One of the biggest is VigiBase, the World Health Organization’s global database for suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre in Sweden.
“Information on suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use.”
Not surprisingly, folks misuse VigiBase numbers, just like they misuse VAERS reports.
JB Handley needs help understanding VigiAccess reports.
To look at the VigiBase reports, you can use VigiAccess.
“VigiAccess has a search interface that allows visitors to retrieve summary statistics on suspected adverse reactions to medicines and vaccines.”
Uppsala Monitoring Centre
While VigiBase “is at the heart of UMC’s signal detection and scientific research,” you aren’t going to learn much from VigiAccess.
“Geographically, only continent-level statistics are shown, due to issues relating to patient confidentiality and data protection in individual countries.”
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.
Believe it or not, some folks don’t think that coincidences are real.
Not believing in coincidences is a well known trope of the anti-vaccine movement.
Is it a coincidence that these folks are the ones who are the most likely to believe that vaccines cause a lot of injuries and vaccine induced diseases?
“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.
Wait. Are they saying that the HPV vaccine is going to cause Guillain-Barré syndrome, seizures, allergic reactions, and anaplylaxis?
Of course not. When the study was done, the kids hadn’t gotten any vaccines yet!
That was the background rate of those conditions.
They happened before the vaccine was given, and you can expect them to continue to happen after these kids start getting vaccinated – at that same rate.
What if they start happening more often after kids get vaccinated?
Then it makes it less likely to be a coincidence and more likely that the vaccine is actually causing an increase in the background rate. And vaccine safety studies look for that, which is how we know that vaccines don’t cause SIDS, transverse myelitis, multiple sclerosis, and many other conditions.
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 on The Signal and the Noise
Of course, when we are talking about coincidences, we are also talking about correlation and causation.
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.
Kawasaki disease is rare and there is a good chance that you have never even heard of it, even though the first case was diagnosed in 1961.
Kids with this condition are typically irritable and can develop high fever, swollen glands in their neck, red eyes, red, cracked lips, red, swollen hands and feet, and a rash.
If you have heard of it, there is a good chance it is because anti-vaccine folks are using Kawasaki disease to scare you away from vaccinating and protecting your kids. Lately, talk about Kawasaki disease and the meningococcal B vaccines have been going around.
What Causes Kawasaki Disease?
Kawasaki disease is a type of vasculitis.
Kids who develop Kawasaki disease, who are typically under age 5 years, develop inflammation of their blood vessels, which leads to many of the symptoms and complications we see.
What causes this inflammation?
“Evidence suggests that Kawasaki disease may be linked to a yet-to-be identified infectious agent, such as a virus or bacteria. However, despite intense research, no bacteria, virus, or toxin has been identified as a cause of the disease.”
Because the cause of Kawasaki disease is unknown, that leads some folks to think that it could be vaccines.
Could it?
That vaccine clinical trial data sometimes finds a higher, although not statistically significant risk for Kawasaki disease, gets some of those folks thinking about it even more, except they don’t seem to think about the fact that the risk is never statistically significant.
But aren’t there case reports of kids getting Kawasaki disease after getting a hepatitis A, yellow fever, hepatitis B, or flu vaccine?
Yes, but getting a case report published about one patient who you think got Kawasaki disease soon after getting a vaccine isn’t strong evidence that it wasn’t a coincidence.
“Childhood vaccinations’ studied did not increase the risk of Kawasaki disease; conversely, vaccination was associated with a transient decrease in Kawasaki disease incidence. Verifying and understanding this potential protective effect could yield clues to the underlying etiology of Kawasaki disease.”
Abrams et al. on Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006.
And not surprisingly, several studies have shown that there isn’t any extra risk for Kawasaki disease after routine vaccines.
One even showed that getting vaccinated could be protective! Another benefit of vaccines and another reason you shouldn’t skip or delay your child’s immunizations.
What to Know About Vaccines and Kawasaki Disease
While anti-vaccine folks often list Kawasaki disease among their vaccine-induced diseases, several studies have shown that vaccines are not associated with Kawasaki disease, except to maybe have a protective effective if you are fully vaccinated.
“Vaccine Injury Denialism is rampant across the mainstream media, where child-abusing vaccine pushers like the New York Times, Washington Post and CNN deliberately contribute to the holocaust of vaccine injuries now devastating humanity’s children. Sadly, the same denialism about the alarming growth in medical injuries caused by vaccines is also endemic across universities, science journals and medical schools, where doctors are indoctrinated into a kind of “Flat Earth” denialism of vaccine injury reality.”
Mike Adams on Vaccine Injury Denialism is the denial of fundamental human dignity
Claims of vaccine injury denial come when we are skeptical or don’t believe that anything and everything is a vaccine injury.
Barbara Loe Fisher’s NVIC even claims that Shaken Baby Syndrome can be a vaccine injury.
For example, in some circles, if you point out that vaccines do not cause asthma, ADHD, autism, Celiac disease, diabetes, eczema, food allergies, infertility, multiple sclerosis, POTS, SIDS, or transverse myelitis, etc., then claims of vaccine injury denial begin to fly.
“IMAGINE YOU LIVE IN A COUNTRY in which a minority of people are taken in the middle of the night, and beaten, kicked, poisoned, half-drowned… they are crippled for life, maimed, and they are expected to accept a doctor’s or a judge’s view that “It wasn’t the Gestapo” or “It’s not even an injury”.
Imagine that minority amounted to tens of millions of people.
Now imagine that these victims are lured into traps by their own doctors with promises of medicine that will prevent illness – but in reality the doctors are paid for every patient they manage to convince to show up – and the doctors determine which injuries they caused and which were just “coincidences”.
Now imagine the media is primed to tell the world that no such injuries ever occur. Now your neighbors are denying it, calling you crazy for thinking there is a link…”
James Lyons-Weiler on Should Vaccine Risk/Injury Denial Be Prosecutable Offenses?
But doctors and the media, and your neighbors for that matter, don’t deny that claims of vaccine injury are real because of some grand conspiracy or simply because they want to.
Anti-vaccine folks like to claim that anyone who doesn’t believe that vaccines cause all of their vaccine-induced diseases are part of a conspiracy of vaccine injury denial.
Why do anti-vaccine folks think that there are so many vaccine reactions?
It is mostly because they think that anything bad that happens after someone is vaccinated, even if it is weeks or months later, must have been caused by the vaccine.
“Differentiation between coincidence and causality is of utmost importance in this respect. This is not always easy, especially when an event is rare and background rates are not available.”
Heininger on A risk-benefit analysis of vaccination
Of course, this discounts that fact that most people have a basic risk, often called the background rate, for developing most of these very same conditions, and they can just coincide with getting vaccinated.
Put more simply, the “reaction” would have happened whether or not they had been vaccinated.
“…when a number of well-controlled studies were conducted during the 1980s, the investigators found, nearly unanimously, that the number of SIDS deaths temporally associated with DTP vaccination was within the range expected to occur by chance. In other words, the SIDS deaths would have occurred even if no vaccinations had been given.”
WHO on Six Common Misconceptions About Immunization
That doesn’t mean that everything automatically gets blamed on coincidence though.
Is It a Vaccine Reaction?
Vaccine reactions can be reported to VAERS online or using a downloadable form.
When trying to determine if a child has had a vaccine reaction, experts typically go through a series of questions, looking at the evidence for and against :
How soon after the vaccine was given did the reaction occur? Was it minutes, hours, days, weeks, months, or years later?
Is there any evidence that something else could have caused the reaction?
Is there a known causal relation between the reaction and the vaccine?
Is there evidence that the vaccine does not have a causal association with the reaction?
Do any lab tests support the idea that it was a vaccine reaction?
Why is it important to consider these and other questions?
Because most of us are very good at jumping to conclusions, are quick to place blame, and like to know the reasons for why things happen.
We don’t like to think that things are just caused by coincidence.
Post hoc ergo propter hoc (after this, therefore, because of this).
We are especially good at linking events and often automatically assume that one thing caused another simply because it occurred afterwards.
It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.
Dr Samuel Johnson
But we also know that correlation does not imply causation. And because of the great benefits of vaccines, it is important to find strong evidence for a correlation before we blame vaccines for a reaction.
Too often though, the opposite happens. Despite strong evidence against a correlation, parents and some pediatricians still blame vaccines for many things, from SIDS and encephalitis to autism.
Background Rates vs Vaccine Reactions
Although anti-vaccine folks are always calling for vaccinated vs unvaccinated studies to further prove that vaccines are indeed safe, much of that work is already done by looking at the observed rate of possible reactions and comparing them to the background rate of reactions and conditions.
We often know how many people are expected to develop certain conditions, from seizures and type 1 diabetes mellitus to acute transverse myelitis and juvenile and rheumatoid arthritis.
“On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.”
Black et al on Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines
Intussusception is a good example of this.
This might surprise some folks, but we diagnosed and treated kids with intussusception well before the first rotavirus vaccines were ever introduced. And then, it was only after the risk of intussusception after vaccination exceeded the background rate that experts were able to determine that there was an issue.
“Knowledge of the background incidence rates of possible adverse events is a crucial part of assessing possible vaccine safety concerns. It allows for a rapid observed vs expected analysis and helps to distinguish legitimate safety concerns from events that are temporally associated with but not necessarily caused by vaccination.”
Gadroen et al on Baseline incidence of intussusception in early childhood before rotavirus vaccine introduction, the Netherlands, January 2008 to December 2012
Fortunately, studies have never found an increased risk above the background rate for SIDS, non-febrile seizures, and other things that anti-vaccine folks often blame on vaccines. So when these things happen on the same day or one or two days after getting vaccinated, it almost certainly truly is a coincidence. It would have happened even if your child had not been vaccinated, just like we see these things happen in the days before a child was due to get their vaccines.
For example, using background incidence rates in Danish children, one study found that if you vaccinated a million children with a new flu vaccine, you could expect that naturally, after seven days, you would see:
facial nerve palsy – one case
seizures – 36 cases
multiple sclerosis – one case
type 1 diabetes – three cases
juvenile and rheumatoid arthritis – three cases
After six weeks, those numbers of course go up. In addition to 4 kids developing MS, 20 develop diabetes, 19 develop arthritis, and 218 have seizures, and there would have been at least two deaths of unknown cause.
Would you blame the flu shot for these things?
What flu shot?
This was a “hypothetical vaccine cohort” that used 30 years of data from the Danish healthcare system to figure out background rates of each condition.
“In addition, the expected number of deaths in Japan following an estimated 15 million doses of H1N1 vaccine administered would be >8000 deaths during the 20 days following vaccination, based on the crude mortality rate.”
McCarthy et al on Mortality Rates and Cause-of-Death Patterns in a Vaccinated Population
Looking at background rates is especially helpful when folks report about vaccine deaths.
Using the Japan example that McCarthy studied, if they had looked at background rates, then all of a sudden, the 107 deaths they found after 15 million doses of H1N1 vaccine were given in 2009 would not have been so alarming. Background rates would have predicted a much, much higher number of deaths to naturally occur in that time period simply based on crude mortality rates.
Again, none of this means that possible vaccine reactions are dismissed as being coincidences. They just aren’t immediately assumed to have been caused by vaccines, because vaccines are necessary and a lot of research has already gone into demonstrating that vaccines are safe and vaccines continue to go through routine safety monitoring to make sure they stay safe.
What to Know About Evaluating Vaccine Reactions
Vaccines are safe and many of the things that folks think are vaccine reactions can be explained by looking at the background rates for these conditions and understanding that they would have happened anyway.
