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Background: Coronavirus disease-2019 (COVID-19) poses expectant mothers to a higher risk of serious complications and mortality. Following a risk-benefit review, a number of governmental and professional bodies from across the globe recently approved the COVID-19 vaccination during pregnancy. Aim(s): This study aimed to investigate knowledge, actual acceptance, and concerns about the COVID-19 vaccine among the obstetric population. Material(s) and Method(s): Participants were selected from among the expecting women who came for antenatal checkup during the study period (October 1, 2021-November 30, 2021). About 150 pregnant women who met the inclusion criteria and consented were recruited into the study. Data related to socio-demographic and clinical characteristics as well as knowledge, actual acceptance, and concerns about COVID-19 vaccine were collected through in-person interviews using a prestructured questionnaire. The SPSS version 23 was used to analyze data. The association between the attitude (acceptance and hesitance) of participants toward the COVID-19 vaccine and their sociodemographic and clinical profile was found by Fisher's exact test. Result(s): The actual acceptance of the COVID-19 vaccine among expecting women was 52.0%. The primary motive for accepting COVID-19 immunization was to protect the fetus, followed by the protection of one's own health. A significant association was found between COVID-19 vaccine acceptance and the level of education, socio-economic status, and presence of comorbidities. The leading causes for vaccine reluctance were concerns about the efficacy and safety of the vaccines and lack of awareness about their usage during pregnancy. Conclusion(s): Multifaceted activities are required to promote the effectiveness and safety profile of the COVID-19 vaccine as well as disseminate knowledge about its usage during pregnancy. Clinical significance: Unlike numerous other studies that have investigated the accepting attitude only, the present one has investigated the actual COVID-19 vaccine uptake among the obstetric population.Copyright © The Author(s).
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Objective: COVID-19 caused a deleterious impact on the health care system globally.The roll out of vaccines seems to be the only effective way to curtail the spread of disease.The purpose of this study is to assess the dermatological adverse effect of post COVID-19vaccination on a gender basis. Methodology: This was an observational,cross-sectional,questionnaire-based survey conducted in Pakistan.The sample comprises 518 participants. The questionnaire was self-designed. The trial lasted six months, from August 1, 2022, until January 31, 2023. We used a non-probability sampling technique.Dermatological adverse effects like burning pain, redness, rashes, and lymphadenopathy at the injection site were recorded.Fever was also noted. All the participants have received booster shots or double doses of any one of CCOVID-19 vaccines, such as AstraZeneca, Pfizer, Sinovac, Sinopharm,Pakvac, etc. A p-value of less than 0.05 was considered statistically significant.Qualitative data was reported as frequency and percentage, and quantitativedata was reported as standard deviation and mean. Result(s): The study included 518 subjects, of whom 262 were males and 256 were females. The mean age of male is 42.70+/-14.05 years and female is 39.04+/-14.6years with a significant difference observed between them (p=0.004). The most common complaint among dermatological adverse effects after first was pain. 106(40.5%) male and 132(51.6%) female reported painwith a significant difference observed between them (p=0.011) followed by swelling which was reported by 92(35.1%) males and 120(46.9%) females with a significant difference observed between them (p=0.006).Burning was reported in 92(35.1%) male and 148(57.8%) female with a significant difference observed between them(p<0.001). Fever was also quite commonly reported in both male 116(44.3%) and female 178(69.5%) with significantdifference observed between them (p<0.001),Likewise post 2nd dose of vaccination, pain was most commonly noted in 90(34.4%) male and female 124(48.4%) female with significant difference observed between them (p=0.001). Moreover, burning was reported by 80(30.5%) malesand 132(51.6%) females with a significant difference observed between them (p<0.001). rashes were reported by76(29.0%) males and 100(39.1%) females with a significant difference observed between them (p=0.016), lymphadenopathy was also significantly associated with genders, (p<0.001). Conclusion(s): This study concluded that the burning pain,redness,rashes,and lymphadenopathywere the most prevalent side effects in male and female post 1st and 2ndCOVID-19 vaccination.Furthermore fever was also reported in majority of subjects.In addition to this higher percentage of side effects were recorded in females as comparedto males.Copyright © 2023 Lahore Medical And Dental College. All rights reserved.
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BACKGROUND: Vaccines are one of the best interventions developed for eradicating COVID-19. In Albania, COVID-19 vaccination uses different types of vaccines: Pfizer, AstraZeneca, CoronaVac, and Sputnik V. Like any other vaccine, these have side effects too. AIM: This study was carried out to identify the perception of the side effects of vaccines. METHOD(S): A quantitative study using a cross-sectional survey was conducted between April and September 2021 to collect data on the effects of the COVID-19 vaccine among individuals in Shkodra region. Data were collected online through a self-administered survey created on Google Forms which had been randomly delivered to individuals (aged >=18 years) using social media sites (Email and WhatsApp). All data collected were analyzed with Microsoft Office Excel 2010, using the exact Fisher's test and x2 test. RESULT(S): This study included 292 citizens, out of which 200 were female and 92 were male;62% were from urban areas and 38% from rural areas of Shkodra region. The random sample of the citizens who took part in this study is 44.5% (18-30 years old). A massive percentage of the participants, 66.4%, had received the second dose of the vaccine. Our study shows that 55.8% of these citizens have had side effects after the first vaccination dose, and only 43.8% have had side effects after the second dose. About 80.6% of the participants were well informed about the type of vaccine they got. CONCLUSION(S): Side effects from vaccines were reported. Injection site pain and fatigue were the most common first dose side effects (55.8%). The same side effects were reported for the second dose. The side effects were presented during the first 12 h after the vaccination in most cases. Side effects were more prevalent in people >50 years old. Older people have a higher probability to have more side effects from the COVID vaccine. There is no statistically significant relationship between gender and the presence of the side effect from the COVID vaccine. People living in urban areas have a higher probability to have side effect from COVID vaccine comparing with people living in rural areas. People being vaccinated with Pfizer vaccine have a higher probability to admit the presence of side effects.Copyright: © 2022 Zamira Shabani, Arketa Guli, Julian Kraja, Arlinda Ramaj, Nertila Podgorica.
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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).
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Objectives: Interception therapy requires an individual to take a treatment today to prevent a future medical event. Patients must trade off treatment burdens incurred today against future benefits. We examined the preferences of high-risk lung cancer (LC) individuals for potential interception therapies that reduce the risk of developing lung cancer. Method(s): An online discrete-choice experiment (DCE) was developed for hypothetical LC interception treatments with four attributes: reduction in risk of LC over 3 years, injection site reaction severity, nonfatal serious infection risk, and death from serious infection risk. Respondents chose between two alternative treatments or a no-treatment option. The DCE was analyzed using random-parameters logit, and maximum acceptable risk for an LC risk reduction was calculated. Logit analysis explored characteristics of respondents who always selected no treatment. Result(s): The sample included 803 adults aged 50-80 years with at least a 20 pack-year smoking history. Respondents had an average willingness to accept interception therapy (alternative-specific constant=1.30, 95% CI: 0.91-1.69). Respondents viewed larger reductions in the risk of LC as most important. Respondents were willing to accept increases in risk of nonfatal serious infection up to 15% for a 15% improvement in relative LC risk reduction and increases in risk of death from serious infection up to 1.5% for a 23% improvement in relative LC risk reduction. However, 16% of respondents selected 'no treatment' for all DCE questions. Older respondents, current smokers who have never tried to quit, and those who did not get regular skin exams for cancer and/or COVID-19 vaccine were more likely to opt out of interception therapy. Conclusion(s): Generally, individuals at high risk of LC are willing to consider interception therapy. Study results can support benefit-risk assessments for future systemic LC interception treatments, and the results may have implications for other therapeutic areas.Copyright © 2023
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Introduction Vaccination for coronavirus disease 2019 (COVID-19) helps develop protective immunity against COVID-19 without experiencing potentially severe illness. Many vaccines are used worldwide, but there is little data on the efficacy and side effects of the Sinopharm vaccine. Therefore, this study aimed to investigate the reported adverse effects of the Sinopharm vaccine among participants. Methods This prospective cross-sectional study was conducted in multiple hospitals in Karachi, Pakistan. The study was eight months, from April 1, 2022, to November 30, 2022. A total of 600 participants who gave informed consent and had received their first and second doses of the Sinopharm vaccine were included in the study. As hypertension and diabetes mellitus (DM) are common prevalent conditions in our population, the duration of DM and hypertension were documented as means and standard deviations apart from age, height, and weight. Side effects of the Sinopharm vaccine were reported as frequencies and percentages. Results The study findings showed that out of 600 participants, 376 (62.7%) were males and 224 (37.3%) were females; their mean age was 42.79±14.44 years. Among them, 130 (21.7%) had hypertension, and 138 (23.0%) had DM. All participants received the Sinopharm vaccine. Fever was the most frequently reported adverse effect following the first dose of the Sinopharm vaccine in 308 (51.3% of participants), followed by burning at the injection site in 244 (40.7% of participants) and pain at the injection site in 228 (38.0% of participants). Following the second dose of the Sinopharm vaccine, fever was the most frequently reported side effect in 254 (42.3%) participants, followed by pain at the injection site in 236 (39.5%) participants and burning at the site of injection in 210 (35.0%) participants. Moreover, joint pain in 194 (32.3%), shortness of breath in 170 (28.3%), swelling of glands in 168 (28.0%), chest pain in 164 (27.3%), and muscle pain were reported by 140 (23.3%) participants. The level of satisfaction showed that the majority of the participants, 334 (55.7%), were satisfied, 132 (22.0%) were very satisfied with their vaccination, and only 12 (2.0%) were dissatisfied. Conclusion This study concluded that fever was the most frequent side effect after both doses of the Sinopharm vaccine. Pain and burning at the injection site and joint pain were among the other common side effects reported by most participants. The Sinopharm COVID-19 vaccine had mild, predictable, and non-life-threatening side effects after the first and second doses.
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Objectives: The objective of this study was to determine the frequency of adverse effects (AE) of vaccination against COVID-19 in patients with SLE who visit medical centers in Asuncion, Paraguay. Method(s): The study performed was observational, transverse, descriptive. 152 patients with SLE were included, who received at least one dose of anti-COVID vaccine. A survey was carried out, which allowed the data collection through phone calls or instant messaging. Each investigator had a spreadsheet that related the generated code with the surveyed patient's name. Once the call ended and if the patient agreed to participate in the study, a code was generated. Result(s): 88.5% of the individuals were female, the average age was 33.93 +/- 11,102 years. Of these, 94.3% received their first dose, 86.3% the second dose, 39.7% the third dose, and 2.3% the fourth dose. Of the total vaccinated patients, 39.38% were administered Sputnik-V, 26.02% Pfizer, 16.43% AstraZeneca, 13.35% Moderna, 4.1% Covaxin, and 0.68% Hayat Vax. Of 292 doses administered, 103 AEs were recorded, 79.6% within the first 5 days and the rest within the next 5 days. 44.03% presented the AE after the first dose, 32.11% after the second dose and 23.85% after the third dose. Themean duration of symptoms was 7.49 +/- 9.877 days. The most important side effect was pain at the injection site, followed by fever and fatigue. The worsening of Lupus due to the administration of the anticovid vaccine was demonstrated in 9.93% of the cases. Conclusion(s): Mild effects were registered. It is concluded that vaccination against COVID-19 is safe for individuals with SLE.
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Objectives: In the Chronic Inflammatory Immune-mediated Diseases (CIMD), infections mainly occur in the respiratory tract and their occurrence is related to drug-induced immunosuppression, underlying diseases and comorbidities. To reduce this morbidity and mortality, vaccination is an effective means of prevention. However, the available studies on SARS-CoV-2 vaccines have not addressed this group of patients with CIMD, and there are still many doubts regarding the indications, adverse effects, safety and efficacy of these vaccines. Objective(s): to evaluate the adverse effects of vaccines against SARS-CoV-2 in adolescent patients with CIMD. Method(s): Research associated to the SAFER Project from Brazilian Society of Rheumatology. It is an observational, longitudinal, ambidirectional study, with follow-up of groups of vaccinated adolescent patients with CIMD, vaccine by Pfizer/BioNTech. Sociodemographic data were collected, stored on an online platform, and adverse events were presented by filling in diaries issued for each patient. This study was approved by the local Research Ethics Committee. Result(s): We included 19 adolescents, aged between 12 to 17 years, who met the inclusion and exclusion criteria. The mean age was 14.63 +/- 2.01 years. Of these, 68.4% were female. In relation to CIMD, 31.6% have Juvenile Idiopathic Arthritis and 68.4% have Systemic Lupus Erythematosus. All were vaccinated with the Pfizer vaccine. In the 1st dose, the main adverse effects presented were Pain at the injection site (85.7%), Headache (42.9%), Tiredness (33.3%) and Edema and skin induration at the injection site (26, 7%). After the 2nd dose, the only adverse effect reported was Pain at the injection site (57.1%), with no other complaints. Conclusion(s): The adverse effects reported are of mild tomoderate reactogenicity;no serious adverse events were reported.
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Objectives: To evaluate the safety and immunogenicity of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with Rheumatoid Arthritis (RA). Method(s): These data are from the 'SAFER (Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases)' study, a Brazilian multicentric longitudinal phase IV study to evaluate COVID-19 vaccine in immunomediated rheumatic diseases (IMRDs). Adverse events (AEs) in patients with RA were assessed after two doses of ChAdOx1 or CoronaVac. Stratification of postvaccination AEs was performed using a diary, filled out daily. The titers of neutralizing antibodies against the receptor-biding domain of SARS-CoV-2 (anti-RBD) were measured by chemilumine scence test after each dose of immunizers. Proportions between groups were compared using the Chi-square and Fisher's exact tests for categorical variables. Clinical Disease Activity Index (CDAI) before and after vaccination was assessed using the McNemar test. Result(s): A total of 188 patients with RA were included in the study, most of them were female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed. The more common AEs after the first dose were pain at injection site (46,7%), headache (39,4%), arthralgia (39,4%) and myalgia (30,5%), and ChAdOx1 had a higher frequency of pain at the injection site (66% vs 32 %, p alpha 0.001) arthralgia (62% vs 22%, p alpha 0.001) and myalgia (45% vs 20%, p alpha 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection site (37%), arthralgia (31%), myalgia (23%) and headache (21%). Arthralgia (41,42 % vs 25 %, p = 0.02) and pain at injection site (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. No patients had a flare after vaccination. The titers of anti-RBDafter two doses of ChAdOx1 were higher compared to two doses of CoronaVac (6,03 BAU/mL vs 4,67 BAU/mL, p alpha 0,001). Conclusion(s): The frequency of local adverse effects, particularly pain at injection site, was high. AEs were more frequent with ChAdOx1, especially after the first dose. The use of the immunizers dis not change the degree of inflammatory activity of the disease. In patients with RA, ChAdOx1 was more immunogenic than CoronaVac. .
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History: Transient and generalized adverse effects are common following COVID-19 vaccination;among other adverse effects, shoulder injuries related to vaccine administration (SIRVA) have been known to occur. In this case, a previously healthy right-hand dominant 62-year-old male presented with left shoulder pain and weakness 3 months after receiving a COVID-19 intramuscular vaccine in the left deltoid. Approximately 2 weeks after the injection, he started experiencing pain and numbness around the injection site along with ipsilateral shoulder weakness. Despite conservative management with Motrin, Medrol Dosepak, gabapentin and physical therapy (PT), the pain and weakness persisted. Physical Exam: Left Shoulder-No calor or erythema;significant atrophy of the anterior and middle deltoid muscle relative to right side;abduction 4/5;external rotation with shoulder adducted 4/5;range of motion for active forward flexion was 150 degrees and passive was 170 degrees;passive range of motion for external rotation was 70 degrees;internal rotation to the level of L5;sensation to light touch was intact. Right Shoulder-Range of motion, strength, and sensation were intact. Cervical Spine-Full ROM;no cervical paraspinal tenderness noted. Negative Spurling's and Lhermitte's tests. Differential Diagnosis: 161. Axillary Nerve Palsy 2/2 Chemical Neurotoxicity 162. Brachial Neuritis 163. Mechanical Axillary Nerve Palsy 2/2 Vaccination 164. Partial-Tear of Left Supraspinatus Tendon 165. Acromioclavicular Osteoarthritis Test Results: Left Shoulder-XR:Mild pseudo-subluxation;MRI w/o contrast: 8x9mmpartial-thickness articular surface tear of the distal supraspinatus tendon (<50%fiber thickness). Minimal subacromial bursitis. Mild acromioclavicular joint osteoarthritis. EMG/NCV: Left and Right Axillary Motor Nerves: prolonged distal onset latency;Left Deltoid: increased insertion activity, moderately increased spontaneous activity, reduced recruitment;Remaining LUE muscles without evidence of electrical instability Final Diagnosis: Axillary Nerve Palsy Secondary To Chemical Neurotoxicity from Intramuscular COVID-19 Vaccine. Discussion(s): We postulate that the neurologic deficits presented in our case may be attributed to chemical neurotoxicity to the axillary nerve following vaccination as the delayed onset of pain and weakness are most consistent with this differential. There are several cases of brachial neuritis following vaccination for the prevention of COVID- 19, however, EMG/NCV results in our patient were not consistent with brachial plexopathy. Additionally, while there have been a handful of reported cases of bursitis following COVID-19 vaccines falling under the SIRVA classification of injuries, this is the first case of reported axillary nerve neurapraxia. Outcome(s): The patient's left shoulder numbness and pain improved with PT and medical management. While mild improvement in strength was noted, weakness and atrophy persisted even on the third follow up visit 6 months after the initial appointment. He was counseled on his injury and was recommended to undergo repeat EMG testing to document recovery after his 6-month follow-up appointment. Follow-Up: The patient did not follow-up for a repeatEMG after his 6-month follow-up appointment. At that time, the patient was clinically stable, tolerating PT, and expecting recovery of his deltoid function.
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Aim. An online survey among social network users was conducted to assess the frequency of COVID-19 cases, the spectrum of medications used for treatment, and the subjective assessment of clinical manifestations of the disease. Material and methods. An anonymous online survey was conducted among users of various social networks using a questionnaire created on the SurveyMonkey survey and research platform. During the first month of December 2021, the survey included 23 questions regarding the clinical and demographic characteristics of respondents, the number of COVID-19 cases, clinical manifestations, and severity, as well as the need for medical help and medication. Results. 752 respondents took part in the online survey, more than 70% of them are under 50 years old. Among the respondents 59.73% had a new coronavirus infection (COVID-19). More than 40% of the participants had COVID-19 in the period from September 2020 to April 2021 (2nd wave in Russia). In 79.2% of people, the presence of a new coronavirus infection was confirmed by one of the diagnostic methods: polymerase chain reaction (PCR test), radiography, the presence of antibodies to Ig G/M, and took into account the presence of contact with infected SARS-CoV-2. 411 participants observed any clinical manifestations of the disease. Most often respondents who had COVID-19 indicated weakness, cough, dyspnea, disappearance or decrease in the acuity of smell and taste. The volume of lung tissue damage in 36.5% of cases was less than 25%. The disappearance of any clinical manifestations of the disease immediately after recovery was noted by 32.0% of respondents. Most of the patients (59.2%) sought medical help at the polyclinic, 38.9% had to self-medicate. 71.9% respondents indicated they had been vaccinated against COVID-19, but without specifying the timing and completeness of the course. Side effects after immunization (fever, weakness, soreness, and redness at the injection site) were subjectively assessed by 41.9% of respondents. Conclusion. Among the surveyed respondents, 62.7% of the disease symptoms were mild. The highest number of cases occurred in the 2nd and 4th waves of COVID-19 morbidity in Russia. Most often respondents indicated symptoms of acute respiratory infection. The complete disappearance of clinical manifestations of the disease immediately after recovery was noted by 32.0 % of respondents, and the persistence of symptoms for up to a year - 7.5. More than 70% of the participants in the online survey reported vaccination against COVID-19, but the questionnaire did not include questions about the timing of vaccinations (before or after COVID-19) and the completeness of the course.Copyright © Eco-Vector, 2023. All rights reserved.
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Purpose: The efficacy and safety of SARS-CoV-2 vaccination have been confirmed in several clinical trials. However, patients with autoimmune liver disease were not subject to clinical trials, and data on the efficacy and safety of vaccines have been not available in these population. Therefore, we retrospectively investigated the safety and effectiveness of SARS-CoV-2 vaccination by questionnaire survey targeting Japanese patients with autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC). Method(s): This is a multi-center, retrospective, cross-sectional, questionnaires-based study. Patients with AIH and PBC who are outpatients at participating facilities, 18 years of age or older, and have given consent to participate in this study are included. We distributed questionnaires asking about sex, date of birth, number and type of vaccinations, the presence and degree of adverse effects (AEs), and the presence or absence of SARS-CoV-2 infection before and after vaccination, and asked them to fill in the questionnaire. In addition, we collected the result of liver tests before and after vaccinations of participating patients from each facility. Result(s): The survey was conducted from September 2021 to May 2022. A total of 471 questionnaires were collected from 220 AIH patients (male/female = 33/187, average age 63.5 +/- 13.1 years old) and 251 PBC patients (38/213, 65.8 +/- 10.1). The number of vaccinations was 0/1/2/unknown = 4/0/210/6 for AIH and 4/2/244/1 for PBC. The median time from the second dose to the completion of the questionnaire was 156 days for AIH and 148 days for PBC. By vaccine type, 193 Pfizer, 11 Moderna, and 16 unknown in AIH, and 223/12/16 in PBC. As for AEs, pain and swelling at the injection site were the most common in both AIH and PBC (75% in the first and 64% in the second in AIH, 64%/61% in PBC), followed by general malaise (19%/21% in AIH, 19%/31% in PBC), and myalgia (16%/ 19% in AIH, 19%/14% in PBC). Fever above 38.5 degreeC was observed in 11%/11% of AIH and 11%/24% of PBC, indicating that more patients with PBC experiencing fever that AIH. Only 1 case of PBC had an anaphylactic reaction. By comparing liver tests before and after vaccinations, 4 (1.8%) and 16 (6.4%) patients with AIH and PBC, respectively, demonstrated elevation to 1.5 times the pre-vaccination value and exceeding the upper normal limit. No patients experienced severe deterioration of liver function. SARS-CoV-2 infection was reported in 4 cases (1.8%) in AIH and 3 cases (1.3%) in PBC. Conclusion(s): The safety and effectiveness of SARS-CoV-2 vaccination is comparable to those in the general population.
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Objectives: Systemic lupus erythematosus (SLE) is an autoimmune disease which presents infections as one of the most frequent complications, including more severe outcomes of Coronavirus disease 2019 (COVID-19). Immunization of these patients has been strongly recommended, however, data on safety are still scarce. In this study we evaluate the safety after vaccination against SARS-CoV2 in patients with SLE. Method(s): Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease - the 'SAFER' study, is a longitudinal Brazilian multicenter phase IV study. In this study patients with SLE (according to the 2019 ACR/EULAR criteria), older than 18 years who received vaccination against SARS-CoV-2 CoronaVac (Inactivated SARS-CoV-2 Vaccine), ChadOx-1 (AstraZeneca) and BNT162b2 (Pfizer-BioNTech) were included. The evaluation of adverse events (AEs) was done by telephone contact, symptom diaries and a face-to-face visit on the 28th day after each dose. Patients were followed up also by disease activity, assessed using SLEDAI-2 K score. Result(s): A total of 367 individuals with SLE were included, 207 received CoronaVac, 128 received ChadOx-1 and 32 received BNT162b2. Ninety percent of the subjects were female with a mean age of 37 years. About 50% (182) of patients were using oral glucocorticoids and azathioprine was the most frequent immunosuppressive therapy. Regarding disease activity parameters, 38%(140) of patients had zero SLEDAI-2Kat baseline and 41%(147) had zero SLEDAI-2 K 28 days after the 2nd dose. After the first and second dose the most frequent AEs were pain at injection site (58%/44%), headache (48%/33%) and pruritus (42%/37%). Comparing the three vaccines, after the first dose, local symptoms, myalgia, and fever were less frequent in patients who received CoronaVac (p alpha 0.001) as well as headache, tiredness (p = 0.001) and arthralgia (p = 0.003). After the second dose, only local symptoms such as pain at the application site and thickening of the skin around the application site were less frequent in the CoronaVac group (p alpha 0.05). Headache, tiredness, musculoskeletal symptoms and fever were more common in patients receiving AstraZeneca. No serious adverse events were reported regardless of the vaccination schedule used. Conclusion(s): This study suggests that vaccines against SARS-COV-2 are safe in SLE patients. Neither severe AEs were reported nor worsening of disease activity were reported. Comparing the different vaccines, CoronaVac had fewer adverse events.
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Intro: The US CDC recommends that COVID-19 vaccines may be coadministered with other age-appropriate vaccines. There is limited data assessing outcomes, including reactogenicity, on such co-administration. For the first time, we present interim safety data of RZV administered concomitantly or sequentially with an mRNA-1273 booster vaccine. Method(s): In this phase 3, randomized, open-label, multi-center study (NCT05047770), adults aged >=50 years were randomized 1:1 to receive the first RZV dose with mRNA-1273 booster (50 mug) at day 1 and the second RZV dose at week (W)8 (Co-Administration group [Co-Ad]), or mRNA-1273 at day 1, the first RZV dose at W2 and the second RZV dose at W10 (Sequential group [Seq]). Descriptive analyses of solicited/unsolicited adverse events (AEs) with onset within 7/30 days post-mRNA-1273 or first RZV dose, and of serious AEs/potential immune-mediated diseases/AEs of special interest (SAEs/pIMDs/AESIs) reported until database freeze are reviewed. Finding(s): The exposed set comprised 267 (Co-Ad) and 272 (Seq) participants. In each group, most solicited AEs were mild/moderate in intensity and each with <=2.5 days median duration, the most frequent were injection site pain, myalgia, and fatigue. Unsolicited (vaccines-related) AEs were reported by 25.0% (2.9%) of participants post-mRNA-1273 in Seq, 25.2% (0.8%) post-RZV in Seq, and 37.1% (3.7%) in Co-Ad. SAEs/pIMDs/AESIs were reported for 6/1/2 participants in Co-Ad and 5/1/3 in Seq. In Seq, one SAE/AESI (pulmonary embolism) and one pIMD/AESI (cutaneous vasculitis) occurred 2 and 9 days postmRNA-1273 (before RZV administration), respectively, and were considered mRNA-1273-related by investigators. In Co-Ad, one AESI (chronic hepatitis) occurred 35 days post-second RZV dose, considered vaccines-related by Sponsor. No fatalities occurred. Conclusion(s): No safety concerns were identified. The frequency/severity/type of AEs were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates. Funding(s): GSKCopyright © 2023
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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.
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Aim. An online survey among social network users was conducted to assess the frequency of COVID-19 cases, the spectrum of medications used for treatment, and the subjective assessment of clinical manifestations of the disease. Material and methods. An anonymous online survey was conducted among users of various social networks using a questionnaire created on the SurveyMonkey survey and research platform. During the first month of December 2021, the survey included 23 questions regarding the clinical and demographic characteristics of respondents, the number of COVID-19 cases, clinical manifestations, and severity, as well as the need for medical help and medication. Results. 752 respondents took part in the online survey, more than 70% of them are under 50 years old. Among the respondents 59.73% had a new coronavirus infection (COVID-19). More than 40% of the participants had COVID-19 in the period from September 2020 to April 2021 (2nd wave in Russia). In 79.2% of people, the presence of a new coronavirus infection was confirmed by one of the diagnostic methods: polymerase chain reaction (PCR test), radiography, the presence of antibodies to Ig G/M, and took into account the presence of contact with infected SARS-CoV-2. 411 participants observed any clinical manifestations of the disease. Most often respondents who had COVID-19 indicated weakness, cough, dyspnea, disappearance or decrease in the acuity of smell and taste. The volume of lung tissue damage in 36.5% of cases was less than 25%. The disappearance of any clinical manifestations of the disease immediately after recovery was noted by 32.0% of respondents. Most of the patients (59.2%) sought medical help at the polyclinic, 38.9% had to self-medicate. 71.9% respondents indicated they had been vaccinated against COVID-19, but without specifying the timing and completeness of the course. Side effects after immunization (fever, weakness, soreness, and redness at the injection site) were subjectively assessed by 41.9% of respondents. Conclusion. Among the surveyed respondents, 62.7% of the disease symptoms were mild. The highest number of cases occurred in the 2nd and 4th waves of COVID-19 morbidity in Russia. Most often respondents indicated symptoms of acute respiratory infection. The complete disappearance of clinical manifestations of the disease immediately after recovery was noted by 32.0 % of respondents, and the persistence of symptoms for up to a year - 7.5. More than 70% of the participants in the online survey reported vaccination against COVID-19, but the questionnaire did not include questions about the timing of vaccinations (before or after COVID-19) and the completeness of the course.Copyright © Eco-Vector, 2023. All rights reserved.
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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.
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Background: Zotatifin (eFT226) is a potent and selective inhibitor of eukaryotic initiation factor 4A (eIF4A), a host RNA helicase required for SARS-CoV-2 replication. In vitro, zotatifin demonstrates broad spectrum antiviral activity against all human coronaviruses tested. Zotatifin has physicochemical and pharmacokinetic (PK) properties suitable for convenient, single subcutaneous (sc) injection. This study assessed the safety, antiviral activity, and PK of zotatifin in non-hospitalized patients (pts) with mild/moderate COVID. Method(s): PROPEL is a randomized, placebo-controlled, double-blind study in non-hospitalized pts with mild/moderate COVID. At randomization, pts must have had a SARS-CoV-2 positive test within 7 days and at least 1 COVID symptom. Pts were randomized (3:1) to zotatifin or placebo sc in 3 cohorts of 12 pts each. Cohort 1, 2 and 3 received a single dose (SD) of zotatifin of 0.01. 0.02 and 0.035 mg/kg or matching placebo. Safety (adverse event (AE) and laboratory tests), antiviral activity (mid-turbinate nasal swabs and saliva), and plasma PK were collected over 30 days. The primary endpoint was safety;key secondary endpoints included SARS-CoV-2 viral load (VL) and PK. The study was not powered for statistical inferential testing. Result(s): 36 pts were enrolled across all three cohorts and completed a 30-day follow up. Data is currently available for pts in cohorts 1 and 2, 18 and 6 of whom received zotatifin and placebo, respectively. Baseline characteristics were comparable between groups. The most common AE was erythema at injection site in cohort 1 (44%) and cohort 2 (89%), vs. 0% in the zotatifin and pooled placebo groups, respectively. Other AE frequencies were comparable between zotatifin and placebo and no serious AEs were reported. The concentrationtime profile of zotatifin from cohorts 1 and 2 following sc administration was similar to that reported previously following IV administration, demonstrated a terminal elimination half-life (t1/2) of ~ 4 days, high steady-state volume of distribution (Vss) of 31 L/kg, and low plasma clearance (Cl) of 3.9 mL/min/kg. A faster time to viral RNA undetectability was observed with zotatifin vs. placebo (see Fig 1. Not statistically significant). Conclusion(s): Zotatifin was safe, well tolerated and demonstrated a trend in clinical antiviral activity in patients with mild to moderate COVID which supports further clinical development. Zotatifin sc route of administration supports a point of care treatment for COVID.
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Background: The safety profiles of the Ad26.COV2.S and AZD1222 COVID-19 vaccines have not been described in a general population in Malawi. We present self-reported adverse reactions (AE) following receipt of these vaccines in Malawi as part of a phone-based syndromic surveillance survey. Method(s): We conducted phone-based syndromic surveillance surveys among adults (>=18 years) with verbal consent from July 2020 to April 2022. We used secure tablets through random digit dialing to randomly select mobile phone numbers and electronic data collection forms. Survey questions included whether the respondent had received at least one dose of the COVID-19 vaccines, whether they had experienced any AE following vaccination, and the severity of the AE. We used multivariable analysis to identify factors associated with self-reported adverse reactions post-COVID-19 vaccination. Result(s): A total of 11,924 (36.0%) out of 33,150 participants reported receiving at least one dose of either Ad26.COV2.S or AZD1222 between July-December 2021;65.1% were female. An estimated 49.2% of the vaccine recipients reported at least one AE, 90.6% of which were mild, and 2.6% were severe. About 16.9% (n=656) of respondents who received the first dose of AZD1222 had AE, while 50.2% (n=2,823) of those who received the second dose of AZD1222 and nearly all individuals (n=2,385) who received Ad26.COV2.S reported AE. Joint pain (45.5%), fever (26.7%), headache (26.1%), pain at the injection site (24.4%), and fatigue (16.6%) were among the commonly reported AE. Males were less likely to report an AE compared to females [Adjusted Odds Ratio (AOR) 0.81 95% confidence interval (CI) 0.75-0.88]. Older age was associated with reduced odds of an AE compared to those aged 18-24 years: 65 years+ (AOR 0.62, 95% CI 0.50- 0.77). The likelihood of reporting AE increased with education level: tertiary education AOR 2.63 95% CI 1.96-3.53. Respondents who thought COVID-19 vaccines were not safe were more likely to report post-vaccination adverse reactions than those who thought it was very safe (AOR 1.44, 95% CI 1.30-1.61). Conclusion(s): Ad26.COV2.S and AZD1222 vaccines are well-tolerated, with primarily mild and few severe AE among adults living in Malawi. Self-report of AE following COVID-19 vaccine receipt is associated with gender, age, education, and concern about the safety of the vaccines. Recognizing these associations is key when designing and implementing COVID-19 vaccination communication messages to increase vaccination coverage.
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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.