A recent PUBMED study by Dr. Peter McCullough used data from the Vaccine Adverse Events Reports System (VAERS) to examine cardiac adverse events (AEs)—specifically myocarditis—following the injection of the first or second dose of one of the three experimental COVID-19 "vaccines" currently being administered under emergency use authorization (EUA) in an "unprecedented fashion." The study revealed it is safe to assume the reporting of heart-related complications, including myocarditis, in VAERS is not rare, but instead, just the "tip of the iceberg."
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Co-authored with Dr. Jessica Rose, the peer-reviewed, approved, and published paper, titled "A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Event System (VAERS) in Association with COVID-19 Injectable Biological Products," was abruptly removed from publication after being fully accepted with executed publishing agreements. Currently, the report displays a "Temporary Removal" status, implying an intentional action to halt access to the study's important information. An archived copy of the original study is available online and is being referenced in this article.
Screenshot / PUBMED
Study Background
VAERS, which was created by the Food and Drug Administration (FDA) and Centers for Disease Control (CDC) in 1990, receives reports about adverse events (AEs) potentially associated with vaccines. The database is meant to serve as an early warning system for AEs not identified during pre-market testing. As noted by multiple experts, the report maintains that under-reporting to VAERS is "a known and serious disadvantage of the VAERS system." In addition to AEs, the report references serious adverse events (SAEs). SAEs are defined as any adverse event that results in death, is life-threatening, or places the individual at immediate risk of death from the event as it occurred, including hospitalization and other conditions which is determined to represent significant hazards. The VAERS handbook states that approximately 15 percent of reported AEs are classified as severe, and myocarditis—often associated with hospitalization—is considered an SAE.
The study confirms that myocarditis rates reported to VAERS were significantly higher in individuals between 13 to 23 years of age, with around 80% occurring in males. Additionally, of the 12 to 15-year old age group, within eight weeks of the FDA May 10, 2021 EUA of the Pfizer jab, the experts found 19 times the expected number of myocarditis cases.
Time series plot - VAERS reports in association with COVID-19 products for 2021.
Not to be taken lightly, myocarditis—the inflammation of the myocardium of the heart— can manifest as chest pain, heart failure, or sudden death. McCullough and Rose point out that myocarditis is a significant risk for cardiac death among the young and is the third leading cause of sudden cardiac death in children and young adults from puberty through the early 30s.
The report describes that in the context of COVID-19 respiratory illness, a substantial number of otherwise healthy patients have experienced heart-related complications, including myocarditis. Still, most of the clinical reports and diagnoses of heart-related complications claim cardiac injury to the patient to be "based on ICU-related injury to the heart." The authors explain that to establish a background rate of myocarditis within COVID-19 in general, it is essential to consider the clinical reports and diagnoses when considering the potential risk of myocarditis from COVID-19 "vaccines" against the risk of myocarditis from the COVID-19 virus itself.
Screenshot / CDC
With that in mind, cardiac injuries associated with the COVID-19 virus show a distinctive set of symptoms that are different from the clinical picture of vaccine-induced myocarditis, known as COVID-19-Injection-Related-Myocarditis (CIRM). CIRM is defined as the onset of clinical myocarditis that is temporarily associated with the injection of one of the COVID-19 "vaccines"—either the mRNA or adenoviral DNA injections—and in the absence of another known cause. CIRM presents with clinical symptoms (effort intolerance, chest pains) together with highly elevated troponin levels (a group of proteins that regulate heart contractions), electrocardiogram (EKG/EGC) changes, and left and right ventricular dysfunction on echocardiography in some cases. In cases where the EKG is inconclusive, cardiac MRI can detect myocardial inflammation.
The study analyzed VAERS data collected of all reported AEs associated with BNT162b2 (Pfizer), mRNA-1273 (Moderna), and Ad26.COV2.S (J&J). These three jabs are the three primary "vaccines" currently being distributed in the U.S. under EUA. The data was sorted to extract myocarditis as a standalone AE, with cardiac events grouped by pulling multiple keywords according to the Medical Dictionary for Regulating Activities Terminology (MedDRA). An international medical terminology emphasizing use for data entry, retrieval, analysis, and display, MedDRA applies to all phases of drug development, excluding animal toxicology, and to the health effects and malfunction of devices.
Broad Study Results
At publishing the paper's publishing, 56 percent of the U.S. population has been what the CDC considers "fully vaccinated" against COVID-19. As of July 9, 2021, 397,262 AEs have been reported to the VAERS system as referenced in the study. This large number is very abnormal compared to reports from previous years before COVID-19 "vaccines" were available. Indeed, if the trend of the past 30 years in VAERS AE reporting continued through to the end of 2021, we would see roughly 65,000 AEs for the entire year of 2021, not the nearly 400,000 AEs we currently see reported over the past six months. To date, there are close to 4,000 different AE types reported to VAERS related to COVID-19 shots, and many of them are SAEs. Despite the VAERS handbook's assumption that close to 15 percent of all the AEs should be classified as SAEs, the percentage holds at 18 percent for COVID-19-related AEs.
In the context of COVID-19 "vaccine" products, myocarditis reports to VAERS are atypically high compared to prior vaccine rollouts and in the context of baseline levels for high-risk groups. In 2019 and 2020, just one single case of myocarditis was reported for each year to VAERS. In early June, shortly after the May 10, 2021, EUA for kids aged 12-15 to receive the Pfizer jab, VAERS saw a significant increase in myocarditis cases reported, with 67 percent were "in the context of the administration of BNT162b2 (Pfizer's jab)."
Bar plot showing the number of myocarditis cases reported from January 1 to July 9, 2021.
Frequency of Myocarditis in Youths, Especially Males
Since July 9, 2021, 559 myocarditis AEs have been reported to VAERS, and 80 percent are male. Interestingly, the study notes that, in general, 71% of all VAERS reports are submitted by females. The authors state, "The increase in myocarditis reports coincides with the COVID-19 injection rollouts in children aged 12-15; thus, we hypothesized that the increased cases of myocarditis were in fact occurring in children of these ages." Paying close attention to the distribution of myocarditis cases by age grouped by decade, 41 percent of all myocarditis reports occurred in children aged 10 through 20, and 72 percent of all myocarditis reports were for individuals aged 10-30 years old. This information is significant.
41% of all myocarditis reports were made for children aged 10 through 20 and 72% of all myocarditis reports were made for young adults aged 10-30 years of age. The distribution is right-skewed toward the younger age groups, and this is statistically significant (I=1.61). This provides strong evidence to support our hypothesis.
Within eight days of the May 10, 2021, EUA for children aged 12-15, 600,000 kids had received a COVID-19 "vaccine" injection. As of June 7, 2021, the study states the CDC assessed a little over 3.4 million children aged 12-15 had received at least one dose of a COVID-19 shot. Since the Myocarditis Foundation reports 1 per 100,000 children per year experiences myocarditis, statistically speaking, we would expect to see less than 5 cases using the June 7 CDC figure. However, that is not the case. The research shows that eight weeks after the "vaccines" were made available to the 12-15-year-old age group (July 2), nearly 19 times the expected number of cases have been submitted to VAERS, with 15-year-old boys representing 80 percent of all cases. Of these cases, the authors state:
"It is important to note that of the 559 myocarditis VAERS reports, 6 died (1.1%), and 33% of these deaths were in individuals under 20 years of age: 1 individual was 13, and one was 19 years of age."
Histogram showing Myocarditis cases reported in VAERS following injection with COVID-19 products according to age and gender.
Acute Myocarditis After 2nd Dose
Myocarditis reports in VAERS are significantly higher following the second dose of the COVID-19 "vaccine" when compared by age and remain more frequent in males. They also occur most often with the Pfizer jab, making up 74 percent of all second-dose reports. In 15 year-old-males, myocarditis reports are six times higher for the second dose. The data shows that myocarditis cases are reported more often after the second dose, regardless of age.
Histogram showing Myocarditis cases reported in VAERS following injection with COVID-19 products according to age and dose.
McCullough and Rose remind that the high-risk age for myocarditis is from puberty through the early 30s and should be considered diagnostically in any young person experiencing shortness of breath, palpitations, or chest pain following the injection of any COVID-19 "vaccine."
Case rates of myocarditis per year based on estimated number of doses per year with respect to the population size for the season normalized to the number of doses administered per vaccine. *Population data extracted from Worldometer and vaccine data extracted from Our World in Data10 and CDC database.
Conclusions and Recommendations by McCullough and Rose
The average timeline to assess safety and efficacy in a clinical trial is typically up to ten years. The current phase III clinical trials for the mRNA COVID-19 "vaccines" were from a rushed, non-FDA-approved product rollout with a maximum observation period of six months, which, the authors declare, is overwhelmingly insufficient. In the current pandemic predicament, it is worth reminding that the three available "vaccines" have not been approved or licensed by the FDA and are authorized under an EUA under the pretense of being the only safe and effective method to prevent COVID-19. They were initially meant for use in individuals 16 years of age and older. Warning of the need to give proper consideration to all AEs in a new drug product—including myocarditis—Rose and McCullough caution:
"mRNA platforms have never before been implemented for use in human subjects on a global scale in the context of viruses, and it has recently been shown that the spike protein itself systemically traffics inducing damage within cells, at the cell surface, and through circulation with endothelial damage and thrombosis. It is unknown which cells and organs are seeded with mRNA, the cellular half-life of the products, duration of spike protein production, reverse transcription, future regulation, and ultimate disposal of mRNA technology. When evidence of harm appears, we need to follow the evidence and immediately take steps to mitigate risks."
It is imperative to remember that children have a negligible risk for COVID-19 respiratory illness, yet they are a high-risk group for myocarditis with vaccination. Furthermore, data from the 12-15 age group reported to VAERS is very early and represents a fraction of the actual total. Despite this, on May 31, 2021, a CDC report insisted no danger of myocarditis from the reported VAERS AE data. Without hesitation, the CDC continues to support and recommends COVID-19 "vaccines" for individuals 12 years of age and older.
The authors conclude that despite limitations—including using the under-reported VAERS dataset for their study—the usable sample sizes presented here have good statistical power. Their examination discloses a strong signal from the VAERS data that the risk of suffering CIRM, especially in males, is unacceptably high. Ultimately, for genuine pharmacovigilance to occur, these study results must be acknowledged and shared.
