Vaccine Safety Datalink

Peng MM. Jick H A population-based study of the incidence, cause, and severity of anaphylaxis in the United Kingdom. Arch Intern Med 2004 164 317-319. Bohlke K, Davis RL, DeStefano F. et al Vaccine Safety Datalink Team. Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organization. J Allergy Clin Immunol 2004 113 536-542. 

A Vaccine Safety Datalink project has been used to compare adverse events after MMR immunization either at... 

Rhodes PH, Swint E, Jackson LA, Barlow WE, Immanuel VH, Benson PJ, Mullooly JP, Drew L, Mendius B, Lewis N, Fireman BH, Ward JI, Vadheim CM, Marcy SM, Jing J, Wuhson M, Lugg M, Osborne P, Wise RP. MMR2 immunization at 4 to 5 years and 10 to 12 years of age a comparison of adverse clinical events after immunization in the Vaccine Safety Datalink project. The Vaccine Safety DataUnk Team. Pediatrics 1997 100(5) 767-71. 

Black S, Shinefield H, Ray P, Lewis E, Chen R, Glasser J, Hadler S, Hardy J, Rhodes P, Swint E, Davis R, Thompson R, Mullooly J, Marcy M, Vadheim C, Ward J, Rastogi S, Wise R. Risk of hospitalization because of aseptic meningitis after measles-mumps-rubella vaccination in one- to two-year-old children an analysis of the Vaccine Safety Datalink (VSD) Project. Pediatr Infect Dis J 1997 16(5) 500-3. 

Reports on adverse events after the administration of the two hepatitis B vaccines licensed in the US (Engerix-B and Recombivax HB) have been compared in two different surveillance systems VAERS and Vaccine Safety Datalink (VSD) (8). VSD is a computerized record linkage system designed to allow more rigorous evaluation of... 

Wassilak SG, Glasser JW, Chen RT, Hadler SC. Utility of large-linked databases in vaccine safety, particularly in distinguishing independent and synergistic effects. The Vaccine Safety Datalink Investigators. Ann NY Acad Sci 1995 754 377-82. 

Rhodes PH, Black SB, et al. Vaccine Safety Datalink Team. Safety of thimerosal-containing vaccines A two-phased study of computerized health maintenance organization databases. Pediatrics 2003 112 1039-48. 

Geier DA, Young HA, Geier MR. Thimerosal exposure increasing trends of premature puberty in the vaccine safety datalink. Indian J Med Res 2010 131 ... 

In a study based on the automated Vaccine Safety Datalink 278 624 subjects who... 

Young HA, Geier DA, Geier MR. Thimerosal exposure in infants and neurodevelopmental disorders an assessment of computerized medical records in the Vaccine Safety Datalink. J Neurol Sci 2008 271(1-2) 110-8. 

Gastrointestinal Reports of intussusception after RotaTeq immunization have been assessed, using data from the VAERS and the Vaccine Safety Datalink, in children enrolled in managed care [43 ]. Observed versus expected rate ratios were determined using vaccine dose distribution data and... 

Vaccine Safety Datalink background rates of intussusception. Between 1 February 2006 and 25 September 2007, the VAERS received 160 reports of intussusception. Assuming that reporting completeness was 75% and that 75% of the distributed doses of RotaTeq were administered, the observed versus expected rate ratios were 0.53 and 0.91 during 1-21 and 1-7 days after immunization respectively. There were three cases of intussusception within 30 days after 111 521 RotaTeq immunizations, compared with six cases after 186 722 non-RotaTeq immunizations during the same period. The authors concluded that these data do not suggest that RotaTeq is associated with intussusception. 

Vaccine safety is a global issue. Collaborative approaches are fundamental to improve precision of the identification of clusters or signals of vaccine safety issues. Europe has looked into a system to enhance the accurate detection of rare AEFI by looking beyond individual coxmtry boundaries. The Vaccine Adverse Events Surveillance and Com-mxmication consortium was set up to establish a European Safety Datalink. They have proposed a shared protocol, with standard case definitions and methods of analysis. 

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