Category: Vaccine Safety

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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Vaccines and Encephalitis

It is thought that vaccines can, very rarely, cause encephalitis.

“Encephalitis: Irritation and swelling (inflammation) of the brain, most often due to infections.”

IOM Report on Adverse Effects of Vaccines

Encephalitis is actually a table injury in the National Vaccine Injury Compensation Program if it occurs:

  • within 72 hours of getting a pertussis containing vaccines
  • within 5 to 15 days of getting an MMR vaccine

And since it is a table injury, then unless another cause is found, “it is presumed that the vaccine was the cause of the injury.”

Most causes of encephalitis are natural infections, including some that are vaccine-preventable. In fact, about 1 in 1,000 people who get measles can develop measles encephalitis.

So the fact that vaccines can, very rarely, cause encephalitis, shouldn’t lead anyone to think that delaying or skipping a vaccine is a good idea.

Autism and Encephalitis

Of course, it isn’t that simple.

The problem?

The misnamed Immunity Education site tries to scare parents into thinking that crying, even excessively, after a vaccine means a child has encephalitis.
The misnamed Immunity Education site tries to scare parents into thinking that crying, even excessively, after a vaccine means that a child has encephalitis.

Anti-vaccine folks claim that an awful lot of things are encephalitis, from crying excessively after getting a vaccine to autism.

Although the Vaccine Information Statement for the DTaP vaccine (it was more common after the older DTP vaccine) does state that children may uncommonly have “non-stop crying, for 3 hours or more” it is not because they have brain inflammation, and the reaction “although unnerving, is otherwise benign.” It is not even a contraindication to getting another dose of DTaP or a later dose of Tdap.

What causes this non-stop crying? It is thought to be a painful local reaction. Fortunately, it does not happen as often with the newer DTaP vaccines.

And autism is not encephalitis.

“That measles infections can cause neurologic side effects on rare occasions is known, but the complication rate for vaccinations is low. After infectious measles encephalitis, risk of an autistic regression has occurred in 1/1000 to 1/10,000 cases. If the trend toward delaying vaccination continues because parents remain misinformed about the MMR, the number of children with neurologic complications of measles or rubella will increase. ”

Chez et al on Immunizations, Immunology, and Autism

Can encephalitis lead a child to have symptoms of autism?

Sometimes.

In addition to natural measles infections, there have been reports of children developing autism after HSV encephalitis, varicella encephalitis, congenital rubella syndrome, and congenital syphilis.

But the great majority of kids with autism do not first have encephalitis. They do not have ongoing brain inflammation.

Saying that encephalitis can cause autism is not the same thing as saying that autism is encephalitis.

Do Vaccines Cause Encephalitis?

And even though encephalitis has long been a table injury for a few vaccines, the 2012 IOM report, “Adverse Effects of Vaccines: Evidence and Causality,” found inadequate evidence to be able to conclude that encephalitis was caused by vaccines.

“Follow-up investigations in that cohort and others, however, found no evidence of a real increased incidence of encephalitis following DTwP. In addition, the most recent IOM report concludes that the evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid-, tetanus toxoid-, or acellular pertussis-containing vaccine and encephalitis or encephalopathy.”

Vaccinophobia and Vaccine Controversies of the 21st Century

That’s not surprising, because follow-up of children studied in the 1980s, from which the original claims about DTP and encephalitis were made, found no evidence of an increased risk of encephalitis.

What about the MMR vaccine?

Again, the IOM report found inadequate evidence, but the problem has always been that “acute encephalitis post-MMR is so rare that it has been impossible to distinguish from the background encephalitis rate of 1 in one million in immune competent hosts.”

Anti-NMDAR Encephalitis

Doesn’t the discovery of anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis prove that vaccines cause autism?

“Anti-NMDA receptor encephalitis is a disease occurring when antibodies produced by the body’s own immune system attack NMDA receptors in the brain.”

The Anti-NMDA Receptor Encephalitis Foundation

Often associated with tumors, isolated case reports do correlate anti-NMDAR encephalitis with vaccines. There are so few cases of anti-NMDAR encephalitis though, it is hard to know what they mean, as are the reports of autism developing after anti-NMDAR encephalitis.

What to Know About Vaccines and Encephalitis

Vaccines still don’t cause autism and the latest safety studies report that vaccines probably don’t cause encephalitis, although a few are still listed as a table injury.

More About Vaccines and Encephalitis

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IOM Vaccine Reports

The Institute of Medicine (IOM) (now known as the The Health and Medicine Division (HMD) of the National Academies of Sciences, Engineering, and Medicine) is an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public.

“With the start of the new school year, it’s time to ensure that children are up to date on their immunizations, making this report’s findings about the safety of these eight vaccines particularly timely,” said committee chair Ellen Wright Clayton, professor of pediatrics and law, and director, Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, Tenn.  “The findings should be reassuring to parents that few health problems are clearly connected to immunizations, and these effects occur relatively rarely.  And repeated study has made clear that some health problems are not caused by vaccines.”

They occasionally issue reports and safety reviews about vaccines:

Reading these reports will help you to understand why vaccine experts argue that vaccines do not cause autism, SIDS, or multiple sclerosis, etc.

For More Information On IOM Vaccine Reports:

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

NVICP

The National Vaccine Injury Compensation Program (NVICP) was created by the National Childhood Vaccine Injury Act of 1986 following years of often frivolous lawsuits against vaccine manufacturers and health professionals, even though similar lawsuits in the UK against vaccine manufacturers failed to find that the DPT vaccine caused vaccine injuries.

The NVICP was created as “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”

Those who think they have suffered a vaccine injury can file a petition with the U.S. Court of Federal Claims – the Vaccine Court. A court-appointed special master eventually decides if the claim should be compensated or dismissed.

For more information:

 

Vaccine Court

The National Vaccine Injury Compensation Program (VICP) was created as “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”

Those who think they have suffered a vaccine injury can file a petition with the U.S. Court of Federal Claims – the Vaccine Court. A court-appointed special master eventually decides if the claim should be compensated or dismissed.

From 2006 to 2014, National Vaccine Injury Compensation Program claims have included:

  • 2,265 claims that were compensated
  • 1,850 compensated claims that were settled and which “cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury.”
  • only 193 claims that were compensated by court decision and for which “the evidence is legally sufficient to show that the vaccine more likely than not caused (or significantly aggravated) the injury; or the injury is listed on, and meets all of the requirements of, the Vaccine Injury Table, and HHS has not proven that a factor unrelated to the vaccine more likely than not caused or significantly aggravated the injury.”
  • only 223 claims that were compensated by concession and for which “it is more likely than not that the vaccine caused the injury or the evidence supports fulfillment of the criteria of the Vaccine Injury Table.”
  • 1,329 claims that were dismissed
  • $1,513,056,840 that was paid

During this same time, over 2.5 billion doses of vaccines were given!

Since the National Vaccine Injury Compensation Program began, in 1988, almost $3.5 billion dollars have been paid out for 4,899 compensated awards.

Again, “over 80 percent of all compensations awarded by the VICP comes as a result of a negotiated settlement between the parties in which the HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”

Although $3.5 billion sounds like a lot, the most important thing to remember is that the small number of real vaccine injuries are dwarfed by the billions of doses of vaccines given and deaths from vaccine-preventable disease prevented.

For more information:

Contraindications to Vaccination

While not as common as some folks think, there are contraindications to getting vaccines.

That’s where medical exemptions for vaccines are used.

Most of these contraindications are specific to one or a few vaccines, such as having a severe allergic reaction, a known severe immunodeficiency, or being pregnant, etc.

For example, you wouldn’t get a live virus vaccine if you had severe combined immunodeficiency disease (SCID), but you should get all of the other inactivated vaccines.

When thinking that a contraindication should apply to all vaccines, remember that:

“The vaccines are all made differently. They’re all based on different biological principles,” said Dr. Paul Offit, infectious diseases expert at Children’s Hospital of Philadelphia. “I can’t understand how a physician could conclude that a person shouldn’t get any vaccines” for the rest of childhood.

And while some are permanent contraindications (a severe allergic reaction), others are temporary. For example, having a “moderate or severe acute illness with or without fever” is a precaution to getting most vaccines, but you can get vaccinated as soon as you get over the acute illness.

Also keep in mind that many things are falsely seen as contraindications to getting vaccinated, such as being autistic or having a sibling with autism.

For more information: