[Norm’s note: merely because I wanted to get this posted before too long, the reference section is a mess. When I make the time, I’ll clean it up. On the other hand, I’m sure a careful reader can navigate his way through that tangle. I’m on my way out the door. But as soon as I can, I’ll get to this.]
Source: The Wayback Machine
Hat tip: Mathew Crawford
A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products
Under a Creative Commons license open access
Following the global rollout and administration of the Pfizer Inc./BioNTech BNT162b2 and Moderna mRNA-1273 vaccines on December 17, 2020, in the United States, and of the Janssen Ad26.COV2.S product on April 1st, 2021, in an unprecedented manner, hundreds of thousands of individuals have reported adverse events (AEs) using the Vaccine Adverse Events Reports System (VAERS). We used VAERS data to examine cardiac AEs, primarily myocarditis, reported following injection of the first or second dose of the COVID-19 injectable products. Myocarditis rates reported in VAERS were significantly higher in youths between the ages of 13 to 23 (p<0.0001) with ∼80% occurring in males. Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males. A total of 67% of all cases occurred with BNT162b2. Of the total myocarditis AE reports, 6 individuals died (1.1%) and of these, 2 were under 20 years of age – 1 was 13. These findings suggest a markedly higher risk for myocarditis subsequent to COVID-19 injectable product use than for other known vaccines, and this is well above known background rates for myocarditis. COVID-19 injectable products are novel and have a genetic, pathogenic mechanism of action causing uncontrolled expression of SARS-CoV-2 spike protein within human cells. When you combine this fact with the temporal relationship of AE occurrence and reporting, biological plausibility of cause and effect, and the fact that these data are internally and externally consistent with emerging sources of clinical data, it supports a conclusion that the COVID-19 biological products are deterministic for the myocarditis cases observed after injection.
SARS-CoV-2; COVID-19; myocarditis; VAERS; adverse events (AEs); COVID-19-Injection-Related Myocarditis (CIRM)
Myocarditis is inflammation of the myocardium or ‘musculature’ of the heart. [1,2,3,4] The myocardium is made up of many cell types however the greatest mass of tissue is accounted for by cardiomyocytes. [4,5,6] Cardiomyocytes are the principal contractile cells and are supported by specialized conduction and stromal cell types. [4,5,6,7,8] Both systole and diastole are active processes that expend energetic resources of cardiomyocytes which are organized into myofibrils. [8,9,10] Myocarditis can manifest as sudden death, chest pain or heart failure. The symptoms of heart failure from myocarditis include effort intolerance, dyspnea, fatigue, and ankle swelling. [1,2,3,4,6,11,12,13] The cause is an inflammation of the heart muscle, often following a viral infection, but not exclusively so. The damaged muscle is prone to lethal cardiac arrythmias as well as having the potential to develop both right and left ventricular dysfunction (cardiomyopathy). [3,4,12,13]Myocarditis is a major risk for cardiac death among the young.  The high-risk age population for myocarditis is from puberty through early 30s, and it is the third leading cause of sudden cardiac death in children and young adults. 1 per 100,000 children per year are affected by myocarditis and it has been reported that 0.05% of all pediatric hospitalizations are for myocarditis. Between 0.5 and 3.5% of heart failure hospitalizations are due to myocarditis. Most cases of myocarditis are identified in young adults with males affected more often than females. [12,13,14,15,16]In the context of COVID-19 respiratory illness, there are a significant number of patients who are otherwise healthy experiencing heart-related complications, including myocarditis, but the majority of clinical reports and diagnoses claim cardiac injury based on ICU-related-related injury to the heart. [17,18,19,20,21,22,23,24,25] This is relevant in terms of contextualizing the potential risk of myocarditis from the COVID-19 products against COVID-19 itself and establishing a background rate of myocarditis in specific contexts. Cardiac injuries associated with COVID-19 respiratory illness reveal a set of parameters based on a combination of measurements of troponin levels, electrocardiogram (ECG/EKG), echocardiogram readings, cardiac magnetic resonance imaging (MRI) and clinical symptoms that are different from the clinical picture of vaccine-induced myocarditis. COVID-19-Injection-Related Myocarditis (CIRM) can be defined as the onset of clinical myocarditis that is temporally associated with COVID-19 mRNA or adenoviral DNA vaccine administration and in the absence of another known cause. CIRM presents with clinical symptoms (chest pain, effort intolerance) combined with excessively elevated troponin levels, EKG changes (diffuse ST segment elevation) and in some cases left and right ventricular dysfunction on echocardiography. In cases where the echocardiogram is unrevealing, cardiac MRI can detect changes in tissue characterization consistent with myocardial inflammation. [22,23,24,25,26,27]The Vaccine Adverse Event Reporting System (VAERS) was created and implemented in 1990 by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to receive reports about adverse events that may be associated with vaccines.  The primary purpose for maintaining the database is to serve as an early warning or signaling system for adverse events not detected during pre-market testing. In addition, the National Childhood Vaccine Injury Act of 1986 (NCVIA) requires health care providers and vaccine manufacturers to report to the DHHS specific adverse events following the administration of those vaccines outlined in the Act.1 Under-reporting is a known and serious disadvantage of the VAERS system. [28,29,30]An Adverse Event (AE) is defined as any untoward or unfavorable medical occurrence in a human study participant, including any abnormal physical exam or laboratory finding, symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research. A serious or severe adverse event (SAE) is defined as any adverse event that results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires, or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects or is another condition which investigators judge to represent significant hazards. [28,30,31] These classifications are based on the Code of Federal Regulations. The VAERS handbook states that approximately 15% of reported AEs are classified as severe.  Myocarditis qualifies as an SAE as it is often associated with hospitalization.The BNT162b2, mRNA-1273, Ad26.COV2.S products have not been approved or licensed by the U.S. Food and Drug Administration (FDA), having been authorized instead for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.2[32,33,34] Ultimately, the roll-out of COVID-19 injectable biologicals are actively being monitored, but all of the risks are not yet known. [16,17,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46]