PMID- 34739573
OWN - NLM
STAT- MEDLINE
DCOM- 20220125
LR  - 20220125
IS  - 1437-160X (Electronic)
IS  - 0172-8172 (Print)
IS  - 0172-8172 (Linking)
VI  - 42
IP  - 1
DP  - 2022 Jan
TI  - COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with 
      systemic rheumatic diseases: a cross-sectional study.
PG  - 31-39
LID - 10.1007/s00296-021-05039-3 [doi]
AB  - 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.
CI  - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Fragoulis, George E
AU  - Fragoulis GE
AUID- ORCID: 0000-0003-4932-7023
AD  - 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.
FAU - Bournia, Vassiliki-Kalliopi
AU  - Bournia VK
AUID- ORCID: 0000-0002-2162-1362
AD  - 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.
FAU - Mavrea, Eugenia
AU  - Mavrea E
AD  - 2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, 
      Hippokration General Hospital, Athens, Greece.
FAU - Evangelatos, Gerasimos
AU  - Evangelatos G
AUID- ORCID: 0000-0003-3822-3093
AD  - 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.
FAU - Fragiadaki, Kalliopi
AU  - Fragiadaki K
AD  - 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.
FAU - Karamanakos, Anastasios
AU  - Karamanakos A
AD  - 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.
FAU - Kravariti, Eyrydiki
AU  - Kravariti E
AD  - 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.
FAU - Laskari, Katerina
AU  - Laskari K
AUID- ORCID: 0000-0002-6477-6583
AD  - 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.
FAU - Panopoulos, Stylianos
AU  - Panopoulos S
AUID- ORCID: 0000-0002-3720-5996
AD  - 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.
FAU - Pappa, Maria
AU  - Pappa M
AD  - 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.
FAU - Mitsikostas, Dimos D
AU  - Mitsikostas DD
AUID- ORCID: 0000-0002-4691-3388
AD  - 1st Neurology Department, Medical School, Aeginition Hospital, National and 
      Kapodistrian University of Athens, Athens, Greece.
FAU - Tektonidou, Maria G
AU  - Tektonidou MG
AUID- ORCID: 0000-0003-2238-0975
AD  - 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.
FAU - Vassilopoulos, Dimitrios
AU  - Vassilopoulos D
AUID- ORCID: 0000-0003-2288-3863
AD  - 2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, 
      Hippokration General Hospital, Athens, Greece.
FAU - Sfikakis, Petros P
AU  - Sfikakis PP
AUID- ORCID: 0000-0001-5484-2930
AD  - 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.
LA  - eng
PT  - Journal Article
DEP - 20211105
PL  - Germany
TA  - Rheumatol Int
JT  - Rheumatology international
JID - 8206885
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - Adult
MH  - Aged
MH  - COVID-19/immunology/*prevention & control
MH  - COVID-19 Vaccines/*therapeutic use
MH  - Cross-Sectional Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nocebo Effect
MH  - Rheumatic Diseases/*immunology
MH  - Vaccination
MH  - *Vaccination Hesitancy
PMC - PMC8569844
OTO - NOTNLM
OT  - Adverse effects
OT  - COVID-19
OT  - Disease flare
OT  - Vaccination
COIS- Nothing to declare.
EDAT- 2021/11/06 06:00
MHDA- 2022/01/27 06:00
PMCR- 2021/11/05
CRDT- 2021/11/05 17:23
PHST- 2021/09/15 00:00 [received]
PHST- 2021/10/22 00:00 [accepted]
PHST- 2021/11/06 06:00 [pubmed]
PHST- 2022/01/27 06:00 [medline]
PHST- 2021/11/05 17:23 [entrez]
PHST- 2021/11/05 00:00 [pmc-release]
AID - 10.1007/s00296-021-05039-3 [pii]
AID - 5039 [pii]
AID - 10.1007/s00296-021-05039-3 [doi]
PST - ppublish
SO  - Rheumatol Int. 2022 Jan;42(1):31-39. doi: 10.1007/s00296-021-05039-3. Epub 2021 
      Nov 5.