title: How common are long-lasting, intensely itching vaccination granulomas and contact allergy to aluminium induced by currently used pediatric vaccines? A prospective cohort study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Primary Health Care, The Sahlgrenska Academy, University of Gothenburg, PO Box 454, 40530, Gothenburg, Sweden, elisabet.bergfors@allmed.gu.se.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Bergfors
authors.forename: Göran
authors.initials: G
authors.lastname: Hermansson
authors.forename: Ulla
authors.initials: U
authors.lastname: Nyström Kronander
authors.forename: Lars
authors.initials: L
authors.lastname: Falk
authors.forename: Lars
authors.initials: L
authors.lastname: Valter
authors.forename: Birger
authors.initials: B
authors.lastname: Trollfors
mesh_terms: D000293:Adolescent; D000535:Aluminum / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects* / Q000737:chemistry; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects* / Q000737:chemistry; D005260:Female; D005500:Follow-Up Studies; D006099:Granuloma / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D018073:Haemophilus Vaccines / Q000009:adverse effects* / Q000737:chemistry; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007223:Infant; D008297:Male; D022242:Pneumococcal Vaccines / Q000009:adverse effects* / Q000737:chemistry; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects* / Q000737:chemistry; D011446:Prospective Studies; D011537:Pruritus / Q000453:epidemiology / Q000209:etiology*; D012306:Risk; D013548:Sweden; D017778:Vaccines, Combined / Q000009:adverse effects / Q000737:chemistry
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; C426945:Pentavac; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; D000535:Aluminum
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