• Luuk Wieske, Laura Y L Kummer, Koos P J van Dam, Eileen W Stalman, Anneke J van der Kooi, Joost Raaphorst, Mark Löwenberg, R Bart Takkenberg, Adriaan G Volkers, D'HaensGeert R A MGRAMDepartment of Gastroenterology and Hepathology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands., Sander W Tas, Phyllis I Spuls, Marcel W Bekkenk, Annelie H Musters, Nicoline F Post, Angela L Bosma, Marc L Hilhorst, Yosta Vegting, Frederike J Bemelman, Joep Killestein, Zoé L E van Kempen, Alexandre E Voskuyl, Bo Broens, Agner Parra Sanchez, Gertjan Wolbink, Laura Boekel, Abraham Rutgers, Karina de Leeuw, Barbara Horváth, VerschuurenJan J G MJJGMDepartment of Neurology, Leiden University Medical Center, Leiden, The Netherlands., Annabel M Ruiter, Lotte van Ouwerkerk, Diane van der Woude, Cornelia F Allaart, Y K Onno Teng, Pieter van Paassen, Matthias H Busch, B Papay Jallah, Esther Brusse, Pieter A van Doorn, Adája E Baars, Dirkjan Hijnen, Corine R G Schreurs, W Ludo van der Pol, H Stephan Goedee, Maurice Steenhuis, Theo Rispens, Anja Ten Brinke, Niels J M Verstegen, ZwindermanKoos A HKAHClinical Research Unit, Amsterdam UMC, Location Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands., van HamS MariekeSMDepartment of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, The Netherlands.Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam, The Netherlands., Taco W Kuijpers, Filip Eftimov, and T2B! immunity against SARS-CoV-2 study group.
• Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
• Bmc Med. 2022 Mar 2; 20 (1): 100.

BackgroundStudies 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).MethodsSelf-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.ResultsIn 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).ConclusionsA 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.Trial RegistrationNL74974.018.20 , Trial ID: NL8900. Registered on 9 September 2020.© 2022. The Author(s).

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