The role of co-morbidities in the development of an AEFI after COVID-19 vaccination in a large prospective cohort with patient-reported outcomes in the Netherlands

References

• Amraotkar AR, Bushau-Sprinkle AM, Keith RJ, et al. Pre-existing comorbidities diminish the likelihood of seropositivity after SARS-CoV-2 vaccination Vaccines (Basel). Aug 20 2022;10(8):1363. doi: 10.3390/vaccines10081363. PMID: 36016250; PMCID: PMC9416221.
   PubMed Web of Science ®Google Scholar
• Choi WS, Cheong HJ. COVID-19 vaccination for people with comorbidities. Infect Chemother. 2021;53(1):155. doi: 10.3947/ic.2021.0302
   PubMed Web of Science ®Google Scholar
• European Medicines Agency (EMA). Consideration on core requirements for RMPs of COVID-19 vaccines - coreRMP19 guidance v3.1. vol. EMA/PRAC/709308/2022. 2022.
   Google Scholar
• Watad A, De Marco G, Mahajna H, et al. Immune-mediated disease flares or new-onset disease in 27 subjects following mRNA/DNA SARS-CoV-2 vaccination. Vaccines. 2021;9(5):435. doi: 10.3390/vaccines9050435
   PubMed Web of Science ®Google Scholar
• Kivity S, Agmon-Levin N, Blank M, et al. Infections and autoimmunity–friends or foes? Trends Immunol. 2009;30(8):409–414. doi: 10.1016/j.it.2009.05.005
   PubMed Web of Science ®Google Scholar
• Álvaro-Gracia JM, Sanchez-Piedra C, Culqui D, et al. Effects of COVID-19 vaccination on disease activity in patients with rheumatoid arthritis and psoriatic arthritis on targeted therapy in the COVIDSER study. RMD Open. 2023;9(1):e002936. doi: 10.1136/rmdopen-2022-002936
   PubMed Web of Science ®Google Scholar
• Agmon-Levin N, Paz Z, Israeli E, et al. Vaccines and autoimmunity. Nat Rev Rheumatol. 2009;5(11):648–652. doi: 10.1038/nrrheum.2009.196
   PubMed Web of Science ®Google Scholar
• Wieske L, Kummer LY, van Dam KP, et al. Risk factors associated with short-term adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory diseases. BMC Med. 2022;20(1):100. doi: 10.1186/s12916-022-02310-7
   PubMed Web of Science ®Google Scholar
• Li L, Lin X-Q, Chen Y, et al. Adverse reactions to inactivated COVID-19 vaccination in patients with chronic liver disease: the effect of anxiety. Human Vaccines Immunother. 2022;18(6):2136435. doi: 10.1080/21645515.2022.2136435
   PubMed Web of Science ®Google Scholar
• Wang J, Hou Z, Liu J, et al. Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): a multicenter study. J Hepatol. 2021;75(2):439–441. doi: 10.1016/j.jhep.2021.04.026
   PubMed Web of Science ®Google Scholar
• Sanders J-S, Bemelman FJ, Messchendorp AL, et al. The RECOVAC immune-response study: the immunogenicity, tolerability, and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant. Transplantation. 2022;106(4):821. doi: 10.1097/TP.0000000000003983
   PubMed Web of Science ®Google Scholar
• Tang K-T, Hsu B-C, Chen D-Y. Immunogenicity, effectiveness, and safety of COVID-19 vaccines in rheumatic patients: an updated systematic review and meta-analysis. Biomedicines. 2022;10(4):834. doi: 10.3390/biomedicines10040834
   PubMed Web of Science ®Google Scholar
• James D, Jena A, Bharath PN, et al. Safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease: a systematic review and meta-analysis. Digestive Liver Dis. 2022;54(6):713–721. doi: 10.1016/j.dld.2022.03.005
   Web of Science ®Google Scholar
• Duijster JW, Lieber T, Pacelli S, et al. Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: a Dutch cohort study and review of the literature. Front Immunol. 2023;14:14. doi: 10.3389/fimmu.2023.1078736
   Web of Science ®Google Scholar
• Rolfes L, Härmark L, Kant A, et al. COVID-19 vaccine reactogenicity–A cohort event monitoring study in the Netherlands using patient reported outcomes. Vaccine. 2022;40(7):970–976. doi: 10.1016/j.vaccine.2022.01.013
   PubMed Web of Science ®Google Scholar
• Kant A, Jansen J, van Balveren L, et al. Description of frequencies of reported adverse events following immunization among four different COVID-19 vaccine brands. Drug Saf. 2022;45(4):319–331. doi: 10.1007/s40264-022-01151-w
   PubMed Web of Science ®Google Scholar
• Raethke M, van Hunsel F, Thurin NH, et al. Cohort event monitoring of adverse reactions to COVID-19 vaccines in seven European Countries: pooled results on first dose. Drug Saf. 2023;46(4):391–404. doi: 10.1007/s40264-023-01281-9
   PubMed Web of Science ®Google Scholar
• Medical Dictionary for Regulatory Activities. Available from: https://www.meddra.org/
   Google Scholar
• Kohl KS, Bonhoeffer J, Braun MM, et al. The Brighton Collaboration. The brighton collaboration: creating a global standard for case definitions (and guidelines) for adverse events following immunization. In: Henriksen K, Battles JB, Marks ES, et al., editors. Advances in patient safety: from research to implementation (volume 2: concepts and methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005. Feb. https://www.ncbi.nlm.nih.gov/books/NBK20507/
   Google Scholar
• Ganesan S, Al Ketbi LMB, Al Kaabi N, et al. Vaccine side effects following COVID-19 vaccination among the residents of the UAE—an observational study. Front Public Health. 2022;10. doi: 10.3389/fpubh.2022.876336
   PubMed Web of Science ®Google Scholar
• Kouhpayeh H, Ansari H. Adverse events following COVID-19 vaccination: a systematic review and meta-analysis. Int Immunopharmacol. 2022;109:108906. doi: 10.1016/j.intimp.2022.108906
   PubMed Web of Science ®Google Scholar
• Menni C, Klaser K, May A, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21(7):939–949. doi: 10.1016/S1473-3099(21)00224-3
   PubMed Web of Science ®Google Scholar
• Loosen SH, Bohlken J, Weber K, et al. Factors associated with non-severe adverse reactions after vaccination against SARS-CoV-2: a cohort study of 908,869 outpatient vaccinations in Germany. Vaccines. 2022;10(4):566. doi: 10.3390/vaccines10040566
   Web of Science ®Google Scholar
• Zhou Z, Shen J, Zhao M, et al. Effect of anxiety and depression on self-reported adverse reactions to COVID-19 vaccine: a cross-sectional study in Shanghai, China. BMC Public Health. 2023;23(1):425. doi: 10.1186/s12889-023-15118-8
   PubMed Web of Science ®Google Scholar
• Geers AL, Clemens KS, Faasse K, et al. Psychosocial factors predict COVID-19 vaccine side effects. Psychother Psychosom. 2022;91(2):136–138. doi: 10.1159/000519853
   PubMed Web of Science ®Google Scholar
• Sever P. Nocebo affects after COVID-19 vaccination. Lancet Reg Health - Eur. 2022;12:100273. doi: 10.1016/j.lanepe.2021.100273
   PubMedGoogle Scholar
• van Lint JA, Jessurun NT, Hebing RC, et al. Patient-reported burden of adverse drug reactions attributed to biologics used for immune-mediated inflammatory diseases. Drug Saf. 2020;43:917–925. doi: 10.1007/s40264-020-00946-z
   PubMed Web of Science ®Google Scholar
• Westerink HJ, Kosse LJ, Jessurun NT, et al. Patients’ and health-care professionals’ perspectives on adverse drug reaction burden attributed to the use of biological DMARDs: a qualitative study. Expert Opin Drug Saf. 2023;22(5):417–424. doi: 10.1080/14740338.2023.2134344
   PubMed Web of Science ®Google Scholar
• Kiecolt-Glaser JK, Derry HM, Fagundes CP. Inflammation: depression fans the flames and feasts on the heat. Am J Psychiatry. 2015;172(11):1075–1091. doi: 10.1176/appi.ajp.2015.15020152
   PubMed Web of Science ®Google Scholar
• Madison AA, Shrout MR, Renna ME, et al. Psychological and behavioral predictors of vaccine efficacy: considerations for COVID-19. Perspectives Psychol Sci. 2021;16(2):191–203. doi: 10.1177/1745691621989243
   Web of Science ®Google Scholar
• Glaser R, Robles TF, Sheridan J, et al. Mild depressive symptoms are associated with amplified and prolonged inflammatory responses after influenza virus vaccination in older adults. Arch Gen Psychiatry. 2003;60(10):1009–1014. doi: 10.1001/archpsyc.60.10.1009
   PubMed Web of Science ®Google Scholar
• Irwin MR, Levin MJ, Laudenslager ML, et al. Varicella zoster virus–specific immune responses to a herpes zoster vaccine in elderly recipients with major depression and the impact of antidepressant medications. Clinl Infect Dis. 2013;56(8):1085–1093. doi: 10.1093/cid/cis1208
   PubMed Web of Science ®Google Scholar
• Boroumand AB, Forouhi M, Karimi F, et al. Immunogenicity of COVID-19 vaccines in patients with diabetes mellitus: a systematic review. Front Immunol. 2022;13:4242. doi:10.3389/fimmu.2022.940357
   Google Scholar
• Gaborit B, Fernandes S, Loubet P, et al. Early humoral response to COVID-19 vaccination in patients living with obesity and diabetes in France. The COVPOP OBEDIAB study with results from the ANRS0001S COV-POPART cohort. Metabolism. 2023;142:155412. doi: 10.1016/j.metabol.2023.155412
   PubMed Web of Science ®Google Scholar
• Kesavadev J, Misra A, Das AK, et al. Suggested use of vaccines in diabetes. Indian J Endocrinol Metab. 2012;16(6):886. doi: 10.4103/2230-8210.102982
   PubMedGoogle Scholar
• Ku CR, Jung KY, Ahn CH, et al. COVID-19 vaccination for endocrine patients: a position statement from the Korean endocrine society. Endocrinol Metab. 2021;36(4):757–765. doi: 10.3803/EnM.2021.404
   Google Scholar
• Gouda N, Dimitriadou M, Sotiriou G, et al. The impact of COVID-19 vaccination on glycaemic control in children and adolescents with type 1 diabetes mellitus on continuous glucose monitoring. Acta Diabetol. 2022;59(12):1609–1614. doi: 10.1007/s00592-022-01968-y
   PubMed Web of Science ®Google Scholar
• Heald AH, Stedman M, Horne L, et al. The change in glycaemic control immediately after COVID‐19 vaccination in people with type 1 diabetes. Diabetic Med. 2022;39(4):e14774. doi: 10.1111/dme.14774
   PubMed Web of Science ®Google Scholar
• Lin C-W, Hung S-Y, Chen I-W. A study of glycemic perturbations following two doses of COVID-19 vaccination for patients with diabetes: the impacts of vaccine type and anti-diabetes drugs. Diabetol Metab Syndr. 2023;15(1):1–8. doi: 10.1186/s13098-023-01059-0
   PubMed Web of Science ®Google Scholar
• Esquivel-Valerio JA, Skinner-Taylor CM, Moreno-Arquieta IA, et al. Adverse events of six COVID-19 vaccines in patients with autoimmune rheumatic diseases: a cross-sectional study. Rheumatol Int. 2021;41(12):2105–2108. doi: 10.1007/s00296-021-05017-9
   PubMed Web of Science ®Google Scholar
• Picchianti Diamanti A, Navarra A, Cuzzi G, et al. The third dose of BNT162b2 COVID-19 vaccine does not “boost” disease flares and adverse events in patients with rheumatoid arthritis. Biomedicines. 2023;11(3):687. doi: 10.3390/biomedicines11030687
   PubMed Web of Science ®Google Scholar
• Spinelli FR, Favalli EG, Garufi C, et al. Low frequency of disease flare in patients with rheumatic musculoskeletal diseases who received SARS-CoV-2 mRNA vaccine. Arthritis Res Ther. 2022;24(1):1–8. doi: 10.1186/s13075-021-02674-w
   PubMed Web of Science ®Google Scholar
• van Dam KP, Wieske L, Stalman EW, et al. Disease activity in patients with immune-mediated inflammatory diseases after SARS-CoV-2 vaccinations. J Autoimmun. 2023;135:102984. doi: 10.1016/j.jaut.2022.102984
   PubMed Web of Science ®Google Scholar