Analysis of data from the CDC/FDA Vaccine Adverse Event Reporting System (1990-2009) on Guillain-Barre syndrome after hepatitis vaccination in the USA

We used data from the Vaccine Adverse Event Reporting System, supplemented by additional data provided by the Center for Biologics Evaluation and Research, to identify 189 patients with Guillain-Barre syndrome (GBS) reported after hepatitis vaccination with a mean age of 30.65 years, affecting men and women equally. Among vaccinated patients, 133 (70%) developed GBS within six weeks, 30(15.9%) after six weeks, and for the remaining 26 (13.7%), the time between GBS occurrence and vaccination was not specified. The reporting rate of post-hepatitis vaccine GBS is approximately 3.4 cases per one million vaccinations, which is in the range expected in the general population. The unbalanced distribution of reports in the first six weeks after vaccination suggests that some cases of GBS may be triggered by vaccination. Nonetheless, the low incidence of hepatitis vaccine-associated GBS, and the dramatic incidence reduction of hepatitis and its complications after vaccination, support the current guidelines for vaccination. (C) 2012 Published by Elsevier Ltd.