Hazard of complex regional pain syndrome following human papillomavirus vaccination among adolescent girls in the United States: a case cohort analysis of insurance claims data
ABSTRACT Objectives: Complex regional pain syndrome (CRPS) cases have followed human papillomavirus (HPV) vaccination, but no causal link has been established. Methods: Using insurance claims, the authors observed unvaccinated 11 year old girls for CRPS diagnoses. The authors used time dependent Cox regression to identify health related CRPS predictors using diagnosis codes. Next, the authors identified HPV vaccinations using procedural codes. HPV vaccination and CRPS predictors were considered time dependent covariates to estimated adjusted hazard ratios (HR) and 95% confidence intervals (CI) for CRPS, 30, 90, and 180 days post vaccination. Results: 1,232,572 girls received 563 unique CRPS diagnoses. In a 10% sub cohort of 123,981 girls accounting for potential confounders and predisposing risk factors (i.e. injury, infection, mental illness, primary care use) CRPS hazard was not significantly elevated 30 days (HR: 0.90, 95% CI: 0.46, 1.73) 90 days (HR: 1.17, 95% CI: 0.83, 1.65) or 180 days post vaccination (HR: 1.11, 95% CI: 0.83, 1.47) Conclusion: The results support the safety and continued administration of HPV vaccines to adolescents.
Expert opinion on drug safety