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

Luuk Wieske; Laura Y.L. Kummer; the T2B! Immunity against SARS-CoV-2 study group; Koos P.J. van Dam; Eileen W. Stalman; Anneke J. van der Kooi; Joost Raaphorst; Mark Löwenberg; R. Bart Takkenberg; Adriaan G. Volkers; Geert R.A.M. D’Haens; 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; Jan J.G.M. Verschuuren; 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; Koos A.H. Zwinderman; SM van Ham; Taco W. Kuijpers; Filip Eftimov

doi:10.1186/s12916-022-02310-7

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

Luuk Wieske, Laura Y.L. Kummer, the T2B! Immunity against SARS-CoV-2 study group, Koos P.J. van Dam, Eileen W. Stalman, Anneke J. van der Kooi, Joost Raaphorst, Mark Löwenberg, R. Bart Takkenberg, Adriaan G. Volkers, Geert R.A.M. D’Haens, 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. BemelmanJoep 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, Jan J.G.M. Verschuuren, 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, Koos A.H. Zwinderman, SM van Ham, Taco W. Kuijpers, Filip Eftimov

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Abstract

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. Trial registration: NL74974.018.20, Trial ID: NL8900. Registered on 9 September 2020.

Original language	English
Article number	100
Journal	BMC Medicine
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s12916-022-02310-7
Publication status	Published - 2 Mar 2022

Bibliographical note

Funding Information:
We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholten for their guidance in the data safety monitoring board.

Funding Information:
JV reported financial support from Target to B consortium, Prinses Beatrix Spierfonds, and has been involved in trials or consultancies for Argenx, Alexion, Rapharma. BH reported fees from Roche, Sanofi, Novartis and Janssen. JK reported speaking and consulting relationships with Biogen, Genzyme, Merck, Novartis, Roche, Sanofi and TEVA. AmsterdamUMC, location VUmc, MS Center Amsterdam, has received financial support for research activities from Biogen, Celgene, Genzyme, Merck, Novartis, Roche, Sanofi and TEVA. PS reported being involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and is one of the main investigator of the TREAT registry taskforce and SECURE-AD registry. ML reported to have served as speaker and/or is a principal investigator for Abbvie, Alimentiv, Bristol Myers Squibb, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Galapagos, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Protagonist Therapeutics, Receptos, Takeda, Tillotts and Tramedico. FE, GW and TK reported a grant from ZonMW for COVID research in patients with auto-immune diseases. No other disclosures were reported.

Funding Information:
This study was supported by ZonMw (The Netherlands Organization for Health Research and Development, 10430072010007). The sponsor had no role in the design, analyses or reporting of the study.

Publisher Copyright:
© 2022, The Author(s).

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Wieske, L., Kummer, L. Y. L., the T2B! Immunity against SARS-CoV-2 study group, van Dam, K. P. J., Stalman, E. W., van der Kooi, A. J., Raaphorst, J., Löwenberg, 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., ... Eftimov, F. (2022). Risk factors associated with short-term adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory diseases. BMC Medicine, 20(1), Article 100. https://doi.org/10.1186/s12916-022-02310-7

@article{1aeafd6becf94c288eb7fcab79541681,

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

abstract = "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{\textquoteright}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. Trial registration: NL74974.018.20, Trial ID: NL8900. Registered on 9 September 2020.",

author = "Luuk Wieske and Kummer, {Laura Y.L.} and {the T2B! Immunity against SARS-CoV-2 study group} and {van Dam}, {Koos P.J.} and Stalman, {Eileen W.} and {van der Kooi}, {Anneke J.} and Joost Raaphorst and Mark L{\"o}wenberg and Takkenberg, {R. Bart} and Volkers, {Adriaan G.} and D{\textquoteright}Haens, {Geert R.A.M.} and Tas, {Sander W.} and Spuls, {Phyllis I.} and Bekkenk, {Marcel W.} and Musters, {Annelie H.} and Post, {Nicoline F.} and Bosma, {Angela L.} and Hilhorst, {Marc L.} and Yosta Vegting and Bemelman, {Frederike J.} and Joep Killestein and {van Kempen}, {Zo{\'e} L.E.} and Voskuyl, {Alexandre E.} and Bo Broens and Sanchez, {Agner Parra} and Gertjan Wolbink and Laura Boekel and Abraham Rutgers and {de Leeuw}, Karina and Barbara Horv{\'a}th and Verschuuren, {Jan J.G.M.} and Ruiter, {Annabel M.} and {van Ouwerkerk}, Lotte and {van der Woude}, Diane and Allaart, {Cornelia F.} and Teng, {Y. K.Onno} and {van Paassen}, Pieter and Busch, {Matthias H.} and Jallah, {B. Papay} and Esther Brusse and {van Doorn}, {Pieter A.} and Baars, {Ad{\'a}ja E.} and Dirkjan Hijnen and Schreurs, {Corine R.G.} and {van der Pol}, {W. Ludo} and Goedee, {H. Stephan} and Maurice Steenhuis and Theo Rispens and {ten Brinke}, Anja and Verstegen, {Niels J.M.} and Zwinderman, {Koos A.H.} and {van Ham}, SM and Kuijpers, {Taco W.} and Filip Eftimov",

note = "Funding Information: We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholten for their guidance in the data safety monitoring board. Funding Information: JV reported financial support from Target to B consortium, Prinses Beatrix Spierfonds, and has been involved in trials or consultancies for Argenx, Alexion, Rapharma. BH reported fees from Roche, Sanofi, Novartis and Janssen. JK reported speaking and consulting relationships with Biogen, Genzyme, Merck, Novartis, Roche, Sanofi and TEVA. AmsterdamUMC, location VUmc, MS Center Amsterdam, has received financial support for research activities from Biogen, Celgene, Genzyme, Merck, Novartis, Roche, Sanofi and TEVA. PS reported being involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and is one of the main investigator of the TREAT registry taskforce and SECURE-AD registry. ML reported to have served as speaker and/or is a principal investigator for Abbvie, Alimentiv, Bristol Myers Squibb, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Galapagos, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Protagonist Therapeutics, Receptos, Takeda, Tillotts and Tramedico. FE, GW and TK reported a grant from ZonMW for COVID research in patients with auto-immune diseases. No other disclosures were reported. Funding Information: This study was supported by ZonMw (The Netherlands Organization for Health Research and Development, 10430072010007). The sponsor had no role in the design, analyses or reporting of the study. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = mar,

day = "2",

doi = "10.1186/s12916-022-02310-7",

language = "English",

volume = "20",

journal = "BMC Medicine",

issn = "1741-7015",

publisher = "BioMed Central Ltd.",

number = "1",

}

Wieske, L, Kummer, LYL, the T2B! Immunity against SARS-CoV-2 study group, van Dam, KPJ, Stalman, EW, van der Kooi, AJ, Raaphorst, J, Löwenberg, M, Takkenberg, RB, Volkers, AG, D’Haens, GRAM, Tas, SW, Spuls, PI, Bekkenk, MW, Musters, AH, Post, NF, Bosma, AL, Hilhorst, ML, Vegting, Y, Bemelman, FJ, Killestein, J, van Kempen, ZLE, Voskuyl, AE, Broens, B, Sanchez, AP, Wolbink, G, Boekel, L, Rutgers, A, de Leeuw, K, Horváth, B, Verschuuren, JJGM, Ruiter, AM, van Ouwerkerk, L, van der Woude, D, Allaart, CF, Teng, YKO, van Paassen, P, Busch, MH, Jallah, BP, Brusse, E , van Doorn, PA , Baars, AE , Hijnen, D, Schreurs, CRG, van der Pol, WL, Goedee, HS, Steenhuis, M, Rispens, T, ten Brinke, A, Verstegen, NJM, Zwinderman, KAH, van Ham, SM, Kuijpers, TW & Eftimov, F 2022, 'Risk factors associated with short-term adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory diseases', BMC Medicine, vol. 20, no. 1, 100. https://doi.org/10.1186/s12916-022-02310-7

TY - JOUR

T1 - Risk factors associated with short-term adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory diseases

AU - Wieske, Luuk

AU - Kummer, Laura Y.L.

AU - the T2B! Immunity against SARS-CoV-2 study group

AU - van Dam, Koos P.J.

AU - Stalman, Eileen W.

AU - van der Kooi, Anneke J.

AU - Raaphorst, Joost

AU - Löwenberg, Mark

AU - Takkenberg, R. Bart

AU - Volkers, Adriaan G.

AU - D’Haens, Geert R.A.M.

AU - Tas, Sander W.

AU - Spuls, Phyllis I.

AU - Bekkenk, Marcel W.

AU - Musters, Annelie H.

AU - Post, Nicoline F.

AU - Bosma, Angela L.

AU - Hilhorst, Marc L.

AU - Vegting, Yosta

AU - Bemelman, Frederike J.

AU - Killestein, Joep

AU - van Kempen, Zoé L.E.

AU - Voskuyl, Alexandre E.

AU - Broens, Bo

AU - Sanchez, Agner Parra

AU - Wolbink, Gertjan

AU - Boekel, Laura

AU - Rutgers, Abraham

AU - de Leeuw, Karina

AU - Horváth, Barbara

AU - Verschuuren, Jan J.G.M.

AU - Ruiter, Annabel M.

AU - van Ouwerkerk, Lotte

AU - van der Woude, Diane

AU - Allaart, Cornelia F.

AU - Teng, Y. K.Onno

AU - van Paassen, Pieter

AU - Busch, Matthias H.

AU - Jallah, B. Papay

AU - Brusse, Esther

AU - van Doorn, Pieter A.

AU - Baars, Adája E.

AU - Hijnen, Dirkjan

AU - Schreurs, Corine R.G.

AU - van der Pol, W. Ludo

AU - Goedee, H. Stephan

AU - Steenhuis, Maurice

AU - Rispens, Theo

AU - ten Brinke, Anja

AU - Verstegen, Niels J.M.

AU - Zwinderman, Koos A.H.

AU - van Ham, SM

AU - Kuijpers, Taco W.

AU - Eftimov, Filip

N1 - Funding Information: We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholten for their guidance in the data safety monitoring board. Funding Information: JV reported financial support from Target to B consortium, Prinses Beatrix Spierfonds, and has been involved in trials or consultancies for Argenx, Alexion, Rapharma. BH reported fees from Roche, Sanofi, Novartis and Janssen. JK reported speaking and consulting relationships with Biogen, Genzyme, Merck, Novartis, Roche, Sanofi and TEVA. AmsterdamUMC, location VUmc, MS Center Amsterdam, has received financial support for research activities from Biogen, Celgene, Genzyme, Merck, Novartis, Roche, Sanofi and TEVA. PS reported being involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and is one of the main investigator of the TREAT registry taskforce and SECURE-AD registry. ML reported to have served as speaker and/or is a principal investigator for Abbvie, Alimentiv, Bristol Myers Squibb, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Galapagos, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Protagonist Therapeutics, Receptos, Takeda, Tillotts and Tramedico. FE, GW and TK reported a grant from ZonMW for COVID research in patients with auto-immune diseases. No other disclosures were reported. Funding Information: This study was supported by ZonMw (The Netherlands Organization for Health Research and Development, 10430072010007). The sponsor had no role in the design, analyses or reporting of the study. Publisher Copyright: © 2022, The Author(s).

PY - 2022/3/2

Y1 - 2022/3/2

N2 - 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. Trial registration: NL74974.018.20, Trial ID: NL8900. Registered on 9 September 2020.

AB - 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. Trial registration: NL74974.018.20, Trial ID: NL8900. Registered on 9 September 2020.

UR - http://www.scopus.com/inward/record.url?scp=85125612390&partnerID=8YFLogxK

U2 - 10.1186/s12916-022-02310-7

DO - 10.1186/s12916-022-02310-7

M3 - Article

C2 - 35236350

AN - SCOPUS:85125612390

SN - 1741-7015

VL - 20

JO - BMC Medicine

JF - BMC Medicine

IS - 1

M1 - 100

ER -

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

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