Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project

•This study utilized large multisite data to evaluate vaccine safety in HIV-infected patients.•Routinely recommended inactivated vaccines for HIV-infected adults are generally safe.•HIV patients with very high viral load might have elevated risk for stroke and cerebrovascular diseases. We evaluate safety of routine vaccination among adults infected with human immunodeficiency virus (HIV) in five healthcare organizations in the United States. We conducted a retrospective cohort study of HIV-infected adults who received inactivated influenza vaccines, hepatitis B vaccines, pneumococcal vaccines, or tetanus, diphtheria, and acellular pertussis vaccines between 2002 and 2013. We conducted self-controlled case series analysis to estimate the relative risk (RR) for 11 pre-specified adverse events (AEs) requiring medical attention. Among 20,417 HIV-infected adults (90.2% male), a total of 137,674 vaccine doses were administered. Based on ICD-9 codes, we detected an increased risk of cellulitis and infection (RR: 1.18, 95% CI: 1.03–1.35) among all patients, and an increased risk of stroke/cerebrovascular diseases among patients with an HIV viral load >10,000 copies/ml (adjusted RR: 3.94, 95% CI: 1.32–11.72). Further analyses on chart confirmed cases of stroke/cerebrovascular diseases indicated no statistically significant increased risk (adjusted RR: 1.72, 95% CI: 0.41–7.24). There was no evidence of increased risk for other AEs following routine vaccination in HIV-infected adults. Routinely administered vaccines are generally safe for HIV-infected adults.