FDA concealed that Pfizer and Moderna mRNA vaccines could cause myocarditis, pericarditis and other serious adverse events including death

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1- Phase 1 of Pfizer’s vaccine clinical trials began on April 29, 2020.
2- Phase 1 of the Moderna vaccine clinical trials started on March 16, 2020
3- Phase 1 of Janssen’s vaccine clinical trials started on September 7, 2020
4- FDA approved Pfizer-Biontech vaccine package insert in December 2020
FDA approved package insert for Pfizer-Biontech COVID-19 vaccine, no mention of GBS as a risk
First Pfizer-BioNTech vaccine package insert (December 2020) approved by the FDA
5- On June 25, 2021, FDA Recognizes Increased Risks After mRNA Vaccination (Pfizer and Modern)
June 25, 2021
The US Food and Drug Administration (FDA) continued to act in the ongoing response to the COVID-19 pandemic:
Today, the FDA is announcing revisions to the patient and provider datasheets for Modern and Pfizer-BioNTechVaccines COVID-19 related to the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) after vaccination. For each vaccine, the package insert for healthcare professionals administering the vaccine (vaccination providers) has been revised to include a notice about myocarditis and pericarditis, and the package insert for recipients and caregivers has been revised to include information on myocarditis and pericarditis.
6- The FDA already knew that mRNA vaccines (gene therapies) could cause myocarditis, pericarditis and other adverse events since a submission on October 22, 2020, but Pfizer’s package insert as of December 2020 omits this information. It is unlikely that the adverse events discussed at presentation are associated with the Janssen viral vector vaccine (gene therapy) as clinical trials for this vaccine began on September 7, 2020.
Notice of Vaccines and Related Biological Products (FDA)
Presentation of the Committee meeting on October 22, 2020
FDA safety surveillance for COVID-19 vaccines:
DRAFT Worklist of possible adverse event outcomes
Subject to change
 Guillain-Barré Syndrome
 Acute disseminated encephalomyelitis
 Transverse myelitis
 Encephalitis / myelitis / encephalomyelitis /
meningoencephalitis / meningitis /
 Seizures / seizures
 Stroke
 Narcolepsy and cataplexy
 Anaphylaxis
 Acute myocardial infarction
 Myocarditis / pericarditis
 Autoimmune disease
 Deaths
 Pregnancy and childbirth outcomes
 Other acute demyelinating diseases
 Non-anaphylactic allergic reactions
 Thrombocytopenia
 Disseminated intravascular coagulation
 Venous thromboembolism
 Arthritis and arthralgia / joint pain
 Kawasaki Disease
 Multisystemic Inflammatory Syndrome
in children
 Disease potentiated by vaccines
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