Persistent crying in infants and children as an adverse event following immunization: Case definition and guidelines for data collection, analysis, and presentation

Vaccine

Volumn 22, Issue 5-6, 2004, Pages 586-591

  Bonhoeffer, Jan ^a   Vermeer, Patricia ^b   Halperin, Scott ^c   Kempe, Anne ^d   Music, Stanley ^e   Shindman, Judy ^f   Walop, Wikke ^g  

^a UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^c DALHOUSIE UNIVERSITY   (Canada)

^d Paediatric Rehabilitation Department Women s and Children s Hospital Campus   (Australia)

^e MERCK RESEARCH LABORATORIES   (United States)

^f Aventis Pasteur Ltd   (Canada)

^g HEALTH CANADA   (Canada)

Author keywords

Adverse events following immunization; Case definition; Crying; Guidelines

Indexed keywords

INACTIVATED VACCINE; LIVE VACCINE; TUMOR VACCINE;

CHILD; CLINICAL FEATURE; CONCEPT FORMATION; CRYING; DATA ANALYSIS; FOLLOW UP; HEALTH STATUS; HUMAN; IMMUNIZATION; INFANT; INFORMATION PROCESSING; PERSISTENT CRYING; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; SAFETY; TIME; VACCINATION REACTION;

EID: 1642575060     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2003.09.006     Document Type: Article

References (19)

1. Johnston C.C., Strada M.A. Acute pain response in infants: a multidimensional description. Pain. 24:1986;373-382.
2. Pellissier J.M., Coplan P.M., Jackson L.A., May J.E. The effect of additional shots on the Vaccine Administration Process: results of a time-motion study in 2 settings. Am. J. Man Care. 6:2000;1038-1044.
3. Cody C.L., Baraff L.J., Cherry J.D., Marcy S.M., Manclark C.R. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children. Pediatrics. 68:1981;650-660.
4. Amir J., Melemed R., Bader J.et al. Immunogenizity and safety of a liquid combination of DTPRP-T vs. lyophilized PRP-t reconstituted with DTP. Vaccine. 15:1997;149-154.
5. Baraff L.J., Manclark C.R., Cherry J.D.et al. Analyses of adverse reactions to diphtheria and tetanus toxoids and pertussis vaccine by vaccine lot, endotoxin content, pertussis vaccine potency and percentage of mouse weight gain. Pediatr. Infect. Dis. J. 8(8):1989;502-507.
6. Englund J., Glezen W., Barreto L. Controlled study of a new five component acellular pertussis vaccine in adults and young children. J. Infect. Dis. 166:1992;1436-1441.
7. Feery B. Incidence and type of reactions to triple antigen (DTP vaccine) and CDT vaccine (DT vaccine). Med. J. Aust. 2:1982;511-515.
8. Mallet E., Fabre P., Pines E.et al. Hexavalent vaccine trial study group. Immunogenicity and safetyof a new liquid hexavalent combined vaccine compared with separate administration of reference licenced vaccines in infants. Pediatr. Infect Dis. J. 19:2000;1119-1127.
9. Vermeer-de Bondt PE, Labadie J, Rumke HC. Adverse events following immunisations under the National Vaccination Programme of The Netherlands. Part II-reports in 1995. RIVM, Bilthoven, The Netherlands.
10. Blumberg D.A., Morgan C.A., Lewis K.et al. An ongoing surveillance study of persistent crying and hypotonic-hyporesponsive episodes following routine DTP immunization: a preliminary report. Tokai. J. Exp. Clin. Med. 131:1988;133-136.
11. Blumberg D.A., Lewis K., Mink C.M., Christenson P.D., Chatfield P., Cherry J.D. Severe reactions associated with diphtheria-tetanus-pertussis vaccine: detailed study of children with seizures, hypotonic-hyporesponsive episodes, high fevers, and persistent crying. Pediatrics. 91:1993;1158-1165.
12. Howson C, How C, Fineberg H. Adverse effects of pertussis and rubella vaccines. A [IOM] report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. National Academy Press, Washington, DC, 1991.
13. Long S.S., Deforest A., Smith D.G., Lazaro C., Wassilak G.F. Longitudinal study of adverse reactions following diphtheria-tetanus-pertussis vaccine in infancy. Pediatrics. 85:1990;294-302.
14. Pichiero M.E., Edwards K.M., Anderson E.L.et al. Safety and immunogenicity of 6 acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four to six year old children. Pediatrics. 105:2000;e11.
15. Langue J., Ethevenaux C., Champsaur A., Bégué P., Saliou P. Safety and immunogenicity of Haemophilus influenzae type b-tetanus toxoid conjugate. Eur. J. Pediatrics. 158:1999;717-722.
16. Dagan R., Melamed R., Zamir O.et al. Safety and immunogenicity of tetravalent pneumacoccal vaccines containing 6B, 14, 19F, and 23F polysacharides conjugated to either tetanus toxoid or diphtheria toxoid in young infants and their boosterability by native polysacharide antigens. Pediatr. Infect Dis. J. 16:1997;1053-1059.
17. Gold R., Scheiffele D., Barreto L.et al. Safety and immunogenicity of Haemophilus influenzae vaccine (tetanus toxoid conjugate) administered concurrently or combined with diphtheria and tetanus toxoids, pertussis vaccine and inactivated poliomyelitis vaccine to healthy infants at 2, 4 and 6 months of age. Pediatr. Infect Dis. J. 13:1994;348-355.
18. Reijneveld S.A., Brugman E., Hirasing R.A. Excessive infant crying: the impact of varying definitions. Pediatrics. 108:2001;893-997.
19. The CONSORT statement and MOOSE, available at: http://www.consort- statement.org/ .