The pediatrician was persistent.
This was a life-saving vaccine, afterall. Why wouldn’t Theresa Tomoser want to vaccinate her 14-year-old daughter?
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In December 2009, the Tampa-area mother felt like she couldn’t put it off any longer and took her daughter, Danielle, to get the shot.
The shot was the first in a series of what should have been three doses of the quadrivalent human papillomavirus vaccine, better known as Gardisil.
Merck Pharmaceuticals was first approved by the Food and Drug Administration in 2006 to use Gardisil in females ages 9 to 26.
Merck’s research had shown the vaccine to prevent HPV types 16 and 18, which are the cause of about 70 percent of all cervical cancers, as well as types 6 and 11, which are responsible for genital warts.
According to the Centers for Disease Control, HPV is the most common sexually transmitted disease in the United States, with an estimated 6.2 million people being infected each year.
Of those infections, about 500,000 worldwide will develop into cervical cancer, and even fewer have the potential of developing into vaginal, vulvar, anal or penile cancer.
The latter cancers prompted Merck to gain approval for Gardisil for use in boys in 2009.
When Danielle Tomoser went to get her second dose of the vaccine, her older brother Chad ended up getting his first dose.
Less than three weeks after Danielle’s second shot and Chad’s first, she experienced a seizure.
“Her brother and father found her on the floor with urine on the floor. Her face was beat up,” described Theresa Tomoser.
The seizure had been so violent, and the bruising so unexpected, that the Department of Children of Families opened an investigation into the Tomoser family.
The state eventually dropped the case after a neurological exam confirmed that Danielle had experienced a grand mal seizure, also known as a tonic-clonic seizure.
Tomoser said the doctors offered little to no explanation behind what happened to the otherwise healthy teenager. Tomoser said there was no history of seizures in their family.
Two months later, she answered a call from Chad’s school explaining that he had also experienced a grand mal seizure.
“When Chad had his first seizure just 83 days after the shot and Danielle’s seizure was 85 days after the shot, that’s when I knew it had to be the Gardisil,” said Tomoser.
Danielle only experienced one seizure but suffered from what doctors called sleep paralysis on several occasions. Her mother said she would wake up from time to time with bruised and bitten lips.
Chad ended up having multiple seizures over the next year until a neurologist was finally able to control the condition with medication. But some of those medications made the teen depressed to the point that he said he contemplated taking his own life.
“Before this happened I was playing football, baseball, hanging out at school with friends all of the time, and all of a sudden it was like my life was almost over. I couldn't do anything,” said the now 21-year-old college senior, who is still not permitted to drive due his medication.
Despite the coincidental timeframe, the Tomosers said no one in the medical community would directly link the seizures to the Gardisil shot.
In fact, the FDA’s safety information for the vaccine lists syncope, which is a form of fainting or paralysis, with clonic-tonic jerking and a seizure-like activity as a possible side effect. It falls short of specifically naming seizures.
In the FDA’s vaccine adverse event reporting system, seizure cluster, seizure anoxic, clonic-tonic convulsions and seizure like phenomenon have been reported 75 times since Gardisil become available through March 2014.
In total, the FDA has catalogued 31,015 adverse events in VAERS, with 127 indicating death and another 556 categorized as life-threatening.