ArticleScientific reports2023
Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection of adverse drug events.
Article in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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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.
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Who cites it
21 citing papers in PubMed, 19 citations in OpenAlex.
- Signal Detection of Adverse Events Associated with PCSK9 Inhibitors: A Nationwide Sequence Symmetry and Combined Worldwide Disproportionality Analysis.Drug safety · 2026Article
- Masking effect in the Spanish spontaneous reporting database FEDRA.European journal of clinical pharmacology · 2026Article
- Potential association of cluster headache with certain COVID-19 vaccines: An assessment from the pharmacovigilance databases.Headache · 2026Article
- Reporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databases.Exploratory research in clinical and social pharmacy · 2026Article
- Evaluation of consistency in adverse event reporting between trial registry and publications in COVID-19 pharmacological intervention trials.International journal of clinical pharmacy · 2026Article
- Reported safety events from ultrasound enhancing agents: a critical reappraisal.Echo research and practice · 2026Article
- Drug-related pulmonary fibrosis: A real-world pharmacovigilance study of the FDA Adverse Event Reporting System.Medicine · 2026Article
- Persistent rise in device-related errors for CGRP monoclonal antibodies: impact of the COVID-19 pandemic and post-pandemic implications.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Serious adverse events reported with sodium-glucose cotransporter-2 (SGLT2) inhibitors in the FAERS database (2013-2024): a pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Comparative analysis of the characteristics and trends of adverse drug reaction reports from patients in Japan and the Japanese Adverse Drug Event Report database.British journal of clinical pharmacology · 2026Article
- The real-world safety evaluation of the selective NaV1.8 inhibitor suzetrigine: disproportionality analysis and flexible empirical bayes signals from FAERS with external triangulation.Frontiers in pharmacology · 2026Article
- Global patterns and trends in spontaneous reporting systems: VigiBase, FAERS, VAERS, and JADER.Frontiers in drug safety and regulation · 2026Article
- Systematic analysis of adverse reaction signals induced by leflunomide, upadacitinib, and baricitinib in the treatment of rheumatoid arthritis: a FAERS database analysis.Frontiers in medicine · 2026Article
- Medication errors and associated serious outcomes in COVID-19 antivirals: a real-world study based on FDA Adverse Event Reporting System database.Therapeutic advances in drug safety · 2026Article
- Factors associated with serious adverse event following immunization: a real-world analysis of the vaccine adverse event reporting system 2025.Frontiers in public health · 2026Article
- Reporting profile of adverse events following DTaP-IPV/Hib pentavalent vaccine: A 13-year real-world surveillance data analysis.Human vaccines & immunotherapeutics · 2025Article
- Pharmacovigilance study for the identification of mogamulizumab-induced immune-related adverse events using a real-world database.The oncologist · 2025Article
- Oropharyngeal Adverse Events to Drugs and Vaccines: Pharmacovigilance Data From Italy (2019-2021).Oral diseases · 2025Article
- Consumers' knowledge and experiences of adverse drug reaction reporting in Australia: a national survey.European journal of clinical pharmacology · 2024Article
- Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.Drug safety · 2024Article
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
External factors severely affecting in a short period of time the spontaneous reporting of adverse events (AEs) can significantly impact drug safety signal detection. Coronavirus disease 2019 (COVID-19) represented an enormous challenge for health systems, with over 767 million cases and massive vaccination campaigns involving over 70% of the worldwide population. This study investigates the potential masking effect on certain AEs caused by the substantial increase in reports solely related to COVID-19 vaccines within various spontaneous reporting systems (SRSs). Three SRSs were used to monitor AEs reporting before and during the pandemic, namely, the World Health Organisation (WHO) global individual case safety reports database (VigiBase®), the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER). Findings revealed a sudden over-reporting of 35 AEs (≥ 200%) during the pandemic, with an increment of the RRF value in 2021 of at least double the RRF reported in 2020. This translates into a substantial reduction in signals of disproportionate reporting (SDR) due to the massive inclusion of COVID-19 vaccine reports. To mitigate the masking effect of COVID-19 vaccines in post-marketing SRS analyses, we recommend utilizing COVID-19-corrected versions for a more accurate assessment.
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Registered trials
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 Socratic graph.