Vaccine adverse event reporting: The importance of follow-up

Expert Review of Vaccines

Volumn 4, Issue 4, 2005, Pages 445-448

  Varricchio, Frederick ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE; VACCINE;

DATA BASE; DRUG APPROVAL; DRUG SURVEILLANCE PROGRAM; EDEMA; ERYTHEMA; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GUILLAIN BARRE SYNDROME; HUMAN; IMMUNIZATION; INJECTION PAIN; INJECTION SITE REACTION; PRIORITY JOURNAL; REVIEW; VACCINE PRODUCTION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VACCINES;

EID: 24744448026     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/14760584.4.4.445     Document Type: Review

References (16)

1. Haber P, DeStefano F, Angulo FJ et al. Guillain Barré syndrome following influenza vaccination. JAMA 29, 2478-2481 (2004).
2. Varricchio F, Iskander J, DeStefano F et al. Understanding vaccine safety information from die Vaccine Adverse Event Reporting System. Pediatr. Infect. Dis. J. 23, 287-294 (2004).
3. 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).
4. Code of Federal Regulations. 21 600.80 (2004).
5. 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).
6. 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).
7. 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).
8. 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).
9. Varricchio F. The Vaccine Adverse Event Reporting System. J. Toxicol. Clin. Toxicol. 36(7), 765-768 (1998).
10. 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).
11. Braun MM, Terracciano G, Salive ME, et al. Report of a US Public Health Service workshop on hypotonichyporesponsive episode (HHE) after pertussis immunization. Pediatrics 102, E52 (1998).
12. Bonhoeffer J, Kohl K, Chen RT et al. Standardized case definitions of adverse events following immunization (AEFI). Vaccine 22, 547-550 (2004).
13. Wise RP, Iskander J, Pratt RD et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA 292(14), 1702-1710 (2004).
14. 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).
15. DuVernoy TS, Braun MM. Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998. Pediatrics 106(4), E52 (2000).
16. Code of Federal Regulations. 45 §164.501. (2002).