Tag: vaers

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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DTaP Vaccine Reactions – Is This Normal?

Vaccines are very safe.

They are not 100% safe though and they can have some side effects.

Fortunately, most of these side effects are harmless and don’t have any long term risks. And of course, the great benefits of vaccines outweigh those risks.

Common DTaP Vaccine Reactions

Although 75% of kids don’t have any reactions at all, some do have mild reactions.

Among the vaccine reactions or side effects that can occur most commonly include:

Vaccine Information Statements from the CDC highlight the risks of each vaccine.
The DTaP Vaccine Information Statement from the CDC highlight all of the vaccine’s possible risks.
  • fussiness
  • fever
  • redness or swelling at the injection site
  • soreness or tenderness at the injection site
  • tiredness
  • poor appetite
  • vomiting

How commonly do they occur?

They range from 1 in 3 kids for some fussiness all the way down to 1 in 50 kids for vomiting.

And they begin 1 to 3 days after the vaccine was given and last for 1 to 7 days.  Fortunately, fever and fussiness don’t last that long, typically going away after just a day or two.

Treatment is symptomatic, with a cold pack or cool cloth/compress and pain reliever

What About More Extensive Swelling and Redness?

Sometimes the swelling and redness after a DTaP vaccine can be more than you expect though. It might even make you think your child has developed a skin infection.

“Sometimes the 4th or 5th dose of DTaP vaccine is followed by swelling of the entire arm or leg in which the shot was given, lasting 1–7 days (up to about 1 child in 30).”

DTaP Vaccine Vaccine Information Statement

This more extensive local reaction, while scary looking, is not dangerous, and will also go away without long term effects.

It is also not an allergic reaction, so your child can finish the DTaP series if he or she still needs another dose.

Call your pediatrician or seek medical attention if you think your child has developed a skin infection after a vaccination, but keep in mind that bacterial cellulitis after getting a vaccine is an extremely rare, almost unheard of, complication.

Other more moderate and severe DTaP vaccine reactions are uncommon or rare.

“A hypotonic-hyporesponsive episode (HHE) is the sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis that occurs within 48 hours after childhood immunizations.”

DuVernoy et al on Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998

What about hypotonic-hyporesponsive episodes (HHE) and seizures? These were removed as table injuries after DTP back in 1995. It is not that HHE can’t occur after DTP, DTaP, or other vaccines, but rather that HHE doesn’t then cause any permanent neurological damage to the child.

And remember that some so-called vaccine induced diseases are simply made up.

Most of these reactions, as well as the risks of getting natural diphtheria, tetanus, and pertussis infections, are listed in the DTaP VIS.

What to Know About Common DTaP Vaccine Reactions

While most kids don’t have any reactions at all after their DTaP vaccines, those that do typically have mild reactions, including some fever, soreness, or swelling at the injection site.

More About Common DTaP Vaccine Reactions

 

Who to Trust About Vaccines

We hear a lot about fake news these days.

Fake news on Facebook, Twitter, and from our Google search results.

So who do you trust, especially on an important topic like vaccines?

Who to Trust About Vaccines

Hopefully you can trust your pediatrician, but the fact that we now have holistic pediatricians and “vaccine friendly” pediatricians who encourage parents to follow alternative schedules means that even then, you might be listening to the wrong person.

“Pediatricians who routinely recommend limiting the numbers of vaccines administered at a single visit such that vaccines are administered late are providing care that deviates from the standard evidence-based schedule recommended by these bodies.”

Edwards et al Countering Vaccine Hesitancy

What about a study published in a medical journal?

You have to trust that, right?

Not necessarily, considering that predatory, pay-to-publish journals are a thing. Just like they sound, these journals will publish just about anything – as long as your check clears.

And of course, anyone can put up a website or publish an e-book pushing anti-vaccine talking points or simply get in front of a microphone and lie about vaccines in an interview.

So how do you find trusted vaccine information?

Which Vaccine Websites to Trust

You have to learn to be skeptical when looking for information about vaccines.

Jenny McCarthy and Jim Carrey went on a mission to Green Our Vaccines in 2008.
Who are you going to trust about vaccines?

Some general questions experts recommend asking, and which will certainly help when visiting a website about vaccines, include:

  • Who runs the Web site?
  • Who pays for the Web site?
  • What is the Web site’s purpose?
  • What is the original source of the Web site’s information?
  • How does the Web site document the evidence supporting its information?
  • Who reviewed the information before the owner posted it on the Web site?
  • How current is the information on the Web site?
  • How does the Web site owner choose links to other sites?
  • What are they selling?

Fortunately, anti-vaccine websites are fairly easy to spot.

Anti-vaccine websites often filled with conspiracy theories, talk about BigPharma, and about how everyone else is hiding the truth about vaccines.
Anti-vaccine websites often filled with conspiracy theories, talk about BigPharma, and ideas about how everyone else is hiding the truth about vaccines.

They are often filled with vaccine injury stories and articles about how vaccines are filled with poison (they aren’t), don’t really work (they do), and aren’t even needed (they certainly are). And many will try to sell you fake vaccine detox kits and autism cures at the same time they are making you terrified about vaccines.

Tragically, their pseudo-scientific arguments can sometimes be persuasive, especially if you don’t understand that they are mostly the same old arguments that the anti-vaccine movement has been using for over 200 years to scare parents away from vaccinating and protecting their kids.

Which Vaccine Journals to Trust

Why do “fake” medical and science journals exist?

Probably because there is a lot of pressure to get published.

Unfortunately, almost all of them get listed in PubMed, which is why anti-vax folks with a list of studies from PubMed don’t usually get very far when trying to argue against the fact that vaccines work, are safe, and are necessary.

So how do you know if you can trust the conclusions of a medical study or journal article?

It can help if you look for studies about vaccines that:

  • are published in a legitimate journal, like Vaccine or Pediatrics, and some of these high-impact journals
  • are not published in predatory journals
  • you can actually read, as just reading the abstract isn’t enough to know if you can really trust the conclusions that have been made in the article
  • don’t involve simply looking at VAERS data
  • are not written by folks with a conflict of interest that makes the article biased
  • are written by people who have expertise on the topic they are writing about

Most importantly, look for studies that have not been refuted by others already, as it is often hard to fully evaluate studies to see if they have been designed properly or have other major flaws.

Also know that research into the safety and efficacy of vaccines is much more complete than anti-vax “experts” lead (mislead) some vaccine-hesitant parents to believe. And that the great majority of people understand that the great benefits of vaccines far outweigh any small risks.

What to Know About Finding Trusted Vaccine Information

Learn to find trusted vaccine information, so you don’t get fooled by the latest tactics of the anti-vaccine movement.

More on Finding Trusted Vaccine Information

Underreporting of Side Effects to VAERS

Vaccine injuries and side effects should be reported to Vaccine Adverse Event Reporting System (VAERS).

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.”

Are they?

Unfortunately, no.

Vaccine adverse events can be reported to VAERS online or using a downloadable form.
Vaccine adverse events can be reported to VAERS online or using a downloadable form.

 

While both doctors and parents can report these side effects, they don’t always get reported.

Underreporting of Side Effects to VAERS

Still, although reports to VAERS are underreported, they are almost certainly not underreported by as much as some folks believe.

Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS?

That’s not true.

That claim is based on an old study about drug reactions and was not specific to vaccines.

We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. For example, one study found that up to 68% of cases of vaccine-associated poliomyelitis (a table injury) were reported to VAERS, while less than 1% of episodes of rash following the MMR vaccine were reported.

That’s not to say that only severe or serious adverse reactions should be reported.

But since VAERS watches “for unexpected or unusual patterns in adverse event reports,” it still works even if each and every side effect isn’t reported.

VAERS Works

Reports to VAERS are underreported.

VAERS still works well though.

Again, that’s because VAERS doesn’t need each and every adverse event to be reported for the system to work and to help it identify vaccines that might not be safe.

“Despite its limitations, VAERS effectively detected a possible problem soon after introduction of RRV-TV in the United States.”

Lynn R. Zanardi, et al on Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System

We saw that with the RotaShield vaccine. After nearly 20 years of research, the first rotavirus vaccine was approved by the FDA on August 31, 1998. About seven months later, in March 1999, the ACIP published their formal recommendations that all infants get RotaShield on a three dose schedule, when they are two, four, and six months old.

By June 11, 1999, VAERS had received 12 reports of intussusception related to the RotaShield vaccine and by July 13, its use was temporarily suspended, as the CDC continued to investigate.

Once the CDC announced the temporary suspension, even more reports of intussusception after RotaShield were made to VAERS. Those extra reports likely mean that intussusception was being underreported initially, but it still triggered the temporary suspension and extra studies that eventually got the manufacturer to withdraw the vaccine.

“VAERS is used to detect possible safety problems – called “signals” – that may be related to vaccination. If a vaccine safety signal is identified through VAERS, scientists may conduct further studies to find out if the signal represents an actual risk.”

CDC on How VAERS is Used

Early signals in VAERS also helped detect a very small increase in the risk of febrile seizures among toddlers who got the 2010-11 flu vaccine combined with either Prevnar or a DTaP vaccine.

Also keep in mind that VAERS isn’t the only system that helps to monitor vaccine safety. We also have the Vaccine Safety Datalink project, the Clinical Immunization Safety Assessment Network, and the Vaccine Analytic Unit.

What to Know About Underreporting of Side Effects to VAERS

Even though underreporting of side effects to VAERS is an issue, because VAERS works by looking at early signals and trends, it still works well to identify possible safety problems from vaccines.

More About Underreporting of Side Effects to VAERS

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

Vaccine Safety Datalink

Like VAERS and CISA, the Vaccine Safety Datalink (VSD) is a part of our system that helps make sure our vaccines are safe.

The Vaccine Safety Datalink is a network of nine large health care organizations throughout the United States that work with the CDC “to monitor safety of vaccines and conduct studies about rare and serious adverse events following immunization.”

The Vaccine Safety Datalink monitors vaccine safety and “conducts vaccine safety studies based on questions or concerns raised from the medical literature and reports to the Vaccine Adverse Event Reporting System (VAERS).”

Using Rapid Cycle Analysis, the Vaccine Safety Datalink can even do near real time analysis to detect possible adverse events after vaccination. This helped, during routine weekly vaccine safety monitoring, detect a small increase in the risk of febrile seizures when getting the combination chickenpox and MMR vaccines.

For more information:

Using and Misusing VAERS Reports

The Vaccine Adverse Event Reporting System (VAERS) is considered “an early warning system to detect possible safety issues with U.S. vaccines.”

Created as part of the National Childhood Vaccine Injury Act in 1990, anyone can report possible vaccine reactions to VAERS. Just remember that just because something is reported to VAERS and is included in the VAERS database, that doesn’t automatically mean that a vaccine caused the reaction.

Additional information is sometimes requested to further look into these reactions, including medical records. Again, it is important to understand that “It is generally not possible to find out from VAERS data if a vaccine caused the adverse event.”

For example, one study of VAERS reports found that only 3% of the adverse events following immunization “were classified as definitely causally related to vaccine received.”

Despite its limitations, VAERS works well.

It was using VAERS data that CDC and FDA vaccine experts quickly discovered that the older RotaShield rotavirus vaccine was associated with an increased risk of intussusception.

For more information: