How common are long-lasting, intensely itching vaccination granulomas and contact allergy to aluminium induced by currently used pediatric vaccines? A prospective cohort study
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The frequency of long-lasting, intensely itching subcutaneous nodules at the injection site for aluminium (Al)-adsorbed vaccines (vaccination granulomas) was investigated in a prospective cohort study comprising 4,758 children who received either a diphtheria-tetanus-pertussis-polio-Haemophilus influenzae type b vaccine (Infanrix®, Pentavac®) alone or concomitant with a pneumococcal conjugate (Prevenar). Both vaccines were adsorbed to an Al adjuvant. Altogether 38 children (0.83 %) with itching granulomas were identified, epicutaneously tested for Al sensitisation and followed yearly. Contact allergy to Al was verified in 85 %. The median duration of symptoms was 22 months in those hitherto recovered. The frequency of granulomas induced by Infanrix® was >0.66 % and by Prevenar >0.35 %. The risk for granulomas increased from 0.63 to 1.18 % when a second Al-adsorbed vaccine was added to the schedule. Conclusion: Long-lasting itching vaccination granulomas are poorly understood but more frequent than previously known after infant vaccination with commonly used diphtheria-tetanus-pertussis-polio-Haemophilus influenzae type b and pneumococcal conjugate vaccines. The risk increases with the number of vaccines given. Most children with itching granulomas become contact allergic to aluminium. Itching vaccination granulomas are benign but may be troublesome and should be recognised early in primary health care to avoid unnecessary investigations, anxiety and mistrust.
KeywordsItching nodule Granuloma Contact allergy Aluminium Adsorbed vaccines Child health care
Child health care (center)
Diphtheria-tetanus-acellular pertussis (vaccine)
- DTaP comb
Combination vaccine including DTaP, polio, Hib, (hepatitis B)
Elisabet Bergfors (project leader of the study)
Haemophilus influenzae type b (vaccine)
Human papilloma virus (vaccine)
Tick-borne encephalitis (vaccine)
We thank Anna-Karin Schöld for handling the epicutaneous testing, Sara Sävemyr for registration of thousands of enquiry responses and Mikael Åkeborg at the Care Data Warehouse of Östergötland County Council for providing us with names, dates of birth and personal code numbers of children born in 2008. The study was carried out with ALF grants from Linköping University and the County Council of Östergötland.
The study was approved by the Ethical Review Board in Linköping, Sweden (Dnr M110-09) and registered in the County Council of Östergötland according to the Personal Data Ordinance. The parents of all children participating in the clinical study gave informed consent before taking part in it.
Conflict of interest
The authors declare that they have no financial relationship with the organization that sponsored the research, nor any other conflict of interest.
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