Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States

• Published in: Vaccine Vol. 18; no. 26; pp. 2963 - 2969
• Main Authors: Takahashi, Hiroshi, Pool, Vitali, Tsai, Theodore F., Chen, Robert T.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.07.2000; Elsevier; Elsevier Limited
• Subjects: Biological and medical sciences; Brain; Disease control; Edema; Encephalitis; Epidemiology. Vaccinations; General aspects; Health risks; Hypersensitivity; Hypersensitivity (delayed); Immunization; Infectious diseases; Japan; Japanese encephalitis vaccine; Japanese encephalitis virus; Licenses; Marketing; Medical sciences; Neurological diseases; Post-marketing surveillance; Surveillance; Travel; USA; Vaccination; Vaccine adverse events; Vaccines; Vector-borne diseases; Asia; United States; North America; Japan; America; Denmark; United States > US; China; USA; Japanese encephalitis vaccine; Vaccine adverse events; Post-marketing surveillance; Human; Nervous system diseases; Toxicity; Vaccination; Cerebral disorder; Infection; Viral disease; Arbovirus disease; Central nervous system disease; Sanitary surveillance; Public health; Japanese encephalitis; Inactivated strain
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/S0264-410X(00)00111-0

We determined the reporting rates for adverse events following the administration of inactivated mouse-brain derived Japanese encephalitis vaccine (JEV) based on post-marketing surveillance data from Japan and the United States. The rate of total adverse events per 100,000 doses was 2.8 in Japan and 15.0 in the United States. In Japan, 17 neurological disorders were reported from April 1996 to October 1998 for a rate of 0.2 per 100,000 doses. In the United States, no serious neurological adverse events temporally associated with JEV were reported from January 1993 to June 1999. Rates for systemic hypersensitivity reactions were 0.8 and 6.3 per 100,000 doses in Japan and the United States, respectively. Passively collected VAERS surveillance data indicate that characteristic hypersensitivity reactions with a delayed onset continue to occur among JEV recipients and that conservative recommendations limiting its use to travelers at high risk of infection with Japanese encephalitis are appropriate.