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.
COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study / 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.; O’Callaghan, A. S.; Nikiphorou, E.; Chatterjee, T.; Tan, A. L.; Cavagna, L.; Saavedra, M. A.; Shinjo, S. K.; Ziade, N.; Knitza, J.; Kuwana, M.; Distler, O.; Chinoy, H.; Agarwal, V.; Aggarwal, R.; Gupta, L.; Joshi, M.; Barman, B.; Singh, Y. P.; Ranjan, R.; Jain, A.; Pandya, S. C.; Pilania, R. K.; Sharma, A.; Manesh Manoj, M.; Gupta, V.; Kavadichanda, C. G.; Patro, P. S.; Ajmani, S.; Phatak, S.; Goswami, R. P.; Chowdhury, A. C.; Mathew, A. J.; Shenoy, P.; Asranna, A.; Bommakanti, K. T.; Shukla, A.; Pande, A. R.; Chandwar, K.; Cansu, D. Ü.; Pauling, J. D.; Wincup, C.; Makol, A.; Del Papa, N.; Sambataro, G.; Fabiola, A.; Govoni, M.; Parisi, S.; Bocci, E. B.; Sebastiani, G. D.; Fusaro, E.; Sebastiani, M.; Quartuccio, L.; Franceschini, F.; Sainaghi, P. P.; Orsolini, G.; De Angelis, R.; Danielli, M. G.; Venerito, V.; Traboco, L. S.; Wibowo, S. A. K.; Serrano, J. R.; García-De La Torre, I.; Tehozol, E. A. Z.; Loarce-Martos, J.; Prieto-González, S.; Gil-Vila, A.; Gonzalez, R. A.; Yoshida, A.; Nakashima, R.; Sato, S.; Kimura, N.; Kaneko, Y.; Tomaras, S.; Gromova, M. A.; Aharonov, O.; Hmamouchi, I.; Hoff, L. S.; Giannini, M.; Maurier, F.; Campagne, J.; Meyer, A.; Nagy-Vincze, M.; Langguth, D.; Limaye, V.; Needham, M.; Srivastav, N.. - In: RHEUMATOLOGY. - ISSN 1462-0324. - 62:1(2023), pp. 65-76. [10.1093/rheumatology/keac305]