title: Network analysis of possible anaphylaxis cases reported to the US vaccine adverse event reporting system after H1N1 influenza vaccine.
abstract: The identification of signals from spontaneous reporting systems plays an important role in monitoring the safety of medical products. Network analysis (NA) allows the representation of complex interactions among the key elements of such systems. We developed a network for a subset of the US Vaccine Adverse Event Reporting System (VAERS) by representing the vaccines/adverse events (AEs) and their interconnections as the nodes and the edges, respectively; this subset we focused upon included possible anaphylaxis reports that were submitted for the H1N1 influenza vaccine. Subsequently, we calculated the main metrics that characterize the connectivity of the nodes and applied the island algorithm to identify the densest region in the network and, thus, identify potential safety signals. AEs associated with anaphylaxis formed a dense region in the 'anaphylaxis' network demonstrating the strength of NA techniques for pattern recognition. Additional validation and development of this approach is needed to improve future pharmacovigilance efforts.
authors: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA. Taxiarchis.Botsis@fda.hhs.gov
authors: Taxiarchis
authors: T
authors: Botsis
authors: Robert
authors: R
authors: Ball
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000465:Algorithms; D000707:Anaphylaxis / Q000453:epidemiology* / Q000209:etiology*; D016000:Cluster Analysis; D003625:Data Collection; D003627:Data Interpretation, Statistical; D057225:Data Mining / Q000379:methods*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000378:metabolism; D007252:Influenza Vaccines / Q000009:adverse effects*; D015233:Models, Statistical; D010363:Pattern Recognition, Automated / Q000379:methods*; D012984:Software; D014481:United States
chemical_list: D007252:Influenza Vaccines