المؤلفون: Nguyen, Minh Tam H, Krause, Gérard, Keller-Stanislawski, Brigitte, Glöckner, Stephan, Mentzer, Dirk, Ott, Jördis J

المصدر: JMIR mHealth and uHealth, Vol 9, Iss 5, p e26289 (2021)

مصطلحات موضوعية: Information technology, T58.5-58.64, Public aspects of medicine, RA1-1270

الوصف: BackgroundFor 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. ObjectiveThe 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. MethodsWe 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. ResultsOf 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). ConclusionsDigital 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.

وصف الملف: electronic resource

العلاقة: https://mhealth.jmir.org/2021/5/e26289Test; https://doaj.org/toc/2291-5222Test

الوصول الحر: https://doaj.org/article/6be4b4b4fa8a459f8730ec05d3dbd8b1Test

المؤلفون: Rolfs, Nele, Huber, Cynthia, Schwarzkopf, Eicke, Mentzer, Dirk, Keller-Stanislawski, Brigitte, Opgen-Rhein, Bernd, Frede, Wiebke, Rentzsch, Axel, Hecht, Tobias, Boehne, Martin, Grafmann, Maria, Kiski, Daniela, Graumann, Iva, Foth, Rudi, Voges, Inga, Schweigmann, Ulrich, Ruf, Bettina, Fischer, Marcus, Wiegand, Gesa, Klingel, Karin, Pickardt, Thomas, Friede, Tim, Messroghli, Daniel, Schubert, Stephan, Seidel, Franziska

المساهمون: Berliner Sparkassenstiftung Medizin, Fördergemeinschaft Deutsche Kinderherzzentren eV

المصدر: American Heart Journal ; volume 267, page 101-115 ; ISSN 0002-8703

مصطلحات موضوعية: Cardiology and Cardiovascular Medicine

الإتاحة: https://doi.org/10.1016/j.ahj.2023.11.006Test
https://api.elsevier.com/content/article/PII:S0002870323003150?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0002870323003150?httpAccept=text/plainTest

المؤلفون: Rolfs, Nele, Huber, Cynthia, Schwarzkopf, Eicke, Mentzer, Dirk, Keller-Stanislawski, Brigitte, Opgen-Rhein, Bernd, Frede, Wiebke, Rentzsch, Axel, Hecht, Tobias, Boehne, Martin, Seidel, Franziska

المساهمون: Rolfs, Nele, Huber, Cynthia, Schwarzkopf, Eicke, Mentzer, Dirk, Keller-Stanislawski, Brigitte, Opgen-Rhein, Bernd, Frede, Wiebke, Rentzsch, Axel, Hecht, Tobias, Boehne, Martin, Seidel, Franziska

الوصف: http://dx.doi.org/10.13039/501100006755Test Berliner Sparkassenstiftung Medizin ; http://dx.doi.org/10.13039/501100003094Test Fördergemeinschaft Deutsche Kinderherzzentren eV

العلاقة: https://resolver.sub.uni-goettingen.de/purl?gro-2/139304Test; S0002870323003150

الإتاحة: https://doi.org/10.1016/j.ahj.2023.11.006Test
https://resolver.sub.uni-goettingen.de/purl?gro-2/139304Test

المؤلفون: Orru', Stefano, Bierbaum, Sibylle, Enk, Alexander Herrmann, Hengel, Hartmut, Hoffelner, Marcus, Huzly, Daniela, Keller-Stanislawski, Brigitte, Mahler, Vera, Mockenhaupt, Maja, Oberle, Doris

المصدر: Eurosurveillance. - 28, 50 (2023) , 2300261, ISSN: 1560-7917

الوصف: Background Shortly after the launch of a novel adjuvanted recombinant zoster vaccine (RZV), Shingrix, cases of suspected herpes zoster (HZ) or zoster-like skin reactions following immunisation were reported. Aim We aimed to investigate if these skin manifestations after administration of RZV could be HZ. Methods Between April and October 2020, general practitioners (GP) reporting a suspected case of HZ or zoster-like skin manifestation after RZV vaccination to the Paul-Ehrlich-Institut, the German national competent authority, were invited to participate in the study. The GP took a sample of the skin manifestation, photographed it and collected patient information on RZV vaccination and the suspected adverse event. We analysed all samples by PCR for varicella-zoster virus (VZV) and herpes-simplex virus (HSV) and genotyped VZV-positive samples. In addition, cases were independently assessed by two dermatologists. Results Eighty eligible cases were enrolled and 72 could be included in the analysis. Of the 72 cases, 45 were female, 33 were 60–69 years old, 32 had skin symptoms in the thoracic and 27 in the cervical dermatomes. Twenty-seven samples tested PCR positive for VZV (all genotyped as wild-type, WT), three for HSV-1 and five for HSV-2. Conclusion It may be difficult to distinguish HZ, without a PCR result, from other zoster-like manifestations. In this study, VZV-PCR positive dermatomal eruptions occurring in the first weeks after immunisation with RZV were due to WT VZV, which is not unexpected as HZ is a common disease against which the vaccine is unlikely to provide full protection at this time.

وصف الملف: pdf

العلاقة: https://freidok.uni-freiburg.de/data/242313Test

الإتاحة: https://doi.org/10.2807/1560-7917.es.2023.28.50.2300261Test
https://freidok.uni-freiburg.de/data/242313Test
https://nbn-resolving.org/urn:nbn:de:bsz:25-freidok-2423138Test
https://freidok.uni-freiburg.de/dnb/download/242313Test

المؤلفون: Bergner, Simone, Grüger, Thomas, Huber, Martin, Lütkehermölle, Walburga, Paeschke, Norbert, Palissa, Harriet, Stephan, Kerstin, Cibura, Sabine, Keller-Stanislawski, Brigitte

المصدر: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 65(5):567-576

مصطلحات موضوعية: Arzneimittel, Risikokommunikation, Pharmacovigilance, Arzneimittelbehörden, Impfstoffe, Medicinal products, Vaccines, Drug regulatory agencies, Risk communication, Pharmakovigilanz

الوصف: Active communication of authorities, such as the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), including maintenance of contacts with health care professionals, as well as press and public relations work, are essential prerequisites for ensuring that information on the risks of using medicinal products reaches both affected patients and healthcare professionals quickly and in a targeted manner. The various instruments of targeted communication describe possible risks and also contain recommendations that help to reduce the risk of using a medicinal product. The supplementary public relations work aims to make the tasks and objectives of the authority known to the public and to experts with the goal of creating and expanding trust in the actions of the authorities. To this end, appropriate communication platforms must be established and accepted so that they are used by both experts and the general public and the authority is perceived and appreciated as a reliable source of risk information. The currently available instruments of targeted risk communication, such as Dear Health Care Professional Communication (DHPC), risk management plans, and educational materials are described in this paper as well as broader communication on official websites or towards the media. Finally, PEI’s risk communication is highlighted with particular reference to COVID-19 vaccines. ; Die aktive Kommunikation von Behörden, wie dem Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und dem Paul-Ehrlich-Institut (PEI), einschließlich der Kontaktpflege zu Fachkreisen sowie Presse- und Öffentlichkeitsarbeit sind wesentliche Voraussetzung dafür, dass Informationen zu Anwendungsrisiken von Arzneimitteln sowohl betroffene Patientinnen und Patienten als auch Angehörige der Heilberufe schnell und gezielt erreichen. Die verschiedenen Instrumente der gezielten Kommunikation beschreiben mögliche Risiken und enthalten darüber hinaus auch Empfehlungen, die helfen, das Anwendungsrisiko eines ...

العلاقة: https://repository.publisso.de/resource/frl:6433647Test; https://doi.org/10.1007/s00103-022-03527-wTest; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9039600Test/

الإتاحة: https://doi.org/10.1007/s00103-022-03527-wTest
https://repository.publisso.de/resource/frl:6433647Test
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9039600Test/

المؤلفون: Kehr, Sarah, Berg, Philipp, Müller, Susanne, Fiedler, Sarah A., Meyer, Britta, Ruppert-Seipp, Gabriele, Witzenhausen, Cornelia, Wolf, Marc E., Henkes, Hans H., Oberle, Doris, Keller-Stanislawski, Brigitte, Funk, Markus B.

المصدر: npj Vaccines ; volume 7, issue 1 ; ISSN 2059-0105

مصطلحات موضوعية: Pharmacology (medical), Infectious Diseases, Pharmacology, Immunology

الوصف: We present the long-term outcomes of 44 patients who developed cerebral venous sinus thrombosis after vaccination with the adenoviral vector ChAdOx1 nCoV-19 COVID-19 vaccine. Assessment of the Extended Glasgow Outcome Scale was performed within 3–6 months after the initial hospital admissions. Patient outcomes ranged from good recovery (13 patients, 29.6%) to moderate disability (11 patients, 25.0%) and severe disability or vegetative state (6 patients, 13.6%). Fatal outcomes were reported in 14 patients (31.8%).

الإتاحة: https://doi.org/10.1038/s41541-022-00491-zTest
https://www.nature.com/articles/s41541-022-00491-z.pdfTest
https://www.nature.com/articles/s41541-022-00491-zTest

المؤلفون: Thiele, Thomas, Weisser, Karin, Schönborn, Linda, Funk, Markus B., Weber, Gabriele, Greinacher, Andreas, Keller-Stanislawski, Brigitte

المساهمون: Deutsche Forschungsgemeinschaft, Pfizer, Daiichi-Sankyo, Boehringer Ingelheim, Novo Nordisk, Bristol-Myers Squibb, Chugai Pharmaceutical

المصدر: The Lancet Regional Health - Europe ; volume 12, page 100270 ; ISSN 2666-7762

مصطلحات موضوعية: Health Policy, Oncology, Internal Medicine

الإتاحة: https://doi.org/10.1016/j.lanepe.2021.100270Test
https://api.elsevier.com/content/article/PII:S2666776221002568?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2666776221002568?httpAccept=text/plainTest

المؤلفون: Koch, Judith, Vygen-Bonnet, Sabine, Bogdan, Christian, Burchard, Gerd, Garbe, Edeltraut, Heininger, Ulrich, Hummers, Eva, Keller-Stanislawski, Brigitte, Von Kries, Rüdiger, Ledig, Thomas, Littmann, Martina, Meerpohl, Joerg, Mertens, Thomas, Oberle, Doris, Röbl-Mathieu, Marianne, Van Der Sande, Marianne, Terhardt, Martin, Überla, Klaus, Wichmann, Ole, Wicker, Sabine, Wiedermann-Schmidt, Ursula, Widders, Gudrun, Zepp, Fred, Ständige Impfkommission (STIKO)

المساهمون: Koch, Judith, Vygen-Bonnet, Sabine, Bogdan, Christian, Burchard, Gerd, Garbe, Edeltraut, Heininger, Ulrich, Hummers, Eva, Keller-Stanislawski, Brigitte, Von Kries, Rüdiger, Ledig, Thomas, Littmann, Martina, Meerpohl, Joerg, Mertens, Thomas, Oberle, Doris, Röbl-Mathieu, Marianne, Van Der Sande, Marianne, Terhardt, Martin, Überla, Klaus, Wichmann, Ole, Wicker, Sabine, Wiedermann-Schmidt, Ursula, Widders, Gudrun, Zepp, Fred, Ständige Impfkommission (STIKO)

الوصف: Seit dem Frühjahr 2021 ist bekannt, dass im Zusammenhang mit der Anwendung der mRNA-Impfstoffe Comirnaty und Spikevax insbesondere bei Jungen und jungen Männern Myo- und/oder Perikarditiden auftreten können. Aufgrund dieser Berichte hat die STIKO ihre Empfehlung zur COVID-19-Impfung mit Spikevax und Comirnaty überprüft und auf der Basis aktueller Daten die im Epidemiologischen Bulletin 46/2021 veröffentlichte erneute Risiko-Nutzen-Analyse durchgeführt.

العلاقة: https://resolver.sub.uni-goettingen.de/purl?gro-2/140186Test

الإتاحة: https://doi.org/10.25646/9278Test
https://resolver.sub.uni-goettingen.de/purl?gro-2/140186Test

المؤلفون: Vygen-Bonnet, Sabine, Hellenbrand, Wiebke, Garbe, Edeltraut, Röbl-Mathieu, Marianne, von Kries, Rüdiger, Bogdan, Christian, Heininger, Ulrich, Keller- Stanislawski, Brigitte, Hummers-Pradier, Eva, Harder, Thomas, AG Pertussis der Ständigen Impfkommission (STIKO)

المساهمون: Vygen-Bonnet, Sabine, Hellenbrand, Wiebke, Garbe, Edeltraut, Röbl-Mathieu, Marianne, von Kries, Rüdiger, Bogdan, Christian, Heininger, Ulrich, Keller- Stanislawski, Brigitte, Hummers-Pradier, Eva, Harder, Thomas, AG Pertussis der Ständigen Impfkommission (STIKO)

الوصف: Die STIKO empfiehlt die Impfung gegen Pertussis für schwangere Frauen zu Beginn des 3. Trimenons. Bei erhöhter Wahrscheinlichkeit für eine Frühgeburt sollte die Impfung ins 2. Trimenon vorgezogen werden. Die Impfung soll unabhängig vom Abstand zu vorher verabreichten Pertussisimpfungen und in jeder Schwangerschaft erfolgen. Das Epidemiologische Bulletin 13/2020 schildert, dass das Ziel der Pertussisimpfung in der Schwangerschaft die Reduzierung von Erkrankungen, Hospitalisierungen und Todesfällen durch Infektionen mit Bordetella pertussis bei Neugeborenen und jungen Säuglingen ist.

العلاقة: https://resolver.sub.uni-goettingen.de/purl?gro-2/140183Test

الإتاحة: https://doi.org/10.25646/6584Test
https://resolver.sub.uni-goettingen.de/purl?gro-2/140183Test

المؤلفون: Orru, Stefano, Bierbaum, Sibylle, Enk, Alexander, Hengel, Hartmut, Hoffelner, Marcus, Huzly, Daniela, Keller-Stanislawski, Brigitte, Mahler, Vera, Mockenhaupt, Maja, Oberle, Doris

المصدر: Eurosurveillance (15607917); 12/14/2023, Vol. 28 Issue 50, p38-50, 13p