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Original Research Open Access

Risk Factors of Chronic Spontaneous Urticaria with COVID-19 Vaccination: A Cross-Sectional Study

  • 1Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
  • 2Department of Allergy and Clinical Immunology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
  • 3MD/MPH Program, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
  • 4Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
  • 5Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran
+ Affiliations - Affiliations

Corresponding Author

Mohammad Amin Gholami, agholami97@gmail.com; Negar Mortazavi, mortazavi_ne@yahoo.com

Received Date: May 12, 2025

Accepted Date: October 08, 2025

Abstract

Background: Chronic Spontaneous Urticaria (CSU) is a multifactorial disease with an incompletely understood etiology. COVID-19 vaccines can influence the immune system. This study evaluates the risk factors and comorbidities associated with CSU in patients who developed CSU following COVID-19 vaccination or infection.

Methods: This cross-sectional study was conducted in Shiraz, Iran, and enrolled thirty-six adult patients with new-onset CSU developing within two months of COVID-19 vaccination or infection, persisting for at least six weeks. Diagnosis of CSU was confirmed by allergy and clinical immunology subspecialists based on EAACI guidelines. Clinical history, physical examination, laboratory findings, and skin prick test (SPT) results were collected. Associated diseases, allergy history, and inflammatory markers were also assessed.

Results: The mean age of participants was 38.17 ± 15.50 years. The median onset of CSU symptoms was 7.0 days (5.25, 12.25) for the AstraZeneca group and 7.0 days (2.50, 10.50) for the COVID-19 infection group, earlier than in other vaccine groups. CSU occurred more frequently after the first vaccine dose (P≤0.001) and more commonly at night. Most patients (66.7%) had a pruritus score of 3; 47.2% had a wheal score of 2. A history of allergy, atopy, or comorbidities was present in most patients. Positive SPT to aeroallergens was found in 63.9%. Laboratory data for autoinflammatory markers (e.g., ESR, CRP) were collected but did not show significant elevation. Daily use of second-generation H1 antihistamines controlled symptoms in 75% of patients.

Conclusion: CSU was most likely to develop within 6.5 days following the first dose of COVID-19 vaccination, especially AstraZeneca and Sinopharm. The high rate of positive SPT and allergy history suggests a predisposing allergic background. Most cases were not severe and responded well to antihistamine therapy.

Keywords

COVID-19, COVID-19 vaccines, Chronic spontaneous urticaria, Skin prick test, Hypersensitivity, Antihistamines, SARS-CoV-2, Inflammatory markers, Allergy history

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