SummaryWe have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.After investigating this issue and seeking advice from an expert panel, the Product Information (PI) and Consumer Medicine Information (CMI) documents for Shingrix were updated. These changes reflect the new reporting data, recognising that GBS is a very rare adverse event.A warning about GBS was already included in the Shingrix PI.

总结我们收到了澳大利亚关于Shingrix疫苗接种后吉兰-巴雷综合征（GBS）的报告。在调查了这个问题并征求了专家小组的意见后，Shingrix的产品信息（PI）和消费者药物信息（CMI）文档得到了更新。这些变化反映了新的报告数据，认识到GBS是一种非常罕见的不良事件。关于GBS的警告已经包含在Shingrix PI中。

This described the findings of an observational study in individuals aged 65 years or older which showed an increased risk of GBS (estimated 3 excess cases per million doses administered) observed during the 6 weeks following vaccination.What health professionals should doHealth professionals should be aware of GBS cases following vaccination with Shingrix.

这描述了一项针对65岁或以上个体的观察性研究的结果，该研究显示在接种疫苗后6周内观察到GBS风险增加（估计每百万剂量有3例过量病例）。卫生专业人员应该做什么卫生专业人员应该了解接种Shingrix疫苗后的GBS病例。

Patients should be warned of this possible but very rare risk and encouraged to seek medical attention if they experience symptoms, as early medical care can reduce severity and improve outcomes.Shingrix is not generally recommended for people with a history of GBS whose first episode occurred within 6 weeks of receiving any vaccine (such as an influenza vaccine or a previous dose of Shingrix vaccine).

应该警告患者这种可能但非常罕见的风险，并鼓励患者在出现症状时寻求医疗救助，因为早期医疗可以减轻严重程度并改善预后。对于有GBS病史且在接种任何疫苗（例如流感疫苗或先前剂量的Shingrix疫苗）后6周内首次发作的人，通常不建议使用Shingrix。

Those with a history of GBS not associated with Shingrix should discuss the risks and benefits of receiving Shingrix with a health professional.Symptoms of GBS include pins and needles (paraesthesia), numbness, weakness and paralysis. Typically, hands and/or feet are affected first, with symptoms progressing up the body to the legs, arms, face and muscles involved with breathing.

那些有GBS病史且与Shingrix无关的人应该与健康专业人员讨论接受Shingrix的风险和益处。GBS的症状包括针刺（感觉异常），麻木，虚弱和瘫痪。通常情况下，手和/或脚首先受到影响，症状从身体发展到腿部、手臂、面部和与呼吸有关的肌肉。

These symptoms may progress over a few days or weeks.We continue to monitor adverse events associated with Shingrix and encourage health professionals to report suspected cases of GBS and other neuroinflammato.

这些症状可能会在几天或几周内进展。我们继续监测与Shingrix相关的不良事件，并鼓励卫生专业人员报告GBS和其他神经炎症的疑似病例。

Up-to-date information for Shingrix can be found in the Product Information (for health professionals) and the Consumer Medicine Information (for consumers).GBS cases reported to the TGAOur public Database of Adverse Event Notifications included 13 reports of GBS following Shingrix vaccination up to 18 September 2024.

Shingrix的最新信息可以在产品信息（针对健康专业人员）和消费药物信息（针对消费者）中找到。向TGAOur不良事件通知公共数据库报告的GBS病例包括截至2024年9月18日接种Shingrix疫苗后的13例GBS报告。

The reports involved patients of both sexes. All were aged from their mid-60s to mid-80s. No deaths were reported.Further readingGoud R, et al. Risk of Guillain-Barré Syndrome following recombinant zoster vaccine in Medicare beneficiaries. JAMA Intern Med 2021;181:1-8. doi: 10.1001/jamainternmed.2021.6227Janusz CB, et al.

这些报告涉及男女患者。所有人的年龄都在60多岁到80多岁之间。没有死亡报告。进一步阅读Goud R等人的《医疗保险受益人接种重组带状疱疹疫苗后格林-巴利综合征的风险》。JAMA实习生医学2021；181:1-8。doi:10.1001/jamainternmed.2021.6227Janusz CB等。

Projected risks and health benefits of vaccination against herpes zoster and related complications in US adults. Hum Vaccin Immunother 2022;18:2060668. doi: 10.1080/21645515.2022.2060668 Nelson JC, et al. Active postlicensure safety surveillance for recombinant zoster vaccine using electronic health record data.

美国成年人接种带状疱疹和相关并发症疫苗的预计风险和健康益处。Hum Vaccin Immunother 2022；18： 2060668年。doi:10.1080/21645515.2022.2060668 Nelson JC等人。使用电子健康记录数据对重组带状疱疹疫苗进行主动许可后安全监测。

Am J Epidemiol 2023;192:205-216. doi: 10.1093/aje/kwac170U.S. Food & Drug Administration. FDA Requires a warning about Guillain-Barré Syndrome (GBS) be included in the prescribing information for Shingrix. FDA Safety Communication, March 2021. .

Am J Epidemiol 2023；192:205-216。doi:10.1093/aje/kwac170U。S、 食品和药物管理局。FDA要求在Shingrix的处方信息中包含有关格林-巴利综合征（GBS）的警告。FDA安全通讯，2021年3月。