Joint Rheumatology Program, Rheumatology Unit, First Department of Propaedeutic Internal Medicine, Athens School of Medicine, National and Kapodistrian University, Mikras Asias 75 str, 11527, Athens, Greece.
2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, Hippokration General Hospital, Athens, Greece.
Rheumatol Int. 2022 Jan;42(1):31-39. doi: 10.1007/s00296-021-05039-3. Epub 2021 Nov 5.
To describe the rate and type of adverse effects (AEs) and the frequency of disease flares after COVID-19 vaccination and to assess the reasons for vaccination hesitancy (non-vaccination) in SRD patients.
Telephone interviews were conducted of SRD patients consecutively enrolled (15/06/2021-1/7/2021). Participants were asked about the type of AEs and disease flare after vaccination. Reasons for vaccination hesitancy were recorded. Univariate and mutivariable analyses examined associations of demographic, clinical and other features, with occurrence of AEs, disease flare and non-vaccination. For the latter, association with negative vaccination behaviour (not influenza vaccinated for the last 2 years) and nocebo-prone behaviour (denoting AEs attributed to negative expectations [Q-No questionnaire]) was also tested.
561 out of 580 contacted patients were included in the study. 441/561 (78.6%) patients were vaccinated [90% (Pfizer, Moderna), 10% (Astra-Zeneca)]. AEs were reported by 148/441 (33.6%), with rates being comparable between the three vaccines. AEs were more common in females and those with chronic obstructive pulmonary disease [OR, 95% CI; females: 2.23 (1.30-3.83); COPD: 3.31 (1.24-8.83)]. Disease flare was reported in 9/441 (2%) patients. For those unvaccinated, fear that the vaccine would be harmful (53.3%), could cause disease flare (24.2%) and/or could cause thrombosis (21.7%) were the main reasons to do so. Multivariable analysis identified as independent variables for non-vaccination: nocebo-prone behaviour (OR; 95% CI, 3.88; 1.76-8.55), negative vaccination behaviour (6.56; 3.21-13.42) and previous COVID-19 infection (2.83; 1.13-7.05). Higher educational status was protective (0.49; 0.26-0.92).
No new safety signals for COVID-19 vaccination were observed. Vaccination campaign should target SRD patients with nocebo-prone and negative influenza vaccination behaviour.
描述 COVID-19 疫苗接种后不良反应（AE）的发生率和类型，以及疾病发作的频率，并评估 SRD 患者接种疫苗犹豫不决（未接种）的原因。
对连续纳入的 SRD 患者（2021 年 6 月 15 日至 7 月 1 日）进行电话访谈。询问患者接种疫苗后的 AE 类型和疾病发作情况。记录接种疫苗犹豫不决的原因。单因素和多因素分析检查人口统计学、临床和其他特征与 AE、疾病发作和未接种疫苗的相关性。对于后者，还测试了与负面疫苗接种行为（过去 2 年未接种流感疫苗）和负性预期导致的易患安慰剂反应（表示归因于负面预期的 AE[Q-No 问卷]）之间的关联。
在联系的 580 名患者中，有 561 名（78.6%）患者纳入研究。441/561（90%（辉瑞、莫德纳），10%（阿斯利康））名患者接种了疫苗。148/441（33.6%）名患者报告出现 AE，三种疫苗的发生率相当。女性和慢性阻塞性肺疾病患者的 AE 更常见[比值比，95%可信区间；女性：2.23（1.30-3.83）；COPD：3.31（1.24-8.83）]。441 名接种疫苗的患者中有 9 名（2%）报告疾病发作。对于未接种疫苗的患者，担心疫苗有害（53.3%）、可能导致疾病发作（24.2%）和/或可能导致血栓形成（21.7%）是主要原因。多因素分析确定未接种疫苗的独立变量为：易患安慰剂反应（比值比，95%置信区间，3.88；1.76-8.55）、负面流感疫苗接种行为（6.56；3.21-13.42）和既往 COVID-19 感染（2.83；1.13-7.05）。较高的教育程度具有保护作用（0.49；0.26-0.92）。
未观察到 COVID-19 疫苗接种的新安全信号。疫苗接种运动应针对易患安慰剂反应和负面流感疫苗接种行为的 SRD 患者。
