internal organ dysfunction or failure – yellow fever vaccine-associated viscerotropic disease (YEL-AVD)
About 1 in 55,000 for severe allergic reactions, 1 in 125,000 for severe nervous system reactions, and 1 in 250,000 for life-threatening severe illness with organ failure.
And the risks are likely higher if you are older than age 60 years, although YEL-AND and YEL-AVD are not reported to happen with booster doses of the yellow fever vaccine.
“People aged ≥60 years may be at increased risk for serious adverse events (serious disease or, very rarely, death) following vaccination, compared with younger persons. This is particularly true if they are receiving their first yellow fever vaccination. Travelers aged ≥60 years should discuss with their healthcare provider the risks and benefits of the vaccine given their travel plans.”
Yellow Fever Frequently Asked Questions
Why would you get the yellow fever vaccine if you were older than aged 60 years and you knew there was a higher risk of severe side effects?
Yellow fever itself is a life threatening disease without a cure and a case fatality rate of up to 50%, and again, YEL-AVD is not common, occurring in about 0.4/100,000 doses.
So you would typically want to get vaccinated if you were traveling to an area where yellow fever was a risk.
“Since January 2018, 10 travel-related cases of yellow fever, including four deaths, have been reported in international travelers returning from Brazil. None of the 10 travelers had received yellow fever vaccination.”
Fatal Yellow Fever in Travelers to Brazil, 2018
In addition to outbreaks, yellow fever is still endemic in forty-seven countries in Africa and Central and South America, leading to 170,000 severe cases and 60,000 deaths in recent years, including some deaths in unvaccinated travelers returning from these areas. Did you read about these deaths in the paper?
Unless you have a true contraindication to getting vaccinated, until a disease is eradicated, the benefits of a vaccine will typically be far greater than its risks.
The switch from the live, oral polio vaccine to the inactivated vaccine is a good example of when this wasn’t the case though. Since OPV could rarely cause vaccine-associated paralytic polio (VAPP), once polio was well controlled in the United States, the risk of this side effect became greater than the benefit of continuing to use the vaccine, but only because we had an alternative polio vaccine that didn’t cause VAPP.
Similarly, the original rotavirus vaccine was withdrawn because the extra risk of intussusception, even though it was small, was thought to be greater than the benefits of the vaccine.
In the great majority of cases though, to think that getting vaccinated is a bigger risk than getting a vaccine preventable disease, you have to buy into the anti-vaccine hype:
Did you actually get the flu in the days or weeks after your flu vaccine?
That’s not a side effect of your flu vaccine. Neither the inactivated flu shot, nor the attenuated FluMist can actually cause a flu infection.
Did you get a little sore at the site where you got your flu shot?
That’s a common side effect to getting a flu shot.
So is having some redness and swelling at the site, all of which begin soon after getting the shot and go away in a few days. You can also get a headache, fever, nausea, and muscle aches or signs and symptoms of an allergic reaction.
Do you have a runny nose or a cough? Side effects of the nasal spray flu vaccine can include a few days of runny nose, wheezing, headache, vomiting, muscle aches, fever, sore throat and cough.
Again, a bad cough and cold after a flu shot isn’t a side effect of the vaccine though.
If you found out you were pregnant shortly after getting a flu shot, you wouldn’t think they were associated, would you?
What about narcolepsy?
“An increased risk of narcolepsy was found following vaccination with Pandemrix, a monovalent 2009 H1N1 influenza vaccine that was used in several European countries during the H1N1 influenza pandemic.”
Narcolepsy Following Pandemrix Influenza Vaccination in Europe
Although the focus has been on the Pandemrix flu vaccine as a trigger for narcolepsy in some countries (the vaccine wasn’t used in the United States), interestingly, several countries that weren’t using the vaccine also saw a spike in narcolepsy cases as the 2009 H1N1 pandemic hit.
What about all of the reports of severe reactions and deaths after getting a flu shot that you might hear about? In addition to vaccine injury stories, those reports are to VAERS and typically are not causally related to getting a vaccine.
Why are there so many reports to VAERS and the NVICP about flu vaccines? Since 2006, over 1.6 trillion doses of flu vaccine have been distributed in the United States, which equals about the total of all other vaccines we use.
What Are the Side Effects of This Year’s Flu Shot
Even when folks understand that flu vaccines don’t typically cause serious side effects, the question always comes up whether or not this year’s flu shot is causing more side effects than usual.
That’s actually not unreasonable, even when you consider that the biggest change in most flu vaccines from year to year is the strain of flu viruses they include, and not any of the other ingredients.
In addition to the Pandemrix flu vaccine, in 2010, the use of one brand of flu vaccines in Australia was suspended because they were causing more side effects (fever and febrile seizures) in young children than expected.
“The studies flesh out preliminary findings from CSL in June 2012, which said that the manufacturing process retained more virus component than that of other manufacturers and that the 2010 virus components triggered an excessive immune response in some young kids.”
CSL studies shed light on 2010 flu vaccine seizures
Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?
“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”
20 VACCINE “FACTS” you need to know to make an informed decision
Would you be surprised to learn that part of their argument is true?
No, not the part that vaccine development isn’t well regulated!
“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”
Vaccine Product Approval Process
Federal regulations and rules ensure that our vaccines are safe.
Public Health Service Act (42 USC 262-63) §351
Food, Drug, and Cosmetic Act (21 USC 301-392)
Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
Title 21 CFR 314 (21 CFR 601.25[d], specific to biologicals – ensures adequate and well-controlled clinical trials
Title 21 CFR 312 – investigational new drug application (IND)
Title 21 CFR 210-211 – good manufacturing practices
Title 21 CFR 58 – good laboratory practices
Title 21 CFR 56 – institutional review boards
Title 21 CFR 50 – protection of human subjects
Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
Food and Drug Agency Modernization Act (FDAMA) of 1997
Food and Drug Agency Amendments Act (FDAAA) of 2007
I meant the part that vaccines aren’t regulated like drugs.
While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:
Center for Biologics Evaluation and Research (CBER) – vaccines
Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs
Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.
“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”
Vaccine Product Approval Process
That’s right, vaccines and drugs go through the same types of clinical trials.
After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.
“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”
Vaccine Product Approval Process
Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.
And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).
“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”
The Regulation of Vaccines for Human Use in Canada
It is also important to keep in mind that this process doesn’t just happen in the United States.
“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.
Myths and Facts about Vaccine Product Price and Procurement
It’s only because vaccines are more strictly regulated than drugs and other products.
Update: the medical examiner has ruled that Senator José Peralta, of Queens, passed away from natural causes, complications of acute promyelocytic leukemia.
Anti-vaccine folks are heavily pushing the idea that José Peralta, a New York State Senator, died as the result of getting a flu shot.
While Senator Peralta did die several days after getting a flu shot, it appears that he had already been sick for several weeks. And no, that doesn’t mean that the flu shot made him even sicker.
“The senator would be disappointed to find that conspiracy theorists are using his death to forward their agenda by misrepresenting the facts.”
Chris Sosa on No Evidence New York Legislator Died from Flu Shot
New York State Sen. José Peralta had reportedly just gotten his flu shot at a public event, where he was encouraging others in his community to get protected with free flu shots.
And while he did die about four days later, there is absolutely no reason to think that his getting a flu shot was connected to his death.
Of course, this is the method of operation of the modern anti-vaccine movement. They make folks think that anything and everything is a vaccine injury and they actually go out of their way to exploit people who have died.
There is no evidence that New York State Senator Jose Peralta died from getting a flu shot.
In fact, the medical examiner has ruled that he had acute promyelocytic leukemia when he died.
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.
“I’m not anti-vaccine, I just don’t believe in flu shots.”
They likely get all other available vaccines for themselves and their kids, but for some reason, they skip the flu shot each year.
I’m Not Anti-Vaccine, I Just Don’t Believe in Flu Shots
Are they just anti-flu vaccine? Is that a thing?
Why don’t they “believe” in flu shots?
Typical answers you might get, if you ask, include:
I never get the flu – since about 5 to 20% of people get the flu each year, it is certainly possible that you never get the flu, especially if you aren’t around many other people that could spread the flu virus to you. But unless you live and work in a bubble, there is a good chance that you will eventually be exposed to someone with the flu, might catch the flu yourself, and will spread it to someone else.
I only get sick when I get a flu shot – flu shots are inactivated and can’t actually give you the flu. Even the live virus nasal mist flu vaccine won’t cause you to have the flu. While flu vaccines can cause mild flu side effects, if you get sick after after a flu shot, it could be that you have another respiratory virus, your flu vaccine didn’t have time to work, or that it wasn’t effective.
Flu shots are too expensive – most insurance plans cover the costs of flu vaccines, but if you don’t have insurance, it is sometimes possible to find free flu shots at a local health clinic, or you could get a flu shot for $24 at Walmart with a GoodRx coupon.
I don’t have time to get a flu shot – do you have time to get sick with the flu? Many doctors now offer regular flu clinics that make it convenient to just come in and get a flu vaccine or if that isn’t possible, you can likely get a flu vaccine at a nearby pharmacy.
Someone on the Internet told me to never get a flu shot because they are poison – if you are avoiding a flu vaccine because you are worried about thimerosal, miscarriages, that they contain a vaginal spermicide, or other misinformation, then you likely aren’t just anti-flu vaccine…
Gloria Copeland told me I didn’t need one – Jesus didn’t give us a flu shot and doesn’t want you to die with the flu, or measles.