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Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18 755 and 27 895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of a diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications, such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47-65.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.
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COVID-19 , Vacunas contra la Influenza , Gripe Humana , Sistemas de Registro de Reacción Adversa a Medicamentos , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Humanos , Vacunas contra la Influenza/efectos adversos , Gripe Humana/prevención & control , Farmacovigilancia , ARN Mensajero/genética , Organización Mundial de la Salud , Vacunas de ARNmRESUMEN
Laparoscopy is a procedure that ultimately reduces hospital stay time and speeds up post-operative recovery. It is mainly performed in high-income countries but its implementation in many low- and middle-income countries (LMICs) is increasing. However, no aggregate data exist regarding the outcomes of this procedure in resource-limited settings. We retrospectively reviewed all cases of laparoscopy recorded from January 2007 to March 2017 at the Department of Surgery of Beira to assess the related outcomes. Moreover, we performed a systematic review of the laparoscopic practices and outcomes in low-income countries. Data from the Department of Surgery of Beira identified 363 laparoscopic procedures, mainly relating to gynecological diseases, cholelithiasis, and appendicectomy with only a 1.6% complication rate (6 cases) and a 1.9% conversion rate (7 cases) to open surgery. The systematic review showed a pooled risk of overall complications significantly lower in laparoscopic vs. open appendicectomy (OR = 0.43; 95% CI 0.19-0.97; I2 = 85.7%) and a significantly lower risk of infection (OR = 0.53; 95% CI 0.43-0.65; I2 = 0.00%). The pooled SMD in operation duration in laparoscopic vs. open appendectomy was 0.58 (95% CI -0.00; 1.15; I2 = 96.52), while the pooled SMD in hospitalization days was -1.35 (95% CI -1.87; -0.82; I2 = 96.41). Laparoscopy is an expensive procedure to adopt as it requires new equipment and specialized trained health workers. However, it could reduce post-operative costs and complications, especially in terms of infections. It is crucial to increase its accessibility, acceptability, and quality particularly in LMICs, especially during this COVID-19 era when the reduction of patient hospitalization is essential.
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Apendicitis , COVID-19 , Laparoscopía , Humanos , Tiempo de Internación , Estudios Retrospectivos , SARS-CoV-2 , Resultado del TratamientoRESUMEN
BACKGROUND: Participation in physical activity has been found to be beneficial for mental and physical health outcomes among cancer survivors. However, to date no intervention exists specifically to promote physical activity among bladder cancer survivors. In light of this knowledge a home-based exercise intervention was co-created for those recently diagnosed with bladder cancer. AIM: The aim of the present study, financially supported by Action Bladder Cancer UK [1], is to pilot the home-based exercise intervention tailored specifically for bladder cancer survivors (i.e. from the point of diagnosis) to improve physical and mental health outcomes (during treatment and beyond) in this population. METHODS: This study will use a randomised controlled trial design. Arm one will consists of the 14 week home-based exercise intervention and arm two usual care (15 participants will be randomised to each arm). Baseline data collection will take place shortly after clinical diagnosis of bladder cancer, and follow-up approximately 7 weeks and then again approximately 14 weeks after commencement of the intervention. At each data collection point data will be collected from participants relating to demographics, physical and mental health. Participants will aslo be asked to wear an Actigraph Accelerometer at each data collection point for seven consecutive days. Immediately after baseline data collection participants in the intervention arm will be given the home-based exercise booklet. ETHICS AND DISSEMINATION: Ethical approval was obtained for the present study via The London- City and East Research Ethics Committee (ID:291676). Results of this study will be disseminated through peer-reviewed publications and scientific presentations.
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INTRODUCTION: The authors present the first case of a patient with single cystic seminal vesicle accompanied by left kidney agenesis, referring for diagnosis and treatment. MATERIAL AND METHODS: This is the case of a 22-year-old patient presented for chronic pelvic pain. INVESTIGATIONS: abdominal and transrectal ultrasound as well as the computer tomography showed a cystic pelvic tumor with a diameter of around 8.5/6 cm, and left kidney agenesis. The treatment for this condition varies from watchful waiting for asymptomatic cysts, to excision. We performed a plasty of the unique seminal vesicle. RESULTS: The postoperative evolution was uneventful with pain remission and improvement of ejaculatory function. CONCLUSIONS: Single seminal vesicle has a very low incidence. For this pathology, partial vesiculectomy represents a viable therapeutic option in order to preserve sexual function in the case of a young patient.