Exhibit 5: Exhibit Shown at FDA Meeting, Oct. 22, 2020 — Case 2:21-cv-00702-CLM (Document 37-5)

Summary

Exhibit 5 to Document 37-5, filed 11/19/21 in Case 2:21-cv-00702-CLM, reproduces a slide shown at an FDA meeting on Oct. 22, 2020 titled FDA Safety Surveillance of COVID-19 Vaccines. The slide is a draft working list of possible adverse event outcomes, marked subject to change, that runs from Guillain-Barré syndrome and deaths through myocarditis/pericarditis, vaccine enhanced disease and autoimmune disease.

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Date: 2021-11-19

Cite this document

“Exhibit 5: Exhibit Shown at FDA Meeting, Oct. 22, 2020 — Case 2:21-cv-00702-CLM (Document 37-5).” Original at archive.org, dated 2021-11-19. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2021-11-19-covid-era-misc-6e5b11f0-1/, SHA-256 6e5b11f0d24e3fe900d72cd90e6862b3a9e91ceb5f4b3c10c73741740228d477.

Full text

Case 2:21-cv-00702-CLM Document 37-5 Filed 11/19/21 Page 1 of 2            FILED
                                                                  2021 Nov-19 PM 11:28
                                                                  U.S. DISTRICT COURT
                                                                      N.D. OF ALABAMA




                        Exhibit 5:

         Exhibit Shown at FDA Meeting
                  Oct. 22, 2020
FDA Safety Case
           Surveillance        of Document
                2:21-cv-00702-CLM COVID-19        Vaccines
                                           37-5 Filed 11/19/21    : 2 of 2
                                                               Page

DRAFT Working list of possible adverse event outcomes
***Subject to change***
   Guillain-Barré syndrome                       Deaths
   Acute disseminated encephalomyelitis          Pregnancy and birth outcomes
   Transverse myelitis                           Other acute demyelinating diseases
   Encephalitis/myelitis/encephalomyelitis/      Non-anaphylactic allergic reactions
    meningoencephalitis/meningitis/
    encepholapathy                                Thrombocytopenia

   Convulsions/seizures                          Disseminated intravascular coagulation

   Stroke                                        Venous thromboembolism

   Narcolepsy and cataplexy                      Arthritis and arthralgia/joint pain

   Anaphylaxis                                   Kawasaki disease

   Acute myocardial infarction                   Multisystem Inflammatory Syndrome
                                                   in Children
   Myocarditis/pericarditis
                                                  Vaccine enhanced disease
   Autoimmune disease

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Our copy: gov.uscourts.alnd.177186.37.5.pdf
Original: archive.org