scholarly journals Adverse events following immunization (AEFI) reports of extended program immunization (EPI) in Indonesia during 1998-2002

2016 ◽  
Vol 44 (4) ◽  
pp. 153
Author(s):  
Nastiti Kaswandani ◽  
Sri Rezeki Hadinegoro ◽  
Rulina Suradi
Keyword(s):  
Adverse Events ◽  
Reaction Rate ◽  
National Committee ◽  
Passive Surveillance ◽  
Ministry Of Health ◽  
Severity Classification ◽  
Reac Tions ◽  
Extended Program ◽  
Death Cases

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.

scholarly journals Passive surveillance of vaccine adverse events: need for standardized severity classification

2015 ◽  
Vol 25 (suppl_3) ◽  
Author(s):  
L Borsari ◽  
MG Gatti ◽  
E Bottosso ◽  
MG Pascucci ◽  
L Osbello ◽  
...  
Keyword(s):  
Adverse Events ◽  
Passive Surveillance ◽  
Severity Classification

scholarly journals Gastrointestinal Events in High-Dose vs Standard-Dose Influenza Vaccine Recipients

2018 ◽  
Vol 5 (6) ◽  
Author(s):  
H Keipp Talbot ◽  
Andrew J Dunning ◽  
Corwin A Robertson ◽  
Victoria A Landolfi ◽  
David P Greenberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Randomized Clinical Trial ◽  
Standard Dose ◽  
High Dose ◽  
Passive Surveillance ◽  
Prospective Randomized Clinical Trial ◽  
Gastrointestinal Events ◽  
Gastrointestinal Adverse Events

Abstract Passive surveillance data had signaled the possibility of gastrointestinal adverse events occurring after the administration of high-dose inactivated influenza vaccine (IIV-HD). However, in a large, prospective randomized clinical trial, rates of serious gastrointestinal events were no greater among IIV-HD recipients than among those who received a standard-dose influenza vaccine.

scholarly journals Risk of Fatal Adverse Events after H1N1 Influenza Vaccine: Limitations of Passive Surveillance Data

2010 ◽  
Vol 51 (7) ◽  
pp. 871-872 ◽  
Author(s):  
Michael M. McNeil ◽  
Karen R. Broder ◽  
Claudia Vellozzi ◽  
Frank DeStefano
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
H1n1 Influenza ◽  
Surveillance Data ◽  
Passive Surveillance ◽  
Fatal Adverse Events

Active and passive surveillance of yellow fever vaccine 17D or 17DD-associated serious adverse events: Systematic review

Vaccine ◽  
2011 ◽  
Vol 29 (28) ◽  
pp. 4544-4555 ◽  
Author(s):  
Roger E. Thomas ◽  
Diane L. Lorenzetti ◽  
Wendy Spragins ◽  
Dave Jackson ◽  
Tyler Williamson
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Yellow Fever ◽  
Yellow Fever Vaccine ◽  
Passive Surveillance ◽  
Serious Adverse Events

Bacillus Calmette-Guérin (BCG) Vaccine Adverse Events in Victoria, Australia: Analysis of Reports to an Enhanced Passive Surveillance System

Drug Safety ◽  
2014 ◽  
Vol 38 (1) ◽  
pp. 79-86 ◽  
Author(s):  
Hazel J. Clothier ◽  
Laine Hosking ◽  
Nigel W. Crawford ◽  
Melissa Russell ◽  
Mee Lee Easton ◽  
...  
Keyword(s):  
Adverse Events ◽  
Surveillance System ◽  
Bcg Vaccine ◽  
Bacillus Calmette Guerin ◽  
Passive Surveillance ◽  
Passive Surveillance System

scholarly journals Expert consensus on a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation: protocol for an international e-Delphi study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e050219
Author(s):  
Martha Funabashi ◽  
Katherine A Pohlman ◽  
Lindsay M Gorrell ◽  
Stacie A Salsbury ◽  
Andrea Bergna ◽  
...  
Keyword(s):  
Adverse Events ◽  
Scoping Review ◽  
Classification System ◽  
Delphi Study ◽  
Best Practice ◽  
Descriptive Analysis ◽  
Research Priorities ◽  
Steering Committee ◽  
Eligibility Criteria ◽  
Severity Classification

IntroductionSpinal and peripheral joint manipulation (SMT) and mobilisation (MOB) are widely used and recommended in the best practice guidelines for managing musculoskeletal conditions. Although adverse events (AEs) have been reported following these interventions, a clear definition and classification system for AEs remains unsettled. With many professionals using SMT and MOB, establishing consensus on a definition and classification system is needed to assist with the assimilation of AEs data across professions and to inform research priorities to optimise safety in clinical practice.Methods and analysisThis international multidisciplinary electronic Delphi study protocol is informed by a scoping review and in accordance with the ‘Guidance on Conduction and Reporting Delphi Studies’. With oversight from an expert steering committee, the study comprises three rounds using online questionnaires. Experts in manual therapy and patient safety meeting strict eligibility criteria from the following fields will be invited to participate: clinical, medical and legal practice, health records, regulatory bodies, researchers and patients. Round 1 will include open-ended questions on participants’ working definition and/or understanding of AEs following SMT and MOB and their severity classification. In round 2, participants will rate their level of agreement with statements generated from round 1 and our scoping review. In round 3, participants will rerate their agreement with statements achieving consensus in round 2. Statements reaching consensus must meet the a priori criteria, as determined by descriptive analysis. Inferential statistics will be used to evaluate agreement between participants and stability of responses between rounds. Statements achieving consensus in round 3 will provide an expert-derived definition and classification system for AEs following SMT and MOB.Ethics and disseminationThis study was approved by the Canadian Memorial Chiropractic College Research Ethics Board and deemed exempt by Parker University’s Institutional Review Board. Results will be disseminated through scientific, professional and educational reports, publications and presentations.

On the protection of infancy in Western Europe

1926 ◽  
Vol 22 (5-6) ◽  
pp. 723-729
Author(s):  
Ye. M. Lepskiy
Keyword(s):  
Child Welfare ◽  
Young Children ◽  
Western Europe ◽  
League Of Nations ◽  
National Committee ◽  
Older Children ◽  
Ministry Of Health ◽  
European Institutions ◽  
Central Council ◽  
Long Time

In the fall of 1925, thanks to the assistance of the NCH and the Hygienic Section of the League of Nations, I got the opportunity to visit a number of Western European institutions for children. Since I had relatively little time at my disposal - only 2 months - I decided to limit my task and get acquainted only with institutions for young children, leaving aside institutions for older children, school hygiene issues, etc. Thanks to the letters with which I supplied the Hygienic Section to the relevant central bodies in England, Germany and France, namely the Central Council for the Protection of Mothers and Infants and the Ministry of Health in London, the Ministry of Health (Reichsgesundheitsamt) in Berlin and the National Committee for Child Welfare and the National Committee for the Protection of tbc in Paris, I could get acquainted both with the institutions that interested me for a long time, and with other show institutions, which were indicated to me by the named organizations.

scholarly journals Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study (Preprint)

2018 ◽  
Author(s):  
Simon de Lusignan ◽  
Ana Correa ◽  
Gaël Dos Santos ◽  
Nadia Meyer ◽  
François Haguinet ◽  
...  
Keyword(s):  
General Practice ◽  
Adverse Events ◽  
Influenza Vaccination ◽  
Data Entry ◽  
European Medicines Agency ◽  
Passive Surveillance ◽  
Electronic Health Record Data ◽  
Practice Population ◽  
Main Period ◽  
Events Data

BACKGROUND The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EMA sets out 3 different ways to conduct such surveillance: (1) active surveillance, (2) enhanced passive surveillance, or (3) electronic health record data mining (EHR-DM). English general practice (GP) is a suitable setting to implement enhanced passive surveillance and EHR-DM. OBJECTIVE This study aimed to test the feasibility of conducting enhanced passive surveillance in GP using the yellow card scheme (adverse events of interest reporting cards) to determine if it has any advantages over EHR-DM alone. METHODS A total of 9 GPs in England participated, of which 3 tested the feasibility of enhanced passive surveillance and the other 6 EHR-DM alone. The 3 that tested EPS provided patients with yellow (adverse events) cards for patients to report any adverse events. Data were extracted from all 9 GPs’ EHRs between weeks 35 and 49 (08/24/2015 to 12/06/2015), the main period of influenza vaccination. We conducted weekly analysis and end-of-study analyses. RESULTS Our GPs were largely distributed across England with a registered population of 81,040. In the week 49 report, 15,863/81,040 people (19.57% of the registered practice population) were vaccinated. In the EPS practices, staff managed to hand out the cards to 61.25% (4150/6776) of the vaccinees, and of these cards, 1.98% (82/4150) were returned to the GP offices. Adverse events of interests were reported by 113 /7223 people (1.56%) in the enhanced passive surveillance practices, compared with 322/8640 people (3.73%) in the EHR-DM practices. CONCLUSIONS Overall, we demonstrated that GPs EHR-DM was an appropriate method of enhanced surveillance. However, the use of yellow cards, in enhanced passive surveillance practices, did not enhance the collection of adverse events of interests as demonstrated in this study. Their return rate was poor, data entry from them was not straightforward, and there were issues with data reconciliation. We concluded that customized cards prespecifying the EMA’s adverse events of interests, combined with EHR-DM, were needed to maximize data collection. INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2016-015469

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