ArticleDrug safety2025
Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS).
Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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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.
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.
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Who cites it
6 citing papers in PubMed.
- Real-world analysis of depression-related adverse events associated with the adsorbed anthrax vaccine: integrating pharmacovigilance signals, machine learning risk prediction, and transcriptomic mechanisms.Infectious diseases of poverty · 2026Article
- A Comprehensive Disproportionality Analysis of Drug-Related Head Injury Reports Using the FAERS Database.Brain and behavior · 2026Article
- Disproportionality Analysis and Timing of Drug-Associated Guillain-Barré Syndrome Onset Based on the Japanese Adverse Drug Event Report Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023-December 2024.Preventive medicine reports · 2025Article
- Real-world pharmacovigilance reports of hepatitis A inactivated and hepatitis B (recombinant) vaccine: insights from disproportionality analysis of the vaccine adverse event reporting system.Frontiers in cellular and infection microbiology · 2025Article
- Post-marketing safety surveillance of pneumococcal vaccines: a real-world pharmacovigilance study using the U.S. vaccine adverse event reporting system (VAERS) database.Frontiers in cellular and infection microbiology · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
backgroundOn June 8, 2021, a new 20-valent pneumococcal conjugate vaccine (PCV20, PREVNAR 20
objectiveTo describe reports to the Vaccine Adverse Event Reporting System (VAERS) after administration of the 20-valent pneumococcal conjugate vaccine in adults.
methodsWe searched the VAERS for reports of adverse events involving persons aged ≥ 19 years who received PCV20 during October 20, 2021, through December 31, 2023. Our evaluation included automated analysis of reports, clinical review of serious reports and pre-specified events of special interest, empirical Bayesian data mining to assess for disproportionate reporting, and estimation of reporting rates for reports of Guillain-Barré syndrome (GBS).
resultsThe VAERS received 1976 reports after PCV20 administration in persons aged ≥ 19 years (6% of reports involved serious events). The most common adverse events among persons aged 19-64 years (n = 798) were injection-site reactions (231, 29%), pain (134, 17%), erythema (118, 15%), and fever (117, 15%). For persons aged ≥ 65 years (n = 1178), the most common adverse events were injection-site reactions (417, 35%), pain (180, 15%), pain in extremity (162, 14%), and erythema (158, 13%). A data mining alert (EB05 = 3.812) for the MedDRA Preferred Term "Guillain-Barre syndrome" was observed for serious reports. Clinical review verified 11 of 20 GBS reports; 7/11 vaccine recipients were aged ≥ 65 years. Among the 11 verified cases, the median time from vaccination to symptom onset was 14 days. Five persons received another vaccine on the same visit. The reporting rate of GBS after PCV20 receipt was 0.5 cases per million doses distributed. No other safety concern was identified.
conclusionsDuring the period of this post-licensure review of PCV20, we found most reports were non-serious and comprised mostly local and systemic (e.g., fever) reactions consistent with prelicensure studies. In serious reports, we also identified a data mining alert for GBS after receipt of PCV20, which Centers for Disease Control and Prevention and the FDA are investigating further. No other new or unexpected safety concern was identified.
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