When you take your child to their pediatrician, you expect to be given all of the information you need to help you make good decisions about their care.
Whether it is about an antibiotic to treat an ear infection, the need for an MRI if your child is having severe headaches, or weaning off an asthma medication, etc., you deserve to be well informed of the risks and benefits of any and all procedures they have.
How Do You Provide Informed Consent to Vaccination?
Of course, informed consent also applies to vaccinations.
How do you provide informed consent to vaccination?
Provide the latest edition of the appropriate Vaccine Information Statement (VIS) before a vaccination is given. Although these aren’t actually “informed consent forms,” they are required to be given by federal law and because “cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed”
Give parents/guardians the chance to take the VIS home to review later.
Answer any questions about the vaccine that their child is about to get.
Hopefully you always get informed consent before your child is vaccinated.
You should also get informed consent before skipping or delaying any of your child’s vaccines, as it risks their getting a life-threatening vaccine-preventable disease and puts others at risk, all without any extra benefit.
“At trial, the parent and physician both acknowledged that the vaccine was recommended, but the parent stated that the risk of death wasn’t mentioned during the discussion.”
Document ‘informed refusal’ just as you would informed consent
Believe it or not, a pediatrician in California was successfully sued after a parent refused to vaccinate their child with Prevnar and their infant died of pneumococcal sepsis, which the vaccine could have prevented.
Although they realized that their pediatrician had recommended the vaccine and they refused it, they claimed that they didn’t realize that their baby could die without it. He did…
Myths About Informed Consent and Vaccines
Not surprisingly, many folks get the idea of informed consent to vaccination wrong.
For one thing, unless it is required by state law, no one has to sign a consent form before getting vaccinated. Many pediatricians and clinics do have you sign that you received the VIS, although federal law does not require this signature.
“Now that case one is settled, I can go back to being loud and proud about my belief that every single patient should receive complete informed consent prior to vaccinations. This two-year period of silence has been tough. I will not rest until every single family has been given access to full, complete, objective, and un-doctored information that makes every parent fully aware of the risks they accept if they don’t vaccinate their child, and all the risks they take if they do vaccinate their child. Period. And I will fight against mandatory vaccination laws until they are no more. When every single person on this planet has access to informed consent, and can make a free choice, I will then be able to say my work is done.”
Dr. Bob Sears
When Dr. Bob talks about vaccines, do you think he mentions the parents who skipped the Prevnar vaccine and then successfully sued their pediatrician for not warning them that their baby would die?
Fever, pain at the injection site, and redness and swelling where the shot was given are all common, mild problems that can be associated with almost any vaccine.
Some vaccines might also commonly cause fussiness, tiredness or poor appetite, and vomiting within 1 to 3 days of getting the vaccine. Others can cause a rash, headache, or muscle and joint pain for a few days.
Even syncope or fainting can commonly occur within 15 minutes of teens getting a vaccine.
Other vaccine side effects can include persistent crying, nodules at the injection site, limb swelling, and febrile seizures, etc.
These are well known vaccine side effects that are often minor and temporary though.
Is It a Vaccine Injury?
Although the term is typically associated with the anti-vaccine movement, as they tend to think everything is a vaccine injury, it is important to understand that vaccine injuries, although rare, are indeed real.
Dr. Samuel Johnson once said that “It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.”
How does this apply to diagnosing vaccine injuries?
Too often we forget that just because one event is subsequent (happens after) another, it does not mean that it was a consequence (was caused by) the first event. It is another way of saying that correlation does not imply causation.
This is also highlighted by missed vaccine stories, events that would surely be blamed on a vaccine injury, except that a vaccine was never actually given for one reason or another.
Most pediatricians have these types of missed vaccine stories, such as:
an infant who begins vomiting on the way home from a well appointment and is diagnosed with intussusception (9 month old visit and didn’t get any vaccines)
a 4 year old who developed encephalitis just one week after his well check up (no vaccines – DTP had been deferred to his 5 year old visit)
a 2 month old who died of SIDS on the night of his scheduled well child visit (no vaccines as they had forgotten to go to the appointment)
a 4 month old who had a seizure at his well child visit (no vaccines were given yet as they were still being drawn up)
Or they have kids who begin to have symptoms or are diagnosed with a condition right around the time of a check up when they would routinely get one or more vaccines, but haven’t yet. From diabetes and POTS to transverse myelitis, some parents would have blamed their child’s vaccines if they had actually been vaccinated at that time and subsequently got diagnosed.
My own son started getting migraines when he was 12 years old and about to start 7th grade. Should I blame his headaches on his middle school booster shots? While it would be convenient, it is more likely that genetics are to blame. I started getting migraines at about the same age, and he began getting them just before he got his booster shots.
Diagnosing Vaccine Injuries
How do you know if your child had a true vaccine injury?
Does the reaction fit into the vaccine injury type AND “time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration” as described in the NVICP vaccine injury tables?
That time period, also known as a risk interval, is when “individuals are considered at risk for the development of a certain adverse event following immunization (AEFI) potentially caused by the vaccine.”
For example, did your child develop an anaphylactic reaction within four hours of getting the DTaP vaccine? While a reaction 14 hours after the vaccine would be much less likely to be caused by the vaccine, if it occurred within 4 hours, that could certainly be a vaccine injury.
How about a child who developed thrombocytopenic purpura 90 days after getting his MMR vaccine? That is unlikely to be a vaccine injury, as the MMR vaccine typically causes TTP within 7 to 30 days.
If you think that your child has had a vaccine injury, be sure to talk to your pediatrician. You should also report any vaccine reaction to Vaccine Adverse Event Reporting System (VAERS) and if you truly believe that your child has been injured by a vaccine, you can file a claim with the National Vaccine Injury Compensation Program (VICP).
“You may file a claim if you received a vaccine covered by the VICP and believe that you have been injured by this vaccine.”
What You Need to Know About the National Vaccine Injury Compensation Program (VICP)
How will your pediatrician figure out if it is a vaccine injury? Among the things that they will consider when evaluating a reaction after a vaccine will be the answers to some key questions, including:
Is there any evidence that something else caused the reaction? While getting a vaccine could cause an anaphylactic reaction, so could the fact that your child just eat a peanut butter and jelly sandwich.
Is there a laboratory test that implicates the vaccine as a cause of the reaction?
If the reaction is an infection, did it have a vaccine or wild type origin?
Your pediatrician will also consider other factors when making a decision, including whether other patients were affected (might implicate a contaminated vaccine), and will make sure that the original diagnosis is correct.
Being able to answer all of these questions often puts pediatricians in the unique position of correctly evaluating potential vaccine injuries. There is even a standardized algorithm that can help your pediatrician collect and interpret all of the data they will get when evaluating a possible vaccine injury.
Another algorithm can help evaluate and manage suspected allergic reactions, including immediate or type 1 hypersensitivity reactions and delayed type 3 hypersensitivity reactions. If the reaction is consistent with an allergic reaction and additional doses of the vaccine are still needed, possible next steps in this algorithm include serologic testing for immunity and skin testing with the vaccine or vaccine components.
For extra help, your pediatrician can consult an allergist or immunologist before considering giving your child another vaccine, if necessary. Experts at the Clinical Immunization Safety Assessment (CISA) are also available for consults about suspected vaccine injuries.
Over-Diagnosing Vaccine Injuries
In addition to vaccine side effects and vaccine injuries, it is much more common for children and adults to develop health problems and symptoms after getting a vaccine that have nothing to do with the vaccine. These are events, sometimes tragic, that would have happened even if they had not been vaccinated.
Despite the evidence against it, some parents may still think that their child has been injured or damaged by a vaccine, especially if they:
For example, studies have repeatedly shown that “vaccination does not increase the overall risk of sudden infant death (SIDS),” and that “the risk of SIDS in vaccinated cases and controls is neither increased nor reduced during the early post-vaccination period.”
So a VAERS report of SIDS on the night that an infant received his 4 month vaccines, while tragic, would likely not end up being classified as a true vaccine injury.
Neither should a case report or package insert about SIDS influence your thinking about SIDS being associated with a vaccine injury.
Still, it is easy to understand why many like to blame vaccines.
Vaccines are an easy target, especially as most vaccine-preventable diseases are under fairly good control compared to the pre-vaccine era. And in some cases of SIDS, a new case of diabetes, or the sudden death of an older child, etc., it may happen soon after the child was vaccinated, and that correlation is hard to ignore for some folks.
At least it is hard to ignore and easy to be influenced by anti-vaccine folks if you don’t understand the background rate of these diseases – or the fact that a certain number of children will be affected no matter what, and because many kids get vaccinated, it is only a matter of chance that the two get correlated together.
Analogies and metaphors are a good way to explain things, including that vaccines are safe and necessary.
Here are some of my favorite vaccine analogies and metaphors.
Getting vaccinated is like:
applying sunscreen before going to the beach
applying insect repellent before going camping in the woods
making sure that your kids are wearing a seat belt or sitting in an age-appropriate car seat or booster seat when you get in the car
installing anti-virus software on your new computer
When do you put on your seat belt? When you get in the car, before you get in an accident. Just like a vaccine. You get it before you get sick. Yes, some vaccines do work after you have been exposed to an illness, but they don’t work after you are already sick.
There is a problem with these metaphors though; they don’t include the risks to other people.
taking driver’s ed and getting your license before driving
taking swimming lessons before going in the water without a life jacket
putting your gun in a locked safe
putting a fence around your backyard so that no one in your neighborhood can drown in your pool
making sure folks don’t text and drive
Vaccination equals protection.
And not just protection for the person getting vaccinated. Being unvaccinated puts others at risk too, as you might start an outbreak.
Getting your kids vaccinated is like taking them to swimming lessons instead of just throwing them in the lake. Either way they can learn to swim and have protection/immunity from drowning. But one method (throwing them in the lake) is much more dangerous than the other.
“Vaccines are a like a wanted poster, they just show your body what the bad guys look like, so when faced with them for real you are ready, prepared, and able to stop them before they cause harm.”
Can vaccines overwhelm the immune system?
Are there analogies that explain the idea of free-riders – folks who intentionally don’t vaccinate their kids and attempt to hide in the herd?
“If all my child’s friends are vaccinated, won’t he be protected by herd immunity? Why should I put my child at risk for vaccine reactions if all the other children around him are already immune?
This is like riding in a carpool where everyone contributes each month to pay for gas, repairs and parking. One morning, a new neighbor shows up and says, “I think I’ll ride along with you. But I’m not going to pay, since you’re going downtown anyway and you have an empty seat.” If enough people choose to take a free ride on other children’s immunity, herd immunity will soon disappear.”
“I have found that it sometimes helps to give parents an analogy. I ask them the following: If they were to put gas in their car and then later got a flat tire, would that mean putting gas in the car had caused the flat tire? No. The two events were just a coincidence.”
There are plenty of other good analogies that help to explain the importance of vaccines.
“Clusters of unvaccinated people are like patches of dry grass that, with a single match, can start a wildfire that will burn not only dry material, but sometimes wet as well. The match could be a student who returns from a trip abroad with measles or a train commuter with whooping cough.”
It’s also important to remember that anyone, even those who are well prepared, can get burned in a wildfire. That’s why the analogy works so well.
“Vaccinating one’s children is like paying taxes. We all have a moral and a legal duty to pay taxes because we have a moral and a legal duty to contribute to the upkeep of our society and to its public goods (e.g., a good public health system, national defence, etc.).”
Vaccine Refusal Is Like Tax Evasion
Why are we concerned about those who are unvaccinated if our own children are fully vaccinated?
“Think of camping as an analogy. If everyone at a campground properly stores their food, bears won’t be enticed to come around. If even one person leaves their food unprotected, it invites bears in to investigate all the campsites for opportunities to eat.”
How does choosing not to immunize affect the community?
“Being intentionally unvaccinated against highly contagious diseases is, to carry Holmes’ analogy a bit further, like walking down a street randomly swinging your fists without warning. You may not hit an innocent bystander, but you’ve substantially increased the chances that you will.
One might usefully analogize the risk of disease to a crapshoot. A person’s chance of being infected is, as Dr. Singer acknowledges, a matter of luck. But is it really OK for the unvaccinated to load the dice to increase the odds against other people? If so, by how much?”
Ronald Bailey on Vaccines and the Responsibility To Not Put Others at Risk
Of course, there are plenty of bad vaccine analogies and metaphors that anti-vaccine folks push:
“genes load the gun but the vaccines pull the trigger”
vaccine manufacturers are like tobacco manufacturers
I won’t set my child on fire to keep yours warm (this doesn’t work as a vaccine analogy, mostly because there is no benefit to setting your child on fire. Would an anti-vaxxer let their child start a campfire to keep their friends from dying in the cold?)
getting a vaccine is like eating a handful of M&Ms out of a big bowl when you know that a few have been poisoned
getting a child vaccinated is like giving 1,000 kids 1,000 cupcakes, telling them to pick one and eat it, knowing that one of the cupcakes is poisoned (it’s maybe like letting a child with a severe peanut allergy choose a cupcake, knowing that there is a one in a million chance that the cupcake he chooses has been made with peanuts…)
I want safer cars, but that doesn’t make me anti-car
You understand why the anti-car one is a bad analogy, right? Folks who want safer cars generally still drive and ride in cars!
Have you heard any good or bad analogies or mataphors about vaccines?
What do kids do when their parents are anti-vaccine?
Whether or not they know it, they hide in the herd, at least until they understand what’s going on.
And then they often make a choice to either continue with their parents beliefs and remain unprotected or they get caught up.
Can Minors Consent to Getting Vaccinated?
Since getting vaccinated is a medical procedure, in most cases, you are still going to need the consent of a parent, guardian, or other adult family member if you are still a minor, which leaves out simply going out and getting caught up.
“State law is generally the controlling authority for whether parental consent is required or minors may consent for their own health care, including vaccination.”
Abigail English, JD on the Legal Basis of Consent for Health Care and Vaccination for Adolescents
Are you still a minor?
“In most states, age 18 is the age of majority and thus, before treating a patient under the age of 18, consent must be obtained from the patient’s parent or legal guardian.”
Ann McNary, JD on Consent to Treatment of Minors
When it comes to immunizations and health care, in addition to what state you live in, that likely depends on whether or not you are an emancipated minor (court order), married minor, pregnant minor, or minor parent (situational emancipation). It also can depend on the type of health care you are seeking, like if a minor is seeking birth control or treatment for an STD.
“States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child.”
Convention on the Rights of the Child
Are you a mature minor? In some states, you can also give consent for medical procedures, including getting vaccinated, if you are a mature minor – someone who is old enough to understand and appreciate the consequences of a medical procedure.
In Washington, for example, minors may get immunizations without their parents consent after their health care provider evaluates the minor’s “age, intelligence, maturity, training, experience, economic independence or lack thereof, general conduct as an adult and freedom from the control of parents.”
Since at least 2004, most vaccine vials and syringes have had barcodes on them.
At first they were linear barcodes (like a UPC code), but since 2016, vaccine products began using 2D barcoding.
Vaccine 2D Barcoding
Although you may have never heard about it, vaccine barcoding has a lot of benefits, including:
improved patient safety by reducing vaccine errors, including flagging when the wrong vaccine or an expired vaccine is scanned
improved efficiency, as using a vaccine barcode scanner is faster than manually entering vaccine lot numbers
And vaccine barcoding makes it easier for clinics to manage their vaccine inventory.
Vaccine Barcode Scanners
Which vaccine barcode scanner should you get?
“Scanners, once configured for the specific EHR/PMS/IIS set-up, can decode the 2D barcode into a “string of numbers”. Once this string of numbers is available, the configuration from the scanner to the health record translates the information into the appropriate data needed to document GTIN, lot number, and expiration date.”
AAP on Getting the Scanner to Work
That’s probably going to depend on which EHR that you use, as you want to make sure that your scanner works with your EHR.
Once you know which model to get, you can also decide if you want one that is corded or that connects via WiFi or Bluetooth. While it might seem most convenient to go with a cordless device, that doesn’t necessarily mean that you can easily use the scanner on multiple computers. Each cordless device typically needs to be paired with a specific computer.
“Recent studies have shown that even individuals with confirmed egg allergy can safely receive the flu vaccine. The Joint Task Force on Practice Parameters of the American Academy of Allergy Asthma and Immunology and the American College of Allergy Asthma and Immunology as well as the American Academy of Pediatrics state that no special precautions are required for the administration of influenza vaccine to egg-allergic patients no matter how severe the egg allergy.”
Egg Allergy and the Flu Vaccine
In fact, it began to change in 2011, when we got the recommendation that it was okay to give flu shots to people with egg allergies, if they only get hives as their reaction. It was still recommended that those with more severe allergic reactions to eggs “be referred to a physician with expertise in the management of allergic conditions for further risk assessment before receipt of vaccine.”
Before that, we would sometimes do skin testing on high risk egg allergic kids, desensitization, or regular chemoprophylaxis.
In 2013, the recommendation changed so that those with severe allergic reactions to eggs should get their flu shot “by a physician with experience in the recognition and management of severe allergic conditions.”
The recommendations were again modified in 2016, removing the recommendation that egg-allergic flu vaccine recipients be observed for 30 minutes and that those with severe egg allergies “should be vaccinated in an inpatient or outpatient medical setting (including but not necessarily limited to hospitals, clinics, health departments, and physician offices), under the supervision of a health care provider who is able to recognize and manage severe allergic conditions.”
Why the changing advice?
It’s because severe allergic reactions to vaccine are rare (in a million doses rare). And even in the flu vaccines that still use eggs, almost all of the egg protein is removed from the final vaccine. So that residual amount of egg protein is unlikely to trigger an allergic reaction. And that’s what we saw as the recommendations were slowly changed year after year.
Getting a Flu Shot When You Are Allergic to Eggs
And that’s why we have our current recommendations:
Those with a history of egg allergy who only get hives can get any age-appropriate flu vaccine.
Those with a history of egg allergy who have severe reactions, including angioedema, respiratory distress, lightheadedness, recurrent emesis, or who required epinephrine or another emergency medical interventions, can still get any age-appropriate flu vaccine, but they should get it in an inpatient or outpatient medical setting (such as a hospital, clinic, health department, or physician’s office). And the vaccine administration should be supervised by a health care provider who is able to recognize and manage severe allergic reactions.
Those who can eat eggs without reaction can get any age-appropriate flu vaccine.
Do you still have to be observed after getting your flu vaccine if you have an egg allergy?
No postvaccination observation period is recommended specifically for egg-allergic persons.
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season
Nope. But that’s likely because although they are rare, reactions might not occur right away.
So yes, you can and you should get a flu vaccine if you are allergic to eggs.