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Guillain-Barré syndrome following receipt of influenza A (H1N1) 2009 monovalent vaccine in Korea with an emphasis on Brighton Collaboration case definition.
Vaccine. 2011 Mar 03; 29(11):2066-70.V

Abstract

BACKGROUND

In 2009-2010 season, with ongoing of influenza A (H1N1), employment of mass vaccination has generated concerns in issue of adverse events following immunization (AEFI). This study investigates the clinical and laboratory data of reported cases of Guillain-Barré syndrome (GBS) and Fisher syndrome (FS) following receipt of influenza A (H1N1) 2009 monovalent vaccine to the National Vaccine Injury Compensation Program (NVICP) in Korea, with all cases reviewed under case definition developed by Brighton Collaboration GBS Working Group.

METHOD

Retrospective review of medical records for all suspected cases of GBS ad FS following receipt of influenza A (H1N1) monovalent vaccine reported to NVICP from December 1, 2009, through April 28, 2010 was conducted. Additional analyses were performed for identification of levels of diagnostic certainty according to Brighton Collaboration case definition.

RESULT

Of 29 reported cases, 22 were confirmed to meet Brighton criteria level 1, 2, or 3 for GBS (21) or FS (1). Of those, 2 (9.1%) met level 1, 9 (40.9%) met level 2, and 11 (50.0%) met level 3. The male to female ratio was 2:0 in cases with level 1, 8:1 in cases with level 2, and 3:8 in cases with level 3. The mean age was older in cases with level 1 (54.0 ± 26.9) than that of cases with level 2 (25.6 ± 22.8), and level 3 (13.6 ± 2.4, P=0.005). The median onset interval was longer in cases with level 1 (16 days) than that of cases that met level 2 (12.44 days), and 3 (1.09 days, P=0.019).

CONCLUSION

The Brighton case definition was used to improve the quality of AEFI data in Korea, and was applicable in retrospective review of medical records in cases with GBS and FS after influenza A (H1N1) vaccination. These findings suggest that standardized case definition was feasible in clarifying the AEFI data, and to further increase the understanding of possible relationship of influenza vaccine and GBS.

Authors+Show Affiliations

Division of Vaccine Preventable Disease Control and National Immunization Program, Korea Centers for Disease Control and Prevention, Osong Health Technology Administration Complex, Pepublic of Korea. choeyj@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21255684

Citation

Choe, Young June, et al. "Guillain-Barré Syndrome Following Receipt of Influenza a (H1N1) 2009 Monovalent Vaccine in Korea With an Emphasis On Brighton Collaboration Case Definition." Vaccine, vol. 29, no. 11, 2011, pp. 2066-70.
Choe YJ, Cho H, Bae GR, et al. Guillain-Barré syndrome following receipt of influenza A (H1N1) 2009 monovalent vaccine in Korea with an emphasis on Brighton Collaboration case definition. Vaccine. 2011;29(11):2066-70.
Choe, Y. J., Cho, H., Bae, G. R., & Lee, J. K. (2011). Guillain-Barré syndrome following receipt of influenza A (H1N1) 2009 monovalent vaccine in Korea with an emphasis on Brighton Collaboration case definition. Vaccine, 29(11), 2066-70. https://doi.org/10.1016/j.vaccine.2011.01.007
Choe YJ, et al. Guillain-Barré Syndrome Following Receipt of Influenza a (H1N1) 2009 Monovalent Vaccine in Korea With an Emphasis On Brighton Collaboration Case Definition. Vaccine. 2011 Mar 3;29(11):2066-70. PubMed PMID: 21255684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Guillain-Barré syndrome following receipt of influenza A (H1N1) 2009 monovalent vaccine in Korea with an emphasis on Brighton Collaboration case definition. AU - Choe,Young June, AU - Cho,Heeyeon, AU - Bae,Geun-Ryang, AU - Lee,Jong-Koo, Y1 - 2011/01/19/ PY - 2010/11/08/received PY - 2011/01/04/revised PY - 2011/01/05/accepted PY - 2011/1/25/entrez PY - 2011/1/25/pubmed PY - 2011/6/18/medline SP - 2066 EP - 70 JF - Vaccine JO - Vaccine VL - 29 IS - 11 N2 - BACKGROUND: In 2009-2010 season, with ongoing of influenza A (H1N1), employment of mass vaccination has generated concerns in issue of adverse events following immunization (AEFI). This study investigates the clinical and laboratory data of reported cases of Guillain-Barré syndrome (GBS) and Fisher syndrome (FS) following receipt of influenza A (H1N1) 2009 monovalent vaccine to the National Vaccine Injury Compensation Program (NVICP) in Korea, with all cases reviewed under case definition developed by Brighton Collaboration GBS Working Group. METHOD: Retrospective review of medical records for all suspected cases of GBS ad FS following receipt of influenza A (H1N1) monovalent vaccine reported to NVICP from December 1, 2009, through April 28, 2010 was conducted. Additional analyses were performed for identification of levels of diagnostic certainty according to Brighton Collaboration case definition. RESULT: Of 29 reported cases, 22 were confirmed to meet Brighton criteria level 1, 2, or 3 for GBS (21) or FS (1). Of those, 2 (9.1%) met level 1, 9 (40.9%) met level 2, and 11 (50.0%) met level 3. The male to female ratio was 2:0 in cases with level 1, 8:1 in cases with level 2, and 3:8 in cases with level 3. The mean age was older in cases with level 1 (54.0 ± 26.9) than that of cases with level 2 (25.6 ± 22.8), and level 3 (13.6 ± 2.4, P=0.005). The median onset interval was longer in cases with level 1 (16 days) than that of cases that met level 2 (12.44 days), and 3 (1.09 days, P=0.019). CONCLUSION: The Brighton case definition was used to improve the quality of AEFI data in Korea, and was applicable in retrospective review of medical records in cases with GBS and FS after influenza A (H1N1) vaccination. These findings suggest that standardized case definition was feasible in clarifying the AEFI data, and to further increase the understanding of possible relationship of influenza vaccine and GBS. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/21255684/Guillain_Barré_syndrome_following_receipt_of_influenza_A__H1N1__2009_monovalent_vaccine_in_Korea_with_an_emphasis_on_Brighton_Collaboration_case_definition_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)00023-5 DB - PRIME DP - Unbound Medicine ER -