Tag: table injury

What Are the Risks of Vaccines?

Vaccines are very safe, but they are not 100% risk free.

They are certainly not as high risk as some anti-vaccine folks will have you believe though.

“Vaccine hesitation is associated with perceived risk. Since vaccine-preventable diseases are rare, an adverse event from a vaccine is perceived by the parent to be of greater risk. Risk perception is critical.”

AAP on Addressing Common Concerns of Vaccine-Hesitant Parents

And when you consider their great benefits, it is easy to see why the great majority of parents get their kids fully vaccinated and protected against all recommended vaccine-preventable diseases.

Risk Perception and Vaccine Hesitancy

Even though the risks and side effects of vaccines are very low, some people think that they are much higher. This is often amplified because of vaccine scare stories and the misinformation found on anti-vaccine websites.

“No intervention is absolutely risk free. Even the journey to a physician’s office with the intention to receive a vaccination carries the risk of getting injured in an accident. With regards to risks of vaccination per se, one has to distinguish between real and perceived or alleged risks.”

Heininger on A risk–benefit analysis of vaccination

Other problems with risk perception include that some people:

  • can be more likely to avoid risks that are associated with an action or having to do something vs. those that involve doing nothing or avoiding an action, even if inaction (skipping or delaying a vaccine) is actually riskier
  • often think about risks based on their own personal experiences (you remember someone’s vaccine injury story), rather than on scientific evidence

These biases in the way we think about risk can actually lead us to make risky choices and they help explain why some people are still so afraid of vaccines. Parents might think the risk of a possible side effect, some of which don’t even exist, is worse than the risk of getting a vaccine-preventable disease, getting someone else sick, or starting an outbreak. Parents also often underestimate the risk of their decision to not vaccinate their child.

“As much previous research claims, this study confirms that individuals characterized by greater trust of healthcare professionals and the possession of more vaccine-related knowledge perceive higher levels of benefits and lower levels of risks from vaccinations.”

Song on Understanding Public Perceptions of Benefits and Risks of Childhood Vaccinations in the United States

So what’s the answer? It is likely for folks to get better educated about vaccines, including getting a good understanding of both their benefits and risks.

What Are the Risks of Vaccines?

Again, vaccines are not 100% safe or risk free.

Most vaccines have some common, mild side effects, which might include (depending on the vaccine):

Vaccine Information Statements from the CDC highlight the risks of each vaccine.
Vaccine Information Statements from the CDC highlight the risks of each vaccine.
  • fever, typically low-grade
  • redness or swelling where the shot was given
  • soreness or tenderness where the shot was given
  • fussiness
  • headache
  • tiredness or poor appetite
  • vomiting
  • mild rash
  • diarrhea
  • swollen glands

How commonly do they occur?

It depends on the vaccine and side effect, but they range from about 1 in 50 to 1 in 3 people. These side effects are typically mild and only last a day or two. And they don’t cause lasting problems.

While not all possible side effects are mild, those that are more moderate or severe are much more uncommon. Febrile seizures, for example, only happen after about 1 out of 3,000 doses of MMR and some other vaccines. And while scary, febrile seizures, crying for 3 hours or more, or having a very swollen arm or leg, some other uncommon vaccine side effects, also don’t cause lasting problems.

Fortunately, the most severe side effects, including severe allergic reactions, are only thought to happen in less than 1 out of a million doses. And although these types of severe reactions can be life threatening, they are often treatable, just like severe allergic reactions to peanuts. For others, like encephalitis, although they are table injuries, it isn’t clear that they are even side effects of vaccines, since they occur so rarely.

All of these side effects can be reported to the Vaccine Adverse Event Reporting System (VAERS), either by your doctor or yourself.

“No medical product or intervention, from aspirin to heart surgery, can ever be guaranteed 100% safe. Even though we will never be able to ensure 100% safety, we know that the risks of vaccine-preventable diseases by far outweigh those of the vaccines administered to prevent them.”

World Health Organization

In addition to side effects, some other risks of getting vaccinated might include that your vaccine didn’t work, after all, although vaccines work very well, they are not 100% effective. You might also, very rarely, be given the wrong vaccine or the right vaccine at the wrong time.

Many other things, including so-called vaccine induced diseases, aren’t actually a risk of vaccines at all. Remember, autism, SIDS, multiple sclerosis, and shaken-baby syndrome, etc., are not a risk of vaccines.

What to Know About the Risks of Vaccines

Any small risks of getting vaccinated, including side effects that are often mild, are not a good reason to think about skipping or delaying a vaccine, especially when you thoughtfully consider all of their great benefits.

More About the Risks of Vaccines

Vaccines and Encephalitis

It is thought that vaccines can, very rarely, cause encephalitis.

“Encephalitis: Irritation and swelling (inflammation) of the brain, most often due to infections.”

IOM Report on Adverse Effects of Vaccines

Encephalitis is actually a table injury in the National Vaccine Injury Compensation Program if it occurs:

  • within 72 hours of getting a pertussis containing vaccines
  • within 5 to 15 days of getting an MMR vaccine

And since it is a table injury, then unless another cause is found, “it is presumed that the vaccine was the cause of the injury.”

Most causes of encephalitis are natural infections, including some that are vaccine-preventable. In fact, about 1 in 1,000 people who get measles can develop measles encephalitis.

So the fact that vaccines can, very rarely, cause encephalitis, shouldn’t lead anyone to think that delaying or skipping a vaccine is a good idea.

Autism and Encephalitis

Of course, it isn’t that simple.

The problem?

The misnamed Immunity Education site tries to scare parents into thinking that crying, even excessively, after a vaccine means a child has encephalitis.
The misnamed Immunity Education site tries to scare parents into thinking that crying, even excessively, after a vaccine means that a child has encephalitis.

Anti-vaccine folks claim that an awful lot of things are encephalitis, from crying excessively after getting a vaccine to autism.

Although the Vaccine Information Statement for the DTaP vaccine (it was more common after the older DTP vaccine) does state that children may uncommonly have “non-stop crying, for 3 hours or more” it is not because they have brain inflammation, and the reaction “although unnerving, is otherwise benign.” It is not even a contraindication to getting another dose of DTaP or a later dose of Tdap.

What causes this non-stop crying? It is thought to be a painful local reaction. Fortunately, it does not happen as often with the newer DTaP vaccines.

And autism is not encephalitis.

“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

Can encephalitis lead a child to have symptoms of autism?

Sometimes.

In addition to natural measles infections, there have been reports of children developing autism after HSV encephalitis, varicella encephalitis, congenital rubella syndrome, and congenital syphilis.

But the great majority of kids with autism do not first have encephalitis. They do not have ongoing brain inflammation.

Saying that encephalitis can cause autism is not the same thing as saying that autism is encephalitis.

Do Vaccines Cause Encephalitis?

And even though encephalitis has long been a table injury for a few vaccines, the 2012 IOM report, “Adverse Effects of Vaccines: Evidence and Causality,” found inadequate evidence to be able to conclude that encephalitis was caused by vaccines.

“Follow-up investigations in that cohort and others, however, found no evidence of a real increased incidence of encephalitis following DTwP. In addition, the most recent IOM report concludes that the evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid-, tetanus toxoid-, or acellular pertussis-containing vaccine and encephalitis or encephalopathy.”

Vaccinophobia and Vaccine Controversies of the 21st Century

That’s not surprising, because follow-up of children studied in the 1980s, from which the original claims about DTP and encephalitis were made, found no evidence of an increased risk of encephalitis.

What about the MMR vaccine?

Again, the IOM report found inadequate evidence, but the problem has always been that “acute encephalitis post-MMR is so rare that it has been impossible to distinguish from the background encephalitis rate of 1 in one million in immune competent hosts.”

Anti-NMDAR Encephalitis

Doesn’t the discovery of anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis prove that vaccines cause autism?

“Anti-NMDA receptor encephalitis is a disease occurring when antibodies produced by the body’s own immune system attack NMDA receptors in the brain.”

The Anti-NMDA Receptor Encephalitis Foundation

Often associated with tumors, isolated case reports do correlate anti-NMDAR encephalitis with vaccines. There are so few cases of anti-NMDAR encephalitis though, it is hard to know what they mean, as are the reports of autism developing after anti-NMDAR encephalitis.

What to Know About Vaccines and Encephalitis

Vaccines still don’t cause autism and the latest safety studies report that vaccines probably don’t cause encephalitis, although a few are still listed as a table injury.

More About Vaccines and Encephalitis

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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

Who is Julie Gerberding?

Dr, Julie Gerberding was the director of the Centers for Disease Control and Prevention from 2002 to 2009, when she was replaced by Tom Frieden.

Julie Gerberding, MD, MPH

A medical doctor with a Masters in Public Health, who had done a fellowship in clinical pharmacology and infectious diseases, she was well trained for the notable issues she faced during her tenure include anthrax bioterrorism, avian flu, SARS, natural disasters, and concerns about autism and vaccines.

Gerberding's CDC did a lot of work to get autistic kids diagnosed early including the 'Learn the Signs, Act Early' campaign.
Gerberding’s CDC did a lot of work to get autistic kids diagnosed early, including starting the ‘Learn the Signs, Act Early’ campaign.

One thing in particular that anti-vaccine folks continue to bring up is the mistaken idea that Dr. Gerberding actually said that vaccines cause autism on CNN following the Hannah Polling case.

GUPTA: And one of those 4,900 cases was the case of nine-year-old Hannah Polling, which has been making a lot of news lately. Luckily, we have the director of the Centers for Disease Control and Prevention, Dr. Julie Gerberding here.

We’re talking a lot about autism, as you know. I should remind people that the — my understanding is the federal government conceded that vaccines caused her autism like symptoms. First of all, is there a difference? I mean, does she have autism or autism like symptoms? What’s the difference?

JULIE GERBERDING, DR., CDC DIRECTOR: Well, you know, I don’t have all the facts because I still haven’t been able to review the case files myself. But my understanding is that the child has a — what we think is a rare mitochondrial disorder. And children that have this disease, anything that stresses them creates a situation where their cells just can’t make enough energy to keep their brains functioning normally. Now, we all know that vaccines can occasionally cause fevers in kids. So if a child was immunized, got a fever, had other complications from the vaccines. And if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.

GUPTA: Yes, I have a two-and-a-half-year-old and a one-year-old as you know. And you know, you know, you think about this all the time. Are we ready to say right now as things stand that childhood vaccines do not cause autism?

GERBERDING: What we can say absolutely for sure is that we don’t really understand the causes of autism. We’ve got a long way to go before we get to the bottom of this. But there have been at least 15 very good scientific studies on the Institute of Medicine who have searched this out. And they have concluded that there really is no association between vaccines and autism.

As many people are aware, Hannah Polling was awarded compensated for a table injury in Vaccine Court. She was not awarded compensated because vaccines caused her to be autistic.

And Dr. Gerberding certainly did not admit or say that vaccines cause autism. You can read that into her statements during the CNN interview if you like, but that isn’t what she said.

She also did not resign “in shame from her post under the Obama regime as director of the CDC in 2009 to return to Merck’s vaccine division.”

As often happens when a new president is elected, President Obama simply brought in a new team to the CDC and many other agencies after he was inaugurated on January 2009.

Dr. Gerberding was appointed by President George Bush.

And while she did become the president of Merck’s vaccine division, it wasn’t a return. She had been at the CDC since 1998 and before that, she directed the Prevention Epicenter at the University of California at San Francisco (UCSF).

Dr. Gerberding is currently the Executive Vice President and Chief Patient Officer, Strategic Communications, Global Public Policy, and Population Health at Merck, where she also has responsibility for the Merck for Mothers program and the Merck Foundation.

What To Know About Julie Gerberding

The first woman to lead the CDC, Dr. Julie Gerberding is an infectious disease expert with a Masters in Public Health who is now the the Executive Vice President at Merck. She never said that vaccines could trigger autism while on CNN or anywhere else.

More Information About Julie Gerberding