Applicability of the Brighton Collaboration Case Definition for seizure after immunization in active and passive surveillance in Canada

Vaccine

Volumn 31, Issue 48, 2013, Pages 5700-5705

  Top, Karina A ^a,b,h   Constantinescu, Cora M ^c   Laflèche, Julie ^d   Bettinger, Julie A ^e   Scheifele, David W ^e,r   Vaudry, Wendy ^f,q   Halperin, S ^h   Law, Barbara J ^d,n   Morris, R ^g   Bridger, N ^g   Dery P ⁱ   Mills, E ^j   Moore, D ^j   Lebel, M ^k   MacDonald, N ^l   Wang, E ^m   Ford Jones, L ^m   Tran, D ^m   Embree, J ⁿ   Tan, B ^o   McConnell, A ^o   Jadavji, T ^p   Vanderkooi, O ^p   Sauve L ^r   more..

^a DALHOUSIE UNIVERSITY   (Canada)

^b Columbia University Medical Center ^*  (United States)

^c UNIVERSITY OF CALGARY   (Canada)

^d PUBLIC HEALTH AGENCY OF CANADA   (Canada)

^e UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^f UNIVERSITY OF ALBERTA   (Canada)

^g Janeway Children's Health and Rehabilitation Centre   (Canada)

^h IWK HEALTH CENTRE   (Canada)

ⁱ LAVAL UNIVERSITY   (Canada)

^j MONTREAL CHILDREN S HOSPITAL   (Canada)

^k UNIVERSITY OF MONTREAL   (Canada)

^l CHILDREN S HOSPITAL OF EASTERN ONTARIO   (Canada)

^m Hospital for the Sick Children   (Canada)

ⁿ CHILDREN S HOSPITAL RESEARCH INSTITUTE OF MANITOBA   (Canada)

^o ROYAL UNIVERSITY HOSPITAL   (Canada)

^p ALBERTA CHILDREN'S HOSPITAL   (Canada)

^q STOLLERY CHILDREN S HOSPITAL   (Canada)

^r BC CHILDREN S HOSPITAL   (Canada)

more..

Author keywords

Adverse event following immunization; Case definition; Seizure; Surveillance

Indexed keywords

INACTIVATED VACCINE; LIVE VACCINE; SUBUNIT VACCINE;

ACTIVE IMMUNIZATION; ARTICLE; BRIGHTON COLLABORATION CASE DEFINITION; CANADA; CANADIAN ADVERSE EVENT FOLLOWING IMMUNIZATION SURVEILLANCE SYSTEM; CHILD; CLINICAL ASSESSMENT; CONTROLLED STUDY; DATA ANALYSIS; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FEASIBILITY STUDY; FEBRILE CONVULSION; FEMALE; FEVER; HEALTH CARE ORGANIZATION; HOSPITALIZED CHILD; HUMAN; IMMUNIZATION MONITORING PROGRAM ACTIVE; INFANT; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; MULTICENTER STUDY; PASSIVE IMMUNIZATION; PRESCHOOL CHILD; PRIORITY JOURNAL; TONIC CLONIC SEIZURE;

ADVERSE EVENT FOLLOWING IMMUNIZATION; CASE DEFINITION; SEIZURE; SURVEILLANCE;

CANADA; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EPIDEMIOLOGICAL MONITORING; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; RETROSPECTIVE STUDIES; SEIZURES; VACCINATION; VACCINES;

EID: 84886949870     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.09.048     Document Type: Article

References (24)

1. Callreus T. Perceptions of vaccine safety in a global context. Acta Paediatr 2010, 99(2):166-171.
2. Andre F.E., Booy R., Bock H.L., Clemens J., Datta S.K., John T.J., et al. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ 2008, 86(2):140-146.
3. Zhou W., Pool V., Iskander J.K., English-Bullard R., Ball R., Wise R.P., et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS) - United States, 1991-2001. MMWR Surveill Summ 2003, 52(1):1-24.
4. Lawrence G., Menzies R., Burgess M., McIntyre P., Wood N., Boyd I., et al. Surveillance of adverse events following immunisation: Australia, 2000-2002. Commun Dis Intell Q Rep 2003, 27(3):307-323.
5. Vaccine safety: vaccine pharmacovigilance 2012, Public Health Agency of Canada, Ottawa, ON.
6. Rosenthal S., Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995, 85(12):1706-1709.
7. Monteiro S.A., Takano O.A., Waldman E.A. Surveillance for adverse events after DTwP/Hib vaccination in Brazil: sensitivity and factors associated with reporting. Vaccine 2010, 28(18):3127-3133.
8. Verstraeten T., Baughman A.L., Cadwell B., Zanardi L., Haber P., Chen R.T., et al. Enhancing vaccine safety surveillance: a capture-recapture analysis of intussusception after rotavirus vaccination. Am J Epidemiol 2001, 154(11):1006-1012.
9. Singleton J.A., Lloyd J.C., Mootrey G.T., Salive M.E., Chen R.T. An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. VAERS Working Group. Vaccine 1999, 17(22):2908-2917.
10. Scheifele D.W., Halperin S.A. Cps/Health Canada IMPA. Immunization Monitoring Program, Active: a model of active surveillance of vaccine safety. Semin Pediatr Infect Dis 2003, 14(3):213-219.
11. Martins R.M., Camacho L.A., Lemos M.C., Noronha T.G., Carvalho M.H., Greffe N., et al. Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program. J Pediatr (Rio J) 2007, 83(6):523-528.
12. Baggs J., Gee J., Lewis E., Fowler G., Benson P., Lieu T., et al. The vaccine safety datalink: a model for monitoring immunization safety. Pediatrics 2011, 127(Suppl. 1):S45-S53.
13. Le Saux N., Barrowman N.J., Moore D.L., Whiting S., Scheifele D., Halperin S., et al. Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT. Pediatrics 2003, 112(5):e348.
14. Report of adverse events following immunization (AEFI) 2012, Public Health Agency of Canada, Ottawa, ON.
15. Law B., Lafleche J. Seizures Reported to the Canadian Adverse Events Following Immunization Surveillance System: 1987-2012. 10th Canadian Immunization Conference 2012, P138.
16. Australian Technical Advisory Group on Immunisation The Australian immunisation handbook 2013, Commonwealth of Australia, Canberra. 10th ed. K. Macartney, J. Jelfs (Eds.).
17. Shui I.M., Shi P., Dutta-Linn M.M., Weintraub E.S., Hambidge S.J., Nordin J.D., et al. Predictive value of seizure ICD-9 codes for vaccine safety research. Vaccine 2009, 27(39):5307-5312.
18. Kohl K.S., Magnus M., Ball R., Halsey N., Shadomy S., Farley T.A. Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunization. Vaccine 2008, 26(50):6349-6360.
19. Bonhoeffer J., Menkes J., Gold M.S., de Souza-Brito G., Fisher M.C., Halsey N., et al. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 2004, 22(5-6):557-562.
20. Marcy S.M., Kohl K.S., Dagan R., Nalin D., Blum M., Jones M.C., et al. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine 2004, 22(5-6):551-556.
21. CIOMS/WHO Working Group on Vaccine Pharmacovigilance Definition and application of terms for vaccine pharmacovigilance 2012, WHO, Geneva.
22. Bonhoeffer J., Bentsi-Enchill A., Chen R.T., Fisher M.C., Gold M.S., Hartman K., et al. Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems. Vaccine 2009, 27(16):2289-2297.
23. Lankinen K.S., Pastila S., Kilpi T., Nohynek H., Makela P.H., Olin P. Vaccinovigilance in Europe - need for timeliness, standardization and resources. Bull World Health Organ 2004, 82(11):828-835.
24. Ackerson B.K., Sy L.S., Yao J.F., Craig Cheetham T., Espinosa-Rydman A.M., Jones T.L., et al. Agreement between medical record and parent report for evaluation of childhood febrile seizures. Vaccine 2013, 31(27):2904-2909.