News

Does the Gardasil Vaccine Come With Crippling Side Effects?

A prominent anti-vaccine web site has promoted heartbreaking stories of illnesses and deaths which they say are a direct result of the Gardasil vaccine, but the causal links are just speculation.

Published June 8, 2017

 (Image Point Fr / Shutterstock.com)
Image Via Image Point Fr / Shutterstock.com

Thinking about getting vaccinated for human papillomavirus, popularly called HPV? Spend a little time on alternative health web sites, and you’d be hard pressed to consider the risks worth it. There you’d find accounts of young girls complaining of shooting, full-body pain and convulsions —  or even paralysis.

It was symptoms like these, related to autoimmune disorders alleged to have been triggered by HPV vaccination (meant to protect against the strains of HPV most likely to cause cervical cancer), that led the Japanese health ministry to remove the vaccines from their country’s list of officially recommended immunizations in 2013 — just months after it was added. Rates of vaccination rates for HPV, which had been on the rise, dropped from 70 percent to less than one percent in some Japanese cities.

The Japanese health ministry based their decision, in a large part, on the fact that 106 women (out of a pool of 8.9 million vaccine recipients) reported joint and other bodily pain, convulsions, or difficulty walking — all potential symptoms of autoimmune disorders. Anti-vaccine movements around the world have used similar data on debilitating autoimmune disorders post-vaccination to sow fear of vaccines. The million dollar question for the HPV vaccine, then, is whether similar numbers of people would exhibit these disturbing symptoms regardless of whether they were exposed to the vaccine?

What happened in Japan was not exactly a surprise for researchers who study vaccine safety. Because autoimmune disorders are common in women, and begin to manifest around the age that women receive the HPV vaccine, the potential to use autoimmune disorder data to try to discredit the vaccine was high — regardless of whether the vaccine did indeed increase the risk.

With this in mind, in November 2007, researchers with the Center for Vaccinology and Neonatal Immunology at the University of Geneva in Switzerland preemptively investigated how frequently adolescent women in emergency room situations consulted with a specialist about autoimmune diseases. The motivation of their study ("Human Papilloma Virus Immunization in Adolescent and Young Adults: A Cohort Study to Illustrate What Events Might Be Mistaken for Adverse Reactions") was to set up a baseline estimate for the rates of these conditions before the HPV vaccine use became widespread:

We are concerned that the large-scale implementation of HPV vaccines in industrialized countries could reactivate the vaccine-safety debates linking vaccination to autoimmune diseases. This could possibly represent a major issue for the sustainability of HPV immunization programs in industrialized countries, and consequently for their implementation in developing countries where they are most needed. [...]

The prevalence of autoimmune diseases in the young adult female population is not low. [...] Consequently, it will be difficult to monitor globally the impact or to demonstrate the lack of impact — of a large-scale immunization program on the incidence of autoimmune conditions.

The study’s authors argued that complaints of autoimmune disorders tied to Gardasil and Cervarix (which were approved for use by the U.S. Food and Drug Administration in 2006 and 2007 and have since been adopted by many nations) could reignite fears about vaccines generally, and the HPV vaccine in particular.

Disturbing Stories, Enigmatic Diseases

Ten years later, that study has proven prescient: just as the scientists predicted, anti-vaccine web sites have amassed a series of increasingly viral stories that tie autoimmune disorder symptoms to the HPV vaccine. The web site Health Impact News has played a particularly vocal role. Stories from their series on HPV vaccines frequently grace our inbox here at Snopes.

Many of those stories in that series come from the producers of the anti-vaccine documentary Vaxxed and anti-vaccine web sites like SaneVax — and the stories are, indeed, heartbreaking. Many involve symptoms like muscle weakness and paralysis, tingling or painful sensations in limbs, dizziness, racing heartbeats, vertigo, nausea and exhaustion:

Lisa in Washington, USA:

When I originally wrote my Gardasil story as a cautionary tale for others, I thought the worst was over. I had battled for almost six years and was left with only periodic numbness/tingling in my hands to deal with at that point. I believed the worst was over and I could begin to get on with my life. That was in October of 2013.

In 2014, the roller coaster ride began again. My hands became worse; the tingling and numbness traveled to my legs. I would have moments of paralysis forcing me to rely on crutches to get around for a few days each month. My sleep patterns became irregular. I would stay awake for 4 days straight before collapsing from sheer exhaustion and physical weakness. The numbness and tingling I previously had in my hands progressed to tremors that never stopped, even when I was sleeping. Tremors so bad they stopped me from successful photography, hindering my ability to complete my home-based projects or even use everyday tools.

Briar in New Zealand, via her mother:

I’ve just carried Briar out of the bath as her legs keep collapsing, this is the amount of pain she is in after painkillers, that her pain feels like a ‘big knife’ in her legs. Just over a year ago she could do all this: have a bath, play sport, just basically have a life. Then the HPV vaccine happened and she can’t do a thing, this is her life and this is the part nobody sees. I didn’t want to cause her more pain but I wanted to show what her life is now.

Korey in Connecticut, USA, via her mother:

[Korey] never received the 3rd shot since she became dizzy and nauseous within a few days of receiving the 2nd shot.  The 2nd shot had triggered a downward spiral in her physical, mental, and emotional health [...]. The dizziness became full blown vertigo and was constant and accompanied by vicious nausea. [...] Korey’s anxiety seemed to increase, and she no longer could sleep in her own room:  She felt flutters in her heart and also reported a rapid beat.  [...]

During the past few months, we added many new complaints to Korey’s list of things that were not quite right:  Fatigue, joint pain, muscle aches, tremors, tics, headaches, neuropathy [pain without physical stimulus, CK], the feeling as though she would pass out.  She would cry frequently and just be out of sorts….not the same girl she was at the beginning of freshman year.

Broadly speaking, this suite of symptoms fits under the umbrella of dysautonomia — a general term that describes a failure of the autonomic nervous system, which controls most of your body’s involuntary functions. The generally unstated suggestion in these posts is that the vaccine caused an overactive immune system to turn against its own nervous system.

Women in the viral stories about the HPV vaccine have reported being diagnosed with (or have reported symptoms similar to those of) three syndromes associated with dysautonomia: Guillain-Barré syndrome, complex regional pain syndrome (CRPS), and postural orthostatic tachycardia syndrome (POTS).

Some of the most alarming stories shared in Health Impact’s HPV vaccine series include symptoms generally ascribed to Guillain-Barré syndrome. According to the National Institutes of Health, Guillain-Barré causes a person’s immune system to attack parts of its own nervous system, resulting in varying degrees of weakness or tingling in the legs and other limbs which, in severe cases, can ultimately result in paralysis. The condition can interfere with respiratory processes and require artificial ventilation — that means it can be life-threatening, though in most cases people can make a full or nearly full recovery.

Complex regional pain syndrome (CRPS) is another frequent diagnosis on these sites. It was was also the primary concern of Japanese officials who decided to stop recommending the HPV vaccine. Scientists believe this collection of symptoms (pain, swelling, and/or changes in skin color) to be the result of damage to the autonomic immune system, and some argue it would be possible for a vaccine to cause that damage.

Finally, many of the women report a diagnosis of — or symptoms generally associated with —  postural orthostatic tachycardia syndrome (POTS): dizziness when standing, racing heartbeats, anxiety, tremors, and fainting. This poorly understood condition makes it difficult to regulate the return of blood to the heart when a sufferer moves from a reclined to an upright position, but the ways in which it can affect daily life, through fatigue, anxiety, heart tremors, depression and others, are varied and in some cases debilitating.

Unfortunately, POTS is often misdiagnosed as chronic anxiety, panic disorder, or other mental illnesses. In fact, many of the women in the Health Impact News anti-Gardasil report doctors telling them that their symptoms were either imagined or signs of mental illness. The rush to jump to psychiatric solutions for these symptoms (a problem that disproportionately affects women in general) has served to further erode trust in the same medical professionals in charge of assuring the public that these vaccines are safe.

So, What’s The Link?

There are a number of reasons why autoimmune disorders of the nervous system make for powerful anti-vaccine fodder. For one thing, the symptoms are crippling and terrifying. For another, researchers don’t yet have a clear grasp on the cause of these diseases, which makes it easier to use one’s own pet theory to explain them. Finally, the link to vaccines sounds generally plausible even to scientists.

Because a vaccine, by its nature, provokes an immune response, researchers and armchair scientists alike have pointed to immune systems altered by vaccination as a cause for myriad autoimmune diseases. A 2009 review on the potential links between Guillain-Barré and vaccines concluded that the links are plausible but speculative:

By their nature, immunizations are intended to stimulate the human immune system, and that stimulation could, at least theoretically, increase the risk of autoimmune diseases.

There are, however, a number of reasons that make linking the HPV vaccine to these dysautonomia symptoms problematic. First and foremost is the fact that these syndromes are poorly defined, have overlapping symptoms, and unclear causes.

Autoimmune disorders have multiple potential risk factors and triggers, some of them unknown. There is ample evidence that Guillain-Barré, for example, is caused or exacerbated by genetics. Lisa, one of the women quoted above and featured by Health Impact News, later learned she had a gene implicated in the development of Guillain-Barré. Lyme disease is also a risk factor for both POTS and Guillain-Barré, and some of the women described in the Health Impact series report a Lyme disease diagnosis.

Further complicating the issue is the fact that those who receive the Gardasil vaccine tend to be adolescent girls. POTS occurs 5 times more frequently in women and the symptoms generally appear starting at age 12 — around the same time that many women are exposed to the vaccine. Autoimmune diseases, as a broad category, also occur much more frequently in women than in men.

The 2007 paper on autoimmune disorders highlighted and anticipated these issues, though the study itself wasn’t enough to completely solve the problem.  To do that, epidemiologists need large-scale studies that compare the background risk of developing these conditions to the risk of developing them after vaccination.

What Is The Actual Risk?

To be clear, people are diagnosed with autoimmune disorders all the time in situations completely unrelated to vaccination. A few studies have shown a slight increased risk for autoimmune conditions connected to HPV vaccination, on the order of 2 extra cases per 100,000 vaccinations. However, most large-scale studies have found no evidence that these vaccines appreciably raise the risk for any of these conditions.

In terms of Guillain-Barré, one study suggested a higher rate of diagnoses 6 weeks after taking the Gardasil vaccine, but this study’s methods were later called into question. Another study based on over 600,000 doses administered between 2006 and 2009 found no statistically significant increase in risk for Guillain-Barré  or any other autoimmune condition.

In terms of of POTS and CRPS, a study based on data from over 2 million individuals in France found no increased risk of any autoimmune disease with the exception of Guillain-Barré, for which they documented only a slight risk increase of two additional cases per 100,000 vaccinated children. Other studies, the World Health Organization noted in a 2015 statement, have failed to replicate this result. The Centers for Disease Control and Prevention and the European Medicines Agency also reject a link between Gardasil and POTS or CRPS.

Large-scale studies following the Japanese health ministry's decision to stop recommending the HPV vaccine have failed to demonstrate that there is any link between those vaccines and cases of POTS in Japan. Despite this, however, the vaccine is still not part of the official vaccination program in that country.

Ultimately, when dealing with increases in odds as low as 1 or 2 cases out of 100,000, it is hard to parse out any signal from noise, and any risk (if it exists at all) needs to be weighed against the risk of developing cervical cancer from the HPV virus — which is much more likely than developing an autoimmune disorder from the HPV vaccine. Cervical cancer is the most common cancer affecting women in the developing world, and is responsible for almost 260,000 deaths each year. Research consistently shows that HPV vaccination successfully reduces the incidence of cervical cancer-causing HPV infections, saving the lives of many women.

Sources

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Alex Kasprak is an investigative journalist and science writer reporting on scientific misinformation, online fraud, and financial crime.