COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study

Parikshit Sen; Naveen Ravichandran; Arvind Nune; James B Lilleker; Vishwesh Agarwal; Sinan Kardes; Minchul Kim; Jessica Day; Marcin Milchert; Tamer Gheita; Babur Salim; Tsvetelina Velikova; Abraham Edgar Gracia-Ramos; Ioannis Parodis; Albert Selva O'Callaghan; Elena Nikiphorou; Tulika Chatterjee; Ai Lyn Tan; Lorenzo Cavagna; Miguel A Saavedra; Samuel Katsuyuki Shinjo; Nelly Ziade; Johannes Knitza; Masataka Kuwana; Oliver Distler; Hector Chinoy; Vikas Agarwal; Rohit Aggarwal; Latika Gupta; John D Pauling; COVAD Study Group; et al

doi:10.1093/rheumatology/keac305

COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study

Parikshit Sen, Naveen Ravichandran, Arvind Nune, James B Lilleker, Vishwesh Agarwal, Sinan Kardes, Minchul Kim, Jessica Day, Marcin Milchert, Tamer Gheita, Babur Salim, Tsvetelina Velikova, Abraham Edgar Gracia-Ramos, Ioannis Parodis, Albert Selva O'Callaghan, Elena Nikiphorou, Tulika Chatterjee, Ai Lyn Tan, Lorenzo Cavagna, Miguel A SaavedraSamuel Katsuyuki Shinjo, Nelly Ziade, Johannes Knitza, Masataka Kuwana, Oliver Distler, Hector Chinoy, Vikas Agarwal, Rohit Aggarwal, Latika Gupta, John D Pauling, COVAD Study Group , et al

Bristol Medical School (THS)

Research output: Contribution to journal › Article (Academic Journal) › peer-review

26 Citations (Scopus)

Abstract

Objectives:

COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination-related adverse events (AEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey.

Methods:

The survey was circulated in early 2021 by >110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details and 7-day vaccine AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type.

Results:

Ten thousand nine hundred respondents [median (interquartile range) age 42 (30–55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 0.010] were more frequent in SAIDs though absolute risk was small (0–4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs.

Conclusion:

Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.

Original language	English
Pages (from-to)	65-76
Number of pages	12
Journal	Rheumatology
Volume	62
Issue number	1
Early online date	17 Jun 2022
DOIs	https://doi.org/10.1093/rheumatology/keac305
Publication status	Published - 1 Jan 2023

Bibliographical note

Publisher Copyright:
© The Author(s) 2022.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Female
Animals
Humans
Adult
Male
COVID-19 Vaccines/adverse effects
COVID-19/prevention & control
Cross-Sectional Studies
Simian Acquired Immunodeficiency Syndrome/etiology
Vaccination/adverse effects
Autoimmune Diseases/epidemiology

Access to Document

10.1093/rheumatology/keac305

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Sen, P., Ravichandran, N., Nune, A., Lilleker, J. B., Agarwal, V., Kardes, S., Kim, M., Day, J., Milchert, M., Gheita, T., Salim, B., Velikova, T., Gracia-Ramos, A. E., Parodis, I., Selva O'Callaghan, A., Nikiphorou, E., Chatterjee, T., Tan, A. L., Cavagna, L., ... al , E. (2023). COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study. Rheumatology, 62(1), 65-76. https://doi.org/10.1093/rheumatology/keac305

@article{bdac8a6b96784354a11f1ef4c28b01c9,

title = "COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study",

abstract = "Objectives:COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination-related adverse events (AEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey. Methods:The survey was circulated in early 2021 by >110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details and 7-day vaccine AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type. Results:Ten thousand nine hundred respondents [median (interquartile range) age 42 (30–55) years, 74\% females and 45\% Caucasians] were analysed; 5867 patients (54\%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3\% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs = 26\%, HCs = 24\%; odds ratio (OR) = 1.1 (95\% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6\%, HCs = 1.4\%; OR = 1.5 (95\% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6\%, HCs = 4\%; OR = 1.3 (95\% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4\%, HCs = 2\%; OR = 1.9 (95\% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5\%, HCs = 0.3\%; OR = 5.7 (95\% CI: 2.9, 11); P = 0.010] were more frequent in SAIDs though absolute risk was small (0–4\%). Major AEs and hospitalizations (<2\%) were comparable across vaccine types in SAIDs. Conclusion:Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.",

keywords = "Female, Animals, Humans, Adult, Male, COVID-19 Vaccines/adverse effects, COVID-19/prevention \& control, Cross-Sectional Studies, Simian Acquired Immunodeficiency Syndrome/etiology, Vaccination/adverse effects, Autoimmune Diseases/epidemiology",

author = "Parikshit Sen and Naveen Ravichandran and Arvind Nune and Lilleker, \{James B\} and Vishwesh Agarwal and Sinan Kardes and Minchul Kim and Jessica Day and Marcin Milchert and Tamer Gheita and Babur Salim and Tsvetelina Velikova and Gracia-Ramos, \{Abraham Edgar\} and Ioannis Parodis and \{Selva O'Callaghan\}, Albert and Elena Nikiphorou and Tulika Chatterjee and Tan, \{Ai Lyn\} and Lorenzo Cavagna and Saavedra, \{Miguel A\} and Shinjo, \{Samuel Katsuyuki\} and Nelly Ziade and Johannes Knitza and Masataka Kuwana and Oliver Distler and Hector Chinoy and Vikas Agarwal and Rohit Aggarwal and Latika Gupta and Pauling, \{John D\} and \{COVAD Study Group\} and et al",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2022. ",

year = "2023",

month = jan,

day = "1",

doi = "10.1093/rheumatology/keac305",

language = "English",

volume = "62",

pages = "65--76",

journal = "Rheumatology",

issn = "1462-0324",

publisher = "Oxford University Press",

number = "1",

}

Sen, P, Ravichandran, N, Nune, A, Lilleker, JB, Agarwal, V, Kardes, S, Kim, M, Day, J, Milchert, M, Gheita, T, Salim, B, Velikova, T, Gracia-Ramos, AE, Parodis, I, Selva O'Callaghan, A, Nikiphorou, E, Chatterjee, T, Tan, AL, Cavagna, L, Saavedra, MA, Shinjo, SK, Ziade, N, Knitza, J, Kuwana, M, Distler, O, Chinoy, H, Agarwal, V, Aggarwal, R, Gupta, L, Pauling, JD, COVAD Study Group & al , E 2023, 'COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study', Rheumatology, vol. 62, no. 1, pp. 65-76. https://doi.org/10.1093/rheumatology/keac305

TY - JOUR

T1 - COVID-19 vaccination-related adverse events among autoimmune disease patients

T2 - results from the COVAD study

AU - Sen, Parikshit

AU - Ravichandran, Naveen

AU - Nune, Arvind

AU - Lilleker, James B

AU - Agarwal, Vishwesh

AU - Kardes, Sinan

AU - Kim, Minchul

AU - Day, Jessica

AU - Milchert, Marcin

AU - Gheita, Tamer

AU - Salim, Babur

AU - Velikova, Tsvetelina

AU - Gracia-Ramos, Abraham Edgar

AU - Parodis, Ioannis

AU - Selva O'Callaghan, Albert

AU - Nikiphorou, Elena

AU - Chatterjee, Tulika

AU - Tan, Ai Lyn

AU - Cavagna, Lorenzo

AU - Saavedra, Miguel A

AU - Shinjo, Samuel Katsuyuki

AU - Ziade, Nelly

AU - Knitza, Johannes

AU - Kuwana, Masataka

AU - Distler, Oliver

AU - Chinoy, Hector

AU - Agarwal, Vikas

AU - Aggarwal, Rohit

AU - Gupta, Latika

AU - Pauling, John D

AU - COVAD Study Group

AU - al , et

PY - 2023/1/1

Y1 - 2023/1/1

N2 - Objectives:COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination-related adverse events (AEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey. Methods:The survey was circulated in early 2021 by >110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details and 7-day vaccine AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type. Results:Ten thousand nine hundred respondents [median (interquartile range) age 42 (30–55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 0.010] were more frequent in SAIDs though absolute risk was small (0–4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs. Conclusion:Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.

AB - Objectives:COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination-related adverse events (AEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey. Methods:The survey was circulated in early 2021 by >110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details and 7-day vaccine AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type. Results:Ten thousand nine hundred respondents [median (interquartile range) age 42 (30–55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 0.010] were more frequent in SAIDs though absolute risk was small (0–4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs. Conclusion:Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.

KW - Female

KW - Animals

KW - Humans

KW - Adult

KW - Male

KW - COVID-19 Vaccines/adverse effects

KW - COVID-19/prevention & control

KW - Cross-Sectional Studies

KW - Simian Acquired Immunodeficiency Syndrome/etiology

KW - Vaccination/adverse effects

KW - Autoimmune Diseases/epidemiology

U2 - 10.1093/rheumatology/keac305

DO - 10.1093/rheumatology/keac305

M3 - Article (Academic Journal)

C2 - 35713499

SN - 1462-0324

VL - 62

SP - 65

EP - 76

JO - Rheumatology

JF - Rheumatology

IS - 1

ER -

COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study

Abstract

Bibliographical note

UN SDGs

Keywords

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