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Evaluating the safety of influenza vaccine using a claims-based health system.
- Source :
-
Vaccine [Vaccine] 2013 Dec 05; Vol. 31 (50), pp. 5975-82. Date of Electronic Publication: 2013 Oct 19. - Publication Year :
- 2013
-
Abstract
- 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.<br />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-Barré 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.<br />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.<br />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.<br /> (Published by Elsevier Ltd.)
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Child
Child, Preschool
Cohort Studies
Female
Guillain-Barre Syndrome epidemiology
Guillain-Barre Syndrome pathology
Humans
Incidence
Infant
Infant, Newborn
Insurance Claim Review
Male
Middle Aged
Retrospective Studies
Seizures epidemiology
Seizures pathology
Young Adult
Drug-Related Side Effects and Adverse Reactions epidemiology
Drug-Related Side Effects and Adverse Reactions pathology
Influenza Vaccines administration & dosage
Influenza Vaccines adverse effects
Influenza, Human prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2518
- Volume :
- 31
- Issue :
- 50
- Database :
- MEDLINE
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 24148577
- Full Text :
- https://doi.org/10.1016/j.vaccine.2013.10.031