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<p>Post-COVID-19 Vaccination Syndrome (PCVS) refers to persistent, multisystemic symptoms developing after SARS-CoV-2 immunization. We established a nationwide registry across 14 Japanese outpatient clinics and analyzed 179 “clinically definitive” cases from 279 enrollees (December 2020–August 2023). All adverse events (AEs) were coded using MedDRA/J Preferred Terms and System Organ Classes; severity followed NCI-CTCAE V5.0. The cohort (66.5% female; mean age 59 years) experienced 493 AEs (median 2 per patient, range 1–29). Three System Organ Classes—General Disorders (29.2%), Nervous System Disorders (22.3%), and Musculoskeletal Disorders (10.1%)—accounted for 61.7% of events; fatigue, brain fog, dizziness, and extremity pain predominated. While 69.4% of AEs arose within 90 days post-vaccination, 12.4% appeared ≥ 360 days later. Severe AEs (≥ Grade 3) occurred in 14.6% of patients; overall improvement was 65.1%, leaving 29.4% unresolved. A provisional phenotype classification combining symptom patterns, onset timing, and severity identified high-risk subgroups with &gt; 60% non-recovery rates. These findings underscore the need for enhanced post-vaccination surveillance systems and comprehensive care frameworks specifically tailored to address the protean manifestations and persistent nature of PCVS.</p>

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Characterizing persistent Post-COVID-19 vaccination symptoms using MedDRA system organ class and preferred term classifications

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月14日

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  • Akinori Fujisawa,
  • Shinichiro Kodama,
  • Nafuko Konishi,
  • Jun Ueda,
  • Akiko Kitagawa,
  • Eri Okada,
  • Mariko Miyokawa,
  • Yuriko Hirai,
  • Eiji Nakatani,
  • Masanori Fukushima

摘要

Post-COVID-19 Vaccination Syndrome (PCVS) refers to persistent, multisystemic symptoms developing after SARS-CoV-2 immunization. We established a nationwide registry across 14 Japanese outpatient clinics and analyzed 179 “clinically definitive” cases from 279 enrollees (December 2020–August 2023). All adverse events (AEs) were coded using MedDRA/J Preferred Terms and System Organ Classes; severity followed NCI-CTCAE V5.0. The cohort (66.5% female; mean age 59 years) experienced 493 AEs (median 2 per patient, range 1–29). Three System Organ Classes—General Disorders (29.2%), Nervous System Disorders (22.3%), and Musculoskeletal Disorders (10.1%)—accounted for 61.7% of events; fatigue, brain fog, dizziness, and extremity pain predominated. While 69.4% of AEs arose within 90 days post-vaccination, 12.4% appeared ≥ 360 days later. Severe AEs (≥ Grade 3) occurred in 14.6% of patients; overall improvement was 65.1%, leaving 29.4% unresolved. A provisional phenotype classification combining symptom patterns, onset timing, and severity identified high-risk subgroups with > 60% non-recovery rates. These findings underscore the need for enhanced post-vaccination surveillance systems and comprehensive care frameworks specifically tailored to address the protean manifestations and persistent nature of PCVS.