COVID-19 Vaccine Janssen: Guillain-Barré syndrome (GBS) listed as a very rare side effect

The European PRAC has assessed the available information (108 cases reported worldwide, when over 21 million had received the vaccine) and concluded that a causal relationship between Covid-19 Vaccine Janssen and the neurological disorder GBS is possible.

SPS commentary:

 In the EU, the product information for Covid-19 Vaccine Janssen will list GBS as a very rare side-effect (Section 4.8), and section 4.4 will be updated with a warning. No announcement from the MHRA on whether this change will also occur in the UK product information is as yet available.

Source:

European Medicines Agency