Author Contributions: Drs Casey, Iskander, and Mootrey had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Casey, Iskander, Roper, Mast,
Török, Chapman, Swerdlow, Morgan, Vitek, Neff, Strikas, Mootrey.
Acquisition of data: Casey, Iskander, Roper, Mast,
Wen, Török, Chapman, Swerdlow, Morgan, Heffelfinger, Vitek, Reef, Hasbrouck, Damon, Vellozzi.
Analysis and interpretation of data: Casey, Iskander, Roper, Wen, Török, Chapman, Morgan, Reef, Hasbrouck, Neff, McCauley, Mootrey.
Drafting of the manuscript: Casey, Iskander, Roper, Heffelfinger,
Critical revision of the manuscript for important intellectual content: Casey,
Iskander, Roper, Mast, Wen, Török, Chapman, Swerdlow, Morgan, Heffelfinger, Vitek, Reef, Hasbrouck, Damon, Neff, Vellozzi, McCauley, Strikas, Mootrey.
Statistical analysis: Roper, Török.
Administrative, technical, or material support: Casey, Iskander, Roper,
Mast, Chapman, Heffelfinger, Vitek, Reef, Hasbrouck, Damon, Vellozzi, Mootrey.
Study supervision: Casey, Mast, Török, Swerdlow, Morgan, Heffelfinger, Vitek, Strikas, Mootrey.
Financial Disclosures: None reported.
Smallpox Vaccine Adverse Events Monitoring and Response Activity (SVAEMRA) Surveillance Team: Sara Critchley, Hayley Hughes, John K. Iskander, Joyce Goff, Madeline Sutton, Phuc Nguyen-Dinh, Roumiana S. Boneva, Roseanne English, and John Copeland. SVAEMRA Executive Team: Gina Mootrey, Eric E. Mast, Herschel Lawson, and Mary McCauley. SVAEMRA Cardiac Team: Christine Robinette Curtis, Patricia Galloway, Beth Hibbs, Paige Hightower, Nidhi Jain, Nancy H. Levine, Mona Marin, Jacqueline Miller, Juliette Morgan, Pedro L. Moro, Martha H. Roper, Richard A. Schieber, Margarita M. Sniadack, and David Swerdlow. SVAEMRA Clinical Team: Francisco M. Averhoff, Christine G. Casey, Louisa E. Chapman, Rosaline Dhara, Kristina L. Ernst, Kirsten Ernst, Kathleen Fullerton, Michael Deming, Daniel Fishbein, Lamar Hasbrouck, James Heffelfinger, Barbara L. Herwaldt, Andrew Kroger, Anne C. Moore, Juliette Morgan, Monica Parise, Meredith Reynolds, Scott Santibanez, James Sejvar, Bruce Tierney, Thomas Török, Claudia Vellozzi, Charles Vitek, and Xiaojun Wen. SVAEMRA State Team: Susan Reef, Eduard Eduardo, Masa Tanaka, John H. McGowan, Danice K. Eaton, Carol Knowles, Kathleen McDuffie, Jennifer L. Cleveland, Jami L. Fraze, Elizabeth Bolyard, Lynne M. Sehulster, Philip M. J. Baptiste III, Ceil Threat, Fred Ingram, and Tracy Thomas.
Funding/Support: All financial and material support for the surveillance efforts was conducted as part of the Centers for Disease Control and Prevention (CDC) and state health department public health response. No additional funding was sought to support these activities.
Role of the Sponsor: The CDC is responsible for the surveillance activities; data collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.
Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the funding agency.
Acknowledgment: We gratefully thank the case patients, health care practitioners, state and local health department officials, Vaccine Adverse Event Reporting System reporters, State Adverse Event Coordinators, and the CDC SVAEMRA team for their assistance in adverse event identification, evaluation, report, and follow-up following smallpox vaccination. For assistance in the development of the surveillance case definitions, we thank the Joint Advisory Committee on Immunization Practices−Armed Forces Epidemiological Board Smallpox Vaccine Safety Working Group, Katrin S. Kohl (CDC), and J. M. Lane (former director of CDC Smallpox Eradication Unit, who was contracted for expertise). We appreciate the surveillance efforts of the Pre-Event Vaccination System staff, David Walker, and Kimp Walton. For coordination of military and civilian data, we thank John Grabenstein and Penina Haber. We appreciate the dermatological expertise and assistance of Scott A. Norton, Toby Maurer, and Art Papier. We thank our CDC colleagues for their expertise and support: Robert T. Chen, Kris Sheedy, Lisa Rotz, Joanne Cono, Rus Regnery, John Becher, Christopher Allen, Cindy Dougherty, Joe Mulinare, Karen Broder, Kristin Kenyan, Bruce Weniger, Frank DeStefano, Scott Campbell, Allison Kennedy, Susanne Pickering, Sean Shadomy, Elaine R. Miller, William Rentz, and the staff of the Clinician Information Line and Strategic Pharmaceutical Stockpile. We thank Ann McMahon, Jacquelyn Polder, Marthe G. Bryant Genevier, and Frederick E. Varricchio, our colleagues at the Food and Drug Administration, Center for Biologics Evaluation and Research, for their contribution. We thank the CDC staff April Vance, Candice Jackson, Angee Key, Maureen Hernandez, Janis Jackson, Alison Howard, and Tamera Murphy for management and administrative support.