This study evaluates the potential association of vaccination and death in the Vaccine Safety Datalink (VSD).
The study cohort included individuals ages 9 to 26 years with deaths between January 1, 2005, and December 31, 2011. We implemented a case-centered method to estimate a relative risk (RR) for death in days 0 to 30 after vaccination.Deaths due to external causes (accidents, homicides, and suicides) were excluded from the primary analysis. In a secondary analysis, we included all deaths regardless of cause. A team of physicians reviewed available medical records and coroner’s reports to confirm cause of death and assess the causal relationship between death and vaccination.
Of the 1100 deaths identified during the study period, 76 (7%) occurred 0 to 30 days after vaccination. The relative risks for deaths after any vaccination and influenza vaccination were significantly lower for deaths due to nonexternal causes (RR 0.57, 95% confidence interval [CI] 0.38–0.83, and RR 0.44, 95% CI 0.24–0.80, respectively) and deaths due to all causes (RR 0.72, 95% CI 0.56–0.91, and RR 0.44, 95% CI 0.28–0.65). No other individual vaccines were significantly associated with death. Among deaths reviewed, 1 cause of death was unknown, 25 deaths were due to nonexternal causes, and 34 deaths were due to external causes. The causality assessment found no evidence of a causal association between vaccination and death.
Risk of death was not increased during the 30 days after vaccination, and no deaths were found to be causally associated with vaccination.