Abstract | OBJECTIVES: METHODS: Descriptive analysis of adverse event reports in the vaccinated population, including the number of cases of CNS demyelinating disease, their frequencies, their dates of onset in relation to dates of report and their distribution according to age, sex and the number of injections. A Kaplan-Meier curve was used to analyze the time period between the last dose of vaccine and the onset of CNS demyelinating disease. RESULTS: Overall, 187 cases of CNS demyelinating disease were spontaneously reported, (0.54 reports per 100,000 doses of GenHevac B distributed). The average time period between the occurring date of onset of the disease and its subsequent report was 24 months. The average age of onset was 31.7 years old and 73% of cases were women. The time between the last dose of vaccine and the onset of disease was regularly distributed from 1 day to 5 years (median: 60 days). CONCLUSION:
|
Authors | B Soubeyrand, F Boisnard, M Bruel, H Debois, D Delattre, A Gauthier, S Soum, C Thébault |
Journal | Presse medicale (Paris, France : 1983)
(Presse Med)
Vol. 29
Issue 14
Pg. 775-80
(Apr 15 2000)
ISSN: 0755-4982 [Print] France |
Vernacular Title | Pathologies démyélinisantes du système nerveux central rapportées après vaccination hépatite B par GenHevac B. Bilan de dix années de notifications spontanées (1989-1998). |
PMID | 10816715
(Publication Type: English Abstract, Journal Article)
|
Chemical References |
- GenHevac B Pasteur
- Hepatitis B Vaccines
|
Topics |
- Adult
- Age of Onset
- Central Nervous System Diseases
(epidemiology, etiology)
- Demyelinating Diseases
(epidemiology, etiology)
- Female
- France
(epidemiology)
- Hepatitis B Vaccines
(administration & dosage, adverse effects)
- Humans
- Incidence
- Male
- Multiple Sclerosis
(epidemiology, etiology)
|