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