The slide is headlined, “FDA Safety Surveillance of COVID-19 Vaccines: DRAFT Working list of possible adverse event outcomes ***Subject to change***.”
Possible adverse reactions shown in the FDA’s “working list” include:
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- Guillain-Barré syndrome
- Acute disseminated encephaloymelitis (“Characterized by a brief but widespread attack of inflammation in the brain and spinal cord that damages myelin – the protective covering of nerve fibers,” according to NIH.)
- Transverse myelitis
- Encephalitis/myelitis/encephalomyelitis/meningoencephalitis/meningitis/encepholaphathy
- Convulsions/seizures
- Stroke
- Narcolepsy and cataplexy
- Anaphlyaxis
- 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
- Vaccine enhanced disease
The list also notes “Multisystem Inflammatory Syndrome in Children” as one possible outcome following vaccination.
While adverse events were generally discussed throughout the meeting, the slide’s contents were not covered in-depth.
The meeting came as the FDA was considering granting emergency use authorization to Pfizer and Biontech’s experimental jab. Read more