Autopsy-based histopathological characterization of myocarditis after anti-SARS-CoV-2-vaccination
Abstract and Figures
- In four patients who received a mRNA vaccination, we identified acute (epi-)myocarditis without detection of another significant disease or health constellation that may have caused an unexpected death. Histology showed patchy interstitial myocardial T-lymphocytic infiltration, predominantly of the CD4 positive subset, associated with mild myocyte damage.
Overall, autopsy findings indicated death due to acute arrhythmogenic cardiac failure. Thus, myocarditis can be a potentially lethal complication following mRNA-based anti-SARS-CoV-2 vaccination. Our findings may aid in adequately diagnosing unclear cases after vaccination and in establishing a timely diagnosis in vivo, thus, providing the framework for adequate monitoring and early treatment of severe clinical cases.
Dec. 21, 2022
Heidelberg University Hospital Autopsy Examination Reveals 5 of 25 Deceased Likely Linked to Vaxxed
Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older
We evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons. The CMS data from December 11, 2020 through Jan 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. We conducted weekly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.
Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines.
This early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.
Per FDA communication of these findings, FDA is currently not taking any regulatory actions based on these signal detection activities because these signals are still under investigation and require more robust study.
Conflict of Interest Statement
Co-authors from U.S. Food and Drug Administration, Acumen LLC, and 4 Centers for Medicare & Medicaid Services declared no conflicts of interests.
This well written article asks WHY it has taken so long for the FDA to print their findings. An in an October investigation for The BMJ, the FDA first disclosed findings in July 2021, noting the detection of four types of potential serious adverse events following receipt of Pfizer’s vaccine in the elderly (65s & over):
- acute myocardial infarction
- disseminated intravascular coagulation
- immune thrombocytopenia
- pulmonary embolism
But these findings were only posted on the agency’s website, with no corresponding press release, preprint, or journal publication. The article also points out a concern that the FDA’s analysis is already out of date due to the cut-off date of Jan. 15, 2022 (four months after the study was submitted to Vaccine), which means there’s now a year’s worth of additional data that has not been reported on by the FDA.
The webpage stated that the FDA “will further investigate these findings” and “share further updates and information with the public as they become available.”
But over one year later, crickets…..
The FDA finally just came out with the information, which claims it shows the system is working.
“How can the FDA seriously assert it’s supporting decision-making when, in the 20 months that they have been aware of the signal, there has not been a single press release or Dear Health Care Provider letter about the FDA’s studies on safety signals, and the label has yet to be updated?” ~ Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ
These studies confirm what concerned doctors, researchers, and injured patients have been shouting about for two years. The FDA finally came out of its coma to notice, but per usual is doing nothing about it.
Dr. Peter McCullough, chief medical adviser for the Truth for Health Foundation, told the Epoch Times via email that the new paper:
“corroborates the concerns of doctors that the large uptick in blood clots, progression of atherosclerotic heart disease, and blood disorders is independently associated with COVID-19 vaccination.”
What’s truly disheartening is that this information should available BEFORE the shots were rolled out to an unsuspecting and trusting public who now must simply deal with the hideous aftermath. Please also note that the push for these shots initially was on the vulnerable, elderly population despite the fact it is common knowledge that “vaccines” are less effective in the elderly due to a declining immune system.
Some of the worst medical and civil rights tyranny is occurring in health care settings like senior residential facilities. A common lunacy heard around the world is, “take the jab or lose your job.” Health care workers, the military, pilots, many schools, workers in companies with more than 100 employees, and many more were mandated to get the jab. This was also true for many senior homes and other institutions. People felt they had no choice. Many quit their jobs due to this. Further, Whistleblowers claim elderly patients were chemically constrained and physically forced to get the injections. Allegedly, caretakers lied to residents about the shot, and forged signatures multiple times. These claims have been corroborated by multiple care directors.
Now, the FDA finally admits that these very people who were often forced to get the jab have a statistical signal for blood clotting due to the very thing they were forced to get.
This does not bode well for public health.
http:// (Approx. 14 Min)
FDA Drops Bombshell over Pfizer Shot
Redacted with Natali and Clayton Morris
Dec. 19, 2022