www.fda.gov/media/143557/download
FDA Safety Surveillance of COVID-19 Vaccines :
DRAFT Working list of possible adverse event outcomes
***Subject to change***
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
FDA-Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting
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