Governor Jerry Brown’s failure to veto California’s new anti-STD law—allowing clinics to give Gardasil shots to children without their parents’ knowledge or permission—could have a dangerous side effect.
Say your kid started having seizures. If you didn’t know he’d been given a vaccine, it wouldn’t even cross your mind to file a VAERS (vaccine adverse event reporting system) report. Nor would you think to contact the vaccine manufacturer.
VAERS is already notoriously fallible. Although those searching it are wont to say, “Look! It says on VAERS that x number of people have—died, acquired a seizure disorder or an autoimmune disease, whatever— from Gardasil!” that’s rarely the case. Doctors and individuals report anything they believe MIGHT be a side effect or adverse event related to the HPV vaccine, and the scientists of VAERS and the FDA are supposed to follow up and try to determine patterns that bear investigation. Many ‘side effects’ are reported. Some will inevitable turn out to have nothing to do with a vaccine, or not as far as the FDA can determine at this point, anyway.
Equally, events that could be related to Gardasil frequently go unreported because a doctor refuses, or sees no need, to make a report. Or maybe a parent fails to connect the dots and ask questions. Look at Jenny Tetlock’s case—her parents turned up two rare and virtually identical cases that hadn’t been reported. Like I said, VAERS is fallible.
And are these busy clinics really going to monitor the health of the kids they are merrily giving the shot to? For months, a year, more? File VAERS reports on anything that seems odd so that the FDA's records are complete? Doesn't seem likely, does it?
I can't think of any other vaccine that has been gifted with such potentially lax oversight.
Here I should say that there is as yet no official link between seizures and Gardasil yet, although the anecdotal evidence is mounting and the FDA is apparently beginning to investigate it more thoroughly (see here).
But how can the FDA even properly begin to make possible connections between Gardasil and seizures, or Gardasil and autoimmune disease, or Gardasil and blood clots, when VAERS reporting is limited even more?
Oh, wait….
Showing posts with label seizures. Show all posts
Showing posts with label seizures. Show all posts
Thursday, October 13, 2011
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 www.gardasilhpv.com
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.
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 www.gardasilhpv.com
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.
Thursday, April 29, 2010
Gardasil convulsions discounted, yet Australia halts flu vaccines on convulsion news
A two-year old girl died within 12 hours of receiving a new trivalent flu vaccine by CSL in Australia, 67 others suffered febrile convulsions, and at least 410 children in suffered from side effects like fever and vomiting.
So Australian health authorities have halted use of the vaccine for children under five while the issue is investigated. One possibility is that the children were more vulnerable to side effects from the vaccine, which includes swine flu as well as two strains of seasonal flu, because of having received the two-shot swine flu vaccine last year.
Although the relatively swift action seems commendable, some Australian parents are complaining that their kids had suffered reactions to last year's swine flu vaccine and their concerns were dismissed without follow-up.
That probably sounds familiar to parents of kids who have, they believe, suffered side effects from Gardasil, Merck's three-shot HPV vaccine series. True, there’s a difference between febrile convulsions, more common in young children, and the convulsions and seizures that are suffered by adolescents post-vaccination (see here and here), but post-Gardasil convulsions and seizures are habitually written off.
As always, it’s important for parents to assess the risks and benefits of vaccines versus the risks of disease for their own families. There’s never a perfect, one-size-fits-all scenario—but it’s crucial that health authorities follow up reports of adverse reactions instead of dismissing them out of hand as either unconnected, statistically insignificant, or just meritless "anti-vaxxer" raving. And they need to follow up more than once when warranted, and investigate the cummulative effects of vaccines, too.
If you suffer an adverse reaction to any vaccine, report it immediately to VAERS and RateADrug.
So Australian health authorities have halted use of the vaccine for children under five while the issue is investigated. One possibility is that the children were more vulnerable to side effects from the vaccine, which includes swine flu as well as two strains of seasonal flu, because of having received the two-shot swine flu vaccine last year.
Although the relatively swift action seems commendable, some Australian parents are complaining that their kids had suffered reactions to last year's swine flu vaccine and their concerns were dismissed without follow-up.
That probably sounds familiar to parents of kids who have, they believe, suffered side effects from Gardasil, Merck's three-shot HPV vaccine series. True, there’s a difference between febrile convulsions, more common in young children, and the convulsions and seizures that are suffered by adolescents post-vaccination (see here and here), but post-Gardasil convulsions and seizures are habitually written off.
As always, it’s important for parents to assess the risks and benefits of vaccines versus the risks of disease for their own families. There’s never a perfect, one-size-fits-all scenario—but it’s crucial that health authorities follow up reports of adverse reactions instead of dismissing them out of hand as either unconnected, statistically insignificant, or just meritless "anti-vaxxer" raving. And they need to follow up more than once when warranted, and investigate the cummulative effects of vaccines, too.
If you suffer an adverse reaction to any vaccine, report it immediately to VAERS and RateADrug.
Friday, April 16, 2010
Gardasil and seizures to be considered by Vaccine Court
Last year the FDA mandated a revised label for Gardasil, warning health care providers about the continuing reports of syncope in those who’ve received the HPV vaccine, including “jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but is not epilepsy.”
However, stories about post- Gardasil epilepsy, continuing seizures and convulsions that are certainly not merely “syncope” continue to pour in—and on Wednesday the Ronan Law Firm filed a petition “in the United States Court of Federal Claims seeking damages for injuries suffered by 16 year old Alexis Wolf after she received the human papillomavirus vaccine, Gardasil. The case seeks recovery under the terms of the National Vaccine Injury Compensation Program.”
Wolf, who is diabetic, received all three Gardasil shots although she had already begun exhibiting some perplexing behavioral issues by the time she got the third shot. Eventually a psychiatrist realized that she was in fact suffering seizures that apparently cannot be controlled by medication. According to information posted by her parents, the former honor roll student now tests at a fourth grade level and is in constant pain.
Yesterday I posed a question about Merck's HPV vaccine Gardasil, seizures and mitochondrial disease here .
It will be interesting to see how the federal vaccine court, which in 2008 awarded damages to a child whose undiagnosed mitochondrial disease was aggravated by multiple vaccines, rules on this new case.
Meanwhile, best wishes to Ms. Wolf and her family.
© 2010 http://www.gardasilhpv.com/.Permission is freely given to reproduce the first two paragraphs of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at gardasilhpv@gmail.com.
However, stories about post- Gardasil epilepsy, continuing seizures and convulsions that are certainly not merely “syncope” continue to pour in—and on Wednesday the Ronan Law Firm filed a petition “in the United States Court of Federal Claims seeking damages for injuries suffered by 16 year old Alexis Wolf after she received the human papillomavirus vaccine, Gardasil. The case seeks recovery under the terms of the National Vaccine Injury Compensation Program.”
Wolf, who is diabetic, received all three Gardasil shots although she had already begun exhibiting some perplexing behavioral issues by the time she got the third shot. Eventually a psychiatrist realized that she was in fact suffering seizures that apparently cannot be controlled by medication. According to information posted by her parents, the former honor roll student now tests at a fourth grade level and is in constant pain.
Yesterday I posed a question about Merck's HPV vaccine Gardasil, seizures and mitochondrial disease here .
It will be interesting to see how the federal vaccine court, which in 2008 awarded damages to a child whose undiagnosed mitochondrial disease was aggravated by multiple vaccines, rules on this new case.
Meanwhile, best wishes to Ms. Wolf and her family.
© 2010 http://www.gardasilhpv.com/.Permission is freely given to reproduce the first two paragraphs of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at gardasilhpv@gmail.com.
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