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COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study.
Fragoulis, George E; Bournia, Vassiliki-Kalliopi; Mavrea, Eugenia; Evangelatos, Gerasimos; Fragiadaki, Kalliopi; Karamanakos, Anastasios; Kravariti, Eyrydiki; Laskari, Katerina; Panopoulos, Stylianos; Pappa, Maria; Mitsikostas, Dimos D; Tektonidou, Maria G; Vassilopoulos, Dimitrios; Sfikakis, Petros P.
  • Fragoulis GE; 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. geofragoul@yahoo.gr.
  • Bournia VK; 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.
  • Mavrea E; 2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, Hippokration General Hospital, Athens, Greece.
  • Evangelatos G; 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.
  • Fragiadaki K; 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.
  • Karamanakos A; 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.
  • Kravariti E; 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.
  • Laskari K; 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.
  • Panopoulos S; 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.
  • Pappa M; 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.
  • Mitsikostas DD; 1st Neurology Department, Medical School, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece.
  • Tektonidou MG; 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.
  • Vassilopoulos D; 2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, Hippokration General Hospital, Athens, Greece.
  • Sfikakis PP; 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.
Rheumatol Int ; 42(1): 31-39, 2022 01.
Article in English | MEDLINE | ID: covidwho-1503952
ABSTRACT

OBJECTIVE:

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.

METHODS:

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.

RESULTS:

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).

CONCLUSION:

No new safety signals for COVID-19 vaccination were observed. Vaccination campaign should target SRD patients with nocebo-prone and negative influenza vaccination behaviour.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Rheumatic Diseases / COVID-19 Vaccines / COVID-19 / Vaccination Hesitancy Type of study: Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Rheumatol Int Year: 2022 Document Type: Article Affiliation country: S00296-021-05039-3

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Rheumatic Diseases / COVID-19 Vaccines / COVID-19 / Vaccination Hesitancy Type of study: Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Rheumatol Int Year: 2022 Document Type: Article Affiliation country: S00296-021-05039-3