ABSTRACT
Objectives: Potential cutaneous adverse drug reactions (cADRs) associated with COVID-19 vaccinations are well-known. However, comprehensive evaluation including detailed patient characteristics, vaccine types, signs and symptoms, treatments and outcomes from such cADRs are still lacking in Taiwan. Method(s): A cross-sectional study was conducted from December 2019 to October 2022 to analyze spontaneous ADR reporting data from Taiwan's largest multi-institutional healthcare system. Physicians and pharmacists initially ensured the data quality and completeness of the reported ADR records. Subsequently, we applied descriptive statistics to analyze the patient cohort based on demographic characteristics, administered COVID-19 vaccines, clinical manifestations, and patient management. Result(s): We identified 242 cADRs from 759 reported COVID-19 vaccine-related ADRs, 88.3% of which were judged as "possible" using the Naranjo Scale. The mean age of patients with cADRs was 48.1+/-17.5 years, with the majority (44.2%) of cADRs reported in the 40-64yr old age group. cADRs were more common in women (68.2%) and most of the patients had no history of allergy to vaccines (99.6%). Oxford/AstraZeneca (58.6%) accounted for the most reported brand of COVID-19 vaccines. Patients developed cADRs within 1 to 198 days (median = 5.5 days), and mostly after first-dose vaccination (77.8%). The most frequently reported cADR was rash/eruption (18.7%), followed by itchiness/pruritus (11.7%) and urticaria (9.2%), mainly affecting the lower limbs (23.8%) and upper limbs (22.6%). Medications were prescribed for 65.1% of the cADRs, and signs and symptoms were resolved within 1 to 167 days (median = 7 days) after treatment with oral antihistamines (23.0%), topical corticosteroids (14.6%) or oral corticosteroids (14.4%). Conclusion(s): Our findings provide comprehensive details regarding COVID-19 vaccine-related cADRs in Taiwan. Certain groups, especially women and the middle-aged, who reported a relatively higher rate of cADRs, may benefit from pre-vaccination counseling about the risks of cADRs and the use of appropriate medications.Copyright © 2023