Tag: adverse events

What Is Standard of Care?

Anti-vaccine folks who are talking about “standard of care” when deciding who gets a medical exemption for vaccines obviously don’t really understand what it means.

Why are these advocating against keeping kids protected against life-threatening vaccine-preventable diseases?
Why are these advocating against keeping kids protected against life-threatening vaccine-preventable diseases?

Maybe that’s why they put standard of care in quotes in the above infographic against SB276, a new vaccine bill in California that will eliminate fake vaccine exemptions.

What Is Standard of Care?

When we talk about standard of care in medicine, it is important to understand that it is a legal term, with a legal definition:

“That which a minimally competent physician in the same field would do under similar circumstances”

Moffett et al on The Standard of Care: Legal History and Definitions: the Bad and Good News

Does this mean that the minimally competent physicians can choose whatever criteria they want to write fake medical exemptions for vaccines?

Of course not!

“Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy.”

NCI Dictionary of Cancer Terms

Just because a few doctors do something a certain way, that doesn’t make it the proper way for it to be done.

These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.
These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.

And that’s why a doctor making up their own rules for what counts as a vaccine medical exemption, especially when it goes against published guidelines and advice, isn’t standard of care.

More on Standard of Care

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

Package Inserts for Vaccines

The package inserts for vaccines are not as useful as many parents believe, especially if they are trying to do research about vaccines.

No, it is not because your pediatrician won’t let you read them, after all, package inserts for each and every vaccine are easy to find.

And it certainly isn’t because package inserts are hiding information that would keep you from getting your kids vaccinated if you were more aware of it.

Again, vaccine package inserts are easy to find.

It is that some of the information in the vaccine package insert is not what you think it is.

Package Inserts for Vaccines

For example, in addition to Data from Clinical Studies, the Adverse Reactions section includes side effects that are voluntarily reported and for which “it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.”

What does that mean?

Just because a side effect is in the package insert, depending on the section, it doesn’t automatically mean that it was caused by the vaccine. That is why autism and SIDS are listed as adverse events for the Tripedia vaccine.

SIDS and autism are listed in Tripedia package insert, but are not causally linked to the vaccine.
SIDS and autism are listed in Tripedia package insert, but are not causally linked to the vaccine.

In fact, many studies have shown that there is no causal relation between vaccines and autism or vaccines and SIDS.

Package inserts are useful, but you should understand why and how they were written and how to read them if you are going to add them to your vaccine research.

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