References
- Haber P, DeStefano F, Angulo FJ et al. Guillain Barré syndrome following influenza vaccination. JAMA 29, 2478–2481 (2004).
- Varricchio F, Iskander J, DeStefano F et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr. Infect. Dis. J. 23, 287–294 (2004).
- Baum C, Kweder SL, Anello C. The Spontaneous Reporting System in the US. Second edition. Strom BL (Ed.), Pharmacoepidemiology Wiley, NY, USA 125–55 (1995).
- Code of Federal Regulations. 21 600.80 (2004).
- Silvers LE, Varricchio FE, Ellenberg SS et al. Pediatric deaths reported after vaccination: the utility of information obtained from parents. Am. J. Prev. Med. 22, 170–176 (2002).
- Rothstein E, Kohl K, Ball L et al. Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 22, 575–585 (2004).
- Bines JE, Kohl KS, Forster J et al. Acute intussusception in infants and children as an adverse event following immunization: definition and guidelines of data collection, analysis, and presentation. Vaccine 22, 569–574 (2004).
- Halperin S, Kohl, K, Varricchio, F et al. Cellulitis at injection site as adverse event following immunization; case definition and guidelines of data collection, and presentation. Vaccine(2005) (In Press).
- Varricchio F. The Vaccine Adverse Event Reporting System. J. Toxicol. Clin. Toxicol.36(7), 765–768 (1998).
- Ball R, Halsey N, Braun MM, et al. Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the Vaccine Adverse Event Reporting System. J. Clin. Epidemiol. 55, 821–830 (2002).
- Braun MM, Terracciano G, Salive ME, et al. Report of a US Public Health Service workshop on hypotonic-hyporesponsive episode (HHE) after pertussis immunization. Pediatrics102, E52 (1998).
- Bonhoeffer J, Kohl K, Chen RT et al. Standardized case definitions of adverse events following immunization (AEFI). Vaccine 22, 547–550 (2004).
- Wise RP, Iskander J, Pratt RD et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA 292(14), 1702–1710 (2004).
- Ball R, Ball LK, Wise RP et al. Stevens–Johnson syndrome and toxic epidermal necrolysis after vaccination: reports to the vaccine adverse event reporting system. Pediatr. Infect. Dis. J. 20(2), 219–223 (2001).
- DuVernoy TS, Braun MM. Hypotonic–hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996–1998. Pediatrics 106(4), E52 (2000).
- Code of Federal Regulations. 45 § 164.501. (2002).
Websites
- US Food and Drug Administration www.FDA.gov/cber/guidance (Accessed July 2005)
- Vaccine Adverse Events Reporting System www.vaers.org (Accessed July 2005)