FDA has added a warning to Johnson & Johnson's Covid-19 vaccine fact sheet after receiving preliminary reports of patients developing the rare neurological condition Guillain-Barré syndrome after receiving the shot, the agency said Monday.
One hundred suspected cases of GBS — among the 12.8 million people who have gotten the J&J shot — have been identified in the federal government's database for adverse side effects after vaccination, FDA and CDC said. Of those, 95 were serious enough to require hospitalization, and one person died, FDA said.
"Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship," FDA said.
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