FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizonal rule
CBER links to product areas
CBER links
horizonal rule

Vaccine Adverse Event Report System (VAERS)

horizonal rule

Documents

Federal Register Notice; Vaccine Adverse Event Reporting System; Revised Form VAERS-2; Availability - 11/20/2001 - (PDF), (Text)

  • Draft Form (for comment) - (PDF), Instructions - (PDF)

Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) - 9/8/1998 (PDF), (Text)

Dear Colleague Letter: Use of Haemophilus influenzae Vaccines in Combination with DTaP in Infants - 8/12/1998

VAERS Bibliography: CDC/FDA Publications

horizonal rule

Consumer Articles

  1. How the FDA works to Ensure Vaccine Safety by Isodora Stehlin. FDA Consumer December 1995

  2. Adults Need Tetanus Shots, Too by Evelyn Zamula. FDA Consumer July-August 1996

  3. First Vaccine for Chickenpox by Isodora Stehlin. FDA Consumer September 1995

  4. Vaccine Safety Crucial but Impossible to Guarantee by CP Jones. Infectious Diseases in Children, 1996;9(1):33-35.

  5. Physicians play a pivotal role in vaccine safety by Susan Ellenberg and Bob Chen. AAP News, Feb., 1996.

horizonal rule

Professional Articles

  1. Ball LK, Ball R, Pratt RD. Assessment of thimerosal use in childhood vaccines. Pediatrics 2001;107:1147-1154.

  2. Ball R, Ball LK, Wise R, Braun MM, Beeler JA, Salive M. Stevens Johnson syndrome and toxic epidermal necrolysis after vaccination: Reports to the Vaccine Adverse Event Reporting System. Pediatric Infectious Disease Journal 2001;20:219-223.

  3. Ball R, Braun MM, Mootrey GT. Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting System. Clinical Infectious Diseases 2001;32:1273-1280.

  4. Beeler J, Varricchio F, Wise RP. Thrombocytopenia after immunization with measles vaccines: Review of the Vaccine Adverse Events Reporting System (1990 to 1994). The Pediatric Infectious Disease Journal. 1996;15:1,88-90.

  5. Braun MM, Ellenberg SS. Descriptive epidemiology of adverse events following immunization: reports to the Vaccine Adverse Events Reporting System (VAERS), 1991-1994. Journal of Pediatrics 1997; 131:529-35.

  6. Braun MM, Mootrey GT, Salive ME, Chen RT, Ellenberg SS, and the VAERS Working Group. Infant immunization with acellular pertussis vaccines in the US: Assessment of the first two years’ data from the Vaccine Adverse Event Reporting System (VAERS). Pediatrics electronic pages 2000;106:e51 and Pediatrics 2000;106:821.

  7. Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Archives of Pediatrics and Adolescent Medicine. 151:255-9; 1997.

  8. Braun MM, Terracciano G, Salive ME, Blumberg DA, Vermeer-de Bondt PE, Heijbel H, Evans G, Patriarca PA, Ellenberg SS. Report of a US Public Health Service Workshop on Hypotonic-Hyporesponsive Episode (HHE) Following Pertussis Immunization. Pediatrics electronic pages 1998;102:e52 and Pediatrics 1998;102:1201-2.

  9. Centers for Disease Control and Prevention. Vaccine Adverse Event Reporting System-United States. MMWR Morbidity and Mortality Weekly Report, 1990; 39(RR-41):730-33.

  10. Chen RT, Glasser JW, Rhodes PH, Wise RP, et. al. Vaccine Safety Datalink Project: A new tool for improving vaccine safety monitoring in the United States. Pediatrics. 99(6):765-73;1997.

  11. Chen RT, Rastogi SC, Mullen JR et. al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine. 1994;12:542-50.

  12. Chen RT, Phillips L, Hadler S. Bottom Line: Vaccination benefits far outweigh risks [letter]. The Nations Health, Dec. 1995;2.

  13. Clements, CJ, Ball, LK, Ball, R. Ball, Pratt, RD. Thiomersal in vaccines (letter). Lancet, 2000; 355:1279-1280.

  14. Commentary. CDC Officials help physicians answer DTP-safety questions. American Academy of Pediatrics News, 1995; 11(3):9-11.

  15. DuVernoy TS, Braun MM. Hypotonic Hyporesponsive Episodes Reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998. Pediatrics electronic pages 2000;106:e52 and Pediatrics 2000;106:821-2.

  16. Ellenberg SS, Chen RT, The complicated task of monitoring vaccine safety. Public Health Reports, 112:10-20, 1997.

  17. Howson, et al. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press, 1991.

  18. Niu MT, Davis, DM, and Ellenberg SS. Recombinant hepatitis B vaccination of neonates and infants: Emerging safety data from the Vaccine Adverse Event Reporting System. Pediatric Infectious Disease Journal, 1996;15:771-76.

  19. Niu MT, Rhodes P, Salive ME, Lively T, Davis DM, et. al. Comparative safety of two recombinant hepatitis B vaccines in children: data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD). Journal of Clinical Epidemiology, 1998; Vol 51, 6:503-510.

  20. Niu MT, Salive ME, Krueger CL, Ellenberg SS. Two year review of hepatitis A vaccine safety: Data from the Vaccine Adverse Event Reporting System (VAERS). Clinical Infectious Disease 1998;26:1475-6.

  21. Niu MT, Salive ME, Ellenberg SS. Post-marketing surveillance for adverse events after vaccination: The national Vaccine Adverse Event Reporting System (VAERS), MEDWATCH CME credit article (FDA/CBER publication), November, 1998.

  22. Niu MT, Salive ME, Ellenberg SS. Reporting adverse events after vaccination: The national Vaccine Adverse Event Reporting System (VAERS) Federal Practitioner 1998; 15; 13-21,37.

  23. Niu MT, Salive ME, Ellenberg SS. Neonatal deaths after hepatitis B vaccine, VAERS, 1991-1998. Arch Pediatr Adoles Med 1999; 153:1279-82.

  24. Rosenthal S, Chen RT. The reporting sensitivities of two passive surveillance systems for Vaccine Adverse Events. American Journal of Public Health, 1995; 85(12):1706-09.

  25. Singleton JA, Loyd, JL, Mootrey, GT, Salive, ME, Chen, RT. An overview of the Vaccine Adverse Event Reporting System (VAERS) as a surveillance system. Vaccine 1999;17(22):2908-17.

  26. Stratton, et al. Adverse Events Associated with Childhood Vaccines, Evidence Bearing on Causality. Washington, DC: National Academy Press, 1993.

  27. Varricchio, F. The vaccine adverse event reporting system. Clinical Toxicology, 36(7), 765-68 (1998).

  28. Wise RP, Kiminyo KP, Salive ME. Hair loss following routine immunizations. Journal of the American Medical Association. 1997; 278:1176-8.

  29. Wise RP, Salive ME, Braun MM, Mootrey GT, Seward JF, Rider LG, Krause PR, Postlicensure safety surveillance for varicella vaccine, Journal of the American Medical Association, September 13, 2000, 284(10):1271-9.

  30. Zanardi LR, Haber P, Mootrey GT, Niu, MT, Wharton M. Intussusception among recipients of rotavirus vaccine--reports to the Vaccine Adverse Event Reporting System, 2001; Pediatrics , in press.

 

Back to VAERS

 

Updated April 17, 2003
 
horizonal rule

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA / Center for Biologics Evaluation and Research