关键词: ACIP, Advisory Committee on Immunization Practices Adolescents Adults CDC, Centers for Disease Control and Prevention CI, confidence interval ED, emergency department GBS, Guillain-Barré syndrome ICD-10-CM, International Classification of Diseases, 10th Revision, Clinical Modification ICD-9-CM, International Classification of Diseases, 9th Revision, Clinical Modification IQR, interquartile range ITP, immune thrombocytopenia MMR MMR, measles, mumps, and rubella vaccine MMRV, measles, mumps, rubella, and varicella vaccine RR, relative risk SCRI, self-controlled risk interval Safety VAERS, Vaccine Adverse Event Reporting System VSD, Vaccine Safety Datalink Vaccine

来  源:   DOI:10.1016/j.jvacx.2023.100268   PDF(Pubmed)

Abstract:
UNASSIGNED: Measles, mumps, and rubella vaccine (MMR) is routinely administered to children; however, adolescents and adults may receive MMR for various reasons. Safety studies in adolescents and adults are limited. We report on safety of MMR in this age group in the Vaccine Safety Datalink.
UNASSIGNED: We included adolescents (aged 9-17 years) and adults (aged ≥ 18 years) who received ≥ 1 dose of MMR from January 1, 2010-December 31, 2018. Pre-specified outcomes were identified by diagnosis codes. Clinically serious outcomes included anaphylaxis, encephalitis/myelitis, Guillain-Barré syndrome, immune thrombocytopenia, meningitis, and seizure. Non-serious outcomes were allergic reaction, arthropathy, fever, injection site reaction, lymphadenopathy, non-specific reaction, parotitis, rash, and syncope. All serious outcomes underwent medical record review. Outcome-specific incidence was calculated in pre-defined post-vaccination windows. A self-controlled risk interval design was used to determine the relative risk of each outcome in a risk window after vaccination compared to a more distal control window.
UNASSIGNED: During the study period, 276,327 MMR doses were administered to adolescents and adults. Mean age of vaccinees was 34.8 years; 65.8 % were female; 53.2 % of doses were administered simultaneously with ≥ 1 other vaccine. Serious outcomes were rare, with incidence ≤ 6 per 100,000 doses for each outcome assessed, and none had a significant elevation in incidence during the risk window compared to the control window. Incidence of non-serious outcomes per 100,000 doses ranged from 3.4 for parotitis to 263.0 for arthropathy. Other common outcomes included injection site reaction and rash (157.0 and 112.9 per 100,000 doses, respectively). Significantly more outcomes were observed during the risk window compared to the control window for all non-serious outcomes except parotitis. Some variability was observed by sex and age group.
UNASSIGNED: Serious outcomes after MMR are rare in adolescents and adults, but vaccinees should be counseled regarding anticipated local and systemic non-serious adverse events.
摘要:
未经证实:麻疹,腮腺炎,风疹疫苗(MMR)通常用于儿童;然而,青少年和成人可能会因为各种原因接受MMR。青少年和成人的安全性研究有限。我们在疫苗安全数据链中报告了该年龄段MMR的安全性。
UNASSIGNED:我们包括从2010年1月1日至2018年12月31日接受≥1剂MMR的青少年(9-17岁)和成年人(≥18岁)。通过诊断代码识别预先指定的结果。临床严重的结果包括过敏反应,脑炎/脊髓炎,格林-巴利综合征,免疫性血小板减少症,脑膜炎,和癫痫。非严重结果为过敏反应,关节病,发烧,注射部位反应,淋巴结病,非特异性反应,腮腺炎,皮疹,和晕厥。所有严重结果均接受病历审查。在预定义的疫苗接种后窗口中计算结果特异性发生率。使用自我控制的风险区间设计来确定接种后风险窗口中与更远的对照窗口相比的每个结果的相对风险。
未经评估:在研究期间,向青少年和成人施用276,327MMR剂量。接种者的平均年龄为34.8岁;65.8%为女性;53.2%的剂量与≥1种其他疫苗同时施用。严重的结果是罕见的,每个评估结果的发生率≤6/100,000剂量,与控制窗口相比,风险窗口期间的发病率没有显著升高.每100,000剂量的非严重结局的发生率为腮腺炎的3.4至关节病的263.0。其他常见结果包括注射部位反应和皮疹(每100,000剂量157.0和112.9,分别)。除腮腺炎外,与所有非严重结局的控制窗口相比,在风险窗口期间观察到更多的结局。按性别和年龄组观察到一些变异性。
未经评估:MMR后的严重结局在青少年和成人中很少见,但应该就预期的局部和系统性非严重不良事件向接种者提供咨询.
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