October is Vaccine Injury Awareness month. Most awareness months raise feelings of support in the community for those suffering with the illness and a spirit of comradery for those who experience the condition daily. Unfortunately, vaccine injury is a very lonely, very politicized, and dividing issue leaving many parents and children to walk their journeys alone and often ridiculed instead of supported. They are told to suppress their stories because of how uncomfortable they make others feel, how they must be wrong. Vaccines are safe and effective, there’s no room for discussion or any experience that goes against that narrative. Maybe that is why instead of a brightly colored ribbon, Vaccine Awareness is represented by a black ribbon.
What is a Vaccine Injury?
Just like any other injury, a vaccine injury is the result of a specific action. Because they generally happen internally, can affect a single or multiple organs or systems, and can go undetected for a period of time, they are often overlooked as vaccine induced. Have you ever known someone who was in an accident and injured their ankle, then years later they had knee or hip pain? Sometimes even on the opposite side. The body is created to adapt, sometimes those adaptations can lead to referred pain, or alternate systems attempting to compensate and adapt to restore health. What about someone who takes a statin drug for their cholesterol only to discover they’ve developed liver damage? Sometimes those compensations and adaptations can lead to more symptoms and more damage.
Vaccine injury is often overlooked because the injuries can surface with a host of symptoms over a period of time. Often these injuries look like new childhood trends in health due to the timing of the bulk of vaccines in a child’s life. Over the years, the childhood vaccine schedule has expanded as well as the growing list of conditions experienced by a larger portion of the childhood population.
Vaccine injury is hard to define in regard to specific reactions. The CDC website states:
no vaccine is actually 100% safe or effective for everyone because each person’s body reacts to vaccines differently.1
In December of 2019, the WHO met to discuss vaccine safety and confidence. Some of the doctors present expressed their concerned with lack of safety data. Concern was raised about using multiple shots at a time, various adjuvants in multiple vaccines, long-term data, and shortcomings in reporting. To learn more about that meeting and the concerns of those doctors, you can watch the video with a commentary here.
Adjustment to the Vaccine Industry in the 1980’s
In 1986, vaccine companies faced large lawsuits due to the number of injuries and claims that resulted. Several vaccine companies halted production as a result due to the higher prices and liability incurred. Fear of a vaccine shortage spurred the U.S. government put into place a no-fault safeguard for vaccine manufacturers.
With protection from liability in place, it was recognized that there is an inherent risk with vaccines. That risk is one the drug manufacturers not only dodged but were happy to pass on to the physicians and vaccine recipients. The Restatement of Torts (the interpretation of many civil laws that have been through the courts and are now held as precedent) is used as reference. The NIH’s commentary and it’s references here uses particularly interesting wording:
A manufacturer is not liable for harm caused by a nondefective product due to its inherent or unavoidable dangerousness. Thus, if a properly manufactured vaccine will cause harmful side effects in some portion of the recipient population, the manufacturer of the vaccine is not liable for those side effects. This principle is the subject of comment k to section 402A.
(k.) Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidably high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians or under the prescription of a physician. . .. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.2
With this new-found release of responsibility and liability, the number of childhood vaccines surged in the past 36 years.
How to Find More Complete, More Accurate Information For Informed Consent
The pastel-colored vaccine information sheets (VIS’s) given to parents in the pediatrician’s office are oversimplified, understated possible reactions to specific vaccines. To get a clearer picture of what the possible side effects are as indicated by the manufacturer, looking at the vaccine insert would be helpful. As is common today, many vaccines are given in combination. Parent’s will receive a VIS per each individual vaccine instead of a combination. This may raise concerns as to how combination vaccines are formulated rather than individual doses.
With some exceptions, there aren’t VISs for combination vaccines. Instead, providers should provide a separate VIS for each vaccine component in the combination (e.g., DTaP-IPV-HepB or DTaP-IPV/Hib). There is a combined VIS that can substitute for any or all of the routine vaccines given from birth–6 months (DTaP, IPV, Hib, PCV and HepB vaccines)2
For example, if you look at the VIS for the DTaP given in a pediatrician’s office, you will see this listed under the Risks of Vaccine Reaction section:
- Soreness or swelling where the shot was given, fever, fussiness, feeling tired, loss of appetite, and vomiting sometimes happen after DTaP vaccination.
- More serious reactions, such as seizures, non-stop crying for 3 hours or more, or high fever (over 105°F) after DTaP vaccination happen much less often.3
Rarely, vaccination is followed by swelling of the entire arm or leg, especially in older children when they receive their fourth or fifth dose. As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.3
If you were to look at the package insert for a commonly used combination vaccine for DTaP, you would read this under the post-marketing section listing other observed adverse events:
The following adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to DAPTACEL.
- Blood and lymphatic disorders
- Cardiac disorders
- Gastro-intestinal disorders
- General disorders and administration site conditions
Local reactions: injection site pain, injection site rash, injection site nodule, injection site mass, extensive swelling of injected limb (including swelling that involves adjacent joints).
- Infections and infestations
Injection site cellulitis, cellulitis, injection site abscess
- Immune system disorders
Hypersensitivity, allergic reaction, anaphylactic reaction (edema, face edema, swelling face, pruritus, rash generalized) and other types of rash (erythematous, macular, maculo-papular)
- Nervous system disorders
Convulsions: febrile convulsion, grand mal convulsion, partial seizures HHE, hypotonia, somnolence, syncope
- Psychiatric disorders
It is easy to see the differences in how this information is presented to parents. If a parent were to hear that it’s likely their child will be “fussy” for a time after a vaccine, they may not consider it such a cause for concern. It is very conceivable a child may not feel well or would have soreness resulting in crying. However, in the post-marketing data when screaming is listed as a psychiatric disorder, this becomes a much higher-level concern. How is a parent to discern what exactly is causing their infant to cry inconsolably?
Events such as the cardiac or blood and lymphatic disorder above aren’t even listed on the VIS given to the parent to take home. That is characterized under a broad statement:
As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.3
How to Research for Yourself
The internet can be a beautiful thing, especially for research. The tricky part is finding a good source. Many people assume those who are advocating for informed consent are radical “anti-vaxxers.” They’ll do anything to discredit people who raise concerns about vaccine safety.
In reality, that’s usually not at all the case. The people who’ve either been injured or who’ve studied are typically in support of individuals doing their own research and making the decision that is right for themselves and their family. Medical autonomy is critical to a free society. Even the CDC and National Institute for Health above recognize there is no such thing as a completely “safe and effective” vaccine for everybody.
Searching Vaccine Information
A good first place to start is reading about the disease the vaccine is supposed to protect from. In many cases, these diseases aren’t a real threat to the population the vaccine is offered for, or just aren’t as severe as we assume they are. The National Vaccine Information Center (NVIC) has very thorough information on each of the diseases currently vaccinated against. The website is robust and filled with statistics on disease, vaccine information, and links to the VAERS (Vaccine Adverse Event Reporting System) site.
The next logical and practical step is to read the actual product insert. As we’ve shown, the VIS is not a comprehensive source of information. You need to read the full insert to truly make an educated decision. The sheet they give you in the doctor’s office is one page. The insert is generally about 20. Many people think they have to be scientists to read these. You don’t. You will need to slow down, read, and think, but you’ll be surprised as to how much you can pick up from those inserts.
Search for the type of vaccine and the words “product insert.” You’ll find links to the FDA approved inserts inside the boxes the doctors get. This FDA webpage is very helpful to find the inserts and various documents associated with the specific vaccine as well.
Searching Vaccine Injuries
In 1990, the VAERS system was created to catch early warning signs and patterns of reactions following vaccines. VAERS is intended to be used to report all U.S. based reactions and international reactions that may be reported to a U.S. based manufacturer of a vaccine. The site is managed by the CDC and provides information to the FDA and CDC to assist in making recommendations. Healthcare providers are required by law to report any reaction that may be linked to a vaccine. Unfortunately, many doctors, nurses and other healthcare professionals don’t receive training in how to report to VAERS. The time-consuming task has often fallen to the wayside and often forgotten.
If you are interested in further research, the following are sites you may use to research additional statistics and information regarding vaccine injuries. Please note that these sites change rapidly, so pay close attention to instructions for searching as they are updated.
To search the official CDC VAERS site is a large task and often requires a bit of knowledge of medical terminology. If you were to search for heart conditions, you would also need to reference conditions like myocardial infarction, cardiac arrest, tachycardia, myocarditis, pericarditis, and several others.
More User-Friendly Options
There are other organizations that have come together to help make navigating this system a bit easier for the general public. These sites provide authentic cases that have been submitted to VAERS and include the VAERS ID number those cases are assigned by the CDC.
The NVIC has a link on their site to search the VAERS site. The difference is in how the search information is processed and laid out for the user. A table is generated, typically by age of vaccine recipient, and specific case reports are included below.
OpenVAERS has become quite popular in recent months with its Red Box Summary of reactions to the COVID-19 vaccines. This is probably one of the easiest sites to navigate.
International Injury Reporting
VigiAccess is the World Health Organization’s (WHO) Collaborating Centre for International Drug Monitoring. While this site doesn’t give specific case instances like VAERS does, it will provide information as to how many cases of specific injury symptoms have been recorded internationally to the WHO.
Other countries also have their own reporting sites. Some you are able to search, others are used for simply reporting. In the UK they use the Yellow Card Scheme.
If You Suspect a Vaccine Injury, Get Help
To have an adverse reaction reported, you can either reach out to your doctor, or take matters into your own hands and reach out to the National Vaccine Information Center for help to ensure it gets reported completely.
1CDC: Overview, History, and How the Safety Process Works
2National Center for Biotechnology Information: Liability for the Production and Sale of Vaccines
3Immunization Action Coalition
4CDC’s Vaccine Information Sheet DTaP