This like many fatally flawed papers uses VAERS data. Rose et al. claim “it seems clear that the COVID-19 vaccines are deterministic for myocarditis.” This cannot be done with VAERS data. VAERS is a passive, unverified, open‑access reporting system. It cannot be used to estimate rates or determine causation. This is made very clear on the “About” page of the VAERS website as quoted below.
- VAERS is a passive reporting system, meaning that reports about adverse events are not automatically collected. Instead, someone who had or is aware of an adverse event following vaccination must file a report.
- Anyone can submit VAERS reports. Some reports can lack details or contain errors. After investigation, scientists find that most events reported to VAERS are not associated with vaccination.
- The number of reports submitted to VAERS can change in response to media attention and public awareness. Such changes in reporting can complicate interpretation of VAERS data.
- When more people hear about vaccine side effects, they may report any health outcomes they experience after vaccination.
- This increase in reporting can complicate detecting patterns of adverse events that should be further assessed in a strong, reliable data analysis system.
- Such increased reporting can also create the misconception that vaccines are dangerous, leading to fear and hesitation about vaccination.
- It is usually not possible to use VAERS data to calculate how often an adverse event occurs in a population.
- The number of people receiving a vaccine is usually not available (a notable exception was during the COVID-19 public health emergency when the number of doses of COVID-19 vaccine administered was reliably reported to CDC).
- VAERS data alone cannot determine if the vaccine caused the reported adverse event. Establishing a causal relationship requires rigorous scientific assessment and consideration of multiple factors beyond just VAERS reports alone.
Another major flaw is that she uses “an under-reporting factor (URF) of 31.” This is a nonsense measure. It is not a metric used in pharmacological research. Further, the claim about adverse events being underreported is flawed as well. Serious adverse events are much more likely to be reported.
So where did this URF come from? Rose made it up herself in a prior paper that doesn’t appear in a real journal.
Another major flaw is comparing VAERS during COVID to what was in the data before COVID. “We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years.” This is completely invalid because COVID vaccinations involved hundreds of millions of doses in a short period, public awareness was unprecedented, reporting requirements were expanded, media attention massively increased reporting, and clinicians were explicitly instructed to report myocarditis. They even admitted this, stating “We recognize that myocarditis has been keyed for reporting in VAERS since the 2021 U.S. FDA warnings were placed on the COVID-19 mRNA products.” They failed to mention this in their conclusions which is evidence of reporting bias.
Their claims get even more ludicrous when trying to draw a temporal associationb between vaccination and events that happen 1-2 years later as seen in the screenshot below. The screenshot is to prove this since anybody looking at this might think I’m misquoting since it’s so absurd.
They note that the myocarditis reports in VAERS “used clinical adjudication in addition to troponin levels or ICD codes with physician review of symptoms, electrocardiogram (ECG/EKG), echocardiography, cardiac magnetic resonance imaging (MRI), and clinical symptoms.” They note this again in their Limitations section, “Despite myocarditis being the MedDRA code listed in VAERS, the diagnosis of myocarditis might be incorrect without clinical adjudication,” but then count every time the word myocarditis is used as a confirmed case.
The editor and publisher have issued an expression of concern about the paper.
