We aimed to identify whether a spontaneous reporting system (SRS) in Croatia could timely identify and confirm signals for COVID-19 vaccines. Post-marketing spontaneous reports of adverse drug reactions (ADRs) following COVID-19 immunisation reported to the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) were extracted and analysed. 6624 cases reporting 30 655 ADRs following COVID-19 immunisation were received from 27 December 2020 to 31st December 2021. Available data in those cases were compared with data available to the EU network at the time when signals were confirmed and minimisation measures were implemented. 5032 cases, reporting 22 524 ADRs, were assessed as non-serious, and 1,592 cases, reporting 8,131 ADRs as serious. The most reported serious ADRs, which were listed in the MedDRA Important medical events terms list, were syncope ( = 58), arrhythmia ( = 48), pulmonary embolism ( = 45), loss of consciousness ( = 43), and deep vein thrombosis ( = 36). The highest reporting rate had Vaxzevria (0.003), followed by Spikevax and Jcovden (0.002), and Comirnaty (0.001). Potential signals were identified, however, they couldn't be timely confirmed solely on cases retrieved by SRS. In order to overcome the limitations of SRS, active surveillance and post-authorisation safety studies of vaccines should be implemented in Croatia.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.2478/acph-2023-0029 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Infections Due to Corynebacterium kroppenstedtii With Focus on Granulomatous Lobular Mastitis for Tissue Specificity, Pathogenesis, Bacteriologic Workup, and Treatment.
Arch Pathol Lab Med
January 2025
From the Divisions of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas (Gan, Y Ding, Wu, Zhang, Meng, QQ Ding, Han).
Objective.—: To report the isolation and significance of C kroppenstedtii, features of patients with GLM, pathologic findings and mechanism, bacteriologic workup, and optimal treatment.
Design.
Curative-Intended Management of Synchronous Esophageal and Rectal Cancer-A Systematic Literature Review.
J Gastrointest Cancer
January 2025
Department of Radiotherapy and Radiation Oncology, Jena University Hospital, 07747, Jena, Germany.
Purpose: Synchronous esophageal (EC) and rectal carcinoma (RC) is a rare and challenging condition, particularly in curative-intended treatment. Especially locally advanced tumors may not be suitable for primary resection and require individual multimodal treatment. This review examines curative-intended management of synchronous EC and RC.
View Article and Find Full Text PDFKeyhole decompression surgery for holospinal epidural abscess: a novel approach for spinal stability preservation.
Eur Spine J
January 2025
Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan.
Purpose: Spinal epidural abscesses are rare yet serious conditions, often necessitating emergency surgical intervention. Holospinal epidural abscesses (HEA) extending from the cervical to the lumbosacral spine are even rarer and present significant challenges in management. This report aims to describe a case of HEA with both ventrally-located cervical and dorsally-located thoracolumbar epidural abscesses treated with a combination of anterior keyhole decompression and posterior skip decompression surgeries.
View Article and Find Full Text PDFValidation of a hypomorphic variant in CDK13 as the cause of CHDFIDD with autosomal recessive inheritance through determination of an episignature.
Clin Epigenetics
January 2025
Faculty of Medicine of TUD Dresden University of Technology, Institute for Clinical Genetics, University Hospital Carl Gustav Carus at TUD Dresden University of Technology, Dresden, Germany.
Autosomal dominant CDK13-related disease is characterized by congenital heart defects, dysmorphic facial features, and intellectual developmental disorder (CHDFIDD). Heterozygous pathogenic variants, particularly missense variants in the kinase domain, have previously been described as disease causing. Using the determination of a methylation pattern and comparison with an established episignature, we reveal the first hypomorphic variant in the kinase domain of CDK13, leading to a never before described autosomal recessive form of CHDFIDD in a boy with characteristic features.
View Article and Find Full Text PDFMalaria prevalence, transmission potential and efficacy of artemisinin-based combination therapy in the Kenyan Central highlands: a zone previously characterized as malaria-free.
Malar J
January 2025
Centre for Biotechnology Research and Development, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Background: The current study sought to re-evaluate malaria prevalence, susceptibility to artemisinin-based combination therapy (ACT), transmission patterns and the presence of malaria vectors in the Kikuyu area of the Kenyan Central highlands, a non-traditional/low risk malaria transmission zone where there have been anecdotal reports of emerging malaria infections.
Methods: Sampling of adult mosquitoes was done indoors, while larvae were sampled outdoors in June 2019. The malaria clinical study was an open label non-randomized clinical trial where the efficacy of one ACT drug, was evaluated in two health facilities.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!