* No statistically significant increased risks were observed for any of the prespecified endpoints including Guillain-Barré syndrome (GBS), stroke, venous thromboembolism, appendicitis, seizures, syncope, allergic reactions, and anaphylaxis (151)
* In another study, rates of 16 autoimmune disorders in the vaccinated population were not increased compared with a matched population of nonvaccinated females (153)
*A large population-based cohort study conducted in Denmark and Sweden analyzed data on >696,000 doses of HPV4 among females. No consistent evidence supporting causal associations between exposure to HPV4 and autoimmune, neurologic conditions, and venous thromboembolism was observed (155)
* In France, a case-control study was conducted to evaluate autoimmune disorders following HPV4. Among 211 cases and 875 controls, no increased risk was observed for idiopathic thrombocytopenic purpura, central demyelination/multiple sclerosis, GBS, connective tissue disorders (including systemic lupus erythematosus, rheumatoid arthritis/juvenile arthritis), type 1 diabetes mellitus, and autoimmune thyroiditis after receipt of HPV4 (156).
*Serious adverse events were evaluated in a pooled safety analysis that included 30,192 females aged 972 years (16,381 received HPV2). Proportions of persons reporting a serious adverse event were similar in vaccine and control groups (5.3% and 5.9%, respectively), as were the types of serious adverse events reported (10).
*In the pooled safety analysis, including 12,772 females who received HPV2 and 10,730 in the control groups, incidence of potential new autoimmune disorders did not differ (0.8% in both groups).
*Overall, among completed and ongoing studies that enrolled 57,323 females aged 972 years, 37 deaths were reported during 7.4 years of follow-up: 20 among those who received bivalent vaccine (0.06%) and 17 among those in the control groups (0.07%). None of the deaths was considered to be vaccine-related.