Evidence map›Paper›PMID 33880140›Full record

ArticleStatistics in biopharmaceutical research2020

Improvement in the Analysis of Vaccine Adverse Event Reporting System Database.

Lili Zhao, Sunghun Lee, Rongxia Li, Edison Ong, Yongqun He, Gary Freed

Open access · greenAbstract read
In one paragraph

Article in Statistics in biopharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

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  6. Vaccine adverse event enrichment tests.Statistics in medicine · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Lili ZhaoDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.
Sunghun LeeDepartment of Statistics, University of Michigan, Ann Arbor, Michigan, USA.
Rongxia LiDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Edison OngDepartment for Computational Medicine and Bioinformatics, University of Michigan, Ann Arbor, Michigan, USA.
Yongqun HeDepartment of Microbiology and Immunology, and Center for Computational Medicine and Bioinformatics, University of Michigan, Ann Arbor, Michigan, USA.
Gary FreedDepartment of Pediatrics and Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA.
University of Michigan · USCenters for Disease Control and Prevention · US

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI THEODORE S LAWRENCE · 1988 to 2026
$178.2M
NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

As a national public health surveillance resource, Vaccine Adverse Event Reporting System (VAERS) is a key component in ensuring the safety of vaccines. Numerous methods have been used to conduct safety studies with the VAERS database. These efforts focus on the downstream statistical analysis of the vaccine and adverse event associations. In this paper, we primarily focus on processing the raw data in VAERS before the analysis step, which is also an important part of the signal detection process. Due to the semi-annual update in the Medical Dictionary for Regulatory Activities (MedDRA) coding system, adverse event terms that describe the same symptom might change in VAERS; therefore, we identify these terms and combine them to increase the signal detection power. We also consider the uncertainty of the vaccine and adverse event pairs that arise from reports with multiple vaccines. Finally, we discuss four commonly used statistics in assessing the vaccine and adverse event associations, and propose to use the statistics that are robust to the reporting bias in VAERS and adjust for potential confounders of the vaccine and adverse event association to increase signal detection accuracy.

Indexed as

Mantel–Haenszel statisticsMedDRASafety signal detectionvaccine adverse eventVAERS

Identifiers

PMID33880140
PMCPMC8054210
OpenAlexW3022148440

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.