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. DESIGN: 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. SETTING: 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. MAIN OUTCOME MEASURES: 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:
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Authors | Carola Bardage, Ingemar Persson, Ake Ortqvist, Ulf Bergman, Jonas F Ludvigsson, Fredrik Granath |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 343
Pg. d5956
(Oct 12 2011)
ISSN: 1756-1833 [Electronic] England |
PMID | 21994316
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adjuvants, Immunologic
- Influenza Vaccines
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Topics |
- Adjuvants, Immunologic
(adverse effects, therapeutic use)
- Adolescent
- Adult
- Bell Palsy
(epidemiology)
- Child
- Cohort Studies
- Diabetes Mellitus, Type 1
(epidemiology)
- Epidemiologic Methods
- Female
- Guillain-Barre Syndrome
(epidemiology)
- Hospitalization
(statistics & numerical data)
- Humans
- Infant
- Inflammatory Bowel Diseases
(epidemiology)
- Influenza A Virus, H1N1 Subtype
- Influenza Vaccines
(adverse effects, therapeutic use)
- Influenza, Human
(epidemiology, prevention & control)
- Male
- Multiple Sclerosis
(epidemiology)
- Narcolepsy
(epidemiology)
- Pandemics
(prevention & control)
- Paresthesia
(epidemiology)
- Pregnancy
- Social Class
- Sweden
(epidemiology)
- Vaccination
(adverse effects)
- Young Adult
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