Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: It was reported in a published article, that up to 215 patient developed Guillain-Barre syndrome (GBS) after vaccination with a dose of hepatitis B virus vaccine rHBsAg. There were 215 cases (mean age 31.15 + 19.67 years) of GBS reported after hepatitis B virus vaccine rHBsAg 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 hepatitis B virus vaccine rHBsAg 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 Guillain-Barre syndrome (GBS) after administration of hepatitis B virus vaccine rHBsAg. BACKGROUND: There are isolated reports of GBS after hepatitis B virus vaccine rHBsAg 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 hepatitis B virus vaccine rHBsAg 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 hepatitis B virus vaccine rHBsAg administered 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- hepatitis B virus vaccine rHBsAg 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 hepatitis B virus vaccine rHBsAg. These results warrant continuous and careful analysis of GBS after hepatitis B virus vaccine rHBsAg 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. Follow up information has been received from an article, that reported up to a total of 189 patients with post-hepatitis vaccination Guillain-Barre Syndrome (GBS) were reported between 1990 and 2009 (93 men, 95 women, one not categorized). The mean patient age was 30.65 + 20.1 years. Miller-Fisher syndrome, a variant of GBS, was reported in four patients (2.12%). Thirty-one patients (16.4%) reported an antecedent respiratory or gastrointestinal viral illness before GBS onset. The distribution of GBS occurrence in the first six weeks after hepatitis vaccine administration demonstrates a peak occurrence in the first two weeks. Among the reported patients, 133 (70.37%) developed GBS within six weeks of vaccine administration, 30 (15.87%) after six weeks, and for the remaining 26 (13.76%) the time between vaccination and GBS occurrence was not specified. The diagnosis was further supported by elevated cerebrospinal fluid protein concentration (>45 mg/dL), with fewer than 10 white blood cells/mm^2, or by electro diagnostic study findings consistent with primary demyelination. Hospitalization was reported in 154 patients (81.5%), disability was reported in 34 (18%) patients, and death was reported in three (1.6%). GBS occurred in 115 (61%) patients when the hepatitis vaccine was administered as a single vaccine. And in 74 (39%) patients when it was combined with other vaccines. The onset interval of reported GBS after hepatitis vaccination (mean onset 20 days) was significant longer than reports of non-GBS adverse events (median onset one day), which was statistically significant (p < 0.05). Most (90%) of non-GBS adverse reactions after the hepatitis vaccine occurred within the first week after vaccination, with 41% of adverse events occurring in the first 24 hours. The data demonstrated a wide fluctuation in the reporting rate of GBS from the VAERS database between 2000 and 2008. The incidence of the Miller-Fisher variant of GBS in our study, 2.12% of the total number of patients with GBS, is within the range reported by other studies conducted in the western hemisphere, where this variant is estimated at 1% to 7% of the total number of patients with GBS. The reporting rate of an antecedent respiratory or gastrointestinal viral illness before the onset of GBS in our study was lower than that observed in unvaccinated subjects, where 40% to 70% of such patients with GBS reported a preceding illness. Patients with Miller-Fisher syndrome, a variant of GBS, were also included in the analysis. Although the author's results suggest that the reporting rate of post-hepatitis GBS overlaps with the incidence of GBS in the general population, the unbalanced distribution of reported patients in the first six weeks after vaccination, with a peak occurrence in the first two weeks, suggested that the hepatitis vaccine any potentially trigger GBS. This is one of several reports received from the same source. No further information is available.