CBER Plans for Monitoring COVID-19Vaccine Safety and Effectiveness

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

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