Health: FDA Adds Rare Neurological Syndrome Warning to Johnson & Johnson COVID-19 Vaccine

Guillain-Barre syndrome is a rare disorder in which the body’s immune system attacks the nerves.

A health worker prepares a dose of the Johnson & Johnson COVID-19 vaccine at a vaccination site in Philadelphia, in March.The Associated Press

The Johnson & Johnson COVID-19 vaccine label now includes a warning about a possible increased risk of a rare disorder known as Guillain-Barre syndrome.

The Food and Drug Administration on Monday changed the label to note that "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."

Guillain-Barre syndrome is a rare complication in which the body's immune system attacks the nerves. Symptoms include tingling and weakness in the extremities. Symptoms usually resolve within weeks, but some cases can cause permanent nerve damage.

Around 100 preliminary reports of the syndrome have been detected in the Vaccine Adverse Event Reporting System out of 12.8 million doses of the J&J vaccine administered, according to the Centers for Disease Control and Prevention.

"These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older," the CDC said in a statement, adding that the topic will be discussed in an upcoming meeting of the agency's vaccine advisory committee.

Data does not show a similar trend in the Pfizer or Moderna coronavirus vaccines, according to CDC. It's the latest setback for the J&J vaccine, which was temporarily paused earlier this year as federal officials investigated a small number of rare and severe blood clots in people who received the shot.

Between 3,000 and 6,000 people in the U.S. typically develop Guillain-Barre syndrome each year, according to the CDC. The exact cause is unknown, though it is usually triggered after a respiratory or gastrointestinal infection.

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