Evaluating the safety of influenza vaccine using a claims-based health system.

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.

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.

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.

• Authors: Natalie L McCarthy, Julianne Gee, Nancy D Lin, Veena Thyagarajan, Yi Pan, Sue Su, Bruce Turnbull, K Arnold Chan, Eric Weintraub
• Journal: Vaccine (Vaccine) Vol. 31 Issue 50 Pg. 5975-82 (Dec 05 2013) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 24148577 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Published by Elsevier Ltd.

Chemical References

• Influenza Vaccines

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Child
• Child, Preschool
• Cohort Studies
• Drug-Related Side Effects and Adverse Reactions (epidemiology, pathology)
• Female
• Guillain-Barre Syndrome (epidemiology, pathology)
• Humans
• Incidence
• Infant
• Infant, Newborn
• Influenza Vaccines (administration & dosage, adverse effects)
• Influenza, Human (prevention & control)
• Insurance Claim Review
• Male
• Middle Aged
• Retrospective Studies
• Seizures (epidemiology, pathology)
• Young Adult