FDA: Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation
https://www.fda.gov/media/143557/download
slide 16 or 17
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 coagulatior Venous thromboembolism
- Arthritis and arthralgia/joint pain Kawasaki disease
- Multisystem Inflammatory Syndrome in Children
- Vaccine enhanced disease