Some counts of objects from VAERS are meaningless
Some counts of objects from VAERS are meaningless
Just because a term is found 17 times in VAERS doesn't mean there were 17 individual reports containing that term
In a recent Substack post [1] Steve Kirsch (hereafter: Steve) presents the claim that, based on his assessment of the number of people in VAERS with the same diagnosis, government data shows it is 99.6% likely that Celine Dion’s recent stiff person syndrome (SPS) diagnosis is due to Covid-19 vaccination.
Background to Stiff Person Disease
Stiff person syndrome was first described in 1956 by Dr Frederick Moersch and Dr Henry Woltman at the Mayo Clinic in Minnesota [2]. At the time they called it stiff man syndrome because men were greater represented in their initial cohort of 14 patients. It is now recognised that most cases occur in women – about twice as many women as men are diagnosed with the condition.
SPS is an extremely rare disorder. The exact incidence and prevalence of SPS is unknown, although one estimate places the incidence at approximately 1 in 1,000,000 individuals in the USA population and another at approximately 1.8 in 1,000,000 in the UK population [3]. The distribution of SPS between men and women indicates a female predominance at a rate of 2 to 1 [4]. SPS usually becomes apparent sometime between 30-60 years of age [3] and the lag between onset of symptoms and diagnosis can be anywhere from a few weeks to more than 6 years [5]. However, SPS has been reported to occur in children and older adults as well [4]. Most people diagnosed with SPS become wheelchair-bound, on average, within 3.5 years of diagnosis [4].
SPS is one of a range of autoimmune conditions that afflict about 4% of the global population, including thyroid disease, rheumatoid arthritis, type 1 diabetes mellitus (T1DM) and multiple sclerosis. 60% of people with SPS have concomitant autoimmune disorders (at least 23% with non-diabetic and 37% with diabetic disorders) [4]. Diagnosis with T1DM either precedes the onset of SPS or develops during the course of the disease [5].
SPS occurs when the immune system attacks a protein called glutamic acid decarboxylase (GAD). The GAD protein aids production of a neurotransmitter (brain chemical) called GABA, which lessens a nerve cell’s ability to receive, create or send chemical messages to other nerve cells [4]. For this reason, GABA is known as an inhibitory neurotransmitter. Antibodies are Y-shaped proteins that look for and latch onto foreign invading objects, such as bacteria and viruses, and mark them for destruction. In people with stiff person syndrome antibodies known as anti-GAD65 latch onto the GAD proteins [5]. These anti-GAD65 antibodies are found in only 1% of the normal population and 5% of patients with other neurological disorders (Parkinson’s Disease, multiple sclerosis and other myelopathies), but are present in very high levels in people with SPS, so their presence in blood or spinal fluid is one way that doctors are able to diagnose the condition [5].
Steve Kirsch’s Substack
In order to accept Steve’s assessment, several things would be required to hold true. However, the reader should note that this analysis only considers whether the three main assertions of Steve’s post were validly made and that, even if they were and they hold to be true, they don’t really begin to help us understand the ultimate question of whether Ms Dion’s SPS was caused by receiving the Covid-19 vaccinations. In a study with Profs Norman Fenton and Martin Neil we explore the counterfactual reasoning needed to understand whether the vaccine may be to blame in cases like this. That post can be found here.
1. The first and most obvious requirement is that Ms Dion needs to have received a Covid-19 vaccine.
Ms Dion has been a very vocal advocate for Covid-19 vaccination, as can be seen in this video [8]. Ms Dion is Canadian and that video, which was filmed in Canada during May 2021, demonstrates that she has been resident there during the relevant Covid-19 pandemic period. During 2021 the Canadian government imposed Covid-19 vaccination requirements on public sector employees and travellers [9]. Employers in Canadian provinces also have the right to manage their workplace and protect business interests, and many unionised and non-unionised employers also implemented vaccination policies that meant that employees, contractors and other related persons needed to demonstrate vaccination status in order to enter premises or be engaged in work within those premises [10]. While employees could challenge these mandates, such challenge would most likely end in either dismissal or resignation of the employee [10]. As a result of the vaccine mandates of both the Canadian Federal and Provincial governments, and those of unions and employers in particular industries (like the airline, post-secondary education and film and television industries), and at the risk of being seen as a hypocrite to her fans, it is unlikely that Ms Dion would be undertaking work in front of the camera and promoting the vaccines without herself having received them.
Outcome: Although not absolutely proven, for the reasons described above it is almost certain that Ms Dion has received Covid-19 vaccinations.
2. It must be clinically accepted that vaccination can trigger symptoms, and eventual diagnosis, of SPS.
Steve’s initial evidence that vaccination can cause SPS is an image of a tweet showing that SPS was one of the many potential side effects of interest in the recently released Pfizer documents. He also asserts on the basis of that document that Pfizer knew the Covid-19 vaccines could cause SPS. We have access to the entire collection of documents from the court-ordered Pfizer/FDA releases and have verified that amongst the list of hundreds of potential side effects that Pfizer sought to observe, SPS was in the list as is shown in the picture. However, the small number of documents that contain this list are simply recording the type of events that were to be captured, not the existence of patients with that diagnosis. While a full search of the around 750,000 pages contained in the Pfizer document release showed a number of trial participants who complained of symptoms that are among those common to SPS (musculoskeletal stiffness, limb pain and stiffness, hypersensitivity to noise, emotional distress and muscle spasms), we failed to turn up a single trial participant diagnosed with SPS during the trial period. That does not mean that vaccination is not a factor in SPS onset or diagnosis. While the exact cause of SPS remains unknown, it is now accepted that a misdirected immune response triggers SPS [11] and that SPS can occur following vaccination [12, 13].
Outcome: While the evidence provided by Steve does not establish that SPS can be caused by vaccination or that Pfizer knew that their Covid-19 vaccine could cause SPS, evidence does exist in the medical literature that clinical experts have found SPS can be triggered by vaccination.
3. The numerator in Steve’s equation to ascertain the statistical probability of 99.6% - i.e.: that 17 people in VAERS have SPS as a result of Covid-19 vaccination, must be true.
Steve provides a screenshot from the MedAlerts website (https://medalerts.org/) reproduced here in Figure 1 that he says proves there have been 17 reports of SPS in VAERS related to the Covid-19 vaccinations.
Figure 1: MedAlert search results image from Steve's Substack Article
We do not dispute the veracity of his image, as we performed our own search on MedAlerts which produced the same result (Figure 2).
Figure 2: Our search results from the MedAlerts website
What we do dispute is Steve’s interpretation of the significance of what this value, 17, means. In order to understand the context of this value we downloaded the VAERS datasets for 2021 and 2022. The VAERS data for each year is divided into three comma-separated value (CSV) files called DATA, VAX and SYMPTOMS. The DATA file contains information about the subject patient of the report, including age, date of vaccination and onset of symptoms and clinical narrative notes describing their medical history, medical tests and current presentation. The VAX file contains details of the vaccination given, including the manufacturer and name of the vaccine administered, The SYMPTOMS file contains up to five symptoms that it is suggested arose after, and therefore potentially because of, administration of the vaccine.
We searched within the SYMPTOM and DATA spreadsheets for instances of the term: “stiff person syndrome”.
In the SYMPTOM file for 2021 we identified five individuals for whom SPS was identified as a post-vaccination symptom. These are listed in Table 1. For the individuals where SPS was located in the Symptom 1 column, SPS was the only symptom identified for these individuals.
In the DATA file for 2021 we identified 16 individuals whose information contained the term SPS. These are listed in Table 2. The vast majority (12 individuals) had SPS as a pre-existing condition for as much as twenty years before receiving the Covid-19 vaccinations. Two individuals had clinical notes that suggested their doctor was questioning whether the array of symptoms the person suffered might be SPS. However, it was clear from the notes of those individuals that SPS had not yet been differentially diagnosed and that the doctor was questioning it as one of several similar neuromuscular conditions. For a single individual, SPS was mentioned as a post-vaccination diagnosis - this could be ascertained also by comparing the date of vaccination against the later date of SPS diagnosis.
In the SYMPTOM file for 2022 there were no instances of SPS, while there were five instances in the 2022 DATA file that related to three individuals - listed in Table 3.
Outcome: Clinical review of the information contained within each of the published VAERS reports fails to support Steve’s interpretation of the number of instances where SPS was mentioned - as identified from his simple MedAlert website search. We found that the vast majority of SPS instances in the VAERS dataset are individuals with SPS as a pre-existing condition, and that the evidence only establishes that 8, and not 17, individuals may have a link between Covid-19 vaccination and their SPS diagnosis (5 where SPS is a post-vaccination symptom, 1 where SPS is a post-vaccination diagnosis, and 2 where SPS is a potential diagnosis pending further medical evaluation).
Addendum:
The more observant will notice that the VAERS report Steve included in his Substack post - VAERS ID 1462791 - is not included in any of the above tables. We wondered the same. On review of the spreadsheets downloaded from the VAERS website we noted that there were gaps in the VAERS ID numbers as shown in Figure 3 - where it seems someone at the USA Health and Human Services (HHS) or Centre for Disease Control (CDC) have chosen to omit VAERS reports prior to publishing the dataset on the downloads website. The downloadable DATA file jumps from record 1462196 to 1463065 and omits any of the reports on VAERS IDs that come between.
Figure 3: Extract from the VAERS DATA spreadsheet for 2021
This is not the first time there has been evidence to suggest something strange is happening to VAERS records. Others have previously reported on unexplained changes in the numbers of VAERS reports previously [14], and while fact checkers simply outright dispute that this is indicative of anything nefarious [15], the fact that numbers change without concomitant explanation from either HHS or the CDC is enough to make people wonder what might be going on.
In this case the explanation is that the female individual was from Japan, and in the most recent data downloads the CDC have moved foreign nationals into a separate 400+mb CSV file. The language, grammar and syntax of the record suggest it was either written by someone who is not a native English speaker, or translated from Japanese by someone who is not a native or regular Japanese speaker. Several people in our wider research group on reading this individual’s VAERS report questioned whether a diagnosis of anaphylaxis was more likely, and pointed to the fact that the pharmacist is described in the Symptom Notes as having reported the reaction to the Covid-19 Vaccine Adverse Events Reporting System (COVAES) as further indication that the person was not an American or English speaker (as the acronym is VAERS and the reporting system is not just for Covid-19 vaccines). In any event, unlike anaphylaxis, SPS is not a condition that would instantly or immediately occur after vaccination. The seemingly instant reaction described in this woman’s report is almost certainly not indicative of newly diagnosed SPS, even though she is described as having ‘gone stiff’. The literature shows that it takes anything from several weeks to years for the symptoms to be diagnosed as being SPS, and that is usually only after either an antibody test (anti-GAD65) or after differential diagnosis has excluded other similar conditions like Multiple Sclerosis and Parkinson’s disease.
When we also performed our search on the FOREIGN DATA file, we identified 14 individuals with SPS noted in their symptom text. More than half were associated with other vaccines - Prevenar 13 pneumococcal vaccine (2) and Cervarix HPV vaccine (7). Of the remaining 5, the first described pre-existing autoimmune conditions including SPS (VAERS ID: 2298855). The other 4 were from Japan, and presented with similarly questionable grammar and syntax. Each one asserted that symptoms more alike an anaphylactic reaction were SPS, suggesting either that the same translator worked on all of the Japanese reports, or that the term stiff person syndrome is a clinical description in Japan for a person presenting as ataxic with rigidity and as such, means something other than the specific disease described by Moersch and Woltman in 1956. Without additional information, the foreign data file does not increase the potential number of individuals who may have attracted an SPS diagnosis as a result of Covid-19 vaccination.
Conclusion:
VAERS has great potential, and indeed has previously been used, to provide safety signals that warn when a vaccine is not as safe as was initially believed. But, as many people on both sides of the Covid-19 and vaccine debates have opined, great care must be taken when interpreting the information contained in any system, but especially VAERS. There is potential for confusion and mistakes to be made where information is drawn from VAERS and used without an understanding of the clinical context (i.e.: was the condition pre-existing and therefore unrelated to the event of interest, and does the number of instances of a term like stiff person syndrome identify the number of individual people with that identified condition). There is also the potential issue of using numbers of events from all countries as the numerator (number of reports of SPS) while using the number of another event in a single country as the denominator (number of vaccinations administered or number of VAERS reports in just the USA). A final issue could be the use of inappropriate numbers as the denominator - for example: contrasting the number of instances of SPS in VAERS against the total number of VAERS reports in no way provides an accurate estimate of any potential increase or decrease of that diagnosis in the general population. A more appropriate assessment would be to contrast the number of diagnoses of SPS before the Covid-19 vaccines (let’s call that value S1) to the number of diagnoses of SPS in Covid-19 vaccinated people (let’s call that value S2). The correct denominator for S1 would be the entire population of interest (for example, the entire population of USA in 2019). While the correct denominator for S2 would be the total number of people in the USA who received a Covid-19 vaccination. If the incidence is calculated to be lower in S2 then we can assume the Covid-19 vaccines do not impact on SPS diagnosis. However, if the incidence is higher for S2 then there may be cause for concern and a reason to further investigate the role of Covid-19 vaccines in triggering autoimmune diseases like SPS.
While we agree with Steve that it is likely Celine Dion was Covid-19 vaccinated and that vaccines are clinically reported as having triggered SPS, we do not agree on the method used to identify the number of people in VAERS for whom the Covid-19 vaccines may have triggered SPS. Nor are we able to agree with his interpretation of the single Japanese individual included in his post. Without further investigation and a counterfactual model, all we can really establish is that Ms Dion has likely been vaccinated and has been diagnosed with SPS. We cannot justify any claim that there is a causal link between these two events, nor that they are even related.
SPS is a terrible and physically debilitating disease that dramatically decreases both lifespan and quality of life. That it can be caused in a small number of people by an act that we are told will benefit our ongoing health such as vaccination is even more disconcerting. We can only express our deepest sympathies to anyone diagnosed with the condition, but especially to someone as vibrant, famous and beloved as Ms Dion.
It's a distraction to argue about vaccine safety at this point. The bigger picture is that the mega-rich control every possible industry, and are busy creating a world that ends humanity's rights and freedoms. Destroying our health with man-made weapons is just the kick-off. They've already destroyed our manufacturing capacity and are currently destroying our energy supply, our food supply, our ability to travel (air and car). They've already destroyed our culture and our ability to bond with others (just ask a typical millennial). Universities and corporations are, right now, spending billions on cradle-to-slave system where kids will be surveilled 24/7 and guided from birth to follow a corporate servitude track where they will live in isolated pods, interacting only through the internet, well- trained to have no expectation of privacy or even human rights.