Long-term clinical course and prognosis of vaccine-related persistent itching nodules (1997-2019): An observational study

Anette Gente Lidholm; Annica Inerot; Martin Gillstedt; Elisabet Bergfors; Birger Trollfors

doi:10.1016/j.jvacx.2022.100163

Long-term clinical course and prognosis of vaccine-related persistent itching nodules (1997-2019): An observational study

Vaccine X. 2022 Apr 29:11:100163. doi: 10.1016/j.jvacx.2022.100163. eCollection 2022 Aug.

Authors

Anette Gente Lidholm^{1

2}, Annica Inerot^{1

2}, Martin Gillstedt^{1

2}, Elisabet Bergfors³, Birger Trollfors⁴

Affiliations

¹ Department of Dermatology and Venereology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
² Department of Dermatology and Venereology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
³ General Practice / Family Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁴ Department of Paediatrics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Abstract

Background: Vaccines adsorbed to aluminium can induce long-lasting intensely itching subcutaneous nodules (granulomas) at the injection site as well as contact allergy to aluminium. In clinical trials of a new acellular pertussis vaccine performed in the 1990s (Gothenburg, Sweden) with 76 000 participants, itching nodules were reported in 745 children. A positive patch test to aluminium was verified in 77% of the tested children with itchy nodules.

Aim: To describe the long-term clinical course and prognosis of vaccine-related itching nodules caused by aluminium-containing pediatric vaccines and to estimate the risk for new symptoms after future vaccination with aluminium-containing vaccines.

Methods: 745 children with vaccine-related itching nodules were followed by regular interviews/questionnaires for more than 20 years. 723 of them received a booster dose of diphtheria/tetanus vaccine either with or without aluminium adjuvant during the follow-up time.

Results: Most study participants (86%) reported a full recovery from their itching nodules after a median duration of 6.6 years. Only a few of the diphtheria/tetanus-booster-vaccinated children (3%) reported mild transient itching and swelling at the new injection site.

Conclusion: Vaccine-induced itching granulomas caused by an aluminium-adsorbed acellular pertussis toxoid vaccine seem to disappear over time. Future vaccinations with aluminium-adsorbed vaccines can be performed with little risk for new itching nodules later in life.

Keywords: ASIT, Allergen-specific immunotherapy; Adverse event; Aluminium; Aluminium allergy; Childhood vaccine; DT, Diphtheria-tetanusvaccine; DTaP, Diphtheria-tetanus-acellular pertussis vaccine; Granulomas; HPV, Human papillomavirus; Itching nodules; SSI, Statens Serum Institut; TBE, Tick-borne encephalitis; aP, Acellular pertussis toxoid vaccine.