Risk factors associated with short-term adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory diseases

• Published in: BMC medicine 2022-03, Vol.20 (1), p.100-6, Article 100
• Main Authors: Wieske, Luuk, Kummer, Laura Y L, van Dam, Koos P J, Stalman, Eileen W, van der Kooi, Anneke J, Raaphorst, Joost, Löwenberg, Mark, Takkenberg, R Bart, Volkers, Adriaan G, D'Haens, Geert R A M, Tas, Sander W, Spuls, Phyllis I, Bekkenk, Marcel W, Musters, Annelie H, Post, Nicoline F, Bosma, Angela L, Hilhorst, Marc L, Vegting, Yosta, Bemelman, Frederike J, Killestein, Joep, van Kempen, Zoé L E, Voskuyl, Alexandre E, Broens, Bo, Sanchez, Agner Parra, Wolbink, Gertjan, Boekel, Laura, Rutgers, Abraham, de Leeuw, Karina, Horváth, Barbara, Verschuuren, Jan J G M, Ruiter, Annabel M, van Ouwerkerk, Lotte, van der Woude, Diane, Allaart, Cornelia F, Teng, Y K Onno, van Paassen, Pieter, Busch, Matthias H, Jallah, B Papay, Brusse, Esther, van Doorn, Pieter A, Baars, Adája E, Hijnen, Dirkjan, Schreurs, Corine R G, van der Pol, W Ludo, Goedee, H Stephan, Steenhuis, Maurice, Rispens, Theo, Ten Brinke, Anja, Verstegen, Niels J M, Zwinderman, Koos A H, van Ham, S Marieke, Kuijpers, Taco W, Eftimov, Filip
• Format: Article
• Language: English
• Subjects: Adverse and side effects; BNT162 Vaccine; Cohort Studies; Complications and side effects; Correspondence; COVID-19 - prevention & control; COVID-19 Vaccines - adverse effects; Drugs; Female; Humans; Immunologic diseases; Prospective Studies; Risk Factors; SARS-CoV-2; Statistics; Vaccination; Vaccination - adverse effects
• ISSN: 1741-7015; 1741-7015
• DOI: 10.1186/s12916-022-02310-7

Studies have suggested incremental short-term adverse events (AE) after repeated vaccination. In this report, we assessed occurrence and risk factors for short-term AEs following repeated SARS-CoV-2 vaccination in patients with various immune-mediated inflammatory diseases (IMIDs). Self-reported daily questionnaires on AEs during the first 7 days after vaccination were obtained of 2259 individuals (2081 patients and 178 controls) participating in an ongoing prospective multicenter cohort study on SARS-CoV-2 vaccination in patients with various IMIDs in the Netherlands (T2B-COVID). Relative risks were calculated for potential risk factors associated with clinically relevant AE (rAE), defined as AE lasting longer than 2 days or impacting daily life. In total, 5454 vaccinations were recorded (1737 first, 1992 second and 1478 third vaccinations). Multiple sclerosis, Crohn's disease and rheumatoid arthritis were the largest disease groups. rAEs were reported by 57.3% (95% CI 54.8-59.8) of patients after the first vaccination, 61.5% (95% CI 59.2-63.7) after the second vaccination and 58% (95% CI 55.3-60.6) after the third vaccination. At day 7 after the first, second and third vaccination, respectively, 7.6% (95% CI 6.3-9.1), 7.4% (95% CI 6.2-8.7) and 6.8% (95% CI 5.4-8.3) of patients still reported AEs impacting daily life. Hospital admissions and allergic reactions were uncommon (