Tag: causation

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

That Time Del Bigtree Admitted He Manipulates Folks and Their Fears of Vaccines

If you work to correct the misinformation about vaccines that is out there, at some point, you wonder if the very vocal anti-vaccine folks who are pushing anti-vaccine talking points really believe any of this stuff.

Del Bigtree admits to misusing VAERS reports.

I mean, do they really believe that vaccines don’t work or that pediatricians get million dollar vaccine bonuses?

That Time Del Bigtree Admitted He Manipulates Folks and Their Fears of Vaccines

It seems that we got an answer this week with a new edition of Fault Lines, The Viral Threat: Measles and Misinformation.

In this interview with John Rushing, Del Bigtree admits that he understands that reports to VAERS do not imply causation.

He knows that when he talks about 400 reported vaccine deaths on his show, it doesn’t really mean that 400 people died from vaccine injuries. He knows that they aren’t confirmed vaccine deaths, even though he never says that on his show.

John Rushing: The numbers the way you’re using them though, it implicitly warns against using them that way.

Del Bigtree: Yeah. Yes.

John Rushing: You’re saying that there are 412 deaths last year.

Del Bigtree: I – no. What I’m saying is there’s 412 reported deaths. I never said there were 412 confirmed deaths reported.

John Rushing: So, so some of those causes of death on VAERS

Del Bigtree: Yeah.

John Rushing: one was a drowning.

Del Bigtree: Sure.

John Rushing: One was from co-sleeping. One was from a pre-existing heart condition. There’s no – because a death is reported in VAERS – there’s no way to show causation to the vaccine.

Del Bigtree: Okay.

John Rushing: But in watching your speech and watching your show – man, you would come away thinking 400 people died from vaccines last year.

Del Bigtree: Okay.

John Rushing: And then I can start to see

Del Bigtree: Okay.

John Rushing: where they get the number. And then I go to the source and the source says “don’t use the number that way.”

The Viral Threat: Measles and Misinformation

Do you believe that there really were 400 vaccine deaths last year?

Now you know why…

More on That Time Del Bigtree Admitted He Manipulates Folks and Their Fears of Vaccines

Mistaking Subsequence for Consequence

Most parents understand that vaccines are safe, with few risks, and necessary, but some are still scared to get their kids vaccinated and protected.

Some even get anxious at the idea of going to their next visit to their pediatrician, because it might mean their baby is going to get shots.

Why?

They have likely heard some of those vaccine injury stories and got to thinking – how could all of those parents be wrong?

Mistaking Subsequence for Consequence

It’s easy to make a hasty judgement about something.

We jump to conclusions and try to link things together when they occur at about the same time as each other.

It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.

That’s because we often mistake subsequence (the state of following something) for consequence (a result of an action).

For example, developing multiple sclerosis (the consequence) six weeks after (subsequent) getting a vaccine, doesn’t mean that the vaccine caused you to develop multiple sclerosis.

Although the source of the quote on subsequence and consequence is Dr. Samuel Johnson, an 18th century writer, it got new life when Justice Jeremy Stuart-Smith used it in a DTP vaccine trial verdict.

“Where given effects, such as serious neurological disease or permanent brain damage, occur with or without pertussis vaccination, it is only possible to assess whether the vaccine is a cause, or more precisely a risk factor, when the background incidence of the disease is taken into account. The question therefore is, does the effect occur more often after pertussis vaccination than could be expected by chance?”

Sir Jeremy Stuart-Smith

What about chance and coincidences?

Instead of thinking that things could simply be the result of chance or a coincidence, we typically want more of an explanation when something happens, and sometimes, we simply want someone or something to blame.

“Establishing or disproving cause and effect, particularly for events of major consequence, proved difficult. Although the original allegations of causation were largely anecdotal and based on the fallacious assumption that subsequences and consequences were synonymous, they raised great concern and stimulated the search for an improved vaccine.”

Vaccines (Seventh Edition)

That leads us to fallacious thinking – post hoc ergo propter hoc (after this, therefore, because of this).

It shouldn’t though.

“Most of you will have heard the maxim “correlation does not imply causation.” Just because two variables have a statistical relationship with each other does not mean that one is responsible for the other. For instance, ice cream sales and forest fires are correlated because both occur more often in the summer heat. But there is no causation; you don’t light a patch of the Montana brush on fire when you buy a pint of Haagan-Dazs.”

Nate Silver

Remember, “correlation does not imply causation.”

Because polio outbreaks often came in summer months, some folks thought the virus must be spread at swimming pools, so they were often closed. It didn't help... Correlation did not equal causation.
Because polio outbreaks often came in summer months, some folks thought the virus must be spread at swimming pools, so they were often closed. It didn’t help… Correlation did not equal causation.

That maxim becomes easier to understand when you see all of the things that correlate together, like ice cream sales and forest fires, but once you think about them, there is no way that one could cause the other.

  • the consumption of high fructose corn syrup and deaths caused by lightning
  • the divorce rate in Maine and the per capita consumption of margarine
  • autism rates and organic food sales
  • autism rates and Jenny McCarthy‘s popularity?!?

Correlation does not imply causation.

“It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.”

Dr Samuel Johnson

Fortunately, it is not as “incident to” (likely to happen to) physicians these days to “mistake subsequence for consequence.”

There are certainly some vaccine friendly pediatricians who pander to the fears of parents and push so-called alternative, non-standard, parent-selected, delayed protection vaccine schedules, who seem to believe in anecdotal evidence above all else, but most doctors understand that vaccines are safe and necessary.

They also know that because correlation can sometimes equal causation, we don’t ignore possible vaccine injuries. And that’s why we have strong vaccine safety systems that can detect and warn us of true vaccine risks.

More on Mistaking Subsequence for Consequence

Bob Sears on Ethan Lindenberger’s Senate Testimony

Not surprisingly, Bob Sears doesn’t seem to like that he was one of the folks who was called out by Ethan Lindenberger during his testimony before Congress.

Remember, Ethan Lindenberger was testifying at the Senate Health, Education, Labor, and Pensions Committee Hearing, Vaccines Save Lives: What Is Driving Preventable Disease Outbreaks?

Bob Sears on Ethan Lindenberger’s Senate Testimony

So what did Ethan Lindenberger have to “say” about Bob Sears?

In his written testimony that was submitted to the Senate Health, Education, Labor, and Pensions Committee, he wrote:

“…the measles outbreak was made out to be a unfounded panic created by big pharmaceutical companies and meant to push legislative agendas. Del Bigtree, a celebrity in the anti-vaccine movement, spoke with “Dr. Bob Sears.” My mom and I sat down, watching this video so she could prove her beliefs were not unfounded. In this video, Dr. Bob Sears claims that in the past 15 years there hasn’t been a single death to the measles. In contrast, 449 people have had fatal reactions to the MMR vaccine.”

Testimony of Ethan Lindenberger Student at Norwalk High school Before the Senate Health, Education, Labor, and Pensions Committee March 5th, 2019

These and many other comments didn’t make it into his oral statements.

Why not?

“Although Ethan did not include this information in his verbal testimony, it was part of his original verbal statements (which were leaked), then edited out – for obvious reasons.”

Bob Sears

The obvious reason is that each witness only had five minutes to speak, not some conspiracy as Dr. Bob seems to be implying!

And his original, written statements weren’t leaked. Like the statements of every other witness, they were posted on the Senate Committee website.

After clearing up all of that, do we still need to discuss how Dr. Bob is trying to justify any of his statements about the MMR vaccine?

Even though you can guess where this is going, let’s go ahead and do it to be complete, especially since Dr. Bob really does seem to want folks to know where “the fact” of the 459 fatal reactions to the MMR vaccine come from.

You likely already know this, but they are simply reports to VAERS. And you likely also know that “inclusion of events in VAERS data does not imply causality.” That little fact is included in a disclaimer when you search the VAERS database, which is why anti-vaccine folks created their own search tool at MedAlerts – the reference Dr. Bob uses.

A report in VAERS – a death following the MMR vaccine that was found to be caused by meningococcal meningitis.

But just because we understand that these reports aren’t proof of causality doesn’t mean that we dismiss them. No one dismisses VAERS reports as unscientific, as Bob Sears claims.

“And if you are the type of doctor, or Legislator, who likes to dismiss VAERS reports as “unscientific,” then please explain why HHS even bothers to collect the data? Spend millions of dollars collecting scientific data, then do nothing with it? Who does that? And what type of scientist ignores data? Is that what Congress had in mind when it created the VAERS system as a Federal Law?”

Bob Sears

For a guy who wrote a book about vaccines, you would think he understood the purpose of VAERS…

“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

VAERS works.

Remember, it was using VAERS data that CDC and FDA vaccine experts quickly discovered that the first RotaShield rotavirus vaccine was associated with an increased risk of intussusception.

“In addition, the American Academy of Pediatrics warned about this in a 1998 publication in Pediatrics that confirmed 48 cases of severe or fatal encephalopathy after Measles Vaccination in the 70s and 80s: 8 children died, and the rest survived but were neurologically devastated.”

Bob Sears

What about the AAP warning about encephalopathy and the measles vaccine?

Dr. Bob is talking about a 1997 paper, Acute Encephalopathy Followed by Permanent Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program, which concluded that “this clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.”

“Nevertheless, with a denominator of 75,000,000 vaccinees throughout 23 years, the incidence of acute encephalopathy caused by measles vaccine in this cohort can reasonably be described as very low.”

Weibel et al on Acute Encephalopathy Followed by Permanent Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program

Bob left that part out, didn’t he?

Considering how many children used to die and develop measles encephalitis each year, this small risk would still seem to greatly outweigh the risk of remaining unvaccinated and at risk to get measles.

Fortunately, even that risk is something we likely don’t have to worry about!

“We did not identify any association between MMR vaccination and encephalitis, aseptic meningitis, or autism.”

Mäkelä et al on Neurologic disorders after measles-mumps-rubella vaccination.

Although encephalopathy or encephalitis is still a table injury, studies have shown it is likely not associated with getting the MMR vaccine.

“For encephalitis and aseptic meningitis, the numbers of events observed within a 3-month risk interval after vaccination were compared with the expected numbers estimated on the basis of occurrence of encephalitis and aseptic meningitis during the subsequent 3-month intervals. “

Mäkelä et al on Neurologic disorders after measles-mumps-rubella vaccination.

And then there is the 2012 IOM report, Adverse Effects of Vaccines: Evidence and Causality, which found inadequate evidence to be able to conclude that encephalitis was caused by vaccines.

“The last child to die from measles infection in the United States was back in 2003. Since then, over 100 fatal VAERS reports have been filed for the MMR vaccine. At what point would mandating this no longer be considered in the interest of the greater good? “

Bob Sears

Bob ignores those reports and ignores the fact that a woman died in 2015.

He also ignores the fact that you don’t even have to go all of the way back to 2003 to find the last child who died of measles.

  • a 17-year-old died of SSPE in 2004
  • a 1-year-old died of measles in 2005
  • an 11-year-old died of SSPE in 2005
  • an 8-year-old and a 12-year-old died of SSPE in 2006
  • a 19-year-old died of SSPE in 2007
  • a 13-year-old died of SSPE in 2008
  • a 17-year-old died of SSPE in 2011
  • an infant died of SSPE in 2012

More importantly though, he ignores that fact that the only reason that there aren’t even more measles deaths these days is because most people are vaccinated and protected! Even Bob used to understand this…

“I also warn them not to share their fears with their neighbors, because if too many people avoid the MMR, we’ll likely see the diseases increase significantly.”

Bob Sears in The Vaccine Book

Unfortunately, people shared their fears with their neighbors… And we are seeing the consequences of what happens when folks scare parents away from vaccinating and protecting their kids.

Vaccines are safe, with few risks, and are obviously necessary.

More on Bob Sears’ Response to Ethan Lindenberger’s Senate Testimony