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The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis.
Vaccine. 2012 Mar 09; 30(12):2168-72.V

Abstract

Adverse events following pandemic (H1N1) 2009 vaccines ("2009 H1N1 vaccines") in Taiwan were passively reported to the National Adverse Drug Reaction Reporting System. To evaluate the completeness of spontaneous reporting, cases of death, Guillain-Barré syndrome (GBS), convulsion, Bell's palsy, and idiopathic thrombocytopenic purpura (ITP) after 2009 H1N1 vaccination that occurred between November 1, 2009 and August 31, 2010 were selected from the National Adverse Drug Reaction Reporting System (NADRRS) database and an additionally constructed nationwide large-linked database (LLDB), and matched on a unique personal identifier, date of vaccination (within ±7 days), and date of diagnosis (within ±7 days). Overall, matches occurred between the two data sources included 21 for death, 5 for GBS, 19 for convulsion, 22 for Bell's palsy, and 5 for ITP. The Chapman capture-recapture estimated spontaneous reporting completeness within 0-42 days of vaccination was 4% for death, 71% for GBS, 3% for convulsion, 9% for Bell's palsy, and 15% for ITP. For the interval ≥43 days after vaccination, reporting completeness was 0.1% for death, 14% for GBS, 0.1% for convulsion, <0.1% for Bell's palsy, and 0% for ITP. The estimated-to-expected ratio for Bell's palsy in the interval 0-42 days after vaccination was 1.48 (95% CI 1.11-1.98). Reporting completeness was higher for GBS than other adverse events after 2009 H1N1 vaccination. Linking the NADRRS to existing data sources in a capture-recapture analysis can be considered as an alternative to enhance Taiwan's postlicensure safety assessment of other routine vaccines. Nevertheless, the possibility of an increased risk for Bell's palsy detected by capture-recapture analyses needs further evaluation by controlled studies.

Authors+Show Affiliations

Epidemic Intelligence Center, Taiwan Centers for Disease Control, Taipei, Taiwan. muagi@cdc.gov.twNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22265861

Citation

Huang, Wan-Ting, et al. "The Reporting Completeness of a Passive Safety Surveillance System for Pandemic (H1N1) 2009 Vaccines: a Capture-recapture Analysis." Vaccine, vol. 30, no. 12, 2012, pp. 2168-72.
Huang WT, Huang WI, Huang YW, et al. The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. Vaccine. 2012;30(12):2168-72.
Huang, W. T., Huang, W. I., Huang, Y. W., Hsu, C. W., & Chuang, J. H. (2012). The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. Vaccine, 30(12), 2168-72. https://doi.org/10.1016/j.vaccine.2012.01.013
Huang WT, et al. The Reporting Completeness of a Passive Safety Surveillance System for Pandemic (H1N1) 2009 Vaccines: a Capture-recapture Analysis. Vaccine. 2012 Mar 9;30(12):2168-72. PubMed PMID: 22265861.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. AU - Huang,Wan-Ting, AU - Huang,Wei-I, AU - Huang,Yu-Wen, AU - Hsu,Chien-Wen, AU - Chuang,Jen-Hsiang, Y1 - 2012/01/17/ PY - 2011/10/18/received PY - 2012/01/05/revised PY - 2012/01/05/accepted PY - 2012/1/24/entrez PY - 2012/1/24/pubmed PY - 2012/6/23/medline SP - 2168 EP - 72 JF - Vaccine JO - Vaccine VL - 30 IS - 12 N2 - Adverse events following pandemic (H1N1) 2009 vaccines ("2009 H1N1 vaccines") in Taiwan were passively reported to the National Adverse Drug Reaction Reporting System. To evaluate the completeness of spontaneous reporting, cases of death, Guillain-Barré syndrome (GBS), convulsion, Bell's palsy, and idiopathic thrombocytopenic purpura (ITP) after 2009 H1N1 vaccination that occurred between November 1, 2009 and August 31, 2010 were selected from the National Adverse Drug Reaction Reporting System (NADRRS) database and an additionally constructed nationwide large-linked database (LLDB), and matched on a unique personal identifier, date of vaccination (within ±7 days), and date of diagnosis (within ±7 days). Overall, matches occurred between the two data sources included 21 for death, 5 for GBS, 19 for convulsion, 22 for Bell's palsy, and 5 for ITP. The Chapman capture-recapture estimated spontaneous reporting completeness within 0-42 days of vaccination was 4% for death, 71% for GBS, 3% for convulsion, 9% for Bell's palsy, and 15% for ITP. For the interval ≥43 days after vaccination, reporting completeness was 0.1% for death, 14% for GBS, 0.1% for convulsion, <0.1% for Bell's palsy, and 0% for ITP. The estimated-to-expected ratio for Bell's palsy in the interval 0-42 days after vaccination was 1.48 (95% CI 1.11-1.98). Reporting completeness was higher for GBS than other adverse events after 2009 H1N1 vaccination. Linking the NADRRS to existing data sources in a capture-recapture analysis can be considered as an alternative to enhance Taiwan's postlicensure safety assessment of other routine vaccines. Nevertheless, the possibility of an increased risk for Bell's palsy detected by capture-recapture analyses needs further evaluation by controlled studies. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22265861/The_reporting_completeness_of_a_passive_safety_surveillance_system_for_pandemic__H1N1__2009_vaccines:_a_capture_recapture_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00028-X DB - PRIME DP - Unbound Medicine ER -