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FDA issues new warning on Johnson & Johnson vaccine

The agency is looking at about 100 cases of a rare and potentially dangerous neurological condition in people who got the shot.

VIRGINIA BEACH, Va. — The FDA just issued a new warning about the Johnson & Johnson COVID-19 vaccine.

The agency is looking at about 100 cases of a rare and potentially dangerous neurological condition in people who got the shot. However, the FDA says as of now, it's not entirely clear whether the shot caused the problem.

Jacqueline Collins’ doctor cleared her to get her COVID-19 vaccine.

"I have COPD and I wanted to make sure that not only me, but anyone I came in contact with was healthy and stays healthy," she said.

On Monday, she and her granddaughter went to get their shot together in Virginia Beach.

"Anyone that feels hesitant about coming to get the vaccine, you know, first of all, it doesn’t hurt. It’s just a quick little shot, it’s over and done," said Collins. "Secondly, not only are you helping yourself, but anyone else in your family who might be elderly or sick, it’s gonna prevent them from getting that disease too."

The FDA says roughly 100 reports of Guillain-Barre syndrome have surfaced. That's among 13 million Americans that have gotten the Johnson & Johnson vaccine.

Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes temporary paralysis. 

The CDC says anywhere from 3,000 to 6,000 people develop the syndrome each year. Health officials can't say with certainty whether the shot caused the problem in those specific 100 cases. 

RELATED: VERIFY | Answering questions about the Guillain-Barre syndrome and the latest warning about the J&J vaccine

Back in April, the FDA pushed pause on the J&J shot after six reports of severe blood clots, before lifting that pause.

Bob Engle with the Virginia Beach Department of Public Health says the FDA took those reports seriously and they followed the guidance here in Hampton Roads.

"They look at it throughout the whole country. It takes a little bit of time, but they’ll do a thorough analysis of what is going on with the Johnson & Johnson," Engle said.

Even with the new warning, about 125 people showed up to get either their Pfizer or J&J shot at College Park Elementary Monday and Engle expects that number to remain high all week.

"Sometimes it’s just a matter of the location being really convenient for people. We’re in schools, we’re in the community, people are more familiar with that. They’re more comfortable with that."

As for Collins, she says she’s happy with her decision.

"Yeah, I’m still happy I got it."

It’s important to note that the 100 reported cases make up a tiny fraction of the nearly 13 million Americans who have received the J&J vaccine. Most of the reported cases happened in men 50 and older and usually about two weeks after vaccination.

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