J Drugs Dermatol. 2021 Apr 1;20(4):374-378. doi: 10.36849/JDD.2021.6041.
Recent reports have surfaced from the United States Food and Drug Administration hearings in December 2020 regarding the COVID-19 vaccines and study participants who developed facial and/or lip swelling after receiving the newly developed drug. Despite an incidence rate of 0.02% in the vaccine arm of the Moderna mRNA-1273 trial, concerns have been expressed about the association of adverse reactions following soft tissue filler injections and the COVID-19 vaccines. The International Society for Dermatologic and Aesthetic Surgery (ISDS) understands these concerns and has designed the following study.
A global survey was designed to capture the incidence of adverse events related to: (1) previous soft tissue filler injections, (2) soft tissue filler injections during positive testing for COVID-19, and (3) soft tissue filler injections during and after receiving any of the COVID-19 vaccines globally available.
The information of 106 survey participants from 18 different countries was analyzed. 80.2% (n=85) never experienced any adverse reaction following their soft tissue filler injection whereas 15.1% (n=16) experienced swelling and 4.7% (n=5) experienced pain that lasted longer than two days. Of those who received at least one dose of the COVID-19 vaccine (n=78), 94.9% reported not to have experienced any adverse reaction related to their previous soft tissue filler injection, whereas 5.1% (n=4) reported to have perceived pain that lasted longer than two days.
The data collected does not support the concern for an increased risk of developing adverse reactions following soft tissue filler injections associated with the COVID-19 vaccines compared to that risk associated with other previously described triggers or the default risk following soft tissue filler injections. J Drugs Dermatol. 20(4):374-378. doi:10.36849/JDD.2021.6041.
最近有报道称，美国食品和药物管理局在 2020 年 12 月举行的听证会上提到了 COVID-19 疫苗，一些研究参与者在接种新研发的药物后出现面部和/或唇部肿胀。尽管 Moderna mRNA-1273 试验疫苗组的发生率为 0.02%，但人们对软组织填充剂注射后不良反应与 COVID-19 疫苗之间的关联表示担忧。国际皮肤和美容外科学会（ISDS）了解这些担忧，并设计了以下研究。
设计了一项全球调查，以捕捉与以下相关的不良事件的发生率：（1）先前的软组织填充剂注射，（2）COVID-19 检测呈阳性期间的软组织填充剂注射，以及（3）全球可获得的任何 COVID-19 疫苗接种期间和之后的软组织填充剂注射。
对来自 18 个不同国家的 106 名调查参与者的信息进行了分析。80.2%（n=85）从未在软组织填充剂注射后经历任何不良反应，15.1%（n=16）出现肿胀，4.7%（n=5）出现持续两天以上的疼痛。在接受至少一剂 COVID-19 疫苗的人群中（n=78），94.9%报告称他们之前的软组织填充剂注射没有不良反应，而 5.1%（n=4）报告称疼痛持续两天以上。
与其他先前描述的触发因素或软组织填充剂注射后的默认风险相比，收集的数据不支持与 COVID-19 疫苗相关的软组织填充剂注射后发生不良反应风险增加的担忧。皮肤病药物杂志。20(4):374-378. doi:10.36849/JDD.2021.6041.
