Preventive Medicine and Public Health Teaching and Research Unit, Faculty of Health Sciences, Rey Juan Carlos University, Alcorcón, Spain.
Clin Drug Investig. 2004;24(8):457-63. doi: 10.2165/00044011-200424080-00004.
To detect the appearance and specify the types of adverse reactions to vaccines registered in a paediatric population.
A 6-month, prospective, observational, multicentre epidemiological vaccine safety study was undertaken in 2002 covering a paediatric population subject to vaccine administration. A two-phase telephone survey of all patients was conducted, comprising an initial call at 1 week and a follow-up call at 30 days after the vaccine administration date. A paediatrician was responsible for diagnosing the specific type of adverse reaction.
Of a total sample of 946 children, ranging in age from 0 to 14 years (50.8% girls, 49.1% boys), 191 non-serious suspected adverse reactions were detected, representing 19% of the vaccinated children. Reactions to the diphtheria, tetanus, pertussis acellular and Haemophilus influenzae type b (DTPa + Hib) vaccine appeared in 43.4% of cases, followed by reactions to the measles, mumps, rubella (MMR) [18.4%] and adult tetanus and diphtheria (Td) [17.8%] vaccines. The most frequent types of adverse reactions to vaccines were: injection-site oedema (12.2 per 1000 doses); pain at site of inoculation (10.3 per 1000 doses); temperature not recorded but believed by parents to be very high (4.6 per 1000 doses); and measured temperature indicating fever of 39-40.5 masculineC (4.4 per 1000 doses). Fifty-five percent (n = 21) of cases of injection-site oedema were attributed to DTPa + Hib vaccine (18.8 per 1000 doses), followed by 18.4% (n = 7) attributable to Td vaccine (112 per 1000 doses). Indeed, this latter vaccine was responsible for 43.8% (n = 14; 226 per 1000 doses) of all reported pain at the site of inoculation. MMR vaccine was linked to the occurrence of fever of 39-40.5 masculineC in 52% of cases (n = 10; 29 per 1000 doses). Two children were treated by the emergency services, but there were no deaths or hospitalisations.
An active search for subjects with suspected adverse reactions to vaccines led to the detection of reactions that are usually not reported. Primary-care physicians and nurses must be vigilant for information on adverse reactions to vaccines in paediatric populations.
检测在儿科人群中注册的疫苗的不良反应出现情况并确定其类型。
在 2002 年开展了一项为期 6 个月的前瞻性、观察性、多中心疫苗安全性研究，研究对象为接受疫苗接种的儿科人群。对所有患者进行了两阶段电话调查，包括接种日期后 1 周的初次电话和 30 天的随访电话。由儿科医生负责诊断特定类型的不良反应。
在总共 946 名年龄在 0 至 14 岁的儿童（50.8%为女孩，49.1%为男孩）中，检测到 191 例非严重疑似不良反应，占接种儿童的 19%。不良反应最常见于无细胞百白破疫苗（DTPa + Hib）（43.4%），其次是麻疹、腮腺炎、风疹疫苗（18.4%）和成人破伤风类毒素和白喉类毒素疫苗（17.8%）。疫苗最常见的不良反应类型为：注射部位水肿（12.2/1000 剂）；接种部位疼痛（10.3/1000 剂）；父母认为体温很高但未记录（4.6/1000 剂）；测量体温显示 39-40.5°C 发热（4.4/1000 剂）。55%（21 例）的注射部位水肿病例归因于 DTPa + Hib 疫苗（18.8/1000 剂），其次是 Td 疫苗（18.4%，7 例）（112/1000 剂）。实际上，后者疫苗导致所有报告的接种部位疼痛的 43.8%（43.8%，14 例；226/1000 剂）。MMR 疫苗导致 52%（10 例）的 39-40.5°C 发热（29/1000 剂）。有 2 名儿童接受了急救服务，但无死亡或住院病例。
积极寻找疑似疫苗不良反应的患者可发现通常未报告的反应。初级保健医生和护士必须对儿科人群中疫苗不良反应的信息保持警惕。
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