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While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available...
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...
In 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4) among 9–26 year-old female vaccine recipients between August 2006 and October 2009.Sequential analyses were conducted weekly to detect associations between HPV4 exposure and pre-specified outcomes. The pre-specified outcomes identified by ICD-9 codes using...
Using a new sequential analytic method, the safety of tetanus–diphtheria–acellular pertussis (Tdap) vaccine was monitored weekly among subjects aged 10–64 years during 2005–2008. Encephalopathy–encephalitis–meningitis, paralytic syndromes, seizures, cranial nerve disorders, and Guillain-Barré syndrome were selected as outcomes based on previous reports and biologic plausibility. The risk following...
Electronic medical records of a large veterinary practice were used for surveillance of potential space–time clustering of adverse events associated with rabies vaccination in dogs. The study population was 257,564 dogs vaccinated in 169 hospitals in 13 US metropolitan areas during a 24-month period. Using a scan statistic for population rate data, significant space–time clusters were identified involving...
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