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Clinical Immunization Safety Assessment (CISA) Project Publications and Technical Reports

Research and evaluation conducted by CDC and the CISA network/project (2001-2013) has led to the publication of many reports, some of which are listed here:


Grohskopf LA, Olsen SJ, Sokolow LZ, Bresee JS, Cox NJ, Broder KR, Karron RA, Walter EB. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) — United States, 2014–15 Influenza Season. Morbidity and Mortality Weekly Report (MMWR). August 15, 2014 / 63(32);691-697

Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, Barrett A, Sosa J, Vellozzi C. Risk of Fever After Pediatric Trivalent Inactivated Influenza Vaccine and 13-Valent Pneumococcal Conjugate Vaccine. JAMA Pediatr. 2014 Jan 6. doi: 10.1001/jamapediatrics.2013.4469. [Epub ahead of print]


Halsey NA, Griffioen M, Dreskin SC, Dekker CL, Wood R, Sharma D, Jones JF, LaRussa PS, Garner J, Berger M, Proveaux T, Vellozzi C; The Hypersensitivity Working Group of the Clinical Immunization Safety Assessment Network. “Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS.” Vaccine. 2013 Oct 8. doi: pii: S0264-410X (13)01342-X.  10.1016/j.vaccine.2013.09.066. [Epub ahead of print]

Pahud BA, Williams SE, Dekker CL, Halsey N, LaRussa P, Baxter RP, Klein NP, Marchant CD, Sparks RC, Jakob K, Aukes L, Swope S, Barnett E, Lewis P, Berger M, Dreskin SC, Donofrio PD, Sejvar JJ, Slade BA, Gidudu J, Vellozzi C, Edwards KM. Clinical Assessment of Serious Adverse Events in Children Receiving 2009 H1N1 Vaccination. Pediatr Infect Dis J. 2013 Feb;32(2):163-168.

Williams SE, Edwards KM, Baxter RP, Larussa PS, Halsey NA, Dekker CL, Vellozzi C, Marchant CD, Donofrio PD, Reimschisel TE, Berger M, Gidudu JF, Klein NP. Comprehensive Assessment of Serious Adverse Events Following Immunization by Health Care Providers. J Pediatr. 2013 Feb 26. doi:pii: S0022-3476(13)00062-0.  10.1016/j.jpeds.2013.01.028. [Epub ahead of print]



Technical Report: The Clinical Immunization Safety Assessment (CISA) Working Group. Review of a published report of cerebral vasculitis after vaccination with the Human Papillomavirus (HPV) Vaccine. November 2012.

Baxter R, Lewis N, Bakshi N, Vellozzi C, Klein NP; CISA Network. Recurrent Guillain-Barre Syndrome Following Vaccination. Infectious Disease Journal. 2012 Mar;54(6):800-4. Web Site Icon

Halsey NA, Edwards KM, Dekker CL, Klein NP, Baxter R, LaRussa P, Marchant C, Slade B, Vellozzi C; the Causality Working Group of the Clinical Immunization Safety Assessment network. Algorithm to Assess Causality after Individual Adverse Events Following Immunizations. Vaccine. 2012 Apr 13. 

Loughlin AM, Marchant CD, Adams W, Barnett E, Baxter R, Black S, Casey C, Dekker C, Edwards KM, Klein J, Klein NP, LaRussa P, Sparks R, Jakob K. Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2012 Nov 26;30(50):7253-9. Epub 2012 Oct 9.

Pahud BA, Rowhani-Rahbar A, Glaser C, Gavali S, Salibay CJ, Fireman B, Dekker CL.  Lack of Association between Childhood Immunizations and Encephalitis in California, 1998-2008.
Vaccine. 2012 Jan 5;30(2):247-53.

Rowhani-Rahbar A, Klein NP, Dekker CL, Edwards KM, Marchant CD, Vellozzi C, Fireman B, Sejvar JJ, Halsey NA, Baxter R; Risk Interval Working Group of the Clinical Immunization Safety Assessment Network. Biologically plausible and evidence-based risk intervals in immunization safety research. Vaccine. 2012 Dec 17;31(1):271-7. Epub 2012 Jul 24.

Rowhani-Rahbar A, Baxter R, Rasgon B, Ray P, Black S, Klein JO, Klein NP. Epidemiologic and Clinical Features of Bell’s Palsy among Children in Northern California.  Neuroepidemiology. 2012;38:252–258. Epub Jun 5, 2012.

Rowhani-Rahbar A, Klein NP, Lewis N, Fireman B, Ray P, Rasgon B, Black S, Klein JO, Baxter R. Immunization and Bell’s palsy in children: A case-centered Analysis. Am J Epidemiol. 2012;175:878-85.

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Klein NP, Gidudu J, Qiang Y, Pahud B, Rowhani-Rahbar A, Baxter R, Dekker C, Edwards K, Halsey N, LaRussa P, Marchant C, Tokars J, Destefano F.  Developing the Next Generation of Vaccinologists. Vaccine. 2011 Nov 21;29(50):9296-7. Epub 2011 Apr 19.

LaRussa P, Edwards K, Dekker C, Klein N, Halsey NA, Marchant C, Baxter R, Engler R, Kissner J, Slade B.. Understanding the Role of Human Variation in Vaccine Adverse Events: The Clinical Immunization Safety Assessment (CISA) Network. Pediatrics. 2011 May;127(5):e1147-53.

Klein N,  Aukes L, Lee J,Fireman B, Shapira S, Slade S, Baxter R, Summar S.  Evaluation of Immunization Rates and Safety Among Children With Inborn Errors of Metabolism. Pediatrics. May 2011; 127 (5)1139-46

Miller EK, Dumitrescu L, Cupp C, Dorris S, Taylor S, Sparks R, Fawkes D, Frontiero V, Rezendes AM, Marchant C, Edwards KM, Crawford DC.  Atopy History and the Genomics of Wheezing after Influenza Vaccination in Children 6-59 Months of Age. Vaccine. 2011 Apr 18;29(18):3431-7

Morgan TM, Schlegel C, Edwards KM, Welch-Burke T, Zhu Y, Sparks R, Summar M; Urea Cycle Disorders Consortium. Vaccines Are Not Associated With Metabolic Events in Children With Urea Cycle Disorders. Pediatrics 2011 May;127(5):e1147-53. Epub 2011 Apr.11.

Navar-Boggan AM, Halsey NA, Escobar GJ, Golden WC, Klein NP.  Underimmunization in the Neonatal Intensive Care Unit.  J Perinatol. 2011 Aug 11. doi: 10.1038/jp.2011.111.

Pahud BA, Glaser CA, Dekker CL, Arvin AM, Schmid DS. Varicella Zoster Disease of the Central Nervous System: Epidemiological, Clinical, and Laboratory Features 10 Years after the Introduction of the Varicella Vaccine. J Infect Dis. 2011 Feb 1;203(3):316-23.

Williams SE, Pahud BA, Vellozzi C, Donofrio PD, Dekker CL, Halsey N, Klein NP, Baxter RP, Marchant CD, Larussa PS, Barnett ED, Tokars JI, McGeeney BE, Sparks RC, Aukes LL, Jakob K, Coronel S, Sejvar JJ, Slade BA, Edwards KM. Causality Assessment of Serious Neurologic Adverse Events Following 2009 H1N1 VaccinationVaccine. 2011 Oct 26;29(46):8302-8.

Williams SE, Klein NP, Halsey N, Dekker CL, Baxter RP, Marchant CD, LaRussa PS, Sparks RC, Tokars JI, Pahud BA, Aukes L, Jakob K, Coronel S, Choi H, Slade BA, Edwards KM. Overview of the Clinical Consult Case Review of Adverse Events Following Immunization: Clinical Immunization Safety Assessment (CISA) Network 2004-2009. Vaccine. 2011 Sep 16;29(40):6920.-

Yen C, Jakob K, Hittier X, Gentsch J, LaRussa P, for the Clinical Immunization Safety Assessment (CISA) Network.  Detection of Fecal Shedding of Rotavirus Vaccine in Infants Following Their First Dose of Pentavalent Rotavirus Vaccine. Vaccine. May 31;29(24):4151-5, 2011.

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Klein N, Gans  H, Sung P, Yasukawa LL, Johnson J, Sarafanov A, Chumakov K, Hansen J, Black  S, and Dekker CL. Preterm Infants T Cell Responses to Inactivated Poliovirus Vaccine. Journal of Infectious Diseases. 2010 Jan; 201(2): 214-22.

Navar-Boggan AM, Halsey NA, Golden WC, Escobar GJ, Massolo M, and Klein NP. Risk of Fever and Sepsis Evaluations Following Routine Immunizations in the Neonatal Intensive Care UnitJournal of Perinatol.  2010 Feb 25; 30(9):632.

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Durbin A, Setse R, Omer S, Palmer J, Spaeder J, Baker J, Lessans F, and Halsey N. Monitoring Adverse Events Following Yellow Fever Vaccination Using an Integrated Telephone and Internet-based System. Vaccine. 2009 Oct 19; 27(44):6143-47.

Klein NP, Edwards KM, Sparks R and Dekker CL; on behalf of the Clinical Immunization Safety Assessment (CISA) Network. Recurrent Sterile Abscesses Following Immunization: A Possible Association with Aluminum Adjuvant. BMJ Case Reports. 2009  pii: bcr09.2008.095.

Klein N, Kissner J, Aguirre A, Sparks R, Campbell S, Edwards K, Dekker C, Shui I, and Gust DA. Differential Maternal Responses to a Newly Developed Vaccine Information Pamphlet. Vaccine 2009 Dec. 11; 28:323–8.

Rosenberg M, Sparks R, McMahon A, Iskander J, Campbell JD, and Edwards KM. Serious Adverse Events Rarely Reported After Trivalent Inactivated Influenza Vaccine (TIV) in Children 6–23 Months of Age. Vaccine. 2009 Jul 9; 27(32):4278-83.

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Halsey NA. The Human Papillomavirus Vaccine and Risk of Anaphylaxis. [Commentary]. CMAJ. 2008 Sep 9; 179(6):509-10. [Epub 2008 Sep 1]. Erratum in: CMAJ. 2008 Sep 23; 179(7):678.

Kohl K, Magnus M, Ball R, Halsey N, Shadomy S, and Farley T. Applicability, Reliability, Sensitivity, and Specificity of Six Brighton Collaboration Standardized Case Definitions for Adverse Events Following Immunization. Vaccine. 2008 Nov 25; 26(50):6349–60.

Lindsey N, Schroeder B, Miller E, Braun M, Hinckley A, Marano N, Slade B, Barnett E, Brunette G, Horan K, Staples J, Kozarsky PE and Hayes E. Adverse Event Reports Following Yellow Fever Vaccination. Vaccine. 2008 Nov 11; 26(48): 6077-82.

Rennels M, Black S, Woo E, Campbell S, Edwards KM. Safety of a Fifth Dose of Diphtheria and Tetanus Toxoid and Acellular Pertussis Vaccine in Children Experiencing Extensive, Local Reactions to the Fourth Dose. Pediatric Infectious Disease Journal. 2008 May; 27(5):464-465.

Wood R, Berger M, Dreskin S, Setse R, Engler R, Dekker L, Halsey N & The Hypersensitivity Working Group of the Clinical Immunization Safety Assessment (CISA) Network. Algorithm for Treatment of Patients with Hypersensitivity Reactions After Vaccines. Pediatrics. 2008 September; 122(3): e771-7.

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Klein N, Fireman B, Enright A, Ray P, Black S, and Dekker CL for the Clinical Immunization Safety Assessment (CISA) Network. Role for Genetics in the Immune Response to the Varicella Vaccine. Pediatr Inf Dis J. 2007 Apr; 26(4):300-5.

Wood RA, Setse R, Halsey N, and the Hypersensitivity Working Group of the Clinical Immunization Safety Assessment (CISA) Network. Irritant Skin Test Reactions to Common Vaccines. Journal of Allergy and Clinical Immunology. 2007 Aug; 120(2):478-81.

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Muralles AA, Ray P, Black S, and Shinefield H. Active Telephone Surveillance to Evaluate Adverse Events Among Civilian Smallpox Vaccine Recipients.  Vaccine. 2006 Jan 23; 24(4):476-84.

Sekaran N, Edwards, K. Extensive Swelling Reaction Associated with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine. Pediatr Infect Dis J. 2006 Apr; 25(4):374-5.

Vellozzi C, Mitchell T,  Miller E, Casey CG, Eidex RB, Hayes EB, The Yellow Fever Vaccine Working Group (Halsey NA contributor). Yellow Fever Vaccine-Associated Viscerotropic Disease (YEL-AVD) and Corticosteroid Therapy: Eleven United States Cases, 1996-2004. Am J Trop Med Hyg. 2006 August; 75(2):333-6.

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Rollison D, Helzlsouer K, Halsey N, Shah K, and Viscidi R. Markers of Past Infection with Simian Virus 40 (SV40) and Risk of Incident Non-Hodgkin Lymphoma in a Maryland Cohort. Cancer Epidemiol Biomarkers Prev. 2005 June; 14(6) 1448-1452.

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Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, Halsey N, Vermeer P; Brighton Collaboration Seizure Working Group. Generalized Convulsive Seizure as an Adverse Event Following Immunization Case Definition & Guidelines for Data Collection, Analysis, and PresentationVaccine. 2004 Jan 26; 22(5-6):557-62.

Rothstein E, Kohl K, Ball L, Halperin S, Halsey N, Hammer S, Heath P, Hennig R, Kleppinger C, Labadie J, Varricchio F, Vermeer P, Walop W, and Brighton Collaboration Local Reaction Working Group. Nodule at Injection Site as an Adverse Event Following Immunization Case Definition & Guidelines for Data Collection, Analysis, and Presentation.  Vaccine. 2004 Jan 26; 22(5-6):575-85.

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Halsey NA.  The Science of Evaluation of Adverse Effects Associated with Vaccination. Seminars in Pediatric Infectious Diseases. 2002 July; 13(3):205-14.

Halsey NA.  Anthrax Vaccine and Causality Assessment from Individual Case Reports. Pharmacoepidemiology and Drug Safety. 2002 Apr-May; 11(3):185-7.

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