Tag: coincidence

How Often Do Severe Events Occur After Vaccines?

Most of us understand that vaccine reactions are usually mild. While severe events can occur after vaccines, they are very rare.

“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

Unfortunately, being worried about severe reactions sometimes scares parents away from vaccinating and protecting their kids.

How Often Do Severe Events Occur After Vaccines?

Hopefully, realizing just how rare these severe reactions are will help more parents understand that all of the benefits of vaccines (very big) truly do outweigh the risks (very small).

How often do severe events occur after MMR vaccines?
How often do severe events occur after MMR vaccines?

So how often do these events occur?

Are there any statistics?

Using the MMR vaccine information statement as an example, we see that it lists the following severe events:

  • deafness – which is so rare to be associated with MMR that it is hard to tell whether they are caused by the vaccine
  • long-term seizures, coma, or lowered consciousness – which is so rare to be associated with MMR that it is hard to tell whether they are caused by the vaccine
  • brain damage – which is so rare to be associated with MMR that it is hard to tell whether they are caused by the vaccine
  • severe allergic reaction – which occurs in less than 1 out of a million doses
  • serious injury or death – which is so rare to be associated with MMR that it is hard to tell whether they are caused by the vaccine

Wait.

Why can’t we tell if these problems are caused by the vaccine?

In some cases, the association is based on a few case reports.

“With respect to the recent claims of deaths caused by MMR vaccine, drawing broad cause and effect conclusions between vaccination and deaths based on spontaneous reports to VAERS, some of which might be anecdotal or second hand, is not a scientifically valid practice. In fact, a review of the VAERS data reveals that many of the death reports for MMR vaccine involved children with serious preexisting medical conditions or were likely unrelated to vaccination (e.g., accidents). These complete VAERS reports and any accompanying medical records, autopsy reports and death certificates have been reviewed in depth by FDA and CDC physicians and no concerning patterns have emerged that would suggest a causal relationship with the MMR vaccine and death.”

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

Mostly though, these type of severe events just occur so rarely after getting vaccinated.

“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

At a rate of less than 1 in a million doses, it gets hard to know if something was really caused by the vaccine or if it was just a coincidence, as you don’t have a lot of cases to compare with each other.

Still, it should be reassuring that even if they were caused by the vaccine, these serious events are extremely rare.

Vaccines are safe, with few risks.

More on How Often Severe Events Occur After Vaccines

Side Effects and Adverse Events Following Immunizations

Vaccines are safe, but they do have some side effects, mostly mild, and they rarely cause some serious and severe adverse reactions.

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.

To help keep our vaccines safe, it is important that all “clinically important adverse events that occur after vaccination of adults and children” be reported to VAERS, not just the ones that are known to be side effects.

Wait.

Isn’t an adverse event the same as a side effect?

Adverse Events Following Immunizations

To better understand that, let’s first look at how we define an adverse event following immunization (AEFI):

“An Adverse event following immunization (AEFI) is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.”

Classification of AEFIs

So it should be clear that not all adverse events are actually caused by vaccines.

Many are coincidental events that simply occur after a vaccine is given.

What’s the Difference Between Side Effects and Adverse Events Following Immunizations?

Others are true vaccine reactions though, including fever, pain, fainting, and allergic reactions, etc.

“A side effect is any health problem shown by studies to be caused by a vaccine. Like any medication, vaccines can cause side effects. Usually vaccine side effects are minor (for example, a sore arm where a shot was given or a low-grade fever after a vaccine) and go away on their own within a few days.”

Understanding Side Effects and Adverse Events

These are the reactions that we call side effects or adverse reactions of the vaccine.

Still, just because a sign or symptom can be a side effect of a vaccine doesn’t mean that it always will be.

“A vaccine reaction is an individual’s response to the inherent properties of the vaccine, even when the vaccine has been prepared, handled and administered correctly.”

Vaccine reactions – WHO Vaccine Safety Basics

Here are some other definitions:

  • adverse event – Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related.
  • adverse reaction/side effect – A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
  • unexpected adverse reaction – Not consistent with applicable product information or characteristics of drug.
  • severe adverse event or reaction – are rarely life-threatening and usually do not result in long-term problems
  • serious adverse event or reaction – Any untoward medical occurrence that at any dose is life-threatening, results in death, requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent of significant disability or incapacity

Does understanding those definitions make it easier to see why you should be skeptical when folks try to scare you with VAERS reports and data from package inserts?

“Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.”

Guide to Interpreting VAERS Data

They both can include reports about adverse events, not just side effects. So they both include events that can very well be coincidental, and not caused by a vaccine.

So when doing your research about vaccines, focus on real side effects, or things that are known to be caused by vaccines. You will find that most vaccine side effects are mild and that more serious or severe side effects are very rare.

More on Side Effects and Adverse Events

More About Measles Deaths in the United States

Anti-vaccine folks like to talk about death and measles, as long as they can talk about vaccine deaths, something they seem to think happens commonly.

“Over the past ten years in the U.S., there has been one reported death from the measles, and it is unclear based on the medical history of the patient whether and how measles played a role in their death. During the same time period (based on Vaccine Adverse Event Reporting System (VAERS) reports), there have been 105 reported deaths associated with the MMR or MMRV vaccinations.”

Measles Madness: Dr. Brian Hooker’s Statement to WA Legislators

There are two big problems with this statement, that is so often repeated that it is clearly a PRATT – a point refuted a thousand times.

The reports in VAERS about deaths after MMR are not proof of a cause-and-effect relationship.

“Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.”

Guide to Interpreting VAERS Data

In fact, studies have shown that most of the reports of deaths submitted to VAERS are coincidental and not causally associated with a vaccine.

But what about deaths following a natural measles infection?

There are plenty of those that anti-vaccine folks love to ignore.

Wide-ranging Online Data for Epidemiologic Research = WONDER
Wide-ranging Online Data for Epidemiologic Research = WONDER

Where are they?

There were actually 5 SSPE deaths and 2 measles deaths in 1999, but I started the list from 2000, as that was when the endemic spread of measles was eliminated in the United States.
There were actually 5 SSPE deaths and 2 measles deaths in 1999, but I started the list from 2000, as that was when the endemic spread of measles was eliminated in the United States.

These deaths are all in the CDC Wonder database.

Before the death of the woman in Washington in 2015, the CDC caused a lot of confusion by stating that “the last verifiable death in the United States from acute measles infection occurred in 2003 when there were 2 reported deaths.”

Does that mean that the measles deaths in 2005, 2009, 2010, and 2012 didn’t happen?

Of course not!

The information in the CDC Wonder database comes from death certificates that are sent in from all over the United States to the National Vital Statistics System. The system isn’t like VAERS though, where just anyone can send in a report. Still, they are unverified, which is why the CDC doesn’t mention them all.

Still, if anti-vaccine folks are going to push VAERS reports that we know are likely coincidental, then they shouldn’t ignore these measles deaths.

More About Measles Deaths in the United States

Why Do Some People Think That Vaccines Cause AFM?

So we know that vaccines don’t cause acute flaccid myelitis.

Consider a five-year-old in Maryland who recently came down with symptoms of AFM.

Was he recently vaccinated?

Nope. It had been some time since his four-year-old vaccines. Almost a year. And he had not gotten a flu vaccine yet.

What he did have were worsening symptoms about two weeks after he had seemed to get over a cold, something he has in common with most other kids with AFM.

“To try to pin a tragic yet uncommon neurological condition caused by enteroviruses on vaccines is dangerous and puts more kids at risk.”

Scott Krugman, MD

As with this case, the CDC reports no correlation with vaccines in the cases that they have investigated.

And remember, some of these kids have been unvaccinated!

That makes you wonder why some folks actually think that vaccines are associated with AFM, doesn’t it?

Why Do Some People Think That Vaccines Cause AFM?

That’s right, as you are likely suspecting, the usual suspects are pushing anti-vaccine propaganda and promoting the idea to scare parents away from vaccinating and protecting their kids.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

If any of these kids had recently gotten the oral polio vaccine, then sure, an adverse reaction to the vaccination would be at the top of the list of possible causes. After all, we know that VAPP can occur after OPV, but that vaccine hasn’t been used in the United States since 2000, when we switched to IPV.

Why do these folks think that they have it all figured out?

Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.
Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.

The AFM outbreaks happen at the beginning of the school year, when kids are all getting their shots, right?

Nope. They happen during the summer and early fall, peaking in August. And despite what some folks think, most parents don’t wait until the end of summer, just before school starts, to vaccinate their kids. Plus, most kids don’t even need vaccines before the start of the school year. Kids typically only get vaccines before starting kindergarten and middle school.

But the outbreaks do coincide with the when kids get their flu shots, right?

How many kids get flu shots in June and July?

If it was flu shots, the peak would be in October and November, when most kids get their flu shots and we would continue to see cases through December and January.

Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.
Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.

Of course, there is absolutely no evidence that flu vaccines, or any other vaccines, cause AFM.

What about the journal article that Brandy Vaughan posts as evidence?

“By reviewing vaccine-associated inflammatory diseases of the central nervous system, this study describes the current knowledge on whether the safety signal was coincidental, as in the case of multiple sclerosis with several vaccines, or truly reflected a causal link, as in narcolepsy with cataplexy following pandemic H1N1 influenza virus vaccination.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

Even if you just read the abstract, as many folks do, you get a good idea where they are going with the article. It talks about how the claims of an association between multiple sclerosis and vaccines were proven to be purely coincidental.

Remember, correlation does not imply causation.

With AFM, you don’t even have much correlation to imply causation though!

Most cases occur just before we start giving flu vaccines and they don’t occur every year or in every state.

But doesn’t the article mention myelitis?

“Most of the published associations are based on individual case reports or small series of patients.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

It does mention myelitis, just like it mentions MS – where an association has been shown to be purely coincidental.

Remember, case reports are not good evidence.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

But isn’t acute flaccid myelitis listed as a possible side affect in the package inserts for our vaccines?

Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myeltitis.
Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myelitis.

While it should be clear that AFM isn’t the same as ADEM and TM, it is very important to understand that even when those other conditions are listed in a package insert, it is in the section that is marked “without regard to causality.”

This isn’t evidence that vaccines cause AFM!

But didn’t the BMJ publish a study about Vaccines and the U.S. Mystery of Acute Flaccid Myelitis?

BMJ seems to allow anyone to publish responses to their articles online...
BMJ seems to allow anyone to publish responses to their articles online…

Nope. What they did is let someone publish what is essentially an online letter to the editor. And anti-vaccine folks are spreading it around like it is an actual BMJ study…

Surprised?

You shouldn’t be.

This is how anti-vaccine propaganda works.

Why are vaccine injury lawyers talking about AFM?
Why are vaccine injury lawyers talking about AFM?

It’s no coincidence that anti-vaccine folks are trying so hard to associate the outbreaks of AFM with vaccines. What better way to scare folks and make them think that vaccines are dangerous?

AFM is all that anti-vaccine folks are talking about these days...
AFM is all that anti-vaccine folks are talking about these days…

How are ‘we’ working on a vaccine for AFM if we don’t even know what causes AFM???

But that’s how many anti-vaccine folks think. Everything is a vaccine injury. Everything is a conspiracy.

Don’t believe them. Vaccines are safe and necessary.

More on Anti-Vaccine Propaganda About AFM