When their 21-year-old daughter died unexpectedly in 2008, shortly after receiving the Gardasil human papillomavirus (HPV) vaccine, the Tarsell family blamed the vaccine for the tragedy and sought to hold the vaccine maker, Merck, accountable. They investigated the case and learned that their daughter had died from an arrhythmia induced by an autoimmune response to the HPV vaccine.

The law protects vaccine manufacturers from being held liable for injuries caused by those vaccines, so the family filed a claim against the Secretary of Health and Human Services. After many years in court, the government conceded that the family had met the burden of proof that Gardasil caused the death.

Family Appeals and Wins Compensation for Alleged Gardasil Death

The young woman died after receiving the third Gardasil vaccine in a series. She had received two other doses in 2007. After her second dose, she showed signs of an irregular pulse (arrhythmia). An electrocardiogram (ECG) confirmed the problem a month later. After the third dose, she reported feeling faint and dizzy, but did not go to the doctor prior to her death on June 23, 2008.

In 2010, the parents filed a claim with the National Vaccine Injury Compensation Program (NVICP). In 2016, the Special Master ruled that the family had not met their burden of proof—that they had failed to demonstrate that the arrhythmia occurred only after the administration of the vaccine, or to show the death was caused by the vaccine.

The family appealed the decision to the Court of Federal Claims. In June 2017, Judge Mary Ellen Coster Williams vacated and remanded the decision, sending it back to the Special Master to reconsider. After doing so, in September 2017, the Special Master awarded compensation to the family for the death of their daughter.

CDC and FDA Researching Possible Gardasil Side Effects

Gardasil received FDA approval in 2006 for the prevention of certain cancers and diseases caused by four HPV types. In 2014, the FDA approved Gardasil 9, an updated version of the vaccine, which covers the same four HPV types as Gardasil, as well as five additional HPV types. The original Gardasil is no longer distributed in the U.S.

In clinical trials used to gain FDA approval, Gardasil was found to be 88 percent effective in the prevention of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and other cervical cancer related to HPV types covered by the vaccine. Though originally approved only for women ages 9 through 26, Gardasil later received expanded approval for ages 27 through 45, as well.

The most commonly reported side effects with Gardasil are pain, swelling, and redness at the injection site, nausea, headache, fever, fatigue, and muscle or joint pain.

The CDC is working with researchers to follow up on two neurological deaths after HPV vaccination, and the CDC and FDA are both undertaking studies on the link between the HPV vaccine and fainting and blood clots.