Call your pediatrician or seek medical attention if you think your child has developed a skin infection after a vaccination, but keep in mind that bacterial cellulitis after getting a vaccine is an extremely rare, almost unheard of, complication.
Other more moderate and severe DTaP vaccine reactions are uncommon or rare.
“A hypotonic-hyporesponsive episode (HHE) is the sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis that occurs within 48 hours after childhood immunizations.”
DuVernoy et al on Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998
What about hypotonic-hyporesponsive episodes (HHE) and seizures? These were removed as table injuries after DTP back in 1995. It is not that HHE can’t occur after DTP, DTaP, or other vaccines, but rather that HHE doesn’t then cause any permanent neurological damage to the child.
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
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
“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
Most vaccines have some common, mild side effects, which might include (depending on the vaccine):
fever, typically low-grade
redness or swelling where the shot was given
soreness or tenderness where the shot was given
tiredness or poor appetite
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.
“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.
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.
We often have to remind people that the anti-vaccine movement didn’t start with Bob Sears, or Jenny McCarthy, or even with Andy Wakefield.
Did you know that the Reverend Cotton Mather’s house was bombed in Boston in 1721? Well, someone through a bomb through his window. Fortunately, it didn’t go off.
That’s 77 years before Jenner developed his smallpox vaccine!
What was Mather doing?
He had started a smallpox variolation program. He was trying to protect people in Boston from smallpox during one of the most deadly epidemics of the time.
So essentially, the anti-vaccine movement started before we even had real vaccines…
Is the Anti-Vaccine Movement Growing?
You see reports of more and more outbreaks of vaccine-preventable diseases, hear about new vaccine laws and mandates, and depending on who your friends are, may see a lot of anti-vaccine articles and vaccine injury stories getting shared on Facebook.
You have probably even heard about pediatricians firing families who refuse to vaccinate their kids.
So what’s the story?
Is the anti-vaccine movement growing?
Is there a growing resistance among parents to getting their kids vaccinated?
“Parents are taking back the truth. It is my expectation that this crack in the dam will serve to sound an alarm. To wake women up. To show them that they have relinquished their maternal wisdom, and that it is time to wrest it back.”
Kelly Brogan, MD
Is the world finally “waking up to the dangers of vaccines,” like many anti-vaccine experts have been claiming for years and years?
The Anti-Vaccine Movement is not Growing
Many people will likely tell you that the anti-vaccine is in fact growing.
You can read it in their headlines:
The worrying rise of the anti-vaccination movement
Will 2017 be the year the anti-vaccination movement goes mainstream?
Pediatricians calling anti-vaccine movement a growing problem
There’s Good Evidence That The Anti-Vaccine Movement Is Growing
I was skeptical that the anti-vaccine movement was gaining traction. Not anymore.
But the anti-vaccine movement is not necessarily growing.
The overwhelming majority of parents and adults are fully vaccinated.
Most parents do their research though, don’t jump on the anti-vaccine bandwagon, and know that vaccines work, vaccines are safe, and vaccines are necessary.
The Anti-Vaccine Movement is Changing
A lot about the anti-vaccine movement hasn’t changed over the last 100 plus years.
Many early critics of vaccines were alternative medicine providers, including homeopaths and chiropractors, just like we see today. And like they do today, they argued that vaccines didn’t work, vaccines were dangerous, and that vaccines weren’t even necessary.
The big difference?
Unlike when Lora Little, at the end of the 19th century, had to travel around the country to distribute her anti-vaccine pamphlet, Crimes of the Cowpox Ring, anti-vaccine folks can now just tweet or post messages on Facebook. It is also relatively easy to self-publish an anti-vaccine book and sell it on Amazon, put up your own anti-vaccine website, post videos on YouTube, or even make movies.
“Whatever you think about Andrew Wakefield, the real villains of the MMR scandal are the media.”
Ben Goldacre on The MMR story that wasn’t
Fortunately, all of that is balanced by something they don’t have anymore.
No, it’s not science. That was never on their side.
It’s that the media has caught on to the damage they were doing and isn’t as likely to push vaccine scare stories anymore.
Explaining the Popularity of the Anti-Vaccine Movement
The anti-vaccine movement has always been around and they are likely not going anywhere, whether or not they are growing.
“By the 1930s… with the improvements in medical practice and the popular acceptance of the state and federal governments’ role in public health, the anti-vaccinationists slowly faded from view, and the movement collapsed.”
Martin Kaufman The American Anti-Vaccinations and Their Arguments
Why so many ups and downs?
It is easily explained once you understand the evolution of our immunization programs, which generally occurs in five stages:
pre-vaccine era or stage
increasing coverage stage – as more and more people get vaccinated and protected, you pass a crossover point, where people begin to forget just how bad the diseases really were, and you start to hear stories about “mild measles” and about how polio wasn’t that bad (it usually wasn’t if you didn’t get paralytic polio…)
loss of confidence stage – although vaccine side effects are about the same as they always were, they become a much bigger focus because you don’t see any of the mortality or morbidity from the diseases the vaccines are preventing. It is at this point that the anti-vaccine movement is able to be the most effective.
resumption of confidence stage – after the loss of confidence in stage three leads to a drop in vaccine coverage and more outbreaks of a vaccine-preventable disease, not surprisingly, more people understand that vaccines are in fact necessary and they get vaccinated again. It is at this point that the anti-vaccine movement is the least effective, as we saw after outbreaks of pertussis in the UK in the 1970s and measles more recently. You also see it when there is a report of an outbreak of meningococcal disease on a college campus or a child dying of the flu on the local news, etc.
eradication stage – until we get here, like we did when smallpox was eradicated, the anti-vaccine movement is able to cycle through stages two to four, with ups and downs in their popularity,
So the anti-vaccine movement is able to grow when they have the easiest time convincing you that the risks of vaccines (which are very small) are worse than the risks of the diseases they prevent (which are only small now, in most cases, because we vaccinate to keep these diseases away, but were life-threatening in the pre-vaccine era).
“As vaccine use increases and the incidence of vaccine-preventable diseases is reduced, vaccine-related adverse events become more prominent in vaccination decisions. Even unfounded safety concerns can lead to decreased vaccine acceptance and resurgence of vaccine-preventable diseases, as occurred in the 1970s and 1980s as a public reaction to allegations that the whole-cell pertussis vaccine caused encephalopathy and brain damage. Recent outbreaks of measles, mumps, and pertussis in the United States are important reminders of how immunization delays and refusals can result in resurgences of vaccine-preventable diseases.”
Paul Offit, MD on Vaccine Safety
Fortunately, most parents don’t buy into the propaganda of the anti-vaccine movement and don’t wait for an outbreak to get their kids vaccinated and protected. They understand that you can wait too long.
The bottom line – except for pockets of susceptibles and clusters of unvaccinated kids and adults, most people are vaccinated. If the anti-vaccine does grow, it eventually gets pulled back as more kids get sick.
What to Know about the Growing Anti-Vaccine Movement
Although they may have an easier time reaching more people on Twitter, Facebook, YouTube, and with Amazon, the overwhelming majority of parents vaccinate their kids and aren’t influenced by what some people think is a growing anti-vaccine movement.
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.
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.
If you are going to ask for a package insert, you should know what’s in it and how it should be read.
Otherwise, it is easy to get misled by antivaccine propaganda, like when Mike Adams claimed he discovered “a vaccine document on the FDA’s own website that openly admits vaccines are linked to autism.”
What goes into a package insert is dictated by the FDA, specifically the Code of Federal Regulations Title 21, and Section 314 of the NCVIA, after consultation with the Advisory Commission on Childhood Vaccines.
Much like the package inserts for other medicines, a vaccine package insert includes up to 17 major sections, including:
Indications and Usage – what the vaccine is used for
Dosage and Administration – the recommended dose of vaccine, when and where it should be given, and how to mix it
Dosage Forms and Strengths – available dosage forms
Warning and Precautions – all adverse reactions and safety hazards that may occur after getting the vaccine and what you should do if they occur
Adverse Reactions – this section includes clinical trials experience, postmarketing experience, and voluntary reports, and it is very important to understand that it is not always possible to establish a causal relationship to vaccination for these adverse effects. So just because something is listed here, whether it is SIDS, autism, drowning, or a car accident, doesn’t mean that it was actually caused by the vaccine.
Drug Interactions – any reactions you might expect between the vaccine and other drugs
Use in Specific Populations – can include recommendations for use in pregnancy, nursing mothers, pediatric use, and geriatric use
Drug abuse and dependence – usually blank
Overdosage – usually blank
Description – general information about the vaccine, including how it was made and all vaccine ingredients.
Clinical Pharmacology – how the vaccine works, including how long you might expect protection to last
Nonclinical Toxicology – must include a section on carcinogenesis, mutagenesis, impairment of fertility, even if it is to say that the vaccine “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”
Clinical Studies – a discussion of the clinical studies that help us understand how to use the drug safely and effectively
References – when necessary, a list of references that are important to decisions about the use of the vaccine
How Supplied/Storage and Handling
Patient Counseling Information – information necessary for patients to use the drug safely and effectively
In addition to not having sections 9 and 10, some vaccines don’t have a section 13. It is not a conspiracy. Some older vaccines, like Varivax, do not have to have a section 13 per FDA labeling rules.
Myths About Package Inserts
Just as important as what’s listed in a vaccine package insert, is what the package insert doesn’t say.
Or what you might be led to believe it says.
“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”
M.D. Green on the Preclinical Toxicology of Vaccines
When reading a package insert, don’t be misled into thinking that:
you should be worried if a package insert states that a vaccine has not been evaluated for carcinogenic (being known or suspected of being able to cause cancer) or mutagenic (being known or suspected of causing mutations in our DNA, which can lead to cancer) potential or impairment of male fertility. Vaccines don’t cause cancer or impair male fertility, or female fertility for that matter. And as you probably know, many vaccines actually prevent cancer. Formaldehyde is the only vaccine ingredient on the list of known carcinogens, but it is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is carcinogenic, not the residual amounts you might get in a vaccine over short amounts of time.
pediatricians are trying to keep parents from reading package inserts. Your pediatrician is probably just confused as to why you want it, as the VIS is designed for parents, not the package insert. But if even if your pediatrician doesn’t hand you a package insert for each and every vaccine your child is going to get, they are readily available from the FDA and many other websites.
“Based on previous experience, carcinogenicity studies are generally not needed for adjuvants or adjuvanted vaccines.”
WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines
Vaccines are thoroughly tested for both efficacy and safety before they are approved.
It is also important to understand that the WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines and the European Medicines Evaluation Agency both state that mutagenicity and carcincogenicity studies are typically not required for vaccines.
It is because vaccines have a low risk of inducing tumors.
There are also very specific guidelines and rules for when a manufacturer needs to perform fertility studies.
So, as expected, there are no surprises in vaccine package inserts. You can be sure that everything that needs to be tested to show that a vaccine is safe has been done. If it has “not been evaluated,” it is simply because it was not necessary.
Get educated about vaccines and get your family vaccinated and protected against vaccine preventable diseases.
What to Know About Reading Vaccine Package Inserts
Learn how to read vaccine package inserts so that you aren’t misled by many of the myths about what they do and don’t say, including why they are likely missing information on the vaccine’s potential to cause carcinogenicity, mutagenicity, or impairment of fertility.
More on How to Read a Package Insert for a Vaccine:
their child is on antibiotics – having a mild illness is not usually a good reason to skip or delay getting vaccines
their child had an allergic reaction to a vaccine – a severe, anaphylactic reaction to one vaccine or vaccine ingredient wouldn’t mean that your child couldn’t or shouldn’t get all or most of the others
a doctor wrote them a medical exemption – there are actually very few true contraindications to getting vaccinated and a permanent exemption to all vaccines would be extremely rare, which casts doubt on the ever growing rate of medical exemptions in many areas
they are Muslim – most Muslims vaccinate their kids and most Islamic countries have very good immunization rates.
someone at home is immunocompromised – since we stopped giving the oral polio vaccine, shedding from vaccines is not a big concern and contacts of those who are immunocompromised are usually encouraged to get vaccinated
they are Buddhist – most Buddhists vaccinate their kids – the Dalai Lama even led an oral polio vaccination drive recently and Buddhist countries have very good immunization rates.
someone in their family had a vaccine reaction – a family history of a vaccine reaction is not a good reason to skip or delay getting vaccinated, as it has not been shown to increase your own child’s risk of a reaction. And yes, this has even been shown for siblings of autistic children, which makes sense, since vaccines don’t cause autism.
What about other religions?
Whether you are Hindu, non-Catholic Christians, Amish, or Jehovah’s Witnesses, etc., remember that all major religions believe in vaccines. Of course, the Amish are a little more selective of when and which vaccines they will get, but as we saw in the Ohio measles outbreak, they do get vaccinated.
On the other hand, Christian Scientists don’t vaccinate, along with some small Christian churches that believe in faith healing and avoid modern medical care.
Still, most people understand why it is important to vaccinate their kids.
What to Know About These Reasons to Not Vaccinate Your Kids
What do you think about these reasons to not vaccinate your kids? Since they aren’t really absolute reasons to not get vaccinated, are you ready to get your kids vaccinated now?
In addition to learning how to give vaccines properly, it can help you answer any questions parents might have and help them understand that vaccines are safe, vaccines work, and vaccines are necessary to protect our kids.
Who needs to get educated about vaccines?
Everyone of course. While it’s great if all of the medical assistants and nurses have done their research about vaccines, you will have missed opportunities to get kids vaccinated and protected if the folks making appointments aren’t.
Learning the Immunization Schedule
How do you know when to give a particular vaccine to an infant, child, or older teen when they come to the office, besides the fact that someone else ordered it or the school says they need it?
“There is no ‘alternative’ immunization schedule. Delaying vaccines only leaves a child at risk of disease for a longer period of time; it does not make vaccinating safer.
Vaccines work, plain and simple. Vaccines are one of the safest, most effective and most important medical innovations of our time. Pediatricians partner with parents to provide what is best for their child, and what is best is for children to be fully vaccinated.”
Karen Remley, MD, Executive Director, American Academy of Pediatrics
For example, while some vaccines must be refrigerated, others must be frozen.
What happens if vaccines aren’t stored at the proper temperature?
If a vaccine gets too warm or too cold, it can lose some of its potency and it probably won’t work well. That can mean vaccinated kids don’t get the immunity you expect and are left unprotected to one or more vaccine-preventable diseases. Hopefully, the office discovers the problem before any kids have gotten the vaccine though and they are just left throwing out some unusable vaccines.
What To Know About Vaccine Education for Pediatric Offices
Vaccines are safe, necessary, and still needed to protect all of our kids from vaccine-preventable diseases. Help make sure everyone in your office is educated about the latest immunization schedule and understands how to give and store vaccines safely.