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J&J’s COVID-19 Shot Might Be Linked to Deep Vein Blood Clotting

October 5, 2021

The European Medicines Agency (EMA)’s safety committee said Johnson & Johnson’s (J&J) COVID-19 vaccine might be associated with cases of deep vein blood clotting — such as the leg, arm or groin — and recommended adding the rare side effect to the shot’s product information.

The EMA’s Pharmacovigilance Risk Assessment Committee noted the very rare side effect is separate from the blood clots and low blood platelets previously seen in some recipients of the J&J and AstraZeneca COVID-19 vaccines, which previously prompted the expert panel to call for adding a warning to the labeling information for those products.

During its late September meeting, the committee also assessed cases of J&J and AstraZeneca shot recipients experiencing immune thrombocytopenia, a bleeding disorder caused by the immune system targeting blood platelets. This side effect was also found to be very rare, but the committee called for adding a warning to both vaccines’ product information.

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