Monday, September 13, 2010

Gardasil and seizures: is VAERS now taking a connection seriously?

Theresa E was floored when she got a phone call from VAERS, the FDA’s vaccine adverse event reporting system. Yes, the caller said, investigators did indeed feel that Theresa’s daughter’s seizures could be a serious reaction to Merck’s anti-HPV vaccine, Gardasil.

Although Theresa had had a hunch that her daughter’s intermittent seizures could have been triggered by the Gardasil vaccine, doctors completely pooh-poohed the idea.

But eventually, encouraged by information from Nina Kenney, whose daughter had also begun suffering seizures post-vaccine, she insisted on filing a VAERS report. Her doctor had for months been “too busy” to get around to the paperwork, she said, “and when I took the almost-completed form to him to finish he was a little shocked that I was serious.”

So when someone from VAERS called shortly afterwards to verify the information she’d provided and made the comment about a serious reaction, Theresa was so stunned that she asked her caller to repeat it. She’s relieved to see that taking the time to report to VAERS was worthwhile; her information will add to what investigators know.

Yes, report post-vaccine seizures—even if your doctor discourages you

"If I can prevent one more person from getting hurt, it’s all worth it. Please encourage people to send as much concrete information to VAERS as possible, because I think that’s why they listened. I didn’t just send the form. There isn’t enough space on the form to give much info, so they got a two-page letter, copies of the school report about where they found my daughter and letters stating that the (Gardasil) vaccines were stored improperly. I felt I was sending too much info, but I am glad I did. Whether it is an active ingredient or an inactive ingredient, they need to find out for sure.”

None of this is to say that there is now a proven connection between Gardasil and seizures: there isn’t, or at least, not at this point. Teenagers do develop epilepsy and seizure disorders with or without Gardasil. But when seizures follow vaccination in multiple cases, medical investigators need to—well, investigate. That’s what the FDA is supposed to do. And, thank God, they’re now doing it.

Do neurologists ask about pre-seizure vaccinations yet?

In February 2009, Gardasil vaccinations were briefly suspended in Spain after three unrelated incidents in which girls began suffering repeated convulsions hours after being vaccinated with the HPV vaccine. Eventually, authorities determined that the vaccine might have triggered, but not caused, the convulsions—a distinction that still eludes me in practical terms—largely because there were few similar cases on the books. (See here). With the best will in the world, investigators can’t reconcile correlation and causation without enough data. So just make the reports, already.

After a young girl, Jenny Tetlock, died post-Gardasil vaccination from a highly unusual ALS/autoimmune-type disease mediated by immune response, her neurologist, knowing of at least one similar case, announced to fellow neurologists that she planned to make a study of girls with ALS-type diseases (see here). Finding any such cases requires that neurologists make a habit of asking patients whether they got the vaccine.

There are so many cases of post-Gardasil seizures that surely it would be smart to call on neurologists seeing new seizure patients to ask them that question, too. Just ask the question—did you get Gardasil? Menactra? Adacel? Together or separately?—and file any appropriates reports with VAERS. Then, if there’s a connection, we’ll know.

Theresa’s daughter got her first Gardasil shot, along with Menactra, in July 2009. She suffered a commotion-causing ‘sleepwalking’ episode in her dorm in August and a second episode after the second shot. Theresa believes that both episodes were really seizures as her daughter was disoriented and appeared to observers to be on drugs; the second time the teenager recalls feeling twitchy and exhausted (common post-seizure symptoms) afterwards. Then her parents actually witnessed her seizing while they were all on vacation. The experience was devastating, but at least they finally knew was wrong. Now in her second year of college, she’s been diagnosed with a nocturnal seizure disorder and is taking Keppra twice daily.

Drugged, drunk—or seizing?

The drugged appearance is all too familiar to Nina. “I’ve never seen Nora seize, but a few weeks ago I saw her right after a seizure. She was extremely disoriented, and in fact I thought she was drunk. She was very perturbed as well. Flat out mean. She tells me this behavior is a common factor with her seizures. She has yelled at paramedics and anyone who's nearby right afterward. Furthermore, she has no memory of the seizure and often, the entire day leading up to the seizure. Post seizure, she's exhausted and has a terrible headache for a day or two afterward.”

When Theresa witnessed her daughter’s seizure on vacation, “our daughter did appear to be drunk or really out of it; she could not correctly answer the questions for paramedics after the seizure. After a bit, she did.”

Which makes one wonder whether some seizures go undiagnosed because the usual reaction to a young adult who appears to be drunk or drugged is an eye-rolling “kids will be kids.”

“As far as the MRI and EEG,” says Nina, “Nora's MRI and CT scan have been normal. She's only had one EEG and, according to the first neurologist she saw, it showed a 'slight abnormality'. I think he used the term compact partial seizure.”

The ER doctor’s diagnosis after Nora’s first seizure was syncope/dehydration because he attributed the episode to alcohol consumption the day before—even though the episode included severe tongue-biting, “a classic seizure symptom,” according to the neurologist Nora later saw. When she seized again after her second Gardasil shot, however, the final diagnosis was Epileptic Seizures, and her VAERS report now shows it as a “positive vaccine re-challenge”—which basically means that the same symptoms, or worse symptoms, presented themselves with the second shot, making a connection highly plausible. Nora did not get the third shot.

Two girls, two different VAERS responses, two years apart

Nina had a very different experience with reporting Nora’s seizures to VAERS two years ago.

When she made the connection between Gardasil and Nora’s seizures, she faxed a letter to Nora’s neurologist, sent another to the pediatrician, filed an online VAERS report, called Merck, filed an online report with Sanofli-Pasteur (because Nora had also received a Menactra shot with her first Gardasil shot), and filed an online report with the NVIC. Only the NVIC and the pediatrician responded.

A few months later, Emily Tarsell, whose daughter Chris died of still-unknown causes after receiving the Gardasil vaccination, suggested that Nina contact the FDA for the Gardasil lot numbers and reports. When the reports arrived, Nina discovered that Nora’s VAERS report seemed to include Nora among the girls who fainted upon getting the shot, probably because of the ER report after the first episode. She immediately faxed VAERS a letter; they contacted her only to get her neurologist’s contact information and left the report essentially unchanged.

Only after Nina sent a strongly-worded letter to the Vaccines and Related Biological Products Advisory Committee, prior to their meeting to decide whether to approve Gardasil for boys, did VAERS actually contact her for a timeline of events and further information. Nina’s letter had commented that a year after she’d made all those reports, no-one had bothered to contact her. Two weeks later, she heard from VAERS. After an entire year.

It bears repeating: Gardasil is not proven to cause seizures in susceptible individuals. If you're considering Gardasil for yourself of your child, you and your doctor need to honestly discuss its pros and cons given your individual circumstances and family health history.

But, “I subscribe to the Epilepsy Foundation site's parent community,” says Nina, “and there are MANY members whose seizures started after Gardasil. So in spite of what most in the medical community say, I believe there's a connection.”

And it appears that if there is one, the FDA's finally started seriously looking for it. So do your part. If your child's seizures began only after an adolescent vaccination of any kind, file the report. With or without the help and/or encouragement of your doctor.

© 2010

Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.


Leslie said...

Great article with excellent information. For more information on the HPV vaccines please check out

Anonymous said...

Lots of information - thank you. I read every word. My daughter started having seizures the day after her vaccine.

Anonymous said...

I was just about to make an appointment for my granddaughter to get her first Gardasil vaccine, when a friend called. I told him what I was doing and he said don't do it. He said his daughter had her first shot about a month ago, and within days could hardley walk. Doctors tried to brush it off, but with their persistance a spinal tap was done and she was diagnosed with Guillian Barre. Needless to say, we won't be getting the vaccine. We'll go with condoms and regular PAPs till more is known.

Debbie said...

My daughter absolutely was affected by the Gardasil vaccination. We were not warned of any side affects at all. Our Doctor insisted that she do the injections. She now has seizures, her personality has changed, she has had damage to her frontal lobe in that she is not mentally retarted but she has suffed damage. She is bipolar. She is totally a different, unpleasant person than she was 3 years ago. She was totally healthy prior to that injection. I absolutely will not allow my granddaughter to take the injection and I encourage all parents to do some major research. With our technology these days, I would much rather deal with the illness than have my duaghter permanetly damaged, which is what happened. I am so glad people are starting to take this more seriously.

Kristin Johns said...

Debbie, I'm so sorry about your daughter--and you did file reports, right? With VAERS, Merck, and, preferably, With VAERS and Merck, it's absolutely essential to give them good contact info. If your doctor doesn't want to file, you can do it yourself.

Unknown said...

I'm concern about this situation with Gardisil.
I have been waiting result for almost two years after I decided to make an appointment for my teen ager daugther. We went to the public hospital and my daugther received Gardasil vaccine on March, by July my dauther had two big seizures, after that she continue having many clonic seizure every days she had been hospitalized, after several test (lumbar included) the lab test didn't show the reason of these seizures not brain herpes, not bacteria or virus she had encephalitis but they don't know the cause,knoe she's in recuperation, I noticed thart everytime she is around her period she started having partial seizures and headache.I told doctor about this vaccine but they omit the possibility of the cause.

Kristin Johns said...

Brenda--I'm so sorry about your daughter. Regardless of what your doctor says, you should file a VAERS report. If you need help, let me know. The purpose of VAERS is to find out things that doctors don't know yet. The seizures may or may not be related to the vaccine, but we'll only know when we have sufficient case histories to research.

Anonymous said...

I have a young teenager (just turned 13) who has not received the vaccine - yet. Every year for the past 3 the pediatrician has recommended it and asks us why not. There is no discussion of pros and cons or individual health history, other than the most generic. I mention some of what I have read, most of which is not confirmed by medical community, and none of which is specifically present or absent in my daughter. How do I decide if/when she should have this vaccine?
Now I read that she needs to have a meningitis vaccine and a dtap booster, so I am also concerned about interactions and cumulative affects on immune system.
And to make matters worse, she absolutely is terrified of needles and flinches when given a vaccine, which also makes the pain afterward worse.

Kristin said...

There's no perfect choice. I've talked to my kids extensively about the risks and rewards of vaccines and the best way to ensure that their bodies shrug off the HPV virus when, almost inevitably, they encounter it.

I am more undecided about the meningitis vaccine as meningitis is not really that common, but if they did get it, the danger is immediate--unlike with HPV.

I'm pretty sure my eldest daughter, about to go to college, will get the recommended shots EXCEPT for Gardasil, which I don't see as necessary. However, I'll take her to an alternative doc for recommendations to counteract negative effects. Can't hurt, might help--worth it IMO as long as you have someone decent and non-exploitative to go to.

Good luck with your decision. Parenting isn't easy, and doctors are not always happy to encounter questions they probably can't answer. In my exprerience they are busy and usually just go by what the AMA recommends and do very little independent study.

Lyndee said...

My daughter received her 2nd shot today. With the first shot there were not adverse side effects at all. However, 30 seconds after receiving the shot today she passed out and had a seizure right there in the Dr's office. They shrugged it off like it was no big deal. I INSISTED that they order an MRI. Seizures are not normal. And then I start reading all of this information online about how many girls are experiencing this same thing. Id like to know why the medical community is not taking this seriously. Why hasnt anyone sued to get them to stop giving this to our young? Now they are pushing it for boys too! I am terrified that my 16 years old daughter may suffer another seizure. I am angry and wish I had read all of this yesterday! What ca we do to get the word out there besides file reports?

Cathy said...

My daughter also started having seizures after her gardasil shot. She had been a perfectly normal 15 year old teenage girl, into sports and other school activities. She was having seizures, on average 3 times a week lasting any where from 15 to 45 mins. This started in June of 2008 and stopped in June of 2010. It has been four years, she had her first one again two days ago, apparently this nightmare is still not over. I was told time and time again that there was no connection, and these episodes were phsyc issues. This shot took her high school years away from her!!!

Lynette said...

Dose 2 of the Gardasil vaccine gave my daughter a seizure immediately following administration. Fortunately, she has not had subsequent episodes (it has been about 5 years since that occurrence). You can bet she did NOT get the 3rd dose, nor did my younger daughters get dosed after that. It is a particularly dangerous vaccine that you need to RUN, not walk, away from.

Observations of PBJ Mom said...

Has there been any other seizures since 2009 or since you posted this in 2014? Just wondering if seizure continued since vaccine

Anonymous said...

so, a friend of a friend of a friends daughter is hospitalized since she suffered a seizure, now trashed and coma induced due to what is being called, NORSE new onset refractory status epileptics. doctors are not able to determine why this healthy young adult girl has suffered this devastating seizure. The first thing I thought of was this HPV vaccine. does this sound familiar? Well I know it does. Just want to get the family some information.

Anonymous said...

I would like to know how many of the girls who suffer seizures after the HPV vaccine had one of the vaccines with the lot #849AA in 2011? My daugher and another girl both had the shots and suffer unexplained seizures and this is one of the lot numbers on one of their vaccines.

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