Vaccine safety datalink project: A new tool for improving vaccine safety monitoring in the United States

Pediatrics

Volumn 99, Issue 6, 1997, Pages 765-773

  Chen, Robert T ^a   Glasser, John W ^a   Rhodes, Philip H ^a   Davis, Robert L ^b   Barlow, William E ^b   Thompson, Robert S ^b   Mullooly, John P ^c   Black, Steve B ^d   Shinefield, Henry R ^d   Vadheim, Connie M ^e   Michael Marcy, S ^f   Ward, Joel I ^e   Wise, Robert P ^g   Wassilak, Steven G ^a   Hadler, Stephen C ^a   Swint, Emmett ^a   Hardy, Janet R ^a   Payne, Thomas ^b   Immanuel, Virginia ^b   Benson, Patti ^b   Draket, Julie ^b   Drew, Lois ^c   Mendius, Barbara ^c   Ray, Paula ^d   Lewis, Ned ^d   Fireman, Bruce H ^d   Jing, Jennie ^e   Wulfsohn, Michael ^e   Lugg, Marlene M ^f   Osborne, Patricia ^f   Rastogi, Suresh ^g   Patriarca, Peter ^g   Caserta, Vito ^h   more..

^a CENTERS FOR DIS CONTR AND PREV   (United States)

^b CENTER FOR HEALTH STUDIES   (United States)

^c CENTER FOR HEALTH RESEARCH   (United States)

^d Pediatric Vaccine Study Center   (United States)

^e HARBOR UCLA MEDICAL CENTER   (United States)

^f KAISER PERMANENTE   (United States)

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

^h HEALTH RESOURCES AND SERVICES ADMINISTRATION   (United States)

Author keywords

adverse reactions; databases; immunization; record linkage; vaccine safety; vaccines

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; MEASLES MUMPS RUBELLA VACCINE; VACCINE;

ARTICLE; AUTOMATION; CHILD HOSPITALIZATION; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DATA BASE; DRUG MONITORING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE MANAGEMENT; HEALTH CARE ORGANIZATION; HEALTH SERVICE; HUMAN; IMMUNIZATION; INCIDENCE; INFANT; MAJOR CLINICAL STUDY; PHARMACOEPIDEMIOLOGY; PRESCHOOL CHILD; PRIORITY JOURNAL; PUBLIC HEALTH; SEIZURE; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BACTERIAL PROTEINS; CHILD; CHILD, PRESCHOOL; DATA COLLECTION; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; HAEMOPHILUS VACCINES; HEALTH MAINTENANCE ORGANIZATIONS; HUMANS; INFANT; INFORMATION SYSTEMS; MEASLES VACCINE; MEASLES-MUMPS-RUBELLA VACCINE; MUMPS VACCINE; PROGRAM DEVELOPMENT; QUALITY CONTROL; RISK; RUBELLA VACCINE; SEIZURES; UNITED STATES; VACCINES; VACCINES, COMBINED;

EID: 17144460170     PISSN: 00314005     EISSN: None     Source Type: Journal    
DOI: 10.1542/peds.99.6.765     Document Type: Article

References (46)

1. World Bank. World Development Report 1993: Investing in Health. New York, NY: Oxford University Press; 1993
2. Expanded programme on immunization. Global advisory group - part 1. Weekly Epidemiol Rec. 1994;69:21-27
3. Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine. 1994;12:542-550
4. Chen RT. Special methodological issues in pharmacoepidemiology studies of vaccine safety. In: Strom BL, ed. Pharmacoepidemiology. Sussex, United Kingdom: John Wiley & Sons; 1994
5. Miller DL, Alderslade R, Ross EM. Whooping cough and whooping cough vaccine: the risks and benefits debate. Epidemiol Rev. 1982;4:1-24
6. Krantz I, Taranger J, Trollfors B. Estimating incidence of whooping cough over time: a cross-sectional recall study of four Swedish birth cohorts. Int J Epidemiol. 1989;18:959-963
7. Kimura M, Kuno-Sakai H. Developments in pertussis immunisation in Japan. Lancet. 1990;336:30-32
8. Galazka AM, Robertson SE, Oblapenko GP. Resurgence of diphtheria. Eur J Epidemiol. 1995;11:95-105
9. Howson CP, Howe CJ, Fineberg HV, eds. Adverse Effects of Pertussis and Rubella Vaccines: A Report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press; 1991
10. Stratton KR, Howe CJ, Johnston RB, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington DC: National Academy Press; 1994
11. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. Guillain-Barré syndrome following vaccination in the national influenza immunization program, United States, 1976-1977. Am J Epidemiol. 1979;110:105-123
12. Walker AM, Jick H, Perera DR, et al. Diphtheria-tetanus-pertussis immunization and sudden infant death syndrome. Am J Public Health. 1987;77:945-951
13. Griffin MR, Ray WA, Fough RL, et al. Monitoring the safety of childhood immunization: methods of linking and augmenting computerized data bases for epidemiologic studies. Am J Prev Med. 1988;4(suppl):5-14
14. Walker AM, Jick H, Perera DR, et al. Neurologic events following diphtheria-tetanus-pertussis immunization. Pediatrics. 1988;81:345-349
15. Wassilak SGF, Classer JW, Chen RT, Black S, Mullooly JP, Thompson RS. Design of a multicenter study of adverse events following vaccination in childhood. J Clin Res Pharmacoepidemiol. 1991;5:294. Abstract
16. Frontiers in medicine: vaccines. Science. 1994;265:1371-1404
17. Karch FE, Lasagna L. Adverse drug reactions. JAMA. 1975;234:1236-1241
18. Strom BL, Carson JL. Use of automated databases for pharmacoepidemiology research. Epidemiol Rev. 1990;12:87-107
19. Farrington CP, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet. 1995;345:567-569
20. Roberts JD, Roos LL, Poffenroth LA, et al. Surveillance of vaccine-related adverse events in the first year of life: a Manitoba cohort study. J Clin Epidemiol. 1996;49:51-58
21. Centers for Disease Control and Prevention. National Childhood Vaccine Injury Act. Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR. 1988;37:197-200
22. Griffin MR, Ray WA, Livengood JR, et al. Risk of sudden infant death syndrome following diphtheria-tetanus-pertussis immunization. N Engl J Med. 1988;319:618-623
23. Fine PEM, Chen RT. Confounding in studies of adverse reactions to vaccines. Am J Epidemiol. 1992;136:121-135
24. Krieger N. Overcoming the absence of socioeconomic data in medical records: validation and application of a census-based methodology. Am J Public Health. 1992;92:703-710
25. Mullooly J. Misclassification model for person-time analysis of automated medical care database. Am J Epidemiol. 1996;144:782-792
26. Institute of Medicine. Reliability of National Hospital Discharge Survey Data. Report of a Study. Washington, DC: National Academy of Sciences; 1980
27. Fox LA, Stearns G, Imbiorski W, eds. The Administrator's Guide to Evaluating Records and the Medical Records Department. Chicago, IL: Care Communications; 1979
28. Mullooly JP, Black S, Thompson RS, Classer JW, Chen RT, Rhodes P. Quality of large, linked HMO databases: estimation and correction of misclassification bias in screening analyses of childhood vaccine safety. Pharmacoepidemiol Drug Safety. 1994;3:S32. Abstract
29. Prentice RL. A case-cohort design for epidemiologic cohort studies and disease prevention trials. Biometrika. 1986;73:1-11
30. Farrington CP, Nash J, Miller E. Case series analysis of adverse reactions to vaccines: a comparative evaluation. Am J Epidemiol. 1996;143:1165-1173
31. Griffin MR, Ray WA, Mortimer EA, et al. Risk of seizures and encephalopathy after immunization with the diphtheria-tetanus-pertussis vaccine. JAMA. 1990;263:1641-1645
32. Marcuse EK, Wentz KR. The NCES reconsidered: summary of a 1989 workshop. Vaccine. 1990;8:531-535
33. Mitchell LA, Tingle AJ, Shukin R, Sangeorzan JA, McCune J, Braun DK. Chronic rubella vaccine-associated arthropathy. Arch Intern Med. 1993;153:2268-2274
34. Ray P, Black S, Shinefield H, et al. Retrospective cohort evaluation of chronic rubella vaccine arthropathy. Abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC: American Society for Microbiology; 1994:240. Abstract
35. Davis R, Vadheim C, Black S, et al. Immunization tracking systems: experience of the CDC vaccine safety datalink sites. HMO Practice. 1997;11:13-17
36. Payne T, Kanvik S, Seward R, et al. Development and validation of an immunization tracking system in a large health maintenance organization. Am J Prev Med. 1993;9:96-100
37. Lieu T, Black S, Sorel M, et al. Missed opportunities for immunization in a HMO. Am J Public Health. 1994;84:1621-1625
38. Lieu TA, Black SB, Sorel ME, Ray P, Shinefield HR. Would better adherence to guidelines improve childhood immunization rates? Pediatrics. 1996;98:1062-1068
39. Thompson RS, Taplin SH, McAfee TA, Mandelson MT, Smith AE. Primary and secondary preventive services in clinical practice. JAMA. 1995;273:1130-1135
40. Cordero JF, Guerra FA, Saarlas KN, eds. Developing immunization registries: experience from the All Kids Count Program. Am J Prev Med. 1997;13(suppl 1):1-128
41. Centers for Disease Control and Prevention. Request for Proposals No. 200-95-0947(P). Comprehensive Linked Data Collection of Medical Events and Immunization (Vaccine Safety and Development Datalink). Atlanta, GA: Centers for Disease Control and Prevention; 1995
42. Williams JC, Goldenthal KL, Burns DL, Lewis BP Jr, eds. Combined Vaccines and Simultaneous Administration: Current Issues and Perspective. New York, NY: New York Academy of Science; 1995
43. Hinman AR, Orenstein WA. Public health considerations. In: Plotkin SA, Mortimer EA, eds. Vaccines. Philadelphia, PA: WB Saunders; 1994: 903-932
44. Evans G. Vaccine liability and safety: a progress report. Pediatr Infect Dis J. 1996;15:477-478
45. Rothman KJ, ed. Causal Inference. Chestnut Hill, MA: Epidemiology Resources, Inc; 1988
46. Centers for Disease Control and Prevention. Recommended childhood immunization schedule - United States, 1997. MMWR. 1997;46:35-40