Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: It was reported in a published article, that up to 215 patient developed Guillian-Barre syndrome (GBS) after vaccination with a dose of RECOMBIVAX HB. There were 215 cases (mean age 31.15 + 19.67 years) of GBS reported after RECOMBIVAX HB vaccine vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51 %) of GBS cases were reported within the first two weeks with a peak in the first week after vaccination. Hospitalization and disability were reported in 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with RECOMBIVAX administrated as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. At the time of the report the patient's statuses were unknown. OBJECTIVE: To determine the rates and characteristics of Gullian-Barre syndrome (GBS) after administration of RECOMBIVAX HB. BACKGROUND: There are isolated reports of GBS after RECOMBIVAX HB vaccination DESIGN/METHODS: We used data from the vaccine Adverse Event Reporting System supplemented by data from the center for biologics and research under the freedom of information act. RESULTS: There were 215 cases (mean age 31.15 + 19.67 years of GBS reported after RECOMBIVAX HB vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51 %) of GBS cases were reported within the first two weeks with a peak In the first week after vaccination. Hospitalization and disability were reported in 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with RECOMBIVAX HB administrated as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. Based on the data obtained from the National Health Interview Survey from 2000 to 2005, it is estimated that an average of 54 millions of patients are vaccinated with influenza vaccine each year. The reporting rate of post- hepatitis vaccine GBS is 4.5 cases per million vaccinations, which is in the range expected for the general population. CONCLUSIONS/RELEVANCE: Although our results suggest that the reporting rate of GBS post- RECOMBIVAX HB overlaps with the incidence of GBS in the general population, the unbalanced distribution of reported cases in the first 6 weeks after vaccination suggest that some cases of GBS are caused by RECOMBIVAX HB. These results warrant continuous and careful analysis of GBS after RECOMBIVAX HB vaccination. Follow up information has been received from a physician who reported that he did not have patient identifiers. The physician reported that they used a database and the Freedom of Information act in researching the article. No further information is available.