Tag Archives: TGA

OpenDAEN: Misleading Australians

Posted in Anti-Vaccination Lobby, COVID-19, COVID-19 Vaccine, Health, Immunisation, Legal, Scam, Science, Social Media by

On Monday 22 January 2024 the unique home for all things COVID conspiracy, Café Locked Out, hosted a video titled The Launch of OpenDAEN, A free database of Adverse Events. Cutting to the chase, OpenDEAN, promoted and launched by Sharon Cousins, purported to be an easy and honest means of access to the Therapeutic Goods Administration, Database of Adverse Event Notification.

Like its namesake previously debunked here, OpenVAERS, the Australian analogue of misleading information, OpenDAEN, presents decontextualised data in a manner that seeks to create the illusion COVID-19 vaccines are inherently unsafe. That “vaccine injuries” are rampant. Again like OpenVAERS it presents as conclusive fact, reports of negative health experiences observed in, or claimed by, an individual after that individual received a COVID-19 vaccine.

Like the TGA, OpenDAEN uses the Medical Dictionary for Regulatory Activities (MedDRA), to classify adverse reactions. It provides filtering with the European Medicines Agency, Important Medical Events list and Pfizer’s analysis of post authorisation adverse events. An additional adverse reaction of “serious” has been added to OpenDAEN. Sharon Cousins is an erstwhile insurance executive, now presenting as an “independent researcher” with a penchant for criticising COVID-19 vaccines. Sharon could not share her screen and was directing suspended NSW anaesthetist Paul Oosterhuis, the third member of this Zoom presentation, around the site.

The primary data interrogation categories on the index page of openDAEN are:

  • Case numbers by Year, Month and Sex
  • Cases by COVID-19 Vaccine Type
  • Case Numbers by Reaction term and Age
  • Case by Frequency of Batch Number
  • Table of case number, date, vaccine manufacturer, MedDRA reactions, Death, Serious cases and the FOI request number the batch number was confirmed by.

The index page offers the following:

Above: Slideshow: OpenDAEN website

OpenDAEN is called a “free database”. Don’t be fooled. The important elements here are reports and post vaccine, combined with the fact almost all adult Australians have had two COVID-19 vaccines, as have two thirds of 5-15 year olds. Random ill health events can and do frequently occur coincidentally with vaccination. It’s also important to realise that the TGA and health authorities encourage Australians to report these events, so that over time a greater understanding of these vaccines will emerge. OpenDAEN.info provides a description on each page footer:

OpenDAEN.Info is a non-commercial and not-for-profit website for the research, study and review of the TGA (Therapeutic Goods Administration) DAEN (Database of Adverse Event Notifications) system in respect of COVID-19 vaccines. The primary source of data on OpenDAEN is the TGA DAEN system and their published FOIs (Freedom of Information). 

Decontextualisation

When taken out of context and denied TGA cautionary disclaimers, the reports become hearsay temporally related to something somebody did. Nothing more. This is decontextualisation. But apparently, we are to assume causation exists. OpenDAEN claims to be able to offer up to date, conclusive data related to adverse events caused by COVID-19 immunisation. These adverse reactions are the subject of reports sent to the TGA DAEN. So, the data themselves have a recognisable source. But can absolute conclusions be made with any real confidence? In reality it takes time for clinically relevant events, specific to any vaccination to be investigated, identified and acted upon. Unless already understood and published on the TGA COVID-19 Vaccine Safety Report (2 November 2023), the quality and quantity of adverse reaction is speculation. To make matters worse, the anti-vaccination lobby has invested an exceptional amount of time spreading disinformation via social media, and one of their primary targets has been the TGA DAEN.

The anti-vaccine lobby want every report to be an absolute reality. They want the figures, diligently and honestly provided to Australia by the TGA, to be accepted without examination as conclusive, in their misguided attempt to wipe out COVID-19 immunisation. We saw this claim time and again in the court affidavits of Peter Fam, Meryl Dorey, Julian Gillespie and Katie Ashby-Koppens; reports presented as if confirmation of death and injury in huge numbers. But correlation is not causation. If you haven’t clicked the link to DAEN by now, let’s see what the TGA, but not OpenDAEN, stress about the contents.

 - DAEN SPLASH SCREEN DISCLAIMER –

Okay, so it confirms what I stressed above. But most crucially, you have to tick the teeny weeny little box next to I have read and understand the above, to access the TGA data. The disclaimer can’t be missed. Only willingly ignored. The importance of what this means and the restrictions the disclaimer places ipso facto, on OpenDAEN was studiously avoided during the video on 22 January. In fairness I will note that a small header on the TGA DAEN page was visible, but also ignored. It reads; Inclusion in DAEN – medicines does not mean that the adverse event has been confirmed or that it was caused by a medicine or vaccine. Clicking it – which the presenters also studiously avoided – reveals a little more about the DAEN content. Due to size restrictions of a screenshot, I’ll pop the text in a paragraph, and include some emphasis (mine):

The DAEN – medicines allows you to search adverse event reports for medicines including vaccines received by the TGA. The TGA uses adverse event reports to identify when a safety issue may be present. The DAEN – medicines does not contain all known safety information. An assessment of the safety of a medicine or vaccine cannot be made using the DAEN – medicines alone.

If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible. 

Talk to a health professional before starting, stopping, or changing your prescription medicines.

Anyone can report a suspected adverse event, including members of the public, health professionals and pharmaceutical companies. We encourage reporting even when it is not clear that a medicine or vaccine is the cause. Information from these reports is published in the DAEN – medicines and reflects the observations of the person who reported the event.

People who experienced an adverse event cannot be identified. Maintaining their privacy is of critical importance to the TGA.

The DAEN – medicines is a ‘living’ database that is frequently updated. Information may change if we receive more details on an existing report or if we identify duplicate reports and combine them. Updates may also occur as part of our data quality assurance activities.

For more information about the search results and how to interpret them, see: More about the DAEN – medicines

– Text from second DAEN disclaimer –

In short, the TGA DAEN database is constantly growing, contains information from any member of the public, reflects the observations of that person, provides no information about the safety or lack thereof, of vaccines and does not confirm that an adverse event was caused by a vaccine. It cannot even confirm if the event has actually occurred. I might add, dear reader, given that the anti-vaccine lobby has gone out of its way to submit to the DAEN clearly impossible and even bogus reports, one must remain extra vigilant when assessing or querying these data.

Indeed, Sharon Cousins herself relayed an abuse of the TGA DAEN system at the 8:30 mark of the video. She had queried via FOI why a reported death of a 6 year old boy was no longer available on the DAEN. Sharon noted that within her FOI report FOI 4077 (“Batch numbers of COVID-19 vaccines of reported deaths”), it was revealed the initial report was submitted as a hoax. The relevant section of the report reads:

FOI 4077 also requested information about why case number 724925 no longer appears in the DAEN. This report was rejected following review of further information for the case. The information demonstrated that the report was submitted as a hoax and as such there is no identifiable patient. The report remains in the TGA’s internal database. However, it no longer is included in the DAEN as it has been rejected because it no longer met the minimum criteria for a valid adverse event report.

Sharon Cousins

Sharon also said the TGA reply included, “Normally we wouldn’t answer this”, after insinuating she has a positive relationship with them. However, that comment is clearly not there. One appreciates Sharon sharing this information, but cannot ignore that it took an FOI query of a fatality to uncover the truth. How many other adverse or serious adverse reactions were, or will be, “rejected following review of further information for the case”. Sharon was eager to reassure viewers that OpenDAEN was not misusing the TGA website, but rather making it “more user friendly”. It will be of benefit to TGA staff Sharon opined, and she had sent the site link “to the coroners”, and to State and Territory head pathologists.

Batch Numbers

Throughout, much is made of the section allowing search of batch numbers. We learn that when it comes to accessing batch numbers, the TGA, “Doesn’t have any search engines on it, is a little bit clunky and it times out”. The TGA freely provide data in CSV format on batch release assessment of COVID-19 vaccines. One of two release pathways is taken; either based on overseas certification or based on TGA laboratory assessment. The TGA explain this in detail. So, what could be wrong with smoother navigation of COVID-19 batch numbers as a function of vaccine type, reported adverse reaction and de-identified data? Usually nothing, unless one ignores TGA advice and extrapolates to conclusion, based on other available data.

At the 50:00 minute mark Sharon directs navigation through the number of cases per batch number, highlighting batch number FP1430 – COMIRNATY, (Pfizer), in section 4. OpenDAEN has accessed the batch numbers via FOI, and that’s fine. OpenDAEN reveals inordinately more adverse reactions for male and female associated with this batch number, compared to those next to it. Sharon instructed more data access and directed navigation to the batch number table. She continued:

Look at the dates! Look at all the dates! Within 24 hours of the Pfizer being released on the younger children, the five to elevens… it was all advertised, tenth of January [2022], five to eleven year olds… within 24 hours we have reported cases. Now that for me is causal proximity.

Sharon continued on, directing suspended doctor Oosterhuis to isolate reported – not confirmed – fatalities using that batch number and age group. They isolate two boys. Zeroing in on the symptoms of one boy, Sharon reads, abdominal pain, then dismisses adverse event following immunisation as “a very bland one”, then cardiac arrest. She has Paul Oosterhuis explain eosinophilia and eosinophilia myocarditis. He assumes he is explaining the findings of both of “these boys”. In fact the data reveal clearly it is only one boy. A five year old.

The ten year old “fatality” has only Adverse Event Following Immunisation listed. The “very bland one”, dear reader. Then Sharon warns us “It’s a little bit distressing now, okay. The two boys both had the same batch number”. She gets Oosterhuis to zoom in and suggests, “So, screen print that people if you don’t believe us”. After zooming in on the case numbers Sharon has Oosterhuis zoom in on the batch numbers again, as if she hadn’t made that point enough times already.

Now, I am not a lawyer but I doubt the strength of Sharon’s “causal proximity” claim. There is another factor Sharon told us herself, that must be considered. As she points out, the roll out for Pfizer for 5-11 year olds was 10 January 2022. Thus, the first factor I would investigate would be the sheer number of children being vaccinated, at the time of release. Over 11 weeks, 76.6% of those 2.3 million children were vaccinated. 1,761,800 children had one dose. 1,552,500 (67.5%) had two doses. The vaccine for 5-11 year olds is one third the dose approved for children aged 12 years and over. Cold chain transport and storage is vital to the success of mass mRNA vaccination programmes.

Using OpenDAEN to interrogate vaccine batch numbers of adverse reports about 5-11 year olds, over the first two months of the rollout, we see virtually one result: FP1430. Yet what is more likely? Batch FP1430 is responsible for all adverse reaction reports? Or most 5-11 year olds vaccinated in the initial days, were dosed from batch FP1430? By the end of February other batch numbers begin to appear and gradually attract more reports. By late March, FP1430 is just another batch number. More so, there are over 500 unknown batch numbers for that age group. However, if you present your disinformation just right, some might believe in the deliberate harming of children:

– Facebook comment –

What do the TGA say?

There have been no deaths in children or adolescents determined to be linked to COVID-19 vaccination. More detail on these deaths is available in the safety report published on 15 December 2022… If we identify a new death likely to be related to vaccination, we will publish this information promptly, as we have for all other cases since the start of the vaccine roll-out. [Source – 2 November 2023]

Of the 14 deaths the TGA confirm are linked to vaccination, none are in the 5-11 year age group. Yet Sharon is convinced of her claim, has already convinced others and will convince more, simply because of bias. Her defence, I suspect, will be that she used FOI legislation to access reports on batch numbers and the TGA lacks the smooth batch number access and navigation of OpenDAEN. Yet Sharon made up her mind before she even started looking. In fact, Inclusion in the DAEN does not mean the event has been confirmed or determined as related to a vaccine, is utterly ignored when using OpenDAEN.

The reactions reported in January, are based on MedDRA. Seen clearly in the video, were cough, vomiting, pallor, lethargy, rash, injection site rash, syncope, cold sweat, decreased appetite, anxiety, dizziness, nausea, abdominal pain, abdominal discomfort, aggravation of existing disease, excessive sweating, hives, muscle stiffness, chest discomfort. The worst on screen were seizure, appendicitis and a seperate loss of consciousness. Searching the batch number/adverse reaction table for 5-11 year olds in my own time, revealed reports of chest pain, syncope, anaphylactic reaction, paraesthesia, ECG ST segment elevation, nystagmus, pneumonia and many others. Some reports were of one reaction and others of multiple. All reports are of conditions children experience everywhere across the globe. Establishing cause or any relationship to COVID-19 vaccines is the role of health authorities.

Elsewhere on OpenDAEN we read that:

Useful search engines, graphs and tables have been developed into a helpful user-friendly database to assist study, research, review and analysis of the Australian Government publicly available data. […] We believe in sharing this information in an open and easy-to-use format (with search engines, tables and graphs etc.) and to help make it quicker for anyone wanting to source data for their own study, research and review. 

The Quack Miranda

So, the team want to share information in a fast open and easy way to help with doing your own research. It sounds almost too good to be true. The Disclaimer and Disclosure tell us:

– Source: OpenDAEN –

Okay then. It is up to the user to get further professional information to confirm if the information is “of value to you”. Accuracy of the information cannot be guaranteed which places further responsibility on the user to seek advice before relying upon it. It’s information they might get wrong and as such will not be liable “for any loss, damage, cost or expense incurred” by reason of relying on that information.

The site has a small section on endorsements. The longest is from Julian Gillespie. Anti-COVID-19 vaccine researcher, legal consultant to the AVN, and Dr. Julian Fidge and author of a ridiculous IJVTPR paper, The Canaries in the Human DNA mine, Gillespie offers:

It is 2024 and world search and data systems can perform enormous and complex requests with astonishing speed and accuracy, yet when Australian governments roll out never before used experimental gene therapies to millions of citizens, Australians are left to report to an antiquated adverse event reporting system (DAENs) still with both feet in last century.

This amounts to a fundamental failure of Pharmacovigilance and the Australian People. Searching through DAENs remains a nightmare for researchers, where one cannot but question the motivations of the TGA and the Australian health departments who feed it Our Information. OpenDAEN greatly assists researchers and students, and data and IT experts desperately needed to review and criticise the current DAEN system which is not fit for purpose.

Hopefully OpenDAEN will motivate Australian governments to take the needed steps towards a national real-time, transparent, and easily accessible adverse event reporting system, for properly protecting the health of Australians and better facilitating valid Informed Consent. The antiquated DAEN system deprives and seemingly hides needed health data necessary for Australians to provide valid Informed Consent.

COVID vaccine injury class action fund raiser, Dr. Melissa McCann writes:

This is amazing and meticulous work by you and your team.

Strong reminders of OpenVAERS and how decontextualised data are used by anti-vaccine activists to mislead, were apparent during the video. Alluding to what is known as the Lazarus Report, after the name of the principle investigator, one commenter offers:

– Facebook comment –

Suggesting that TGA DAEN statistics are only “(10%?)” of “ACTUAL injuries and deaths”, is linked to a bogus belief of widespread underreporting to VAERS in the USA. I addressed this in a post challenging OpenVAERS, writing.

The figure of 1% comes from a report from Harvard Pilgrim Health Care, Inc., authored by Ross Lazarus. Data examined are from 1 December 2007 to 30 September 2010. These data include all possible adverse events. Prior evaluation of the reporting rates of various events confirms that minor events are rarely reported and more serious events routinely reported. A 2014 report on surveillance of adverse events following immunisation in NSW, Australia noted that:

Only 11% of the reported adverse events were categorised as serious.

In short, most adverse events such as a sore arm, nausea, swelling, redness, headaches, vomiting and other self correcting issues are indeed underreported, but make up the vast bulk of adverse events following immunisation. Yet since the Lazarus report, anti-vaxxers love to spread tales of widespread death and terrifying injury, then solemnly add “only 1% are ever reported”.

Paul Offit is a strong supporter of VAERS which he refers to as a “hypothesis-generating mechanism”. Reports there of intussusception approximately once per 10,000 doses led to suspension of his own RotaShield vaccine which was ultimately recalled, before returning as a safe product. In fact health authorities want parents or doctors to report minor events as soon as possible. Much can be learned about self limiting reactions, and more concerning to severe reactions can be gauged by pattern changes, properly identified and suspended under section 29D of the Therapeutic Goods Act 1989.

Perhaps the most damning page on OpenDAEN is the resources page. A curated smattering of COVID-19 vaccine pseudoscience and “vaccine injury” class actions, peppered with all the anti-COVID mandate and health advice groups, it seems designed to lead readers into a field of gaping rabbit holes. Dr. Melissa McCann’s COVID class action vaccine injuries video tops the page. The World Council for Health Spike protein detox guide is there. R.F. Kennedy Jr.’s Children’s Health Defense Australia, The Zelenko Protocol, The Australian Medical Professionals Society, many of whom we’ve met here before, World of Wellness and the National Institute of Integrative Medicine to name a few.

Conclusion

OpenDAEN is not an exciting addition to the TGA DAEN database. It is not a positive, user-friendly addition to TGA staff or to genuine researchers and academics. It is created, managed, supported and provided by and for respectively, members of the anti-vaccine community, convinced that COVID-19 vaccines are the cause of multiple health ailments and death. No professionals were available for its launch. All invitations were ignored. It has no integrity and no academic standing. No coroners or State and Territory head pathologists will care.

Like its namesake in the USA, OpenVAERS, it is designed to allow users to gather misleading collections of coincidental report material and present this as causal COVID-19 vaccine adverse reactions. To be sure, the results it produces, easy to construct as they are, will find their way onto websites, social media and court affidavits. OpenDAEN won’t enjoy the success OpenVAERS did, because now only diehards remain. During the launch of OpeanDAEN, events two years old were focused on, to craft a demonstrably bogus, yet very serious accusation against COVID-19 vaccines.

The colours are a nice change though.

Vaccine Safety Information You Can Trust

Last update: 2 February 2024

♠︎ ♠︎ ♠︎ ♠︎

Mal Vickers coming to Skepticon 2023

Posted in Alternative "medicine" scams, General, Science, Skeptic by

Mal Vickers is a skeptical activist with a singular focus on shonky so-called treatments, and the much-to-be-desired responses of regulators responsible for keeping our community safe.

According to Skepticon 2023 website:

Mal Vickers

In 2016 Mal received the ‘Skeptic of the Year’ award, jointly with Dr Ken Harvey for complaints about chiropractors. While studying towards a Master of Public Health, Mal investigated the complementary medicines market using the complaints made about its advertising and products. Mal is a mild-mannered bio-medical engineer and enjoys photography and tinkering in his workshop.

Working with Dr. Ken Harvey Mal has been instrumental in targeting false claims that can harm consumers. They reported on persistent non-evidence based claims in breach of the Chiropractic Board and AHPRA guidelines, and the absence of appropriate responses from these regulators.

Mal and Ken published the first review of the TGA’s Complaints Resolution Panel over its entire 19 year life. The analysis comprehensively demonstrated the failure of the TGA to ensure regulatory compliance by advertisers of complementary medicines.

While our regulatory system is meant to rein in violations, from 1999 to 2018 complaints and established breaches of the law greatly increased. 
At Skepticon, Mal will peel back the layers of misleading advertising that ultimately wastes people’s time and money. 

How do the companies behind these products get away with it? And, who tops the list for unethical behaviour? 

Mal is also on social media:

You can still get tickets to Skepticon for either the physical or online experience.

There’s Something About VAERS

Posted in Anti-Vaccination Lobby, COVID-19, COVID-19 Vaccine, Health, Science, Social Media by

Since the inception of VAERS, anti-vaccination activists have misused reports as a cornerstone in their campaign to misinform and mislead. Vaccination against COVID-19 has led to that misuse exploding.

What is VAERS?

VAERS is the U.S. based Vaccine Adverse Event Reporting System managed by the Department of Health and Human Services (HHS) and co-managed by the Centers for Disease Control (CDC). It is an early warning system that collates reports of suspected adverse events following immunisation. A full explanation is here. Reports may be submitted by anyone who has received a vaccine authorised in the United States. Doctors, health workers, family members and associates can also submit reports. It is an open passive reporting system that allows reports from anyone who is aware of an adverse event they perceive as related to a vaccine.

It follows that the reports are just that; reports. Reports that contain no information about causality or indeed accuracy. This is not to say they are inaccurate. Rather that their true meaning, and indeed impact, can only be borne out in the context of further evaluation. Evaluation will assess any pattern of events, related health problems, any identifiable mechanism of causality and the time frame between vaccination and adverse event. Suspect vaccines would be suspended and emergency investigations employed to assess the scale and seriousness of adverse reaction(s). If the adverse event is confirmed to be more significant than in pre-licencing trials, the vaccine is removed from market.

Research and peer reviewed publication would follow, describing these findings. This information is of enormous benefit to the design, manufacture and trial of future vaccines. What stands out immediately is that determining adverse events due to vaccination requires significant input seperate from VAERS. The most important and irrefutable element about VAERS reports is that they do not represent cause and effect.

The VAERS site includes a Guide to Interpreting VAERS Data.

Under Evaluating VAERS Data:

When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. […]

VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

Under VAERS Data Limitations:

Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors. […]

No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. VAERS accepts all reports without judging whether the event was caused by the vaccine.

The above is a small selection from the guide. Yet it is enough to inform readers seeking definitive information on adverse events linked to vaccines, that it will not be found there. Exploiting the reports to provide an accurate picture of potential or existing problems takes resources. Resources that individuals don’t have. Consider the case of RotaShield. This rotavirus vaccine was taken off the U.S. market in 1999 because of an association between the vaccine and intussusception. The U.S. Advisory Committee on Immunisation Practices (ACIP) voted for its removal after an in depth review of available data. RotaShield was available for just months.

Paul Offit is well schooled in how VAERS is misused. He is also a firm supporter of civilian reporting because, as intended, unanticipated side effects can be caught this way. He has referred to VAERS as a “hypothesis-generating mechanism”, and observed about RotaShield:

There were a number of VAERS reports that patients within a week developed an intestinal blockage. A study was done and it was shown to be a causal association. VAERS was the tipoff. There’s value in it.

Medscape provide detail on the scale of the study:

The suspected association between RRV-TV and intussusception based on a review of VAERS data led CDC, in conjunction with state and local health departments, to implement a case-control study [in 19 U.S. states among 429 infants and 1,763 matched controls] and case-series analysis and a retrospective cohort study [among 463,277 children].

So yes. If it’s confirmation of adverse events due to vaccination one seeks, merely perusing VAERS isn’t enough. This doesn’t stop antivaxxers from abusing the VAERS database to create the illusion of wide scale “vaccine injury”. As we’ve seen time and again during the COVID-19 vaccine rollout, screenshots and memes reach a large audience. Discredited Australian Instagram influencer and anti-vaccine advocate, Taylor Winterstein, has misused VAERS data to attack “mainstream mentality”. These tactics have the added advantage of side-stepping the guide to interpreting what is limited data on VAERS. The same approach is used by right wing cable news outlets. There are numerous techniques used to avoid the reality that there is only a temporal, and not a causal, relationship between vaccine and adverse reaction. Presenting government data carries a certain authority. Stripping it of context ensures it is inaccurate.

OpenVAERS

Post hoc ergo propter hoc: After this therefore because of this. This fallacy is the fuel driving the VAERS misinformation empire. Without it, outright claims cannot stand. Nor could the inference and extrapolation that comes from accepting widespread vaccine injury and death. The Vaxxed II bus in Australia is a typical example. It began last year, collecting dubious testimonials on “the vaccine-killed and injured”. Last month it began targeting the COVID-19 vaccine. Removing context from VAERS data ensures post hoc fallacy. This is exactly what the OpenVAERS project does. Launched in September 2019, it was initially run from archivist.net as confirmed on the Facebook page of The Archivist. In January 2021 the domain switched to openvaers.com and focused on COVID-19 vaccination data. Unsurprisingly OpenVAERS is a favourite of antivaxxers. Until recently, the index page offered:

The OpenVAERS Project allows browsing and searching of the reports without the need to compose an advanced search (more advanced searches can be done at medalerts.org or vaers.hhs.gov).

That’s what we find on the archived index page as at 1 August 2021. The next capture is 23 August 2021. At some time between these captures, OpenVAERS included a link to its own copy of the VAERS disclaimer both on the index page and its impactful VAERS COVID Vaccine Data page. The change on the vaccine data page was minor. Compare the 23 July and 20 August pages below. Keep in mind this is what readers see when they land on the data page. To appreciate the importance of context I’ve included a screenshot of the government VAERS data page.

Prior to this, users of OpenVAERS would have to navigate to the About page and follow the link to the VAERS About page. The change came just prior to the publication by Logically, a misinformation tracking group, of an article on 12 August which revealed the name and face behind the site. Logically had posed questions and a request for comment, which may have prompted the design change. Lizabeth Pearl Willner (below) better known as Liz Willner believes her daughter was injured by vaccination and began posting anti-vaccine content on social media in April 2019. She insists the site exists to provide easy access to official data.

There were significantly more visits to OpenVAERS (1.23 million) than to VAERS (796.63k) between February and July this year. Logically discovered that 30 percent of referrals to OpenVAERS are from the right wing, fake news site, Gateway Pundit. 10 percent are from conspiracy theorist Vernon Coleman (old man in a chair). These sites promote COVID conspiracies, pseudoscience and anti-vaccination rhetoric. Willner’s now deleted Facebook account and recently deactivated Twitter handle @1pissedoffmom1, amplified the reach and impact of OpenVAERS.

Until April 2021 OpenVAERS included a dedicated and searchable vaccine excipients table. The OpenVAERS blog now returns a 404 page. Indeed those behind OpenVAERS seem intent on having their deleted content also removed from archive.org. When running, the blog provided a one stop antivax shop for COVID-19 misinformation for “warrior moms, dads and grandparents”.

Call For Action posts contained alarming inaccuracies about the COVID-19 pandemic and the safety of the COVID-19 vaccine. The posts linked to ready-made PDFs to be printed out and mailed to “friends, family, and elected officials”. The drill, as they called it, was “10 copies, 10 stamps, 10 envelopes, 10 chances to wake someone up”.

As recently as 2 August this year we find:

Unfortunately, coronavirus vaccines excel at producing iatrogenic injury. Since their rushed introduction in December, these shots have produced four times more fatalities than the terrorist attacks on 9/11.

A link to that particular post, along with the 9/11 reference was shared on The Defender. That’s the “news and views” site of Robert F. Kennedy Jr.’s Children’s Health Defense. The potential for harm by encouraging vaccine hesitancy in the midst of a pandemic is significant. Willner has ignored requests for comment from VICE News. The OpenVAERS blog also claims to be getting around “the criminal censorship of essential vaccine information on social media”.

Successful misuse of data this way relies upon the base rate fallacy. When vast sections of the population are involved, background mortality and morbidity become significant. Adverse events and deaths are reported in such numbers not because the vaccine is responsible, but because so many people are being vaccinated on any given day. Each person is given literature on how to report adverse reactions to VAERS. The V-Safe initiative includes regular text messages asking about any symptoms or changes to health. Attention given COVID-19 vaccination is unparalleled and this is reflected in data. Reports to VAERS (CSV VAERS Data accessed 3 September 2021) for all of 2020 totalled 63,544. To date, reports for 2021 ending 20 August, total 674,382. Not only are these reports unconfirmed but the safety of the COVID-19 vaccine is regularly affirmed.

Kolina Koltai is a Postdoctoral Fellow at the Center for an Informed Public based at the University of Washington. She describes OpenVAERS as “misinformation 101” and stresses that such decontextualisation is common to misinformation. Koltai uses such examples in classes that she teaches. In responses to questions posed by Logically, Liz Willner accused them of misrepresenting both VAERS and OpenVAERS. She cited data collected between 1990 – 2010 to argue, misleadingly, that “83% of reports are health care workers and Pharma”. Despite all evidence pointing to her, she insists OpenVAERS is a team effort. This is reflected on the site.

From the FAQ. Why is OpenVAERS necessary?

We built openVAERS because we found the HHS site difficult to navigate and get information from. We wanted a way to browse reports. Once we had that we decided to make it public.

How generous. Who is behind OpenVAERS?

OpenVAERS is a project developed by a small team of people with vaccine injuries or have children with vaccine injuries. We do not accept donations or solicit fees. There is zero monetization of this site. It is purely created in order to help others browse the VAERS records and to identify the reported signals that may otherwise get missed.

Here Willner misuses the term “signals”, specifically in how they relate to establishing risk. According to the CDC under How VAERS works:

Patterns of adverse events, or an unusually high number of adverse events reported after a particular vaccine, are called “signals.” If a signal is identified through VAERS, scientists may conduct further studies to find out if the signal represents an actual risk.

The design of OpenVAERS allows immediate access to VAERS reports. These, in conjunction with tabulated figures, can be easily screenshot and spread via social media. Misleading commentary on these platforms aims to encourage vaccine hesitancy. One claim is that COVID-19 vaccines cause serious cardiac events and heart attack. In addressing this topic the indefatigable Orac picks apart flawed manipulation of data from Robert F. Kennedy Jr. and Children’s Health Defense. Back in May the energetic David Gorski addressed the “vaccine holocaust” based on VAERS data that Mike Adams bravely announced. Examples abound. The one constant, and undoubtedly something to be factored into public education, is that misuse of unverified reports is a key driver of vaccine hesitancy.

Despite long standing problems, VAERS works. RotaShield is a case in point. Twenty years of research preceded its approval by the FDA. Four months after ACIP recommended a three dose schedule for all infants it was suspended to allow for a CDC investigation. There had been twelve reports to VAERS of intussusception. Dorit Reiss, a law professor at UC Hastings and pro-vaccination activist, shares Paul Offit’s view that submitting reports to VAERS should be easy for members of the public. Reiss has suggested withholding reports that are “clearly not credible”.

One imagines this would include suicides, drownings, car accidents, homicides, and so on. To appreciate the less credible, or in this case incredible, consider the case of James Laidler M.D. He submitted a report to the effect that the influenza vaccine turned him into The Incredible Hulk. It was accepted. To reinforce this flaw Kevin Leitch of Left Brain Right Brain, submitted a report to VAERS that his daughter had turned into Wonder Woman following vaccination. This too was accepted. The ease of submitting dubious reports has been raised with antivaxxers. The unanimous reply is that submitting a false report to VAERS is a felony. This was also argued by Liz Willner when defending her conduct to Logically. The Hulk and Wonder Woman however, remain felony free.

It is clear though, that VAERS as it presently exists is of benefit to U.S. public health. Given that so much of the anti-vaccination response to the COVID-19 vaccine rollout was anticipated it is unfortunate that the abuse of VAERS was not proactively met. The outlay of resources to say, educate, or at least inform the public would not be prohibitive. The probable cost of managing the harm that exploitation of the system has, and will continue to cause is significant. Of course that’s an easy observation to make in hindsight. Nonetheless, any measures taken now to manage misinformation adversely effecting vaccine uptake would likely be justified.

VAERS Underreporting

The misuse of VAERS data is rarely complete without also misrepresenting the fact that adverse events following vaccination go largely unreported. In other words VAERS data represents underreporting. Given that the majority of events are minor, such as injection site soreness and redness or involve headaches, fever, aches, nausea, itching and so on, this is to be expected. For the anti-vaccination lobby the aim has always been to create the illusion of large scale death and serious injury, then compound this by claiming it represents only a small fraction of actual cases. Judy Wilyman favoured this tactic to smear successful HPV immunisation campaigns and indeed all vaccines. Liz Willner doesn’t disappoint.

VAERS is the Vaccine Adverse Event Reporting System put in place in 1990. It is a voluntary reporting system that has been estimated to account for only 1% (see the Lazarus Report) of vaccine injuries. OpenVAERS is built from the HHS data available for download at vaers.hhs.gov.

From the OpenVAERS blog post of 2 August 2021:

The 518,769 injury reports are just the tip of the iceberg as a government-funded study concluded that “fewer than 1% of vaccine adverse events are reported.”

This is more decontextualisation. It is unlikely visitors will read the report or indeed search for definitive reviews of the one percent finding. Also, as data are from a government authority, and underreporting is represented on government sites, an appeal to authority is in constant play. Antivaxxers have thus quite confidently used this two pronged approach for over a decade. Adapting to the rollout of the COVID-19 vaccine while obfuscating increased reporting of symptoms and the role of V-Link, has proven seamless for established lobbyists.

The figure of 1% comes from a report from Harvard Pilgrim Health Care, Inc., authored by Ross Lazarus. Data examined are from 1 December 2007 to 30 September 2010. These data include all possible adverse events. Prior evaluation of the reporting rates of various events confirms that minor events are rarely reported and more serious events routinely reported. A 2014 report on surveillance of adverse events following immunisation in NSW, Australia noted that:

Only 11% of the reported adverse events were categorised as serious

Reuters report the case of an antivaxxer reiterating falsely that only one percent of deaths and injuries following the COVID-19 vaccine are reported. The article includes this comment from a CDC spokesperson:

Mild events, like a rash, tend to be reported less frequently than severe events (like a seizure). We have data to show that serious adverse events that occur after vaccination are more likely to be reported than non-serious adverse events. Events such as a sore arm at the injection site might not get reported since they are expected and therefore people don’t feel the need to report them.

A December 1995 study of passive surveillance sensitivity in The American Journal of Public Health reported 72% for poliomyelitis after the oral polio vaccine and less than 1% for rash and thrombocytopenia after MMR. A 2020 study of VAERS sensitivity published in Vaccine noted in Background, a similar rate of 68% capture for poliomyelitis after oral polio vaccine and 47% capture of intussusception cases after rotavirus vaccine. The target objective of anaphylaxis and GBS following various vaccines revealed a range from 12% to 76%. As early as 2003 a study found that serious events are rare.

What antivaxxers won’t tell you

The evident paucity inherent in the misuse of VAERS data becomes apparent when examining another appeal to authority employed by antivaxxers. Namely the amount of money awarded to “victims of vaccine injury” via the Vaccine Injury Compensation Program (VICP). Total compensation paid out over the life of the VICP, since 1988, is in the area of $4.6 billion US. Members of the anti-vaccine lobby often cite various approximations of this figure to underscore their claim that vaccine damage occurs on a huge scale. In fact a simple analysis of VICP figures reveals the opposite to be true.

The report states that for every 1 million vaccine doses, “approximately 1 individual was compensated”. This is a familiar figure. The table below contains the monthly VICP statistics update report for 1 January 2024. It may be found on page three of the data and adjudication statistics report from Health Resources and Services Administration. It is headed Adjudication Categories, by Alleged Vaccine for Petitions Filed Since the Inclusion of Influenza as an Eligible Vaccine for Filings. NB: Influenza doses = 45% of total doses since 2006.

From 1 January 2006 to 1 January 2024 the number of vaccine doses distributed, as sourced from the CDC, totals 5,050,074,788. The total number of compensable cases is 8,182. Or 0.00016% of distributed doses. The Influenza vaccine accounts for 73.9% of compensable doses. Total settlements, including dismissed cases and non-compensable cases to date, have reached 11,421. Or 0.00023% of distributed doses. This represents a striking absence of vaccine injury. Unsurprisingly you will not hear these figures from the anti-vaccination lobby.

TABLE: Petitions Filed Since the Inclusion of Influenza as an Eligible Vaccine for Filing [updated monthly]

Since January 1988, 24,538 petitions have been filed [page 5]. 8,439 or 34% of petitions were compensated. More so, as the HRSA report states, “Being awarded compensation for a petition does not necessarily mean that the vaccine caused the alleged injury”.

And:

Approximately 60 percent of all compensation awarded by the VICP comes as a result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.

Before moving on it’s worth reflecting on the fact that both VAERS and the VICP exist thanks to the efforts of established anti-vaccine campaigners such as Barbara Loe Fisher. Their campaigning led to the creation of the 1986 National Childhood Vaccine Injury Act, which is itself the subject of Andrew Wakefield’s most recent film claiming widespread vaccine injury. As we can plainly see not only are compensated cases exceedingly rare, but only 40% of those demonstrate a causal link to any vaccine. One expects it is not rash to expect that in time we will see similar figures pertaining to COVID-19 vaccines.

Antivax Winning Formula

Misrepresenting VAERS data is a simple winning formula for antivaxxers. It follows that it can be applied to any adverse event reporting system, particularly those employing passive surveillance. The COVID-19 vaccine rollout is unprecedented and subject to significant scrutiny. Governments support the reporting of adverse events and deaths post COVID-19 vaccination. The winning formula thus ensures the anti-vaccination lobby has a significant advantage in spreading its message. Data from the U.K., the E.U. and Australia have also been misused this way. The exploitation of coincidental deaths following COVID-19 vaccination was met quickly and comprehensively by Australia’s Therapeutic Goods Administration. Not surprisingly this had no effect on those opposed to vaccination against COVID-19.

Analysis of application of the winning formula to other government reporting systems is beyond the scope of this post. However, Australians have made good use of the tactic both before and during the COVID-19 pandemic. Underreporting of adverse events was mentioned in a May 2019 press release from the Informed Medical Options Party. They promise a “more accurate” system if elected. More recently, misused data from the U.K. Yellow Card voluntary reporting system was retweeted by Australian senator Malcom Roberts. United Australia Party leader, Craig Kelly, randomly texts Australians with a link to screenshots of reports to the TGA Database of Adverse Event Notifications. In April 2021 Judy Wilyman cited conspiracy theory website accounts of unverified reports to smear COVID-19 vaccine. A flyer packed with false and unverified deaths and injuries from four different reporting systems was tweeted by Meryl Dorey in mid June 2021. Watch this space.

Conclusion

The U.S. Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system open to the public that has, since its inception, been exploited by the anti-vaccination lobby. The absence of any causal relationship between vaccine and report is ignored by antivaxxers. The introduction of the COVID-19 vaccine has accompanied unprecedented reporting due to increased vaccination with active encouragement of recipients to use the VAERS system. The rise in reports was to be expected. This clinical reality has been obfuscated by players in the anti-vaccination community who have skilfully used social media to present background mortality and morbidity as causally linked to COVID-19 vaccination.

The website OpenVAERS, dedicated to misrepresenting VAERS data has focused exclusively on COVID-19 vaccination since January 2021. An investigation by Logically found Lizabeth Pearl Willner from California is the force behind the site. A frenetic antivaxxer, Liz Willner attempted to dismiss her activity as provision of easy access to data. Since the investigation she has been actively removing her anti-vaccination footprint on social media whilst keeping the site active.

Payouts from the Vaccine Injury Compensation Program to date total $4.6 billion. Often cited by antivaxxers as further evidence of widespread vaccine related harm, VICP settlements from 2006 – 2019 equate to 0.00015% of vaccine doses given in that period. The Influenza vaccine accounts for 71.6% of this total.

Misrepresenting VAERS data to convince others that vaccines cause significant harm has proven to be both durable and successful. Combined with the misleading claim that only one percent of all events are reported, the result has almost certainly been an as yet unknown increase in vaccine hesitancy. Familiarising the public with the manner in which such data are misused may alleviate some amount of vaccine hesitancy.

COVID-19 vaccines are safe and effective.

References and reading

Vaccine Adverse Event Reporting System – HHS

Guide to interpreting VAERS data – HHS

CDC: VAERS

Surveillance for Adverse Events Following Immunization Using VAERS – CDC

Selected Adverse Events Reported After COVID-19 Vaccination – CDC

Anti-vaccine activists use a government database to scare the public – Science

Anti-Vaxxers Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous – VICE

California Woman Behind Antivax Site Outperforming Government Database – Logically

The Woman Who Secretly Runs One of the World’s Biggest Anti-Vax Websites From Her House – VICE

Hugely Popular Antivax Site Is Just Some Lady In Piedmont

Unverified reports of vaccine side effects in VAERS aren’t the smoking guns portrayed by right-wing media outlets – they can offer insight into vaccine hesitancy – The Conversation

Reports of adverse effects in US database aren’t confirmed to be linked to vaccination – Fact check

Large real-world study: Pfizer’s COVID vaccine is safe

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) – PDF

Underreporting and Post-Vaccine Deaths in VAERS Explained

The reporting sensitivity of VAERS for anaphylaxis and for Guillain-Barré syndrome

VICP Monthly Statistics Report October 2021

VICP Monthly Statistics Report November 2021

Last update: 27 January 2024

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COVID-19 vaccination: an uninsurable experimental medical procedure?

Posted in Anti-Vaccination Lobby, Australian Vaccination-risks Network, AVN, COVID-19, COVID-19 Vaccine, General, Health, Immunisation, Legal, Meryl Dorey, Scam, Science, Skeptic, Social Media by

The COVID-19 vaccine is in fact an experimental medical procedure and because of this insurance companies have made void any claims relating to this “vaccine”.

The experimental trial in Australia runs until 2023 and thus it is only available due to an emergency use clause. Insurance companies are linking adverse reactions and deaths to this trial. As companies won’t pay out for injury and death due to experimental treatment it follows that such events following COVID-19 vaccination are not covered by hospital or life insurance.

Not a word of the above is true. Yet this notion is circulating on social media in the usual and predictable places. Despite it being demonstrably false and something one can refute for themselves in a few minutes, it is a notion with active supporters. Many others go further and contend that consent has not been given to be part of this experiment. Thus a breach of the Nuremberg Code is happening right before us.

Ethically relevant but not legally enforceable the Nuremberg Code remains semantically powerful. As such it is regrettably abused by anti-vaccine activists who have for years peddled the false claim that vaccines are not tested for safety and efficacy. It just so happens that global scrutiny of the development of COVID-19 vaccines also provided firm evidence of Phase III trials. This again refutes the anti-vaccine position and I touched on this last September. Yet as antivaccinationists are apt to do the facts have been twisted into falsehoods to support ongoing attacks on the COVID-19 vaccine rollout and to boost claims of further breaches of the Nuremberg Code.

Now, whilst this post isn’t focusing on Meryl Dorey and the Australian Vaccination-risks Network, it just so happens that she can assist us. On March 13th during an error-packed Under The Wire, Dorey presented a detailed performance outlining the absurdities that constitute the Nuremberg Code fallacy specific to COVID-19 immunisation. You may download the MP3 here, or listen below.

All of the points above popped up today in a thread on a COVID freedom fighter’s Facebook page. Elle Salzone is a feverishly active defender of anti-science beliefs. Elle moves from business to business, scheme to scheme and presently pushes ClearPHONE. Salzone and buddies sell the phone, claiming it provides the privacy necessary for today’s freedom fighters. How reliable a service it provides is uncertain. Elle fights with and also films police over her refusal to wear masks or remain in quarantine when necessary. But that’s okay if you decide to be a Sovereign Citizen. Elle is anti-COVID related responsibility. You can peruse her page for details on these pursuits.

Today one of her posts [Update: quietly deleted on 8 April] was screenshot by a tireless defender of reason, and thus came to my attention. It turned out to be an obvious forgery from this Allianz Product Disclosure Statement (PDS) and could be promptly demonstrated as such. The slideshow below is of the Allianz forgery and the two original parts of the document that were used in making it.

Salzone posts the forgery and states;

THIS IS EXTREMELY CONCERNING!!!! 😱

Imagine getting the experimental shot thinking you’re protecting your health, then getting seriously injured and having no private health cover to help you and not being to sue because all vaccine manufacturers have been indemnified…

All to maybe protect you for a virus with a 99% Survival rate..

You literally can’t make this shit up..

“You literally can’t make this shit up”. In fact you can and in this case someone literally did. A quick search yielded the document in question. Even before presenting the original, un-cropped and pre-defaced, pages the text itself was screaming forgery. Insurance companies do not tend to torment font in that fashion. Apart from the caps lock, no policy section is referenced. Then there is the sneer at “vaccine” and the impossible consent self-infliction. Ouch! Finally at risk of boring you there’s that nagging bit about posting this most important development in the glossary.

Suffice it to say the above points were mentioned and a discussion took place.

Verified by multiple sources eh? The original source was “easily found” (comment now deleted) but Elle couldn’t find it. So screenshots of the original source were provided along with a link.

This resulted in an admission that it was posted in the knowledge it was a fake. Apparently however the information it conveyed is not only true but would be confirmed by Allianz if I checked;

For the record this forgery consists of four different screenshots from the original document pasted in a sequence that creates a misleading ‘preamble’ aiming to justify the bogus claims made beneath in added red font. The added text further presents existing terms from the Allianz PDS to construct a fraudulent disclosure statement. A significant amount of time and forethought has gone into this. It is a calculated work of disinformation that has succeeded in misleading vulnerable recipients of its message. The preparation date of the current Allianz Life Plan PDS is 5 march 2021. The date in the forgery is 31 July 2020, suggesting it could have been in circulation for some time.

Perhaps the most important aspect to look at is the claim that COVID-19 vaccines are part of an experimental “medical procedure”. This is frequently peddled by anti-vaccine activists and was also pushed by Meryl Dorey in the audio above. It is linked to other claims that the vaccine is not actually a vaccine. One contention is that mRNA vaccines are DNA modifying agents. Another is that viral vector vaccines [CDC] are completely experimental and also alter DNA. Despite available data on the molecular action, development, safety and efficacy of Pfizer, Moderna and AstraZeneca vaccines, antivaccinationists ignore this in favour of a conspiracy theory.

Viral vector vaccines are well understood due to decades of research and do not alter DNA. mRNA vaccines are also well understood and are incapable of altering DNA. The claim that COVID-19 vaccination is an experiment is often presented with the contention that the experiment will go on until 2023. Like all persistent falsehoods this has an element of fact to it. The reality is that in Australia both Pfizer and AstraZeneca vaccines have provisional approval from the TGA. The approval is valid for two years and the AstraZeneca vaccine will require review in February 2023. On 16 February 2021 the TGA stated;

The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia.

COVID-19 Vaccine AstraZeneca is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation of individuals 18 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. […]

Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.

Reading the final paragraph above we can see also how the claim that data is still being collected for the experimental trial is peddled around with such confidence. Yet post-market assessment is a vital part to better understand all drugs and vaccines. There’s no trial, no experiment. It’s worth noting this fallacy is at times linked to another false claim. That of emergency use provision for the vaccine. This was a contention made by one Clive Palmer, deconstructed handsomely here by ABC corona check. Palmer has not alleged the COVID-19 vaccine rollout is an experimental medical procedure. Although he has pushed fear over the absence of one, three and five year safety data.

When it comes to hospital cover, insurance companies will not cover treatments for which no Medicare Benefits are payable. This includes cosmetic surgery, experimental treatments or experimental pharmaceuticals. Medicare will cover certain clinical research studies. For insurers if the device, trial or treatment is not recognised by Medicare or the Medical Services Advisory Committee it will be excluded from standard hospital cover. Still, there is insurance and indemnity available for clinical trials. This helps us understand why the term being used to misrepresent the COVID-19 vaccine is “experimental”.

Allianz also have a strong supportive position on the COVID-19 vaccine and like Bupa offer a comprehensive series of answers to possible questions. In a May 2020 article Allianz cover in depth the importance of research in developing a COVID-19 vaccine and the role of insurance for subjects in clinical trials. This is not what we would expect from a company that would deny insurance cover for adverse reactions post COVID-19 vaccine. Thus the claim by Salzone that refusal to cover is “verified by multiple sources”, in conjunction with the initial and consequent screenshot, appears to be disinformation. Insurance companies across Australia cover illnesses requiring hospitalisation following vaccination.

This leaves the obsession with claiming a 99% recovery rate as some type of stamp of insignificance. It is a rather tired trope having emerged about a year ago. This may also be linked to the frankly appalling claim that people die “with COVID, not of COVID”. Thus fatalities are incorrectly labelled an overestimation. Given this is pushed often by those who falsely insist vaccines kill and injure on a large scale it reflects a rather bizarre lack of compassion. As pointed out by USA Today the COVID-19 fatality rate is ten times that of influenza. More so it may be a serious diagnosis depending on age and health. To this we must add the emerging problems of ‘long haul’ symptoms perhaps in as many as 32% of those who have recovered from COVID-19.

In an interesting twist it was another wannabe COVID conspiracy-freedom-fighter who provided confirmation from Bupa that adverse reactions requiring hospitalisation are covered if their policy covers the treatment provided. It’s a bit of a story so another slide show is needed.

In the first image we see Bupa’s reply to anti-vaccine activist and COVID conspiracy theorist Matt Lawson, on social media. It outlines quite clearly that treatment covered by policy is available for adverse reactions post COVID-19 vaccination. In the next we see Lawson has engaged in a chat with ‘Cheryl’ from Bupa and presented this to Bupa on Instagram to challenge the prior response. The last screenshot was uploaded by Elle Salzone in the thread we’re discussing as another example of an insurance company denying cover to injury or reaction after COVID-19 vaccination.

Yet viewed in context we can see that during the chat Lawson supplied his policy number (image 3). So ‘Cheryl’ was answering in a specific sense, relative to his policy. This is absolutely in line with the claim made by Bupa in image 1 and also with feedback I’ve received from Bupa Australia. Still, image 2 reveals Lawson’s ill-informed, provocative reaction. The theme of acting with aggressive predetermined agendas is ingrained in the new age COVID conspiracy theorists. Matt Lawson reveals his conspiracy theory thinking when he writes;

Do you cover injuries caused by the convid19 experimental biological injection or not?

This comprehensive article reveals Bupa’s support for the COVID-19 vaccine and is in line with the position of global health authorities. There is no suggestion Bupa view the vaccine as experimental. Quite the opposite.

The letter mentioned in Lawson’s Instagram chat with Bupa Australia is circulating in social media within Australia. Within the Elle Salzone’s Facebook thread the image was uploaded twice, in support of the Allianz forgery. One commenter stated, “Another example shared of a void policy”. The second observed, “I think Bupa were one of the first…”. The image is below.

The text is as follows;

23 March 2021

Dear [redacted]

Thank you for speaking to me.

I confirm that side effects arising from the COVID-19 vaccine are not covered under our exclusion for: Complications from excluded or restricted conditions/treatment and experimental treatment exclusion.

If you are injured whilst doing COVID-19 swab yourself, cover would be available towards the injury.

I hope this information is helpful. If there is anything else we can help you with, please call our team on the above helpline number.

Yours sincerely

[signature]

Even if genuine, this letter has no impact on Australians. Peering at the Bupa letterhead we can confirm it is from Bupa Place in Salford Quays, Manchester U.K. Anti-vaccination activists will contend that the first paragraph confirms that side effects and complications from the COVID-19 vaccine are excluded from cover because it is an experimental treatment. The second paragraph conveys that insurance cover is available if one is injured, “whilst doing COVID-19 swab yourself”. In the U.K. home test kits are available.

Australians can also dismiss this as here it is illegal to advertise testing kits for serious infectious diseases. The TGA have a very clear warning to consumers and advertisers on their website. Thus there is no reason for Bupa to even consider such cover in Australia and Bupa members can disregard the letter and its claims.

Still, anti-vaccine claims are global in their reach, as is social media. If we take a cautious and in depth look into the origins of this letter there are different possible conclusions. It is a poorly written fake or a badly written follow up with a customer. Neither confirm the claim of an uninsurable experimental vaccine.

Bupa U.K. explain excluded and restricted cover in this Bupa Membership Guide [Archived]. This document provides a likely source for the information that the author presents with notably poor grammar. The opening paragraph is difficult to grasp. It may be that English is not the author’s first language.

With respect to the terminology used in the letter, on page 35 of the U.K. Bupa Membership Guide we find;

Exclusion 7 Complications from excluded conditions, treatment and experimental treatment

We do not pay any treatment costs, including any increased treatment costs, you incur because of complications caused by a disease, illness, injury or treatment for which cover has been excluded or restricted from your membership. […]

We do not pay any treatment costs you incur because of any complications arising or resulting from experimental treatment that you receive or for any subsequent treatment you may need as a result of you undergoing any experimental treatment.

On page 38 we find under Exclusion 16 Experimental Drugs and Treatment, this paragraph;

Please also see ‘Complications from excluded conditions/treatment and experimental treatment’ […]

There we have it. The text could have been copied and pasted in an extremely poor customer follow up, and that’s it above. Or copied and cobbled together in a dodgy forgery. The antivaccinationist lie of an uninsurable experimental vaccine is quite vocal on social media in the U.K. Yet under the glare of fact it is a demonstrably pointless effort.

In the U.K. COVID-19 vaccine side effects are covered under the Vaccine Damage Payments Scheme, established in 1979. This provides no-fault compensation for Adverse Events Following Immunisation. It is possible that offering cover is not an option for insurance companies. Either way, side effects are not covered by Bupa U.K. So it may well be that treatment of complications is classified as restricted and/or excluded regarding hospital cover.

The most important point here is that the COVID-19 vaccine is not an experimental treatment. Yet this letter is being pushed in Australian anti-vaccine circles to contend insurance companies are of the view it is experimental. Whilst a bogus claim, the overall forgery scam is reinforcing that claim in COVID conspiracy circles.

Bupa Australia are aware of this letter and have taken the chance to assure those who ask (such as the argumentative Matt Lawson) that cover is certainly available. When I raised this specific issue I was informed by Bupa Australia;

Private health care in the UK and Australia can vary greatly. But rest assured that our members will be covered for any hospital admission following an adverse reaction to the COVID vaccine, as long as the service is included in their cover, and any waits have been served.

Ultimately all the anti-vaccine points put forward by Elle Salzone and others on her Facebook page are demonstrably false. A search for insurance cover and COVID-19 vaccine adverse events yields results from around the world, not just Australia. For example cover for AEFI after the COVID-19 vaccine is available in Singapore whilst there’s a WHO compensation fund for people in developing nations suffering side effects. In general, insurance companies are involved in many areas specific to the COVID-19 vaccines, including in China where they are looking to cover adverse reactions.

Sadly some Facebook visitors to Elle Salzone’s page, who take her word on trust, are absolutely convinced of the dark side as this reply to me, packed with five pieces of misinformation, confirms. [Note – this is not from Salzone but a vulnerable visitor].

Sigh. Still all hope is not lost. As the well-known phrase from the X Files reminds us:

The truth is out there.

Last update: 8 April 2021

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Judy Wilyman – unedited TV interview

Posted in Anti-Vaccination Lobby, General, Health, HPV Vaccine, Human Rights, Judy Wilyman, Legal, Science by

Some thoughts on vaccine conspiracy theorist Judy Wilyman’s misleading “TV interview” which was published on YouTube on August 16th, 2018.

Viewers are being mislead by Ms. Wilyman’s constant and repetitive referral to “university research” and the allusion to an existing “scientific debate” on vaccination. The science on vaccination is settled and there is certainly no genuine debate. Only anti-vaccine conspiracy theorists constantly seeking to create the impression there is a debate and that the truth is being suppressed.

One wonders. What is the “objective and evidence based university research (approved by the University of Wollongong)” of which Ms. Wilyman speaks? What was the study design? What was the sample size? By what methodology were vaccine ingredients causally linked to chronic disease? Which ingredients were shown to cause chronic disease or pathological changes? By what mechanism do which ingredients cause pathology? How did the study control for other variables? What methods of analysis and statistical verification were used?

Where was this research, “approved by the University of Wollongong [UOW]”, published? Has it been reproduced? How many unsuccessful attempts to falsify the research have there been? Certainly Ms. Wilyman has not published any original research or data. Indeed apart from startlingly unverified claims gleaned frequently from dubious sources, Ms. Wilyman is yet to produce the basic outline of any study design. Rather Ms. Wilyman has joined the ranks of those who misrepresent the purpose of package inserts, and why certain information is included for legal purposes. Not as an indication of what vaccine recipients should expect.

Some Australians are aware that Ms. Wilyman was awarded a PhD from UOW Humanities Department on the basis of a literature review that sought to criticise the Australian Immunisation Schedule and the safety of vaccines in general. Ms. Wilyman has no qualification in health, medicine, public health, epidemiology, vaccine science or any qualifications relating to immunisation at all. During this interview Ms. Wilyman contends, whilst failing to cite any supporting research that vaccine ingredients are causing chronic disease in Australian children.

All Wilyman cites appears to be her own literature review, in which she mistakes correlation for causation. More so, the references cited by Ms. Wilyman in her thesis are firmly biased toward her anti-vaccine theory, and blatantly so. Because of this fact Wilyman has reinforced the fact there is no scientifically reputable debate on the safety and efficacy of mass vaccination at all. In cases where a debate on any topic could be mounted the author of a literature review would present bipartisan sources, review and critique the value of each then finally argue a conclusion based upon the material reviewed.

However the scientific consensus from peer reviewed material addressing vaccine safety and vaccination schedules is one that demonstrates absolutely the safety and success of vaccines. Ms. Wilyman is unable to demonstrate a scientific consensus in peer reviewed literature that suggests widespread chronic disease as a result of mass vaccination because such a consensus does not exist. Ms. Wilyman underscores the intellectual paucity of her stance by insisting that “it has not been proven that autism is not linked to the vaccines”. It has indeed been demonstrated over and over again that autism is not linked to MMR or any vaccine.

One finds it more than disturbing that someone awarded a PhD from an Australian university is incapable of understanding the vast body of work dismissing any link between autism and immunisation. More so, Wilyman goes on to falsely claim there have been deaths and widespread harm causally linked to vaccines. There have been no deaths linked to vaccination in Australia for close to 45 years. On November 21st, 2015 The Social Services Legislative Amendment Bill (No Jab, No Pay) in Brisbane was informed serious reactions to vaccines occur from zero to five times per year in Australia.

These figures reveal Ms. Wilyman’s claims of frequent death and disability from vaccination as bogus. Her abuse of the right to freedom of speech is significantly disturbing as she consciously presents demonstrably false information with the ability to cause community harm, harm to infants and children and the sabotage of public health. For over 17 minutes Judy Wilyman pushes the standard anti-vaccine conspiracy theory, and at one alarming point suggests the Australian Vaccination Schedule with the added incentive of No Jab, No Pay is a breach of The Nuremberg Code.

Let’s clear up what the purpose of the Nuremberg Code is. Following the Nuremberg trials and the conviction of Nazi doctors for human experiments on concentration camp prisoners, the Code was introduced in August 1947. It seeks to give clear instructions and rules as to what is legal when conducting human experiments. There are ten points to the Nuremberg Code.

Comments (below) in response to the video are predictably from the conspiracy theory handbook. The first observes that the government wants to hide what is in a vaccine. You may have noticed above that I linked to vaccine ingredients on this Australian Government Dept. of Health Fact Sheet. The second comment notes “government or doctors” don’t read package inserts. Deaths and serious sickness is covered up.

The harm caused by this misinformation – which is being constantly pushed (and certainly not corrected) by Judy Wilyman is not something one can take lightly.

YouTube comments;

  • “It’s very very suspicious when a government and the AMA want to hide the truth from the public about what is in a vaccine. The whole idea of vaccines is to sterilise the population and polysorbate 80 is in all of them. Obviously that idea has come from the minds of psychopaths”.
  • “All those who promote the lies of the safety of vaccines are equally responsible as BigPharma for the poisoning and maiming of their own people, (sic) They should recall the Nuremberg Trials and the consequences of those who experimented on the innocent people. The risks of vaccines are listed on the Data sheets of the vaccines and also the Package inserts, which are not studied by government or doctors, and the deaths and serious sicknesses are covered up.”

Ms Wilyman would be wise to stick to humanities it would seem.

 

Update: Note; Reference to “scientific debate” on vaccination above refers to the contention of the anti-vaccination lobby that the risk/benefit ratio of vaccines is something that is still being debated or a topic that warrants debate. The benefit of vaccines far outweighs the extremely small risk of harm.