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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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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: 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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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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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: 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.
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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.
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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.
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Introduction (contexte de la recherche): Although the SARS-CoV-2 vaccines have undergone preclinical tests and clinical trials evaluating their efficacy and safety, few data have been reported in the post-licensure real-world setting. Objectif: We aimed to assess the safety of COVID-19 vaccines among a Tunisian Pharmacovigilance database. Methodes: An exhaustive observational study including all adverse events following COVID-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital. Resultats: A total of 336 events were collected. The patients' sex ratio was 1.4. Elderly patients (>= 65-years-old) represented 54% of cases. The most common adverse reaction was fatigue and fever (30%, respectively), followed by headache (21%), muscle soreness (15%) and localized pain at the injection site (13%). Skin eruptions accounted for 14% of the reported events and anaphylaxis was noted in 0.6% of cases. The most reported events were mild. However, 15 patients developed serious events [anaphylaxis (seven cases), thrombotic reactions (seven cases), and thrombocytopenia (one case)]. The event was fatal in five patients. Pfizer-BioNTech vaccine was implicated in 65% of reported events, followed by AstraZeneca vaccine (11%). Pfizer-BioNTech vaccine was implicated in 9/15 serious events. Fatal events were observed with Pfizer-BioNTech vaccine in three cases, and AstraZeneca and CoronaVac vaccines in one case each. Conclusion(s): Our study implies that the COVID-19 vaccines have a favorable safety profile due to the low incidence of self-reported adverse reactions. Further large-scale studies are needed to confirm the safety of COVID-19 vaccines.Copyright © 2023
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Background: Although the SARS-CoV- 2 vaccines have undergone preclinical tests and clinical trials evaluating their efficacy and safety, few data have been reported in the post-licensure real-world setting. We aimed to assess the safety of Covid-19 vaccines among a Tunisian Pharmacovigilance database. Method(s): An exhaustive observational study including all adverse events following Covid-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital from April to December 2021. Result(s): A total of 336 events were collected. The patients' sex ratio was 1.4. Elderly patients (>=65 years old) represented 54% of cases. The most common adverse reaction was fatigue and fever (30%, respectively), followed by headache (21%), muscle soreness (15%) and localized pain at the injection site (13%). Skin eruptions accounted for 14% of the reported events and anaphylaxis was noted in 0.6% of cases. The most reported events were mild. However, 15 patients developed serious events (anaphylaxis (seven cases), (thrombotic reactions (seven cases), and thrombocytopenia (one case)). The event was fatal in five patients. Pfizer-BioNTech vaccine was implicated in 65% of reported events, followed by AstraZeneca vaccine (11%). Pfizer-BioNTech vaccine was implicated in 9/15 serious events. Fatal events were observed with Pfizer-BioNTech vaccine in three cases, and AstraZeneca and CoronaVac vaccines in one case each. Conclusion(s): Our study implies that the Covid-19 vaccines have a favorable safety profile due to the low incidence of self-reported adverse reactions. Further large-scale studies are needed to confirm the safety of Covid-19 vaccines.
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Introduction: Studies are showing that a high antibody response increases the protection against variants in the fight against the COVID-19 pandemic. In this study, we aimed to investigate the relationship between antibody response and side effects based on the number of doses administered to healthcare workers who were vaccinated against COVID-19. Material(s) and Method(s): Healthcare workers, who were vaccinated with two doses of BNT162b2 (Group 1), a single dose of BNT162b2 following two doses of CoronaVac (Group 2), or two doses of BNT162b2 following two doses of CoronaVac (Group 3), were randomly assigned to this study. Serum samples were taken from the participants 30 +/- 2 days after the last vaccination date, and the SARSCoV- 2 anti-spike S1 RBD IgG test was administered to these samples. A questionnaire was conducted detailing the demographics of the patients as well as their post-vaccination complaints. The results were analyzed statistically. Analysis results with a p-value of <0.05 were considered significant. Result(s): A total of 179 healthcare professionals with a mean age of 41.7 +/- 10.6 years were included in our study. Of the studied samples, 95.5% (n= 171) were interpreted as anti-spike S1 RBD IgG seropositive. Positivity rates and mean antibody levels were 93.2%, 95.9%, 97.8%, and 107.4 +/- 117.1, 152.7 +/- 108.5, 201.4 +/- 114.9 (AU/mL) for Group 1, Group 2, and Group 3, respectively (p< 0.05). In general, no significant differences in antibody response were seen based on gender or age. However, a significant correlation was found between the occurrence of vaccine-related side effects and antibody titer (p< 0.001). The most common side effect was pain in the area where the vaccine was administered, with a rate of 77.4% (n= 48). More vaccine-related side effects were reported in participants under the age of 40 and in female healthcare workers. Conclusion(s): We believe that booster doses are effective for increasing the immune response and thus protecting against COVID-19. More extensive research should be conducted to confirm the link between the occurrence of vaccine-related side effects and antibody titer. Furthermore, studies on the safety of increasing the number of vaccine doses are required.Copyright © 2023 Bilimsel Tip Yayinevi. All rights reserved.
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Background: Since the outbreak of COVID-19, vaccination has been considered as an important measure against it. Side effects have always been an inseparable component of vaccination, which in this study, Sinopharm vaccine, its side effects and the differences of their manifestation amongst men and women have been investigated. Objective(s): This study aimed to compare the side effects of the Sinopharm vaccine among men and women working in some medical centers in Tehran, Iran. Method(s): This cross-sectional descriptive-analytical study on 890 healthcare workers of 7 medical centers in Tehran within 2 months, from late June to late August 2021. The samples were selected by the complete enumeration method, and the required data were collected using a questionnaire. Only those who received the Sinopharm vaccine at least 10 days before the study were included. Result(s): Of 890 participants, 22.96% and 77.30% were women and men, respectively, and 65.8% of women and 78.1% of men were in the age range of 20-29 years. It was revealed that 74.75% of women and 26.16% of men had at least one side effect. The incidence of at least one side effect was significantly higher in women than in men (P<0.001). It was also found that 12 side effects were significantly higher in women than in men. Most men and women had side effects within the first 24 h after vaccination. There was no significant difference in taking therapeutic measures to reduce or minimize the post-vaccination complications between men and women;however, 9.4% of men and 27.2% of women reported a decline in their ability to perform daily activities as they were unable to do their everyday tasks the day after vaccination which was significantly different between the two groups (P<0.001). Conclusion(s): The results showed that the occurrence rate of side effects after receiving the Sinopharm vaccine was significantly higher in women than in men. Moreover, women were significantly less able to perform daily routines than men.Copyright © 2022, Author(s).
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Background Vaccinations against SARS-CoV-2 have been a topic of political, social, and medical intrigue since the declaration of the COVID-19 pandemic in early 2020. The vaccine side effects have been relatively mild to date, with few observed systemic effects. Case presentation A 69-year-old previously healthy female presented with symptoms of asymmetric bilateral lower and upper extremity weakness 2 days after vaccination with the Pfizer-BioNTech mRNA vaccine. MRI of the cervical spine revealed a non-compressive myelitis extending from C3-4 to T2-3. Common known causes of transverse myelitis were ruled out by diagnostic techniques. Conclusions Transverse myelitis is a rare autoimmune disorder that has been shown to have a temporal association with vaccination in the past. With a progressively partisan societal view on vaccinations, it is important for clinicians to remain vigilant on documenting potential associations without encouraging fear of causation.Copyright © 2021 The Author(s)
ABSTRACT
Background. Patients with autoimmune and inflammatory rheumatic diseases (AIRDs) are at high risk of developing COVID-19. Vaccination is an effective method of preventing this disease, which may be unsafe for patients with AIRDs. The aim of the study is to assess the safety of Gam-COVID-Vac in patients with IVRD in real clinical practice. Material and methods. A cross-sectional study was carried out. The main group consisted of patients with AIRDs, the control group consisted of individuals without AIRDs. All participants were interviewed by the research physician using a unified questionnaire, additional information was obtained from medical records. Results. The study included 222 patients with AIRDs (119 with rheumatoid arthritis, 36 with ankylosing spondylitis, 17 with psoriatic arthritis, 17 with Sjogren's disease, 10 with undifferentiated spondyloarthritis, 8 with systemic lupus erythematosus, 4 with metabolic arthritis, 3 with systemic scleroderma, 3 with systemic vasculitis, 2 with polymyalgia rheumatica, 2 with undifferentiated systemic connective tissue disease, 1 with adult Still's disease) and 111 patients without AIRDs. The number of patients with AIRDs who had a combination of local and systemic adverse events (AE) on the introduction of the first component of the vaccine was significantly less than in the control group (22.1 and 44.1%, respectively, P<0.001). Similar differences were also noted after the introduction of the second component (14.0 and 29.7%, respectively, P<0.001). AEs such as pain at the injection site without restriction of movement, weakness, fever, arthralgia/myalgia, headache, and chills were significantly more common in the control group after the introduction of the first component of the vaccine. After complete immunization, AEs were absent in 35.6% of patients with AIRDs and in 21.6% of control group patients (P=0.01). Exacerbations of AIRDs and new autoimmune phenomena were not registered in any cases. Conclusions. According to preliminary data, immunization of patients with AIRDs with the Gam-COVID-Vac combined vector vaccine appears to be quite safe.Copyright © Team of Authors, 2022.