https://scholars.lib.ntu.edu.tw/handle/123456789/375896
標題: | Evaluating the safety of influenza vaccine using a claims-based health system | 作者: | Kin-Wei Chan McCarthy, Natalie L. Gee, Julianne Lin, Nancy D. Thyagarajan, Veena Pan, Yi Su, Sue Turnbull, Bruce Chan, K. Arnold Weintraub, Eric |
關鍵字: | Claims; H1N1; Influenza; Vaccine safety | 公開日期: | 2013 | 卷: | 31 | 期: | 50 | 起(迄)頁: | 5975-5982 | 來源出版物: | Vaccine | 摘要: | Introduction: As part of the Centers for Disease Control and Prevention's monitoring and evaluation activities for influenza vaccines, we examined relationships between influenza vaccination and selected outcomes in the 2009-2010 and 2010-2011 influenza seasons in a claims-based data environment. Methods: We included patients with claims for trivalent influenza vaccine (TIV) and/or 2009 pandemic influenza A H1N1 vaccine (H1N1) during the 2009-2010 and 2010-2011 influenza seasons. Patients were followed for several pre-specified outcomes identified in claims. Seizures and Guillain-Barr? Syndrome were selected a priori for medical record confirmation. We estimated incidence rate ratios (IRR) using a self-controlled risk interval (SCRI) or a historical comparison design. Outcomes with elevated IRRs, not selected a priori for medical record review, were further investigated with review of claims histories surrounding the outcome date to determine whether the potential event could be ruled-out or attributed to other causes based on the pattern of medical care. Results: In the 2009-2010 season, no significant increased risks for outcomes following H1N1 vaccination were observed. Following TIV administration, the IRR for peripheral nervous system disorders and neuropathy was slightly elevated (1.07, 95% CI: 1.01-1.13). The IRR for anaphylaxis following TIV was 28.55 (95% CI: 3.57-228.44). After further investigation of claims histories, the majority of potential anaphylaxis cases had additional claims around the time of the event indicating alternate explanatory factors or diagnoses. In the 2010-2011 season following TIV administration, a non-significant elevated IRR for anaphylaxis was observed with no other significant outcome findings. Conclusion: After claims history review, we ultimately found no increased outcome risk following administration of 998,881 TIV and 538,257 H1N1 vaccine doses in the 2009-2010 season, and 1,158,932 TIV doses in the 2010-2011 season. ? 2013. |
URI: | http://www.scopus.com/inward/record.url?eid=2-s2.0-84887606858&partnerID=MN8TOARS http://scholars.lib.ntu.edu.tw/handle/123456789/375896 |
DOI: | 10.1016/j.vaccine.2013.10.031 | SDG/關鍵字: | influenza vaccine; 2009 H1N1 influenza; adolescent; adult; anaphylaxis; angioneurotic edema; article; ataxia; Bell palsy; brain hemorrhage; brain ischemia; cataplexy; child; cohort analysis; cranial neuropathy; demyelinating disease; drug hypersensitivity; encephalitis; encephalomyelitis; Guillain Barre syndrome; health insurance; human; incidence; infant; influenza vaccination; Influenza virus A H1N1; major clinical study; medical record review; myelitis; myocarditis; narcolepsy; outcome assessment; pericarditis; peripheral neuropathy; preschool child; priority journal; retrospective study; school child; seasonal influenza; seasonal variation; seizure; United States; urticaria; Claims; H1N1; Influenza; Vaccine safety; Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Cohort Studies; Drug-Related Side Effects and Adverse Reactions; Female; Guillain-Barre Syndrome; Humans; Incidence; Infant; Infant, Newborn; Influenza Vaccines; Influenza, Human; Insurance Claim Review; Male; Middle Aged; Retrospective Studies; Seizures; Young Adult |
顯示於: | 醫學系 |
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