FDA Adds Warning Label to J&J Vaccine over Links to Rare Neurological Condition

FDA Adds Warning Label to J&J Vaccine over Links to Rare Neurological Condition


The Food and Drug Administration (FDA) on Monday added warning labels to Johnson & Johnson’s single-dose vaccine for the Chinese coronavirus over links to a rare neurological condition.

In an updated fact sheet for healthcare providers administering the J&J vaccine, the FDA provides a list of warnings of adverse side effects, including acute allergic reactions, thrombosis with thrombocytopenia, capillary leak syndrome, and now, Guillain-Barré Syndrome — a nervous system disorder.

“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” the fact sheet reads.

According to officials, the FDA and Centers for Disease Control and Prevention (CDC) have reviewed reports of “about 100 people developing the syndrome after receiving the one-dose vaccine.”

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“Almost all of were hospitalized and one person died, the FDA said,” according to the AP:

Guillain-Barre syndrome

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