not mention any of the more serious side effect reports, as both the agency and Merck insist that information showing a connection between these incidents and Gardasil is “inconclusive”. There are still no studies planned to determine what link any of these incidents might have to Gardasil.