Safety of ChAdOx1 nCoV-19 vaccination in patients with end-stage renal disease on hemodialysis

• Published in: PloS one 2022-09, Vol.17 (9), p.e0273676-e0273676
• Main Authors: Yang, I-Ning, Lu, Chin-Li, Tang, Hung-Jen, Kuo, Yu-Chi, Tsai, Li-Hwa, Tu, Kuan Chieh, Wang, Jhi-Joung, Chien, Chih-Chiang
• Format: Article
• Language: English
• Subjects: Analgesics; Biology and Life Sciences; Body temperature; Care and treatment; Catheters; Chronic kidney failure; Chronic obstructive pulmonary disease; Complications and side effects; Coronaviruses; COVID-19; COVID-19 vaccines; Diabetes mellitus; Diarrhea; Disease transmission; End-stage renal disease; Females; Fever; Headaches; Health risks; Hemodialysis; Herpes zoster; Influenza; Kidney diseases; Lethargy; Medicine and Health Sciences; Mortality; mRNA vaccines; Pain; Pandemics; Patient outcomes; Patients; Population; Questionnaires; Risk analysis; Risk factors; Safety; Signs and symptoms; Thirst; Thromboembolism; Thrombosis; Vaccination; Vaccines
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0273676

COVID-19 vaccination is essential. However, no study has reported adverse events (AEs) after ChAdOx1 nCoV-19 vaccination in patients with end-stage renal disease (ESRD) on hemodialysis (HD). This study investigated the AEs within 30-days after the first dose of ChAdOx1 nCoV19 (Oxford-AstraZeneca) in ESRD patients on HD. A total of 270 ESRD patients on HD were enrolled in this study. To determine the significance of vascular access thrombosis (VAT) post vaccination, we performed a self-controlled case study (SCCS) analysis. Of these patients, 38.5% had local AEs; local pain (29.6%), tenderness (28.9%), and induration (15.6%) were the most common. Further, 62.2% had systemic AEs; fatigue (41.1%), feverishness (20%), and lethargy (19.9%) were the most common. In addition, post-vaccination thirst affected 18.9% of the participants with female predominance. Younger age, female sex, and diabetes mellitus were risk factors for AEs. Five patients had severe AEs, including fever (n = 1), herpes zoster (HZ) reactivation (n = 1), and acute VAT (n = 3). However, the SCCS analysis revealed no association between vaccination and VAT; the incidence rate ratio (IRR)-person ratio was 0.56 (95% CI 0.13-2.33) and 0.78 (95% CI 0.20-2.93) [IRR-event ratio 0.78 (95% CI 0.15-4.10) and 1.00 (95% CI 0.20-4.93)] in the 0-3 months and 3-6 months period prior to vaccination, respectively. Though some ESRD patients on HD had local and systemic AEs after first-dose vaccination, the clinical significance of these symptoms was minor. Our study confirmed the safety profile of ChAdOx1 nCoV-19 in HD patients and presented a new viewpoint on vaccine-related AEs. The SCCS analysis did not find an elevated risk of VAT at 1 month following vaccination. Apart from VAT, other vaccine-related AEs, irrespective of local or systemic symptoms, had minor clinical significance on safety issues. Nonetheless, further coordinated, multi-center, or registry-based studies are needed to establish the causality.