VAED: Infection + injection = heart injury

Evidence of vaccine-enhanced disease (VAED) from the horse's mouth

Summary

An analysis of US VAERS reports about boys 12-17 who experienced an adverse events within 30 days of receiving dose 2 of a modRNA vaccine and were reportedly exposed to SARS-COV-2 revealed:

• 26.1% (95% CI: 24.5-27.8%) of reports included a diagnosis for myocarditis

• 42.2% (95% CI: 39.3-45.4%) of reports fulfilled CDC’s criteria for suspected myocarditis

In boys 12-17 who were not reportedly exposed to SARS-COV-2, but also experienced an adverse event within 30 days of receiving dose 2, these proportions were much lower:

• Only 6.6% (95% CI: 6.5%-6.6%) of reports included a diagnosis for myocarditis

• Only 10.2% (95% CI: 10.1%-10.3%) of reports fulfilled CDC’s criteria for suspected myocarditis

The reporting odds ratios between subsamples about boys with and without reported SARS-COV-2 exposure for diagnosed myocarditis are 29.5 (95% CI: 16.4-53.0), 5.0 (95% CI: 3.5-7.2) and 9.6 (95% CI: 7.1-12.9) for 1st, 2nd and any dose respectively.

The reporting odds ratios between subsamples about boys with and without reported SARS-COV-2 exposure for suspected myocarditis are 26.3 (95% CI: 15.5-44.5), 6.4 (95% CI: 4.7-8.8) and 10.6 (95% CI: 8.2-13.6) for 1st, 2nd and any dose respectively.

Introduction

The CDC made several remarkable statements about the potential risks associated with COVID-19 vaccination on January 29, 2021:

1. “Severe COVID-19 disease can be an indication of vaccine-enhanced disease (VAED)”

2. “Myopericarditis has been reported as part of COVID-19 disease pathology and

   could indicate VAED”

Within the document is a link to their definition of myocarditis:

In the same document the CDC announces:

“Two main approaches to data mining are Proportional Reporting Ratios (PRRs) and Empirical Bayesian Geometric Means [11,12,13]. Both have published literature suggesting criteria for detecting “signals” [14]. PRR will be used at CDC for potential signal detection”.

Even if the CDC have performed these analyses, they have never released their results to the public.

Instead of calculating proportion ratios between subsamples of reports about different vaccines like the CDC announced a long time ago, I simply looked at proportions of terms in various subsamples of COVID-19 vaccine adverse event reports to determine if boys who catch a SARS-COV-2 infection in close temporal proximity to their vaccination are at an increased risk to suffer cardiac injury.

Methods

I limit the analysis to the US subsample of the public VAERS dataset due to inconsistencies in reporting behaviour between foreign regulatory agencies (German article).

If the CDC failed to populate all of the age fields, I run a Regular Expression on the SYMPTOM_TEXT field:

/\W(\d{1,3})\W*ye*a*rs*\W*old$/i

If this does not yield the patient age, the report is dropped from the analysis.

I then calculate the proportions of reports containing each of the following MedDRA terms:

• Echocardiogram abnormal

• Electrocardiogram abnormal

• Myocarditis

• Troponin increased

• Chest pain

and the proportion of reports containing either at least one or at least two of the five terms in subsamples of reports about events occurring in boys aged 12-17 within 30 days of:

• dose 1 (without known virus-exposure)

• dose 2 (without known virus-exposure)

• dose 1 (with known virus-exposure)

• dose 2 (with known virus-exposure)

Finally I calculate the proportional differences between events occurring within 30 days of dose 2 with co-reported SARS-COV-2 exposure and events occurring within 30 days of dose 2 without known SARS-COV-2 exposure.

Results

One can clearly see that the largest absolute increase in proportions for every term occurs between the subsamples double-dosed boys without known exposure to SARS-COV-2 and double-dosed boys with exposure to SARS-COV-2 with a proportional difference of +19.5% (+13.3% - +26.2%).

The largest relative increase can be seen between the subsamples single-dosed boys without known exposure to SARS-COV-2 and single-dosed boys with exposure to SARS-COV-2 with an odds ratio of 29.5 (95% CI: 16.4-53.0).

Since the proportions of reports mentioning chest pain in the subsamples double-dosed boys without known exposure to SARS-COV-2 and single-dosed boys with exposure to SARS-COV-2 are almost equal, I assume that not all reports about chest pain are referring to cardiogenic chest pain or at least not to myocarditis-associated chest pain.

To refine the result I determined the proportions of reports mentioning at least one or two of the five terms and visualized them next to myocarditis on a separate chart. All reports in the latter of the two groups fulfil the criteria for myocarditis or suspected myocarditis:

The point-estimates and 95% confidence intervals for the Bernoulli distributed report proportions are:

• Myocarditis (dose 2, virus-exposed):

  26.1% (24.5% - 27.8%)

• Any of the five terms (dose 2, virus-exposed):

  63.9% (59.6% - 68.5%)

• Suspected myocarditis or myocarditis (dose 2, virus-exposed):

  42.2% (39.3% - 45.4%)

The point-estimates and 95% confidence intervals of the proportional differences between those who were and were not reportedly exposed to SARS-COV-2 are:

• Myocarditis:

  +19.5% (+13.3% - +26.2%)

• Any of the five terms:

  +45.8% (+38.5% - +52.7%)

• Suspected myocarditis or myocarditis:

  +32.0% (+24.8% - +39.3%)

Conclusion

The proportion of reports about boys aged 12-17 who have suffered myocarditis within 30 days of their 2nd dose of a modRNA vaccine increases by +19.5% (+13.3% - +26.2%) to 26.1% (24.5 - 27.8%) if the search is limited to those who were knowingly exposed to SARS-COV-2.

The proportion of reports about boys aged 12-17 who are suspected to have suffered myocarditis within 30 days of their 2nd dose of a modRNA vaccine increases by +32.0% (+24.8% - +39.3%) to 42.2% (39.3-45.4%) if the search is limited to those who were knowingly exposed to SARS-COV-2.

The odds ratios between subsamples about boys with and without reported SARS-COV-2 exposure for diagnosed myocarditis are 29.5 (95% CI: 16.4-53.0), 5.0 (95% CI: 3.5-7.2) and 9.6 (95% CI: 7.1-12.9) for 1st, 2nd and any dose respectively.

The odds ratios between subsamples about boys with and without reported SARS-COV-2 exposure for suspected myocarditis are 26.3 (95% CI: 15.5-44.5), 6.4 (95% CI: 4.7-8.8) and 10.6 (95% CI: 8.2-13.6) for 1st, 2nd and any dose respectively.

Discussion

1. Disease enhancement

The analysis does not take into account the exact temporal relationship between injection and infection. An unknown proportion of reports are about events that occured in patients who had a prior infection.

I consider it highly likely that the report proportions would be significantly higher if the search was limited to reports about patients who had COVID-19 at the time the drug was administered.

In my time working with the VAERS database, I noticed that disease enhancement is not limited to myocarditis, but extends to other pathological processes across patients of every age and gender.

These are a few examples of terms which report proportions increase with each exposure to vaccine or virus:

• Acute kidney injury (1, 2, 3, 4)

• Death (1, 2, 3, 4)

• Hypophagia (1, 2, 3, 4)

• Acute myocardial infarction (1, 2, 3, 4)

2. Myocarditis in virus-naïve individuals after single-dose

A Polish team of researchers had 1,249 hospital and university workers and students report their experiences via a questionnaire and concluded “having earlier suffered from COVID-19 had an impact on the occurrence of more severe side effects after the first dose of the COVID-19 vaccine”.

The proportion of reports mentioning myocarditis after the first dose without mentioning SARS-COV-2 exposure is below 0.5%. It is possible that the boys in those reports unknowingly or unreportedly had a prior SARS-COV-2 infection.

Hypotheses

1. Injection of COVID-19 modRNA vaccines into muscle tissue of single-dosed patients currently infected with SARS-COV-2 enhances disease in a reliable manner and produces myocarditis in the majority of boys age 12 or older.

2. A single dose of modRNA vaccine is incapable of producing myocarditis in individuals naïve to both vaccine and disease.

Notes

I feel the need to clarify why the underreporting factor was never of any interest when trying to establish the side effects profile of the modRNA vaccines.

There are a large number of side effects that can be caused by the COVID-19 modRNA vaccines. The occurrance of any type of side effects can be reported to the CDC spontaneously by patients, their relatives or their medical professionals. Even the mishandling of the product without the occurrance of adverse events is regularly reported.

This generates a large number of diverse reports.

Across all reports about boys aged 12-17 who experienced an adverse event within 30 days of receiving the second dose of their modRNA vaccine and mention a SARS-COV-2 infection only 36.1% percent did not also mention symptoms of myocarditis and only 57.8% of reports did not fit the CDC’s criteria for suspected myocarditis.

Even the CDC state in their VAERS disclaimer: “The number of reports alone cannot be interpreted as evidence”.

That’s why it’s time to start thinking in report proportions.