Begier Elizabeth M, Burwen Dale R, Haber Penina, Ball Robert
Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852-1448, USA.
Clin Infect Dis. 2004 Mar 15;38(6):771-9. doi: 10.1086/381548. Epub 2004 Feb 26.
Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis.
伤寒沙门氏菌Typhi血清型疫苗用于预防国际旅行者,并有作为反生物恐怖主义制剂的潜在用途。疫苗不良事件报告系统(VAERS)通常在没有进一步研究的情况下无法确定疫苗与报告的不良事件之间的因果关系,但已成功检测到疫苗未被识别的副作用。我们回顾了1990年7月至2002年6月期间向VAERS报告的美国许可的伤寒疫苗情况。我们收到了321份关于注射用Vi荚膜多糖疫苗的报告和345份关于口服减毒活Ty21a疫苗的报告,分别有7.5%和5.5%描述了死亡、住院、永久性残疾或危及生命的疾病。经常意外报告的症状包括Vi疫苗引起的头晕和瘙痒以及Ty21a疫苗引起的疲劳和肌痛。接种Ty21a疫苗后出现的类似肠胃炎的疾病以及接种Vi疫苗后出现的腹痛,这些是先前已认识到的事件,偶尔需要住院治疗。两种疫苗均报告有非致命性过敏反应。VAERS报告未表明有任何意外的严重副作用会影响这些疫苗用于旅行者预防。