The b-CAPSA I capsular polysaccharide vaccine for Haemophilus influenzae type b was given to 87,541 children 2 through 5 years of age in the Kaiser Permanente Medical Care Program, and the children were then followed using a multiple modality surveillance. Phase 1 consisted of 24-hour recall of immediate side effects which were recorded on questionnaires given to families of 13,500 children. Local side effects were found to be uncommon: 2.3% had a temperature of ≥38.3°C (≥101°F); 4.8% had local erythema, 2.9% local swelling, and 12.6% local tenderness; two children had wheezing shortly after immunization. In Phase 2, 30 days after immunization, questionnaires were mailed to parents of all 87,541 children, who were asked to respond to questions about illnesses and health care. Phase 3 consisted of active surveillance of patient health care use by physicians and nurses during the 30 days after immunization. During the 30-day reporting periods, there were 40 hospitalizations, including one for wheezing and one for febrile seizure. Of the 40 hospitalizations, only the one for wheezing was believed by the admitting physician to be probably associated with vaccine administration. Three children had seizures within 30 days of immunization. None of the seizures was believed by the reporting physician to be associated with immunization. Adverse effects of the vaccine were mild, limited to local reactions and occasional temperature elevation; bronchospasm after immunization occurred rarely.
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机译：在Kaiser Permanente Medical Care计划中，向87,541名2至5岁的儿童接种了b型流感嗜血杆菌的b-CAPSA I荚膜多糖疫苗，然后对其进行多模式监测。第一阶段包括24小时召回立即产生的副作用，这些副作用记录在发给13500名儿童家庭的问卷中。发现局部副作用不常见：2.3％的温度≥38.3°C（≥101°F）;局部红斑为4.8％，局部肿胀为2.9％，局部压痛为12.6％;免疫后不久，有两个孩子喘气。在第2阶段，免疫后30天，问卷被邮寄给所有87,541名儿童的父母，他们被要求回答有关疾病和保健的问题。第3阶段包括免疫后30天内医生和护士对患者医疗保健使用情况进行的主动监视。在30天的报告期内，有40例住院治疗，其中1例因喘息而1例因高热发作。在这40例住院中，主治医师认为只有一种喘息的病可能与疫苗接种有关。免疫30天内有3名儿童癫痫发作。报告医师认为没有癫痫发作与免疫有关。疫苗的不良反应轻微，仅限于局部反应和偶尔的温度升高。免疫后支气管痉挛很少发生。
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