For example, while it might sound like there have been a lot of adverse drug reaction reports for the DTaP vaccine, with 179,447 reports in VigiAccess, since those are worldwide reports since 1968, it is likely among many billions of doses of vaccines being given.
Most importantly though, as with VAERS, “The reports in VigiBase result from suspicions of a relationship between a drug and a reaction. No causal relation has been confirmed.”
So how do you put the numbers from VigiBase and VigiAccess in context?
If you consider that reports and safety signals from VigiBase, VigiMatch, VigiRank, and other tools used by the Uppsala Monitoring Centre continue to find that vaccines are safe, then to put the DTaP numbers in context, they help us know that vaccines are being well monitored for safety.
And since we know that these diseases haven’t disappeared, any further context, if you need it, would be that since vaccines are safe and necessary, then you should get yourself and your family vaccinated and protected.
“When I undertook the study with the current vaccine strain on my own two triple-negative children and their three playmates, also triple- negatives, I thought: “I am going to do this very carefully now,” and, like Dr. Gear, I set up certain time schedules. I said: “I am going to start to give the vaccine now.” Every time I said “I am going to start to give it” and did not give it, two to three or four days later they came down with either pharyngitis, vomiting and abdominal pain, or a little fever.
I waited for approximately six weeks for those children to stop having some sort of febrile episode. I finally gave up. It so happened that after they got the vaccine they did not have any such episode.”
Albert Sabin on Recent Studies And Field Tests With A Live Attenuated Poliovirus Vaccine
When Albert Sabin was first researching his oral polio vaccine, he understood the problem. How could he really know if any signs or symptoms that occurred after he gave someone his vaccine were really caused by the vaccine, or just a coincidence?
“However, a report later to be given by Dr. Smorodintsev will deal with approximately 7,500 children who had received the vaccine and were carefully followed, as compared with another group, in similar number, who had not, for various types of illnesses which were occurring during the period.”
Albert Sabin on Recent Studies And Field Tests With A Live Attenuated Poliovirus Vaccine
The solution? They studied kids who had not gotten his vaccine.
You can just look at the background rate of a symptom or condition, and compare the periods before and after you start using a vaccine.
For instance, consider this study from Australia about using the HPV vaccine in boys, in which they made some predictions of what would happen after introducing the HPV vaccine.
Assuming an 80% vaccination rate with three doses per person — which equates to about 480 000 boys vaccinated and a total of 1 440 000 doses administered nationally per year in the first 2 years of the program — about 2.4 episodes of Guillain-Barré syndrome would be expected to occur within 6 weeks of vaccination. In addition, about 3.9 seizures and 6.5 acute allergy presentations would be expected to occur within 1 day of vaccination, including 0.3 episodes of anaphylaxis.
Clothier et al. on Human papillomavirus vaccine in boys: background rates of potential adverse events.
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.
When correlation doesn’t equal causation, then it’s probably a coincidence. Or it’s at least caused by some other factor.
And coincidences happen all of the time.
Is It a Vaccine Injury or a Coincidence?
That something could be a coincidence is not typically want parents want to hear though, especially if their child has gotten sick.
What does it mean that something happens coincidentally?
“Most sudden cardiac deaths that remain unexplained after necropsy are probably caused by primary cardiac arrhythmias.”
Sudden death in children and adolescents
Often it just means that it is unexplained. And that it is chance alone that it occurred as the same time as something else.
“In the absence of a specific etiology for ASDs, and a tendency among parents of children with a disability to feel a strong sense of guilt, it is not surprising that parents attempt to form their own explanations for the disorder in order to cope with the diagnosis.”
Mercer et al on Parental perspectives on the causes of an autism spectrum disorder in their children
Again, when folks blame vaccines, it is often because they have nothing else to blame.
“In some fraction of the American population, however, the belief in a link remains. One reason is a coincidence of timing: children are routinely vaccinated just as parents begin to observe signs of autism. Most vaccines are administered during the first years of life, which is also a period of rapid developmental changes. Many developmental conditions, including autism, don’t become apparent until a child misses a milestone or loses an early skill, a change that in some cases can’t help but be coincident with a recent vaccination.”
Emily Willingham on The Autism-Vaccine Myth
Think that it is too big of a coincidence that some infants develop spasms shortly after their four month vaccines?
Dr. William James West first described these types of infantile spasms in the 1840s!
And the “Fifth Day Fits,” seizures that began when a newborn was five days old, was described in the 1970s, well before we began giving newborns the hepatitis B vaccine.
But SIDS was only discovered after we began vaccinating kids, right?
“But, with millions upon millions of doses given each year to infants in the first 6 months of life across industrialized countries and with sudden infant death syndrome being the most common cause of infant death among infants 1 month or older, the coincidence of SIDS following DTP vaccination just by chance will be relatively frequent. When the two events occur, with SIDS following vaccination, well-meaning and intelligent people will blame the vaccine. They seek order out of randomly occurring events.”
Jacobson et al. on A taxonomy of reasoning flaws in the anti-vaccine movement
Of course not.
Cases of SIDS have been described throughout recorded history and have been well studied to prove that they are not associated with vaccines.
“Some events after immunisation are clearly caused by the vaccine (for example, a sore arm at the injection site). However, others may happen by coincidence around the time of vaccination. It can therefore be difficult to separate those which are clearly caused by a vaccine and those that were going to happen anyway… Scientific method is then used to determine if these events are a coincidence or a result of the vaccine.
Vaccine side effects and adverse reactions
It is easy to blame a vaccine when something happens and a child was recently vaccinated. That is especially true now that anti-vaccine folks turn every story of a child’s death or disability into a vaccine injury story.
“Autism was known well before MMR vaccine became available.”
Chen et al. on Vaccine adverse events: causal or coincidental?
Blaming vaccines when it is clear that vaccines aren’t the cause doesn’t help anyone though. It scares other parents away from vaccinating and protecting their kids. And it doesn’t help parents who need support caring for a sick child or help coping with the loss of a child.
What to Know About Vaccine Injuries vs Coincidences
While all possible adverse events after getting a vaccine should be reported to VAERS and your pediatrician, remember that just because something happened after getting vaccinated, it doesn’t mean that it was caused by the vaccine.
Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.
It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.
Did the US Government Lose a Landmark Vaccine Lawsuit?
While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.
The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.
It should be clear that the HHS has done plenty to promote vaccine safety though.
Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.
And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.
Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?
a Task Force on Safer Childhood Vaccines was established and completed a report, “identifying key issues and enhancing collaboration on behalf of vaccine safety” in 1996. Did someone forget to send it to Congress?
the Salk inactivated polio vaccine (IPV) replaced the oral polio vaccine (OPV) in 1996 because of a small risk of vaccine-associated paralytic poliomyelitis (VAPP), beginning with a sequential IPV-OPV vaccine schedule and then going to an all IPV schedule in 2000
the DTaP vaccine, which is supposed to have fewer side effects than DTP is licensed, and replaces DTP for all required doses by 1997, although DTP is never actually shown to have caused seizures or brain damage
RotaShield, the first rotavirus vaccine is licensed in 1998 but is soon withdrawn from the market in 1999 after it is associated with an increased risk of intussusception, a form of bowel obstruction
a new National Vaccine Plan was established in 2010, with the goal to develop new and improved vaccines, enhance the vaccine safety system, support communications to enhance informed vaccine decision-making, ensure a stable supply of, access to, & better use of recommended vaccines in the U.S., and increase global prevention of death & disease through safe & effective vaccination. Was the plan sent to Congress?
They did settle a lawsuit though, a lawsuit which was then dismissed.
So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.
Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.
So why would some people think that vaccines could actually cause meningitis?
Meningitis is listed as a possible adverse event in the package insert of some vaccines, but only in the section that includes spontaneously reported data from post-marketing experience, where it “may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.”
Meningitis is typically caused by a virus, bacteria, parasite, or fungus, etc.
While a live virus vaccine might rarely be able to cause an infection, few of the meningitis vaccines are live virus vaccines. Prevnar, Hib and the meningococcal vaccines are all sub-unit vaccines. Since only a part of bacteria (antigens) is actually present in the vaccine, it is not possible for them to cause an infection.
What about the live virus vaccines, like MMR, chicken pox, and rotavirus?
Since these viral infections rarely cause meningitis, except for mumps, you wouldn’t expect the rare vaccine induced infection to cause meningitis either. A natural measles infection, for example, is more likely to cause encephalitis instead.
“…there is no evidence to link Jeryl Lynn mumps vaccine to aseptic meningitis.”
MMR Package Insert
What about the chicken pox vaccine? There is a case report of a vaccinated child who later developed shingles and meningitis, caused by vaccine strain chicken pox virus. He recovered fully and it is important to note that folks with natural chicken pox are thought to be even more likely to develop shingles, and they too can develop meningitis.
The bottom line is that if someone has meningitis, even if they were recently vaccinated, you shouldn’t be blaming the vaccines.
Like they do with VAERS reports, misusing package inserts is a common method that anti-vaccine folks use to scare parents away from vaccinating and protecting their kids.
What to Know About Meningitis and Vaccine Package Inserts
Although included in some vaccine package inserts, except for rare circumstances with some live virus vaccines, none actually claim that vaccines cause meningitis.
Although it would be great if mistakes never ever happened, the best we can do is to understand that mistakes do sometimes happen and take steps to avoid them.
How can we avoid mistakes and errors about vaccines?
Avoiding Vaccine Errors
It can help to:
understand the 7 Rights of vaccine administration, including that you give the Right vaccine to the Right patient at the Right time by the Right route at the Right injection site and then follow it with the Right documentation
use a screening checklist to help avoid giving vaccines that are contraindicated
double check vaccines that look alike or have names that sound like, such as DTaP and Tdap
double check expiration dates
make sure you aren’t giving live vaccines within 28 days of each other, unless they are given at the same time
make sure you aren’t giving the wrong dosage amount for the patient’s age, as some vaccines have different formulations depending on the age of the patient, including flu shots, hepatitis A, and hepatitis B vaccines
be careful so that you don’t give a combination vaccine, such as Pediarix, Pentacel, Kinrix, Quadracel, or ProQuad, inappropriately
That we are have a 4-day grace period does help avoid the need to revaccinate some kids when vaccines are given a little too early.
“With the exception of rabies vaccine, ACIP allows a grace period of 4 days (i.e., vaccine doses administered up to 4 days before the recommended minimum interval or age can be counted as valid). However, if a dose was administered 5 or more days earlier than the recommended minimum interval between doses, it is not valid and must be repeated. The repeat dose should be spaced after the invalid dose by the recommended minimum interval.”
Ask the Experts About Scheduling Vaccines
In many cases, as long as vaccine doses were administered less than or equal to 4 days before the minimum interval or age, then they can still be counted and are considered valid.
Common Vaccine Errors
It’s easier than you think to prevent vaccine errors.
the rotavirus vaccine series must be completed by 8 months (32 weeks)
ProQuad, the MMR and chicken pox combination vaccine, is not licensed for kids who are older than 12 years, although if a teen or adult did get ProQuad, it could be considered an off-label dose and could still count.
Kinrix and Quadracel, the DTaP and polio combination vaccines are only licensed for the 5th dose of DTaP and 4th dose of polio in children who are 4 to 6 years old, so wouldn’t be appropriate for an 18-month-old, even if he needs both (DTaP and polio) vaccines. Earlier doses can sometimes count as off-label doses though.
the combination vaccines Pediarix and Pentacel are only licensed up through age six years, but don’t necessarily need to be repeated if given to older kids.
children and adolescent’s get a pediatric dose (0.5ml) of the hepatitis A vaccine, while older teens, who are at least 19-years-old, get an adult (1.0ml) dose. Since most kids get vaccinated when they are younger, many pediatricians may not have the adult version of the hepatitis A or even realize that there is a different version.
children and adolescent’s get a pediatric dose (0.5ml) of the hepatitis B vaccine, while older teens, who are at least 20-years-old, get an adult (1.0ml) dose. Since most kids get vaccinated when they are younger, many pediatricians may not have the adult version of the hepatitis B vaccine or even realize that there is a different version.
Most importantly, even when giving vaccines on schedule, be sure to triple check everything. This is especially important if multiple kids in the same room are getting immunizations.
Although none of these vaccine errors are very common (hundreds of millions of doses of vaccines are given in the United States each year), understanding which ones occur the most often can help to make sure that they don’t happen in your office.
She even defends Andrew Wakefield and doesn’t believe that people died of measles once MMR vaccination rates went down after Wakefield’s study was published.
A Crazymother Visits Her Pediatrician to Talk About Vaccines
As someone who is mindful that language can promote stigmas and stereotypes, it is not a term that I chose.
It is the name of a parenting group.
Wait until you hear what this pediatrician has to say when a Crazymother informs her she will no longer be vaccinating!
“Ok, today is just a hepatitis vaccine.”
I have made the decision that I no longer want my kids to be vaccinated.
At all. So, I know that’s not what you want to hear.
“It isn’t. It scares me. It scares me a lot.”
I know. I hear that, but I also have to do what I feel is best.
“Is there a specific concern that you have?”
Oh, there is a lot of things.
“What are they?”
There’s a lot. I’m worried about a lot. I wasn’t planning on having this conversation today. I didn’t know he was getting a shot. I wasn’t prepared. I thought he coming in for a blood test today. There’s a lot of reached out and met a lot of other moms who just have a lot of really sad stories and I just kind of started doing my own research and I just don’t feel like it is best for my kids and … I’m very concerned for his health and him getting vaccinated with all of these problems that he already has isn’t going to benefit him right now so I may change my mind down the road.
That last paragraph says an awful lot about why some parents are choosing to delay or skip their children’s vaccines:
“So my job at every visit is to let you know what you are declining and what we’re trying to protect against. It’s also very important if you decide not to immunize to remember that he’s at risk for a lot of other things so if he gets a fever its going to mean something different to mean than a child who is fully immunized as a fever… so if you call us after hours and he has a fever, make sure you tell us, oh by the way, he isn’t immunized…”
How does it mean something different if a child is intentionally not vaccinated?
While a vaccine-preventable disease should be in the back of your mind for any kid if their symptoms fit the disease, since vaccines aren’t 100% effective, they move higher up your list of possibilities if you know the child is unvaccinated and unprotected.
“I also just want to tell you that there’s a very big difference between anecdotal evidence and population based evidence, so just because someone has a sad story doesn’t mean that what happened to them is truly related to the vaccine.”
Crazymothers – OMG, I can’t even with this… She said that children didn’t get the MMR and many died. That’s not true. If you look at the cases of measles after 1998 when the Lancet study was published the measles cases actually went down. Nobody died. Nobody has died in America for years and years from the measles. It is completely silly.
Measles cases went down?
“Between 2001 and 2013 there was a sharp rise in the number of UK measles cases, and three people died.”
Current measles risks in the UK and Europe
As most folks now, before Wakefield was stripped of his medical license, he practiced in the United Kingdom, and not surprisingly, that’s where we saw a big effect on MMR rates. They went down and measles cases went up.
But even as measles cases and deaths have gone down globally, measles outbreaks and measles deaths have been much worse in the rest of Europe.
Even in the United States, cases have gone way up since we hit a record low of 37 cases in 2004 and there have been deaths, with the last in 2015.
“Again, this was very contentious and you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines.”
It is amazing how many times you hear the phrase “that’s not true” in this video about things that are so easy to confirm as facts.
“Continue to give it some thought because to me vaccines are modern miracles and it scares me to death to have people not getting vaccinated… He’ll probably be okay, but that’s because I’ve vaccinated my kids the other day, so we’re protecting your kid… The more people who stop doing it, forget about it, it’s going to go back to the old days where people are dying all of the time.”
Crazymothers – There’s that herd immunity myth. She says that your kid is going to be okay because I’m doing the right thing. I’m vaccinating my child. And anybody who studies this knows that’s not true! Herd immunity is a myth. Go outside and talk to a 30-year-old, 40-year-old, 50-year-old, who hasn’t been recently vaccinated and you can clearly see, plain as day…
As far as I know, we have indoor plumbing, we have sewage systems, we have clean water, and we have access to whole foods, we have ways to supplement with vitamins and minerals, we have all of these amazing things and that is what actually brings disease rates down.
Proper sanitation, sewage systems, all of the modern things that we take for granted – that is what is actually bringing the disease down, because clearly, in under-developed countries, we still see the diseases rampant, right?
But herd immunity is disease specific, so when we talk about herd immunity for measles, it doesn’t matter if someone has immunity against hepatitis A or Hib. Also, some vaccines, like Hib and Prevnar, have indirect effects, protecting adults even though they aren’t vaccinated, because vaccinated kids are less likely to become infectious.
There is only clearly one modern thing that that anti-vaccine folks take for granted – vaccines.
My uncle got polio around 1950, in Brooklyn, just before the first polio vaccine was developed.
You know what?
They had indoor plumbing, sewage systems, clean water, whole foods, vitamins and minerals, and medicine – he was hospitalized for six months – yet many people still died of polio.
At that time, during the pre-vaccine era, many people also died of measles, tetanus, pertussis, chicken pox, and many other diseases that are now prevented with vaccines.
And unfortunately, many under-developed countries still don’t have proper sanitation, sewage systems, or good nutrition, but do you know what they also don’t have?
We are very close to eradicating polio all over the world. Only two countries, Afghanistan and Pakistan still have cases of wild polio today. And so far this year, there have only been 11 cases. Did every other country in the world suddenly get proper sanitation, sewage systems, and good nutrition? Is that why we are so close to eradicating polio?
Of course not. It’s the polio vaccine.
Vaccines work. Vaccines are safe and necessary. They have few risks and many benefits. You won’t learn any of that from the Crazymothers group and that’s likely why you have made the decision that you no longer want your kids to be vaccinated.
What to Know About Crazymothers Propaganda
Don’t let Crazymothers propaganda scare you away from vaccinating and protecting your kids.
The reason why Kat Von D won’t vaccinate her baby!
Actually, despite the hype, a new video from Del Bigtree, who works with Andrew Wakefield, never does reveal the reason why Kat Von D won’t vaccinate. That shouldn’t be a surprise from a guy who produced a movie about a whistleblower, but left the whisteblower out of the movie.
“We are not against vaccines. Just because we have hesitancies and valid concerns about injecting our baby with specific chemicals and toxins does not mean we are anti anything.”
Kat Von D
We don’t know… Most people assumed it was because she was vegan, but many vegan parents do vaccinate their kids.
“As a soon-to-be-parent [and especially as a first-time-mom] I do feel it my responsibility to have questions, and to listen to my motherly instinct to question things, and do my research.
What we have found is that sometimes it isn’t always so black and white.
While we believe medications, including vaccines, are not all bad – we also can’t dismiss the fact that some may not be good for everyone.
There are plenty of studies that show some vaccinations can work wonders. And there are also studies that show some people [including mothers, and babies] may be more susceptible to vaccine injuries more than others.
It’s unfair for anyone to expect me [or any parent] to take the word of the pharmaceutical companies who have much to gain from and industry worth billions without question – and then have to dismiss any concerns of my own.”