U.S. FDA has added a serious bleeding issue to the fact sheet for Johnson & Johnson’s COVID-19 vaccine on Tuesday.

A rare bleeding disorder called immune thrombocytopenia was added to the fact sheet for Johnson & Johnson’s COVID-19 vaccine on Tuesday by the U.S. Food and Drug Administration.

“Reports of adverse events following use of the Janssen COVID-19 vaccine under emergency use authorization suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination,” the FDA wrote to J&J’s subsidiary, Janssen Biotech Inc.

Easy bruising or small blood spots under the skin, as well as unusual or heavy bleeding, are among the symptoms, according to the FDA.

Other agencies have taken similar actions in the past for the vaccine, notably the European Medicines Agency in October.

Both the J&J and AstraZeneca vaccines, which are built on the same platform, have previously been linked to another extremely unusual combination of blood clotting and low platelet counts known as thrombosis with thrombocytopenia syndrome.

The U.S. Centers for Disease Control and Prevention also said last month that people should get one of two other COVID-19 vaccines from Pfizer-BioNTech instead of J&J’s single-dose shot because of the very rare but sometimes fatal risk.

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