Guillain-Barré syndrome (GBS) will be listed as a very rare side effect of COVID-19 Vaccine Janssen and a warning will be included in the product information to raise awareness among healthcare professionals and people taking the vaccine. 

GBS is a rare neurological disorder in which the body’s immune system damages nerve cells which can result in pain, numbness and muscle weakness, progressing to paralysis in the most severe cases. Most people fully recover from the disorder.

Although cases of GBS after vaccination with COVID-19 Vaccine Janssen have been reported very rarely, healthcare professionals should be alert to signs and symptoms of GBS, in view of the seriousness of this condition, to allow for early diagnosis, supportive care and treatment. 

Vaccinated people are advised to seek immediate medical attention if they develop signs and symptoms suggestive of GBS, such as weakness in the extremities, double vision or difficulty moving eyes (see below for list of symptoms).

EMA confirms that the benefits of COVID-19 Vaccine Janssen continue to outweigh the risks of the vaccine.