A Short Rant & Some Issues with the Saudi Arabian Study that found 27.11% Cardiac Complications Post COVID-19 mRNA Vaccination
When researchers deny their own findings
The authors of a recent study published in Cureus investigated self-reported physician-diagnosed cardiac complications post mRNA COVID-19 vaccination. 27.11% of participants reported they had been diagnosed with such injuries following the jabs (and 72.89% said they were not). For the vast majority of those who did, the onset duration was less than 1 month post-vaccine. A large proportion of those affected spent 1-3 days in the hospital as a result.
(Note: For the exact numbers, please see the paper. However, there are some issues and questions as I will describe below).
Despite these extremely high proportions, the authors seem pleased with the result. They keep emphasizing that their data, which they portray as supporting the favorable safety profile of mRNA COVID-19 vaccines, should support public trust and help guide global health practices.
The authors repeatedly highlight the need for transparent communication to support, among others, vaccination behavior and public perceptions, writing
“Methodological rigor, ethical considerations, and acknowledgment of limitations enhance credibility.”
Then how do they manage to explain away the astronomical percentage of the physician-diagnosed heart issues?
The authors stress the distinctive demographic and epidemiological landscape in Saudi Arabia. In the paper, they place a lot of attention on psychosocial aspects, hesitancy, comorbidities, and pre-existing health conditions. Those listed do not seem to be unique to Saudi Arabia.
To me, this raises issues and questions:
Why stress that “This study acutely recognizes the rarity of cardiac complications post-vaccination” and downplay “Key findings included a high mRNA vaccine uptake with a frequency of 747 (92.79%) and a mere frequency of 218 (27.11%) reporting cardiac complications post vaccination.” Why put a spin on it as if this is minor (indicated by “mere”)? Don’t the authors think that people understand that the numbers are horrific?
Manufacturing issues, aka hot lots, across geopolitical influences: what would have happened if the same high rate had been observed in Germany, say? Would it even be published, or is there a manufacturing-related or political reason they seemingly do not have such a high rate?
The way the numbers are reported is not very clear and sometimes seems misleading. For example, sometimes the term “not applicable” is, appropriately, used for those who were not injured. However, in other instances, it suggests something entirely different. In Table 4, for example, the question “Have you been admitted to the critical care unit or ward?” suggests it applies to those who had the reported and confirmed injuries. But in fact, it includes those who were not (the 72.89%). Asking this question to those who never experienced complications does not seem to be appropriate. Only for some of the questions, the table is more clear, e.g. “What was the duration of hospitalization?” allows a “N/A” response (which applied to the 72.89% who were not injured).
Some of the percentages do not add up to 100%. Specifically, in Table 4, the percentages to the question “What is the onset duration of cardiac complications diagnosed by a physician post vaccination?” only add up to roughly 73%. (Clearly, these 73% cannot refer to those who never reported complications). This indicates some significant statistical problems. The way it is presented now makes the percentages for the reported injuries much smaller and, therefore, obfuscates genuine associations. Knowing a temporal relationship is key. So, omitting some 27% is huge. (The percentages to “Have you been admitted to the critical care unit or ward?” do not add up to 100% either, but with 100.13% are at least somewhat close).
There is an apparent discrepancy in the study population: on the one hand, those experiencing heart complications were MOSTLY younger individuals (Table 1 - only 5.85% were in the 55+ category). On the other hand, the comorbidities that seem to be suggested as the (partial) culprits were: diabetes mellitus, hypertension, dyslipidemia, and to a lesser degree, obesity, sedentary lifestyle, and smoking-related. It appears as if these would be more prevalent in the older population - whereas it was predominantly the younger ones that experienced the heart issues.
The authors emphasize the need for public “perception” and “knowledge and awareness-based inquiries” during their study. Would it not be more important to admit a clear statistical association (some may say, causation)? And ironically, while the importance of ethical considerations is stressed again and again, these are never in the context of vaccine safety and informed consent related to vaccination. Rather, the ethical “standards” only seem relevant to their study design.
Rather than referring to related work, some of the strongest assertions in the paper are given without providing any references at all. The way it is written parrots the narrative that the mRNA COVID-19 vaccines prevent transmission and are essential for achieving population immunity. That these claims are actually true is never demonstrated or based on referenced literature. In the same way, the narrative is built, without any proof, that previous and related work shows that cardiac complications following vaccination are rare.
Regarding
“The study's findings carry substantial implications for public health policies globally. The tailored recommendations informed by the study could prove instrumental in maximizing the benefits of vaccination programs while minimizing potential risks [9]. The communication strategies outlined in the study contribute to the broader global challenge of building and maintaining public trust in vaccination, especially with emerging vaccine technologies.”
I am not sure if I understand the “tailored recommendations.” Does it mean that 27.11% is “rare?” Are they promoting a new measurement and evaluation system so that anything smaller than a politically-determined cutoff is classified as “rare?” Would something slightly less than 50% still be regarded as rare, or even an event that is strictly less than 100%?
Is the idea really that if you tell people that almost one-third chance of sustaining substantial complications is such good news that this should support their “trust?”
Sadly, it seems that “expert opinion” nowadays is no longer determined by raw and convincing numbers but by wordplay and politics.
At first sight, this study is clearly and irremediably flawed. The key point is in my opinion that they used a google form to disseminate their survey, declaring that " The distribution strategy involved sharing the survey with the intended population through group posts and direct messages, ensuring broad accessibility for potential participants", however the "intended population" is never defined and it is likely that they just collected responses as they came, with no control of the sample composition, which is likely eventually representative of nothing. In the inclusion criteria they mention only vaccine inoculation while in data collection the write "The study was conducted on individuals who had previously experienced the onset and duration of cardiac complications". It is likely that mainly people who sufferend from any post vaccine complications answered the survey, and this could well explain the high percentage of subjects with cardiac issues. In other terms, there is a fatal selection bias which makes this study irrelevant, flawed and misleading It should have been rejected and now it deserves retraction. Imho.