FDA Safety Surveillance of COVID-19 Vaccines: Working List of Possible Adverse Event Outcomes
“Adverse Events” as listed above:
Guillain-Barré syndrome
Acute disseminated encephaloymelitis
Transverse myelitis
Encephalitis/ myelitis/ encephalomyelitis/meningoencephalitis/meningitis/encepholaphathy
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
This list can be found on the 2:33:40 minute mark of the FDA video titled, “Vaccines and Related Biological Products Advisory Committee - 10/22/2020”.