Updated: Apr 8, 2022
Chapter 7: Article 4
If you want a true picture of the side effects caused by a vaccine, you need to read the package inserts. Doctors and media say vaccines are harmless and perfectly safe, but the truth is, few doctors or reporters have ever read the package inserts.
It is important to note that the 1-3 page handouts given to patients (or parents) in the doctor's office are NOT the package insert. Those brief 1-3 page handouts are condensed summaries often called "consumer information sheets." The package insert is a 20-60 page document.
In addition to reading the section titled, "Adverse Events," there is usually a section titled "Post-marketing." This is an important section to review. The post-marketing introduction usually begins with a similar statement as quoted below:
Decisions to include these [adverse] events in labelling were based on one or more of the following factors: 1) severity of the event, 2) frequency of reporting, or 3) strength of causal connection to [this vaccine].
If you look at the FDA Code of Federal Regulations 21 CFR 201.57 you learn that only adverse effects that likely have a causal relationship with the vaccine are to be included on these package inserts. The Code of Federal Regulations states:
For purposes of prescription drug labeling, an adverse reaction is an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.
So, if you see an adverse event or medical condition listed anywhere on the package insert, it's because the manufacturer and FDA have basis to believe that condition is caused by the vaccine.
Below is a consolidated list of all the serious and deadly health conditions that the manufacturers list in their inserts. Instead of conducting the proper long term placebo controlled studies, to determine whether or not the vaccines cause these outcomes, the manufacturers instead provide a vague blasé warning, with carefully chosen wording which gives the reader the impression that there is no relationship. This vague warning also gives the manufacturers legal protection. Should a person experience that medical condition following vaccination, and should that person sue the manufacturer for damages (in many countries like the US you can't sue the vaccine makers) the manufacturer then points to the label saying, "We provided the appropriate information, in warning, and by accepting receipt of this vaccine the recipient subsequently agreed to accept any risk of that potential outcomes."
Of course the patient was never given the package insert that contains the warning, they were given the short consumer information sheet instead. The following is a consolidated list (most items below link to a government webpage, or manufacturer or respected medical webpage providing an explanation of the condition). I've also noted each condition that is related to impaired immune actions:
Allergic reaction / anaphylaxis (immune system disorder)
Seizures or convulsions
Transverse Myelitis (immune system disorder)
Acute disseminated encephalomyelitis (neurologic, immune system disorder)
Multiple Sclerosis (autoimmune disease)
Myasthenia (autoimmune disease)
Myositis (autoimmune disease)
Encephalopathy (brain disease, damage, or malfunction)
Myocarditis (autoimmune response)
Autoimmune hemolytic anemia (autoimmune disease)
In the manufacturers listing above, they admit that vaccination may be causing at least 11 different serious immune system disorders, in addition to the other 25 serious adverse events or conditions.
Seeing as autoimmune diseases (which result from the immune system attacking the body) have increased dramatically since WWII, then it only makes sense to start looking first at vaccination. That's not to say other factors have not played a role, BUT, vaccination is the ONLY environmental change that we have imposed since WWII, where the sole intent was to directly affect the immune system itself. Nothing else has had that same intent.
We regularly hear that vaccines rarely cause serious side effects, and such a statement is usually quantified by saying "serious adverse events occur only once in every one million doses administered." But that statement is based upon assumption, not on scientific testing and comparison against a never vaccinated control group.
Remember, according to the Autoimmunity and the Gut paper, it explained that autoimmune diseases can take years, before vague symptoms progress and become debilitating enough that a doctor is able to diagnose the autoimmune disease. Of course, we've learned directly from the manufacturers that most vaccine trial participants are monitored for a whopping 14 days or less, following each dose of vaccine administered.
So, using the commonly stated claim that vaccination harms only one in a million recipients, it also becomes reasonable to use that same figure to hypothesize that maybe vaccination causes one additional occurrence of each of the above listed serious adverse events in every one million doses administered. And of course, we can hypothesize that vaccination may lead to the eventual development of each of the 80 autoimmune diseases, with each occurring at least once from every one million vaccinations. With that hypothesis, that gives a total of 102 different serious possible adverse outcomes, meaning a serious adverse event will occur following every 9,803 vaccine appointments.
Remember, Canadian researchers found one additional case of narcolepsy for every one million vaccinated. That subtle increased rate of narcolepsy in Canada would never have been detected, had it not been for an explosion of narcolepsy cases occurring in Finland, following Pandemrix vaccination. It was only because Finland asked, "Are you experiencing this too?" that Canada looked. When first confronted with Finland's inquiry, Canadian officials assumed, "Nope! There's no additional narcolepsy here." But after looking directly for it, they discovered evidence that their initial assumption was very wrong. And remember, the study compared vaccinated and differently vaccinated people. What might be the result if we compare vaccinated people to those never vaccinated?
Vioxx Labelling Changes
One of the most challenging issues we face within this vaccine controversy, is TIME. For those of us who are deeply concerned about a lack of data for vaccine safety, we face the frustration that time has not been working in our favour. The studies we want to see done, they are not being conducted, nor does it appear that they will be conducted in the near future. Not only that, sometimes these studies take years to complete.
And although time can be a very frustrating thing, it is also only through the passage of time that we become more enlightened to things that were completely unknown before. That reality has played out for all to see in countless historical examples, and in the realm of drugs, Vioxx is a perfect example of this. If you take a look at the Vioxx package inserts, from start to present, you see a progression in safety information presented. The very first package insert approved by the FDA in 1999 stated nothing about cardiovascular events. One and a half years later the insert was changed to include a precaution (not warning) noting a possible risk of cardiovascular events. And recently, in 2016 (17 years after Vioxx was first licensed), a new Vioxx package insert begins with a very prominent, highly emphasized, bolded warning, which explains it's quite possible that Vioxx causes serious fatal cardiovascular events.
Seeing the progression of warning change through time leaves me cautiously hopeful.
Coming up, we’ll move into a discussion of the untestable factors which also affect vaccine safety. Before doing so, I’d like to ask you to reflect on each issue presented in the last three chapters. Each study design “failure” stems from the government’s official position that vaccines are the miraculous answer. The assumption is that vaccines can’t have a serious affect on health, outside of preventing the disease targeted for elimination through the vaccine itself. As a result, long term studies on health aren’t conducted, meaning safety is given less priority compared to efficacy. The CDC framed their statement saying that long term studies on safety are not “practical” or “ethical” when an effective vaccine is available.
I often hear people make the statement that it's reasonable to give their kids all the vaccines which they received in their childhoods during the 70s, 80s and 90s. What people don't realize is that by the 90s, all those vaccines that we received, the DPT, oral polio vaccine and MMR vaccines, all those vaccines were pulled from the market. The DPT vaccine was pulled because side effects were too severe, it was replaced with the DTaP vaccine. The oral polio vaccine, was replaced with the inactivated polio vaccine, because the oral vaccine was causing polio. A previous formulation of MMR was determined to be ineffective, and the updated formulation had to be pulled in Canada, Britain and Brazil for causing meningitis.
More recently, the RotaShield vaccine was pulled from the market after it was discovered that the vaccine caused intussesception in many infants, a serious and potentially fatal condition. And most recently, we had the Pandemrix and Arepanrix vaccines, both of which have been found causally associated with an increased rate of narcolepsy.
It was only after these vaccines were being used on the entire population, of children, that the harm was discovered.
Immunologists have clearly stated that vaccination causes gene alterations within the immune system cells. Not only do they not know what those specific gene alterations are, or how those alterations have changed immune system actions and performance, they admittedly don't even know what a healthy immune system looks like, or how it operates when it's working optimally.
How probable do you think it is, in any field of science, any field of mechanics, that lay people, who have no idea or understanding how a system works or looks when it’s functioning at its optimum, that those lay people might impose intentional changes directly onto that system and actually improve that system’s performance? Does that sound even remotely probable or likely? Or does that sound laughable? And to think, Government officials arrogantly believe they have improved a system they don’t understand. Consequently, they insist it’s unethical to compare the two systems, a vaccinated system and never vaccinated system, to learn how they differ now after the imposed changes were implemented. The incredible nonsense they come up with makes me just shake my head in disbelief!
Moving forward, the most essential thing that absolutely needs to happen is a comparison of long term health outcomes between a fully vaccinated population, a partially vaccinated population, and a never vaccinated population. If that study is never demanded by the public, then that means society is relying upon assumption and belief, not on scientific evidence - which they emphasize is the foundation of our medical system - “evidence-based medicine.”
Moving forward, the most essential thing that absolutely needs to happen is a comparison of long term health outcomes between a fully vaccinated population, a partially vaccinated population, and a never vaccinated population. If that study is never demanded by the public, then that means society is relying on assumption and belief, not on science.
CONTINUE to the next article: Ch8: Article 1
Article Sources - Vioxx Information
FDA - All FDA information on Vioxx Here
1999 -Original Vioxx Package Insert Here
2001 - Change to Vioxx Label, showing the addition of a "Precaution" for cardiovascular effects as a result of the VIGOR study Here
2016 - Change to the Vioxx Label - showing the addition of a prominent and emphasized warning for cardiovascular events Here
The VIGOR Study completed in 2000 Here
David Graham's 2005 study published in the Lancet on the Risk of Sudden Cardiac Death from Vioxx Here Additional Article Sources
2004 - David Graham Testimony to US Government Here
2005 Interview with David Graham Here
US Court Document - Ruling that SIDS death likely caused by vaccine Here
CDC - 3700 Sudden Unexplained Infant Deaths annually Here
Research - Decreased Orexin (Hypocretin) in infants who died of SIDS Here
Allergies - 6th leading cause of chronic illness Here
CDC Whistleblower, Dr. William Thompson's official statement Here
Documentary - Vaxxed From Cover-Up to Catastrophe Here
Research - 83 Cases where Vaccine Court provided compensation for vaccine-induced brain injury which left the child autistic Here
Neurologist and father Dr. Jon Poling, talks about his vaccine court ruling that conceded his daughter's autism resulted from her vaccine-induced brain injury Here
Discussion by Dr. James Lyons Weiller - how vaccine safety studies are manipulated Here