key: cord-0720308-em30iv4b authors: Deng, Zhenhan; Zhang, Xiaobo; Liu, Yan; Xiao, Jie; Zheng, Yizi; Huang, Yan; Xu, Jian title: Post-SARS-CoV-2-vaccine shoulder pain: Is it relevant to the vaccine injection? – Correspondence date: 2022-03-18 journal: Int J Surg DOI: 10.1016/j.ijsu.2022.106603 sha: 7cd79d3e019cce7fa68cbb5c776e7931051f8259 doc_id: 720308 cord_uid: em30iv4b nan This study was approved by the Ethics Committee of the People's Hospital of Xiangxi Autonomous Prefecture (2021-004). Not applicable. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. We declare no competing interests. This study was supported by the National Natural Science Foundation of China (81902303, 81902682, 82102632, 82160412), Liuzhou Science and Technology Project (2021-CBB0106) and COVID-19 Emergency special project of Changde science and Technology Bureau (2020SK005). ZD and JX contributed to the study concept and design and drafted the manuscript. XZ and JX collected the data. YL analyzed the data. YZ and YH revised the manuscript. All authors reviewed and approved the final manuscript. Dear Editor, The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has aroused a worldwide concern for the tremendous loss it caused to human [1, 2] . Several effective vaccines have been developed by using diverse techniques [3] . After over 400 million people have been vaccinated worldwide, the risk of serious adverse effects is now rarely reported [3, 4] . China is one of the leading countries in receiving SARS-CoV-2 vaccine injection [5] . Post-vaccine can cause acute pain and swelling in the shoulder. How the pain progresses and its clinical significances are unanswered questions because of the lack of epidemiological studies. This is a study to investigate shoulder pain after SARS-CoV-2 vaccine injection. Before the study, the protocol was approved by the Ethics Committee of The People's Hospital of Xiangxi Autonomous Prefecture, Hunan, China. The survey was conducted by an online questionnaire using the WeChat app. The inclusion criteria were individuals: 1) aged over 18 years; 2) vaccinated with SARS-CoV-2 vaccine; 3) responded to the online questionnaire successfully. The online questionnaire was conducted anonymously after obtaining informed consent from the study participants. Eventually, 2133 participants with a median age of 33.0 years (IQR, 26.0-40.0) were included in this study. Table 1 shows 776 participants reported shoulder pain, mostly from the group of 30-40 yrs. When the participants were further divided into the pain group and pain-free group, more females experienced shoulder pain (69.5% vs 53.6%) than males. Patients who had a history of shoulder pain were more prone to develop pain (9.8% vs 5.2%). Limitations in shoulder range of motion (ROM) showed no significant difference between the two groups, implying that pain did not cause any J o u r n a l P r e -p r o o f 2 degree of frozen shoulder. The use of different types of vaccine showed the adenovirus vectored vaccine group presented with a higher rate of shoulder pain, but these was no relationship with whether the mixed vaccine strategy or single vaccine strategy was used. Participants who had comorbidities including diabetes, hypertension, Parkinson's disease, myocardial infarction and cerebral infarction showed no significant differences in shoulder pain between the two groups. The characteristics of pain are shown in Supplementary Table 1 . Pain occurred mostly at the injection site on the second day after vaccine injection, and usually lasted for no more than one week. However, a few participants suffered from pain for 3 to 6 months after injection, with 42.2% of the pain group complained of continuous shoulder pain, and 18% reported pain combined with limited ROM. The findings of this study showed that shoulder pain after SARS-CoV-2 vaccine injection to be transient and in most individuals did not cause limitation to shoulder ROM. Gender difference and a history of shoulder pain were related to pain. Pain mainly occurred in the age range of 30-40yrs. Vaccine injection strategy had no effect on pain, but the type of vaccine played an affecting role. The findings of this study not only supported safety of SARS-CoV-2 vaccine, but they also provided novel insights into future research on mechanisms of shoulder pain and the strategy to prevent this adverse event. The limitations of this study are: First, more individuals, especially elderlies should be enrolled as this study mainly focused on young participants who could complete the questionnaire online smoothly. Second, multicenter clinical studies with large sample sizes to provide high evidence-based researches are needed to provide more information. Coronapod: COVID death toll is likely millions more than official counts Why do COVID death rates seem to be falling? All eyes on a hurdle race for a SARS-CoV-2 vaccine SARS-CoV-2: vaccines in the pandemic era Advances in the design and development of SARS-CoV-2 vaccines human studies -charge •Prospero -for systematic reviews -free •There are many national registries approved by the UN that can be found here Elsevier does not support or endorse any registry Unique Identifying number or registration ID: NA Hyperlink to your specific registration (must be publicly accessible and will be checked): NA Not applicable. The following additional information is required for submission. Please note that failure to respond to these questions/statements will mean your submission will be returned. If you have nothing to declare in any of these categories, then this should be stated. This study was approved by the Ethics Committee of the People's Hospital of Xiangxi Autonomous Prefecture (2021-004). The World Medical Association's Declaration of Helsinki 2013 states in article 35: 'Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject'. Editors of IJS require that all types of research studies involving human participants should be registered prospectively and failing that retrospectively. There are many places to register your research, and you can choose which is the most suitable for your needs:•https://www.clinicaltrials.gov/ -for all human studies -free •http://www.chictr.org.cn/index.aspx -for all human studies -free •https://www.researchregistry.com/ -for all human studies -charge Please specify the contribution of each author to the paper, e.g. study design, data collections, data analysis, writing. Others, who have contributed in other ways should be listed as contributors.ZD and JX contributed to the study concept and design and drafted the manuscript.XZ and JX collected the data. YL analyzed the data. YZ and YH revised the manuscript. All authors reviewed and approved the final manuscript. The Guarantor is the one or more people who accept full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish. Please note that providing a guarantor is compulsory. Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data would remain confidential and would not be shared.