The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barré syndrome
Section snippets
Background
The Vaccine Adverse Event Reporting System (VAERS) was authorized by the National Childhood Vaccine Injury Act of 1986 [1]. Co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), VAERS is a national spontaneous reporting (passive surveillance) system for monitoring U.S.-licensed vaccines. VAERS accepts reports of adverse events (AEs) following vaccination from healthcare providers, vaccine manufacturers, and the general public [1]
Methods
In the current analysis, we estimate VAERS reporting sensitivity, meaning the percentage of actual vaccine AEs that VAERS is able to capture. We calculated VAERS reporting sensitivity for two distinct AEs which are very different in terms of the expected onset intervals: 1) anaphylaxis after seven different vaccines, and 2) Guillain-Barré syndrome (GBS) after the 2009 H1N1 inactivated pandemic vaccine, the quadrivalent human papillomavirus vaccine (4vHPV) and the 2012–2013 inactivated seasonal
Anaphylaxis
Table 1 shows published rates from VSD of anaphylaxis after specific vaccines for 2009–2011 [7], with corresponding reporting rates of anaphylaxis from VAERS [10], [13], [14], [15], [16]. VAERS reporting sensitivity for anaphylaxis after the seven vaccines studied ranged from 13% to 76% (Table 1).
Guillain-Barré syndrome
The VSD published rate of GBS with symptom onset within 42 days after administration of the 2009 H1N1 inactivated pandemic vaccine included 9 cases that met Brighton Collaboration GBS criteria levels
Discussion
For the clinically serious AEs of anaphylaxis and GBS, estimated VAERS capture of overall cases is comparable to previous estimates of case capture sensitivity for other important AEs. Previous reports showed VAERS’ case capture at 68% for vaccine associated polio disease and 47% for intussusception after rotavirus vaccine [2], [3].
For anaphylaxis after the vaccines included in this review, VAERS captured 13–76% of cases, with the highest percent captured after the 2009 H1N1 inactivated
Funding source
This study was supported solely by the CDC and no external funding was secured.
Financial disclosure
None of the authors have any financial relationships to disclose.
Disclaimer
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC) or the U.S. Food and Drug Administration (FDA). Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC or FDA.
Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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