Vaccine adverse event reporting system reporting source: a possible source of bias in longitudinal studies
Abstract
OBJECTIVE: The US Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system to which anyone can report an event. Publicity related to potential adverse events may change reporting patterns. The objective of this paper is to show how litigation-related reports have influenced the trends in possible adverse event reports to VAERS. METHODS: The VAERS public-use data files were downloaded in July 2004 and translated into identical SAS data sets for analysis. Cases that were related to litigation were identified using a word search algorithm. All cases for the most frequently reported symptoms in litigation (overdose, neuropathy, autism, "mental retardation," arthralgia, and "speech disorder") were reviewed. RESULTS: In recent years, most case reports to VAERS that were related to overdose, neuropathy, and thimerosal were related to litigation. Many cases that were related to autism and mental retardation were as well. CONCLUSIONS: This review shows a previously undisclosed rise in the number of reports to the VAERS related to pending litigation for vaccine injury. The implications of this for understanding longitudinal reporting patterns are discussed.
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The VAERS is a self-reporting system with reporting bias.
“the VAERS is a self-reporting system with reporting bias,10”
From A comprehensive analysis of the efficacy and safety of COVID-19 vaccines (2021) · cites this paper as [10]
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A comprehensive analysis of the efficacy and safety of COVID-19 vaccines
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- Authors
- Goodman, M. J., & Nordin, J.
- Affiliations
- HealthPartners (US)
- Regions Hospital (US)
- Corresponding author
- Nordin, James
- ORCID
- Nordin, James
- Venue
- PEDIATRICS
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 2006-02-01
- Volume
- 117
- Issue
- 2
- Pages
- 387-390
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- OpenAlex
- W2065736303
- Cited by
- 65
- References
- 13
- Citations by year
- 2026: 2 · 2025: 1 · 2023: 2 · 2021: 5 · 2020: 1 · 2019: 3 · 2018: 2 · 2017: 8 · 2016: 2 · 2015: 1 · 2014: 1 · 2013: 12 · 2012: 4
- FWCI
- 5.05
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PEDIATRICS (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Centers for Disease Control and Prevention
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Epidemiology › Data-Driven Disease Surveillance
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- VAERS, vaccine adverse events, litigation, reporting bias, passive surveillance, vaccine injury, thimerosal, autism spectrum disorder, neuropathy, drug overdose
- MeSH terms
- Humans, Longitudinal Studies, United States, Vaccination, Vaccines, Bias, Liability, Legal, Adverse Drug Reaction Reporting Systems
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