Tag: vaccine injury

VigiAccess Numbers in Context

Most people are familiar with VAERS, the Vaccine Adverse Event Reporting System.

They sometimes forget that it is only the Vaccine Adverse Event Reporting System for the United States.

Other countries have their own vaccine safety systems.

VigiAccess Numbers in Context

One of the biggest is VigiBase, the World Health Organization’s  global database for suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre in Sweden.

“Information on suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use.”

Not surprisingly, folks misuse VigiBase numbers, just like they misuse VAERS reports.

JB Handley needs help understanding VigiAccess reports.
JB Handley needs help understanding VigiAccess reports.

To look at the VigiBase reports, you can use VigiAccess.

“VigiAccess has a search interface that allows visitors to retrieve summary statistics on suspected adverse reactions to medicines and vaccines.”

Uppsala Monitoring Centre

While VigiBase “is at the heart of UMC’s signal detection and scientific research,” you aren’t going to learn much from VigiAccess.

“Geographically, only continent-level statistics are shown, due to issues relating to patient confidentiality and data protection in individual countries.”

Uppsala Monitoring Centre

The biggest problem?

You don’t know how many vaccines were given to all of those people.

For example, while it might sound like there have been a lot of adverse drug reaction reports for the DTaP vaccine, with 179,447 reports in VigiAccess, since those are worldwide reports since 1968, it is likely among many billions of doses of vaccines being given.

Most importantly though, as with VAERS, “The reports in VigiBase result from suspicions of a relationship between a drug and a reaction. No causal relation has been confirmed.”

So how do you put the numbers from VigiBase and VigiAccess in context?

If you consider that reports and safety signals from VigiBase, VigiMatch, VigiRank, and other tools used by the Uppsala Monitoring Centre continue to find that vaccines are safe, then to put the DTaP numbers in context, they help us know that vaccines are being well monitored for safety.

And since we know that these diseases haven’t disappeared, any further context, if you need it, would be that since vaccines are safe and necessary, then you should get yourself and your family vaccinated and protected.

More on VigiBase and VigiAccess

 

Personal Stories About Vaccine-Preventable Diseases

Parents these days seem to get bombarded with vaccine injury stories and videos on Facebook.

Is that because vaccines cause so many bad reactions?

Of course not.

It’s because some folks think that everything that happens to their kids is a vaccine injury.

Personal Stories About Vaccine-Preventable Diseases

If you are going to watch those videos and listen to their stories, getting scared in the process, be sure to also listen to the stories of parents who’s kids have suffered through actually getting a vaccine-preventable disease.

While it’s great that these diseases are much less common because most people vaccinate and protect their kids, one side effect of that progress is that we don’t have many reminders of just how terrible these diseases are anymore.Have you ever seen a baby with congenital rubella syndrome?

Or a child with tetanus or diphtheria?

Have you ever even seen photos of these diseases?

Will you read these stories of parents who have lost a child to a vaccine-preventable disease.

“Kimberly Coffey was buried three days before her high school graduation in the prom dress she didn’t get to wear. She didn’t have the opportunity to be vaccinated against Meningitis B.”

Kim’s Meningitis Story

In Kimberly‘s case, the Men B vaccine wasn’t yet available, but in many other cases, parents have shared their stories of unvaccinated children who suffered with a disease that was vaccine preventable at the time.

“From 2010 to 2016, young children continued to be at the greatest risk for influenza-associated pediatric deaths. Children without preexisting medical conditions accounted for half of all deaths. Vaccination coverage was low among influenza-associated pediatric deaths.”

Shang et al. on Influenza-Associated Pediatric Deaths in the United States, 2010–2016

Tragically, there are also many flu stories.

But the flu isn’t the only vaccine-preventable disease that still harms children.

This family didn't have a choice about their son getting sick - he was too young to be vaccinated when he was exposed to an unvaccinated child with measles.
This family didn’t have a choice about their son getting sick – he was too young to be vaccinated when he was exposed to an unvaccinated child with measles

There are other diseases. Other stories.

Read these stories.

Listen to these parents.

Are the stories supposed to scare you into vaccinating your kids?

Of course not. Just like you shouldn’t let the myths and propaganda from the anti-vaccinate movement scare you away from vaccinating and protecting your kids.

Instead of being motivated by fear, you should make your decision because you understand that the many benefits of vaccines are far greater than their small risks.

What to Know About Vaccine-Preventable Disease Stories

Reading stories of vaccine-preventable diseases are a good reminder that these diseases are not so mild as some folks suggest, and they are instead life-threatening diseases that are best avoided by getting fully vaccinated.

More Vaccine-Preventable Disease Stories

“Pro-Safe Vaccine” Doesn’t Mean What You Think It Means

As a pediatrician who has always fully vaccinated and protected his own kids, I didn’t totally understand what it meant when my first parents told me that they were pro-safe vaccine.

If they were interested in safe vaccines, I thought, why not get their kids vaccinated and protected? After all, vaccines are safe! Their baby was due to get several very safe vaccines at her upcoming two-month checkup.

At a screening for Vaxxed, Paul Thomas, MD, joked that kids with autism were brain damaged. And everyone laughed.
At a screening for Vaxxed, Paul Thomas, MD, joked that kids with autism were brain damaged! And everyone laughed.

I eventually got an answer.

“You don’t have to dig far to know that vaccines have caused tremendous harm. Have they had benefits? Absolutely. Which is why I remain somewhat on the neutral side in saying that I am not anti-vaccine,” said Dr. Paul Thomas. “I’m pro-safe vaccines. I’ve progressed along to the point where I now don’t believe there is such a thing.”

Folks who say that they are pro-safe vaccines typically:

And they want new, safer vaccines that can’t possibly cause any kind of side effects.

Of course, these new, safer vaccines must be toxin-free, without any preservatives, stabilizers, and especially, no chemicals of any kind. They should also be free of gluten, antifreeze, thimerosal, vaginal spermicides, and heavy metals. Essentially, they would just be antigens, without other ingredients, because these folks don’t understand how vaccines are really made.

“Pro-Safe Vaccine” Doesn’t Mean What You Think It Means

Are you starting to see the problem with folks who say that they are pro-safe vaccines now?

“I’m not for starting an epidemic of another disease. We just want there to be some type of conversation, once. Sit down with our side, with our doctors and scientists, to take a look at what we’re talking about. We’re not an anti-vaccine movement. We’re pro-safe-vaccine schedule. Until we have that conversation, people are going to think it’s an anti- and pro- side.”

Jenny McCarthy

Who were these doctors and scientists that she had on her side?

“In our community we say, “Yeah.” We firmly believe the cause of the epidemic of autism is due to a vaccine injury and/or other environmental exposures — pesticides also. But what on this earth we all kind of share the most is vaccines.”

Jenny McCarthy

Right. So she is not anti-vaccine, but she thinks that vaccines injure people and have caused and epidemic of autism?

And that’s where her pro-safe vaccine schedule comes in…

And we’re saying: “Delay them. Delay them till age 2. Skip some that you might not need.”

Jenny McCarthy

Like all of the other alternative vaccine schedules out there, Jenny McCarthy’s pro-safe vaccine schedule had no evidence that it was safe or effective.

And that gets to the root of the issue. We don’t know what causes autism, so it must be vaccines.

“To our community, Andrew Wakefield is Nelson Mandela and Jesus Christ rolled up into one.”

J. B. Handley

But what about the folks who have moved beyond listening to Jenny McCarthy and being concerned about autism?

They have the same goals and are still scaring parents with the same old messages that have been used by the anti-vaccine movement for hundreds of years.

And they just don’t believe the overwhelming evidence that vaccines are safe and necessary.

What Does It Mean to Be Pro-Safe Vaccine?

So what does it mean to say that you are pro-safe vaccine?

Essentially, it means that you are anti-vaccine, but don’t want to say that you are anti-vaccine.

More on the Pro-Safe Vaccine Movement

 

Can Parents Still Sue Vaccine Manufacturers?

Have you heard the myth that vaccine manufacturers have no liability and that you can no longer sue them

Of course, it isn’t true.

After all, isn’t there a class action lawsuit against Merck about the mumps vaccine?

Can Parents Still Sue Vaccine Manufacturers?

The Wisconsin Coalition for Informed Vaccination is pushing myths about the liability of vaccine manufacturers.
The Wisconsin Coalition for Informed Vaccination is pushing myths about the liability of vaccine manufacturers.

Vaccines are safe, but they are not without some risks, so what happens if a child does suffer a vaccine injury? Hopefully, even if it is a rare life-threatening condition, they can get treated and improve, avoiding that particular vaccine in the future.

They can also file a petition with the Vaccine Court and if the reaction is determined to be caused by a vaccine, they can be compensated.

So parents don’t usually sue vaccine manufacturers directly – they go through Vaccine Court.

But that isn’t there only option…

Parents can still sue vaccine manufacturers:

  • if the claim is not related to vaccine injury
  • in state court for vaccine injury, as long as the claim is not of design defect, and as long as they have already gone through Vaccine Court

So it certainly isn’t true that “under no circumstance may you sue a vaccine manufacturer.”

What’s the benefit of going through Vaccine Court, “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions?”

For one thing, the majority of compensated claims in Vaccine Court are settled claims, in which “cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury.”

etitioners would not get to use the Althen standard if the National Childhood Vaccine Injury Act and NVICP were rescinded.
Petitioners would not get to use the Althen standard if the National Childhood Vaccine Injury Act and NVICP were rescinded.

It is likely that at least some of those claims wouldn’t win if they weren’t in Vaccine Court, where:

  • causation is presumed (you automatically win) if you are claiming a table injury
  • the rules for evidence are relaxed and expert testimony does not necessarily have to meet the  strict requirements of the Daubert standard
  • petitioners must meet a fairly lenient standard to win, the regular standard of proof for a civil trial (more likely than not), but only have to provide a plausible theory for vaccine injury. Instead of providing scientific evidence or proving causation, they simply have to provide a theory that “is ‘logical’ and legally probable, not medically or scientifically certain.”
  • you don’t have to show that the vaccine was defective to make your case

Another benefit of Vaccine Court? All lawyer fees are paid, whether you win or lose, and lawyers do not get part of the award if you win. In traditional court, lawyers might get up to thirty-three percent of your award.

What to Know About Vaccine Manufacturer Liability and Vaccine Court

Although they must usually go through Vaccine Court first, folks can still sue vaccine manufacturers in some cases.

More on Vaccine Manufacturer Liability and Vaccine Court

Dear Anti-Vaxxers,

As someone who has always understood that vaccines are safe and necessary, who vaccinates his children, I’m asking you to hear me out.

Dear anti-vaxxers. Vaccinate your kids.

I don’t think that you are either stupid, uneducated, crazy, or that questioning vaccine safety is always associated with  believing in conspiracy theories.

I understand and appreciate that you do care about your children, that you care about their health, and that you want what’s best for your family.

I actually do get that. I really do.

But I know that while you believe that you have done years of research and investigation to help you decide that the potential benefits of vaccines don’t outweigh their risks, going out of your way to find information to support your decision and ignoring all of the rest that says you are wrong, isn’t really doing research.

Whether you have never set foot on a college campus, you have a PhD in immunology, or you are a toxicologist, I know that you are still vulnerable to the same cognitive biases, heuristics, and logical fallacies as everyone else, and those can keep you from coming to a truly informed decision.

And I know that you are mostly motivated by fear, anger, and mistaken ideas of vaccine injury, vaccine induced disease, and unexplained illness and sudden deaths.

We all care about our children and families. The difference between us is that you still believe that there are two sides to the vaccination debate.

There isn’t.

Vaccines are safe, necessary, and they work well to protect our kids from life-threatening vaccine-preventable diseases.

No, vaccines are not 100% safe and they don’t work 100% of the time, but neither are they responsible for all of the things you see in vaccine scare stories or all of the so-called vaccine induced diseases we hear about.

“What if doctors never actually learn about vaccines, their ingredients, or adverse events, in medical school? What if the medical textbooks are written with an enormous amount of funding from the pharmaceutical industry? What if the CDC owns patents on vaccines? What if the pharmaceutical industry is corrupt and funds studies which conveniently stop monitoring test subjects before adverse effects begin to manifest? What if vaccines contain toxic substances at levels which can cause chronic illness when children are repeatedly injected with them? What if we are trading temporary illness for the development of autoimmune and neurological disease later in life? What if the threat and danger of these “preventable” diseases has been inflated to push more vaccines? What if these vaccines are not even truly effective as we have been led to believe and we will always need more booster shots to try to make up for that fact? What if there is evidence for all of the above, you just haven’t seen it yet?”

Ashley Everly Cates

Listen.

If you don’t want to vaccinate your kids, then don’t.

But don’t be influenced by folks who say they have done their research and don’t believe in conspiracy theories, but use a book by Neil Z Miller as a reference and push every major anti-vaccine conspiracy theory.

And don’t expect that your vaccine choice will be consequence free, including that your child will be at increased risk to get a vaccine-preventable disease, you will be putting others at risk to get a vaccine-preventable disease if your intentionally unvaccinated child gets sick, and you may be kept out of daycare or school if you live in a state that doesn’t allow non-medical exemptions.

I hope that you will keep an open mind and genuinely take time to look into this for yourself, beyond the myths and claims of anti-vaccine heroes who ignore or are unaware of the massive amount of evidence that contradict their claims.

Please take caution and know that I don’t do this to be popular. I don’t do this to make friends, get likes on my Facebook page, or sell vitamins and supplements in an online store.

Truly. The only reason I speak out is to protect my children and your children from unnecessary harm.

After all, is it really so hard to believe that the great majority of pediatricians, infectious disease specialists, immunologists, toxicologists, and public health experts in the world and throughout history are right about vaccines?

More for Anti-Vaxxers

There Is a New Treatment for an Old Vaccine Induced Disease

Mutation screening of the SCN1A gene can help diagnosis kids and adults with Dravet syndrome.
Mutation screening of the SCN1A gene can help diagnosis kids and adults with Dravet syndrome.

Many children who once developed seizures after getting a pertussis containing vaccine were thought to have a vaccine injury.

In fact, HHE and seizures from DPT were once table injuries.

Since then, many of those children have been found to have Dravet syndrome, which is not a vaccine injury or vaccine induced disease. Dravet syndrome includes children who develop severe, fever-related seizures before their first birthday.

First described by Dr. Charlotte Dravet in 1978, using mutation screening of the SCN1A gene, in 2006, Dr. Samuel Berkovic found that many adults had Dravet syndrome too.

“We present here the cases of 5 children who presented for epilepsy care with presumed parental diagnoses of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome.”

Reyes et al on Alleged cases of vaccine encephalopathy rediagnosed years later as Dravet syndrome

Others soon replicated Berkovic’s work and found other children with the SCN1A mutation that causes Dravet syndrome. These children had hard to control seizures, developmental delays, and autism-like characteristics and included some with an “alleged vaccine encephalopathy.”

That they didn’t have a vaccine injury wasn’t a surprise to many people, as many of the early reports about the DPT vaccine and seizures were wrong. In 1973, Dr. John Wilson took to the media to scare parents because he had “seen too many children in whom there has been a very close association between a severe illness, with fits, unconsciousness, often focal neurological signs, and inoculation.” What followed was a drop in DPT vaccinations in many countries and vaccine lawsuits, even though his study was later found to be seriously flawed, with most having no link to the DPT vaccine.

“Although Dravet syndrome is a rare genetic epilepsy syndrome, 2.5% of reported seizures following vaccinations in the first year of life in our cohort occurred in children with this disorder.”

Verbeek on Prevalence of SCN1A-Related Dravet Syndrome among Children Reported with Seizures following Vaccination: A Population-Based Ten-Year Cohort Study

What’s the association between Dravet syndrome and vaccines?

Since infants with Dravet syndrome have febrile seizures, any fever can trigger those seizures. Of course, vaccines can cause fever. And so infants with Dravet syndrome who get a fever after their vaccines can have seizures. Even without getting vaccines, they will eventually have seizures, so skipping or delaying vaccines isn’t a good idea for these kids.

There Is a New Treatment for an Old Vaccine Induced Disease

Have you ever heard of Dravet syndrome?

Even though Dravet syndrome is now known to be at least twice as common as once thought – at about 1 in 15,000 children, many parents have still never heard of it.

“Multiple prolonged febrile seizures in an otherwise well child, usually starting by 8 months of age, are the early clinical hallmarks of Dravet syndrome. Other typical features of this devastating disorder include refractory and multiple seizure types after 12 months of age, including partial, myoclonic, atonic, and absence seizures, and developmental delays and motor impairment such as ataxia and spasticity.”

Wu et al on the Incidence of Dravet Syndrome in a US Population

If you have been locked into the idea that your child was vaccine injured or vaccine damaged after the DPT vaccine, then you have likely not have heard of Dravet syndrome.

Without a diagnosis, Cossolotto said, she would probably still believe — erroneously — that the DPT shot caused Michaela’s illness. “I understand this is a genetic condition,” she said. “Having an answer does make a difference.”

Medical mystery: Seizures strike baby after routine vaccine

That’s unfortunate, as there is a new treatment for Dravet syndrome that is showing a lot of promise. Although not a cure by any means, use of cannabidiol (CBD) oral solution has been shown to reduce seizures in children with Dravet syndrome.

And no, getting a prescription for cannabidiol oral solution from a neurologist is not the same as buying CBD oil, hemp oil, or CBD hemp oil on the internet. While they are all free of THC, you have no idea of the real concentration of CBD when you buy these substances on the internet. Also, hemp oil doesn’t even contain CBD, so won’t control seizures or do much of anything else.

“Previously, many children with severe epilepsy and intellectual disability did not receive a specific diagnosis; there was only limited ability to take the diagnosis further. With advances in clinical epileptology, genetics, and neuroimaging, specific forms of severe epilepsy that lead to progressive intellectual deterioration can be identified.”

Samuel Berkovic, MD on Cannabinoids for Epilepsy — Real Data, at Last

How would you know if your child has Dravet syndrome? Mutation screening of the SCN1A gene, something that is now routinely done for infants with repeated febrile seizures.

Is mutation screening of the SCN1A gene to test for Dravet syndrome something your MAPS doctor would suggest for your older child?

What to Know About Getting Diagnosed and Treating Dravet Syndrome

Children with Dravet syndrome were once misdiagnosed as having a vaccine encephalopathy and may have some new hope in having resistant seizures treated with cannabidiol oral solution.

More on Getting Diagnosed and Treating Dravet Syndrome

 

Misdiagnosis of Kids with Autism and Vaccine Injury

Awareness of autism has greatly increased in recent years.

Some people are even suggesting that we have gotten to the point where autism is being over-diagnosed.

Remember when folks got upset because Seinfeld said that he might be on the autism spectrum?

Misdiagnosis of Kids with Autism and Vaccine Injury

Although autism might be over-diagnosed in some situations, it is just as likely to be under-diagnosed in others. That’s especially true when you hear about misdiagnosed autistic adults. No, not adults who were misdiagnosed with autism, but adults who are actually autistic, but were misdiagnosed with other conditions, like schizophrenia, anxiety, or personality disorders.

It is also probable that autism is actually sometimes misdiagnosed. That’s right, there are some other conditions that can be confused or misdiagnosed as autism.

“Generation Rescue believes that childhood neurological disorders such as autism, Asperger’s, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning.”

When Generation Rescue, Jenny McCarthy‘s autism organization, was founded, they believed that autism was caused by mercury poisoning. Actually, not just caused by, but that autism actually was a “misdiagnosis for mercury poisoning.”

No one really seems to believe that anymore, but there are some other conditions that can legitimately be misdiagnosed as autism.

Many people see Jenny McCarthy battling doctors to save or recover her son as being anti-autism.
Some people say that Jenny McCarthy’s son might have been misdiagnosed with autism and might actually have LKS instead.

Consider Landau-Kleffner syndrome (LKS), which is also known as Progressive Epileptic Aphasia or Aphasia with Convulsive Disorder. Children with LKS develop normally, but then have:

  • a severe regression in language functioning, with a progressive loss of speech, especially receptive speech or understanding what other people say
  • seizures, including focal motor seizures, focal seizures that become tonic-clonic seizures, atypical absence seizures, and atonic seizures.
  • behavioral problems, including having poor attention, being hyperactive and aggressive, and having anxiety

LKS can be difficult to diagnose because the seizures can be subclinical (only recognized on an EEG) at first, so the child may have already regressed by the time they have obvious seizures. And they might improve as the seizures are treated.

“After 35 years as a speech pathologist, I’ve seen many children with a diagnosis of autism that turned out to be a combination of language delay, sensory issues and apraxia.”

What If the Diagnosis of Autism Is Wrong?

Other conditions can have signs and symptoms that overlap with autism too (although they also sometimes occur with autism), making a misdiagnosis possible, including:

  • anxiety
  • childhood apraxia of speech – children with this motor speech disorder have a hard time talking
  • language delays
  • selective mutism – only affects children in some situations, like at school, but they talk well at home with close family
  • sensory issues
  • 22q11.2 deletion syndrome – a chromosomal disorder that causes many signs and symptoms, including some that resemble autism

But how can a child be misdiagnosed with autism?

“…inexperienced professionals, with narrow, preconceived notions of what ASD is, may place too much weight on symptoms that although associated with ASD, are not necessarily definitive of ASD. In other cases, and as noted above, problems in social relatedness and social interaction observed during the diagnostic process, may be artifacts of the unfamiliarity and artificiality of the setting itself.”

Barry M. Prizant On the Diagnosis and Misdiagnosis of Autism Spectrum Disorder

It shouldn’t be hard to imagine that a child could be misdiagnosed with autism, especially as there are more children with suspected autism, including children getting screened at an earlier age, meaning that there is a big demand for autism evaluations.

“Ideally, the definitive diagnosis of an ASD should be made by a team of child specialists with expertise in ASDs.”

AAP on the Identification and Evaluation of Children With Autism Spectrum Disorders

Unfortunately, that can mean that some of those evaluations are being done by health care providers without any added expertise in formally diagnosing autism, including some pediatricians, neurologists, counselors, and social workers, etc.

While many health care providers can evaluate and diagnose autism, from a child neurologist, developmental pediatrician, and child psychiatrist to a child psychologist, speech-language pathologist, pediatric occupational therapist, and social worker, they should all have expertise in autism spectrum disorders (ASDs).

Getting the Diagnosis Right

Why is it so important to get the diagnosis right?

Most importantly, a correct diagnosis means that a child will get the right treatment as early as possible. Also though, in an age when some parents still try to associate vaccines with autism, a misdiagnosis can be especially problematic, perhaps leading to a vaccine injury story.

Remember back in the 1970s when many parents blamed the DPT vaccine for causing their kids to have seizures and brain damage? We now know that some, if not many, of them had Dravet syndrome, a genetic condition (SCN1A mutation) in which children develop severe, fever-related seizures before their first birthday.

“We present here the cases of 5 children who presented for epilepsy care with presumed parental diagnoses of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome.”

Reyes et al on Alleged cases of vaccine encephalopathy rediagnosed years later as Dravet syndrome

In addition to the seizures, these children have developmental delays and autism-like characteristics. They don’t have a “vaccine encephalopathy.” Just like autistic kids don’t have mercury poisoning or any kind of vaccine damage.

What to Know About the Misdiagnosis of Kids with Autism and Vaccine Injury

To help avoid a misdiagnosis, if possible, a team of child specialists with expertise in evaluating kids with autism spectrum disorders should see your child with suspected autism.

More on Misdiagnosis of Kids with Autism and Vaccine Injury