Author Contributions: Dr Wise had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Wise, Iskander, Ball,
Acquisition of data: Wise, Pless, Campbell.
Analysis and interpretation of data: Wise,
Iskander, Pratt, Ball, Campbell, Braun.
Drafting of the manuscript: Wise, Iskander,
Critical revision of the manuscript for important
intellectual content: Wise, Iskander, Pratt, Pless, Ball, Campbell,
Administrative, technical, or material support:
Wise, Iskander, Pless, Ball, Campbell, Braun.
Study supervision: Wise, Ball, Braun.
Technical expertise: Wise, Iskander, Pratt,
Campbell, Ball, Pless, Braun.
Disclaimer: This report reflects work by the
coauthors in their capacity as federal employees of the US Food and Drug Administration
(FDA) and the Centers for Disease Control and Prevention (CDC). They received
no additional funding or support. Data collection and management of the Vaccine
Adverse Event Reporting System (VAERS) database is a joint responsibility
of the FDA and CDC.
Role of the Sponsors: The coauthors are solely
responsible for the design and conduct of the study, the analysis and interpretation
of the data from the VAERS program, and the preparation of the report. Supervisors
at the FDA and CDC reviewed drafts, recommended improvements, and approved
the final version.
Acknowledgment: Susan Ellenberg, Frank DeStefano,
Karen Goldenthal, Karen Midthun, Mary McCauley, Beth Begier, and Ann McMahon
offered very helpful comments on advanced drafts. Staff of Constella Group,
Inc (formerly Analytical Sciences, Inc) supplied critical database support.
Wyeth-Ayerst-Lederle Vaccines submitted many VAERS reports and assisted in
identification of occasional duplications. We also appreciate the support
of the other VAERS Working Group members (at CDC: Robert Chen, Roseanne English-Bullard,
Penina Haber, Sharon Holmes, Anne Huang, Elaine Miller, Susanne Pickering,
Vitali Pool, Ali Rashidee, Weigong Zhou; at FDA: David Davis, Evan Macosko,
Tatiana Oussova, Phil Perucci, Sarah Richman, Sean Shadomy, Lise Stevens,
Frederick Varricchio, Xu Wang, Jane Woo). We feel special gratitude to all
patients and their parents, nurses, pharmacists, physicians, and others who
reported adverse events to the VAERS program.
Other Resources: The following Internet sites
provide additional information for people wishing to file a report to VAERS
or to learn more about the VAERS program: http://www.vaers.org; http://www.fda.gov/cber/vaers/vaers.htm; http://www.cdc.gov/nip.