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COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study

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...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8569844/
https://www.ncbi.nlm.nih.gov/pubmed/34739573
http://dx.doi.org/10.1007/s00296-021-05039-3
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author 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.
author_facet 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.
author_sort Fragoulis, George E.
collection PubMed
description 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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spelling pubmed-85698442021-11-05 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. Rheumatol Int Observational Research 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. Springer Berlin Heidelberg 2021-11-05 2022 /pmc/articles/PMC8569844/ /pubmed/34739573 http://dx.doi.org/10.1007/s00296-021-05039-3 Text en © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Observational Research
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.
COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study
title COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study
title_full COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study
title_fullStr COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study
title_full_unstemmed COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study
title_short COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study
title_sort covid-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study
topic Observational Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8569844/
https://www.ncbi.nlm.nih.gov/pubmed/34739573
http://dx.doi.org/10.1007/s00296-021-05039-3
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