The fact sheet for Johnson & Johnson’s COVID-19 vaccine has been revised by U.S. regulators to warn of the risk of a rare bleeding disorder.
The FDA said in a letter to the company on Tuesday (Jan. 11) that adverse-event reports suggested an increased risk of immune thrombocytopenia during the 42 days following vaccination.
Symptoms include bruising or excessive or unusual bleeding, according to the agency.
Johnson & Johnson’s COVID-19 vaccine has also been previously connected to rare but serious blood clots, a condition called thrombosis with thrombocytopenia syndrome. Women ages 30 to 49 were at the highest risk, according to the CDC.
Roughly 17 million Americans have already been given the Johnson & Johnson injection.