Tag: Vaccine Safety Datalink

Can Vaccines Cause Kawasaki Disease?

Kawasaki disease is rare and there is a good chance that you have never even heard of it, even though the first case was diagnosed in 1961.

Kids with this condition are typically irritable and can develop high fever, swollen glands in their neck, red eyes, red, cracked lips, red, swollen hands and feet, and a rash.

If you have heard of it, there is a good chance it is because anti-vaccine folks are using Kawasaki disease to scare you away from vaccinating and protecting your kids. Lately, talk about Kawasaki disease and the meningococcal B vaccines have been going around.

What Causes Kawasaki Disease?

Kawasaki disease is a type of vasculitis.

Kids who develop Kawasaki disease, who are typically under age 5 years, develop inflammation of their blood vessels, which leads to many of the symptoms and complications we see.

What causes this inflammation?

“Evidence suggests that Kawasaki disease may be linked to a yet-to-be identified infectious agent, such as a virus or bacteria. However, despite intense research, no bacteria, virus, or toxin has been identified as a cause of the disease.”

AAP on Kawasaki disease

We don’t know.

Can Vaccines Cause Kawasaki Disease?

Ask about Kawasaki disease if your child has a fever for five days and other symptoms of Kawasaki disease.
Courtesy of the kdfoundation.org

Because the cause of Kawasaki disease is unknown, that leads some folks to think that it could be vaccines.

Could it?

That vaccine clinical trial data sometimes finds a higher, although not statistically significant risk for Kawasaki disease, gets some of those folks thinking about it even more, except they don’t seem to think about the fact that the risk is never statistically significant.

But aren’t there case reports of kids getting Kawasaki disease after getting a hepatitis A, yellow fever, hepatitis B, or flu vaccine?

Yes, but getting a case report published about one patient who you think got Kawasaki disease soon after getting a vaccine isn’t strong evidence that it wasn’t a coincidence.

“Childhood vaccinations’ studied did not increase the risk of Kawasaki disease; conversely, vaccination was associated with a transient decrease in Kawasaki disease incidence. Verifying and understanding this potential protective effect could yield clues to the underlying etiology of Kawasaki disease.”

Abrams et al. on Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006.

And not surprisingly, several studies have shown that there isn’t any extra risk for Kawasaki disease after routine vaccines.

One even showed that getting vaccinated could be protective! Another benefit of vaccines and another reason you shouldn’t skip or delay your child’s immunizations.

What to Know About Vaccines and Kawasaki Disease

While anti-vaccine folks often list Kawasaki disease among their vaccine-induced diseases, several studies have shown that vaccines are not associated with Kawasaki disease, except to maybe have a protective effective if you are fully vaccinated.

More on Vaccines and Kawasaki Disease

Vaccines and Sudden Unexplained Death in Children

Can a child be fine one day and then die the next?

Tragically, they can.

There is even a name for it – sudden unexplained death in childhood.

Sudden Death in Children

Although 10% of deaths in children over age 12 months are classified as sudden death, most have explanations, such as asthma, epilepsy, or a heart problem (congenital malformations and arrhythmias). Unfortunately, some of these conditions, especially some infections and heart problems, aren’t discovered until after the child dies.

“Most sudden cardiac deaths that remain unexplained after necropsy are probably caused by primary cardiac arrhythmias.”

Sudden death in children and adolescents

About 16% of these sudden deaths don’t have any explanation though.

Surprisingly, these types of sudden, unexplained deaths are the 5th leading cause of death in children between the ages of 1 and 4 years. That adds up to about 400 deaths a year in the United States alone!

Vaccines and Sudden Unexplained Death in Children

Have you guessed the connection with vaccines?

If up to 16% of children who die suddenly don’t have a good explanation for why they died, then that leaves some to blame vaccines, often with a little help with myths and misinformation from anti-vaccine folks.

“…making general assumptions and drawing conclusions about vaccinations causing deaths based on spontaneous reports to VAERS – some of which might be anecdotal or second-hand – or from case reports in the media, is not a scientifically valid practice.”

Miller et al on Deaths following vaccination: What does the evidence show?

That’s despite the fact that both our safety monitoring systems and other studies have shown that vaccines are not associated with sudden unexplained deaths. In fact, deaths after vaccines are very rare.

“As for vaccines causing death, again so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically.”

WHO on Six common misconceptions about immunization

Studies have even shown a protective effect of getting vaccinated against SIDS.

“At the present time there is not enough known about the underlying mechanisms of death in SUDC to allow prediction of which children might die suddenly and unexpectedly. Additionally, there is no way to prevent SUDC since its cause is unknown. Through research, we strive to discover the risk factors and underlying causes of SUDC that will lead to its prevention. In the meantime, optimal pediatric care recommendations, including attending well child visits, maintaining current vaccinations, and obtaining appropriate health care when clinically indicated, should be followed.”

SUDC Foundation on Frequently Asked Questions

And it’s not just SIDS. We also see a “healthy vaccinee effect” in older kids, who have lower mortality rates than the general population, which includes some folks who aren’t vaccinated.

We don’t know what causes sudden unexplained death in children, although with continued research we hopefully soon will, and can then learn to prevent them. Until then, parents should feel confident that it is not caused by the vaccines, which are safe and necessary and work to protect them from many life-threatening vaccine-preventable diseases.

What to Know About Vaccines and Sudden Unexplained Death in Children

Vaccines are not associated with sudden unexplained death in children.

More on Vaccines and Sudden Unexplained Death in Children

Can Vaccines Cause Transverse Myelitis?

Transverse myelitis is not common, so most people probably haven’t heard of it.

“The term myelitis refers to inflammation of the spinal cord; transverse refers to the pattern of changes in sensation—there is often a band-like sensation across the trunk of the body, with sensory changes below.”

Transverse Myelitis Fact Sheet

The symptoms of transverse myelitis depend on where the inflammation occurs and sometimes, on the cause. They can include back pain, weakness or paralysis of the legs and arms, paresthesias (sensory alterations in the neck, arms, or legs), and bowel and bladder dysfunction.

What Causes Transverse Myelitis?

An MRI of a teen with transverse myelitis.
An MRI of a teen with transverse myelitis that resolved after total body irradiation therapy was stopped.

Many things can cause transverse myelitis.

Possible triggers can include:

  • infections – following bacterial, viral, fungal, and parasitic infections
  • immune system disorders
  • inflammatory disorders
  • vascular disorders

Unfortunately, it isn’t usually known what causes someone to develop transverse myelitis.

There are treatments though and many people with transverse myelitis have at least a partial recovery, although it may take months to years.

Transverse myelitis is not thought to be genetic and rates are highest in two age groups – those between 10 and 19 years (when many preteens and teens get vaccinated) and those between 30 and 39 years.

Can Vaccines Cause Transverse Myelitis?

Have you heard that vaccines can cause transverse myelitis?

“Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause transverse myelitis.”

Institute for Vaccine Safety on Do Vaccines Cause Transverse Myelitis?

While there are some case reports that tell of a temporal association between getting a vaccine and later developing transverse myelitis, the evidence does not support any association.

Why do we see these case reports?

Just like SIDS, autism, type 1 diabetes, and many other conditions, transverse myelitis has a background rate of disease or a number of cases that you can expect to occur in a given population. Once you know this background rate, you can then predict how many people will coincidentally develop transverse myelitis within one, seven, forty-two, or more days after they are vaccinated.

With a background rate of about 0.36 per 100,000 people, if one million get a vaccine, you would expect:

  • at least 1 to 2 of them to develop transverse myelitis coincidentally after 1 day
  • at least 1 to 2 of them to develop transverse myelitis coincidentally after 7 days
  • at least 2 to 4 of them to develop transverse myelitis coincidentally after 42 days

If the rate is higher than that, it could indicate a problem.

Let’s do the math.

There are about 1,400 new cases of transverse myelitis in the United States each year.

How many vaccines are given? About 286 million doses – each year. Some of those are given on the same day, but that would still mean that 100s of people should be getting transverse myelitis within 1 to 7 days if vaccines were a cause.

They aren’t.

“Correlation does not imply causation.”

In fact, an Institute of Medicine report, Adverse Effects of Vaccines: Evidence and Causality, dismissed most of the evidence for an associated between vaccines and transverse myelitis as insufficient and lacking.

And further studies found no association:

  • A Vaccine Safety Datalink study, Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis, looked at nearly 64 million vaccine doses of vaccines and also “found no association between TM and prior immunization.”
  • Another study, Maternal safety of trivalent inactivated influenza vaccine in pregnant women, used “a large, geographically diverse, retrospective cohort of pregnant women” and found no cases of transverse myelitis.

Not only do vaccines not cause transverse myelitis, but many vaccine-preventable diseases can. So vaccines can likely protect you from developing transverse myelitis by protecting you from these diseases!

What to Know About Transverse Myelitis

Vaccines do not cause transverse myelitis, although many vaccine-preventable diseases can.

More on Transverse Myelitis

Global Vaccine Side Effect Reporting Systems

Has your child had a bad reaction to a vaccine or what you think is a vaccine injury?

Did you or your pediatrician report it?

Reporting Side Effects to VAERS

The CDC advises that “all significant adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event.”

But VAERS isn’t for everyone.

VAERS is for anyone who gives or receives a licensed vaccine in the United States.

Global Vaccine Side Effect Reporting Systems

What to folks do outside the United States?

In Canada, Adverse Events following Immunization (AEFI) forms are submitted to the Canadian Adverse Events Following Immunization Surveillance System.
In Canada, Adverse Events following Immunization (AEFI) forms are submitted to the Canadian Adverse Events Following Immunization Surveillance System.

Not surprisingly, most countries have a reporting system for possible adverse events to vaccines that is similar to VAERS, including, but not limited to:

You can also report possible side effects directly to vaccine manufacturers.

And like our Vaccine Safety Datalink, in addition to having a passive reporting system, like VAERS, many countries have an active vaccine safety surveillance system to make sure that their vaccines are safe:

  • Australia – AusVaxSafety monitors 156 surveillance sites
  • Canada – IMPACT or Canada’s Immunization Monitoring Program ACTive that actively monitors “12 Canadian centres, which represent about 90% of all tertiary care pediatric beds in Canada” for “adverse events following immunization, vaccine failures and selected infectious diseases that are, or will be, vaccine preventable.”
  • UK – the Clinical Practice Research Datalink (CPRD)

A lot of this work is also done as part of the World Health Organization’s Global Vaccine Safety Initiative (GVSI). In fact, many (about 110) WHO member countries report to the VigiBase system that is actively monitored by the WHO’s Uppsala Monitoring Centre.

What to Know About Global Vaccine Side Effect Reporting Systems

Passive and active vaccine side effect reporting systems in countries around the world help to make sure that our vaccines are safe.

More on Global Vaccine Side Effect Reporting Systems

 

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Vaccine Safety

Although vaccines can have some risks and  mild or even moderate side effects and very rarely cause more severe reactions, vaccines are safe and necessary to keep your kids protected against vaccine-preventable diseases.

Vaccine Safety

Vaccines go through a long process of development and testing to make sure they are safe before they are approved.

“Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.”

The History of Vaccines on Vaccine Development, Testing, and Regulation

But it doesn’t stop then.

We continue to see testing and monitoring for vaccine safety:

  • by monitoring the potency of vaccines after they are manufactured
  • by monitoring the temperatures of the vaccines while they are being shipped and stored
  • continuing to do quality testing, even after the vaccine is released
  • using phase 4 trials and with our post-licensure vaccine safety systems, including VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Project

All of this testing and monitoring has led to some vaccine recalls and the withdrawal of the original rotavirus vaccine because of its association with intussusception.

What to Know About Vaccine Safety

Vaccines are well tested and monitored for safety, both before they are approved and after.

More on Vaccine Safety

Updated October 21, 2017