scholarly journals Examining Socioeconomic and Computational Aspects of Vaccine Pharmacovigilance

2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Vasiliki Soldatou ◽  
Anastasios Soldatos ◽  
Theodoros Soldatos
Keyword(s):  
Adverse Event ◽  
Enrichment Analysis ◽  
Vaccine Safety ◽  
Molecular Data ◽  
Adverse Event Reporting ◽  
Computational Techniques ◽  
Behavioral Determinants ◽  
Clinical Patient ◽  
Adverse Event Data ◽  
The Impact

Background. Vaccine pharmacovigilance relates to the detection of adverse events, their assessment, understanding, and prevention, and communication of their risk to the public. These activities can be tedious and long lasting for regulatory authority scientists and may be affected by community practices and public health policies. To better understand underlying challenges, we examined vaccine adverse event reports, assessed whether data-driven techniques can provide additional insight in safety characterization, and wondered on the impact of socioeconomic parameters. Methods. First, we integrated VAERS content with additional sources of drug and molecular data and examined reaction and outcome occurrence by using disproportionality metrics and enrichment analysis. Second, we reviewed social and behavioral determinants that may affect vaccine pharmacovigilance aspects. Results. We describe our experience in processing more than 607000 vaccine adverse event reports and report on the challenges to integrate more than 95500 VAERS medication narratives with structured information about drugs and other therapeutics or supplements. We found that only 12.6% of events were serious, while 8.97% referred to polypharmacy cases. Exacerbation of serious clinical patient outcomes was observed in 8.88% VAERS cases in which drugs may interact with vaccinations or with each other, regardless of vaccine activity interference. Furthermore, we characterized the symptoms reported in those cases and summarized reaction occurrence among vaccine-types. Last, we examine socioeconomic parameters and cost-management features, explore adverse event reporting trends, and highlight perspectives relating to the use and development of digital services, especially in the context of personalized and collaborative health-care. Conclusions. This work provides an informative review of VAERS, identifies challenges and limitations in the processing of vaccine adverse event data, and calls for the better understanding of the socioeconomic landscape pertaining vaccine safety concerns. We expect that adoption of computational techniques for integrated safety assessment and interpretation is key not only to pharmacovigilance practice but also to stakeholders from the entire healthcare system.

Understanding vaccine safety information from the Vaccine Adverse Event Reporting System

2004 ◽  
Vol 23 (4) ◽  
pp. 287-294 ◽  
Author(s):  
FREDERICK VARRICCHIO ◽  
JOHN ISKANDER ◽  
FRANK DESTEFANO ◽  
ROBERT BALL ◽  
ROBERT PLESS ◽  
...  
Keyword(s):  
Adverse Event ◽  
Reporting System ◽  
Safety Information ◽  
Adverse Event Reporting System ◽  
Vaccine Safety ◽  
Adverse Event Reporting ◽  
Event Reporting

scholarly journals Change Point Analysis for Detecting Vaccine Safety Signals

Vaccines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 206
Author(s):  
Seung-Hun You ◽  
Eun Jin Jang ◽  
Myo-Song Kim ◽  
Min-Taek Lee ◽  
Ye-Jin Kang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Change Point ◽  
Predictive Value ◽  
Public Safety ◽  
Vaccine Safety ◽  
Adverse Event Reporting ◽  
Change Point Analysis ◽  
Event Reporting ◽  
Point Analysis ◽  
Safety Signals

It is important to detect signals of abrupt changes in adverse event reporting in order to notice public safety concerns and take prompt action, especially for vaccines under national immunization programs. In this study, we assessed the applicability of change point analysis (CPA) for signal detection in vaccine safety surveillance. The performances of three CPA methods, namely Bayesian change point analysis, Taylor’s change point analysis (Taylor-CPA), and environmental time series change point detection (EnvCpt), were assessed via simulated data with assumptions for the baseline number of events and degrees of change. The analysis was validated using the Korea Adverse Event Reporting System (KAERS) database. In the simulation study, the Taylor-CPA method exhibited better results for the detection of a change point (accuracy of 96% to 100%, sensitivity of 7% to 100%, specificity of 98% to 100%, positive predictive value of 25% to 85%, negative predictive value of 96% to 100%, and balanced accuracy of 53% to 100%) than the other two CPA methods. When the CPA methods were applied to reports of syncope or dizziness following human papillomavirus (HPV) immunization in the KAERS database, Taylor-CPA and EnvCpt detected a change point (Q2/2013), which was consistent with actual public safety concerns. CPA can be applied as an efficient tool for the early detection of vaccine safety signals.

scholarly journals Adverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials

2020 ◽  
pp. 174077452095931
Author(s):  
Guilherme S Lopes ◽  
Christophe Tournigand ◽  
Curtis L Olswold ◽  
Romain Cohen ◽  
Emmanuelle Kempf ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Event Reporting ◽  
Data Sets ◽  
Event Data ◽  
Event Reporting ◽  
Adverse Event Data ◽  
Data Points ◽  
First Time ◽  
Reporting Method ◽  
Specific Adverse Event

Background Current adverse event reporting practices do not document longitudinal characteristics of adverse effects, and alternative methods are not easily interpretable and have not been employed by clinical trials. Introducing time parameters in the evaluation of safety that are comprehensive yet easily interpretable could allow for a better understanding of treatment quality. In this study, we developed and applied a novel adverse event reporting method based on longitudinal adverse event changes to aid describing, summarizing, and presenting adverse event profile. We termed it the “Adverse Event Load, Onset, and Maximum Grade” method. Methods We developed two adverse event summary metrics to complement the traditional maximum grade report. Onset time indicates the time period in which the maximum grade for a specific adverse event occurred and was defined as “early” (i.e. maximum grade happened for the first time before 6 weeks) or “late” (i.e. after the 6th week). Adverse event load indicates the overall severity of a specific adverse event over the entire treatment. Higher adverse event load indicates a worse overall experience. These metrics can be calculated for adverse events with different maximum grades, in treatments with planned changes (e.g. dosage changes), using data sets with different number of adverse event data points between treatments (e.g. treatments with longer cycle lengths may have less adverse event data points) and on data sets with different adverse event data availability (e.g. cycle basis and patient-outcome reports). We tested the utility of this method using individual patient data from two major backbone therapies (“Irinotecan” and “Oxaliplatin”) from the N9741 trial available in the Fondation ARCAD database ( fondationarcad.org ). We investigated profiles of diarrhea, neutropenia/leukopenia, and nausea/vomiting. Results Our method provided additional information compared to traditional adverse event reports. For example, for nausea/vomiting, while patients in Irinotecan had a higher risk of experiencing maximum grade 3–4 (15.6% vs 7.6%, respectively; p < 0.001), patients in both groups experienced similar severity over time (adverse effect load = 0.102 and 0.096, respectively; p = 0.26), suggesting that patients in Oxaliplatin experienced a lower-grade but more persistent nausea/vomiting. For neutropenia/leukopenia, more patients in Irinotecan experienced their maximum grade for the first time early in the treatment compared to patients in Oxaliplatin (67.9% vs 41.7%; p < 0.001), regardless of maximum grade. Longitudinal information can help compare treatments or guide clinicians on choosing appropriate interventions for low-grade but persistent adverse event or early adverse event onset. Conclusion We developed an adverse event reporting method that provides clinically relevant information about treatment toxicity by incorporating two longitudinal adverse event metrics to the traditional maximum grade approach. Future research should establish clinical benchmarks for metrics included in this adverse event reporting method.

scholarly journals Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States

2021 ◽  
Vol 4 (9) ◽  
pp. e2124502
Author(s):  
Kalyani Sonawane ◽  
Yueh-Yun Lin ◽  
Haluk Damgacioglu ◽  
Yenan Zhu ◽  
Maria E. Fernandez ◽  
...  
Keyword(s):  
United States ◽  
Adverse Event ◽  
Human Papillomavirus ◽  
Vaccine Safety ◽  
The United States ◽  
Adverse Event Reporting ◽  
Human Papillomavirus Vaccine ◽  
Event Reporting ◽  
Safety Concerns ◽  
Papillomavirus Vaccine
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