The following is a news analysis.
When Covid-19 vaccines were being introduced to the market, it was more important than ever for safety monitors to be vigilant in looking for adverse events.
After all, since the vaccines were approved quickly 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 their experts would be paying close attention to when monitoring the Vaccine Adverse Event Reporting System (VAERS), where patients and physicians can file all problems encountered after a vaccine is administered; and through the Vaccine Safety Datalink (VSD), a special active system of monitoring Covid-19 vaccine patients.
The list includes Guillain-Barre syndrome, an autoimmune disorder which can be deadly, causing irrecoverable paralysis. The FDA recently warned that the Johnson and Johnson Covid-19 vaccine may be linked to numerous cases of Guillain-Barre syndrome. The early list also included blood clots, also the subject of a warning added later to the Johnson and Johnson vaccine; and thrombocytopenia (low blood platelets), a condition reported after Covid-19 vaccination.
Prior to the U.S. warning about Johnson and Johnson, cases of Guillain-Barre syndrome were already reported in other countries after Pfizer's Covid-19 vaccine, as well as Astra Zeneca's (which is not given in the U.S.).
The FDA says the list represents “possible, not known, adverse event outcomes that the FDA will be monitoring for as the vaccine is deployed.”
FDA's Preliminary List of Vaccine Adverse Event Reporting System (VAERS) Adverse Events of Special Interest
- Covid-19 disease
- Vaccination during pregnancy and adverse pregnancy outcomes
- Guillain-Barre syndrome: autoimmune nerve disorder that can cause paralysis and death
- Acute disseminated encephalomyelitis: inflammation and damage of the brain and spinal cord that can cause seizures and coma
- Transverse myelitis (TM): inflammation of both sides of the spinal cord that can be associated with multiple sclerosis (MS) and cause severe pain and total paralysis
- Multiple Sclerosis (MS): an immune system disease of the brain and spinal cord
- Optic Neuritis (NS): inflammation of the optic nerve, possibly leading to blindness
- Acute disseminated encephalomyelitis (ADEM): attack of inflammation in the brain and spinal cord that damages the protective covering of nerve fibers, sometimes following vaccination for measles, mumps, or rubella
- Chronic inflammatory demyelinating polyneuropathy (CIDP): inflammation of nerves closely related to Guillain-Barre paralysis
- Encephalitis: brain damage caused by inflammation, sometimes autoimmune-induced
- Meningoencephalitis: encephalitis involving the three membranes that line the skull and vertebral canal, and enclose 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 movement
- Narcolepsy and cataplexy: sleepiness and muscle weakness triggered by strong emotions
- Autoimmune disease such as: Addison, celiac, Graves, skin 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 levels of platelets in the blood
- Disseminated intravascular coagulation (DIC): abnormal blood clotting often caused by inflammation
- Venous thromboembolism: blood clots that start in veins
- Arthritis and arthralgia/joint pain
- Kawasaki disease: a serious immune disorder also known as mucocutaneous lymph node syndrome, which causes inflammation, high fever and peeling skin
Included on a draft slide but not seen in the final presentation:
- Multisystem inflammatory Syndrome in Children: potentially deadly inflammation of heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs
- Vaccine enhanced disease
The adverse event slide and other information from the Sept. 22 meeting can be found in the presentation at the link below:
The U.S. and world governments have issued numerous warnings and advisories regarding Covid-19 vaccines. However, the FDA and CDC say the vaccines being given in the U.S. are safe and effective for emergency use.
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