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Clinical Immunization Safety Assessment (CISA) Project Publications

Research and evaluation conducted by CDC and the CISA Project has led to the publication of many reports, some of which are listed here:


Stockwell MS, Broder KR, Lewis P, Jakob K, Iqbal S, Fernandez N, Sharma D, Barrett A, LaRussa P. Assessing Fever Frequency After Pediatric Live Attenuated Versus Inactivated Influenza Vaccination. J Pediatric Infect Dis Soc. 2016 Jun. J Pediatric Infect Dis Soc. 2016 Jun 14. [Epub ahead of print]


Baxter R, Lewis N, Bohrer P, Harrington T, Aukes L, Klein NP. Sudden-Onset Sensorineural Hearing Loss after Immunization: A Case-Centered Analysis. Otolaryngol Head Neck Surg. 2016 Mar 29. [Epub ahead of print]



Hofstetter AM, Jakob K, Klein NP, Dekker CL, Edwards KM, et al. Live vaccine use and safety in DiGeorge syndrome. Pediatrics. 2014 Apr;133(4):e946-54. doi: 10.1542/peds.2013-0831. Epub 2014 Mar 31.

Grohskopf LA, Olsen SJ, Sokolow LZ, Bresee JS, Cox NJ, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) — United States, 2014–15 Influenza Season. MMWR. 2014 Aug 15;63(32):691-697.

Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, et al. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr. 2014 Mar;168(3):211-9. doi: 10.1001/jamapediatrics.2013.4469.

Press release: Brief fever common in kids given influenza, pneumococcal vaccines together.


Halsey NA, Griffioen M, Dreskin SC, Dekker CL, Wood R, et al. Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS. Vaccine. 2013 Dec 9;31(51):6107-12. doi: 10.1016/j.vaccine.2013.09.066. Epub 2013 Oct 8.

Pahud BA, Williams SE, Dekker CL, Halsey N, LaRussa P, et al. 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, et al. Comprehensive assessment of serious adverse events following immunization by health care providers. J Pediatr. 2013 Jun;162(6):1276-81, 1281.e1. doi: 10.1016/j.jpeds.2013.01.028. Epub 2013 Feb 26.

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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. Clin Infect Dis. 2012 Mar;54(6):800-4. doi: 10.1093/cid/cir960. Epub 2012 Jan 19.

Halsey NA, Edwards KM, Dekker CL, Klein NP, Baxter R, et al. Algorithm to assess causality after individual adverse events following immunizationsVaccine. 2012 Aug 24;30(39):5791-8. Epub 2012 Apr 14.

Loughlin AM, Marchant CD, Adams W, Barnett E, Baxter R, et al. 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, et al. 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, et al. 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(4):252-8. doi: 10.1159/000338303. Epub 2012 Jun 5.

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 May 1;175(9):878-85. doi: 10.1093/aje/kws011. Epub 2012 Mar 12.

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Klein NP, Gidudu J, Qiang Y, Pahud B, Rowhani-Rahbar A, et al. 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, et al. 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, et al. Evaluation of immunization rates and safety among children with inborn errors of metabolism. Pediatrics. 2011 May;127(5):e1139-46. doi: 10.1542/peds.2010-3706. Epub 2011 Apr 11.

Miller EK, Dumitrescu L, Cupp C, Dorris S, Taylor S, et al. 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, et al. 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. 2012 May;32(5):363-7. doi: 10.1038/jp.2011.111. Epub 2011 Aug 11.

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, et al. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination. Vaccine. 2011 Oct 26;29(46):8302-8.

Williams SE, Klein NP, Halsey N, Dekker CL, Baxter RP, et al. 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. 2011May 31;29(24):4151-5.

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Klein N, Gans  H, Sung P, Yasukawa LL, Johnson J, et al. Preterm infants T cell responses to inactivated poliovirus vaccine. J Infect Dis. 2010 Jan 15;201(2):214-22. doi: 10.1086/649590.

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 unit. J Perinatol. 2010 Sep;30(9):604-9. doi: 10.1038/jp.2010.8. Epub 2010 Feb 25.

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Durbin A, Setse R, Omer S, Palmer J, Spaeder J, et al. 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 Rep. 2009. pii: bcr09.2008.0951. doi: 10.1136/bcr.09.2008.0951. Epub 2009 Mar 17.

Klein N, Kissner J, Aguirre A, Sparks R, Campbell S, et al. Differential maternal responses to a newly developed vaccine information pamphlet. Vaccine. 2009 Dec 11;28(2):323-8. doi: 10.1016/j.vaccine.2009.10.046. Epub 2009 Oct 30.

Rosenberg M, Sparks R, McMahon A, Iskander J, Campbell JD, et al. 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. doi: 10.1016/j.vaccine.2009.05.023. Epub 2009 May 28.

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Halsey NA. The human papillomavirus vaccine and risk of anaphylaxis. [Commentary]. CMAJ. 2008 Sep 9;179(6):509-10. doi: 10.1503/cmaj.081133. Epub 2008 Sep 1. Erratum in: CMAJ. 2008 Sep 23; 179(7):678.

Kohl K, Magnus M, Ball R, Halsey N, Shadomy S, et al. 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, et al. 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. Pediatr Infect Dis J. 2008 May;27(5):464-5. doi: 10.1097/INF.0b013e31816591f7.

Wood R, Berger M, Dreskin S, Setse R, Engler R, et al. 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. J Allergy Clin Immunol. 2007 Aug;120(2):478-81. Epub 2007 Jun 4.

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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, et al. 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, et al. Generalized convulsive seizure as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation. Vaccine. 2004 Jan 26; 22(5-6):557-62.

Rothstein E, Kohl K, Ball L, Halperin S, Halsey N, et al. 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. Semin Pediatr Infect Dis. 2002 Jul;13(3):205-14.

Halsey NA. Anthrax vaccine and causality assessment from individual case reports. Pharmacoepidemiol Drug Saf. 2002 Apr-May;11(3):185-7; discussion 203-4.

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