Pattern of Adverse Events Following COVID-19 Vaccine among Vaccinated Individuals Aged Above 18 yrs in Kerala

Background: Coronavirus pandemic is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). WHO declared the outbreak as a Public Health Emergency of International Concern in January 2020 & a pandemic in March 2020. In India Oxford University-Astra Zeneca's Covishield vaccine, manufactured by serum institute of India and Bharath Biotech's Covaxin are being used for vaccination programme. In this study, we assess adverse reactions following Covid-19 vaccination & incidence of COVID-19 disease among vaccinated people across Kerala. Since it was newer vaccine and general population was afraid of side effects. The present study aimed to study the adverse effects of COVID-19 vaccination among general population aged above 18 years in Kerala. Method(s): A descriptive cross sectional study was conducted among COVID-19 vaccinated individuals above 18 yrs of age residing in Kerala from July 2021 to December 2021. Pattern of adverse events following COVID-19 vaccination (AEFI) were assessed using a semi structured questionnaire. An online questionnaire using Kobo Toolbox was developed and shared via online platform to record the self-reported adverse events following vaccination. A respondent driven sampling method was used. The data was downloaded in MS Excel and analysed using Microsoft excel. Result(s): Study was conducted among 526 people across Kerala, among which both males(45.63%) and females (54.18%). Majority of them received COVISHEID (92.97%) and rest of them received COVAXIN (6.24%) and SPUTNIK (0.57%). Out of which 65.97% received 2 doses and 34.03% received only one dose of vaccine. More than half of them (61.5%) faced side effects during post vaccination period. The symptoms were very mild in which fever (65.74%) and tiredness (76.85%) were the commonest symptoms. Conclusion(s): In the present study, majority of the vaccinated people experienced very mild and self limiting adverse effects, those were very mild & self limiting. It is a fact that COVID-19 vaccines doesn't provided 100% efficiency, but our study indicates that it does provides protection against COVID-19 infection to a great extend & breakthrough infections are very less severe and asymptomatic for vaccinated people.Copyright © 2023, Dr. Yashwant Research Labs Pvt. Ltd.. All rights reserved.

Adverse events following immunization associated with the ChAdOx1nCoV-19 and BBV152 vaccine-a cross-sectional study

COVID-19, an infectious disease, has become a leading cause of death in many people. The rapid emergence of the pandemic prompted the development of a vaccine to mitigate the disease's harmful consequences. Vaccination is the only effective way to prevent infection from spreading and build immunity to the virus. However, developing adverse effects has become a major problem for vaccine reluctance. Accordingly, the interest has been shifted towards identifying the adverse effects developed following immunization. The current study objective is to assess and compare the intensity of adverse effects following 1st and 2nd dose of COVID-19 vaccination and the medication administered to relieve the symptoms associated with vaccination. A cross-sectional study was performed in a community over six months. A total of 836 participants were involved in the study. All the data regarding the vaccination were collected through a specially designed questionnaire form and analyzed in all the participants within the study group. According to the study, at least 1 AEFI was developed in about 90% of the study population. The most common systemic and local effect developed in the study population was fever (59.42%) and pain at the injection site (69.82%), respectively. With both vaccines (ChAdOx1 nCoV-19 and BBV152), the incidence and severity of AEFIs were lower after the second dose than after the first dose, and most of the symptoms associated with vaccination were alleviated by taking home remedies and symptomatic treatment. The adverse effects reported after receiving the ChAdOx1 nCoV-19 and BBV152 vaccines are typical of most vaccines, and the majority of them were tolerated, and most subsided in less than 24 hours.

Safety profile of inactivated COVID-19 vaccine in indonesian adults.

Background: Vaccines are urgently needed to handle the morbidity and mortality of the COVID-19 pandemic in Indonesia. The inactivated vaccine is widely used in Indonesia's national immunization program due to its eligibility of stock, easier to transport, and considered to be more established than newer platforms. In this study, we aimed to evaluate the safety profile of the inactivated vaccine and analyze the safety profile between adults and the elderly. Methods: A prospective analytical study was conducted to evaluate the safety profile of inactivated COVID-19 vaccine among healthy adults aged ≥ 18 years from September 2nd to December 28th, 2021, at ten primary health centers from 5 districts in Jakarta, Indonesia. The participants were instructed to record the symptoms after inactivated COVID-19 vaccine injection in the diary card for 28 days. Chi-square tests were carried out to analyze the relationship between the adverse event following immunization (AEFI) in adults and elderly groups. Results: Four of 1113 participants were not included in this study due to the lack of follow-up. Out of 1109 participants, there were 1044 adults (18-59 years) and 65 elderly (>59 years). There were no serious AEFI cases reported. Most AEFI cases were mild to moderate and resolved after several days of injection. Local pain, myalgia and fatigue were the most frequent adverse events reported. We found that there was no correlation between the adults and elderly age group with the incidence of AEFI (p = 0.924) for local reactions (p = 0.181) and most of the systemic reactions (p = 0.629). However, there is an increased risk of fever in the elderly group compared to the adult group (OR 4.046, 95 % CI 1.794-9.124, p = 0.003) following immunization. Conclusions: Our study demonstrated that the inactivated COVID-19 vaccine is safe, considering that all symptoms experienced were mild to moderate and resolved entirely.

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.

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.

Capillary leak syndrome following COVID-19 vaccination: Data from the European pharmacovigilance database Eudravigilance.

Capillary leak syndrome (CLS) emerged as new adverse event after immunization (AEFI) associated to COVID-19 vaccination. CLS is a rare condition characterized by increased capillary permeability, resulting in hypoalbuminemia, hypotension, and edema mainly in the upper and lower limbs. Our pharmacovigilance study aims to evaluate the CLS onset following receipt of COVID-19 mRNA vaccines (mRNA-1273 and BNT162b2) compared to viral vector vaccines (Ad26.COV2-S and ChAdOx1-SARS-COV-2). We carried a cross-sectional study using all Individual Case Safety Reports (ICSRs) reporting a COVID-19 vaccine as suspected drug and CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. We applied the Reporting Odds Ratio (ROR) 95% CI for the disproportionality analysis. During our study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19(ChAdOx1-SARS-COV-2 = 36; Ad26.COV2-S = 9). The mRNA COVID-19 vaccines were reported in 39 ICSRs (BNT162b2 =33; mRNA-1273 =6). Majority of ICSRs were reported by healthcare professionals (71.4%). Majority of the patients were adult (58.3%) and the female gender accounted in more than 65% of ICSRs referred both to classes vaccines. In particular, women were more represented in ICSRs referred to mRNA-1273 (83.3%) and to ChAdOx1-SARS-COV-2 (72.2%). The CLS outcome was more frequently favorable in mRNA ICSRs (33,3%) than the viral vector ones (13.3%). Among the ICSRs reporting CLS with unfavorable outcome, we found also 9 fatal cases (BNT162b2 = 1; ChAdOx1-SARS-COV-2 = 4; Ad26.COV2-S = 4). From disproportionality analysis emerged a lower CLS reporting probability after vaccination with mRNA vaccines compared to viral vector-based ones (ROR 0.5, 95% CI 0.3-0.7; p <0.001).Our findings, even if subject to the limitations of spontaneous reporting systems, suggest a small but statistically significant safety concern for CLS following receipt of COVID-19 viral vector vaccines, in particular with Ad26.COV2-S. Cytokine-release following T-cell activation could be involved in CLS occurrence, but a precise mechanism has been not yet identified. COVID-19 vaccines remain attentive as possible triggers of CLS.

Safety of COVID-19 Vaccines.

By June 1, 2022, there were 38 prophylactic COVID-19 vaccines approved in 197 countries around the world. The ongoing approval of new vaccines and the accumulation of more than a year's worth of data on their use give particular importance to the consolidation and analysis of information on the safety of such vaccines. The aim of study was to analyse the information on adverse events after immunisation (AEFIs) with coronavirus vaccines in the individual case safety reports entered into the VigiBase database by June 1, 2022. Material(s) and Method(s): the author analysed safety reports retrieved from VigiBase through the VigiLyze interface in the expert access mode. The search was carried out using the generic keyword "Covid-19 vaccine" in combination with the trade names of all 38 coronavirus vaccines. Result(s): the article presents consolidated information on the number and content of the safety reports on COVID-19 vaccines. The author noted that the reports were characterised by a high level of information completeness and quality, which could be due to the fact that the main reporters were the countries with developed pharmacovigilance systems. The analysis of patient complaints showed that the reported symptoms of AEFIs coincided with the manifestations of side effects of the vaccines included in the package leaflets. The author carried out a review of the cases of serious AEFIs and the cases of adverse events of special interest requiring additional monitoring after immunisation. It revealed a positive correlation of individual vaccines with the cases of somnolence in post-COVID-19 patients. Conclusion(s): the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators.Copyright © 2023 Safety and Risk of Pharmacotherapy. 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.

Assessment of Adverse events following Immunization of COVID - 19 vaccination in Health Care Workers (HCWs) of Shaheed Hasan Khan Mewati Govt. Medical College Nalhar, Nuh, Haryana, India

Background: We assess the profile of adverse events following immunization of COVID - 19 vaccination of COVISHIELD in health care workers (HCWs) in Shaheed Hasan Khan Mewati Govt. Medical college Nalhar, Nuh, Haryana, India. Method(s): The Cross sectional and prospective observational study was conducted with a period of 3 months or till the desired sample size recruited in the study with follow up period of 15 days for all those subjects who were vaccinated for covid-19 in SHKM, GMC Hospital to look for AEFI with sample size more than 300. Active surveillance was done on days 3, 6 and 9 after days of vaccination for AEFI). Any AEFI noted will be managed as per the standard guidelines. Result(s): We present the results of an interim analysis of 400 patients out of total 550 participants with 244(61.00%) male and 156 (39.00%) female participants respectively. AEFIs following first dose were reported in 400 participants and 269 participants after second dose. Fever was the major AEFI with 150(37.50%) after first dose and 78(28.99%) after second dose respectively. In the study age wise AEFIs percentage of participants were also calculated. In the present study different systemic diseases percentage also calculated. Conclusion(s): The AEFIs associated with the COVISHIELD (ChAdOx1 nCoV-19), the COVID-19 vaccine injected in hospital health care workers is found to be safe for use in except for a few minor reactions.Copyright © RJPT. All right reserved.

Safety of COVID-19 Vaccines.

By June 1, 2022, there were 38 prophylactic COVID-19 vaccines approved in 197 countries around the world. The ongoing approval of new vaccines and the accumulation of more than a year's worth of data on their use give particular importance to the consolidation and analysis of information on the safety of such vaccines. The aim of study was to analyse the information on adverse events after immunisation (AEFIs) with coronavirus vaccines in the individual case safety reports entered into the VigiBase database by June 1, 2022. Material(s) and Method(s): the author analysed safety reports retrieved from VigiBase through the VigiLyze interface in the expert access mode. The search was carried out using the generic keyword "Covid-19 vaccine" in combination with the trade names of all 38 coronavirus vaccines. Result(s): the article presents consolidated information on the number and content of the safety reports on COVID-19 vaccines. The author noted that the reports were characterised by a high level of information completeness and quality, which could be due to the fact that the main reporters were the countries with developed pharmacovigilance systems. The analysis of patient complaints showed that the reported symptoms of AEFIs coincided with the manifestations of side effects of the vaccines included in the package leaflets. The author carried out a review of the cases of serious AEFIs and the cases of adverse events of special interest requiring additional monitoring after immunisation. It revealed a positive correlation of individual vaccines with the cases of somnolence in post-COVID-19 patients. Conclusion(s): the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators.Copyright © 2023 Safety and Risk of Pharmacotherapy. All rights reserved.

Adverse event reports of anaphylaxis after Comirnaty and Vaxzevria COVID-19 vaccinations, Western Australia, 22 February to 30 June 2021.

Within the first 4 months of the Western Australian COVID-19 immunisation programme, 49 suspected anaphylaxis cases were reported to the vaccine safety surveillance system. Twelve reports met Brighton Collaboration case definition, corresponding to rates of 15.9 and 17.7 per million doses of Vaxzevria and Comirnaty administered respectively.

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study.

Although the safety profiles of mRNA COVID-19 vaccines (mRNA-1273 and BNT162b2) were evaluated in pre-authorization clinical trials, real-world data allow us to better define their benefit/risk ratio in the paediatric population. The current study aimed to evaluate the safety profiles of mRNA COVID-19 vaccines in children by analysing the pharmacovigilance data of the European spontaneous reporting system database EudraVigilance (EV) in the period from 1 January 2021, to 1 October 2022. During our study period, overall 4838 ICSRs related to mRNA COVID-19 vaccines referring to 5-11-year-old subjects were retrieved from EV, of which 96.9% were related to BNT162b2 and 49.3% were related to males. A total of 12,751 Adverse Events Following Immunization (AEFIs) were identified, of which 38.7% were serious. The most frequently reported AEFIs were pyrexia, headache, and vomiting. Only 20 Individual Case Safety Reports (ICSRs) reported Multisystem Inflammatory Syndrome (MIS) as an AEFI, all related to BNT162b2. The majority of MIS cases were females, and six cases were completely resolved at the time of reporting. Our results show a favourable risk-benefit profile for all mRNA COVID-19 vaccines in this paediatric sub-population, supporting their use in children. Considering the peculiarity and fragility of children, continuous safety monitoring of COVID-19 vaccines is required.

Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity.

Introduction: Adverse Events Following Immunization (AEFI) of the COVID-19 vaccine is one of the important considerations, especially in patients with autoimmunity. This study aims to compare the number of CoronaVac AEFIs in women with and without autoimmunity. Methodology: This is a retrospective cohort study with an unpaired comparative analytic design with a retrospective cohort method. We recruited 602 volunteers, 182 women with autoimmunity and 420 without autoimmunity. We included women who received the CoronaVac vaccine, aged 17-65 years. Data were analyzed using the chi-square or fisher exact method as an alternative. Results: We found a generally increased risk for AEFI in women with autoimmunity (RR = 1.179; 95% CI 1.059-1.313; p = 0.007) compared to women without autoimmunity, especially for systemic (RR = 1.1271; 95% CI 1.045-1.545; p = 0.025), allergic (RR = 2.052; 95% CI 1.070-3.932; p = 0.045), fever (RR = 2.163 95%; CI 1.093-4.282; p = 0.039), fatigue (RR = 2.182 95%; CI 1.558-3.056; p = 0.001), and headache (RR = 1.619 95%; CI 1.164-2.251; p = 0.006). On the other hand, we found no increased risk for the overall severity of AEFI (RR = 0.851 95% CI; 0.655-1.105; p = 0.256). We also found a relapse of autoimmune condition in 10.4% (n = 19) after CoronaVac vaccination. Conclusions: There is an increased risk of AEFI after CoronaVac vaccination in women with autoimmunity compared to those without the condition. Although the severity of AEFIs and risk of autoimmune relapse were relatively low.

Assessing the Self-reported After Events Following Immunization of COVID-19 Vaccines in Turkey and Bangladesh.

Though mass vaccination programs helped to reduce the severity of the ongoing pandemic, various unwanted effects were reported in Turkey and Bangladesh after taking vaccines. The purpose of this study was to evaluate and compare the adverse effects of several vaccines in Turkey and Bangladesh and how the population of both countries prioritizes the continuation of vaccination compared to the side effects. An online survey with a pretest was conducted to gather data over the research period from July 10, 2021 to December 10, 2021. Finally, the questionnaire was shared with the mass population of Turkey and Bangladesh who have received at least one or two doses of the COVID-19 vaccines. The quality of the questionnaire was evaluated with Cronbach's alpha test. The study consisted of 1508 respondents from Bangladesh and 602 respondents from Turkey. Among the total 2110 respondents, 50.0% were male 66.8% were from the 18-30 years age range, and 77.5% reported living in the city area. Among all the respondents, 64.99% of those vaccinated in Bangladesh and 67.28% of those vaccinated in Turkey reported side effects after vaccinations. Participants receiving mRNA vaccines (Pfizer and Moderna) experienced the most side effects, with many reporting pain at the injection site in both nations. Following that, fever, body pain, and headache were common in Bangladesh, whereas body pain, fatigue, and arm numbness were common in Turkey. The study found no significant adverse events reported in Turkey and Bangladesh following the first and second doses of COVID-19 vaccination. These COVID-19 vaccines showed similar patterns of efficacy and safety during the short period of analysis. Vaccines from different manufacturers showed a non-significant level of adverse events during this binational AEFI approach to COVID-19 vaccines. More studies are recommended on the efficacy and safety of several vaccines to discover unexpected effects.

Outcomes following COVID-19 vaccination and associated factors among healthcare professionals in Oromia region, Ethiopia.

Vaccines are not free from adverse outcomes. However, the evidence of adverse outcomes following COVID-19 vaccination among health-care professionals (HCPs) in the study setting was scanty. Aimed to assess outcomes following COVID-19 vaccination and associated factors among health-care professionals in Oromia region, Ethiopia. An online cross-sectional survey was conducted from 1 October to 30 October 2021. Data were collected using questionnaire created on Google forms. A snowball sampling technique through the authors' network on the popular social media was used. Data analysis was performed using SPSS version 25. The Adjusted Odd Ratio (AOR) along with the 95% confidence level and variables with a p value <.05 were considered to declare the statistical significance. About 93.9% of the participants had experienced mild-to-moderate adverse outcomes following COVID-19 vaccination. Being married [AOR = 4.19, 95% CI:2.07,8.45] ,family size >5 [AOR = 5.17, 95% CI: 1.74, 15.34], family not tested for COVID-19 [AOR = 0.39, 95% CI: 0.15,0.97], lack of family support to take the vaccine [AOR = 3.58, 95% CI: 1.75, 7.33], heard anything bad about the vaccine [AOR = 4.17, 95% CI: 1.90,9.13] and very concerned as the vaccine could cause Adverse Events Following Immunization (AEFI) [AOR = 6.24, 95% CI: 1.96,19.86] were statistically associated with the outcome. The study showed that over nine out-of-often participants had experienced mild-to-moderate adverse outcomes following COVID-19 vaccination. However, severe adverse outcome experienced was very low, which could not hinder to take the vaccine due to fear of its side effects. Marital status, family size, family tested for COVID-19, lack of family support to take the vaccine, hearing anything bad about the vaccine, and being concerned about as the vaccine could cause adverse events were factors associated with the outcome.

Incidence of Early Adverse Events Following Covishield (ChAdOx1 nCoV-19) Vaccination: A Prospective Study.

Background: Minor adverse event following immunizations (AEFIs) are often underreported and self-treated. This study aimed to collect information regarding any and every probable adverse event experienced by the recipient of Covishield vaccine up to 10 days following the first and second dose of vaccine. To find the incidence of minor adverse events following Covishield vaccination; draw an association between adverse events and individuals' demographic factors and comorbidities; and report new adverse events, if any. Materials and Methods: A descriptive observational study was conducted among 409 participants randomly sampled from the Vaccination Centre at a Tertiary Care Hospital, Mumbai. Participants were followed up post their first and second doses to enquire about adverse events. Results: Most commonly reported adverse events included injection site pain, tenderness, chills, fatigue, fever, and myalgia. Females reported more adverse events compared to men (p < 0.05). Younger individuals (18-24) experienced adverse events more as compared to individuals above 40 years of age (p < 0.005). Reported adverse events were lesser after the second dose in comparison with the first dose. Few participants reported dysgeusia. Conclusions: Covishield vaccination has a mild AEFI profile, most commonly: injection site pain, tenderness, chills, and fatigue. It is hoped that the findings of this study will dispel anxiety around the adverse events of vaccination and reduce any persisting vaccine hesitancy. Effective communication with the population on vaccination will enable individuals to make educated and informed decisions.

Risk of Repeated Adverse Effects following Booster Dose of mRNA COVID-19 Vaccine: Results from the MOSAICO Study.

The successful deployment of safe and effective vaccines against coronavirus disease 2019 (COVID-19) has been crucial in reducing the global disease burden. Owing to the need for vaccination series over time, continuous observational studies are needed to estimate the COVID-19 vaccine response in real-world conditions. In particular, the detection, assessment, and understanding of adverse effects following immunization (AEFI) with a COVID-19 vaccine are crucial to better address vaccination strategies. Therefore, this study aimed to investigate the risk of repeated AEFI post-administration of a booster dose of mRNA COVID-19 vaccine in a sample of healthcare workers (HCWs) in an Italian teaching hospital. The data on any local and systemic AEFI were studied in multivariate Poisson regression analyses to model the association between the incidence of each postvaccination symptom and its prior reporting after the administration of the previous doses. Overall, compared with the primary vaccination series, the majority of post-third dose AEFI were less reported. The results from multivariable models showed that the likelihood of reporting an AEFI after the third dose was higher in those who experienced the same postvaccination symptom after the second dose (all AEFI except for itch at injection site) and, although not significant for all AEFI, after the first dose. Any associations with age, gender, smoking habits, previous SARS-CoV-2 infection and other characteristics, as well as the health impact of AEFI were also assessed. Taken together, the results from this research support reframe AEFI symptoms as signals of a robust postvaccination reaction as well as of common vaccine response, and they add important data to inform booster vaccination strategies in HCWs and, extensively, in the adult population.

A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5-17 Years) Living in Saudi Arabia.

The objective of this study is to assess the frequency and severity of adverse events following immunization (AEFI) in Indian children aged 5-17 years who received the Pfizer-BioNTech mRNA COVID-19 vaccine, as well as to investigate for predictors of AEFI. To examine AEFI following the first and second doses of Pfizer's vaccine, semi-structured questionnaires were distributed as Google forms at Indian schools in Saudi Arabia. The 385 responses included 48.1% male and 51.9% female children, with 136 responses of children aged 5-11 years (group A) and 249 responses from children aged 12-17 years (group B). Overall, 84.4% of children had two shots. The frequency of AEFI was reported to be higher after the first dose than after the second (OR = 2.12, 95% CI = 1.57-2.86). The reported AEFIs included myalgia, rhinitis, local reaction with fever, a temperature of 102 °F or higher, and mild to moderate injection site reactions. While group B frequently reported multiple AEFIs, group A typically reported just one. Local reaction with low grade fever was more frequently reported in group B after the first dose (24.1%) and second dose (15.4%), while local reaction without low grade fever was most frequently observed in group A after the first (36.8%) and second dose (30%). Only prior COVID-19 infection (OR = 2.98, 95% CI = 1.44-6.2) was associated with AEFI after the second dose in the study sample, whereas male gender (OR = 1.71, 95% CI = 1.13-2.6) and prior COVID-19 infection (OR = 2.95, 95% CI = 1.38-6.3) were predictors of AEFI after the first dose. Non-serious myocarditis was reported by only one child. According to the analysis conducted, the Pfizer's mRNA COVID-19 vaccination was found to be safe in Indian children.

Co-VAN study: COVID-19 vaccine associated neurological diseases- an experience from an apex neurosciences centre and review of the literature.

BACKGROUND: Recent studies have shown various neurological adverse events associated with COVID-19 vaccine. OBJECTIVE: We aimed to retrospectively review and report the neurological diseases temporally associated with COVID-19 vaccine. METHODS: We performed a retrospective chart review of admitted patients from 1st February 2021 to 30th June 2022. A total of 4672 medical records were reviewed of which 51 cases were identified to have neurological illness temporally associated with COVID-19 vaccination. RESULTS: Out of 51 cases, 48 had probable association with COVID-19 vaccination while three had possible association. Neurological spectrum included CNS demyelination (n = 39, 76.5 %), Guillain-Barré-syndrome (n = 3, 5.9 %), stroke (n = 6, 11.8 %), encephalitis (n = 2, 3.9 %) and myositis (n = 1, 2.0 %). Female gender had a greater predisposition (F:M, 1.13:1). Neurological events were more commonly encountered after the first-dose (n = 37, 72.5%). The mean latency to onset of symptoms was 13.2 ± 10.7 days after the last dose of vaccination. COVIShield (ChAdOx1) was the most commonly administered vaccine (n = 43, 84.3 %). Majority of the cases with demyelination were seronegative (n = 23, 59.0 %) which was followed by anti-Myelin oligodendrocyte-glycoprotein associated demyelination (MOGAD) (n = 11, 28.2 %) and Neuromyelitis optica (NMOSD) (n = 5, 12.8 %). Out of 6 Stroke cases, 2 cases (33.3 %) had thrombocytopenia and coagulopathy. At discharge, 25/51 (49.0 %) of the cases had favourable outcome (mRS 0 to 1). Among six patients of stroke, only one of them had favourable outcome. CONCLUSION: In this series, we describe the wide variety of neurological syndromes temporally associated with COVID-19 vaccination. Further studies with larger sample size and longer duration of follow-up are needed to prove or disprove causality association of these syndromes with COVID-19 vaccination.

Investigation of Adverse Events Experienced by Healthcare Workers following Immunization with Homologous orHeterologous COVID-19 Booster Vaccinations.

OBJECTIVE: A comparative analysis was performed to investigate the potential risk factors of Adverse Events Following Immunization (AEFI) after receiving different booster vaccines. METHODS: From 18 January 2021 to 21 January 2022, the Health Care Workers (HCWs) of Guizhou Provincial Staff Hospital (Guizhou Province, China) who received a third Booster vaccine, that was either homologous (i.e., (i) a total of three doses of Vero cell vaccine or (ii) three doses of CHO cell vaccine) or (iii) heterologous with two first doses of Vero cell vaccine, being either CHO cell vaccine or adenovirus type-5 (Ad5) vectored COVID-19 vaccine, were asked to complete a self-report questionnaire form to provide information on any AEFI that may have occurred in the first 3 days after vaccination with the booster. The frequency of AEFI corresponding to the three different booster vaccines was compared, and the risk factors for predicting AEFI were determined by multivariate logistic regression analysis. RESULTS: Of the 904 HCWs who completed the survey, 792 met the inclusion criteria. The rates of AEFI were 9.8% (62/635) in the homologous Vero cell booster group, 17.3% (13/75) in the homologous CHO cell booster group, and 20.7% (17/82) in the heterologous mixed vaccines booster group, and the rates were significantly different (c2 = 11.5, p = 0.004) between the three groups of vaccines. Multivariate logistic regression analysis showed that: (1) compared to the homologous Vero cell booster group, the risk of AEFI was about 2.1 times higher (OR = 2.095, 95% CI: 1.056-4.157, p = 0.034) in the CHO cell booster group and 2.5 times higher (OR = 2.476, 95% CI: 1.352-4.533, p = 0.003) in the mixed vaccines group; (2) the odds for women experiencing AEFI were about 2.8 times higher (OR = 2.792, 95% CI: 1.407-5.543, p = 0.003) than men; and (3) compared to the non-frontline HCWs, the risk of AEFI was about 2.6 times higher (OR = 2.648, 95% CI: 1.473-4.760, p = 0.001) in the doctors. CONCLUSION: The AEFI in all three booster groups are acceptable, and serious adverse events are rare. The risk of AEFI was higher in doctors, which may be related to the high stress during the COVID-19 epidemic. Support from government and non-governmental agencies is important for ensuring the physical and mental health of HCWs.