Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the Vaccine Adverse Event Reporting System

Journal of Clinical Epidemiology

Volumn 55, Issue 8, 2002, Pages 819-824

  Ball, Robert ^a,f   Halsey, Neal ^b   Braun, M Miles ^a   Moulton, Lawrence H ^b   Gale, Arnold D ^c   Rammohan, Kottil ^d   Wiznitzer, Max ^e   Johnson, Richard ^b   Salive, Marcel E ^a  

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

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d OHIO STATE UNIVERSITY   (United States)

^e CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Adverse events; Encephalitis; Encephalopathy; Immunization; Multiple sclerosis; Safety; Surveillance; Vaccine

Indexed keywords

PERTUSSIS VACCINE; VACCINE;

ARTICLE; BRAIN DISEASE; CALCULATION; DATA ANALYSIS; DISEASE CLASSIFICATION; DISEASE SEVERITY; DRUG SURVEILLANCE PROGRAM; ENCEPHALITIS; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; MULTIPLE SCLEROSIS; PERTUSSIS; PRIORITY JOURNAL; RISK FACTOR; VACCINATION;

ACUTE DISEASE; ADVERSE DRUG REACTION REPORTING SYSTEMS; CENTERS FOR DISEASE CONTROL AND PREVENTION (U.S.); DIAGNOSIS, DIFFERENTIAL; ENCEPHALITIS; HUMANS; INFANT; INFANT, NEWBORN; MULTIPLE SCLEROSIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VACCINES;

EID: 0036697763     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0895-4356(01)00500-5     Document Type: Article

References (21)

1. Chen R.T., Rastogi S.C., Mullen J.R.et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine. 12:1994;542-550.
2. Ellenberg S.S., Chen R.T. The complicated task of monitoring vaccine safety. Public Health Reports. 112:1997;10-20.
3. "COSTART" Coding Symbols for Thesaurus of Adverse Reaction Terms. Rockville, MD: Public Health Service, Food and Drug Administration, 1995.
4. MMWR. Withdrawal of rotavirus vaccine recommendation. MMWR. 48:1999;1007.
5. Ball R., Ball L.K., Wise R., Braun M.M., Beeler J., Salive M. Stevens Johnson syndrome and toxic epidermal necrolysis after vaccination. Reports to the Vaccine Adverse Event Reporting System Pediatric Infectious Disease Journal. 20:2001;219-223.
6. DuVernoy T.S., Braun M.M., VAERS Working Group Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998. Pediatrics. 106:2000;e52.
7. Braun M.M., Patriarca P.A., Ellenberg S. Syncope after immunization. Arch Pediatr Adolesc Med. 151:1997;255-259.
8. Wise R.P., Kiminyo K.P., Salive M.E. Hair loss after routine immunizations. JAMA. 278:1997;1176-1178.
9. Beeler J., Varricchio F., Wise R. Thrombocytopenia after immunization with measles vaccines. Review of the Vaccine Adverse Event Reporting System (1990 to 1994) Pediatric Infectious Disease Journal. 15:1996;88-90.
10. Haber P., Gordon S., Eltermann D., House S., Chen R. Assessing extent of misclassification of early Guillain-Barre Syndrome after influenza vaccination-Vaccine Adverse Event Reporting System, US, 1990-1994. Pharmacoepidemiol Drug Saf. 3:1994;S34.
11. Braun M.M., Terracciano G., Salive M.E.et al. Report of a US Public Health Service workshop on hypotonic-hyporesponsive episode (HHE) after pertussis immunization. Pediatrics. 102:1998;e52.
12. Singleton J.A., Lloyd J.C., Mootrey G.T., Salive M.E., Chen R.T. VAERS Working Group. An overview of the Vaccine Adverse Event Reporting System (VAERS) as a surveillance system. Vaccine. 17:1999;2908-2917.
13. Howson C.P., Howe C.J., Fineberg H.V. Adverse effects of pertussis and rubella vaccines. 1991;National Academy Press, Washington DC.
14. Stratton KR, Howe CJ, Johnston Jr. RB, eds. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington DC: National Academy Press, 1994.
15. Rosner B. Fundamentals of Biostatistics. 1995;Wadsworth Publishing Company; Belmont, CA.
16. Table VI. 42 Code of Federal Regulations section 100.3. Available at frwebgate.access.gpo.gov/nara/cfr.
17. Miller D.L., Ross E.M., Alderslade R., Bellman M.H., Rawson N.S.B. Pertussis immunisation and serious acute neurological illness in children. BMJ. 282:1981;1595-1599.
18. Beghi E., Nicolosi A., Kurland L.T., Mulder D.W., Hauser W.A., Shuster L. Encephalitis and aseptic meningitis, Olmstead County Minnesota, 1950-1981. I. Epidemiology. Ann Neurol. 16:1984;283-294.
19. Poser C.M., Paty D.W., Scheinberg L.et al. New diagnostic criteria for multiple sclerosis. Guidelines for research protocols Ann Neurol. 13:1983;227-231.
20. Fazekas F., Barkhof F., Filippi M.et al. The contribution of magnetic resonance imaging to the diagnosis of multiple sclerosis. Neurology. 53:1999;448-456.
21. The Brighton collaboration for standardized case definitions of adverse events following immunization. Available at http://brightoncollaboration.org.