Myths About Warnings and Adverse Reactions in the MMR Package Inserts
Is that really in the MMR package insert?
Let’s see, 42 paragraphs of warning and adverse reactions???
The Warning Section, which lists all adverse reactions and safety hazards that may occur after getting a vaccine and what you should do if they occur, actually only contains five paragraphs!
There are 23 more paragraphs in the Adverse Reactions section, but as most folks understand, this section includes clinical trials experience, postmarketing experience, and voluntary reports, so it is not always possible to establish a causal relationship to vaccination for the adverse effects listed here.
What does the MMR package insert say about seizures, encephalitis, hearing loss, and death?
“Measles is also known as rubeola. It is a serious illness. Measles virus can be passed to others if you have it. Measles can give you a high fever, cough, and a rash. The illness can last for 1 to 2 weeks. In rare cases, it can also cause an infection of the brain. This could lead to seizures, hearing loss, mental retardation, and even death.
Mumps can also be passed to others. This virus can cause fever and headache. It also makes the glands under your jaw swell and be painful. The illness often lasts for several days. Sometimes, mumps can make the testicles swell and be painful. In some cases, it can cause meningitis, which is a mild swelling of the coverings of the brain and spinal cord.
Rubella is also known as German measles. It is often a mild illness. Rubella virus can cause a mild fever swollen glands in the neck, pain and swelling in the joints, and a rash that lasts for a short time. It can be very dangerous if a pregnant woman catches it. Women who catch German measles when they are pregnant can have babies who are stillborn. Also, the babies may be blind or deaf, or have heart disease or mental retardation.”
So the package insert is telling folks to get vaccinated and protected to avoid seizures, encephalitis, and death. Why don’t anti-vaccine folks ever mention that part of the package insert?
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.
Everyone knows that the DPT vaccine caused a lot of vaccine injuries, right?
“I got interested in the topic of vaccines way back in medical school. A friend of mine convinced me to read a book about vaccines, and it ended up being a very anti-vaccine book. It was all about an old vaccine called the DTP vaccine that we don’t use anymore. But the book talked a lot about the risks and the dangers of that vaccine. The author of that book was calling for that vaccine to no longer be used.
A number of years later, it turns out that they did discover that vaccine was causing a lot of very severe, life-threatening, even fatal side effects, so they did end up taking that vaccine off the market.
So it kind of opened my eyes to the fact that there are some very severe, fortunately very rare, side effects to vaccines, and I wanted to learn more about this issue. I started reading a lot more books.”
Bob Sears, MD on The Vaccine War
After all, it was after reports of those vaccine injuries, including seizures and encephalitis, that led to:
Barbara Loe Fisher, believing that her child was damaged by the DPT vaccine, forming the Dissatisfied Parents Together organization (she later changed the name to the National Vaccine Information Center), and writing the book DPT: A Shot in the Dark (this is the anti-vaccine book that Bob Sears is talking about above)
the National Vaccine Injury Compensation Act passing in 1986, creating the National Vaccine Injury Compensation Program and the Vaccine Court
the DTaP vaccine replacing the DTP vaccine
But were those reports true?
And did they ever really discover that the DPT “vaccine was causing a lot of very severe, life-threatening, even fatal side effects,” which led to them “taking that vaccine off the market” as Dr. Bob said?
“During the period of transition from use of whole-cell DTP to DTaP, whole-cell DTP is an acceptable alternative to DTaP for any of the five doses. For the first four doses, whole-cell DTP combined with Hib vaccine (DTP-Hib vaccine) is an acceptable alternative to DTaP and Hib vaccine administered at separate sites.”
ACIP on Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children Recommendations of the Advisory Committee on Immunization Practices
No, it was replaced by a newer vaccine – DTaP.
And actually, it is still used in some parts of the world.
The whole-cell DTP vaccine did cause more side effects than the newer DTaP vaccine, but we are talking about relatively mild side effects, like local reactions, pain, and fever. And while that it is good, it comes at a cost, a less effective vaccine.
What about epilepsy and encephalitis?
One clue that the DTP vaccine didn’t cause many of the problems that were blamed on it, is that the same vaccine lawsuits that were succeeding in driving vaccine manufacturers out of business in the United States, were failing in the UK.
“Where given effects, such as serious neurological disease or permanent brain damage, occur with or without pertussis vaccination, it is only possible to assess whether the vaccine is a cause, or more precisely a risk factor, when the background incidence of the disease is taken into account. The question therefore is, does the effect occur more often after pertussis vaccination than could be expected by chance?”
Justice Jeremy Stuart-Smith
There is also the fact that many children who were originally thought to have been vaccine injured after their DPT vaccine are now known to have Dravet syndrome.
Without a diagnosis, Cossolotto said, she would probably still believe — erroneously — that the DPT shot caused Michaela’s illness. “I understand this is a genetic condition,” she said. “Having an answer does make a difference.”
Medical mystery: Seizures strike baby after routine vaccine
And then there are the reports and studies that found:
no association with brain injury, epilepsy, SIDS, or infantile spasms
no increased risk for serious neurological illness in the week after getting vaccinated with DPT
no increased risk for encephalopathy in the 90 days after receiving DTP and MMR vaccines
no difference in severe reactions after DPT vs DTaP, including encephalopathy, seizures, and allergic reactions
So no, the DPT vaccine was never really as dangerous as folks said or thought it was, despite what you might read or hear in anti-vaccine books or news reports.
What to Know About the Safety of the DPT Vaccine
Misconceptions about the risks and safety of the DPT vaccine created the modern anti-vaccine movement and unfortunately, continues to influence many people.
Hannah Poling is autistic and her family was compensated by the Vaccine Court. But she wasn’t compensated for autism.
“Because she had an existing encephalopathy (presumably on the basis of a mitochondrial enzyme defect) and because worsening of an existing encephalopathy following measles-containing vaccine is a compensible injury, Hannah Poling was compensated.”
Why was Hannah Poling compensated?
Hannah Poling was compensated because she had a table injury.
Has the Vaccine Court Compensated over 70 Families for Autism?
Those were the test cases that represented three different theories of how vaccines could possibly be associated with autism. None of them were upheld by the Vaccine Court and none of the families were compensated.
“The devil is in the details. You can call autism many different things and it looks very much differently to different folks. But at the end of the day, the Vaccine Court has awarded over 70 families that their children now have autism and these children developed encephalitis, which is brain inflammation, that turned into autism. 70 families. And your viewers can google Hannah Poling and Baxter Bailey. Those are two of the most popular cases. And the U.S. government said to them, your child received autism because of this. I mean, they were awarded. So, it’s in the books.”
Liza Longoria Greve on KOCO News 5
So how could anyone be saying that over 70 families of autistic children have been compensated by the Vaccine Court?
I guess folks can say whatever they want, especially when the media doesn’t understand the idea of false balance and gives them a platform, after all, that’s how you explain much of propaganda of the anti-vaccine movement.
Again, folks can say whatever they want, but this is actually a little different from what they usually claim, that autism is encephalitis.
Of course, it isn’t.
70 Families? Google It
So what happens if you ‘google it‘ and actually research Liza Longoria Greve’s claim?
We already know about Hannah Poling… Again, she has a mitochondrial disorder and autism and she was compensated because it was thought that she had an adverse event to getting vaccinated because of her mitochondrial disorder.
And Baxter Bailey? You don’t find anything if you look for Baxter Bailey, but you will eventually find information about Bailey Banks, who was compensated for (acute disseminated encephalomyelitis) ADEM, which led to Pervasive Developmental Delay (PDD). He wasn’t compensated for autism though.
What about the other families she is talking about?
A little more googling and you find that she is likely talking about an article, Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, that was published in the Pace Environmental Law Review in 2011 by Mary Holland, in which she reports finding “eighty-three cases of autism among those compensated for vaccine-induced brain damage.”
Well, there have been studies warning people about giving Tylenol before vaccines. It had nothing to do with side effects though. They suggested that a vaccine might be less effective if the child got Tylenol before his vaccines. It is important to note that they never really found that the vaccines didn’t work as well, as all of the kids in the study still had protective levels of antibodies, they were just a little lower than kids who didn’t get Tylenol.
Other studies have found the same effect if Tylenol was given after a child got his vaccines. Although interestingly, other studies have found that giving Tylenol after vaccines does not affect antibody titers.
“Antibody titres to diphtheria and tetanus toxoids and pertussis bacteria of the placebo (n = 25) and acetaminophen (n = 34) groups did not differ significantly from each other. It is concluded that acetaminophen in a single dose schedule is ineffective in decreasing post-vaccination fever and other symptoms.”
Uhari et al on Effect of prophylactic acetaminophen administration on reaction to DTP vaccination
The only thing that this had to do with side effects though, is that the kids who got Tylenol had a little less fever.
What about the association of MMR, Tylenol and autism? Although one study did suggest that to be true, the study, a parental survey, was found to be “fatally flawed.”
Can I Give My Kids Tylenol When They Have Their Vaccines?
So, can you give your kids Tylenol when they get their vaccines?
The better question is, should you give your kids Tylenol either before or after they get their vaccines?
Notwithstanding the very small chance that giving Tylenol might cause decreased immunogenicity (lower antibody production) if you give it before your kids get their vaccines, since there is a good chance that they won’t have any pain or fever and won’t even need any Tylenol, then why give it?
Skip the “just in case” dose and wait and see if they even need it.
What about afterwards?
If your kids have pain or fever and are uncomfortable, then you should likely give them something for pain or fever control, such as an age appropriate dose of either acetaminophen or ibuprofen. Will that cause lower antibody production? Maybe. Will that mean that their vaccines won’t work. That’s doubtful. It certainly won’t lead to increased side effects though, unless they a reaction to the dose of Tylenol itself.
Should you give a pain or fever reducer after a vaccine “just in case?” Again, there is a good chance that your kids might not need it, so it is likely better to wait and see if they do, instead of giving a dose automatically after their shots.
There is even some evidence that giving acetaminophen or ibuprofen before vaccines, or as a routine dose right after, especially with booster shots, doesn’t really prevent side effects that well anyway. They work better if given on an as needed basis instead, and these kinds of doses are less likely to be associated with decreased antibody production.
What to Know About Tylenol and Vaccines
Giving a pain or fever reducer either before or after your child’s vaccinations likely won’t affect how it works, but since it often isn’t necessary, it is likely best to only given one, like Tylenol or Motrin, if it is really needed.
“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.
“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.
Fortunately, they can usually be comforted quickly.
Historically, there has been one situation where kids might cry for longer periods of times.
Non-Stop Crying After DTaP Vaccines
The DTP vaccine was known to cause non-stop crying, for 3 hours or more in up to about 1 child out of 1,000.
“Persistent crying following DTaP (as well as other vaccines) has been observed far less frequently than it was following the use of DTP. When it occurred after DTP, it was considered to be an absolute contraindication to further doses of pertussis-containing vaccine. When it occurs following DTaP, it is considered a “precaution” (or warning). If you believe the benefit of the pertussis vaccine exceeds the risk of more crying (which, although unnerving, is otherwise benign), you can administer DTaP.”
Immunization Action Coalition on Ask the Experts about DTP
Although uncommon, it is certainly scary to have a child cry for 3 hours or more after a vaccine.
I guess that’s one good reason we don’t use the DTP vaccine anymore. On the other hand, although the newer DTaP has fewer side effects, it doesn’t work as well as the older DTP vaccine at protecting kids against pertussis.
What Causes Non-Stop Crying After DTaP Vaccines?
Some people have very wrong ideas about what caused this non-stop crying after the DTP vaccine, which is reflected in the nick-names they gave it, such as the “DTP scream,” “cry-encephalitis,” or the “encephalitic cry.”
If your child has had non-stop crying after their DTP vaccine, or DTaP vaccine for that matter, you can be reassured that they didn’t have encephalitis!
Again, although it is scary to have your child crying non-stop for 3 hours or more, this crying is benign and has no long term effects.
Crying non-stop for 3 hours or more after a vaccine can be scary. Fortunately, DTaP crying is not caused by encephalitis or any other terrible thing you might read about. It is a painful local reaction.