Prelicensure		Postlicensure (CISA, VAERS, VSD)

Archive 2003-1995

Postlicensure 2009

Death and Serious Illness following Influenza Vaccination: A Multidisciplinary Investigation Authors: Rue-Cover A, Iskander J, Lyn S, et al. Source: Pharmacoepidemiol Drug Saf, April 16, 2009

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Safety of Trivalent Inactivated Influenza Vaccines in Adults: Background for Pandemic Influenza Vaccine Safety Monitoring Authors: Vellozzi C, Burwen DR, Dobardzic A, Ball R, Walton K, Haber P Source: Vaccine, March 26, 2009, Vol. 27(15):2114-2120

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Routine Vaccination against Pertussis and the Risk of Childhood Asthma: A Population-Based Cohort Study Authors: Spycher BD, Silverman M, Egger M, Zwahlen M, Kuehni CE Source: Pediatrics, March 2009, Vol. 123(3):944-50

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Varicella Vaccination and Ischemic Stroke in Children: Is There an Association? Authors: Donahue JG, Kieke BA, Yih WK, et al. Source: Pediatrics, February 2009, Vol. 123(2):e228-34

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Vaccines and Guillain-Barré Syndrome Authors: Haber P, Sejvar J, Mikaeloff Y, Destefano F Source: Drug Saf, 2009, Vol. 32(4):309-23

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Postlicensure 2008

A Distributed Research Network Model for Post-Marketing Safety Studies: The Meningococcal Vaccine Study Authors: Velentgas P, Bohn RL, Brown JS Source: Pharmacoepidemiol Drug Saf, December 2008, Vol. 17(12):1226-34

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A Population-Based, Postlicensure Evaluation of the Safety of a Combination Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, and Inactivated Poliovirus Vaccine in a Large Managed Care Organization Authors: Zangwill KM, Eriksen E, Lee M, et al. Source: Pediatrics, December 2008, Vol. 122(6):e1179-85

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Guidelines for Collection, Analysis and Presentation of Vaccine Safety Data in Pre- and Post-Licensure Clinical Studies Authors: Bonhoeffer J, Bentsi-Enchill A, Chen RT, et al. Source: Vaccine, December 1, 2008

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Applicability, Reliability, Sensitivity, and Specificity of Six Brighton Collaboration Standardized Case Definitions for Adverse Events following Immunization Authors: Kohl KS, Magnus M, Ball R, Halsey N, Shadomy S, Farley TA Source: Vaccine, November 25, 2008, Vol. 26(50):6349-60

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Adverse Event Reports following Yellow Fever Vaccination Authors: Lindsey NP, Schroeder BA, Miller ER, et al. Source: Vaccine, November 11, 2008, Vol. 26(48):6077-82

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Adverse Events after Anthrax Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007 Authors: Niu MT, Ball R, Woo EJ, Burwen DR, Knippen M, Braun MM; The VAERS Working Group Source: Vaccine, November 6, 2008

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Trends in Intussusception Hospitalizations among US Infants, 1993-2004: Implications for Monitoring the Safety of the New Rotavirus Vaccination Program Authors: Tate JE, Simonsen L, Viboud C, Steiner C, Patel MM, Curns AT, Parashar UD Source: Pediatrics, May 2008, Vol. 121(5):e1125-32

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Elective Termination of Pregnancy after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS): 1990-2006 Authors: Chang S, Ball R, Braun MM Source: Vaccine, May 2, 2008, Vol. 26(19):2428-32

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Syncope after Vaccination--United States, January 2005-July 2007 Author: Centers for Disease Control and Prevention Source: MMWR, May 2, 2008, Vol. 57(17):457-60

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Safety Profile of Pneumococcal Conjugate Vaccines: Systematic Review of Pre- and Post-Licensure Data Authors: Destefano F, Pfeifer D, Nohynek H Source: Bull World Health Organ, May 2008, Vol. 86(5):373-80

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A Process for Sentinel Case Review to Assess Causal Relationships between Smallpox Vaccination and Adverse Outcomes, 2003-2004 Authors: Chapman LE, Iskander JK, Chen RT Source: Clin Infect Dis, March 15, 2008, Vol. 46 Suppl 3:S271-93

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Monitoring the Safety of a Smallpox Vaccination Program in the United States: Report of the Joint Smallpox Vaccine Safety Working Group of the Advisory Committee on Immunization Practices and the Armed Forces Epidemiological Board Authors: Neff J, Modlin J, Birkhead GS, Poland G Source: Clin Infect Dis, March 15, 2008, Vol. 46 Suppl 3:S258-70

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A Review of the Smallpox Vaccine Adverse Events Active Surveillance System Authors: Thomas TN, Reef S, Neff L, Sniadack MM, Mootrey GT Source: Clin Infect Dis, March 15, 2008, Vol. 46 Suppl 3:S212-20

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Live Attenuated Measles and Mumps Viral Strain-Containing Vaccines and Hearing Loss: Vaccine Adverse Event Reporting System (VAERS), United States, 1990-2003 Authors: Asatryan A, Pool V, Chen RT, Kohl KS, Davis RL, Iskander JK; VAERS team Source: Vaccine, February 26, 2008, Vol. 26(9):1166-72

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Inactivated Influenza Vaccine (IIV) in Children <2 Years of Age: Examination of Selected Adverse Events Reported to the Vaccine Adverse Event Reporting System (VAERS) after Thimerosal-Free or Thimerosal-Containing Vaccine Authors: McMahon AW, Iskander JK, Haber P, Braun MM, Ball R Source: Vaccine, January 17, 2008, Vol. 26(3):427-9

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Effects of Stratification on Data Mining in the US Vaccine Adverse Event Reporting System (VAERS) Authors: Woo EJ, Ball R, Burwen DR, Braun MM Source: Drug Saf, 2008, Vol. 31(8):667-74

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Postlicensure 2007

Diphtheria, Pertussis, Poliomyelitis, Tetanus, and Haemophilus influenzae Type b Vaccinations and Risk of Eczema and Recurrent Wheeze in the First Year of Life Authors: Kummeling I, Thijs C, Stelma F, et al Source: Pediatrics, February 2007; 119:367-373

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Sudden Infant Death Syndrome: No Increased Risk after Immunisation Authors: Vennemann MM, Butterfass-Bahloul T, Jorch G, et al Source: Vaccine, January 4, 2007; 25:336-340

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Postlicensure 2006

Has the Measles-Mumps-Rubella Vaccine Been Fully Exonerated? (Commentary) Author: Katz SL Source: Pediatrics, October 2006, Vol. 118(4):1744-1745

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No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells from Children with Autism Spectrum Disorder Authors: D'Souza Y, Fombonne E, Ward BJ Source: Pediatrics, October 2006, Vol. 118(4):1664-1675

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Encephalopathy after Whole-Cell Pertussis or Measles Vaccination: Lack of Evidence for a Causal Association in a Retrospective Case-Control Study Authors: Ray P, Hayward J, Michelson D, et al Source: Pediatr Infect Dis J, September 2006, Vol. 25(9):768-773

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Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links with Immunizations Authors: Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D Source: Pediatrics, July 2006, Vol. 118(1):e139-e150

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Solicited Adverse Events after Influenza Immunization among Infants, Toddlers, and Their Household Contacts Authors: Skowronski DM, Jacobsen K, Daigneault J, et al Source: Pediatrics, June 2006, Vol. 117:1963-1971

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Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies Authors: Goodman MJ, Nordin J Source: Pediatrics, February 2006, Vol. 117(2):387-390

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Postlicensure 2005

Vaccine Safety Controversies and the Future of Vaccination Programs Authors: Francois G, Duclos P, Margolis H, et al Source: Pediatr Infect Dis J, Nov. 2005, Vol. 24(11):953-961

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Vaccine Safety Research, Data Access, and Public Trust Authors: Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program Source: National Academies Press, February 2005

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Postlicensure 2004

The Role of the Vaccine Adverse Event Reporting System (VAERS) in Monitoring Vaccine Safety Authors: Iskander JK, Miller ER, Chen RT Source: Pediatric Annals, September 2004, Vol. 33(9):599-606

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Notice to Readers: Public Comment Sought on CDC's Vaccine Safety Source: MMWR, August 13, 2004, Vol. 53(31):720

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MMR Vaccination and Febrile Seizures Authors: Vestergaard M, Hviid A, Meldgaard Madsen K, et al. Source: JAMA, July 21, 2004, Vol. 292(3):351-7

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Vaccine Risk Perception Among Reporters of Autism after Vaccination: Vaccine Adverse Event Reporting System 1990-2001 Authors: Woo EJ, Ball R, Bostrom A, et al. Source: American Journal of Public Health

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Understanding Vaccine Safety Information from the Vaccine Adverse Reporting System Authors: Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen RT Source: Pediatric Infectious Diseases Journal, April 2004, Vol. 23(4):287-294

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Adverse Events after Immunisation with Aluminum-Containing DTP Vaccines: Systematic Review of the Evidence Authors: Jefferson T, Rudin M, Di Pietrantonj C Source: The Lancet: Infectious Diseases, February 1, 2004, Vol. 4(2):84-90

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Postlicensure Archive

Postlicensure journal articles