Judicial Watch Reports 371 Serious Adverse Events From Gardasil

Public interest group Judicial Watch reported 371 serious adverse events in patients who received Merck’s cervical cancer vaccine Gardasil, including three deaths.

As of May 11, 1,637 side effects were reported to the FDA through the Vaccine Adverse Event Reporting System (VAERS), the group said. Judicial Watch received the information through a Freedom of Information Act request. Approximately 77 percent of the adverse reactions were typical, including pain at the injection site, itching, fever, nausea and dizziness, the group noted.

However, one female patient died of a blood clot three hours after receiving the vaccine, the group said. A 19-year-old patient died of heart failure partially caused by large blood clots two weeks after getting the vaccine. According to the Centers for Disease Control and Prevention, both patients were taking birth control pills, which can cause clotting. In addition, a 12-year-old patient died of heart complications six days after receiving Gardasil, according to the VAERS reports.

Eighteen of the 42 women who received Gardasil while pregnant experienced adverse side effects, ranging from spontaneous abortion to fetal abnormalities. Clinical trials used in the FDA’s review of Gardasil last year showed five cases of birth defects among women who received the vaccine within 30 days of conception. Gardasil is not recommended for pregnant women, according to the product’s label.

Merck recently submitted a supplemental biologic license application to the FDA to market Gardasil to prevent vaginal and vulvar cancers.