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. 2018 Apr;27(4):391-397.
doi: 10.1002/pds.4397. Epub 2018 Feb 15.

Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method

Rongxia Li  1 , Eric Weintraub  1 , Michael M McNeil  1 , Martin Kulldorff  2 , Edwin M Lewis  3 , Jennifer Nelson  4 , Stanley Xu  5 , Lei Qian  6 , Nicola P Klein  3 , Frank Destefano  1
Affiliations

Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method

Rongxia Li et al. Pharmacoepidemiol Drug Saf. 2018 Apr.

Abstract

Purpose: The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D using the tree-temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a large distributed safety data setting.

Methods: Traditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting AEs based on pre-defined sets of conditions or diagnoses. Using a newly developed tree-temporal scan statistic data mining method, we performed a pilot study to evaluate the safety profile of the meningococcal conjugate vaccine Menactra® (MenACWY-D), screening thousands of potential AE diagnoses and diagnosis groupings. The study cohort included enrolled participants in the Vaccine Safety Datalink aged 11 to 18 years who had received MenACWY-D vaccination(s) between 2005 and 2014. The tree-temporal scan statistic was employed to identify statistical associations (signals) of AEs following MENACWY-D at a 0.05 level of significance, adjusted for multiple testing.

Results: We detected signals for 2 groups of outcomes: diseases of the skin and subcutaneous tissue, fever, and urticaria. Both groups are known AEs following MENACWY-D vaccination. We also identified a statistical signal for pleurisy, but further examination suggested it was likely a false signal. No new MENACWY-D safety concerns were raised.

Conclusions: As a pilot study, we demonstrated that the tree-temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine-AE associations within a large health care data network.

Keywords: Bell's palsy; Menactra; adverse events; pharmacoepidemiology; post-licensure.

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Conflict of interest statement

CONFLICT OF INTEREST

None declared.

Figures

FIGURE 1
FIGURE 1
A diagram illustrating possible risk windows and comparison windows during 1 to 56 study period (X: maximum day for risk windows)
FIGURE 2
FIGURE 2
A hierarchical tree for branch 6 (disease of the nervous system and sense organs) that includes statistical signals for nodes in Table 1 (the first 4 levels are MLCCS codes; the last level is ICD-9 code)
FIGURE 3
FIGURE 3
A hierarchical tree for branch 12 (diseases of the skin and subcutaneous tissue) that includes statistical signals for nodes in Table 1 (nodes with gray background indicate AE signals after removing signals following well-care visits; the first 4 levels are MLCCS codes; the last level is ICD-9 code) [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 4
FIGURE 4
A hierarchical tree for branch 17 (signs and ill-defined conditions and factors influencing health status) that includes statistical signals for nodes in Table 1 (nodes with gray background indicate AE signals after removing signals following well-care visits; the first 4 levels are MLCCS codes; the last level is ICD-9 code) [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 5
FIGURE 5
A hierarchical tree for branch 8 (diseases of respiratory system) that includes statistical signals for nodes in Table 1 (nodes with gray background indicate AE signals after removing signals following well-care visits; the first 4 levels are MLCCS codes; the last level is ICD-9 code) [Colour figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

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References

    1. Gilles D Rotavirus vaccine withdrawal in the United States; the role of postmarketing surveillance. Can J Infect Dis. 2000;11(1):10–12. - PMC - PubMed
    1. Martin D, Menschik D, Bryant-Genevier M, Ball R. Data mining for prospective early detection of safety signals in the vaccine adverse event reporting system (VAERS): a case study of febrile seizures after a 2010–2011 seasonal influenza virus vaccine. Drug Saf. 2013;36(7):547–556. - PubMed
    1. Niu MT, Erwin DE, Braun MM. Data mining in the US vaccine adverse event reporting system (VAERS): early detection of intussusception and other events after rotavirus vaccination. Vaccine. 2001;19(32):4627–4634. - PubMed
    1. DuMouchel W Bayesian data mining in large frequency tables, with application to the FDA spontaneous reporting system. Am. Stat 1999;53(3):177–190.
    1. Varricchio F, Iskander J, DeStefano F, et al. Understanding vaccine safety information from the vaccine adverse event reporting system. Pediatr Infect Dis J. 2004;23(4):287–294. - PubMed