Adverse Reaction reporting in the US, EU and the UK
By Eva Wisenbeck 30/05/2021
Listen to Part One of the Interview HERE
Watch the Video HERE
COVID-19 - Reporting of adverse events for injections and responsibility
This is what the current official reporting is showing for the US, EU and the UK when it comes to Adverse Events (aka side effects) and suspected deaths linked to the injections.
It does get a bit odd from here on in, if a product is still in a medical trial phase, one could be forgiven for thinking that ongoing data is gathered and analysed – alas it is not really that straightforward!
Talking about the US, EU, and the UK each entity has an existing system for reporting any issues, in the US it is VAERS, in EU it is EudraVigilence and in the UK it is the Yellow Card.
All these systems are “passive” websites/apps meaning they are relying on people to self-report. Already here there are huge red flags, firstly I personally know about 10 people who has had a covid injection, I know that 9 technically had “adverse events” such as shingles, heart attack, tinnitus, headaches, chills, fever etc.
None were reported!
Now a few of the reactions in my direct circle were rather more significant than minor and one would think the manufacturers and the governments would like to know.
Then of course we have far more serious issues such as the blood clotting, strokes and of course – death!
Again, here there are two big issues, one is that the person needs to recognise it and report it (or their families), and/or a treating physician would have to suspect a correlation to a previous injection, feel the likelihood was strong enough and then be willing to report it.
There sure are many steps and ifs and buts…
And all along, let’s not forget that Big Pharma all have complete indemnity and cannot be made to be held responsible if you or a loved one are injured or killed.
In fact I find it outright distrurbing when media (and society) are saying well it’s for “the greater good” and there is always “collateral damage”.
Again, not saying any of this is good or bad, it merely is where we are at and I think we all should be aware. For me any medical treatment or procedure should be undertaken with the aim of gaining or protecting one’s own health and that informs the questions to ask.
Do we need a vaccine?
Well let’s backtrack and turn over some more stones
If the survival rate is over 99% (currently I’m seeing about 99.6% in European countries) does the whole world population need to be vaccinated for Covid-19?
What is the total overall mortality where you live compared to the last 5 or 10 years?
If this is a syndemic aka acute disease mixed with chronic lifestyle related diseases, what is the best way to approach and correct the underlying issues rather than just focus on the “pathogen”?
“A syndemic or synergistic epidemic is the aggregation of two or more concurrent or sequential epidemics or disease clusters in a population with biological interactions, which exacerbate the prognosis and burden of disease. The term was developed by Merrill Singer in the mid-1990s.” Wikipedia
What happens when the next virus comes, as it will, they always have?
How come there has been very little airtime and debate around clinically proven, and research supported, risk reductions such as addressing Vitamin D deficiencies and metabolic disorders etc?
Why are many countries not treating Covid-19? There are several treatment protocols out there utilising existing and proven medications.
What is my personal health status and risk profile for any disease?
What is my past history of tolerance and issues with medication and vaccines?
What is the balance between, “for the greater good”, commercial profit etc?
Financial Times – “The future Covid-19 vaccine market could be worth more than $10bn a year, generating bumper revenues for pharmaceutical companies that have funded large parts of their research with government money. The calculations by analysts at Morgan Stanley and Credit Suisse assume that people will need to take a Covid-19 vaccine every year, like a flu jab, and are based on projected costs for the shot, currently hovering at about $20 a dose.”
Informed Consent and Health and Medical Freedom
To keep it short and clear, here is a great description from NCBI (The National Center for Biotechnology Information is part of the United States National Library of Medicine, a branch of the National Institutes of Health):
“Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body.”
Although this refers to the US the same applies in many countries. I will add the link to the UK NHS page below in sources.
For the UK an incredible Scottish initiative have gone over the marketing material provided for the injections, with informed consent in mind, and their counter reply is most interesting, take a look here. If you are short of time scroll to page 4 onwards.
And what about the Nuremberg Rules of Conduct? Well it seems it might be a bit more “grey” than I thought. Regarding human research it’s been eclipsed by the World Medical Association Declaration of Helsinki in 1964.
The original Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps.
The 10 elements of the code are:
Voluntary consent is essential
The results of any experiment must be for the greater good of society
Human experiments should be based on previous animal experimentation
Experiments should be conducted by avoiding physical/mental suffering and injury
No experiments should be conducted if it is believed to cause death/disability
The risks should never exceed the benefits
Adequate facilities should be used to protect subjects
Experiments should be conducted only by qualified scientists
Subjects should be able to end their participation at any time
The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur
And what are guidelines and codes of conduct vs legal obligations I genuinely can’t answer… That is one for lawyers to debate and I have a feeling that will happen in various countries as the Covid-19 vaccines become increasingly more available!
What I do know is that you certainly have a right to ask questions, and gain access to data and risk assessments, before taking any medical decision (yes yes if you are indeed conscious and of sane mind and all that jazz). And our favourite motto still stands – ask questions – What does Informed Consent mean where you live? What rights do you have? What obligations does your doctors have?
Our amazing VAERS data analyst Albert @WelcomeTheEagle88, whom we chatted to in the podcast (which can be found at the top of this blog), can be found here with much more information:
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ConservativeWoman - Vaccine risks versus rewards – what your GP won’t tell you
Real-time database and meta analysis of 588 COVID-19 studies
Financial Times - Covid-19 is really a syndemic — and that shows us how to fight it https://www.ft.com/content/34a502b1-5665-42ff-8a8d-1298b71f1e7b
Microbenotes - Vaccines- Introduction and Types with Examples https://microbenotes.com/vaccines-introduction-and-types/
NCBI - Informed Consent https://www.ncbi.nlm.nih.gov/books/NBK430827/#:~:text=Informed%20consent%20is%20the%20process,undergo%20the%20procedure%20or%20intervention.
NHS – Consent to Treatment https://www.nhs.uk/conditions/consent-to-treatment/
JAMA - The Nuremberg Code 70 Years Later https://jamanetwork.com/journals/jama/fullarticle/2649074
imarc - THE NUREMBERG CODE AND ITS IMPACT ON CLINICAL RESEARCH https://www.imarcresearch.com/blog/bid/359393/nuremberg-code-1947