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Background: Patients affected by pre-existing chronic spontaneous/Inducible urticaria (CSU/CIU) still feel unsafe due to the potential risk of an Adverse Event Following Immunization (AEFI) and Cutaneous Adverse Reactions (CARs) of COVID-19 vaccines. The appropriate management in this field remains debated and evidence is still lacking. Methods: We considered 160 CSU/CIU patients in Omalizumab/antihistamine therapy who received two doses of Comirnaty/Moderna mRNA vaccines; 20 of them also received a booster dose. Urticaria Activity Score-7 (UAS7) was used to assess the severity of the disease. Demographics, medical history, AEFI and CARs outcome after vaccination were collected by administering a web-based questionnaire completed by phone interview. Results: In total, 147 patients did not show urticaria relapse (91.88%). Worsening cutaneous symptoms were experienced by 13 of our patients (8.12%). Exacerbation had a mean duration of 2 days and 11 h and mostly occurred after the first dose (69.23%). Systemic mild side effects were experienced by 9 patients (5.62%). No severe reactions were observed. Conclusions: Omalizumab can potentially prevent CARs and AEFI; however, major problems were registered during the 2-month stop period scheduled in the treatment. We suggest patients should not undergo vaccination during this period. CSU/CIU exacerbations appear to be transient and can be managed by antihistamines.

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