National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia.
Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia.
Commun Dis Intell (2018). 2021 Apr 30;45. doi: 10.33321/cdi.2021.45.23.
This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found.
本报告总结了澳大利亚 2019 年向治疗用品管理局（TGA）报告的不良事件（AEFI）的自发监测数据，并描述了 2000 年 1 月 1 日至 2019 年 12 月 31 日 20 年来的报告趋势。2019 年共报告了 3782 例疫苗接种后不良事件，每 10 万人中有 14.9 例不良事件报告率。与 2018 年（每 10 万人中有 16.9 例）相比，2019 年的总体 AEFI 报告率下降了 11.8%。2019 年 AEFI 报告率下降主要归因于与人类乳头瘤病毒（HPV）、dTpa、脑膜炎球菌 ACWY 和季节性流感疫苗相关的不良事件报告减少。2019 年大多数个别疫苗的 AEFI 报告率与 2018 年相似。最常见的不良事件是注射部位反应（35.8%）、皮疹（16.6%）、发热（15.3%）、呕吐（8.1%）、荨麻疹（5.8%）、疼痛（5.8%）和头痛（5.7%）。TGA 报告了五例死亡病例。在一份报告中，时间和临床发现与疫苗接种的因果关系一致。在其余四份报告中，未发现与疫苗接种有明确的因果关系。
