gardasil adverse events

Vitamin D Plays an Integral Role in Adaptive Immunity

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Severe Adverse Reactions Include Vitamin D Deficiency and Autoimmunity

Hormones Matter researchers discovered that, inter alia, severe adverse reactions to any of the surveyed drugs trigger significant but varying autoimmune responses. Moreover, the research revealed an underlying consistency involving all reviewed drugs: vitamin D deficiency.

Vitamin D Helps Regulate the Adaptive Immune System

The adaptive immune system comprises the body’s intricate network of antibodies and special types of white blood cells (called sensitized lymphocytes ) to thwart new and previous invaders including viruses, bacteria, and drugs. When the adaptive immune system is not strong enough to endure external disruptions such as severe side effects of drugs, it can go awry by signaling antibodies and sensitized lymphocytes to attack healthy cells. This response is called autoimmunity—when the adaptive immune system’s cells do not recognize previous invaders and designate healthy cells as those invaders. In other words, the body’s immune cells attack its own healthy cells.

Scientific research over the past three decades solidifies the connection between vitamin D and autoimmunity. Vitamin D plays an integral role in the regulation of the adaptive immune system. Adequate vitamin D in our bodies can protect us from autoimmunity because adaptive immune cells contain vitamin D receptors (VDRs). These receptors are attached to the surface of the adaptive immune system’s antibodies and sensitized lymphocytes. The VDRs act as “gate keepers” by signaling what external substances, e.g., components of medications, can enter a cell. The VDRs must be replete with vitamin D to effectively regulate adaptive immunity. When the VDRs receive adequate amounts of vitamin D, they enable the adaptive immune system to function properly by attacking new and previous invaders.

When the VDRs attached to the adaptive immune system’s cells do not contain sufficient vitamin D to attack invaders, autoimmunity may kick in, causing the death of healthy immune cells. Thus, low vitamin D levels can lead to autoimmune diseases including thyroid disorders such as Hashimoto’s and demyelinating diseases including multiple sclerosis (MS).

Vitamin D and Hashimoto’s Autoimmune Thyroid Disease

The Real Women, Real Data research also uncovered another consistency among severe adverse reactions to the reviewed drugs: Hashimoto’s thyroiditis, an autoimmune disease caused by abnormal cells constantly assaulting the thyroid gland
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Vitamin D receptors are present in the thyroid as well as the pituitary, the pea-shaped gland that controls the thyroid. Not surprisingly, low levels of serum vitamin D have been linked to Hashimoto’s thyroiditis, according to recent Turkish medical research:

Published in a 2013 issue of the journal Endocrine Practice, a study conducted at a training and research hospital in Ankara demonstrated that serum vitamin D levels of female chronic Hashimoto’s patients were significantly lower than healthy subjects. Furthermore, the researchers discovered a direct correlation between serum vitamin D levels and thyroid volume as well as an inverse correlation to the antibodies involved in the thyroid.

Researchers at Medeniyet University’s Goztepe Education and Research Hospital in Istanbul learned that 92 per cent of their 161 Hashimoto’s thyroiditis cases had serum vitamin D levels lower than 30 ng/mL (12 nmol/L), a value characterized as “insufficient.” Published in a 2011 issue of the journal Thyroid, the study reports an association between vitamin D insufficiency and Hashimoto’s thyroiditis.

Vitamin D and Demyelinating Disorders

Another disturbing outcome of the Real Woman, Real Data research is the reporting of neurological and neuromuscular symptoms, many which of are consistent with demyelinating disorders such as MS, an autoimmune disease. The development of MS occurs when a poorly functioning, adaptive immune system gradually attacks the protective covering of the nerve cells (called the myelin sheath) of the brain and spinal cord. This potentially debilitating process is called demyelination.

Scientific—primarily epidemiological—research indicates an association between vitamin D levels and the risk of developing a demyelinating disorder such as MS. VDRs exist on nerve cells and the myelin sheath. When the VDRs receive adequate amounts of vitamin D, they help protect the integrity of the myelin sheath. However, when the VDRs do not contain sufficient vitamin D, autoimmunity may occur, resulting in the death of healthy nerve cells. Numerous clinical trials are underway to assess the connection between vitamin D status and the likelihood of developing demyelinating disorders.

Low Vitamin D: The Chicken or the Egg?

The connection between low vitamin D status and the development of autoimmune disease is genuine. However, medical research has not yet determined if vitamin D deficiency plays a role in the development of autoimmune disease, if low vitamin D levels are a consequence of the disease itself, or if vitamin D deficiency acts as both a cause and effect. The authors of the aforementioned 2013 Hashimoto’s study concluded,

“Finally, our results suggested that there may be a causal relation between vitamin D deficiency and development of Hashimoto’s thyroiditis. On the other hand, there might be a possible relation between severity of vitamin D deficiency and progression of thyroid damage. However, further studies are needed especially about the effects of vitamin D supplementation on prevention and/or progression of autoimmune thyroid disease.”

Proactive Protection against Severe Adverse Reactions

We could wait years (or decades) to garner the results of further scientific studies and clinical trials to define the exact relationship between vitamin status and severe adverse reactions to vaccines and medications that culminate in autoimmune disorders. Or we could be proactive by taking daily vitamin supplements and enjoying moderate sunlight exposure to increase our vitamin D levels.

It is imperative to take enough vitamin D3 so this essential nutrient will be stored in your cells to help regulate your immune system. The greater your serum vitamin D level (easily obtained from a simple blood test called 25(OH) D, the more likely you will benefit from a stronger immune system that protects your body’s cells from attacking one another.

No one wants to endure severe adverse reactions to drugs such as Gardasil and Lupron, let alone an autoimmune disease. Attaining and maintaining adequate supplementation provides a safe, easy, and inexpensive approach to improved preventive health. By empowering yourself with adequate vitamin D, you may reap the benefits of avoiding disease and enjoying better quality of life.

Copyright © 2013 by Susan Rex Ryan. All rights reserved.

This article was published previously on Hormone Matter in September 2013.

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My Son’s Gardasil Story and Thiamine Deficiency

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On June 16th 2012 my son complained of ear pain, so I took him to his doctor thinking he had an ear infection. He had no infection but his doctor suggested doing a physical exam since he had not been in for a couple of years. My son had just turned 18 years old three weeks prior and just graduated from high school. He was happy, healthy, and active. After the exam I was called into the room. His doctor said he was in good health and observed no problems, but since he would be going off to college in the fall, he recommended that he should receive the meningococcal vaccine along with the Gardasil vaccine. In his words, “HPV is rampant in colleges and he should have this vaccine.” This had been my son’s physician since birth, and having no prior knowledge of the Gardasil vaccine controversy, I trusted him and agreed to these two vaccines that day.

There was absolutely no discussion of possible harmful side effects.

My son did not have any immediate reactions that I can remember, but on July 30th 2012 that all changed. We were out to lunch and when his food arrived he looked at me with a very strange look on his face and said that he just didn’t feel right, something was wrong. He could not eat that day even though he was hungry just prior. He would complain of severe stomach pain that came and went over the next few weeks.

On August 7th 2012 he received the second dose of Gardasil. His stomach pain increased in severity, but we still did not make the Gardasil connection. Who would think that a vaccine for HPV would cause stomach aches?

Just nine days after that second injection, he felt he needed to go in and see his doctor. The pain was becoming unbearable. The doctor prescribed antacids but this only made his problem worse, so he then suggested an endoscopy. The endoscopy came back completely normal. At this point his doctor felt that his stomach pain was due to stress and anxiety because he was going off to college. The doctor suggested that he should “go talk to someone.” I knew for a fact that the pain was not in his head or simply due to stress. It was real. Now, almost a year later, and with the knowledge of the possible side effects of the Gardasil vaccine, I am very angry that his doctor did not recognize “severe stomach aches” as being one of the Gardasil side effects. How did he not connect those dots, especially given the fact that my son was in his office just nine days after receiving the second dose complaining of that very thing? This recognition would have prevented him from getting that dreadful final dose.

My son left for college and soon after began developing other symptoms, mainly extreme fatigue and brain fog. He made it through the quarter and came home for Winter break. On December 27th he received the 3rd and final dose of Gardasil. The very next evening he became extremely sick. All the symptoms he had been experiencing along with many others became instantly worse. I was finally able to make the Gardasil connection. Since then he has had more symptoms than I can list, sinus headaches, pain at the base of his skull, fever, chills, hair loss, vision changes, gallbladder pain/gallstones, sleep disturbances, tingling, numbness, no appetite, weight loss, anxiety, excessive thirst, salt cravings, kidney issues, liver issues, heart palpitations, slow heartbeat, fast heartbeat, dizzy, rashes, mouth sores, yeast issues, low stomach acid… the list goes on. To this day he still suffers from many of these symptoms.

What has followed are many doctors and  many, many tests; most of which have come back normal with the exception of his most recent test. After reading Dr. Lonsdale’s article on thiamine deficiency and his recommendation for Gardasil injured to have a red cell transketolase blood test,  I immediately requested one for my son. I researched the symptoms of thiamine deficiency and he pretty much had every single one. The test came back strongly positive. He was severely thiamine deficient.

This is where we are today. We started immediate supplementation with oral alliathiamine and we are looking into possible IV supplementation, for perhaps, a quicker, more thorough improvement. I sincerely hope that this discovery might be the key to my son finally being well again and that this devastating nightmare may finally come to an end.

Participate in Research

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine (we hope to launch the male version soon), please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

To take one of our other Real Women. Real Data.TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news and research participation opportunities click here.

To share your health story with our community, click here.

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Post Gardasil Thiamine Deficiency: A Mother’s Quest for Answers

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My daughter has struggled since she got her second Gardasil shot in December 2008. Even though she has improved immensely and was finally able to return to college after missing 3 years, she still had some problems including issues with swelling/edema, gut, thyroid, and temperature regulation.

In July, I came across a 2008 article written by Leslie Botha about the Gardasil side-effects that were being reported at the time.  A woman who was knowledgeable about thiamine deficiency because it runs in her family read the article and realized that the side effects of Gardasil were similar to thiamine deficiency. She speculated in her post that the yeast in the vaccine, or possibly the manufacturing process, might be responsible for the beriberi type reactions people were having.

The more I read about beriberi, the more I became convinced that this was causing many of my daughter’s problems. She had all the symptoms of thiamine deficiency with cardiovascular involvement including Postural Orthostatic Tachycardia Syndrome (POTS), chest pains, edema, sleep disturbance, abdominal discomfort, and  trouble digesting and processing foods, especially carbs.

I contacted Dr. Lonsdale, a long-time expert in Thiamine Deficiency, and he has been immensely helpful and willing to share his knowledge. After an erythrocyte transketolase test confirmed that my daughter was extremely thiamine deficient, she started taking a form of thiamine that crosses the blood brain barrier.  In the two months she has been on the supplement her lab tests show a substantial improvement in several areas including swelling, ability to detox, and hormone and thyroid levels. Her energy level has also improved.

Over the past five years we have tried a wide gamut of treatments including hyperbaric oxygen therapy, IV’s, supplements, infrared sauna, thyroid medications, low dose naltrexone, UV blood irradiation, homeopathic and chiropractic treatments, acupuncture and countless others. Although she improved nothing fully explained the root cause of her symptoms until I came across thiamine deficiency and talked with Dr. Lonsdale. Although he says it can take months to treat thiamine deficiency, we have already seen many good things happen.

Participate in Research

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

To take one of our other Real Women. Real Data.TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

A Day in the Life of Alexis Wolf: Six Years After Gardasil

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Alexis is now 20 years old. Six years have passed since her first injection of Gardasil. Life has changed drastically since then. After the Gardasil vaccine, Alexis developed encephalopathy, Traumatic Brain Injury (TBI) and a horrible seizure disorder that has yet to be controlled. Read the first part of Alexis’ Gardasil journey here.

Post Gardasil Brain Injury

Alexis’ brain injury post Gardasil is in the frontal lobe. This part of the brain controls so much of who we are. This has left Alexis with the mental capacity of about an 8 year old. She gets very confused easily and struggles with short term and long term memory so she requires constant supervision with frequent redirection on everyday tasks. Her skill level of preparing meals for herself and daily personal hygiene is almost nonexistent. She can no longer take showers due to the danger of having a seizure and falling. I have to help her take a bath and make sure she gets clean. I have to assist in washing her hair to make sure it gets clean. I also have to get her clothes ready for her. She can usually dress herself with little assistance.

Post Gardasil Bowel and Bladder Problems

Since receiving Gardasil, Alexis progressively lost bladder and bowel control.  She has to wear adult diapers.  Sometimes she will put her fingers inside her anus to try to help herself go #2. Although we have discussed this with all of her doctors and with her, telling her it is very dangerous for her and everyone one else, she cannot control herself. We make her wash her hands OFTEN. I wipe things down with Lysol wipes OFTEN.

Post Gardasil Pain

Alexis has often expressed frustration, depression and suicidal thoughts as to her present life and her future. She can be swift to anger and have great mood swings. She will slam doors, throw things, spit at us and call us a variety of cuss words. She is miserable most of the time. She complains about pain constantly. We have been turned away by three different pain specialist because they review her records and tell me she is “too complex” for them to treat. The only thing she has to help her with the pain is medical marijuana in the form of tinctures and vapors. When her head hurts really badly she will hit her forehead with the palm of her hand and say “brain get better, brain get better…” She also complains about all over body aches, sharp pains in her chest, joint and muscle pain. She will tell us that everything looks scary, strange and unusual even herself. The best description she was able to give us was that it looked like the walls were melting and people looked like cartoons. I had to take her out of high school for the above reasons. Her teachers were not very patient with her and they would push her buttons so one day she hit one of her teachers in the arm. The school called the police so I took her out of school.

Post Gardasil Seizures

Alexis’ speech patterns can often digress to repetitive statements over and over. This occurs without the knowledge that she is engaged in that behavior. Her motivation level is very low due to her brain injury. Getting her to do anything is quite the struggle. Almost every task is labored and takes lots of patience from the person helping her. Often at times she will flat out refuse to move and begs to take a nap. She naps off and on all day every day. We really do not know how long she sleeps at night but we think it is no longer than two hours at a time. The seizures happen all the time and they wake her up while she is sleeping. She is usually unable to fall back to sleep, so she wanders the house and searches for food. She has horrible impulse control and she is not able to tell if she is full or not. We have to keep the fridge and the pantry locked up at all times so she does not eat herself into a coma. If she eats a full meal and then has a seizure she will forget that she has just eaten and she begs for food saying that she is starving. We also lock up her medications because she will forget that she has taken them and try to take more even though I store them in those daily dose medicine boxes. She can have many, many seizures in a day. She takes anti-seizure meds and she also has a device implanted in her chest called a VNS therapy. It is supposed to reduce or stop her seizures but so far we have not really noticed a difference. She has had it for 3 years and soon she will be due for a battery replacement that will require another surgery. The battery should have lasted 5-10 years but the doctors have made so many adjustments on the therapy levels that the battery only has a few months left of power.

Alexis having a Seizure in 2010

Six Years and Counting

In the past six years we have had to deal with many people who do not understand the side-effects of the Gardasil vaccine. We have been accused of horrible things. We have had to endure being investigated by Child Protective Services, Adult Protective Services, police, detectives and more. Family, friends and neighbors have turned their heads and left us behind. Alexis’ father has not spoken to her in two years and all the help he had once offered is nonexistent. The government services that should support Alexis and her brain injury are bogged down so she is on a waiting list of over 40,000 people. I was told she MIGHT get services in 2019 when her name comes up next on the list. The way things have been going it is possible that all money and services may dry up and go away before her name even comes up.

Alexis’ inability to live independently will require lifelong care and assistance. I worry all the time about what will happen to her when I am no longer able to care for her. Every day new challenges arise so I can never put down my guard. I have been told by at least two doctors that I should look into some sort of institutional assisted living facility, but I cannot wrap my mind around that just yet. Life is quite different than it was six years ago, before Gardasil. Six years ago Alexis was a normal 14 year old. Starting to wear make-up and get interested in boys…working hard in school and enjoying honor roll. She had her whole life ahead of her and now she spends every day in a living hell filled with pain and misery, begging to be better, begging everyone to pray for her.

Six years ago, before Gardasil, life was very different.

Alexis Wolf before Gardasil
Alexis Wolf, age 14, before her first Gardasil injection.

 

Alexis Wolf after Gardasil
Alexis Wolf, age 20, six years after Gardasil.

 

Participate in Research

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

To take one of our other Real Women. Real Data.TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

 

Gardasil Cervarix Online Study Continues – Participate Now

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Controversy surrounds the HPV vaccines, Gardasil and Cervarix. Since their release, the vaccine industry, the media and medical societies have touted the safety and success of the vaccines in preventing or reducing HPV viral infections and thus, in preventing cervical cancer. Patient groups, mom’s of vaccine injured girls and anti-vaccine groups on the other hand, argue loudly that the rate and severity of serious adverse events are seriously under-reported by industry and the proof that these vaccines prevent or reduce cervical cancer is lacking. Even one of the lead developers of the vaccine, Diane Harper has come out against it.

Somewhere in the middle is the Vaccine Adverse Event Registry (VAERS), where only 1-10% of a very limited range adverse events are reported. Even with the limited reporting to VAERS, the severity and frequency of adverse events is growing and should not be ignored. Data collected from VAERS indicates a serious adverse event rate 4.3 per 100,000 doses of Gardasil. Serious adverse events are those that cause death or are life threatening, require hospitalization, cause persistent disability or incapacity and/or require medical treatment to prevent permanent impairment or damage. This is compared to a risk of cervical cancer of 7.9 per 100,000 and death from cervical cancer at 2.4 per 100,0000 cases in the US.

Considering the severity of the reported adverse reactions and the noted adverse events reporting rate of less than 10% of all cases, having more credible and complete data about true severity and prevalence of said reactions as well as more detailed data about who is at risk for those adverse events is critical.

As a parent, a researcher and the founder of Hormones MatterTM, I decided to do something about the lack of data in this and other areas of women’s health. As part of the Real Women, Real Data series,  The Gardasil Cervarix HPV Vaccine Survey was launched In May of 2013.  It is a comprehensive, online study of Gardasil and Cervarix side-effects and adverse events. The study will run until a study sample of 1000 is reached. The goal is to provide a more accurate and unbiased look at the rate, range and severity of side-effects and adverse events associated with the HPV vaccines, Gardasil and Cervarix.

Take a survey. Share a survey. Suggest a survey.

We need your help to gather these data.  Please take this survey, if have had either vaccine – whether you experienced any side-effects or not. Understanding who is at risk and who is not, is very important. Share the survey link with your friends, sisters, colleagues and anyone you know who has been given the HPV vaccine. Please post it on your Facebook pages and share on Twitter, Linkedin, Reddit and other social media. Write about and re-post this link on your blogs. Anything you can do to spread the word is appreciated. We will need at least a thousand women to find the connections.

It is up to us to protect our daughters. Understanding this vaccine is one way to do that.

Purpose the Gardasil – Cervarix Survey

Women and their physicians need more data about the side-effects of the HPV vaccines, Gardasil and Cervarix. There is a lack of data about who is at risk for adverse events and whether certain pre-existing conditions increase one’s risk for an adverse event. There is also a lack of data about the long term health effects of these vaccines. The purpose of this survey is to fill that data void; to learn more about the risks for and nature of adverse events associated with each of the HPV vaccines, Gardasil and Cervarix.

Who Should Take the Gardasil Cervarix HPV Vaccine Survey?

Girls or women who have been given either vaccine or the parents or other family members of young girls given the vaccine.

We are not currently collecting data on the adverse reactions for men and boys, but intend to launch a separate survey to tackle that population.

How Long Does the Gardasil Cervarix HPV Vaccine Survey Take?

This is a long survey. We felt it was important to assess the full depth, breadth, onset and severity of adverse reactions in order to give parents and women the data they need to make informed medical decisions. This necessitated a longer than desired survey. We estimate it will take approximately 20-30 minutes to complete the survey.  We hope, given what is at risk, survey respondents will take the time to complete the entire survey.

Is the Survey Anonymous and Secure?

Yes. We do not collect personal identifying information and the survey is hosted with SSL encryption using a verisign certificate Version 3, 128 bit encryption.

How Will the Data be Used?

To inform future research and women’s health decision-making.

Who is Conducting this Research?

Researchers from LucineTM, Hormones MatterTM. For more information on Lucine, click here. For more information about Hormones MatterTM , click here.

What Can I Do To Help?

Our organization is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. Get involved and help us prove that hormones matter and that women’s health data matter. Become an advocate, spread the word about our site, our research and our mission. Join our team. Write for us, partner with us, help us grow. For more information contact us at: info@hormonesmatter.com.

To take the Gardasil Cervarix HPV Vaccine Survey, click here.

To take one of our other Real Women. Real Data.TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

Thank you in advance for your help.

Rolling the Dice with the HPV Vaccine

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If you are the parent of a minor child, you most likely have heard about one or both of the HPV (human papillomavirus) vaccines currently on the market. A trip to the pediatrician’s office with a teen or pre-teen is typically where the first discussion takes place. The doctor will dutifully recite information. HPV is the most common sexually transmitted virus in the United States. As a parent, that gets your attention. They go on to further state that the vaccine will protect your child from the strains of the virus that most commonly cause cervical cancer in females and genital warts in males. These are both very uncomfortable subjects for most of us. However, as parents, we want to protect our children at all costs from anything and everything possible.

As with any vaccine, the parent is provided a pamphlet or sheet containing the standard information: what is HPV, why get vaccinated, who should get vaccinated, and the obligatory safety information. After reading the information and listening to the doctor’s recommendation explaining that the vaccine is very safe (and it seems to be for most patients), many parents make the decision to have their child protected. I was one of them. I rolled the dice and sadly, my daughter lost.

The information pamphlet states that the vaccine has been used in the United States for about six years and has been very safe. You are warned about pain and swelling of the injection site, fever, headache, and the most troublesome side effect, fainting. The patient is required to remain in the doctor’s office for a period of time after the injection as a safety precaution.

What the information pamphlet does not address is that over 29,300 injuries and 136 deaths have been reported following HPV vaccines. Vaccine injury reporting is voluntary in our country and the Center for Disease Control acknowledges that adverse events, as they are called, may be 10 to 100 times greater than those actually reported. Do the math.  The reported numbers seem very significant to me, but I am the mother of one of the injured. I trust we can all agree that the actual numbers could be staggering.

The list of new medical conditions being reported following the HPV vaccine is also staggering, I counted 144 conditions. My daughter has 31 of them. She suffers mainly from neurological, autoimmune, and adrenal issues. The worst offender is a migraine-like headache that has been present every day, all day and night for more than a year. The neurologist refers to it as migraine-like because all the symptoms are there yet it does not respond to any medication. Her immune system has also been compromised. She suffers from leaky gut syndrome and now has sensitivity to 20 common foods. Dealing with this for more than a year now has taken a toll on her 16-year-old body. Chronic pain has lead to depression and adrenal fatigue. All of this in a girl who had what was described as an “unremarkable’ medical history prior to vaccination.

While my daughter’s symptoms are grave, she really is one of the lucky ones.  Many of the injured suffer from daily seizures or even multiple seizures per day.  My daughter does not. For that, I am thankful every day. Having a child in crisis is hard. Having a child with a medical crisis that medical doctors do not know how to reverse is even more difficult. My decision to protect her, in fact, caused her great harm.

Choosing to give your child a vaccination is a personal decision, but it is one that should not be taken lightly. Do your own research, do not simply rely on the information pamphlet, it is, after all, written by the vaccine manufacturer. I learned this lesson the hard way.  When you decide if you will roll the dice, please, for the sake of your child, remember this:  Education conquers fear and knowledge is power.

Gardasil Cervarix HPV Vaccine Research

Hormones MatterTM is conducting a large scale assessment of symptoms and adverse reactions associated with the HPV vaccines, Gardasil and Cervarix. If you, your daughter, other family member or friend have had either of these vaccines, we encourage you to take this important survey. The data collected with help delineate the range, severity, frequency and onset of health symptoms associated with Gardasil and/or Cervarix. For more information or to take the survey: The Gardasil Cervarix HPV Vaccine Survey.

 

 

 

Gardasil Autopsies Reveal Cerebral Vasculitis

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Controversy about Gardasil and Cervarix related injuries surrounds the HPV vaccine. Almost to a tee, major medical centers, presumed thought leaders, post market surveillance, regulatory agencies and the press, promote the safety of these vaccines. It is incomprehensible to these organizations that such a perfect vaccine could cause serious injury or death. Any new report suggesting otherwise is quickly and summarily rejected, the families of the young women injured or killed are lambasted.  Rarely, does anyone standup and support the injured, lest they too be considered among the fringe. All the while, girls and women and their families continue to be injured or even worse lose their lives, by what pro-industry PR suggests are unexplained reasons.

Well, explain them damn it. If it is not the vaccine, then what? Neither the post-vaccine reactions nor the deaths are random and though the culprits may be complicated, basic human decency, not to mention medical ethics demand that we make an effort to understand the causes of the adverse reactions so that we might prevent them.

Looking for Clues

A group of researchers from University of British Columbia are attempting to do just that –  to understand the constellation of adverse reactions reported post vaccine. In one of their latest reports, published last fall in the open access journal Pharmaceutical Regulatory Affairs, they uncovered evidence of a deadly and difficult to diagnose condition called cerebral vasculitis.The syndrome fits clinically based on the presentation of symptoms reported. The study is not without problems and certainly not without criticism from industry. Here is a review and my thoughts on the research and the reactions to the study from industry and regulators.

What is Vasculitis?

Vasculitis is an autoimmune mediated attack within the walls of the blood vessels, that weaken and sometimes necrotize or kill the vessel. The central feature of vasculitis is the inflammatory destruction of the blood vessel. Vasculitides, as they are called, can develop anywhere in the body, in large or small vessels. Where the vasculitides develop and the size and type of vessels involved determines the types of symptoms that present and how the functioning of the injured physiological system will be affected.  As a result, the symptoms often appear heterogeneous and non-specific, making vasculitis very difficult to diagnose – unless one was looking for it. This report suggests that we ought to begin looking for it.

Peripheral and Cerebral Vasculitis

When vasculitis occurs in the body – peripheral or systemic vasculitis, symptoms include but are not limited to:

When vasculitis develops in the central nervous system – the brain and the spinal cord, symptoms include but are note limited to:

  • nerve problems (including numbness, muscle weakness, and pain)
  • severe headaches that last a very long time
  • strokes or transient ischemic attacks (“mini-strokes”)
  • forgetfulness or confusion
  • delirium and/or depressed consciousness
  • problems with eyesight (likely problems with hearing, but no cases cited)
  • speech problems
  • emotional regulation problems
  • seizures or convulsions
  • encephalopathy (swelling of the brain)
  • sensation abnormalities

Cerebral vasculitis, also called autoimmune encephalitis, represents one of the rarest forms of vasculitis because it requires the toxin or mediator to cross the blood brain barrier. Current estimates suggest an annual incidence of only 1-2 cases of cerebral vasculitis per million adults. Cerebral vasculitis is also the most deadly, as the immune system mediated attack of the small to medium blood vessels in the brain often leads hemorrhagic or ischemic stroke and can lead to death.

Gardasil Autopsy Reports

The current study, Death after Quadravalent Human Papillomavirus (HPV) Vaccination: Causal or Coincindental? examined the brain tissue of two young women who died suddenly after receiving the HPV vaccine, Gardasil. One of the young women was 19, healthy, medication free and had no previous medical history. She died in her sleep after being given the third dose of the vaccine, which elicited an apparent exacerbation of symptoms that had developed soon after the first dose.The symptoms that emerged after her first dose included: warts on her hands, fatigue, muscle weakness, tachycardia, chest pain, tingling in her extremities, irritability, confusion and memory lapses or amnesia.

The other young woman was 14 years old, had a history of migraines and was using oral contraceptives. Within two weeks of her first dose, she developed a constellation of symptoms that included exacerbation of migraines, speech problems, dizziness, weakness, inability to walk, excessive vomiting, depressed consciousness, confusion, amnesia. Two weeks after the second dose, she was found dead in the bathtub by her parents.

The original autopsies for each the young women revealed no abnormalities and no precise cause of death. With the second girl, the coroner noted cerebral edema and what is called cerebellar herniation – a condition where brain swelling pushes against lower brainstem compressing the region responsible for respiration (breathing) and heart function.  Even though histopathology was done as part of the autopsy, the coroner’s reports provided no indication of which antibodies were used for histology investigations, suggesting only general and non-specific histopathology, making it near impossible to determine if the HPV vaccine was in involved.

Advanced Immunohistochemistry

Without the appropriate immunohistochemical (IHC) examinations, using specific antibodies to tag the antigens used in the HPV vaccine, there was no way for the coroner to determine whether the HPV vaccine elicited or contributed to the deaths of these girls. Knowing this, the current researchers developed a specific IHC to examine the brain tissue and determine whether the vaccine was responsible. What they found was disturbing, but incredibly important.

The IHC from this study found evidence of autoimmune cerebral vasculitis triggered by the HPV16L1 component of the vaccine. HPV16L1particles were identified all over the cerebral vasculature including adhering to the vessel walls. They also observed an increased expression of the complement of immune markers consistent with vasculopathic syndromes. These included:

  • Excessive adhesion of T lymphocytes
  • MHC- II signaling and deposition of immunoglobulin G-immune complexes to cerebral vasculature
  • Increased MMP
  • Intense micro- and astrogliosis

Diagnosing Vasculitis

Diagnosing vasculitis is difficult both because of its rarity, especially in young, previously healthy, individuals and because the constellation of symptoms often mimic other conditions. Blood work, angiography and often a biopsy of the tissue in question are required but not always confirmatory, making this diagnosis as much about clinical expertise as testing.

Once diagnosed, the treatments include, high-dose corticosteroids and sometimes, chemotherapeutic agents.  If diagnosed, it can be treated or at least maintained. The problem, is that currently few physicians are looking at vasculitis as a possible culprit for the range of symptoms exhibited by Gardasil or Cervarix injured young women. This study suggests we should. There are however, dissenting opinions.

Dissenting Opinions and Possible Problems with the Findings

Following the publication of these findings in October 2012, the CDC convened a panel in November 2012 to review the report. The CDC panel  identified concerns with the study methods and interpretation of findings. The working group contends that:

  1. A finding of vasculitis requires evidence of inflammatory infiltrate damage within the vessel wall and that standard histopathology testing (hematoxylin and eosin- H&E stain) stain would have identified said damage. Since the H&E stain was negative, vasculitis was not evident and did not exist.
  2. Details of the authors’ histopathology methods/staining and the appropriate control data (HPV vaccine free brain tissue) were not included, are new, have not been tested and therefore, are not valid.
  3. HPV-16L1 particles are too small to identify using light microscopy, electron microscopy (EM) would have been required. The authors provided no evidence that EM was used. And again, the issue of the lack of control specimen was indicated as a flaw.
  4. Lack of information about alternative causes of death.

Rebuttal of CDC Panel Findings

Comparing apples to oranges. Neither of the two studies the CDC offers as evidence against the finding of cerebral vasculitis involves research on cerebral vasculitis. One of studies cited is a letter to the editor published in the Rheumatology journal reporting two cases of skin vasculitis, post-Gardasil vaccine; evidence that appears to support a linkage between the HPV vaccine and vasculitis in general rather than dismiss it.

The second study cited as evidence against cerebral vasculitis was the CDS’s own study, a 2009 Post Liscensure Gardasil Surveillance Report that reviewed and tabulated the Vaccine Adverse Event Reports (VAERs) data from June 2006, through December 2008. Neither cerebral vaculitis nor other forms of vasculitis was an endpoint or outcome variable evaluated in this study. Using the CDC’s Surveillance report, which neither included the very endpoints in question, nor gathered manufacturer independent data to verify claims to negate the findings cerebral vasculitis, is spurious at best, and disingenuous or worse when one considers the potential risks involved for getting this diagnosis wrong.

Technical and methodological criticisms. The technical criticisms against the cerebral vasculitis findings involve utilizing new, less well understood methods to detect the disease process versus accepted and tools and techniques. Only time and additional testing will tell whether these concerns are valid. This was a preliminary study, to reject it based on its newness and novelty, particularly when the risks are so high, seems unwarranted. Instead, additional research should be undertaken immediately to confirm or reject the claims and to validate or invalidate the methods.

No control data. This is a red herring, used against some studies when necessary and dismissed in others when it suits the critic. Other highly praised Gardasil studies, for example, find it perfectly acceptable to have no controls groups. Certainly, a control group would be ideal, but in preliminary case reports it is not necessary. The authors of the study in question address the lack of control subjects and recognize the need for additional research. It should be noted, however, that postmortem brain tissue analysis in young, healthy women is not common and it would be difficult to determine what was ‘normal’ versus abnormal. Again, rather than reject the findings of cerebral vasculitis outright, additional testing should begin to validate or invalidate these findings.

Is Cerebral Vasculitis or Vasculitis Linked to the HPV Vaccines?

At this point it is not clear, additional research is needed. However, the clinical presentation of adverse reactions appears to support cerebral and other regional vasculitides. Together with this preliminary postmortem tissue evidence, not only does the vasculitis linkage warrant additional investigation, I feel it should it be included in the diagnostic differential, particularly for the treatment refractory constellation of neurological and autoimmune symptoms so commonly reported by vaccine recipients.

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The Gardasil Cervarix HPV Vaccine Survey

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Introducing the third in our series of Real Women. Real Data.TM surveys: The Gardasil Cervarix HPV Vaccine Survey.

At Hormones MatterTM we have covered the Gardasil story many times. We have been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines. We are concerned by the lack non-industry sponsored data regarding the range, frequency and severity of adverse events. We aim to solve that problem and we need your help.

About Gardasil and Cervarix

Individual reports abound about the dangers of the HPV vaccine, Gardasil. Less is known about Cervarix. Data collected from Vaccine Adverse Event Reporting System (VAERS) and reported on here, indicates a serious adverse event rate 4.3 per 100,000 doses of Gardasil. Serious adverse events are those that cause death or are life threatening, require hospitalization, cause persistent disability or incapacity and/or require medical treatment to prevent permanent impairment or damage.  This is compared to a death rate of cervical cancer, which according to the WHO stands at 1.7 per 100,0000 cases in the US.

What we don’t know is who is most at risk for these adverse events. Are there particular pre-existing conditions, medications or even menstrual cycle triggers that increase the risk for an adverse event?  What is the full range of side-effects and adverse events, short term and long term? Is either vaccine more risky than the other?  These are questions that must be addressed so that as medical consumers we can make educated decisions about vaccine safety.

We need your help to gather these data.  Please take this survey and share it with your friends, sisters, colleagues and anyone you know who has been given the HPV vaccine. Please post on your Facebook pages and share on Twitter, Linkedin, Reddit and other social media. We will need thousands of women to find the connections. That requires crowdsourcing and sharing amongst women.

Purpose the Gardasil – Cervarix Survey

Women and their physicians need more data about the side-effects of the HPV vaccines, Gardasil and Cervarix. There is a lack of data about who is at risk for adverse events and whether certain pre-existing conditions increase one’s risk for an adverse event. There is also a lack of data about the long term health effects of these vaccines. The purpose of this survey is to fill that data void; to learn more about the risks for and nature of adverse events associated with each of the HPV vaccines, Gardasil and Cervarix.

Who Should Take the Gardasil Cervarix HPV Vaccine Survey

Girls or women who have been given either vaccine or the parents or other family members of young girls given the vaccine.

We are not currently collecting data on the adverse reactions for men and boys, but intend to launch a separate survey to tackle that population.

How Long Does the Gardasil Cervarix HPV Vaccine Survey Take?

This is a long survey. We felt it was important to assess the full depth, breadth, onset and severity of adverse reactions in order to give parents and women the data they need to make informed medical decisions. This necessitated a longer than desired survey. We estimate it will take approximately 20-30 minutes to complete the survey.  We hope, given what is at risk, survey respondents will take the time to complete the entire survey.

Is the Survey Anonymous and Secure?

Yes. We do not collect personal identifying information and the survey is hosted with SSL encryption using a verisign certificate Version 3, 128 bit encryption.

How Will the Data be Used?

To inform future research and women’s health decision-making.

Who is Conducting this Research?

Researchers from LucineTM, Hormones MatterTM. For more information on Lucine, click here. For more information about Hormones MatterTM , click here.

What Can I Do To Help?

Our organization is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. Get involved and help us prove that hormones matter and that women’s health data matter. Become an advocate, spread the word about our site, our research and our mission. Join our team. Write for us, partner with us, help us grow. For more information contact us at: info@hormonesmatter.com.

To take the Gardasil Cervarix HPV Vaccine Survey, click here.

To take one of our other Real Women. Real Data.TM surveys, click here.

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Thank you in advance for your help.