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      Superficial venous thrombosisas a possible consequence of ChAdOx1 nCoV-19 vaccine: two case reports

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          Abstract

          Background

          Many scientists across the world got involved in the race to develop successful anti-SARS-CoV-2 vaccines to overcome COVID-19 pandemic. Among the different vaccines developed against SARS-CoV-2, Covishield was the first vaccine approved for emergency use in Nepal. We report two cases of Superficial Vein Thrombosis (SVT) for the first time in the literature after vaccination with the Chimpanzee Adenovirus-vectored Vaccine (ChAdOx1 nCoV-19 vaccine).

          Cases presentation

          Two cases, a 24-year-old young Chhetri male and a 62-year-old Chhetri female who have received Covishield (ChAdOx1 nCoV-19) vaccine, developed pain in left calf after 2 weeks and 10 weeks of vaccination, respectively. Both the case belongs to the Chhetri ethnic group of Nepal. The pain became severe on the fourth week of immunization in the first case while the pain was acute and severe on the 10 th week of vaccination in the second case. The first presented to emergency room and second case was referred to the emergency room from Orthopedic Clinic. On evaluation the first patient had normal vitals with no history of fever and swelling yet displayed non-radiating mild to moderate intensity pain localized to left leg below the knee which became aggravated by movements. In the second case however pain was more intense with other characteristics as first case. Both cases had low wells score (< 4). On local examination tenderness was noted on squeezing but other systemic examination findings of the patient were within normal limits in both cases. Among the numerous vaccines used to fight the battle against COVID-19 disease, the ChAdOx1 nCoV-19 vaccine, Covishield, has been widely used in Nepal and India. Apart from other minor side effects, in few cases thromboses have been reported after vaccination of ChAdOx1 nCoV-19, Covishield, vaccine.

          Conclusion

          These cases reporting Superficial Vein Thrombosis may be an additional adverse effect to the list of adverse events associated with ChAdOx1 nCoV-19, Covishield, vaccine. However, the benefits of the vaccine in breaking the chain of COVID 19 spread are certainly greater than the risk of thromboses.

          Highlights/Take-away message

          1. The Chimpanzee Adenovirus-vectored Vaccine (ChAdOx1 nCoV-19 vaccine) has been widely used in Himalayan Country, Nepal and India.

          2. Apart from other minor side effects, delayed thromboses in superficial vein have been reported after vaccination of ChAdOx1 nCoV-19 vaccine and they may be the consequences of vaccination though larger study is needed to verify them.

          3. Superficial vein thrombosis (SVT) should be an additional adverse effect to be mentioned in the list of adverse events associated with ChAdOx1 nCoV-19, Covishield, vaccine.

          4. The benefits of the vaccine in breaking the chain of COVID 19 spread are certainly greater than the risk of thromboses.

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          Most cited references11

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          Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

          Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
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            The Socio-Economic Implications of the Coronavirus and COVID-19 Pandemic: A Review

            The COVID-19 pandemic has resulted in over 1.4 million confirmed cases and over 83,000 deaths globally. It has also sparked fears of an impending economic crisis and recession. Social distancing, self-isolation and travel restrictions forced a decrease in the workforce across all economic sectors and caused many jobs to be lost. Schools have closed down, and the need of commodities and manufactured products has decreased. In contrast, the need for medical supplies has significantly increased. The food sector has also seen a great demand due to panic-buying and stockpiling of food products. In response to this global outbreak, we summarise the socio-economic effects of COVID-19 on individual aspects of the world economy.
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              COVID-19 and its implications for thrombosis and anticoagulation

              Severe acute respiratory syndrome coronavirus 2, coronavirus disease 2019 (COVID-19)-induced infection can be associated with a coagulopathy, findings consistent with infection-induced inflammatory changes as observed in patients with disseminated intravascular coagulopathy (DIC). The lack of prior immunity to COVID-19 has resulted in large numbers of infected patients across the globe and uncertainty regarding management of the complications that arise in the course of this viral illness. The lungs are the target organ for COVID-19; patients develop acute lung injury that can progress to respiratory failure, although multiorgan failure can also occur. The initial coagulopathy of COVID-19 presents with prominent elevation of D-dimer and fibrin/fibrinogen-degradation products, whereas abnormalities in prothrombin time, partial thromboplastin time, and platelet counts are relatively uncommon in initial presentations. Coagulation test screening, including the measurement of D-dimer and fibrinogen levels, is suggested. COVID-19–associated coagulopathy should be managed as it would be for any critically ill patient, following the established practice of using thromboembolic prophylaxis for critically ill hospitalized patients, and standard supportive care measures for those with sepsis-induced coagulopathy or DIC. Although D-dimer, sepsis physiology, and consumptive coagulopathy are indicators of mortality, current data do not suggest the use of full-intensity anticoagulation doses unless otherwise clinically indicated. Even though there is an associated coagulopathy with COVID-19, bleeding manifestations, even in those with DIC, have not been reported. If bleeding does occur, standard guidelines for the management of DIC and bleeding should be followed.
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                Author and article information

                Contributors
                sahmukeshkumar88@gmail.com
                bishnusingh2047@gmail.com
                res.pujasinha@pahs.edu.np
                res.preritdevkota@pahs.edu.np
                sudhiyadav4@gmail.com
                szon.stha@gmail.com
                ashisshrestha@pahs.edu.np
                Journal
                J Med Case Rep
                J Med Case Rep
                Journal of Medical Case Reports
                BioMed Central (London )
                1752-1947
                7 May 2022
                7 May 2022
                2022
                : 16
                : 182
                Affiliations
                [1 ]GRID grid.452690.c, ISNI 0000 0004 4677 1409, Department of Emergency Medicine and General Practice, , Patan Academy of Health Sciences, ; Lalitpur, Bagmati Province Nepal
                [2 ]GRID grid.417187.c, ISNI 0000 0004 0644 2774, Patan Hospital, ; Lalitpur, Nepal
                [3 ]GRID grid.64337.35, ISNI 0000 0001 0662 7451, Public Health Expert, Louisiana State University, ; Shreveport, LA USA
                [4 ]GRID grid.452690.c, ISNI 0000 0004 4677 1409, Department of Emergency Medicine and General Practice, , Patan Academy of Health Sciences, ; Lalitpur, Nepal
                Author information
                http://orcid.org/0000-0002-4363-9678
                http://orcid.org/0000-0002-5711-9948
                http://orcid.org/0000-0001-7169-0377
                http://orcid.org/0000-0003-3138-3211
                http://orcid.org/0000-0001-9568-6903
                http://orcid.org/0000-0001-5495-7973
                http://orcid.org/0000-0001-9572-0649
                Article
                3407
                10.1186/s13256-022-03407-6
                9076162
                35524323
                4f9cfa8d-fb4a-429d-afaa-faee859a1c93
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 15 June 2021
                : 7 April 2022
                Categories
                Case Report
                Custom metadata
                © The Author(s) 2022

                Medicine
                chadox1 ncov-19,covishield vaccine,superficial venous thrombosis (svt),venous thrombosis,superficial saphenous vein (ssv),covid 19

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