Adverse events following yellow fever preventive vaccination campaigns in eight African countries from 2007 to 2010

Vaccine

Volumn 31, Issue 14, 2013, Pages 1819-1829

  Breugelmans, J G ^a   Lewis, R F ^b   Agbenu, E ^c   Veit, O ^b   Jackson, D ^d   Domingo, C ^e   Bothe M ^e   Perea, W ^b   Niedrig, M ^e   Gessner, B D ^a   Yactayo, S ^b  

^a Agence de Medecine Preventive   (France)

^b Global Alert and Response (HSE/GAR)   (Switzerland)

^c UNIVERSITY OF LOMÉ   (Togo)

^d New Level Thinking   (Canada)

^e ROBERT KOCH INSTITUTE   (Germany)

Author keywords

Adverse event; Adverse event following immunization; Unified database; Vaccine safety; Yellow fever; Yellow Fever Initiative; Yellow fever vaccine; Yellow fever vaccine associated neurologic disease; Yellow fever vaccine associated viscerotropic disease; Yellow fever vaccine safety

Indexed keywords

YELLOW FEVER VACCINE;

ABDOMINAL PAIN; ADOLESCENT; ADULT; ADVERSE DRUG REACTION; AGED; AIRWAY OBSTRUCTION; ANAPHYLACTIC SHOCK; ANOREXIA; ARTICLE; BENIN; BLEEDING; CAMEROON; CHILD; COMA; CONVULSION; DIZZINESS; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SURVEILLANCE PROGRAM; DYSPNEA; EDEMA; FACIAL NERVE PARALYSIS; GUINEA; HEALTH PROGRAM; HUMAN; INCIDENCE; INFECTION PREVENTION; JAUNDICE; LEG EDEMA; LIBERIA; MAJOR CLINICAL STUDY; MALI; MENTAL HEALTH; MUSCLE SPASM; MUSCLE WEAKNESS; NAUSEA; PAIN; PRESCHOOL CHILD; PRIORITY JOURNAL; PRURITUS; RESPIRATORY DISTRESS; SCHOOL CHILD; SENEGAL; SIDE EFFECT; SIERRA LEONE; TOGO; ULCER; UNCONSCIOUSNESS; URTICARIA; VACCINATION; VOMITING; YELLOW FEVER;

ADULT; AFRICA; AGED; CHILD, PRESCHOOL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; INFANT; MALE; MASS VACCINATION; MIDDLE AGED; PHARMACOVIGILANCE; YELLOW FEVER; YELLOW FEVER VACCINE; YOUNG ADULT;

EID: 84875266874     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.01.054     Document Type: Article

References (41)

1. World Health Organization Yellow Fever Initiative - Providing an opportunity of a lifetime. 2010. WHO/HSE/GAR/ERI/2010.3 [accessed 6.01.13]. http://www.who.int/csr/disease/yellowfev/brochure/en/index.html.
2. Martin M., Tsai T.F., Cropp B., Chang G.J., Holmes D.A., Tseng J., et al. Fever and multisystem organ failure associated with 17D-204 yellow fever vaccination: a report of four cases. Lancet 2001, 358(9276):98-104.
3. Chan R.C., Penney D.J., Little D., Carter I.W., Roberts J.A., Rawlinson W.D. Hepatitis and death following vaccination with 17D-204 yellow fever vaccine. Lancet 2001, 358(9276):121-122.
4. Vasconcelos P.F., Luna E.J., Galler R., Silva L.J., Coimbra T.L., Barros V.L., et al. Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases. Lancet 2001, 358(9276):91-97.
5. Centers for Disease Control and Prevention Adverse events associated with 17D-derived yellow fever vaccination-United States, 2001-2002. MMWR Morb Mortal Wkly Rep 2002 November 8;51(44):989-93.
6. Belsher J.L., Gay P., Brinton M., DellaValla J., Ridenour R., Lanciotti R., et al. Fatal multiorgan failure due to yellow fever vaccine-associated viscerotropic disease. Vaccine 2007, 25(50):8480-8485.
7. Doblas A., Domingo C., Bae H.G., Bohorquez C.L., de Ory F., Niedrig M., et al. Yellow fever vaccine-associated viscerotropic disease and death in Spain. J Clin Virol 2006, 36(2):156-158.
8. Centers for Disease Control and Prevention Yellow fever vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2010 July 30;59(RR-7):1-27.
9. McMahon A.W., Eidex R.B., Marfin A.A., Russell M., Sejvar J.J., Markoff L., et al. Neurologic disease associated with 17D-204 yellow fever vaccination: a report of 15 cases. Vaccine 2007, 25(10):1727-1734.
10. Domingo C., Niedrig M. Safety of 17D derived yellow fever vaccines. Expert Opin Drug Saf 2009, 8(2):211-221.
11. Khromava A.Y., Eidex R.B., Weld L.H., Kohl K.S., Bradshaw R.D., Chen R.T., et al. Yellow fever vaccine: an updated assessment of advanced age as a risk factor for serious adverse events. Vaccine 2005, 23(25):3256-3263.
12. Lindsey N.P., Schroeder B.A., Miller E.R., Braun M.M., Hinckley A.F., Marano N., et al. Adverse event reports following yellow fever vaccination. Vaccine 2008, 26(48):6077-6082.
13. Martins R.M., Maia M.L.S., Santos E.M., Cruz R.L.S., Santos P.R.G., Carvalho S.M.D., et al. Yellow fever vaccine post-marketing surveillance in Brazil. Procedia Vaccinol 2010, 2(2):178-183.
14. World Health Organization Surveillance of adverse events following immunization against yellow fever: field guide for staff at the central, intermediate and peripheral level, 2010. 2010. Available on the world wide web: [last accessed 6.01.13]. http://whqlibdoc.who.int/hq/2010/WHO_HSE_GAR_ERI_2010.1_eng.pdf.
15. ICH Harmonised Tripartite guidelines. Clinical safety data management: definitions and standards for expedited reporting E2A. 1994. Available on the world wide web: [last accessed 6.01.13]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf.
16. World Health Organization Immunization safety surveillance: guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. 1999. Available on the world wide web: [last accessed 6.01.13]. http://www.who.int/immunization_safety/publications/aefi/en/AEFI_WPRO.pdf.
17. World Health Organization Detection and investigation of serious adverse events following yellow fever vaccination: guidance from an informal consultation of experts, 18-19 November 2008, Geneva, Switzerland, 2010. Available on the world wide web: [last accessed 6.01.13]. http://whqlibdoc.who.int/hq/2010/WHO_HSE_GAR_ERI_2010.2_eng.pdf.
18. Centers for Disease Control and Prevention and the Food and Drug Administration Vaccine Adverse Event Reporting System (VAERS). [last accessed 6.01.2013]. http://vaers.hhs.gov/index.
19. Rüggeberg J.U., Gold M.S., Bayas J-M., Blum M.D., Bonhoeffer J., Friedlander S., et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine 2007, 25(31):5675-5684.
20. Tapiainen T., Prevots R., Izurieta H.S., Abramson J., Bilynsky R., Bonhoeffer J., et al. Aseptic meningitis: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine 2007, 25(31):5793-5802.
21. Sejvar J.J., Kohl K.S., Bilynsky R., Blumberg D., Cvetkovich T., Galama J., et al. Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2007, 25(31):5771-5792.
22. Gershman M.D., Staples J.E., tsi-Enchill A.D., Breugelmans J.G., Brito G.S., Bastos Camacho L.A., et al. Viscerotropic disease: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2012, 30(33):5038-5058.
23. Domingo C., Patel P., Yillah J., Weidmann M., Mendez J.A., Nakoune E.R., et al. Advanced yellow fever virus genome detection in point-of-care facilities and reference laboratories. J Clin Microbiol 2012, 50(12):4054-4060.
24. Bae H.G., Nitsche A., Teichmann A., Biel S.S., Niedrig M. Detection of yellow fever virus: a comparison of quantitative real-time PCR and plaque assay. J Virol Methods 2003, 110(2):185-191.
25. Reinhardt B., Jaspert R., Niedrig M., Kostner C., L'age-Stehr J. Development of viremia and humoral and cellular parameters of immune activation after vaccination with yellow fever virus strain 17D: a model of human flavivirus infection. J Med Virol 1998, 56(2):159-167.
26. Niedrig M., Lademann M., Emmerich P., Lafrenz M. Assessment of IgG antibodies against yellow fever virus after vaccination with 17D by different assays: neutralization test, haemagglutination inhibition test, immunofluorescence assay and ELISA. Trop Med Int Health 1999, 4(12):867-871.
27. Niedrig M., Kursteiner O., Herzog C., Sonnenberg K. Evaluation of an indirect immunofluorescence assay for detection of immunoglobulin M (IgM) and IgG antibodies against yellow fever virus. Clin Vaccine Immunol 2008, 15(2):177-181.
28. Bae H.G., Domingo C., Tenorio A., de Ory F., Munoz J., Weber P., et al. Immune response during adverse events after 17D-derived yellow fever vaccination in Europe. J Infect Dis 2008, 197(11):1577-1584.
29. Scaramozzino N., Crance J.M., Jouan A., DeBriel D.A., Stoll F., Garin D. Comparison of flavivirus universal primer pairs and development of a rapid, highly sensitive heminested reverse transcription-PCR assay for detection of flaviviruses targeted to a conserved region of the NS5 gene sequences. J Clin Microbiol 2001, 39(5):1922-1927.
30. Casas I., Tenorio A., Echevarria J.M., Klapper P.E., Cleator G.M. Detection of enteroviral RNA and specific DNA of herpesviruses by multiplex genome amplification. J Virol Methods 1997, 66(1):39-50.
31. Grywna K., Kupfer B., Panning M., Drexler J.F., Emmerich P., Drosten C., et al. Detection of all species of the genus Alphavirus by reverse transcription-PCR with diagnostic sensitivity. J Clin Microbiol 2010, 48(9):3386-3387.
32. Demby A.H., Chamberlain J., Brown D.W., Clegg C.S. Early diagnosis of Lassa fever by reverse transcription-PCR. J Clin Microbiol 1994, 32(12):2898-2903.
33. Kitchener S. Viscerotropic and neurotropic disease following vaccination with the 17D yellow fever vaccine, ARILVAX. Vaccine 2004, 22(17-18):2103-2105.
34. Guimard T., Minjolle S., Polard E., Fily F., Zeller H., Michelet C., et al. Short report: incidence of yellow fever vaccine-associated neurotropic disease. Am J Trop Med Hyg 2009, 81(6):1141-1143.
35. Fitzner J., Coulibaly D., Kouadio D.E., Yavo J.C., Loukou Y.G., Koudou P.O., et al. Safety of the yellow fever vaccine during the September 2001 mass vaccination campaign in Abidjan, Ivory Coast. Vaccine 2004, 23(2):156-162.
36. Monath T., Cetron M.S., Teuwen D.E. Yellow fever vaccine. Vaccines 2008, 959-1055. Saunders Elsevier, Philadelphia, Pa. 5th ed. S.A. Plotkin, W.A. Orenstein, P.A. Offit (Eds.).
37. World Health Organization Yellow fever vaccine. WHO posiiton paper. Weekly Epidemiological Record 2003; 40 (78) 349-360.
38. Central Intelligence Agency The World Factbook. Available on the world wide web: [last accessed 6.01.13]. https://www.cia.gov/library/publications/the-world-factbook.
39. Monath T.P. Neutralizing antibody responses in the major immunoglobulin classes to yellow fever 17D vaccination of humans. Am J Epidemiol 1971, 93(February (2)):122-129.
40. Nacher M. Interactions between worm infections and malaria. Clin Rev Allergy Immunol 2004, 26(2):85-92.
41. World Health Organization WHO Programme for International Drug Monitoring. Available on the world wide web: [last accessed 6.01.13]. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/National_PV_Centres_Map/en/index.html.