Tag: adverse events

Have Over 75,000 Adverse Reactions to the HPV Vaccine Been Reported?

Why do some people think that over 75,000 adverse reactions to the HPV vaccine have been reported?

The adverse reactions to the HPV vaccine they are talking about are reports to VAERS and are almost all non-serious, including injection site reactions.
I fixed this anti-vax sign to make it less misleading… The adverse reactions they are talking about are reports to VAERS and are almost all non-serious, including injection site reactions.

Oh, the anti-vax sign folks…

Have Over 75,000 Adverse Reactions to the HPV Vaccine Been Reported?

So is it true?

Actually, it probably is.

After all, the first HPV vaccine was approved in 2006 and over 110,000,000 doses have been distributed to children, teens, and young adults in the United States alone.

And the adverse reactions they are talking about are reports to VAERS, which means that they are not actually known to be causally linked to the vaccine.

“During June 2006–March 2014, the Vaccine Adverse Event Reporting System (VAERS) received a total of 25,176 adverse event reports after HPV vaccination in the United States. Among these, HPV4 was cited in 99% of reports (22,867 and 2,196 reports among females and males, respectively); 92.4% of the HPV4 reports were classified as nonserious. Since October 2009, when HPV4 was licensed for males, the most commonly reported symptoms among males were similar to those among females, including injection site reactions, dizziness, syncope, nausea, and headache. Overall, reporting of adverse events to VAERS is consistent with prelicensure clinical trial data and consistent with the 2009 published summary of the first 2.5 years of postlicensure reporting to VAERS.”

Human Papillomavirus Vaccination Coverage Among Adolescents, 2007–2013, and Postlicensure Vaccine Safety Monitoring, 2006–2014 — United States

Anyway, the overwhelming majority of the HPV vaccine reports to VAERS haven’t been serious.

And those that are classified as serious weren’t to the point of being severe or anything…

“Among the 7.9% of HPV4-related VAERS reports classified as serious, headache, nausea, vomiting, fatigue, dizziness, syncope, and generalized weakness were the most frequently reported symptoms.”

Human Papillomavirus Vaccination Coverage Among Adolescent Girls, 2007–2012, and Postlicensure Vaccine Safety Monitoring, 2006–2013 — United States

Study after study have shown that HPV vaccines are safe, with few risks.

“After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.”

Donahue et al on Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine.

Also remember that HPV vaccines prevent cancer!

The next time you see one of these anti-vax propaganda signs, think about why they are trying to scare parents away from vaccinating and protecting their kids, risking their getting life-threatening vaccine-preventable diseases and cancer.

More on Adverse Reactions to the HPV Vaccine

Bobby Kennedy’s Vaccine Injury Debate

Why do some folks think that vaccine injuries are so common?

Unlike Bobby Kennedy, the CDC explains that severe injuries from vaccines are very rare.
Unlike Bobby Kennedy, the CDC explains that severe injuries from vaccines are very rare.

Oh, the usual suspects…

Bobby Kennedy’s Vaccine Injury Debate

Hopefully everyone sees what Bobby Kennedy is doing here.

He is mixing up a lot of different things, hoping you won’t notice and that you will walk away scared to vaccinate and protect your kids.

First things first.

Does the CDC say that 1 in 1,000,000 may be injured by shots?

Actually, no.

That sounds like the rate for severe vaccine injuries, like anaphylaxis and death.

What Bobby Kennedy is talking about though, that Federal Study, is a report, Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS), that was conducted at Harvard Pilgrim Health Care, Inc.

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

The study identified all possible reactions, including minor reactions, like pain and fever, and wasn’t looking at just vaccine injuries, unless that is what you consider to be a vaccine injury. And since the study was looking at VAERS and possible reactions, they were not even necessarily causally related to the vaccines that the kids were given.

What else does Bobby Kennedy say?

“Slide 3 is a table from HHS’s 2016 Neiss-Cades survey published in JAMA reporting an astonishing 19.5% of children under five who are admitted to emergency rooms for drug reactions are suffering vaccine injuries.”

Bobby Kennedy

What kind of vaccine injuries?

They are vaccination reactions – any adverse effect from a vaccine. They could be fever, hives, or a febrile seizure – we don’t know. Importantly, only a very small percentage of those kids who went to the ER were hospitalized.

Lastly, Bobby Kennedy wonders how a pediatrician might claim to have never seen a vaccine injury.

It’s easy to understand his confusion.

Getting listed in a vaccine insert doesn't automatically make something a vaccine injury.
Getting listed in a vaccine insert doesn’t automatically make something a vaccine injury.

Most people reserve the term vaccine injury for the more severe reactions covered under the Vaccine Injury Table, like anaphylaxis, VAPP, thrombocytopenic purpura, and intussusception.

And they use the term side effects for the more temporary reactions that are thought to be caused by a vaccine.

All of these vaccine adverse events can be reported to VAERS online or using a downloadable form.
All of these vaccine adverse events can be reported to VAERS online or using a downloadable form.

That’s very unlike those folks who consider anything and everything that happens after a child is vaccinated, even if it is many months later, to be a vaccine injury, including things like ADHD, diabetes, and autism, etc.

More on Vaccine Injuries

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