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WASHINGTON D.C, December 8, 2020 (LifeSiteNews) – A document drawn up by the Food and Drug Administration (FDA), listing the possible side-effects from a COVID-19 vaccine, includes strokes, encephalitis, auto-immune disease, birth defects, and Kawasaki disease among the potential side-effects to be monitored.

slideshow presentation compiled by the FDA in October contains an extensive list of possible side effects which are to be monitored in conjunction with administering a COVID-19 vaccine. There is to be both passive and active surveillance of side effects related to the vaccine. Under the former system, the FDA is to partner with the Centers for Disease Control (CDC) to manage the Vaccine Adverse Event Reporting System (VAERS), whereby individuals report adverse side effects to their health care provider. 

Legal immunity for vaccine producers

And due to a little-known federal law from the 1980s, pharmaceutical companies cannot be sued in court if their vaccines injure or kill someone. Instead, people injured or killed by vaccines (or their relatives) must use the National Vaccine Injury Compensation Program, which was created in 1986. It protects pharmaceutical companies from lawsuits related to vaccine injuries or deaths.

“It was created after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates, which they believed could cause a resurgence of vaccine preventable diseases,” Children’s Health Defense explains.

Children’s Health Defense reports, “According to the vaccine-injured and their loved ones, the program has failed miserably as a litigious, broken system where the injured are up against a government vaccine program, government owned vaccine patents, government health officials who administer the program and government paid attorneys from the Department of Justice. There is no judge, no jury of your peers and no discovery. Claimants feel the system is set up for their claims to fail.”

With the active surveillance, the FDA plans to use the “Biologics Effectiveness and Safety (BEST) System,” with numerous partners. MarketScan, the largest number of the partner companies, has over 250 million patients. 

Along with the Center for Medicare & Medicaid Services (CMS), the FDA states that its data can cover “approximately 55 million elderly US beneficiaries >65yrs of age.” It is through using the CMS data that the FDA plans to monitor side-effects from COVID vaccines, based on rapid-cycle analyses.

FDA admits long list of possible negative side-effects

The working list presented has 22 separate entries of “possible adverse event outcomes.” 

First on the list is “Guillain-Barré syndrome,” described as “a rare disorder in which your body's immune system attacks your nerves.” The syndrome has “no known cure” and it mortality rate is “4% to 7%.” In contrast, John Hopkins University estimates that the current percentage of deaths reportedly due to COVID-19 cases in the U.S, is only 1.9%.

“Acute disseminated encephalomyelitis,” a “rare inflammatory condition that affects the brain and spinal cord,” is second on the FDA’s list. Third is “Transverse myelitis,” a neurological disorder which inflames the spinal cord, causing “pain, muscle weakness, paralysis, sensory problems, or bladder and bowel dysfunction.”

Also listed as a possible outcome of a potential vaccine is “Anaphylaxis,” the severe allergic reaction which can lead to anaphylactic shock. 

A “stroke,” and “convulsions/seizures” are further possible side-effects, along with “Acute myocardial infarction” or heart attacks, inflammation of the muscles around the heart, and even death. 

The U.K. government’s warning for the Pfizer vaccine says it should not be used by pregnant or breast-feeding mothers and children. The document adds that it is as yet unknown what effect the vaccine will have on fertility. It also says, “women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.”

The FDA also suggested that Kawasaki disease as being a possibility after the vaccine. The disease “mainly affects children under the age of 5,” and is “always treated in hospital.”

Children might also be affected by the COVID vaccine, through developing “Multisystem Inflammatory Syndrome,” (MIS-C) which the CDC notes is connected to COVID-19. However, The Mayo Clinic gives more detail, explaining that whilst most children with COVID-19 “have only a mild illness,” those who develop MIS-C are much more seriously affected. Organs and tissues, “such as the heart, lungs, blood vessels, kidneys, digestive system, brain, skin or eyes” can become severely inflamed.

The full list of possible side-effects of a COVID vaccine, according to the FDA, are “Guillain-Barré syndrome; Acute disseminated encephalomyelitis; Transverse myelitis; Encephalitis/myelitis/encephalomyelitis/ meningoencephalitis/meningitis/ encepholapathy; Convulsions/seizures; Stroke; Narcolepsy and cataplexy; Anaphylaxis; Acute myocardial infarction; Myocarditis/pericarditis; Autoimmune disease; Deaths; Pregnancy and birth outcomes; Other acute demyelinating diseases; Non-anaphylactic allergic reactions; Thrombocytopenia; Disseminated intravascular coagulation; Venous thromboembolism; Arthritis and arthralgia/joint pain; Kawasaki disease; Multisystem Inflammatory Syndrome in Children; Vaccine enhanced disease.”

Later in the FDA document, it is noted that side-effects from vaccines for COVID-19 have yet to be fully understood. “There may be limited information available at licensure on level and duration of effectiveness,” the text reads. This might prompt manufacturers to “conduct certain COVID-19 vaccine effectiveness post-licensure studies.”

Trials for the Pfizer COVID-19 vaccine, have in fact produced “severe” side-effects, with volunteers reporting headaches, fevers, migraines and symptoms akin to a hangover. 

Doctors have also been warning the CDC of the dangers of the vaccines, with Dr. Sandra Fryhofer of the American Medical Association urging that people be warned of the possible results. “We really need to make patients aware that this is not going to be a walk in the park,” she said. “They are going to know they had a vaccine. They are probably not going to feel wonderful. But they’ve got to come back for that second dose.”

LifeSiteNews has produced an extensive COVID-19 vaccines resources page. View it here.


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