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

Wieske, L.; Kummer, L.Y.L.; Dam, K.P.J. van; Stalman, E.W.; Kooi, A.J. van der; Raaphorst, J.; ... ; T2b Immunity SARS-CoV-2 Study Grp (2022)

Article / Letter to editor

Background: 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).Methods: 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.Results: 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 (<0.7%).Female sex (aRR 1.43, 95% CI 1.32-1.56), age below 50 (aRR 1.14, 95% CI 1.06-1.23), a preceding SARS-CoV-2 infection (aRR 1.14, 95% CI 1.01-1.29) and having an IMID (aRR 1.16, 95% CI 1.01-1.34) were associated with increased risk of rAEs following a vaccination. Compared to the second vaccination, the first vaccination was associated with a lower risk of rAEs (aRR 0.92, 95% CI 0.84-0.99) while a third vaccination was not associated with increased risk on rAEs (aRR 0.93, 95% CI 0.84-1.02). BNT162b2 vaccines were associated with lower risk on rAEs compared to CX-024414 (aRR 0.86, 95% CI 0.80-0.93).Conclusions: A third SARS-CoV-2 vaccination was not associated with increased risk of rAEs in IMID patients compared to the second vaccination. Patients with an IMID have a modestly increased risk of rAEs after vaccination when compared to controls. Most AEs are resolved within 7 days; hospital admissions and allergic reactions were uncommon.

• All authors: Wieske, L.; Kummer, L.Y.L.; Dam, K.P.J. van; Stalman, E.W.; Kooi, A.J. van der; Raaphorst, J.; Lowenberg, M.; Takkenberg, R.B.; Volkers, A.G.; D'Haens, G.R.A.M.; Tas, S.W.; Spuls, P.I.; Bekkenk, M.W.; Musters, A.H.; Post, N.F.; Bosma, A.L.; Hilhorst, M.L.; Vegting, Y.; Bemelman, F.J.; Killestein, J.; Kempen, Z.L.E. van; Voskuyl, A.E.; Broens, B.; Sanchez, A.P.; Wolbink, G.; Boekel, L.; Rutgers, A.; Leeuw, K. de; Horvath, B.; Verschuuren, J.J.G.M.; Ruiter, A.M.; Ouwerkerk, L. van; Woude, D. van der; Allaart, C.F.; Teng, Y.K.O.; Paassen, P. van; Busch, M.H.; Jallah, B.P.; Brusse, E.; Doorn, P.A. van; Baars, A.E.; Hijnen, D.; Schreurs, C.R.G.; Pol, W.L. van der; Goedee, H.S.; Steenhuis, M.; Rispens, T.; Brinke, A. ten; Verstegen, N.J.M.; Zwinderman, K.A.H.; Ham, S.M. van; Kuijpers, T.W.; Eftimov, F.; T2b Immunity SARS-CoV-2 Study Grp
• Date: 2022-03-02
• Journal: BMC Medicine
• Volume: 20
• Issue: 1
• DOI: doi:10.1186/s12916-022-02310-7
• Link: https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02310-7