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”.