| アブストラクト | OBJECTIVE: To assess the safety of 20-valent pneumococcal conjugate vaccine (PCV20) in children in the United States using data from the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous surveillance system. STUDY DESIGN: We searched VAERS for reports of adverse events (AEs) following PCV20 in children aged 0 - 17 years who received PCV20 from June 22, 2023, through January 24, 2025. We reviewed reports and available medical records for all serious reports and for adverse events of special interest (AESIs; seizures, anaphylaxis, hypotonic hyporesponsive episode, Kawasaki disease). We used empirical Bayesian data mining to identify AEs that were disproportionally reported. RESULTS: VAERS received 1,040 reports after receipt of PCV20 in children 0-17 years; 107 (10.3%) were serious, which included 26 (2.5%) death reports. In 970 (93.3%) reports, PCV20 was concomitantly administered with another vaccine. The most reported AEs were fever (109, 10.4%), rash (75, 7.2%), urticaria (68, 6.5%), and injection site erythema (54, 5.2%). The most commonly reported AESI was seizures (42, 4.0%). Empirical Bayesian data mining revealed disproportionate reporting for "wrong product administered," but no adverse health events were associated with this vaccination error. CONCLUSIONS: Most reports following PCV20 administration in children were non-serious. The most common AEs were local and systemic reactions, consistent with pre-licensure clinical trials. |
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| ジャーナル名 | The Journal of pediatrics |
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| Pubmed追加日 | 2026/7/2 |
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| 投稿者 | Moro, Pedro L; Zauche, Lauren Head; Zhang, Bicheng; Dooley, Cara; Oliveira, Mayra; Stroud, Erin |
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| 組織名 | Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for;Disease Control and Prevention, Atlanta, Georgia, USA. Electronic address:;pmoro@cdc.gov.;Disease Control and Prevention, Atlanta, Georgia, USA.;Center for Biologics Evaluation and Research, Food and Drug Administration, 10903;New Hampshire Ave, Silver Spring, MD 20993, USA.;Federal University of Sao Paulo, R. Napoleao de Barros, 754-Vila Clementino, Sao;Paulo, SP 04024-002, Brazil. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42386124/ |
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