In rare cases, the vaccinated patients were diagnosed with Guillain-Barre syndrome.

As expected, the FDA will add a new warning related to a rare autoimmune disease to the instructions for the Johnson & Johnson coronavirus vaccine, the Washington Post reported on Monday, citing four sources familiar with the situation.

According to the newspaper, about 100 preliminary reports of the occurrence of Guillain-Barre syndrome (GBS) after vaccination with the J&J vaccine were identified in the United States, mainly in men, many of whom were over 50 years old. About 12.8 million people received the single-component vaccine in the United States.

Neither J&J nor the FDA has yet given comments.

GBS is a rare neurological disease in which the body’s immune system attacks the protective coating of nerve fibers. In most cases, this condition occurs after a bacterial or viral infection.

In the past, a link between this disease and vaccination has already been identified, primarily during the swine flu outbreak in the United States in 1976, and decades later with the vaccine used during the H1N1 flu pandemic in 2009.