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Shrestha, Shrijana, Ranjan Prasad Devbhandari, Ashis Shrestha, Sushant Aryal, Piyush Rajbhandari, Binnam Shakya, Prabesh Pandey, Ram Krishna Shrestha, Mayuri Gupta, and Archana Regmi. "Adverse events following the first dose of ChAdOx1 nCoV-19 (COVISHIELD) vaccine in the first phase of vaccine roll out in Nepal." Journal of Patan Academy of Health Sciences 8, no. 1 (April 29, 2021): 9–17. http://dx.doi.org/10.3126/jpahs.v8i1.36242.
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Introduction: Nepal started the first phase of COVID-19 vaccination for frontline healthcare workers in January 2021 with the ChAdOx1 nCoV-19 (COVISHIELD) vaccine. We conducted active surveillance of Adverse Effect Following Immunization (AEFI) after the first dose of the vaccine administered at one of the sentinel sites for vaccination, Patan Academy of Health Sciences (PAHS).
Method: All the 5591 first dose ‘COVISHIELD’ vaccine recipients between 27 Jan -5 Feb 2021 at PAHS, were approached through phone calls to collect data on AEFI. Incidence of common AEFIs in different age groups, gender and those with previous history of COVID-19 were analyzed. Presence of any Adverse Events of Special Interest (AESI) were evaluated.
Result: Out of 5591 vaccines recipient, 3991 (71.3%) responded to the phone call and AEFI was noted in 3394 (85.04%) of them. Minor AEFI was seen in 3391 (84.9%), severe Minor AEFI in 1 (0.02%) and Serious AEFI in 2 (0.05%). Out of 807 vaccine recipients with previous history of COVID-19, 709 (87.9%) had AEFI while of the 3184 with no past history of COVID-19, 2685 (84.3%) had AEFI. However, some of the systemic AEFIs were noted more frequently in those with past COVID-19 infection. A total of 1886 (55.6%) took self-medication for symptom relief, 278 (8.2%) took leave from work while 26 (0.76%) visited health facility for the AEFIs.
Conclusion: Most AEFIs following the first dose of COVISHIELD vaccine were mild and resolved within a few days. Except for one case of anaphylaxis, no other AESI were encountered.
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Aborigo, Raymond Akawire, Paul Welaga, Abraham Oduro, Anna Shaum, Joseph Opare, Alex Dodoo, Hilda Ampadu, and Jane F. Gidudu. "Optimising reporting of adverse events following immunisation by healthcare workers in Ghana: A qualitative study in four regions." PLOS ONE 17, no. 12 (December 20, 2022): e0277197. http://dx.doi.org/10.1371/journal.pone.0277197.
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Introduction Despite the emphasis on reporting of Adverse Events Following Immunisation (AEFIs) during didactic training sessions, especially prior to new vaccine introductions, it remains low in Ghana. We explored the factors underlying the under-reporting of AEFI by healthcare workers (HCWs) to provide guidance on appropriate interventions to increase reporting. Methods We conducted an exploratory descriptive in-depth study of the factors contributing to low reporting of AEFI among HCWs in four regions in Ghana. Key informant interviews (KII) were held with purposively selected individuals that are relevant to the AEFI reporting process at the district, regional, and national levels. We used KII guides to conduct in-depth interviews and used NVivo 10 qualitative software to analyse the data. Themes on factors influencing AEFI reporting were derived inductively from the data, and illustrative quotes from respondents were used to support the narratives. Results We conducted 116 KIIs with the health managers, regulators and frontline HCWs and found that lack of information on reportable AEFIs and reporting structures, misunderstanding of reportable AEFIs, heavy workload, cost of reporting AEFIs, fear of blame by supervisors, lack of motivation, and inadequate feedback as factors responsible for underreporting of AEFIs. Respondents suggested that capacity building for frontline HCWs, effective supervision, the provision of motivation and feedback, simplification of reporting procedures, incentives for integrating AEFI reporting into routine monitoring and reporting, standardization of reporting procedures across regions, and developing appropriate interventions to address the fear of personal consequences would help improve AEFI reporting. Conclusion From the perspectives of a broad range of key informants at all levels of the vaccine safety system, we found multiple factors (both structural and behavioural), that may impact HCW reporting of AEFI in Ghana. Improvements in line with the suggestions are necessary for increased AEFI reporting in Ghana.
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Longley, Ashley T., Kashmira Date, Stephen P. Luby, Pankaj Bhatnagar, Adwoa D. Bentsi-Enchill, Vineet Goyal, Rahul Shimpi, et al. "Evaluation of Vaccine Safety After the First Public Sector Introduction of Typhoid Conjugate Vaccine—Navi Mumbai, India, 2018." Clinical Infectious Diseases 73, no. 4 (January 27, 2021): e927-e933. http://dx.doi.org/10.1093/cid/ciab059.
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Abstract Background In December 2017, the World Health Organization (WHO) prequalified the first typhoid conjugate vaccine (TCV; Typbar-TCV). While no safety concerns were identified in pre- and postlicensure studies, WHO’s Global Advisory Committee on Vaccine Safety recommended robust safety evaluation with large-scale TCV introductions. During July–August 2018, the Navi Mumbai Municipal Corporation (NMMC) launched the world’s first public sector TCV introduction. Per administrative reports, 113 420 children 9 months–14 years old received TCV. Methods We evaluated adverse events following immunization (AEFIs) using passive and active surveillance via (1) reports from the passive NMMC AEFI surveillance system, (2) telephone interviews with 5% of caregivers of vaccine recipients 48 hours and 7 days postvaccination, and (3) chart abstraction for adverse events of special interest (AESIs) among patients admitted to 5 hospitals using the Brighton Collaboration criteria followed by ascertainment of vaccination status. Results We identified 222/113 420 (0.2%) vaccine recipients with AEFIs through the NMMC AEFI surveillance system: 211 (0.19%) experienced minor AEFIs, 2 (0.002%) severe, and 9 serious (0.008%). At 48 hours postvaccination, 1852/5605 (33%) caregivers reported ≥1 AEFI, including injection site pain (n = 1452, 26%), swelling (n = 419, 7.5%), and fever (n = 416, 7.4%). Of the 4728 interviews completed at 7 days postvaccination, the most reported AEFIs included fever (n = 200, 4%), pain (n = 52, 1%), and headache (n = 42, 1%). Among 525 hospitalized children diagnosed with an AESI, 60 were vaccinated; no AESIs were causally associated with TCV. Conclusions No unexpected safety signals were identified with TCV introduction. This provides further reassurance for the large-scale use of Typbar-TCV among children 9 months–14 years old.
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Vasavi, Santosh, Poojita Santosh Rao, and Deepak Langade. "A retrospective cross-sectional study assessing adverse events following immunization (AEFI) of COVID 19 vaccine in a subset of Indian population." Journal of Community Health Management 9, no. 3 (September 15, 2022): 148–54. http://dx.doi.org/10.18231/j.jchm.2022.029.
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As the COVID-19 pandemic is an emerging healthcare concern, there has been swift vaccine development with minimal clinical trials questioning its protective efficacy outside of clinical trial conditions. The study aims to analyze the adverse events following immunization (AEFI) with COVID-19 vaccines among the domestic Indian population. It also aimed to evaluate the association between AEFI and demographic characteristics, comorbidities, and type of vaccine. This cross-sectional survey included participants ≥ 18 years of Indian origin for passive reporting of AEFI with COVID-19 vaccination using a questionnaire. The incidence of AEFI was calculated in percentage; the Chi-square test was used to determine associations between AEFI and independent variables. The incidence of reported AEFI was 76.4%. The most frequently reported AEFI was redness [74.38% (n = 328)], followed by pain [52.83% (n = 233)], swelling [52.83% (n = 233)], and fever [50.34% (n = 222)]. The majority of AEFIs were mild to moderate and resolved spontaneously. Females had significantly more AEFI with longer duration than males. The type of vaccine received had no significant effect on the number or duration of AEFI; 3.63% tested positive for COVID-19 after the first dose and 3.11% after the second dose of the vaccine, with no significant correlation between comorbidities and the presence of AEFI. More than three-fourths of the vaccines resulted in one or more forms of adverse events, but most events were self-limiting. Females were more prone to develop AEFI. Knowledge about what to expect after vaccination will help educate the public, allay misconceptions and reduce vaccine hesitancy.
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Mishra, Neel M., Sandeep Dhingra, and K. M. Adhikari. "Adverse events following immunization: orchestrated outcome of mothers' knowledge and behavior on vaccination practices." International Journal Of Community Medicine And Public Health 8, no. 2 (January 27, 2021): 802. http://dx.doi.org/10.18203/2394-6040.ijcmph20210242.
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Background: Adverse events following immunization (AEFI) are a common occurrence in children after vaccination and can lead to loss of trust in the immunization program. Fear of AEFIs is a major factor implicated in ‘Vaccine Hesitancy’ as seen in countries with high vaccination coverage and low burden of vaccine preventable diseases. The study aimed at assessing the knowledge, attitudes and practices of mothers regarding AEFI and its impact on vaccination of their childrenMethods: A descriptive, cross sectional survey was conducted at the immunization clinic of a tertiary care hospital of western India. Mothers attending the immunization clinic were interviewed using a validated questionnaire. A sample size of 221 was derived based on the incidence of common AEFIs.Results: Awareness of AEFI was present in 86.4% participants while only 28% mothers confirmed that information regarding AEFIs was given to them at the time of immunization. Though awareness of minor side effects like fever (98%) and local reaction (85%) was good, less than 15% of the mothers were aware of serious AEFIs such as seizures and anaphylaxis. Only 66% mothers indicated that they would first consult their doctor in case of an adverse effect. Knowledge regarding true contraindications to vaccination was poor.Conclusions: Awareness of the possibility of AEFI was good and trust in immunization as a vital health intervention was intact. Awareness about serious AEFIs which necessitate prompt management was inadequate while that for minor side effects was satisfactory. Healthcare seeking behavior of mothers to serious AEFIs was appropriate.
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Suresh, Aneena. "Awareness of Immunisation Health Care Providers on Adverse Events Following Immunisation: A Multicentre Study." Journal of Communicable Diseases 54, no. 1 (March 31, 2022): 1–9. http://dx.doi.org/10.24321/0019.5138.202241.
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Introduction:Adverse events following immunisation (AEFI) are often under-reported in India due to limited awareness among immunisation health care providers negatively affecting the immunisation programme of the country. This study assesses the knowledge, attitude and reporting practices (KAP) of AEFI among immunisation healthcare providers (IHPs) of private hospitals and clinics in South India.Methods: Using a semi-structured questionnaire, 58 IHPs were interviewed. The mean age was found to be 14.5 ± 7.2 years. Few IHPs had good knowledge (34.5%) while 91.4% had a good attitude, but it didn’t influence their good reporting practices (25.9%). The overall KAP score was the highest for physicians (50%), followed by pharmacists (43.8%) and nurses (37.8%).Results: Barriers to effective reporting were lack of knowledge about AEFI surveillance, filling an AEFI reporting form, time constraints and unfamiliarity with electronic reporting.Conclusion: KAP of immunisation health care providers isn’t satisfactory. In recent years, the rate of serious AEFIs has decreased to a greater extent. This also decreased the IHPs’ awareness of AEFI reporting as they don’t need to frequently report. Improving the perception of AEFI and active participation in reporting by IHPs can strengthen the nation’s AEFI surveillance system.
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Jain, Kriti M., Proma Paul, and D. Scott LaMontagne. "Monitoring adverse events following immunisation in developing countries: experience from human papillomavirus vaccination demonstration projects." Sexual Health 10, no. 1 (2013): 57. http://dx.doi.org/10.1071/sh11161.
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Background Surveillance of adverse events following immunisation (AEFIs) is important for maintaining trust in vaccination. This paper discusses retrospective reports by parents and guardians of girls experiencing AEFIs during human papillomavirus (HPV) vaccine demonstration projects in Uganda and Vietnam. Methods: A secondary analysis of data from a population-based survey measuring HPV vaccine coverage of eligible girls and acceptability among parents and guardians was conducted. Survey data from parents were analysed for frequency and type of AEFI and actions taken. Results: Of the 1700 eligible households contacted, all responded to the survey; of those, 1313 respondents had an eligible child who had received at least one dose of the HPV vaccine. Data were missing from 49 respondents, resulting in 1264 surveys. Twenty-five percent reported an AEFI, with fever (29.1%) and pain or swelling at the injection site (62.0%) being the most common. Events totalled 386 (10.5%) of the 3684 doses administered. Most parents reported that they took no action (63.9%) or cared for girls at home (16.1%) following an AEFI. Thirty-three parents sought advice from health workers or attended a clinic for 46 events (0.8% of all doses). Frequency of reporting varied by respondent identity, geographic location and vaccination location. Conclusions: AEFIs reported were similar to Phase III vaccine trials. Most parents reporting AEFIs took no action or treated the girl at home, suggesting that most AEFIs were not serious enough to contact the health system. AEFI reports were more frequent when solicited in surveys compared with reports from routine monitoring.
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Yamoah, Peter, Varsha Bangalee, and Frasia Oosthuizen. "Knowledge and Perceptions of Adverse Events Following Immunization among Healthcare Professionals in Africa: A Case Study from Ghana." Vaccines 7, no. 1 (March 8, 2019): 28. http://dx.doi.org/10.3390/vaccines7010028.
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The spontaneous reporting of suspected adverse events following immunization (AEFI) by healthcare professionals (HCPs) is vital in monitoring post-licensure vaccine safety. The main objective of this study was to assess the knowledge and perceptions of AEFIs among healthcare professionals (HCPs) in Africa, using the situation in Ghana as a case study. The study was of a cross-sectional quantitative design, and was carried out from 1 July 2017 to 31 December 2017 with doctors, pharmacists, and nurses as the study participants. A 28-item paper-based questionnaire, delivered by hand to study participants, was the data collection tool in the study. The study was conducted in 4 hospitals after ethical approval was granted. The desired sample size was 686; however, 453 consented to partake in the study. Data were analyzed using SPSS (software version 22, IBM, Armonk, NY, USA), and chi-square and binary logistic regression tests were used for tests of association between HCPs’ characteristics and their knowledge and perceptions. Detailed knowledge of AEFIs was ascertained with a set of 9 questions, with 8 or 9 correctly answered questions signifying high knowledge, 5 to 7 correctly answered questions signifying moderate knowledge, and below 5 correctly answered questions signifying low knowledge. A set of 10 questions also ascertained HCPs’ positive and negative perceptions of AEFI. Results revealed that knowledge of AEFIs was high in 49 (10.8%) participants, moderate in 213 (47.0%) participants, and low in 191 (42.2%) participants. There was no statistically significant correlation between AEFI knowledge and professions. The highest negative perception was the lack of desire to learn more about how to diagnose, report, investigate, and manage AEFI, whereas the lowest was the lack of belief that surveillance improves public trust in immunization programs. There was a general awareness of AEFIs among HCPs in this study. However, negative perceptions and the lack of highly knowledgeable HCPs regarding AEFIs were possible setbacks to AEFI diagnosis, management, prevention, and reporting. More training and sensitization of HCPs on AEFIs and vaccine safety will be beneficial in improving the situation. Future research should focus on assessing the training materials and methodology used in informing HCPs about AEFIs and vaccine safety.
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Nguyen, Minh Tam H., Gérard Krause, Brigitte Keller-Stanislawski, Stephan Glöckner, Dirk Mentzer, and Jördis J. Ott. "Postmarketing Safety Monitoring After Influenza Vaccination Using a Mobile Health App: Prospective Longitudinal Feasibility Study." JMIR mHealth and uHealth 9, no. 5 (May 7, 2021): e26289. http://dx.doi.org/10.2196/26289.
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Background For the safety monitoring of vaccinations postlicensure, reports of adverse events after immunization (AEFIs) are crucial. New technologies such as digital mobile apps can be used as an active approach to capture these events. We therefore conducted a feasibility study among recipients of the influenza vaccination using an app for assessment of the reporting of AEFIs. Objective The goal of the research was to determine factors influencing adherence to and correct use of a newly developed app for individuals to report AEFI for 3 months using regular reminder functions, to identify determinants of AEFI occurrence and define reported AEFI types. Methods We developed the app (SafeVac) and offered it to recipients of the influenza vaccination in 3 occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFIs were generated through SafeVac for 3 months. Using logistic and Cox regression, we assessed associations between app adherence, correct app entry, AEFIs, and sociodemographic parameters. Results Of the individuals who logged into SafeVac, 61.4% (207/337) used the app throughout a 3-month period. App use adherence was negatively associated with female sex (odds ratio [OR] 0.47; CI 0.25-0.91) and correct app entry was negatively associated with older age (OR 0.96; CI 0.93-0.99) and lower education (OR 0.31; CI 0.13-0.76). AEFI occurrence was associated with female sex (hazard ratio 1.41; CI 1.01-1.96) and negatively with older age (hazard ratio 0.98; CI 0.97-0.99). The most common AEFIs reported were injection site pain (106/337), pain in extremity (103/337), and fatigue/asthenia (73/337). Conclusions Digital AEFI reporting was feasible with SafeVac and generated plausible results for this observation period and setting. Studies directly comparing SafeVac with conventional passive reporting schemes could determine whether such digital approaches improve completeness, timeliness, and sensitivity of vaccine vigilance. Further studies should evaluate if these results are transferable to other vaccinations and populations and if introduction of such a tool has an influence on vaccination readiness and therefore vaccine safety.
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Thorakkattil, Shabeer Ali, Suhaj Abdulsalim, Mohammed Salim Karattuthodi, Mazhuvanchery Kesavan Unnikrishnan, Muhammed Rashid, and Girish Thunga. "COVID-19 Vaccine Hesitancy: The Perils of Peddling Science by Social Media and the Lay Press." Vaccines 10, no. 7 (June 30, 2022): 1059. http://dx.doi.org/10.3390/vaccines10071059.
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Introduction: Vaccines are the best tools to end the pandemic, and their public acceptance is crucial in achieving herd immunity. Despite global efforts to increase access to vaccination, the World Health Organization explicitly lists vaccination hesitancy (VH) as a significant threat. Despite robust safety reports from regulatory authorities and public health advisories, a substantial proportion of the community remains obsessed with the hazards of vaccination. This calls for identifying and eliminating possible causative elements, among which this study investigates the inappropriate dissemination of medical literature concerning COVID-19 and adverse events following immunization (AEFI), its influence on promoting VH, and proposals for overcoming this problem in the future. Methods: We searched PubMed, Embase, and Scopus databases, using the keywords “adverse events following immunization (AEFI),” “COVID-19”, “vaccines,” and “hesitancy”, and related medical and subjective headings (MeSH) up to 31st March 2022, and extracted studies relevant to the COVID-19 AEFI and associated VH. Finally, 47 articles were chosen to generate a narrative synthesis. Results: The databases depicted a steep rise in publications on COVID-19 AEFI and COVID-19 VH from January 2021 onwards. The articles depicted multiple events of mild AEFIs without fatal events in recipients. While documenting AEFIs is praiseworthy, publishing such reports without prior expert surveillance can exaggerate public apprehension and inappropriately fuel VH. VH is a deep-rooted phenomenon, but it is difficult to zero in on the exact reason for it. Spreading rumors/misinformation on COVID-19 vaccines might be an important provocation for VH, which includes indiscriminately reporting AEFI on a massive scale. While a number of reported AEFIs fall within the acceptable limits in the course of extensive COVID-19 vaccinations, it is important to critically evaluate and moderate the reporting and dissemination of AEFI in order to allay panic. Conclusions: Vaccination programs are necessary to end any pandemic, and VH may be attributed to multiple reasons. VH may be assuaged by initiating educational programs on the importance of vaccination, raising public awareness and monitoring the inappropriate dissemination of misleading information. Government-initiated strategies can potentially restrict random AEFI reports from lay epidemiologists and healthcare practitioners.
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Yamoah, Peter, and Frasia Oosthuizen. "An Assessment of the Reporting Pattern of Adverse Events Following Immunizations in VigiAccess." Global Journal of Health Science 10, no. 11 (October 13, 2018): 46. http://dx.doi.org/10.5539/gjhs.v10n11p46.
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PURPOSE: Globally, adverse events following immunization (AEFI) reporting continues to be a challenge. It is estimated that about 95% of AEFIs never get reported after vaccinations necessitating strategies to improve it. The introduction of databases such as VigiAccess in which AEFI data from Pharmacovigilance centres around the world can be assessed is an important step towards improving AEFI reporting and enhancing vaccine safety. This study assessed the reporting pattern of AEFIs from the various continents of the world in VigiAccess, an open-access pharmacovigilance database.
METHODS: VigiAccess was thoroughly searched on the 5th of February 2018 for the categories of reported AEFIs and number and types of AEFIs reported for measles vaccine, oral polio vaccine, yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and BCG vaccine.
RESULTS: After a thorough search through VigiAccess, 27 categories of reported AEFIs were retrieved. The total number of AEFIs for the 8 vaccines was 813,973. General disorders and administration site conditions were the highest number of AEFIs (251,405 representing 30.9%) followed by skin and subcutaneous tissue disorders (93,011 representing 11.4%) and nervous system disorders (89,077 representing 10.9%). With the continental data, the Americas recorded the highest number of AEFIs followed by Europe, Oceania, Asia and Africa.
CONCLUSION: General and vaccine administration site conditions were the highest number of AEFIs. The Americas recorded the highest number of AEFIs whereas Africa recorded the least. VigiAccess needs improvement in data synchronization to enhance its reliability.
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Umar, Ahmad, Muawiyyah Sufiyan, Dahiru Tukur, Mary Onoja-Alexander, Lawal Amadu, and Sulieman Bashir. "Knowledge of Adverse Events Following Immunization Reporting Tool and System Among Primary Healthcare Workers in Jigawa State." Infection Control & Hospital Epidemiology 41, S1 (October 2020): s308. http://dx.doi.org/10.1017/ice.2020.895.
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Background: Adverse events following immunization (AEFI) surveillance largely depends on the ability of the healthcare worker (HCW) to timely detect and report cases using the correct reporting tools through an appropriate system. AEFI surveillance is carried out regularly during both routine immunization services and supplemental immunization activities in the state. Objective: We assessed knowledge of adverse events following immunization reporting tools and system among primary HCWs in Jigawa state, northwestern Nigeria. Method: A descriptive cross-sectional design was used for this study. A multistage sampling technique was used to select 290 HCWs that had spent at least 6 months in immunization units of primary healthcare centers of Jigawa state. Data were collected using pretested self-administered structured questionnaire with open and closed ended questions and were analyzed using IBM SPSS version 20 software. All statistical tests were 2-tailed with P < .05 as the statistical significance level. Results: Most of the primary HCWs (93.2%) had AEFI reporting forms in their health facilities, and 68.9% said that the AEFI reporting form could be obtained from a focal or contact person in the health facility. Up to 96.4% of the primary HCWs were aware of how to report AEFI. Also, ~76.6% of primary HCWs knew the correct AEFI reporting flow, but only 15.8% knew that only serious AEFIs are reported. Furthermore, ~78.8% and 19.4% of HCWs mentioned telephone and filling forms as some of the appropriate methods of AEFI notification, respectively. Conclusions: Most primary HCWs had reporting forms in their health facilities and were aware of how to report an AEFI. Most of the respondents knew the correct AEFI reporting flow. The state in collaboration with local government authorities should provide quality training on AEFI reporting and reporting system.Funding: NoneDisclosures: None
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Parajuli, Surya Bahadur, Ayushma Shakya, Sujita Pokhrel Koirala, Heera KC, and Puru Koirala. "Adverse events following immunization after COVISHIELD vaccination among Nepali population of eastern Nepal." Journal of Patan Academy of Health Sciences 8, no. 3 (December 31, 2021): 5–13. http://dx.doi.org/10.3126/jpahs.v8i3.33352.
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Introduction: Vaccines require continuous monitoring to increase their compliance, quality, and safety. We conducted this study to fulfill the research gap for the adverse events following immunization (AEFIs) after COVISHIED (ChAdOx1nCoV-19) vaccination among Nepali of eastern Nepal. Method: A cross-sectional study was conducted from 25 Jan 2021 to Jul 2021 at Birat Medical College Teaching Hospital of Morang, Nepal. The data on COVISHIELD vaccine recipients at this center were analyzed for AEFI. Ethical clearance was obtained. Result: Out of 167 vaccine recipients, the mean age was 28.08±7.35 y. The AEFI occurred in 122(73.1%) and 89(72.9%) who developed symptoms on the same day of vaccination. The AEFI symptoms were less common in males (OR 0.43; CI (0.19-0.96; P 0.03). In both sexes, the AEFI symptoms were reported on the same day of vaccination than the next day but it had no significant association. Conclusion: The AEFI following COVISHIED vaccination was reported by 2/3rd recipients mostly on the same day of the vaccine and less common in males.
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Qureshi, Samreen Ashraf, Naveed Masood, Asif Syed, Mudassar Hussain, Kashif Hussain, Saeed Ahmed Bhurt, Muhammad Ali Gadehi, Fahad Memon, and Muhammad Juman Bahoto. "Surveillance System Evaluation for COVID-19 Vaccine–Associated Adverse Events Following Immunization (AEFI), Sindh Pakistan (2021)." Iproceedings 8, no. 1 (February 18, 2022): e36635. http://dx.doi.org/10.2196/36635.
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Background In February 2021, a mass vaccination campaign commenced in Sindh Province in response to the COVID-19 epidemic. An adverse-events-following-immunization surveillance system (AEFI-SS) was established to monitor the adverse events following vaccination. Objective We evaluated the AEFI-SS with the aim to identify its strengths and weaknesses and suggest recommendations. Methods In May-June 2021, a descriptive evaluation study was conducted in Sindh Province, Pakistan. The Centers for Disease Control and Prevention’s (CDC) updated guidelines for evaluation of SS-2001 were followed to measure the qualitative, quantitative, and utility attributes of the AEFI-SS. Key stakeholders were identified based on their involvement in the AEFI-SS and were interviewed. Case investigation proformas for the AEFI were randomly reviewed for data quality, timeliness, and completeness. Sensitivity was calculated. Each attribute was rated as good, fair, or poor based on a scoring legend. Results The SS was useful in effectively identifying 7147 cases of AEFIs. Timeliness of all AEFI cases was good and was found to be 100%, as all cases were reported within 24 hours. The World Health Organization (WHO)-approved case definition was used for the identification of AEFI cases and had a simple flow of information. The AEFI-SS was good in data quality and completeness (100%), and data collection tools were filled by trained medical officers. Sensitivity was 100%, and the predictive value positive (PVP) was not calculated due to the absence of a laboratory component. Good representativeness (>80%) of the population was covered by 1004 vaccination centers. The system was found to be stable as resources of the health department government of Sindh were being used. The AEFI-SS was paper based and deficient in a feedback mechanism. Conclusions Sindh Province has an appropriate surveillance mechanism for AEFI detection and management for the ongoing COVID-19 vaccination SS. The representativeness can be increased by involvement of the private health sector. Establishment of a feedback mechanism and digital data transformation and integration of the AEFI system with the Expanded Program on Immunization (EPI) are recommended.
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Mesfin, Yonatan Moges, Allen Cheng, Jock Lawrie, and Jim Buttery. "Use of routinely collected electronic healthcare data for postlicensure vaccine safety signal detection: a systematic review." BMJ Global Health 4, no. 4 (July 2019): e001065. http://dx.doi.org/10.1136/bmjgh-2018-001065.
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BackgroundConcerns regarding adverse events following vaccination (AEFIs) are a key challenge for public confidence in vaccination. Robust postlicensure vaccine safety monitoring remains critical to detect adverse events, including those not identified in prelicensure studies, and to ensure public safety and public confidence in vaccination. We summarise the literature examined AEFI signal detection using electronic healthcare data, regarding data sources, methodological approach and statistical analysis techniques used.MethodsWe performed a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Five databases (PubMed/Medline, EMBASE, CINAHL, the Cochrane Library and Web of Science) were searched for studies on AEFIs monitoring published up to 25 September 2017. Studies were appraised for methodological quality, and results were synthesised narratively.ResultWe included 47 articles describing AEFI signal detection using electronic healthcare data. All studies involved linked diagnostic healthcare data, from the emergency department, inpatient and outpatient setting and immunisation records. Statistical analysis methodologies used included non-sequential analysis in 33 studies, group sequential analysis in two studies and 12 studies used continuous sequential analysis. Partially elapsed risk window and data accrual lags were the most cited barriers to monitor AEFIs in near real-time.ConclusionRoutinely collected electronic healthcare data are increasingly used to detect AEFI signals in near real-time. Further research is required to check the utility of non-coded complaints and encounters, such as telephone medical helpline calls, to enhance AEFI signal detection.Trial registration numberCRD42017072741
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Ahsan, Marya, Riyaz Ahamed Shaik, Ayaz K. Mallick, Saeed S. Banawas, Thamer A. M. Alruwaili, Yousef Abud Alanazi, Hayat Saleh Alzahrani, et al. "A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5–17 Years) Living in Saudi Arabia." Vaccines 11, no. 2 (January 17, 2023): 207. http://dx.doi.org/10.3390/vaccines11020207.
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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.
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Sarika P Patil, Sushant S Chavan, Amol D Kinge, and Vikrant S Pagar. "A study to determine adverse event following immunization using COVISHIELD vaccine for prevention of COVID-19 infection in a field practice area of urban health center." Asian Journal of Medical Sciences 13, no. 6 (June 1, 2022): 1–6. http://dx.doi.org/10.3126/ajms.v13i6.44474.
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Background: The COVID-19 vaccination program was introduced in India on 16 January 2021. The Government-issued fact sheet was the only source of information regarding Adverse Events Following Immunizations (AEFIs) for these vaccines. Aims and Objectives: The objective of this study was to assess the AEFI reported following COVISHIELD vaccination in an urban health center. Materials and Methods: The spontaneous reporting method was used for data collection for 3 months. A data collection form was designed to collect the data from the study population who reported adverse events. Collected data were analyzed and categorized by severity and seriousness. The causality assessment was done using the World Health Organization’s causality assessment algorithm. Results: A total of 3,486 doses of COVISHIELD vaccine were administered at the study site during the study period. In all, 306 AEFIs were reported from 190 subjects with an incidence rate of 5.45%. The majority of the subjects with AEFIs belonged to the age group of 18–45 years. Out of the total 306 AEFIs, 287 AEFIs were expected as per the fact sheets. Most of the AEFIs (59.47% [n=182]) were observed at the system organ class of “General disorders and administration site conditions.” After the causality assessment, out of 433 AEFIs to COVISHIELD vaccine, 94.22% (n=287) of events were categorized to have “consistent causal association with immunization.” All of them recovered from their adverse events without any sequelae. Conclusion: Most common AEFI after COVISHIELD vaccination was found to be general disorders and administration site conditions. No severe AEFI reported.
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Fens, Tanja, Pieter T. de Boer, Eugène P. van Puijenbroek, and Maarten J. Postma. "Inclusion of Safety-Related Issues in Economic Evaluations for Seasonal Influenza Vaccines: A Systematic Review." Vaccines 9, no. 2 (February 2, 2021): 111. http://dx.doi.org/10.3390/vaccines9020111.
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(1) Background: Vaccines for seasonal influenza are a good preventive and cost-effective strategy. However, it is unknown if and how these economic evaluations include the adverse events following immunization (AEFI), and what the impact of such inclusion is on the health economic outcomes. (2) Methods: We searched the literature, up to January 2020, to identify economic evaluations of seasonal influenza vaccines that considered AEFIs. The review protocol was published in PROSPERO (CDR42017058523). (3) Results: A total of 52 economic evaluations considered AEFI-related parameters in their analyses, reflecting 16% of the economic evaluations on seasonal influenza vaccines in the initial study selection. Most studies used the societal perspective (64%) and evaluated vaccination of children (37%). Where considered, studies included direct medical costs of AEFIs (90%), indirect costs (27%), and disutilities/quality-adjusted life years loss due to AEFIs (37%). The majority of these studies accounted for the effects of the costs of AEFI on cost-effectiveness for Guillain–Barré syndrome. In those papers allowing cost share estimation, direct medical cost of AFEIs was less than 2% of total direct costs. (4) Conclusions: Although the overall impact of AEFIs on the cost-effectiveness outcomes was found to be low, we urge their inclusion in economic evaluations of seasonal influenza vaccines to reflect comprehensive reports for the decision makers and end-users of the vaccination strategies.
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Tebaa, Amina, Raja Benkirane, Loubna Alj, Imad Cherkaoui, and Rachida Soulaymani-Bencheikh. "Monitoring the safety of influenza A/H1N1 pandemic and seasonal vaccines in Morocco." Therapeutic Advances in Vaccines and Immunotherapy 10 (January 2022): 251513552210881. http://dx.doi.org/10.1177/25151355221088157.
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Background: A vaccination campaign against pandemic influenza A/H1N1 was implemented in Morocco between November 2009 and April 2010. Overall, 705,883 subjects were vaccinated by Pandemrix, Arepanrix, and Panenza. The adverse events following immunization (AEFIs) data comparison was made with the 2014/2015 seasonal influenza vaccination campaign that was specifically investigated. Aim: To evaluate the safety of the 2009 pandemic influenza A/H1N1 vaccine and to compare it to that of 2014 seasonal influenza vaccine. Methods: During the pandemic vaccination campaign, the Morocco Pharmacovigilance Centre reinforced passive AEFI surveillance with an active and prospective monitoring programme of 1000 immunized people over 6 months at 10 randomly selected vaccination centres. For the 2014/2015 seasonal vaccination campaign, AEFI data were collected from spontaneous notifications. Results: Active monitoring of 2009 pandemic collected 771 AEFI reports, corresponding to an AEFI incidence rate of 77.1% with vaccination by either Pandemrix or Arepanrix vaccine in 95% of cases. Reported AEFI were most frequently local (37.7%), general (29.5%), and neurological reactions (20.3%). Most of the AEFI (95.5%) were observed during the first 48 hours after vaccination, and the remainder within 2 weeks. None of the reported AEFI were serious case. The highest rate of notification was documented for health professionals, followed by patients with diabetes or chronic respiratory diseases. Concerning passive surveillance, the AEFI notification rate was significantly higher for the 2009/2010 pandemic vaccine (3.1 vs 1.2 per 10,000). However, there was no significant difference between pandemic and seasonal vaccination with regards to the serious adverse events (SAE) notification rate (0.3 vs 0.2 per 10,000). Conclusion: Data analysis indicates that the vaccines used against 2009 pandemic influenza in Morocco have a satisfactory safety profile, similar to the seasonal influenza vaccine with the exception of local reactions as observed previously in other countries.
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Sebastian, Juny, Parthasarathi Gurumurthy, Mandyam Dhati Ravi, and Madhan Ramesh. "Active surveillance of adverse events following immunization (AEFI): a prospective 3-year vaccine safety study." Therapeutic Advances in Vaccines and Immunotherapy 7 (January 2019): 251513551988900. http://dx.doi.org/10.1177/2515135519889000.
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Background: Vaccines used in national immunization programs are considered safe and effective but immunization safety has become as important as the efficacy of vaccination programs. The objective of the study was to detect adverse events following immunization (AEFIs) to all vaccines administered to a pediatric population in India. Methods: The prospective active vaccine safety surveillance study enrolled eligible children in the age group 0–5 years receiving vaccination from the immunization center at JSS Hospital, Mysuru. Study participants were monitored at the site for 30 min following vaccination and a telephonic survey was made after 8 days to identify all AEFIs. Causality assessment of the AEFIs were done using a new algorithm developed by the safety and vigilance department of the World Health Organization. Results: The incidence of reported AEFIs was 13.7%. The most frequently reported AEFI was fever ( n = 3095, 93.2%) with an incidence of 109.7 per 1000 doses of vaccine administered, followed by persistent crying ( n = 69, 2.4 per 1000 doses of vaccine) and diarrhea ( n = 57, 2.0 per 1000 doses of vaccine). The majorly implicated vaccine for AEFIs was Pentavac® followed by BCG. Consistent causal association to immunization was observed in 93.4% of cases. Conclusions: A high incidence rate of AEFI was observed in our study population when compared with previous published studies. AEFI surveillance studies help to detect changes in the frequency of adverse events, which may be an alert to consider vaccine quality or identify a specific risk among the local population.
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Utami, Jewi, Didi Kurniawan, and Musfardi Rustam. "GAMBARAN KEJADIAN IKUTAN PASCA IMUNISASI (KIPI) PASCA VAKSINASI COVID-19 PADA MAHASISWA KEPERAWATAN." Coping: Community of Publishing in Nursing 10, no. 5 (October 31, 2022): 540. http://dx.doi.org/10.24843/coping.2022.v10.i05.p10.
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The COVID-19 pandemic is set to become a disturbing Public Health Emergency of International Concern (PHEIC) that requires a new strategy as an effective intervention, namely vaccination. The use of vaccines can cause vaccination reactions called Adverse Events Following Immunization (AEFI). This study aims to determine and explain the picture of Adverse Events Following Immunization (AEFI) post-COVID-19 vaccination in nursing students. This study used a retrospective descriptive design using univariate analysis. The research sample amounted to 649 respondents, with sampling using a total sampling technique. The measuring instrument used is the AEFI questionnaire via google form. The characteristics of respondent majority of late adolescents aged 17-25 years of 639 (98,4%), with most of the female gender 578 (89,1%). The majority of Dose-1 vaccination types are Sinovac amounting to 581 (89,5%), Dose-2 vaccination the majority are also Sinovac at 338 (87,6%), and the majority Dose-3 vaccination is Pfizer-BioNTech totaling 113 (55,7%). Respondents experienced AEFI on Dose-1 vaccination with a total of 649 respondents, the most symptoms were muscle pain by 245 (37,8%), Dose-2 vaccination with a total of 386 respondents obtained the majority of muscle pain by 90 (23,3%), and vaccination Dose-3 with a total of 203 respondents, the majority of muscle pain was 65 (32,0%). The AEFI category in the Dose-1 vaccination was mostly in the low category by 290 (44,7%). The majority of Dose-2 vaccination AEFIs are in the low category of 225 (58,3%), and the majority of Dose-3 vaccinations are in the low category of 90 (44,3%). The most common AEFI symptom experienced by respondents is muscle pain, and the majority of AEFI post-COVID-19 vaccinations are in low category.
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Tereshkina, N. V., I. I. Snegireva, and M. A. Darmostukova. "Possible Causes of and Measures to Minimise Risks of Abscesses Following DTP Vaccination." Safety and Risk of Pharmacotherapy 9, no. 1 (March 16, 2021): 3–14. http://dx.doi.org/10.30895/2312-7821-2021-9-1-3-14.
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Registration and analysis of adverse events following immunisation (AEFIs) allow for objective assessment and systematisation of AEFI causes, and promotion of vaccination safety. Development of abscesses after DTP vaccination is a fairly common AEFI, however, they are not included in the “Side effects” part of the patient information leaflet of the vaccine. The aim of the study was to analyse reasons for abscess development after DTP vaccination and to elaborate recommendations on enhancing the vaccine safety. The review of literature data, solicited reports on AEFIs, and AEFI investigation reports submitted to the Scientific Centre for Expert Evaluation of Medicinal Products during 2014–2018 suggests that abscesses associated with DTP vaccination may be caused by the vaccine reactogenicity, quality defects arising during production or distribution, and vaccine administration errors by healthcare personnel. Lack of information in the documents submitted by medical institutions does not allow to rule out any of the identified reasons. The minimisation of risks of abscesses requires quality control of DTP vaccines, maintenance of the cold chain during transportation and storage, and compliance with aseptic regulations during administration. Additional pharmacovigilance measures will also help enhance vaccination safety: improvement and standardisation of data collection during investigation of abscess development in the post-vaccination period, obligatory inclusion of data on the thickness of children’s subcutaneous adipose tissue (weight, body mass index) and the length of the needle used for vaccination in AEFI investigation reports. It is advisable to add information on abscess risk in the “Side effects” part of the patient information leaflet of the DTP vaccine, and to update the “Dosage regimen and administration route” and “Precautions” parts in order to minimise the risk. Personnel of healthcare facilities performing vaccination should be made aware of the importance of providing detailed data on AEFIs for subsequent objective analysis.
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Barański, Kamil, Maksymilian Gajda, Bogumiła Braczkowska, and Małgorzata Kowalska. "Parental Declaration of Adverse Event Following Immunization in a Cross-Sectional Study in Poland." International Journal of Environmental Research and Public Health 16, no. 20 (October 22, 2019): 4038. http://dx.doi.org/10.3390/ijerph16204038.
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Vaccines are a well-known and effective preventive measure in communicable diseases. However, like any medical product, vaccines can cause some adverse effects. With increasing population awareness, the number of reported events related to vaccination has increased. Aim: The aim of the study was to assess the frequency and type of reported adverse events following childhood immunization (AEFI), and to recognize the determinant of their occurrence related with a socio-demographic situation, parental knowledge, and/or opinions on vaccinations. Material and Methods: The self-administrated questionnaire was distributed to a group of 3000 random parents or legal guardians living in the Silesian Voivodship (the southern part of Poland) in 2016. The response rate was eventually 41.3% from 1239 participants. Both, the number of children and the percentage of vaccinations given in the studied region, was representative for Poland as a whole. Results: Approximately one-third (32%) of surveyed parents declared the occurrence of AEFI in their children. The most frequently declared AEFIs were: redness, pain, swelling at the injection site (27%), and fever (24.9%). The frequency of reported AEFI was associated with a higher level of parental education and the number of vaccinations given. A negative attitude toward vaccination and the belief that vaccination is unsafe were associated with a higher number of reported AEFI. Conclusions: The results obtained confirmed that the number of declared mild and moderate AEFI is related to a lower parental educational level and is associated with a better experience as a consequence of a higher number of vaccinations given. Frequent AEFI reporters represent negative attitudes toward vaccinations. Further investigation with the exact surveillance system is needed to improve parental trust in vaccination safety.
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Kaushal, Suneel Kumar, Ashok Kumar Patel, Mukesh Yadav, and Navin Kumar. "Assessment of adverse event following immunization and its co-relates among COVID-19 vaccine recipient in Bundelkhand region of Uttar Pradesh: A cross-sectional study." Indian Journal of Community Health 33, no. 2 (June 30, 2021): 379–82. http://dx.doi.org/10.47203/ijch.2021.v33i02.027.
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Background: The COVID-19 pandemic is a global emergency. AEFIs reporting and assessment should be done with high priority as they could change the benefit-risk profile of the vaccine. Objective: To assess adverse effects after COVID-19 vaccination. Methods: This cross-sectional study conducted among 605 heath functionaries taken part from January 2021 to March 2021. Results: The most common AEFI reported was pain at injection site (51.9%). Gender, previous COVID status and perception before vaccination were significantly associated with AEFI. Conclusion: There was no serious adverse event after vaccination. COVID vaccine has a good safety profile.
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Kaushal, Suneel Kumar, Ashok Kumar Patel, Mukesh Yadav, and Navin Kumar. "Assessment of adverse event following immunization and its co-relates among COVID-19 vaccine recipient in Bundelkhand region of Uttar Pradesh: A cross-sectional study." Indian Journal of Community Health 33, no. 2 (June 30, 2021): 379–82. http://dx.doi.org/10.47203/ijch.2021.v33i02.027.
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Background: The COVID-19 pandemic is a global emergency. AEFIs reporting and assessment should be done with high priority as they could change the benefit-risk profile of the vaccine. Objective: To assess adverse effects after COVID-19 vaccination. Methods: This cross-sectional study conducted among 605 heath functionaries taken part from January 2021 to March 2021. Results: The most common AEFI reported was pain at injection site (51.9%). Gender, previous COVID status and perception before vaccination were significantly associated with AEFI. Conclusion: There was no serious adverse event after vaccination. COVID vaccine has a good safety profile.
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Salter, Sandra, Gurkamal Singh, Lisa Nissen, Kevin Trentino, Kevin Murray, Kenneth Lee, Benjamin Kop, Ian Peters, and Alan Leeb. "Active vaccine safety surveillance of seasonal influenza vaccination via a scalable, integrated system in Western Australian pharmacies: a prospective cohort study." BMJ Open 11, no. 6 (June 2021): e048109. http://dx.doi.org/10.1136/bmjopen-2020-048109.
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ObjectivesWe integrated an established participant-centred active vaccine safety surveillance system with a cloud-based pharmacy immunisation-recording program in order to measure adverse events following immunisation (AEFI) reported via the new surveillance system in pharmacies, compared with AEFI reported via an existing surveillance system in non-pharmacy sites (general practice and other clinics).DesignA prospective cohort study.Participants and settingIndividuals >10 years receiving influenza immunisations from 22 pharmacies and 90 non-pharmacy (general practice and other clinic) sites between March and October 2020 in Western Australia. Active vaccine safety surveillance was conducted using short message service and smartphone technology, via an opt-out system.Outcome measuresMultivariable logistic regression was used to assess the primary outcome: differences in proportions of AEFI between participants immunised in pharmacies compared with non-pharmacy sites, adjusting for confounders of age, sex and influenza vaccine brand. A subgroup analysis of participants over 65 years was also performed.ResultsOf 101 440 participants (6992 from pharmacies; 94 448 from non-pharmacy sites), 77 498 (76.4%) responded; 96.1% (n=74 448) within 24 hours. Overall, 4.8% (n=247) pharmacy participants reported any AEFI, compared with 6% (n=4356) non-pharmacy participants (adjusted OR: 0.87; 95% CI: 0.76 to 0.99; p=0.039). Similar proportions of AEFIs were reported in pharmacy (5.8%; n=31) and non-pharmacy participants (6; n=1617) aged over 65 years (adjusted OR: 0.94; 95% CI: 0.65 to 1.35; p=0.725). The most common AEFIs in pharmacy were: pain (2%; n=104), tiredness (1.9%; n=95) and headache (1.7%; n=88); and in non-pharmacy sites: pain (2.3%; n=1660), tiredness (1.9%; n=1362) and swelling (1.5%; n=1121).ConclusionsHigh and rapid response rates demonstrate good participant engagement with active surveillance in both pharmacy and non-pharmacy participants. Significantly fewer AEFIs reported after pharmacist immunisations compared with non-pharmacy immunisations, with no difference in older adults, may suggest different cohorts attend pharmacy versus non-pharmacy immunisers. The integrated pharmacy system is rapidly scalable across Australia with global potential.
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Muhas, C., VP Anuradha, KB Sreelakshmi, Samrin Aysha, Ahmed NP Shida, and Anfas P. Muhammed. "Observational Study on Prevalence of Adverse Effects of COVID Vaccination among General Population in South India." Journal of Drug Delivery and Therapeutics 12, no. 6 (November 20, 2022): 142–46. http://dx.doi.org/10.22270/jddt.v12i6.5679.
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Introduction: COVID-19 is a viral disease due to the Severe Acute Respiratory Syndrome Coronavirus 2. The patients show flu-like symptoms with a dry cough, sore throat, high fever, and breathing problems. This was conducted to assess the adverse effects after taking Covid 19 vaccines in general population of Kerala state.
Methodology: About 353 participants were enrolled in the study according to inclusion and exclusion criteria for a period of November 2021 to April 2022. Data collection was done with structured questionnaire in google form. The data were analysed and reported using tables, pie diagram, bar diagrams and different charts forms.
Results: Majority of patients enrolled in the study were vaccinated with 2 dosed of Covid vaccines. From 351 participants vaccinated with Covid 19 vaccine 249 experienced an AEFI. The most reported AEFI was fever, body pain and injection site reactions. From the results it was found that females had experienced more AEFI than males. Most of the participants from our study were vaccinated with Covishield and all participants taken Sputnik vaccine had experienced some adverse effects.
Conclusion: The present study reveal that majority of people vaccinated by Covid 19 vaccines had experienced any kind of AEFIs. Majority of patients enrolled in the study were vaccinated with 2 dosed of Covid vaccines. The most reported AEFI was fever, body pain and injection site reactions. From the results it was found that females had experienced more AEFI than males.
Keywords: Adverse effects, Covid 19, Covishield, Covaxin, Immunization, Vaccination
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Zafack, Joseline Guetsop, Alexandre Bureau, Danuta M. Skowronski, and Gaston De Serres. "Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials." BMJ Open 9, no. 5 (May 17, 2019): e026953. http://dx.doi.org/10.1136/bmjopen-2018-026953.
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Objectives(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.DesignRisk-interval designSettingThree randomised controlled trials conducted in Europe.ParticipantsA total of 5026 healthy 2-month-old to 15-month-old infants.Interventions4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administered concomitantly or separately 1 month apart, in regular (2, 4, 6 and 12 months), accelerated (2, 3, 4 and 12 months) or delayed (two doses of 4CMenB at ≥12 months of age) schedules.Outcome measuresPrimary: Fever (≥38°C) during the first 48 hours post immunisation. Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site.ResultsCompared with separate administration, concomitant administration decreased the overall incidence of fever (≥38°C), 86% versus 75%, and other systemic AEFIs but increased the incidence of 4CMenB injection site tenderness, 55% versus 66%, moderate/severe fevers (≥39°C), 13% versus 18%, and long-lasting (>1 day) fevers, 23% versus 33%. Co-administration reduced AEFI risk by 4%–49% with the greatest impact among infants with prior AEFI(s). Fever recurrence risk was proportional to the number of prior fever events: 79% at dose 2 with one prior episode; 44% and 74% at dose 3 with one and two prior episodes, respectively; and 29%, 45% and 60% at dose 4 with one, two and three prior episodes, respectively. Severity was not increased at recurrence and a similar pattern of recurrence risk proportional to the number of prior events was observed for other AEFIs.ConclusionsThe cumulative risk of AEFI is reduced with concomitant versus separate administration of 4CMenB and routine infant vaccines. Infants with a prior AEFI are at higher risk of the same AEFI at subsequent immunisations, but severity with recurrence is usually not increased.Trials registration numberNCT00657709,NCT00847145,NCT00721396andNCT02712177; Pre-results.
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Rakhmadhani, Irzal, Erna Yulida, Akhmad Fauzan, and Abdul Kadir Jaelani. "Adverse events following immunization Post Moderna (mRNA-1273) booster vaccination after two primary doses of CoronaVac." International journal of health sciences 6, no. 1 (February 6, 2022): 160–73. http://dx.doi.org/10.53730/ijhs.v6n1.3626.
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This study aims to investigate the prevalence of Adverse Events Following Immunization infection among health workers in the Hulu Sungai Utara Regency following two doses of CoronaVac. The study takes a descriptive research method. This research data is taken from two hundred fifty-eight individuals who indicated their willingness to participate in the study. 99 health workers (38.37%) had a history of AEFI at the first and second doses, with symptoms of malaise (36.36%), local pain (32.32%), and fever (22.22%) with an onset of 1–5 days (24.81%), and the majority did not require treatment (72.48 %). The study results showed that almost all health care professionals developed AEFI, both local and systemic, following the third immunization dosage. 257 health care workers (99.6 %) reported experiencing local AEFIs, with pain (95.35 %), swelling (37.60 %), and a red rash (37.60 %). Systemic AEFI was diagnosed in 239 health care workers (92.63 %), with the most common systemic reaction being arthralgia, myalgia (70.54 %), fever (62.02 %), and malaise (38.37 %). The response length was between 1 and 5 days (74.03 %), and 195 health workers (75.58 %) took NSAIDs to alleviate the reaction.
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Goswami, Shweta, Shefali Gupta, Mitasha Singh, and Ekta Gupta. "Adverse Events Following Pneumococcal Vaccination among Infants attending Immunization Clinic at a Tertiary Hospital in Northern India." Indian Journal of Community Health 32, no. 3 (September 30, 2020): 569–73. http://dx.doi.org/10.47203/ijch.2020.v32i03.018.
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Background: Pneumococcal conjugate vaccine (PCV-13) has been introduced in India in a phased manner. In Haryana it was introduced in 2017. The adverse events following immunization (AEFI) with PCV in real community setting are yet to be detected. Objective: To calculate the incidence and associated factors for various AEFI after pneumococcal vaccination at a tertiary centre of Faridabad, Haryana. Methodology: The descriptive observational study was conducted from April through October 2019 at the immunization centre of a tertiary care centre of Faridabad, Haryana. Each dose of PCV-13 given to the infants attending immunization centre was the study unit. A telephonic contact was done within 24 hours, after 48 hours and between 5-7 days to enquire about any adverse events (minor & major), if occurred. Results: A total of 135 PCV-13 doses were followed up for any AEFIs. 113 AEFIs (incidence: 67.3 per 100 dose) reported in 93 infants. Incidence of fever was 45 per 100 dose followed by tenderness and erythema (39 per 100 doses for each). Incidence of Swelling was 21 per 100 doses. Conclusion: Active surveillance and co administration of Pentavalent vaccine could have resulted in higher proportion of AEFIs.
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Channon-Wells, Samuel William, Emily Tough, Neda So, Daniel O'Connor, and Matthew D. Snape. "Differentiating vaccine reactions from invasive bacterial infections in young infants presenting to the emergency department in the 4CMenB era: a retrospective observational comparison." BMJ Paediatrics Open 6, no. 1 (October 2022): e001559. http://dx.doi.org/10.1136/bmjpo-2022-001559.
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BackgroundDifferentiating infants with adverse events following immunisation (AEFIs) or invasive bacterial infection (IBI) is a significant clinical challenge. Young infants post vaccination are therefore often admitted to the hospital for parenteral antibiotics to avoid missing rare cases of IBI.MethodsDuring a service evaluation project, we conducted a single-centre retrospective observational study of infants with IBI, urinary tract infection (UTI) or AEFI from two previously published cohorts. All patients presented to hospital in Oxfordshire, UK, between 2011 and 2018, spanning the introduction of the capsular group-B meningococcal vaccine (4CMenB) into routine immunisation schedules. Data collection from paper and electronic notes were unblinded. Clinical features, including National Institute for Health and Care Excellence (NICE) ‘traffic light’ risk of severe illness and laboratory tests performed on presentation, were described, and comparisons made using regression models, adjusting for age and sex. We also compared biochemical results on presentation to those of well infants post vaccination, with and without 4CMenB regimens.ResultsThe study included 232 infants: 40 with IBI, 97 with probable AEFI, 24 with possible AEFI, 27 with UTI and 44 post vaccination ‘well’ infants. C-reactive protein (CRP) was the only discriminatory blood marker, with CRP values above 83 mg/L only observed in infants with IBI or UTI. NICE risk stratification was significantly different between groups but still missed cases of IBI, and classification as intermediate risk was non-differential. Fever was more common in probable AEFI cases, while seizures and rashes were equally frequent. Diarrhoea and clinician-reported irritability or rigours were all more common in IBI.ConclusionsClinical features on presentation may aid risk stratification but cannot reliably differentiate IBI from AEFI in infants presenting to the emergency department. Blood results are generally unhelpful due to post vaccination inflammatory responses, particularly in children receiving 4CMenB vaccination. Improved biomarkers and clinical prediction tools are required to aid management in febrile infants post vaccination.
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Kaswandani, Nastiti, Sri Rezeki Hadinegoro, and Rulina Suradi. "Adverse events following immunization (AEFI) reports of extended program immunization (EPI) in Indonesia during 1998-2002." Paediatrica Indonesiana 44, no. 4 (October 10, 2016): 153. http://dx.doi.org/10.14238/pi44.4.2004.153-9.
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Background The incidence of adverse events following immuni-zation (AEFI) increased in correlation with the number of vaccinedoses. Meanwhile AEFI reports should be managed properly tomaintain the compliance and immunization coverage.Objectives The aims of this study were to investigate the inci-dence and profile of AEFI, its onset, severity, classification, andoutcome.Methods This study was a passive surveillance of AEFI reportsreceived by the National Committee on AEFI, Ministry of Health ofIndonesia, during 1998 to 2002.Results Two hundreds and four AEFI cases were reported; 4 casesas zero reports, 182 cases as individual reports, and 18 clusterreports. The AEFI incidence was 0.44 per 1 million doses of vac-cines. Vaccine reaction rate was 1 per 2.3 million vaccine doses.The most common vaccines reported as the causes of AEFI wereDTP, Polio, and TT. Among 182 reported cases, local or mild AEFIreactions were observed in 45, moderate in 49, and severe in 88.Based on WHO field classification, this study reported that 84 casesbelonged to coincidence, 72 to vaccine reactions, 13 to program-matic errors, 7 to injection reactions, and 6 to unclassified reac-tions. Forty-seven patients died, 12 had some sequelae, and 123completely recovered. Meanwhile, among the death cases, 70%occurred coincidently, 17% due to vaccine reactions, and 6 wereunclassified.Conclusions The incidence of AEFI in the extended program im-munization (EPI) in Indonesia during the period of 1998-2002 were182 cases, thus vaccine reaction rate was 1 per 2.3 million vac-cine doses. The most common vaccine which caused AEFI wasDTP. Most AEFI with severe symptoms happened in 4-24 hoursafter immunization.
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Bellavite, Paolo, and Alberto Donzelli. "Adverse events following measles-mumps-rubella-varicella vaccine: an independent perspective on Italian pharmacovigilance data." F1000Research 9 (September 28, 2020): 1176. http://dx.doi.org/10.12688/f1000research.26523.1.
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Vaccine surveillance programs are crucial for the analysis of the vaccine’s safety profile and the guidance of health policies. The Epidemiological Observatory of the Italian Apulia Region carried out an active surveillance program of adverse effects following immunization (AEFI) after the first dose of the measles-mumps-rubella-varicella (MMRV) vaccine, finding 462 AEFIs per 1000 doses, with 11% rated serious. Applying the World Health Organization (WHO) causality assessment algorithm, 38 serious AEFIs/1000 enrolled were classified as ‘consistent causal associations’ with MMRV immunization. Severe hyperpyrexia, neurological symptoms and gastrointestinal diseases occurred in 38, 20 and 15 cases/1000 enrolled, respectively. A projection of such AEFIs in an Italian birth cohort would give tens of thousands of serious AEFIs. These incidence data are much greater than the incidence of serious AEFIs reported by the Italian Medicines Agency (AIFA) for years 2017 and 2018, mainly based on passive (or mixed) pharmacovigilance. In a previous epidemiological study in the same Italian Region, during an eight year passive surveillance, the reporting rate of serious AEFI was 0.06/1000 doses, and no cases of febrile seizures were detected applying the WHO algorithm. Taken together, the data suggest that passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs and that current methods of assessing causality may be questioned. Active surveillance programs are required in representative population samples, with results presented separately from those of spontaneous reporting, and causality assessment should be performed carefully and using a correct technique for AEFIs presenting as complex and multifactorial diseases, like those with serious neurologic disorders.
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Bellavite, Paolo, and Alberto Donzelli. "Adverse events following measles-mumps-rubella-varicella vaccine: an independent perspective on Italian pharmacovigilance data." F1000Research 9 (January 6, 2021): 1176. http://dx.doi.org/10.12688/f1000research.26523.2.
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Vaccine surveillance programs are crucial for the analysis of the vaccine’s safety profile and the guidance of health policies. The Epidemiological Observatory of the Italian Apulia Region carried out an active surveillance program of adverse effects following immunization (AEFI) after the first dose of the measles-mumps-rubella-varicella (MMRV) vaccine, finding 462 AEFIs per 1000 doses, with 11% rated serious. Applying the World Health Organization (WHO) causality assessment algorithm, 38 serious AEFIs/1000 enrolled were classified as ‘consistent causal associations’ with MMRV immunization. Severe hyperpyrexia, neurological symptoms and gastrointestinal diseases occurred in 38, 20 and 15 cases/1000 enrolled, respectively. A projection of such AEFIs in an Italian birth cohort would give tens of thousands of serious AEFIs. These incidence data are much greater than the incidence of serious AEFIs reported by the Italian Medicines Agency (AIFA) for years 2017 and 2018, mainly based on passive (or mixed) pharmacovigilance. In a previous epidemiological study in the same Italian Region, during an eight year passive surveillance, the reporting rate of serious AEFI was 0.06/1000 doses, and no cases of febrile seizures were detected applying the WHO algorithm. Taken together, the data suggest that passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs and that current methods of assessing causality may be questioned. Active surveillance programs are required in representative population samples, with results presented separately from those of spontaneous reporting, and causality assessment should be performed carefully and using a correct technique for AEFIs presenting as complex and multifactorial diseases, like those with serious neurologic disorders.
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Varghese, Meera, Prathibha K, Saju R, and Jini P. "A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India." National Journal of Physiology, Pharmacy and Pharmacology 13, no. 5 (2022): 1. http://dx.doi.org/10.5455/njppp.2023.13.09462202202102022.
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Background: The World Health Organization had proclaimed the outbreak of the novel coronavirus (COVID-19) as a worldwide pandemic on March 11, 2020. Immunization against the disease was the need of the hour to curtail the spread of COVID-19 pandemic. Two vaccines manufactured in India were approved for emergency use authorization initially. They are ChAdox1CoV-19 vaccine – CoviShield and Covaxin. Aims and objectives: This study aimed at assessing the occurrence of adverse effects following immunization (AEFI) among individuals who received the CoviShield vaccine. The objective of this research was to evaluate the type of AEFI among vaccinated beneficiaries and to determine the factors contributing to the development of AEFI. Materials and Methods: A cross-sectional study was done at a teaching hospital in Kerala. All beneficiaries who were administered CoviShield vaccine during the study period, that is, from January 2021 to June 2022 were incorporated in the study. Data regarding AEFI were collected from all vaccinated individuals by direct or telephonic enquiry. Results: The incidence rate of AEFI is 4.5/1000 doses (111/24925 doses). The reporting of AEFI was high among age group of 20–30 years and commonly seen in males (97.3%). The most common AEFI reported with CoviShield vaccine was fever (63%), myalgia (51%), and headache (40%). AEFI was seen commonly after administration of first dose (94%). Only 7 cases (6.3%) of serious AEFI were reported which included death, autoimmune encephalitis, Bell’s palsy, hypotension, and hypersensitivity reactions. There was no significant association between age and type of AEFI (P > 0.05) and dose of vaccine and type of AEFI (P > 0.05). Conclusion: The immunization with CoviShield vaccine is safe among adults (>18 years) with lesser incidence of serious adverse effects. Higher incidence of AEFI is witnessed after administration of first dose and it was commonly seen in males.
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Mehmeti, Irsida, Silva Bino, Erida Nelaj, and Eugena Tomini. "AEFI Reporting Rates in Albania During 2008-2015: A Retrospective Analysis of AEFI Reporting Forms." European Journal of Interdisciplinary Studies 2, no. 4 (December 1, 2016): 62. http://dx.doi.org/10.26417/ejis.v2i4.p62-70.
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In Albania, passive AEFI surveillance is conducted by Institute of Public Health, which is under the supervision of Ministry of Health. Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Control of infectious disease department in the Institute of Public Health and recorded in a central database. In this study AEFI database is analysed for individual AEFI reporting forms during 2008-2015. AEFI reporting rates and their patterns were assessed. At 2003 a national standardized AEFI reporting form was introduced to the health-care workers who were obligated to report any observed AEFI. This form was changed and added more requisites in 2008 and nowadays this is the formal AEFI reporting form in Albania. Safe vaccines are essential to preserve high adherence to immunization programs¬ [1]. During the last years the reporting rate increased significantly due to implementation of enhanced vaccine safety reporting strategies but it is still low and underreporting remains one of the limits of passive surveillance. Reporting rates were calculated using as a denominator the administered doses of vaccines.
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Mehmeti, Irsida, Silva Bino, Erida Nelaj, and Eugena Tomini. "AEFI Reporting Rates in Albania During 2008-2015: A Retrospective Analysis of AEFI Reporting Forms." European Journal of Interdisciplinary Studies 6, no. 1 (December 1, 2016): 62. http://dx.doi.org/10.26417/ejis.v6i1.p62-70.
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In Albania, passive AEFI surveillance is conducted by Institute of Public Health, which is under the supervision of Ministry of Health. Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Control of infectious disease department in the Institute of Public Health and recorded in a central database. In this study AEFI database is analysed for individual AEFI reporting forms during 2008-2015. AEFI reporting rates and their patterns were assessed. At 2003 a national standardized AEFI reporting form was introduced to the health-care workers who were obligated to report any observed AEFI. This form was changed and added more requisites in 2008 and nowadays this is the formal AEFI reporting form in Albania. Safe vaccines are essential to preserve high adherence to immunization programs¬ [1]. During the last years the reporting rate increased significantly due to implementation of enhanced vaccine safety reporting strategies but it is still low and underreporting remains one of the limits of passive surveillance. Reporting rates were calculated using as a denominator the administered doses of vaccines.
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Jhaj, Ratinder, Deepa Chaudhary, Ajay K. Shukla, and Jayanthi Yadav. "Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines." Vaccines 10, no. 12 (December 13, 2022): 2133. http://dx.doi.org/10.3390/vaccines10122133.
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In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive. This retrospective observational study was conducted at a designated Regional Training Centre for Pharmacovigilance cum Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India. The data sources were stimulated spontaneous reports of Adverse Events Following Immunization (AEFI) due to the COVID-19 vaccines from 10 January to 31 December 2021. A total of 51,010 COVID vaccine doses were administered during the study period. There were 330 AEFI reported (AEFI rate: 0.65%). Six AEFI were serious events among which three were Adverse Events of Special Interest. The majority of the AEFI were systemic, reported after the first dose, and with an onset between 1 and 24 h after vaccination. On comparing Covishield and Covaxin, there were no statistically significant differences in the AEFI reported with either vaccine in terms of gender, seriousness, lag period, duration, recovery, causality, treatment received for AEFI, presence of co-morbidity, or history of COVID-19 infection. Overall, the rates of AEFI was uncommon, and serious AEFI were rare with both Covishield and Covaxin, with a higher rate after the first dose. Whether immunological tolerance or allayed anxiety was responsible for the lower AEFI risk with the second dose remains to be investigated.
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Laryea, Eunice Baiden, Joseph Asamoah Frimpong, Charles Lwanga Noora, John Tengey, Delia Bandoh, George Sabblah, Donne Ameme, Ernest Kenu, and Kwame Amponsa-Achiano. "Evaluation of the adverse events following immunization surveillance system, Ghana, 2019." PLOS ONE 17, no. 3 (March 1, 2022): e0264697. http://dx.doi.org/10.1371/journal.pone.0264697.
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Background With over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana’s Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system’s performance in meeting its objectives. Methods A case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use. We reviewed surveillance data and procedures for the period 2014 to 2018 and interviewed key stakeholders. Adapting the CDC’s Updated Guidelines for Evaluating Public Health Surveillance Systems, we assessed the system’s attributes and usefulness. We performed summary descriptive statistics on quantitative data and directed content analysis on information gathered from interviews. Results In all, 2,282 AEFI cases including 476 (21%) serious cases (life threatening events) were reported for the period. The highest case detection rates of 61.45 AEFIs per 100,000 surviving infants was recorded in 2018. Reporting forms were modified to accommodate new indicators without any disruption in the function of the system. At the national level, completeness of 100 randomly sampled reporting forms (100%) and was higher than the region (27%) but timeliness (50%) was lower than the region (83%). All (16/16) Community Health Nurses interviewed indicated “fear of being victimized” as the reason for underreporting, nonetheless, the system was useful as it made them cautious when vaccinating children to prevent reactions. Data on AEFI surveillance was also useful in guiding training needs and provision of vaccination logistics. Conclusion The AEFI surveillance system is useful at all levels but partially meeting its objective due to underreporting. We recommend training and supportive supervision to improve timeliness of reporting, data completeness and acceptability.
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Verma, Smita, Nirmal Verma, Neha Shrivastav, Swapnil V. Shinkar, Ashish Sahu, Bhupendra Kumar Sahu, Ankit Dewangan, Ankita Saha, and Nitish Sahu. "Assessment of knowledge about adverse events following immunization among health care workers of Raipur city." International Journal Of Community Medicine And Public Health 9, no. 1 (December 27, 2021): 187. http://dx.doi.org/10.18203/2394-6040.ijcmph20214994.
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Background: Vaccines used in national immunization programme are extremely safe and effective. Although, no vaccine is 100% safe and effective and adverse effects occurs. Process of immunization itself is potential source of adverse reactions. Knowledge and reporting of adverse events following immunization (AEFI) is very important for health care workers. Objective of this study is to assess knowledge about AEFI among health care workers.Methods: This cross-sectional study was conducted among health care workers of primary health care centres of Raipur City. All the ANM, Staff Nurse and MPWs posted in all the primary health centers of Raipur city (C.G.) were selected for the study. A pre designed pretested questionnaire was administered after taking verbal consent. Data was collected, compiled and analyzed in MS excel.Results: A total 157 health care workers participated in study. Mean age of the participants was 36.4±8.8. More than 80% participants knew vaccine product and vaccine quality defect-related reaction as possible causes of AEFI. 87.3% knew about swelling as commonest AFEI. The 59.9% had knowledge about management of common AEFI. 99.3% Health care workers knew anaphylaxis as one of severe AEFI and 91.08% were aware that AEFI should be reported.Conclusions: Majority of study participants had knowledge about possible causes of AEFI, minor and serious AEFI.
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Hu, Yu, Qian Li, Luoya Lin, Enfu Chen, Yaping Chen, and Xiaohua Qi. "Surveillance for Adverse Events following Immunization from 2008 to 2011 in Zhejiang Province, China." Clinical and Vaccine Immunology 20, no. 2 (December 12, 2012): 211–17. http://dx.doi.org/10.1128/cvi.00541-12.
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ABSTRACTThis study summarizes passive surveillance data for adverse events following immunization (AEFI) reported to the National AEFI Surveillance System (NASS) in Zhejiang province and describes reporting trends from 2008 to 2011. AEFI reporting rates were calculated using denominator data from the Individual Immunization Information System and the Zhejiang provincial Bureau of Statistics. A total of 6,265 AEFI records were reported; the overall reporting rate was 9.2 per 100,000 doses. There were two peaks of reporting rates, which were associated mainly with the introduction of the pandemic H1N1 influenza virus vaccine (pH1N1) in 2009 and the measles-mumps vaccine (MM) campaign in 2010. The majority of the AEFI described nonserious events. Fifteen deaths were recorded, but only one was possibly related to immunization. The most frequently reported reactions were fever and injection site reaction. Vaccines distributed in Zhejiang province have proven to be generally safe. The data on AEFI surveillance provide a reference point for ongoing reporting of trends and illustrate the value of the NASS database as a surveillance tool for monitoring of AEFI.
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Lee, Hankil, Hye-Young Kang, Sunghwa Cho, Seonyoung Park, Ah-Young Kim, Sun-Young Jung, Baik Lin Seong, and Young-Mock Lee. "Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome." Vaccines 8, no. 1 (February 24, 2020): 101. http://dx.doi.org/10.3390/vaccines8010101.
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South Korea operates a National Vaccine Injury Compensation Program (VICP) for people who experience adverse events following immunization (AEFI). To run this program rationally, it is a prerequisite to confirm whether adverse events were caused by immunization. Guillain–Barré syndrome (GBS), a severe neurological disease with limb pain and muscle weakness as cardinal symptoms, is attracting attention as an AEFI. However, algorithm or guidelines for assessing the causality between vaccination and the incidence of GBS are lacking. We aimed to develop guidelines for causality assessment of GBS as an AEFI and suggest using these guidelines in alignment with the VICP. We systematically searched for other previously published algorithms or guidelines and found a WHO-AEFI guideline used worldwide; however, it only provides general instructions and is not tailored to specific adverse events. We translated and locally adapted the structure of this guideline and then added contents related to GBS. The GBS-specific guideline consists of four steps: case ascertainment of GBS, checklist (including (1) order of incidence, (2) temporal proximity, (3) evidence for other causes and (4) published evidence), an algorithm, and final classification. We listed key information on confirming GBS and whether any other causes of GBS were present. For real world application of the guideline along with the VICP, we collaborated with a panel of neurologists, epidemiologic investigators, and committee members from the VICP. To ensure transparency and a scientific approach, regular updates and collaboration with neurologists are essential. We expect that this guideline will contribute to logical causality assessment and compensation decisions for GBS and will provide the basic structure for causality assessment of other AEFIs.
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García-Alanis, Mario, Marisa Morales-Cárdenas, Liz Nicole Toapanta-Yanchapaxi, Erwin Chiquete, Isaac Núñez, Santa Elizabeth Ceballos-Liceaga, Guillermo Carbajal-Sandoval, et al. "Psychological and Psychiatric Events Following Immunization with Five Different Vaccines against SARS-CoV-2." Vaccines 10, no. 8 (August 11, 2022): 1297. http://dx.doi.org/10.3390/vaccines10081297.
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Background: Despite the high number of vaccines administered against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) worldwide, the information on the psychological/psychiatric adverse events following immunization (AEFI) with these newly developed vaccines remains scarce. Objective: To describe the frequency of psychological/psychiatric symptoms among recipients of five different anti-SARS-CoV-2 vaccines and to explore the factors associated with their development reported in the nationwide Mexican registry of AEFI against SARS-CoV-2. Methods: Descriptive study of all the psychological/psychiatric symptoms, including anxiety, panic attacks, insomnia, and agitation reported to the Mexican Epidemiological Surveillance System from 21 December 2020 to 27 April 2021, among adult (≥18 years old) recipients of 7,812,845 doses of BNT162b2, ChAdOx1 nCov-19, rAd26-rAd5, Ad5-nCoV, or CoronaVac. The factors associated with their development are determined by multivariate regression analysis. Results: There were 19,163 AEFI reports during the study period; amongst them, 191 (1%) patients had psychological/psychiatric symptoms (median age of 41 years, interquartile range of 32–54; 149 [78%] women) for an observed incidence of 2.44 cases per 100,000 administered doses (95% confidence interval [CI] 2.12–2.82), 72.8% of psychiatric AEFIs were reported among recipients of BNT162b2. The median time from vaccination to symptom onset was 35 min (interquartile range: 10–720). Overall, the most common psychological/psychiatric symptoms were anxiety in 129 (67.5%) patients, panic attacks in 30 (15.7%), insomnia in 25 (13%), and agitation in 11 (5.7%). After adjusting for the confounding factors, the odds for developing psychological/psychiatric symptoms were higher for those concurrently reporting syncope (odds ratio [OR]: 4.73, 95% CI: 1.68–13.33); palpitations (OR: 2.47, 95% CI: 1.65–3.70), and dizziness (OR: 1.59, 95% CI: 1.10–2.28). Conclusion: In our population, psychological/psychiatric symptoms were extremely infrequent AEFIs. No severe psychiatric AEFIs were reported. Immunization stress-related responses might explain most of the detected cases.
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Devbhandari, Ranjan, Sumana Bajracharya, Sushant Aryal, Piyush Rajbhandari, Tripti Shakya, Mayuri Gupta, Shreyashi Tuladhar, Binnam Shakya, and Ashis Shrestha. "Adverse events following Pfizer-BioNTec vaccine against COVID-19 in population more than 12 years of age, Nepal." Journal of Patan Academy of Health Sciences 9, no. 1 (April 30, 2022): 5–11. http://dx.doi.org/10.3126/jpahs.v9i1.44273.
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Introduction: Pfizer-BioNTec vaccine was started in Nepal for the age group of more than 12 y. This study was conducted to find out the adverse event following immunization with Pfizer-BioNTech vaccine against COVID-19 at Patan Academy of Health Sciences (PAHS). Method: This is a descriptive study conducted at PAHS from November to December 2021. The vaccine recipients were called over the phone after 72 h of receiving the vaccine to find out adverse events following immunization (AEFI). They were inquired about the list of pre-defined AEFI. Ethical approval was obtained. Result: A total of 1377(27.4%) individuals among 5014 receiving the first dose and 983(71.4%) of 1377 receiving the second dose were enrolled in the study. Vaccine recipients who had minor AEFI in the first dose were 462(33.6%) and in the second dose were 205(20.9%). Reported AEFI in both first and second dose was pain 377(27.4%) and 97(9.9%) respectively, followed by fever in 65(4.8%) and 91(9.3%) respectively. There were no severe AEFI reported in both doses of vaccination. The AEFI started within 24 h and subsided within 72 h. Conclusion: Minor AEFI of pain and fever was reported with the first and second dose of the Pfizer-BioNTech vaccine. There were no severe and serious AEFI reported in this study population.
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Kumar, Vinay, Vandana Kashyap, and A. G. Shenoy. "The occurrence of adverse events following immunization after first and/or second dose of Covishield or Covaxin vaccine at a tertiary care hospital: An observational study." International Journal Of Community Medicine And Public Health 9, no. 3 (February 28, 2022): 1416. http://dx.doi.org/10.18203/2394-6040.ijcmph20220705.
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Background: With the introduction of the COVID-19 vaccine, many cities of India are reporting minor, mild, and severe AEFI cases during half an hour of observation and after that. No vaccine can protect everyone receiving it and is safe too for everyone. Effective vaccines could produce a few unwanted side effects mainly mild and clear up frequently.Methods: After the COVID-19 vaccination, everyone was asked to wait for 30 minutes in the observation room to check for any type of AEFI. While waiting, all second dose beneficiaries were asked to fill a printed case record form with all demographic details, including AEFI events experienced after their first dose of the COVID-19 vaccine. Phone calls were made to all 500 beneficiaries after seven days of vaccination to know about the type of AEFI experienced after the second dose.Results: Safety of product is of paramount importance and in this study, we actively captured adverse events post-vaccination. Fever, headache, weakness, body pain, were the most common adverse events along with pain at the injection site. In our study, the younger age group was associated with minor AEFIs. However, we did not find any supporting evidence for high reactogenicity among women, and this may be due to an almost similar proportion of men and women in our sample.Conclusions: The advantages of immunization in disease prevention have significantly exceeded the risks of immunization-associated adverse events. COVID vaccines have their largest potential to end the COVID-19 pandemic if they are widely accepted and used. As we all want to get rid of the diseases which are not curable easily and spread with very large intensity, now is the time to get vaccinated and control them.
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Lv, Huakun, Xuejiao Pan, Hui Liang, Yaping Chen, Ying Wang, Fuxing Chen, Linzhi Shen, and Yu Hu. "A Comparison with Adverse Events Following Immunization Associated with Sabin-Strains and Salk-Strains Inactivated Polio Vaccines in Zhejiang Province, China." Vaccines 10, no. 2 (February 17, 2022): 319. http://dx.doi.org/10.3390/vaccines10020319.
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Objectives: One dose of Sabin-strains inactivated polio vaccine (IPV) was introduced into the Chinese immunization program on 1 May 2016. This study aimed to evaluate the safety of Sabin-strains IPV and provide a comparison with conventional Salk-strains IPV. Methods: Adverse events following immunization (AEFI) records associated with Sabin-strains IPV and Salk-strains IPV were extracted from the national AEFI surveillance system (NAEFISS) from 1 May 2016 to 31 December 2020. The vaccination information on Sabin-strains IPV and Salk-strains IPV during the same period was obtained from the Zhejiang provincial immunization information system. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories and were compared between Sabin-strains IPV and Salk-strains IPV. Results: In total, 3,861,758 doses of Sabin-strains IPV and 1,018,604 doses of Salk-strains IPV were administered during the study period. The overall AEFI reporting rate for Sabin-strains IPV (3.96/10,000 doses) was significantly lower than that for Salk-strains IPV (5.03/10,000 doses) due to the reporting rate of the minor vaccine product-related reaction following Sabin-strains IPV was significantly lower than that for Salk-strains IPV (2.76/10,000 doses vs. 3.83/10,000 doses). The most frequently reported symptoms/signs were fever, induration/swelling, and rash/urticaria. The most frequently reported serious AEFI with a causal relationship was febrile convulsion, with the reporting rates of 0.10/10,000 doses for Sabin-strains IPV and 0.08/10,000 doses for Salk-strains IPV. No significant difference was found in the reporting rates of the other serious AEFI between the two types of IPV. Conclusion: Most of the AEFI following Sabin-strains IPV and Salk-strains IPV were mild and common adverse reactions. The reporting rate of serious AEFI was not significantly different between Sabin-strains IPV and Salk-strains IPV. Sabin-strains IPV had a favorable safety profile and could be widely used.
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Shivangna Singh, Suchi Jain, Bushra Hasan Khan, Vivek Gautam, and Mayank Batola. "Assessment of adverse events following first dose of COVISHIELD in healthcare workers of a tertiary care hospital in western Uttar Pradesh: A prospective observational study." Asian Journal of Medical Sciences 13, no. 5 (May 3, 2022): 18–22. http://dx.doi.org/10.3126/ajms.v13i5.43014.
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Background: COVID‑19 pandemic is a great health challenge around the world. Immunization appears best preventive strategy where monitoring the safety of COVID-19 vaccines is immensely important as limited safety data available on them. Aims and Objectives: This study was conducted to perform safety surveillance and causality assessment of adverse events following immunization (AEFI) with COVID-19 vaccine. Materials and Methods: This prospective observational study was conducted on healthcare workers who received their first dose of COVISHIELD during first phase of COVID-19 vaccination in January–February 2021 at F.H. Medical College and Hospital, Tundla, Firozabad. Approval for the study was taken from institutional ethical committee. The details of AEFIs were collected and duly noted in standard AEFI case reporting form of Ministry Of Health And Family Welfare, Immunization Division, Govt. of India and reported to District Immunization Officer. Causality assessment was done in accordance with protocol of the World Health Organization. Results: Out of 419 vaccinees, 210 had developed AEFIs, and 527 AEFIs were reported considering the fact that one recipient could have experienced multiple AEFIs. Majority AEFIs were related to general disorders and administration site conditions (67.35%), where fever (28.46%), chills (16.69%),and pain at injection site (15.75%) were more common, followed by musculoskeletal and connective tissue disorders (19.55%) where myalgia (18.03%) was more commonly reported. Out of 527 AEFIs reported, majority (524, 99.43%) showed consistent causal association to immunization and 3 (0.57%) AEFIs showed inconsistent association. AEFIs classified as consistent causal association (524) mostly were vaccine product related reactions (520, 99.23%) and rest (4, 0.76%) were immunization anxiety related reactions. Severity assessment of AEFIs was done using Modified Hartwig and Siegel Severity Scale, out of total 527 AEFIs reported 60.9% were of mild severity and rest 39.1% were categorized as moderate severity. Conclusion: As adverse events post-vaccination with COVISHIELD were mild to moderate in severity and lasted for a short duration, the inconvenience caused by these AEFIs outweigh the protection offered by the vaccination against COVID-19.
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Subedi, Prativa, Gopal Kumar Yadav, Binod Paudel, Anu Regmi, and Prajjwal Pyakurel. "Adverse events following the first dose of Covishield (ChAdOx1 nCoV-19) vaccination among health workers in selected districts of central and western Nepal: A cross-sectional study." PLOS ONE 16, no. 12 (December 21, 2021): e0260638. http://dx.doi.org/10.1371/journal.pone.0260638.
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Introduction The study aimed at exploring the adverse events following immunization (AEFI) and their incidences among health workers in three different districts of central and western Nepal following the first dose of Covishield vaccine,. It also aimed at studying the association of AEFI with demographic and clinical characteristics of vaccinees, pre-vaccination anxiety level and prior history of COVID-19 infection (RT- PCR confirmed) status. Materials and methods This was a cross-sectional study carried out via face-to-face or telephonic interview among 1006 health workers one week after receiving their first dose of the Covishield vaccine. Incidence of adverse events was calculated in percentage while Chi-square Test was used to check the association of AEFI with independent variables. Logistic regression was used to find out the adjusted odd’s ratio at 95% CI. Results Incidence of AEFI was 79.8% with local and systemic AEFI being 68.0% and 59.7% respectively. Injection site tenderness was the commonest manifestation. Local and systemic symptoms resolved in less than one week among 96.8% and 98.7% vaccinees respectively. Females were more likely to develop AEFI than males (AOR = 1.7, 95% CI = 1.2–2.4). Vaccinees aged 45–59 years were 50% less likely to develop AEFI as compared to those aged less than 30 years (AOR 0.5, 95% CI = 0.3–0.8). Most of the vaccinees had not undergone RT-PCR testing for COVID-19 (59.8%). Those who were not tested for COVID-19 prior were 1.5 odds more likely to develop AEFI compared to those who were negative (AOR = 1.5, 95% CI = 1.1–2.1). Conclusion More than two-third of the vaccinees developed one or more forms of adverse events, but most events were self-limiting. Females and young adults were more prone to develop AEFI.
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Ferrara, Pietro, Domenico Ponticelli, Lorenzo Losa, Claudia Romeo, Roberto Magliuolo, Andrea Vitale, Anna Zampella, et al. "Risk of Repeated Adverse Effects following Booster Dose of mRNA COVID-19 Vaccine: Results from the MOSAICO Study." Vaccines 11, no. 2 (January 22, 2023): 247. http://dx.doi.org/10.3390/vaccines11020247.
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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.
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Seo, Chi Yon, Mohammed Rashid, Tara Harris, Jody Stapleton, and Shelley L. Deeks. "Assessing safety of Ontario’s publicly funded MMR and MMRV immunization programs, 2012 to 2016." Paediatrics & Child Health 25, no. 6 (April 8, 2019): 358–64. http://dx.doi.org/10.1093/pch/pxz037.
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Abstract Background The combined measles, mumps, rubella (MMR) and measles, mumps, rubella, and varicella (MMRV) vaccines are part of Ontario’s routine immunization schedule. Objective To assess adverse events following immunization (AEFIs) reported in Ontario following administration of MMR and MMRV vaccines between 2012 and 2016. Methods Reports of AEFIs were extracted from the provincial surveillance database on May 9, 2017. Events were grouped by provincial surveillance definitions. Reporting rates were calculated using provincial population estimates or net doses distributed as the denominator. A serious AEFI is defined as an AEFI that resulted in an in-patient hospitalization or death. Results Overall, 289 AEFIs were reported following administration of MMR (n=246) or MMRV (n=43) vaccines, for annualized reporting rates of 16.6 and 8.8 reports per 100,000 distributed doses, respectively. The highest age-specific reporting rate was in children aged 1 to 3 years for MMR (7.7 per 100,000 population) and children aged 4 to 9 years for MMRV (0.8 per 100,000 population). Systemic reactions were the most frequently reported event category, while rash was the most frequently reported event for both vaccines. There were 22 serious AEFIs, 19 following MMR and 3 following MMRV (1.3 and 0.6 per 100,000 doses distributed, respectively). Conclusions Our assessment found a low reporting rate of adverse events following MMR and MMRV vaccines in Ontario. No safety concerns were identified. Our findings are consistent with the safety profiles of these vaccines. Continued monitoring of vaccine safety is necessary to maintain timely detection of unusual postvaccine events and public confidence in vaccine safety.