COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study
Authors: Sen Parikshit , Ravichandran Naveen , Nune Arvind , Lilleker James B , Agarwal Vishwesh , Kardes Sinan , Kim Minchul , Day Jessica , Milchert Marcin , Gheita Tamer , Salim Babur , Velikova Tsvetelina , Gracia-Ramos Abraham Edgar , Parodis Ioannis , Selva O’Callaghan Albert , Nikiphorou Elena , Chatterjee Tulika , Tan Ai Lyn , Cavagna Lorenzo , Saavedra Miguel A , Shinjo Samuel Katsuyuki , Ziade Nelly , Knitza Johannes , Kuwana Masataka , Distler Oliver , Chinoy Hector , Agarwal Vikas , Aggarwal Rohit , Gupta Latika ,   COVAD Study Group, Joshi Mrudula , Barman Bhupen , Singh Yogesh Preet , Ranjan Rajiv , Jain Avinash , Pandya Sapan C , Pilania Rakesh Kumar , Sharma Aman , Manesh Manoj M , Gupta Vikas , Kavadichanda Chengappa G , Patro Pradeepta Sekhar , Ajmani Sajal , Phatak Sanat , Goswami Rudra Prosad , Chowdhury Abhra Chandra , Mathew Ashish Jacob , Shenoy Padnamabha , Asranna Ajay , Bommakanti Keerthi Talari , Shukla Anuj , Pandey ArunKumar R , Chandwar Kunal , Cansu Döndü Üsküdar , Pauling John D , Wincup Chris , Makol Ashima , Del Papa Nicoletta , Sambataro Gianluca , Fabiola Atzeni , Govoni Marcello , Parisi Simone , Bocci Elena Bartoloni , Sebastiani Gian Domenico , Fusaro Enrico , Sebastiani Marco , Quartuccio Luca , Franceschini Franco , Sainaghi Pier Paolo , Orsolini Giovanni , De Angelis Rossella , Danielli Maria Giovanna , Venerito Vincenzo , Traboco Lisa S , Wibowo Suryo Anggoro Kusumo , Serrano Jorge Rojas , García-De La Torre Ignacio , Loarce-Martos Erick Adrian Zamora Tehozol; Jesús , Prieto-González Sergio , Gil-Vila Albert , Aranega Raquel , Nakashima Ran , Sato Shinji , Kimura Naoki , Kaneko Yuko , Tomaras Stylianos , Gromova Margarita Aleksandrovna , Aharonov Or , Hmamouchi Ihsane , Hoff Leonardo Santos , Giannini Margherita , Maurier François , Campagne Julien , Meyer Alain , Nagy-Vincze Melinda , Langguth Daman , Limaye Vidya , Needham Merrilee , Srivastav Nilesh , Hudson Marie , Landon-Cardinal Océane , Shaharir Syahrul Sazliyana , Zuleta Wilmer Gerardo Rojas , Silva José António Pereira , Fonseca João Eurico , Zimba Olena 
Published: June 2022

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 &gt;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 &lt; 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 (&lt;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.