The Food and Drug Administration announced a change to the fact sheet on Johnson & Johnson’s COVID-19 vaccine Monday. The warning of an increased risk of Guillain-Barré syndrome, a neurological disorder that damages the nerves and can lead to paralysis.
FDA spokesperson said in a statement that based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered. According to the FDA, Ninety-five of the cases were serious and required hospitalization, with one reported death.
Those who got a Johnson & Johnson shot should seek medical attention if they develop the symptoms like weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes, or difficulty with bladder control or bowel function.Johnson & Johnson said it is in discussions with the FDA and other regulators about the link between its COVID-19 vaccine and syndrome. The company also said that the rate of reported cases of the syndrome exceeds the background rate by a small degree.