title: Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden.
abstract: OBJECTIVE
  To examine the risk of neurological and autoimmune disorders of special interest in people vaccinated against pandemic influenza A (H1N1) with Pandemrix (GlaxoSmithKline, Middlesex, UK) compared with unvaccinated people over 8-10 months.
  
  
  METHODS
  Retrospective cohort study linking individualised data on pandemic vaccinations to an inpatient and specialist database on healthcare utilisation in Stockholm county for follow-up during and after the pandemic period.
  
  
  METHODS
  Stockholm county, Sweden. Population All people registered in Stockholm county on 1 October 2009 and who had lived in this region since 1 January 1998; 1,024,019 were vaccinated against H1N1 and 921,005 remained unvaccinated.
  
  
  METHODS
  Neurological and autoimmune diagnoses according to the European Medicines Agency strategy for monitoring of adverse events of special interest defined using ICD-10 codes for Guillain-Barré syndrome, Bell's palsy, multiple sclerosis, polyneuropathy, anaesthesia or hypoaesthesia, paraesthesia, narcolepsy (added), and autoimmune conditions such as rheumatoid arthritis, inflammatory bowel disease, and type 1 diabetes; and short term mortality according to vaccination status.
  
  
  RESULTS
  Excess risks among vaccinated compared with unvaccinated people were of low magnitude for Bell's palsy (hazard ratio 1.25, 95% confidence interval 1.06 to 1.48) and paraesthesia (1.11, 1.00 to 1.23) after adjustment for age, sex, socioeconomic status, and healthcare utilisation. Risks for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, and rheumatoid arthritis remained unchanged. The risks of paraesthesia and inflammatory bowel disease among those vaccinated in the early phase (within 45 days from 1 October 2009) of the vaccination campaign were significantly increased; the risk being increased within the first six weeks after vaccination. Those vaccinated in the early phase were at a slightly reduced risk of death than those who were unvaccinated (0.94, 0.91 to 0.98), whereas those vaccinated in the late phase had an overall reduced mortality (0.68, 0.64 to 0.71). These associations could be real or explained, partly or entirely, by residual confounding.
  
  
  CONCLUSIONS
  Results for the safety of Pandemrix over 8-10 months of follow-up were reassuring -notably, no change in the risk for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, or rheumatoid arthritis. Relative risks were significantly increased for Bell's palsy, paraesthesia, and inflammatory bowel disease after vaccination, predominantly in the early phase of the vaccination campaign. Small numbers of children and adolescents with narcolepsy precluded any meaningful conclusions.
authors: Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden.
authors: Carola
authors: C
authors: Bardage
authors: Ingemar
authors: I
authors: Persson
authors: Ake
authors: A
authors: Ortqvist
authors: Ulf
authors: U
authors: Bergman
authors: Jonas F
authors: JF
authors: Ludvigsson
authors: Fredrik
authors: F
authors: Granath
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D020330:Bell Palsy / Q000453:epidemiology; D002648:Child; D015331:Cohort Studies; D003922:Diabetes Mellitus, Type 1 / Q000453:epidemiology; D004812:Epidemiologic Methods; D005260:Female; D020275:Guillain-Barre Syndrome / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D015212:Inflammatory Bowel Diseases / Q000453:epidemiology; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D009103:Multiple Sclerosis / Q000453:epidemiology; D009290:Narcolepsy / Q000453:epidemiology; D058873:Pandemics / Q000517:prevention & control*; D010292:Paresthesia / Q000453:epidemiology; D011247:Pregnancy; D012923:Social Class; D013548:Sweden / Q000453:epidemiology; D014611:Vaccination / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines