A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

Vaccine

Volumn 26, Issue 52, 2008, Pages 6800-6813

  Gidudu, Jane ^a   Kohl, Katrin S ^a   Halperin, Scott ^b   Hammer, Sandra Jo ^c   Heath, Paul T ^d   Hennig, Renald ^e   Hoet, Bernard ^f   Rothstein, Edward ^g   Schuind, Anne ^h   Varricchio, Frederick ⁱ   Walop, Wikke ^j  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b DALHOUSIE UNIVERSITY   (Canada)

^c CALIFORNIA DEPARTMENT OF PUBLIC HEALTH   (United States)

^d ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^e Pharmacovigilance Services   (Germany)

^f GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^g Pennridge Pediatric Associates   (United States)

^h GLAXOSMITHKLINE   (United States)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j PUBLIC HEALTH AGENCY OF CANADA   (Canada)

more..

Author keywords

A local reaction; Adverse event; Case definition; Guidelines; Immunization

Indexed keywords

VACCINE;

ABSCESS; ALGORITHM; ARTICLE; ATROPHY; BLEEDING; CELLULITIS; CODING; CYST; DATA ANALYSIS; DRUG SAFETY; ERYTHEMA; GRANULOMA; HEMATOMA; HUMAN; IMMUNIZATION; INFORMATION PROCESSING; INJECTION SITE REACTION; NECROSIS; PAIN; PIGMENTATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; SKIN INDURATION; SWELLING;

DATA COLLECTION; DATA INTERPRETATION, STATISTICAL; DEMOGRAPHY; DOCUMENTATION; FORMS AND RECORDS CONTROL; HUMANS; IMMUNIZATION; INJECTIONS; SAFETY; SKIN; TERMINOLOGY AS TOPIC; VACCINATION;

EID: 56949101583     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2008.10.006     Document Type: Article

References (46)

1. Zhou W., Pool V., Iskander J.K., et al. Surveillance for safety after immunization: vaccine adverse event reporting system (VAERS)-United States, 1991-2001. MMWR 52 (2003) 1-24
2. Rothstein E., Kohl K.S., 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 (2004) 575-585. http://www.brightoncollaboration.org/internet/en/index/definition_guidel ines.html Also available on the world wide web: [last accessed 17.07.07]
3. Scott H., Kohl K.S., Jane G., Leslie B., Hammer S.J., Paul H., et al. Cellulitis at injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 25 (2007) 5803-5820. http://www.brightoncollaboration.org/internet/en/index/definition_guidel ines.html Also available on the world wide web: [last accessed 17.07.07]
4. Kohl K.S., Leslie B., Jane G., Hammer S.J., Scott H., Paul H., et al. Abscess at injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 25 (2007) 5821-5838. http://www.brightoncollaboration.org/internet/en/index/definition_guidel ines.html Also available on the world wide web: [last accessed 17.07.07]
5. Kohl K.S., Wikke W., Jane G., Leslie B., Scott H., Hammer S.J., et al. Induration at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 25 (2007) 5839-5857. http://www.brightoncollaboration.org/internet/en/index/definition_guidel ines.html Also available on the world wide web: [last accessed 17.07.07]
6. Kohl K.S., Wikke W., Jane G., Leslie B., Scott H., Hammer S.J., et al. Swelling at or near injection site: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine 25 (2007) 5858-5874. http://www.brightoncollaboration.org/internet/en/index/definition_guidel ines.html Also available on the world wide web: http://www.brightoncollaboration.org/internet/en/index/definition_guidel ines.html
7. Kohl K.S., Jane G., Jan B.M., Miles B., Michael B., Robert T.C., et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine 22 (2007) 5671-5674
8. MedDRA-the Medical Dictionary for Regulatory Activities. Also available on the world wide web: [last accessed 24.03.08].
9. Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART). 5th ed. Rockville (MD): U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 1995.
10. The World Health Organization adverse event reaction terminology (WHO-ART). Also available on the world wide web at: [last accessed 24.03.2008].
11. Jason J., Archibald L.K., Nwanyanwu O.C., et al. Clinical and immune impact of Mycobacterium bovis BCG vaccination scarring. Infect Immun 70 (2002) 6188-6195
12. Zeerleder S., Hack C.E., Caliezi C., Hebeisen R., and Wuillemin W.A. Bacillus Calmete-Guerin sepsis. Shift of an intended local toward a detrimental systemic cytotoxic immune response. Blood 8 (2001) 890-891
13. Roth A., Gustafson P., Nhaga A., et al. BCG vaccination scar associated with better childhood survival in Guinea-Bissau. Int J Epidemiol 34 (2005) 540-547
14. Stavrianeas N.G., Katoulis A.C., Kanelleas A., Hatziolou E., and Georgala S. Papulonodular lichenoid and pseudolymphomatous reaction at the injection site of hepatitis B virus vaccination. Dermatology 205 (2002) 166-168
15. Froehlich H., and Verma R. Arthus reaction to recombinant hepatitis B virus vaccine. Clin Infect Dis 33 (2001) 906-908
16. Saywell C.A., Wittal R.A., and Kossard S. Lichenoid reaction to hepatitis B vaccination. Australas J Dermatol 38 (1997) 152-154
17. Gilson R.T., and Schissel D.J. Recurrent, localized urticaria and erythema multiforme: a review and management of cutaneous anthrax vaccine-related events. Cutis 73 (2004) 319-325
18. Lewis W.H., Wan K.C., and Luk S.C. Hypertrophic scar and prolonged reaction to BCG vaccination-evidence for common genetic control. Br J Biomed Sci 54 (1997) 224-225
19. Park Y.M., Kang H., Cho S.H., and Cho B.K. Lichen scrofulosorum-like eruption localized to multipuncture BCG vaccination site. J Am Acad Dermatol 41 (1999) 262-264
20. Richman S.P., Mavligit G.M., Wolk R., Gutterman J.U., and Hersh E.M. Epilesional scarification. Preliminary report of a new approach to local immunotherapy with BCG. JAMA 234 (1975) 1233-1235
21. Afari E.A., Kamiya Y., Nkrumah K., et al. Randomized controlled trial of acellular diphtheria, pertussis and tetanus vaccines in southern Ghana. Ann Trop Paediatr 16 (1996) 39-48
22. Al-Eissa Y.A. Reactogenicity and safety of meningococcal A and C vaccine in Saudi children. Ann Trop Paediatr 14 (1994) 275-279
23. Ambrosch F., Fritzell B., Gregor J., Jonas S., Kollaritsch H., Teulieres L., et al. Combined vaccination against yellow fever and typhoid fever: a comparative trial. Vaccine 12 (1994) 625-628
24. Amir J., Melamed R., Bader J., et al. Immunogenicity and safety of a liquid combination of DT-PRP-T vs lyophilized PRP-T reconstituted with DPT. Vaccine 15 (1997) 149-154
25. Andre F.E., D'Hondt E., Delem A., and Safary A. Clinical assessment of the safety and efficacy of an inactivated hepatitis A vaccine: rationale and summary of findings. Vaccine 10 (1992) 160-168
26. Annunziato P.W., Rothstein E.P., Bernstein H.H., Blatter M.M., Reisinger K.S., and Pichichero M.E. Comparison of a three-component acellular pertussis vaccine with a whole-cell pertussis vaccine in 4-through 6-year-old children. Arch Pediatr Adolesc Med 148 (1994) 503-507
27. Araujo O.O., Forleo-Neto E., Vespa G.N.R., et al. Associated or combined vaccination of Brazilian infants with a conjugate haemophilus influenzae type B (Hib) vaccine, a diphtheria-tetanus-whole-cell pertussis vaccine and IPV or OPV elicits protective levels of antibodies against Hib. Vaccine 19 (2001) 367-375
28. Aristegui J., Dal-Re R., Garrote E., Gonzalez A., Arrate J., and Perez A. Assessment of the immunogenicity and reactogenicity of a quadrivalent diphtheria, tetanus, acellular pertussis and hepatitis B (DTPa-HBV) vaccine administered in a single injection with haemophilus influenzae type b conjugate vaccine, to infants at 2, 4, and 6 months of age. Vaccine 16 (1998) 1976-1981
29. Auerbach B.S., Lake A.M., Wilson M.E., et al. Dose-response to a two component acellular pertussis vaccine in infants and comparison with whole-cell vaccine. Biologicals 26 (1998) 145-153
30. Blum M.D., Dagan R., Mendelman P.M., et al. A comparison of multiple regimens of pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine and pneumococcal polysaccharide vaccine in toddlers. Vaccine 18 (2000) 2359-2367
31. Feery B.J., Finger W.K., Kortus Z., and Jones G.A. The incidence and type of reactions to plain and adsorbed DTP vaccines. Aust Paediatr J 21 (1998) 91-95
32. Rothstein E.P., Kamiya H., Nii R., et al. Comparison of diphtheria-tetanus-two component acellular pertussis vaccines in United States and Japanese infants at 2, 4, and 6 months of age. Pediatrics 97 (1996) 236-242
33. Feldman S., Perry S., Andrew M., Jones L., and Moffitt J.E. Comparison of acellular 9B type and whole-cell pertussis-component diphtheria-tetanus-pertussis vaccines as the first booster immunization in 15- to 24-month-old children. J Pediatr 121 (1993) 857-861
34. Bell F., Heath P., MacLennan J., et al. Adverse effects and sero-response to an acellular pertussis/diphtheria/tetanus vaccine when combined with Haemophilus influenzae type b vaccine in an accelerated schedule. Eur J Pediatr 158 (1999) 329-336
35. Beyer W.E., Palache A.M., Kerstens R., and Masurel N. Gender differences in local and systemic reactions to inactivated influenza vaccine, established by a meta-analysis of fourteen independent studies. Eur J Clin Microbiol Infect Dis 15 (1996) 65-70
36. Deloria M.A., Blackwelder W.C., Decker M.D., et al. Association of reactions after consecutive acellular or whole-cell pertussis vaccine immunizations. Pediatrics 96 (1995) 592-594
37. Pichichero M.E., Edwards K.M., Anderson E.L., et al. Safety and immunogenicity of six 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-e111
38. Pichichero M.E., Blatter M.M., Kennedy W.A., Hedrick J., Descamps D., and Friedland L.R. Acellular pertussis vaccine booster combined with diphtheria and tetanus toxoids for adolescents. Pediatrics 117 (2006) 1084-1093
39. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidelines for clinical safety assessment (E2a-e). Available on the world wide web: [last accessed 09.02.08].
40. Council for International Organizations of Medical Sciences (CIOMS). Reporting form for international reporting of adverse drug reactions. Available on the world wide web: [last accessed 09.02.2006].
41. CDC. Guidelines for maintaining and managing the vaccine cold chain. MMWR 52 (2003) 1023-1025. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5242a6.htm Available on the world wide web at: [accessed 26.01.08].
42. CDC. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 55 15 (2006) 1-48. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm%3Fs_cid=rr5515a1_e %250d%250a Available on the world wide web at: [accessed 26.01.08]
43. Moher D., Schulz K.F., Altman D., and CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285 (2001) 1987-1991. http://www.consort-statement.org/Initiatives/complements.htm Available on the world wide web at: [last accessed 28.02.08]
44. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomized controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 1999;354:1896-900. Available on the world wide web: [last accessed 28.03.06].
45. Stroup D.F., Berlin J.A., Morton S.C., Olkin I., Williamson G.D., Rennie D., et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 283 (2000) 2008-2012. http://www.consort-statement.org/Initiatives/complements.htm Available on the world wide web at: [last accessed 28.02.08]
46. Beigel J, Kohl KS, Khuri-Bulos N, Bravo L, Nell P, Marcy SM, et al. Rash including mucosal involvement: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2007; 25:5697-706. Also available on the world wide web: http://www.brightoncollaboration.org/internet/en/index/definition_guidel ines.html [last accessed 17.07.07].