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The following is an analysis of the news.
When Covid-19 vaccines first hit the market, it was more important than ever for security monitors to be vigilant in looking for adverse events.
After all, since the vaccines were quickly approved for emergency use, they bypassed the normal system of approvals and studies.
On September 22, 2020, the FDA held a meeting and listed the potential serious adverse events that their experts would pay special attention to when monitoring the Vaccine Adverse Event Reporting System (VAERS), where patients and physicians can record all problems encountered after a vaccine. is administered; and via the Vaccine Safety Datalink (VSD), a special active monitoring system for patients vaccinated against Covid-19.
Read: Exclusive summary of concerns about the Covid-19 vaccine
The list includes Guillain-Barré syndrome, an autoimmune disease that can be fatal, causing irremediable paralysis. The FDA recently warned that the Johnson and Johnson Covid-19 vaccine could be linked to many cases of Guillain-Barre syndrome. The first list also included blood clots, also the subject of a warning added later to the Johnson and Johnson vaccine; and thrombocytopenia (low blood platelet count), a condition reported after vaccination against Covid-19.
Before the US warning regarding Johnson and Johnson, cases of Guillain-Barre syndrome had already been reported in other countries after Pfizer’s Covid-19 vaccine, as well as that of Astra Zeneca (which is not administered in the USA).
The FDA says the list represents “possible, unknown side effects that the FDA will monitor as the vaccine is rolled out.”
FDA Preliminary List of Adverse Events of Special Interest from the Vaccine-Related Adverse Event Reporting System (VAERS)
September 2020
- Covid-19 disease
- Death
- Vaccination during pregnancy and adverse pregnancy outcomes
- Guillain-Barré syndrome: an autoimmune nervous disorder that can lead to paralysis and death
- Acute disseminated encephalomyelitis: inflammation and damage to the brain and spinal cord that can cause seizures and coma
- Transverse myelitis (TM): inflammation on both sides of the spinal cord which can be associated with multiple sclerosis (MS) and cause severe pain and total paralysis
- Multiple sclerosis (MS): a disease of the immune system of the brain and spinal cord
- Optic neuritis (NS): inflammation of the optic nerve which can lead to blindness
- Acute disseminated encephalomyelitis (ADEM): an attack of inflammation in the brain and spinal cord that damages the protective covering of nerve fibers, sometimes following vaccination against measles, mumps or rubella
- Chronic inflammatory demyelinating polyneuropathy (CIDP): inflammation of the nerves closely related to Guillain-Barré palsy
- Encephalitis: brain damage caused by inflammation, sometimes of autoimmune origin
- Meningoencephalitis: encephalitis involving the three membranes that line the skull and the spinal canal, and surround the brain and spinal cord
- Meningitis: inflammation (swelling) of the protective membranes covering the brain and spinal cord
- Encephalopathy: brain damage and / or disease
- Ataxia: degenerative disease marked by loss of control of muscles and voluntary movements
- Convulsions / convulsions
- Stroke
- Narcolepsy and cataplexy: drowsiness and muscle weakness triggered by strong emotions
- Autoimmune diseases such as: Addison’s, Celiac, Graves, Rashes and Disorders, Arthritis, Diabetes, Lupus, POTS and MS
- Anaphylaxis: a severe allergic reaction
- Non-anaphylactic allergic reactions
- Acute myocardial infarction: heart attack
- Thrombocytopenia: abnormally low level of platelets in the blood
- Disseminated intravascular coagulation (DIC): abnormal blood clotting often caused by inflammation
- Venous thromboembolism: blood clots that start in the veins
- Arthritis and arthralgia / joint pain
- Kawasaki disease: a serious immune disorder also known as cutaneous-mucous lymph node syndrome, which causes inflammation, high fever, and peeling of the skin
Included on a slide draft but not visible in the final presentation:
- Multisystem inflammatory syndrome in children: life-threatening inflammation of the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs
- Vaccine-enhanced disease
The slide on adverse events and other information from the September 22 meeting is available in the presentation at the link below:
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-09/COVID-03-Shimabukuro-508.pdf
The US and world governments have issued numerous warnings and advisories regarding Covid-19 vaccines. However, the FDA and CDC claim that vaccines administered in the United States are safe and effective for emergency use.
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