What’s the Process for Determining if an Adverse Event Following Vaccination was Caused by the Vaccine?

How is it determined whether or not an adverse event following vaccination was CAUSED by the vaccine ?

It turns out that the US Department of Health and Human Services has a stringent set of criteria that, as far as we can tell, are impossible to meet.
This article discusses them in detail: https://academic.oup.com/lpr/article/12/3-4/189/916822. But we’d like to discuss them, too, in simpler terms.
Author Richard Moskowitz, MD, in his book “Vaccines,” describes the criteria by the following 8 categories:

“1) the exact chronology must be known;
2) the illness or injury must already have been linked to a specific vaccine;
3) it must be ‘biologically plausible,’ whatever that means;
4) it must be confirmed by appropriate laboratory testing;
5) it must be shown to recur with subsequent revaccination; and
6) a placebo-controlled study must prove that the vaccinated group are more at risk for it than their unvaccinated controls.”

So let’s discuss each criteria separately.

  1. EXACT CHRONOLOGY
    It is nearly impossible to establish exact chronology with many autoimmune/chronic diseases, because they tend to develop very slowly, with symptoms becoming apparent only weeks or months after something starts to go wrong. People often go to doctors for years before one being correctly diagnosed.

    It takes an average of 11 years to be correctly diagnosed with celiac disease, for example. That’s 3 years beyond the 3-year statute of limitations required to file a claim with the so-called “Vaccine Court.”

    There IS a specific compensation program for serious adverse reactions to drugs and vaccines given emergency authorization. Covid-19 vaccines would be in this category.

    The program has a 1-year statute of limitations.

    Think about that.

  2. DEFINING “ADVERSE REACTION.”
    Restricting the definition of adverse reactions to those already recognized and linked to specific vaccines means that unanticipated reactions, those that have not yet been understood or recognized, are entirely excluded.

    What happens when the industry has chosen to bury evidence of unanticipated outcomes, as they have down with opioids, and countless other drugs?

  3. PROVE THAT IT’S PLAUSIBLE
    Requiring proof of “biological plausibility" sounds reasonable — but the t effectively rules out autoimmune diseases, since they are, thus far, incompletely understood, and “biological plausibility” has never been proven even for their accepted triggers, like emotional stress being linked with shingles.
  4. CONFIRM WITH TESTING
    This, too sounds plausible — except for many disordered, there is no diagnostic test available. Requiring laboratory confirmation effectively rules out all diseases classified as “syndromes,” since by definition, they are diagnoses of exclusion, with no single lab test that can definitively diagnose the condition. Examples include Meniere’s Disease, Sjogren’s Syndrome, and MS.

    This requirement also rules out developmental disorders.

    Think about what that could mean.

  5. PROVE WHAT WILL HAPPEN
    The requirement of proving that an adverse event will happen to the victim again with subsequent re-vaccination is outrageous. Anyone who has had an already-frightening reaction to a previous vaccine may have a worse one the next time, OR the same reaction again, OR no reaction at all.

    It all depends on WHY the event happened in the first place. Was the vaccine from a “hot lot?” Or mishandled by the provider? An allergic reaction? A reaction due to simultaneous exposure to something else, requiring both exposures? (Example: lead poisoning from tainted water.) A reaction exacerbated by an already-existent sub-clinical infection?

  6. PROVIDE PLACEBO-CONTROLLED STUDIES PROVING CAUSALITY
    This is such hypocrisy, it’s practically diabolical.

    For all vaccines already approved by the FDA, both the CDC and the industry's own safety trials did not use true inert placebos. They used either other vaccines as comparitors, or they used one or more potentially reactive ingredients, such as the adjuvant (the single ingredient added to many vaccines in order to trigger a stronger immune response), and disingenuously labeled this as “placebo.”

    The result is that “placebo” groups in these studies have similar safety profiles to the vaccine groups. Not surprising, if the ingredient or combination of ingredients that’s most dangerous was given to both groups.

Vaccine safety critics have been demanding true inert placebo-controlled studies for years, and have been repeatedly told that this would be “unethical.”

We note that Covid-19 safety studies are the first vaccines we are aware of whose prelicensure safety studies use saline placebos, and show an unprecedentedly high rate of adverse reactions from the actual vaccine.

We only wish that such stringent criteria were used to prove that the vaccines in question actually prevent the targeted infections, including asymptomatic infections.

But neither manufacturers nor the government are required to do that.