Tuesday, December 8, 2020

Working list of possible adverse event outcomes

 "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/encephalopathy,
  • 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, and
  • Vaccine enhanced disease.

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