FDA accidentally displays list of COVID vaccine side effects including death, myocarditis and autoimmune disease

Dawn Barlowe | TheBL 19 hours ago

Pfizer COVID-19 vaccine doses, on Dec. 12, 2020. (Marco Verch/ Flickr/CC 2.0)

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A federal agency responsible for protecting public health unwittingly admitted people could die or suffer serious medical complications from being immunized against the deadly disease.

The U.S. Food and Drug Administration (FDA) accidentally distributed a presentation slide, showing potential side effects of different COVID-19 vaccines. The list included death, myocarditis, autoimmune disease, and seizures according to HumanAreFree.

The slide in question showed the FDA’s initial list of “possible adverse event outcomes” at a public meeting of the FDA’s Product Advisory Committee on the safety and efficacy of COVID-19 vaccines on Oct. 22, 2020.https://platform.twitter.com/embed/Tweet.html?dnt=false&embedId=twitter-widget-0&features=eyJ0ZndfZXhwZXJpbWVudHNfY29va2llX2V4cGlyYXRpb24iOnsiYnVja2V0IjoxMjA5NjAwLCJ2ZXJzaW9uIjpudWxsfSwidGZ3X2hvcml6b25fdHdlZXRfZW1iZWRfOTU1NSI6eyJidWNrZXQiOiJodGUiLCJ2ZXJzaW9uIjpudWxsfSwidGZ3X3NwYWNlX2NhcmQiOnsiYnVja2V0Ijoib2ZmIiwidmVyc2lvbiI6bnVsbH19&frame=false&hideCard=false&hideThread=false&id=1420512587284889607&lang=en&origin=https%3A%2F%2Fthebl.com%2Fhealth%2Ffda-accidentally-displays-list-of-covid-vaccine-side-effects-including-death-myocarditis-and-autoimmune-disease.html&sessionId=5275d5d470a0b839b628d251521958401c03884e&theme=light&widgetsVersion=1890d59c%3A1627936082797&width=550px

The slide had the working title, “FDA Safety Surveillance of COVID-19 Vaccines: DRAFT Working list of possible adverse event outcomes ***Subject to change***.”

A presentation slide from the Vaccines and Related Biological Products Advisory Committee meeting on Oct. 22, 2020. (U.S. Food and Drug Administration Screenshot via TheBL/YouTube)

The full list of possible side effects includes:

• Guillain-Barré syndrome
• acute disseminated encephaloymelitis (a brief and widespread inflammation of the brain and spinal cord that damages myelin–the protective nerve fiber cover)
• 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.

While adverse events were discussed at the meeting, the slide’s contents were not examined in depth.

Despite the lengthy list of potential side effects FDA still granted Pfizer emergency use authorization just two months after the meeting, on Dec. 11, 2020.

The Vaccine Adverse Event Reporting System recorded 4,201 deaths out of the 18,528 patients who suffered from adverse reactions, between Dec. 14, 2020 and May 14, 2021.

During Centers for Disease Control and Prevention (CDC) Immunization Safety Office Deputy Director Tom Shimabukuro’s presentation revealed a similar list of adverse reactions.

A presentation slide from the Vaccines and Related Biological Products Advisory Committee meeting on Oct. 22, 2020. (U.S. Food and Drug Administration Screenshot via TheBL/YouTube)

A presentation slide from the Vaccines and Related Biological Products Advisory Committee meeting on Oct. 22, 2020. (U.S. Food and Drug Administration Screenshot via TheBL/YouTube)

The standard model of vaccination uses small amounts of virus to generate an immune response. Pfizer and Moderna use mRNA technology where a protein that ‘commands’ cells to generate protein spikes is injected into the patient. Once the human body’s defense system recognizes the protein spikes as ‘invaders,’ it attacks them. In this way, the body is prepared for when the real virus tries to infect the cells.

However, CDC still encourages people to be vaccinated despite the FDA warning label added to the Pfizer and Moderna vaccines.https://googleads.g.doubleclick.net/pagead/ads?gdpr=0&us_privacy=1—&client=ca-pub-2791219656443006&output=html&h=280&adk=3587093300&adf=836366053&pi=t.aa~a.1279620081~i.22~rp.4&w=984&fwrn=4&fwrnh=100&lmt=1628079987&num_ads=1&rafmt=1&armr=3&sem=mc&pwprc=2645797240&psa=1&ad_type=text_image&format=984×280&url=https%3A%2F%2Fm.thebl.tv%2Fhealth%2Ffda-accidentally-displays-list-of-covid-vaccine-side-effects-including-death-myocarditis-and-autoimmune-disease.html&flash=0&fwr=0&pra=3&rh=200&rw=984&rpe=1&resp_fmts=3&wgl=1&fa=27&adsid=ChAI8PWoiAYQhMehqNPvj6IvEkgAD2iaZGoiIPUNtlB9mTZin2lgdbPHRzUjgMHXJEEDNdZDU6I3HfVQOvkilFlXEU-kCfI1h9YsZZG8urWz4LZzd6BLQ3_tuKQ&uach=WyJXaW5kb3dzIiwiNi4xIiwieDg2IiwiIiwiOTIuMC40NTE1LjEzMSIsW10sbnVsbCxudWxsLG51bGxd&tt_state=W3siaXNzdWVyT3JpZ2luIjoiaHR0cHM6Ly9hdHRlc3RhdGlvbi5hbmRyb2lkLmNvbSIsInN0YXRlIjo3fV0.&dt=1628079968176&bpp=10&bdt=5472&idt=11&shv=r20210729&mjsv=m202108030101&ptt=9&saldr=aa&abxe=1&cookie=ID%3D68c84b90cbb99634%3AT%3D1628079974%3AS%3DALNI_MahCwCE_Hcfbof7oz_lRKNVmXxjOA&prev_fmts=0x0%2C984x280%2C1358x657&nras=4&correlator=4305577399082&frm=20&pv=1&ga_vid=1756346671.1628079566&ga_sid=1628079967&ga_hid=1747320490&ga_fc=0&u_tz=-150&u_his=1&u_java=0&u_h=768&u_w=1366&u_ah=728&u_aw=1366&u_cd=24&u_nplug=3&u_nmime=4&adx=187&ady=4577&biw=1358&bih=657&scr_x=0&scr_y=1957&eid=42530672%2C20211866%2C21067496&oid=3&psts=AGkb-H8lGzikNIicfyZguZQow2JEP5iEwcGnmRN1-yTHxZd8PqnPcz4IRjc6i2TyweaLzi2P0tpTvT-mF58&pvsid=498437304242473&pem=608&eae=0&fc=1408&brdim=0%2C0%2C0%2C0%2C1366%2C0%2C1366%2C728%2C1366%2C657&vis=1&rsz=%7C%7Cs%7C&abl=NS&fu=128&bc=31&jar=2021-08-04-08&ifi=5&uci=a!5&btvi=2&fsb=1&xpc=lT9zf2RTPD&p=https%3A//m.thebl.tv&dtd=18871

“Facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” CDC Director Rochelle Walensky said according to the San Francisco Chronicle. “We strongly encourage everyone aged 12 and older, who are eligible to receive the vaccine under emergency use authorization, to get vaccinated.”

If the FDA knew there were so many potential adverse reactions as severe as death, it is unclear why they did they not warn the people about the dangers and still approved it anyway.

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