**Related Video Above: Taking a closer look at the J&J COVID vaccine concerns during pause back in April.**
(WJW) — The Food and Drug Administration is offering a new warning regarding the Johnson & Johnson COVID-19 vaccine.
Earlier today The Washington Post and The New York Times reported the FDA planned to discuss a possible link in those who’ve received the vaccine and a rare autoimmune disorder called Guillain-Barré syndrome. Now the FDA announced the warning will be included in literature regarding the vaccines.
There have been a reported 100 cases of the disorder among those 12.8 million people who’ve gotten the single-dose vaccine, the FDA confirmed, and most were among men 50 or older. Most of the people were hospitalized, the FDA said, and one person reportedly did die.
The Times reported earlier that those who’ve received the J&J vaccine have a three to five times higher chance of coming down with the syndrome.
Guillain-Barré affects the nerves and initial symptoms are often tingling and weakness in the extremities, according to Mayo Clinic. The syndrome reportedly can be fatal for a small amount of sufferers.
The FDA and Centers for Disease Control and Prevention called for a pause on the distribution of the vaccine earlier this spring following blood clots in some patients. The pause was lifted in late April.