The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines.

Background: Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6-23 months of age during the 2013-14 and 2014-15 influenza seasons.

Methods: Using claims data and a self-controlled risk interval design, we compared the febrile seizure rate in a risk interval (0-1 days) versus control interval (14-20 days).

Kawasaki disease and 13-valent pneumococcal conjugate vaccination among young children: A self-controlled risk interval and cohort study with null results.

Background: Kawasaki disease is an acute vasculitis that primarily affects children younger than 5 years of age. Its etiology is unknown. The United States Vaccine Safety Datalink conducted postlicensure safety surveillance for 13-valent pneumococcal conjugate vaccine (PCV13), comparing the risk of Kawasaki disease within 28 days of PCV13 vaccination with the historical risk after 7-valent PCV (PCV7) vaccination and using chart-validation.

Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System.

Purpose: To develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in the Sentinel System (formerly the Mini-Sentinel Pilot), a Food and Drug Administration-sponsored national surveillance system that typically relies on data that are mature, settled, and updated quarterly.

Methods: Three Data Partners provided their earliest available ("fresh") cumulative claims data on influenza vaccination and health outcomes 3-4 times on a staggered basis during the 2013-2014 influenza season, collectively producing 10 data updates. We monitored anaphylaxis in the entire population using a cohort design and seizures in children ≤4 years of age using both a self-controlled risk interval design (primary) and a cohort design (secondary).

Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females.

After the Food and Drug Administration (FDA) licensed quadrivalent human papillomavirus vaccine (HPV4) in 2006, reports suggesting a possible association with venous thromboembolism (VTE) emerged from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink. Our objective was to determine whether HPV4 increased VTE risk. The subjects were 9-26-year-old female members of five data partners in the FDA's Mini-Sentinel pilot project receiving HPV4 during 2006-2013.

Patterns of childhood mortality in a region of Belarus, 1980-2000.

Unlabelled: The public health infrastructure of the former Soviet Union was impacted by both the Chernobyl disaster in 1986 and the Soviet breakup in 1991. This paper examines mortality patterns among children aged 1-14 years within the Mogilev region of Belarus between 1980 and 2000. This study utilized a regional cohort design that included all childhood deaths (ages 1-14 years) occurring among persons residing within the Mogilev oblast of Belarus between 1980 and 2000.

Infant mortality trends in a region of Belarus, 1980-2000.

Background: The Chernobyl disaster in 1986 and the breakup of the former Soviet Union (FSU) in 1991 challenged the public health infrastructure in the former Soviet republic of Belarus. Because infant mortality is regarded as a sensitive measure of the overall health of a population, patterns of neonatal and postneonatal deaths were examined within the Mogilev region of Belarus between 1980 and 2000.

Methods: Employing administrative death files, this study utilized a regional cohort design that included all infant deaths occurring among persons residing within the Mogilev oblast of Belarus between 1980 and 2000.