The Food and Drug Administration has flagged Guillain-Barre syndrome, a rare neurological condition, as a potential risk for Pfizer’s respiratory syncytial virus vaccine.
Two people in their 60s who received the shot were diagnosed with Guillain-Barre syndrome, out of about 20,000 vaccine recipients who participated in Pfizer’s Phase 3 clinical trial, according to the FDA document. One person’s illness had completely resolved after three months, while the other continues to show signs of improvement six months later.
There were no cases in the trial’s placebo group or among those who did not receive the shot.
