FDA Updates Face Sheets Because of Elevated Dangers of Myocarditis and Pericarditis
As the risk of myocarditis and pericarditis becomes clearer after the Covid vaccination, I have a simple question for all of us with children who cannot tell us exactly or at all about their state of health.
If your child has an fast beating, fluttering or pounding heart, Would he or she have the ability to tell you?
At home, that answer is a resounding NO, NO, and NO. Let’s say your child could communicate or you were able to figure out the problem through your super duper autism parenting intuition with special secret life decoder skills. Would your child tolerate any of the tests that would be done in the emergency room?
Worse, your doctor may not be able to diagnose properly! Classified as a rare disease, myocarditis is misdiagnosed by doctors and is the third leading cause of sudden death in young people. Source: Myocarditis Foundation
Diagnosing myocarditis is difficult because it looks like so many other diseases. The diagnosis is first made through medical history and a physical exam by a doctor. A physical exam may show rapid heart rate, abnormal blood pressure and breathing rate, an abnormal examination of the heart and lungs, and sometimes an enlarged liver. Special tests such as a chest x-ray, electrocardiogram, and echocardiogram can help make the diagnosis. Sometimes blood tests are done to show the presence or cause of inflammation. The best way to diagnose myocarditis is to look at a small piece of heart muscle under a microscope. Samples of the heart muscle are taken with a bioptome, a thin, flexible tube with small cutting jaws on the tip. The bioptome is inserted through a vein in the patient’s neck and positioned in the heart. Once the bioptome is in position, it takes very small heart muscle samples for analysis.
Source: Chicago Children’s Hospital
Last week we passed out a student in karate class. He stumbled towards me as we were in line and collapsed in my arms. Thank goodness he came to quickly and could speak and concentrate. We hope it was due to dehydration and heat. We do not know it.
The FDA released this information in a press release last week and updated the datasheets as reports continue to come in on the global experiment called Covid Vaccination:
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Source: FDA
The U.S. Food and Drug Administration (FDA) has continued to take action as part of the ongoing response to the COVID-19 pandemic:
Today, the FDA announced revisions to the patient and vendor datasheets for Moderna and Pfizer-BioNTech’s COVID-19 vaccines to address the suspected increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart). after vaccination. For each vaccine, the leaflet for healthcare providers who administer vaccines (vaccination providers) has been revised to include a warning about myocarditis and pericarditis, and the leaflet for recipients and carers has been revised to include information about myocarditis and pericarditis. This update follows an in-depth review of the information and discussion by the CDC’s Advisory Committee on Vaccination Practices on Wednesday. The data presented at this meeting reinforced the FDA’s decision to revise the data sheets and also provided information about the specific revisions. The warning in the leaflets for healthcare providers who deliver vaccines indicates that Adverse event reports suggest an increased risk of myocarditis and pericarditis, especially after the second dose and with onset of symptoms within a few days of vaccination. In addition, the fact sheets for recipients and carers of these vaccines indicate that Vaccine recipients should see a doctor immediately if they experience chest pain, shortness of breath, or the feeling that they have a fast beating, fluttering, or pounding heart after vaccination. The FDA and CDC are monitoring the reports, gathering additional information, and will take follow-up action to evaluate the longer-term results over several months.