Traditional Chinese Medicine Syndrome Differentiation of Delta and Omicron Variants of SARS-CoV-2 Carriers in Changsha,Hunan.

Objective: To summarize and compare the main traditional Chinese medicineTCMsyndromes of Delta and Omicron variants of severe acute respiratory syndrome coronavirus 2SARS-CoV-2 carriers to provide references for the syndrome evolution and syndrome differentiation of SARS-CoV-2 infection. Method(s):The TCM medical records of imported and local cases of infection with Delta and Omicron variants of SARS-CoV-2 in Changsha since September 23,2021 to March 27,2022 were collected,including 18 Delta variant cases and 36 Omicron variant cases. Their TCM diagnosis information and TCM pathogenesis were analyzed and compared. Result(s): The common manifestations in Delta variant cases were cough,fever,chest distress/shortness of breath,sore muscles,nausea,dry mouth,dry or sore throat,thick and greasy tongue coating,and rapid and slippery pulse. The predominant pathogenesis was dampness-heat in the upper-energizer and heat stagnation in the lesser Yang combined with dampness. The occurrence of chest distress/shortness of breath,greasy tongue coating,slippery pulse,and the proportion of dampness-heat in the upper-energizer syndrome were higher in Delta variant cases than in Omicron variant cases P<0.05. The common manifestations in Omicron variant cases were itchy and sore throat,nasal congestion,running nose,fever,mild aversion to cold,dry mouth,dizziness,slightly reddish tongue with thin white coating,and rapid or wiry pulse. The predominant pathogenesis was wind-dryness invading defensive exterior,and heat stagnation in the lesser Yang. The occurrence of white-coated tongue and the proportion of wind-dryness invading defensive exterior syndrome were higher in Omicron variant cases than in Delta variant casesP<0.05. Conclusion(s): There are certain differences in TCM syndromes and the corresponding pathogenesis between Delta variant and Omicron variant cases in Changsha,Hunan. The Delta variant of SARS-COV-2 tends to induce dampness-heat syndrome, whereas Omicron variant infection tends to elicit wind-dampness syndrome,which is expected to provide a reference for the pathogenesis evolution of SARS-COV-2 infection.Copyright © 2022, China Academy of Chinese Medical Sciences Institute of Chinese Materia Medica. All rights reserved.

Experiences of adult epilepsy patients with COVID-19 infections and vaccinations

Objective: To assess the course of COVID-19 infections and the tolerability of the mRNA vaccines of Moderna and Pfizer/BioNTech and the viral vector vaccines from Astra Zeneca and Johnson & Johnson in adult patients with epilepsy (PWE). Method(s): From July 2020 to July 2021, we consecutively included adult outpatients with confirmed epilepsy. These PWE were interviewed about COVID-19 infections and vaccinations. Results of follow-up visits were added until the cut-off date (December 31, 2021). The data of COVID-19-infected without vaccinations or fully vaccinated PWE without COVID-19 infections were analyzed. Full vaccination was defined as a double vaccination with the Pfizer/BionTech, Moderna, or Astra Zeneca vaccines or a single Johnson & Johnson vaccination. Result(s): At cut-off, 612 of 1152 PWE fulfilled the inclusion criteria: 51 PWE had been infected without vaccination and 561 had full vaccination without infection. Among the infected PWE, 76.5% presented with symptoms;9.8% had a severe course (one death). The leading symptoms were influenza-like disorders (48.7% of infected PWE with symptoms), anosmia (28.2%), and ageusia (20.5%). Seizure increases or relapses after sustained seizure freedom occurred in 7.8%. Adverse events (AEs) were reported by 113 vaccinated PWE (20.1% of all vaccinated PWE). The leading AEs were fatigue, fever, and headache. The AE rate per vaccine was 14.0% for Pfizer/BionTech, 32.7% for Moderna, 25.8% for Astra Zeneca, and 46.2% for Johnson & Johnson. Of the AEs, 93.3% lasted <=1 week. Seizure increase or relapse occurred in 1.4% and was significantly less frequent than in the infected group (p= 0.0016). Conclusion(s): The course of COVID-19 infections and the tolerability of the vaccines were similar as in the general population, yet, seizure worsening occurred more often after the infection than after the vaccination.Copyright © 2023, The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, part of Springer Nature.

Management of cardiovascular complications of BTKis: Are we complying with the good practice guidelines?

Bruton tyrosine kinase inhibitors (BTKis) were approved for use at the end of 2013 and have since been used for indications including chronic lymphocytic leukaemia (CLL), Waldenstrom's macroglobulinaemia and mantle cell lymphoma. The use of BTKis has increased significantly in the UK since they achieved NICE (National Institute for Health and Care Excellence) approval for frontline treatment of CLL in 2021. However, they are associated with significant adverse cardiovascular events. In September 2021 the British Journal of Haematology published good practice guidelines for the management of cardiovascular complications of BTKis. Our aim was to see whether these guidelines had been adhered to for patients taking BTKis. Method(s): Data was collected for all patients being prescribed BTKis (ibrutinib and acalabrutinib) in the South Tees NHS Trust in July 2022. Patients' medical records were used to assess whether their management adhered to the good practice guidelines. Data was collated for 67 patients in total. Result(s): The data showed that although all patients were consented for the risk of atrial fibrillation only 6% were consented for hypertension and only 1.5% for ventricular arrhythmias and sudden cardiac death. The guidelines recommend a baseline ECG (electrocardiogram) on commencement of treatment;however, only 7% had this completed and 0% had the minimum monitoring recommendation of 6-monthly ECGs. Thirty patients (45%) had an indication for a baseline echocardiogram;however, only one had this completed. For patients reporting symptoms of syncope, dizziness or palpitations only 50% had an ECG completed. Three patients developed worsening heart failure. The recommendations suggest referral to a cardio-oncologist;however, due to lack of availability of this service the referrals were instead made to the usual cardiologist. Conclusion(s): Although there was a lack of compliance with guideline recommendations, it should be considered that most usual checks were affected by COVID-19 outbreaks and a drop in face-to- face clinics, which were replaced by phone clinics and home delivery of medications. However, the premade consent forms for BTKis need to be updated to include consent for ventricular arrhythmias and sudden cardiac death. There also needs to be routine procedures in place to ensure that regular blood pressure testing and ECG monitoring occurs and that there is prompt recognition of cardiovascular complications. Action and implementation: To ensure improved compliance with these guidelines we plan to update our consent forms and create a proforma for clinic use to ensure that clinicians are aware of the various monitoring criteria required.

Progress and treatment of "long COVID" in non-hospitalized patients: A single-center retrospective cohort study

Background: "Long COVID" or "post-COVID conditions" describes prolonged symptoms after the acute phase of coronavirus disease 2019 (COVID-19). However, there is a paucity of published reports on its treatment. Method(s): This retrospective cohort study included adult, non-hospitalized patients with COVID-19 symptoms at least one month after the onset who had been examined at the isolation facility in Miyagi prefecture between October 2020 and September 2021. Result(s): In total, 70 patients with a median age of 46 (21-69) years were included, and 37 were women (52.9%). The median time from onset to the end of treatment was 46 (28-396) days. Thirty-eight patients (53.5%) showed improvement in all symptoms, while four (5.7%) did not recover within the study period. The symptoms at six months with high residual rates were dizziness (33.3%), fatigue (14.3%), myalgia (14.3%), abdominal discomfort (14.3%), and taste dysfunction (11.8%). For treatment of prolonged symptoms, formulae of Kampo medicine (Japanese traditional medicine) were used alone or in combination with Western medications in 76%, 66%, 53%, and 66% of patients at 1-2 months, 2-3 months, 3-6 months, and over 6 months respectively. Kampo formulae with anti-inflammatory effects were used in the early period;however, tonifying formulae and blood stasis-resolving formulae were used in the late period. Conclusion(s): Non-hospitalized patients with COVID-19 may suffer from persistent symptoms after the acute phase of infection. For the management of long COVID, a comprehensive and holistic approach is needed. Kampo medicine should be considered as a treatment option for long COVID.Copyright © 2023 The Authors. Traditional & Kampo Medicine published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Oriental Medicine and Japan Society of Medical and Pharmaceutical Sciences for Traditional Medicine.

A descriptive study of older medical cannabis users in medical cannabis clinics

Introduction: There is a dearth of information on older users (65+ years) of medical cannabis, who may face unique challenges due to altered metabolism with aging, concurrent medication use, and risk of adverse effects. This observational study aimed to describe a large cohort of older medical cannabis users in Canada. Method(s): From Oct 2014 to Oct 2020, a commercial medical cannabis provider based in Canada collected anonymized data for research purposes from patient volunteers. Data included demographic, social, and health details (at intake) and cannabis products, self-perceived changes in symptoms and change in medications (at follow-up, variable duration). Cannabis products were categorized as cannabidiol (CBD) only, tetrahydocannabinol (THC) only or mixed CBD/THC. Of the mixed, formulations could be in 1:1 ratios (CBD+/THC+), predominantly CBD (CBD+/THC-) or predominantly THC (CBD-/THC+). Result(s): In total, 9766 subjects in the older cohort (65+ years old) completed the entire questionnaire (mean age (SD) = 73.6 (6.8) y, 60% female). They represented 23.1% of the total dataset (N = 42,267, mean (SD) =51.5 (16.8) y). The proportion of adults in the older cohort tended to increase over time (pre-2018: 17.6%;2018: 26.7%;2019: 31.2%;2020: 22.7%, when the overall intake decreased from 8869 to 5644). Among the older cohort, 15.5% were previous cannabis users and 67.7% were referred for chronic pain (mainly arthritis, chronic pain, lower back pain). Concomitant analgesic use was common (over-the-counter analgesics: 44.5%;opioids: 28.3%;NSAIDs: 24.5%). 7.9% of the sample (compared to 19.9% in the whole sample) were referred for psychiatric disorders, though 21.4% indicated antidepressant use and 12.3% indicated benzodiazepine use. Another 7% were referred for neurological disorders. Follow-up data were captured in visits (11,992) from 4698 older patients, averaging 2.5 visits per patient. The type of medical cannabis used changed over time, with increasing use of cannabis oil compared to herbal cannabis. In 2020, of 2478 visits, 78.9% use was cannabis oil and 6.7% was herbal forms (pre-2018: 57.6% vs 36.2%). The composition of cannabis oil demonstrated a preference for cannabinoid oil (CBD+) over tetrahydrocannabinol (THC+) in 6043 visits: 45.2% were using CBD+ preparations, only 3.2% were using THC+ preparations, and for CBD/THC combinations, CBD predominated (CBD+/THC-: 30.5%;CBD+/THC+: 16.8%;CBD-/THC+: 4.3%). Adverse-effects (7062 visits) included dry mouth (15.8%), drowsiness (8.6%), dizziness (4%) and hallucinations (0.6%). Patients reported improved pain, sleep and mood over time, though 15-20% reported no improvement or worsening. Medication use was mostly unchanged, though 40% of opioid users reported requiring reduced dosages. Conclusion(s): These data were drawn from a large convenience sample. The data suggest an increasing proportion of older users of medical cannabis, though COVID-19 may have affected recent use. Female users comprised a higher proportion, and cannabis oil containing CBD was preferred. Systematic studies of effectiveness and safety in older users of cannabinoids are needed given its increasing use. Funding(s): No funding was received for this work.Copyright © 2021

Health-related quality of life in long COVID-19 in context of symptom type

Aim: Coronavirus disease 2019 (COVID-19) is complex multisystem disease. After 4 weeks of persistent symptoms, it is termed as Long COVID-19. Long COVID-19 causes a decrease in health-related quality of life (HRQoL). In this study, it was aimed to determine which symptoms were associated with lower HRQoL in Long COVID-19 in this study. Material(s) and Method(s): This cross-sectional study was conducted in a tertiary research hospital. Patients who have positive RT-PCR results at least 28 days and at most 180 days ago were selected for the study. Online survey was applied to 266 patients who had positive PCR test results for COVID-19. The EuroQoL 5D-3L scale was used to measure the HRQoL as a dependent variable. Socio-demographic features and symptoms were assessed by the survey as independent variables. Due to heteroscedasticity, a robust standard error regression analysis was conducted to make inferences on the effects of persistent symptoms on HRQoL. Result(s): Of the total 266 participants, 163 were females (63.3%). The mean age was 41.2 +/- 11.8 years. One hundred forty-two patients (53.3%) did not report any ongoing symptom. Female gender and lower education level as socio-demographic variables, visual problems and myalgia as persistent symptoms were identified as risk factors for reduced HRQoL in Long COVID-19 patients. Discussion(s): Long COVID-19 patients experience lower levels of HRQoL, especially those with visual problems and/or myalgia. Interventions to raise the HRQoL of Long COVID-19 patients should first target visual problems and myalgia.Copyright © 2023, Derman Medical Publishing. All rights reserved.

Comparison of Immediate Adverse Effects of COVID-19 Vaccine (COVAXIN BBV152) in Pregnant vs Nonpregnant Women

Aims and objectives: The aim of this study was to compare the immediate adverse effects of the coronavirus disease 2019 (COVID-19) vaccine (COVAXIN) in a pregnant woman with that of a nonpregnant woman. Material(s) and Method(s): It is a prospective observational study done at Vanivilas Hospital, Bangalore Medical College & Research Institute (BMCRI) for 2 months. The sample size was 100 pregnant and 100 nonpregnant women. Telephonically, patients were followed-up, and details of the side/adverse effects were collected in a proforma after 2 and 14 days. Data collected from both groups were analyzed using the Chi-square test or Fisher's exact test. Result(s): The majority of women were in the age group of <=25 years (64.0% and 36.0%, respectively) with a mean age of 25.01 +/- 3.71 years among the pregnant and 28.52 +/- 6.00 years among nonpregnant women. About 25.0% of pregnant women and 38.0% of nonpregnant women reported side effects. About 15.0% and 22.0% had taken treatment for side effects among pregnant women and nonpregnant women, respectively. Among the pregnant women, the common side effects reported were injection site pain (17) followed by fever (5), fatigue (4), and myalgia (03). Whereas among the nonpregnant women, the common side effects reported were injection site pain (28) followed by fever (6), myalgia (3), headache (2), and fatigue (1). Conclusion(s): Side effects reported following the administration of Covaxin in pregnant and nonpregnant women are fever, fatigue, injection site pain, myalgia, and headache. The proportion of side effects was not significantly different in the pregnant and nonpregnant women following Covaxin administration. Clinical significance: Covaxin is an inactivated killed vaccine against COVID-19 by Bharat Biotech. The vaccine has been recommended for pregnant women by the Government of India during corona pandemic. Studies are lacking regarding the difference in adverse events in pregnant versus nonpregnant women, after vaccine administration.Copyright © The Author(s).

Evaluating a Questionnaire in Telephone Balance Consultations during the Coronavirus Disease 2019 Pandemic.

INTRODUCTION: During the coronavirus disease 2019, pandemic clinical practice had to change, and this study trialled a diagnostic questionnaire to assess patients with dizziness over the telephone. METHODS: All 115 patients awaiting otorhinolaryngological assessment for balance were randomised to receive a dizziness questionnaire in the post prior to their telephone consultation or not. Consultation outcomes were recorded by the clinicians conducting the consultation. Follow-up data were collected in June 2022 for final outcomes. RESULTS: 82/115 patients had consultations with complete data collection: 35 in the questionnaire group (QG) and 47 in the no questionnaire group (NQG), with a 70% response rate in the QG. Clinicians made a diagnosis in 27/35 QG consultations versus 27/47 NQG consultations. Nine out of 35 QG patients required additional investigations compared to 34/47 in the NQG (p < 0.05). Only 6/35 QG patients needed additional telephone follow-up, compared to 20/47 NQG patients (p < 0.05). CONCLUSION: Using a diagnostic questionnaire increased clinicians' ability to come to a diagnosis in telephone consultations.

Rare dizziness, syncope, loss of consciousness, seizure, and risk of falling after vaccination

Some individuals experience dizziness, syncope (temporary loss of consciousness caused by a fall in blood pressure), seizure, and similar rare adverse events after vaccination. Sudden impacts to alertness, consciousness, ability to talk, vision, or balance may pose rare risks for some vaccinees for a few days post vaccination. Herein, the Vaccine Adverse Event Reporting System (VAERS) database is examined for relevant adverse events. These adverse events exhibit a consistent pattern of onset soon after vaccination consistent with other reported reactogenicity adverse events. The onset of these adverse events soon after vaccination provides supportive evidence to reject the hypothesis that the majority of these adverse events represent background occurrences unrelated to vaccination. The immediate onset timing of these adverse events represent a pattern that warrants further study. The observed onset pattern for multiple unrelated vaccines are consistent with the possible etiology of innate immune responses to vaccination as causative for these observed adverse events. Cautionary avoidance of some activities immediately following vaccination may reduce accidental injuries.

Audiovestibular and vaccination complications of COVID-19

Objectives: Since its first appearance in Wuhan December 2019, SARS-CoV2 virus received great attention due to its severe symptoms and high spread causing COVID-19 disease which spread all over the world like a pandemic. The causative virus is capable of human-to-human transmission via droplet and direct contact suggesting that upper respiratory tract is the main site to virus manifestations. There is a great diversity in its clinical picture, although the severe respiratory and neurological symptoms are commonly present;however, other symptoms are present. Although otological manifestations are reported in many COVID-19 patients even in asymptomatic cases, they did not receive much attention compared with other critical manifestations. In this article, we paid our attention specifically to the otological manifestations of COVID-19 and their relevance either to the virus infection, treatment, or vaccination through literature review. Conclusion(s): COVID-19 disease has a deleterious effect on the inner ear. This effect is not only due to SARS-Cov-2 infection, but it could be also due to the ototoxic drugs used for treatment. The COVID-19 vaccinations are found to be implicated in the otological symptoms in some cases.Copyright © 2022, The Author(s).

Prognostic criteria for the development of severe clinical forms of COVID-19 in medical organization workers

Employees of medical organizations are one of the risk groups for infection with a new coronavirus infection (COVID-19), including with the development of severe clinical forms. The aim of the study was to analyze the clinical manifestations of a new coronavirus infection in medical workers with the determination of laboratory markers for the development of severe COVID-19. Material and methods. The study included 186 medical workers who had COVID-19 in 2020. In 67 people (observation group), the disease occurred in the form of pneumonia, in 119 people (comparison group) - acute respiratory infection caused by SARS-CoV-2. In the acute period of the disease, a laboratory examination was carried out: a general clinical blood test, CD-typing of lymphocyte subpopulations, assessment of biochemical parameters, determination of parameters of the hemostasis system and cytokine levels. Using the binary logistic regression method, we have built multifactor models. To determine the threshold values of the indicators, we used ROC analysis. Statistical processing of materials was carried out using Microsoft Office 2016 and IBM SPSS Statistics (version 26). The differences were considered statistically significant at p<0.05. Results and discussion. The most frequent clinical manifestations of COVID-19 were: weakness, fever, myalgia, arthralgia, difficulty in nasal breathing, serous-mucous discharge from the nose, sore throat, cough, feeling of "tightness" in the chest, shortness of breath, headache, pain in the eyeballs, dizziness, anosmia, ageusia and dyspeptic manifestations in the form of diarrhea, nausea or vomiting. Markers associated with the development of severe pneumonia associated with COVID-19 have been identified. Threshold values of laboratory parameters for predicting the severe course of COVID-19 were determined: the number of platelets (less than 239x109/l), lymphocytes (less than 1.955x109/l), cytotoxic T-lymphocytes (less than 0.455x109/l), T-helper cells (less than 0.855x109/l), NK-cells (less than 0.205x109/l), ESR (more than 11.5 mm/h), LDH (more than 196 units/l), total protein (less than 71.55 g/l), D-dimer (more than 0.325 mcg/ml), CRP (more than 4.17 mg/l), IL-6 (more than 3.63 pg/l). Conclusion. The data obtained make it possible to predict the possibility of developing a severe variant of the COVID-19 course.Copyright © 2022 Infectious Diseases: News, Opinions, Training. All rights reserved.

Structure of Adverse Events Following Immunisation against Coronavirus Infection (COVID-19) in the Kyrgyz Republic.

There is considerable interest worldwide in developing safe and effective vaccines against COVID-19. Pharmacovigilance of adverse events following immunisation (AEFIs) is a key to making informed decisions regarding the global COVID-19 vaccination campaign. In the Kyrgyz Republic, there have been developed a national immunisation information system (IIS) for automated recording of vaccines, vaccinated persons, and AEFIs and a mobile application for AEFI reporting, called Den Sooluk. The aim of the study was to analyse the pattern of AEFIs against COVID-19 in the Kyrgyz Republic. Material(s) and Method(s): the study analysed the spontaneous safety reports submitted to the national IIS database through the Den Sooluk mobile application from 29.03.2021 to 25.09.2022. Result(s): according to the data available by 25.09.2022, the total number of vaccinated people in the country amounted to 2,940,082. At the time, the IIS database included 2111 AEFIs: 1 fatal (and coincidental), 3 severe and 2108 minor ones. AEFIs were more frequent in the young and middle-aged population (81.5%), than in the elderly (18.5%). The following AEFIs were reported: injection site pain (21.25%), fatigue (20.7%), headache (19.8%), body temperature above 38 C (10.10%), miscellaneous symptoms (5.12%), chills (4.41%), dizziness (4.32%), sore throat (3.36%), myalgia (2.9%), and nausea (2.2%). Conclusion(s): all COVID-19 vaccines used in the Kyrgyz Republic can be considered adequately safe. Pharmacovigilance of AEFIs is an integral part of the requirements to ensure the safe use of vaccines, and collecting of spontaneous reports on AEFIs supports adequate functioning of the post-marketing surveillance system. It is essential to provide access to electronic information platforms to health professionals and patients in order to ensure vaccination transparency and coordination and enable quick and safe reporting of AEFIs associated with the use of COVID-19 vaccines.Copyright © NEICON ISP LLC. All rights reserved.

Safety and tolerability of losmapimod for the treatment of FSHD

Evaluate the safety and tolerability of losmapimod in the treatment for FSHD. FSHD is a relentless, variably progressive disease leading to accumulation of disability over decades. Fulcrum is developing losmapimod, a small molecule p38 alpha/beta MAPK inhibitor, to treat FSHD. Losmapimod has been generally well-tolerated in more than 3,600 subjects across multiple clinical studies, including >100 subjects with FSHD. Fulcrum has assessed losmapimod in FSHD in one completed phase 1 study (FIS 001-2018) and two ongoing Phase 2 studies in the open label extension period (FIS 001-2019 and FIS 002-2019). Subjects aged 18-65 years with genetically confirmed FSHD1, clinical severity score 2-4, and MRI-eligible muscles for biopsy were exposed to losmapimod 7.5 or 15 mg twice daily PO for 14 days and up to 76 weeks. In study FIS 001-2018, 6 subjects were exposed to 7.5 mg and 11 subjects to 15 mg twice daily dosing for 14 consecutive days. In studies FIS 001-2019 and FIS 002-2019, 14 and 77 subjects respectively, received at least one dose of losmapimod 15 mg twice daily for up to 76 weeks. A total of 108 subjects with FSHD1 have been exposed to losmapimod, with approximately 131 patient-years of exposure. Fifty-seven subjects have been exposed to losmapimod for 12 to 18 months, and 30 have been exposed for over 18 months. Most adverse events (AEs) observed during the studies were considered of mild to moderate in severity. The most common AEs were alanine aminotransferase (ALT) increase, headache, dizziness, dry skin, eczema and gastrointestinal disorders. The majority of AEs resolved with continued dosing. Dosing has been paused for 14 days in four subjects (3 in FIS 001-2019 and 1 in FIS 002-2019) subjects due to COVID-19 infection. There were no reported drug related SAEs, deaths, discontinuations due to AEs, or clinically significant changes in vital signs, clinical laboratory results, or ECG parameters. Losmapimod given as up to 15 mg twice daily in >100 subjects with FSHD1 for up to 76 weeks has been generally well-tolerated, consistent with that previously reported in other patient populations. Therefore, the benefit-risk profile of losmapimod for the treatment of FSHD remains favorable.Copyright © 2022

Safety Monitoring of Covid-19 Vaccine: In a Tertiary Care Hospital in Haryana

Objective: The present study aimed to ensure the safety and related potential adverse effects following ChAdOx1 nCoV-19 vaccination (AZD1222) in a scenario when numerous vaccines have been approved on an emergency basis by the WHO and other regulatory agencies to prevent the widespread of COVID-19 infection and to decrease the associated mortality and morbidity. Method(s): This study was an open, non-comparative, non-interventional, observational study conducted on healthcare workers of BPS Govt. medical college for women and elderly people who received the first dose of COVID-19 vaccinationChAdOx1 nCoV-19 vaccine (AZD1222) by conducting their interviews and recording the data Results: Between January and March 2021, a total of 1907 participants were enrolled in this study. Out of 1907 recipients, 70 recipients reports adverse drug events following vaccination. Myalgia (0.629%), headache (1.31%), fever >=(37.5 degreeC, 0.839%) and fever with chills (>= 37.5 degreeC, 1.048) were the most common adverse events after the first dose of vaccination of ChAdOx1 nCoV-19 vaccine (AZD1222. Throat irritation (0.209 %) and Generalised itching (0.262) were the least common adverse events. Conclusion(s): ChAdOx1 nCoV-19 (Astrazeneca) has an acceptable safety profile as observed in this study. To our knowledge, very few studies are done that review the safety of COVID-19 vaccines. Further safety data from a larger sample size and of longer duration are warranted to establish safetyCopyright © 2023 Innovare Academics Sciences Pvt. Ltd. All rights reserved.

Assessment and Analysis of Adverse Events Following Covid-19 Vaccination among Children Aged 15-18 Y at Tertiary Care Teaching Hospital, Telangana: A Prospective Observational Study

Objective: Government of India (GOI) has allowed vaccination for age group of 15-18 y. It is a positive step toward boosting immunization rates across the nation. As per guidelines, BBV152 vaccine, Bharat Biotech's "Covaxin" is approved for adolescents. The study was designed to evaluate adverse events following immunization (AEFI) among adolescents. Method(s): A prospective, observational survey was carried out among the first 315 beneficiaries (adolescents of age 15-18 y) for a period of 5 mo at Osmania medical college and hospitals. Within 24 h, 48-72 h, and two weeks following the first and second doses of Covaxin, active and passive surveillance using telephonic inquiry and documentation relating to adverse events was conducted. The prevalence of AEFI and its association with demographic factors have been identified. Collected data were analyzed using SPSS 25. Result(s): The first 315 beneficiaries (Adolescents between the ages of 15 and 18) who received Covaxin were identified. All AEFIs reported were within the first 24-72 h of vaccination. AEFI incidence was higher in 1st dose (16.6%) when compared to 2nd dose (3.5%). No AEFIs were noted after 2 w. We found no association of AEFI with sex, age group, and past history of Covid as this finding is not significant (p>0.05). Conclusion(s): Overall, Covaxin has a good safety profile in adolescents. Symptoms were transient and of low intensity. There were no documented severe and serious AEFI. It is obligatory for documentation as the AEFI profile will encourage vaccine adoption and lessen reluctance.Copyright © 2023 The Authors. Published by Innovare Academic Sciences Pvt Ltd.

Retrospective study on adverse effects following COVID- 19 vaccination among teenagers in Klang Valley

Introduction: Preventive approach via vaccination remains one of the most effective ways of controlling the COVID-19 pandemic. Safety concerns especially among children and teenagers is a concern. The aim of the study was to determine the adverse effects of COVID -19 vaccine among teenagers in Klang Valley. Method(s): A retrospective study involved 12 to less than 18 years old received COVID-19 Pfizer-BioNTech (BNT162b2) mRNA vaccine from 1st September 2021 until 15th November 2021 in Hospital Tunku Azizah. They were interviewed via telephone on the adverse effects of COVID -19 vaccination after available parental consent and assents. Result(s): A total of 300 teenagers recruited. There were 166 (55.3%) males and their mean age was 13.8 +/- 1.7 years. During first vaccination, 267 (87.0%) experienced local adverse effects (injection site pain, swelling and redness), 58 (18.0%) had systemic adverse effects and 77 (25.0%) had general symptoms (fever, lethargy, giddiness, chills and flush) during first 48 hours. About 5% had symptoms by second to seven days post-vaccination. Almost all adverse effects resolved by second week. For second vaccination, 251 (83.0%) had local adverse effects, 39 (13.0%) had systemic adverse effects and 71 (24.6%) had general symptoms within first 48 hours. Less than 6.0% had side effects between second to seventh day and almost all resolved by second week of vaccination. Adverse side effects were not related to their underlying medical problems, age and gender. Conclusion(s): Common adverse effects following COVID-19 vaccination among teenagers were localised to injection within the first 48 hours.

A Prospective Observational Study on the Clinical Characteristics of Pregnant Women Post COVID-19 Vaccines

Background: The use of mydriatic and cycloplegic eye drops is a common practice in ophthalmology for various diagnostic and therapeutic procedures like for estimation of refractive error and for thorough fundus examination. The combination of Tropicamide and Phenylephrine has been a subject of debate among ophthalmologists regarding its efficacy and side effects. Aims and Objectives: The aim of this study was to evaluate the efficacy and safety of 1% Tropicamide alone versus a combination of 0.8% Tropicamide and 5% Phenylephrine for mydriasis and cycloplegia. The objectives were to compare the rate of mydriasis and maximal mydriasis after instilling a single drop of each solution and to measure the degree of cycloplegia and amount of residual accommodation at 25 minutes after instillation of the drops. Method(s): This was a hospital-based, analytic cross-sectional study conducted on 100 patients between 15 and 35 years of age presenting to the Department of Ophthalmology, Government Medical College and Associated Group of Hospitals, Kota for refraction or fundus examination. Patients were randomly assigned to either the Tropicamide group or the Tropicamide-Phenylephrine group. The study measured the rate of mydriasis, maximal mydriasis after eye drop instillation. Study also measured the degree of cycloplegia and amount of residual accommodation at 25 minutes after instillation of the drop. Result(s): The combination of Tropicamide and Phenylephrine resulted in a higher rate of mydriasis and maximal mydriasis than Tropicamide alone. Tropicamide alone uncovered significantly higher mean latent error of refraction and had higher cycloplegic effect as compared to combination group. The study also found that increasing age lead to increased cycloplegia and decreased residual accommodation in both groups. It was also found that both groups had a similar safety profile, with no significant adverse effects observed except significant increase in pulse rate after instillation of combination eye drop. Conclusion(s): The combination of Tropicamide and Phenylephrine is more effective than Tropicamide alone for inducing mydriasis with a similar safety profile except significant change in pulse rate. While Tropicamide alone had better cycloplegic effect.Copyright © 2023, Dr. Yashwant Research Labs Pvt. Ltd.. All rights reserved.

COVID-19 vaccination and changes in blood pressure

Introduction: Some healthcare staff observed an increase in their blood pressures (BP) after the SARS-CoV-2 vaccination, thus Hospital Pulau Pinang (HPP) began collecting vital signs during the second dose of the vaccination. We aimed to compare the changes in BP after vaccination. Method(s): This was an observational study using secondary data collected as part of the SARSCoV- 2 vaccination in HPP. Changes in BP immediately after and 15-30 minutes post vaccination were compared with baseline using paired t-tests. Result(s): A total of 4906 staffs received 2 doses of the BNT162b2 mRNA COVID-19 vaccine. Most subjects did not report any adverse effects. Common adverse effects were redness, pain or swelling at the injection site, tiredness, fever, chills, headache and myalgia. Mean pre-vaccination systolic and diastolic BPs were 130.1 (SD 17.38) mmHg and 80.2 (SD 11.62) mmHg, respectively. BP was increased in more than half of the subjects immediately and 15-30 minutes post vaccination however, the mean increases were small. Among those with hypertension (n=244), only increases in diastolic blood pressure were significant. Overall, 58 (1.02%) were admitted into the observation room either due to hypertensive urgency or complaints of giddiness. Conclusion(s): Overall, the increases were relatively small and may not prevail over the benefits offered by vaccination. However, monitoring of BP may be warranted to prevent any unexpected serious events.