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Vaccine adverse events

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https://www.readbyqxmd.com/read/28526773/us-government-website-for-collecting-adverse-events-after-vaccination-is-inaccessible-to-most-users
#1
Peter Doshi
No abstract text is available yet for this article.
May 19, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28522338/year-round-influenza-immunisation-during-pregnancy-in-nepal-a-phase-4-randomised-placebo-controlled-trial
#2
Mark C Steinhoff, Joanne Katz, Janet A Englund, Subarna K Khatry, Laxman Shrestha, Jane Kuypers, Laveta Stewart, Luke C Mullany, Helen Y Chu, Steven C LeClerq, Naoko Kozuki, Monica McNeal, Adriana M Reedy, James M Tielsch
BACKGROUND: Influenza immunisation during pregnancy is recommended but not widely implemented in some low-income regions. We assessed the safety and efficacy in mothers and infants of year-round maternal influenza immunisation in Nepal, where influenza viruses circulate throughout the year. METHODS: In this phase 4, randomised, placebo-controlled trial, we enrolled two consecutive sequential annual cohorts of pregnant women from the Sarlahi district in southern Nepal...
May 15, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28521688/vasculitis-following-influenza-vaccination-a-review-of-the-literature
#3
Toru Watanabe
BACKGROUND: Influenza vaccine is safe and effective for the general population as well as for patients with autoimmune diseases. However, although rare, vasculitis has been reported as an adverse event following influenza vaccination. OBJECT: The aims of this literature review were to identify patients who developed vasculitis following influenza vaccination and to clarify the clinical manifestations of vasculitis in these patients. METHODS: Using the PubMed database and search engine, we performed a search of the English-language literature by combining the term influenza vaccination with each term for a specific form of vasculitis from January 1966 through April 2016...
May 17, 2017: Current Rheumatology Reviews
https://www.readbyqxmd.com/read/28516442/vaccines-for-the-common-cold
#4
REVIEW
Daniel Simancas-Racines, Juan Va Franco, Claudia V Guerra, Maria L Felix, Ricardo Hidalgo, Maria José Martinez-Zapata
BACKGROUND: The common cold is a spontaneously remitting infection of the upper respiratory tract, characterised by a runny nose, nasal congestion, sneezing, cough, malaise, sore throat, and fever (usually < 37.8º C). The widespread morbidity caused by the common cold worldwide is related to its ubiquitousness rather than its severity. The development of vaccines for the common cold has been difficult because of antigenic variability of the common cold virus and the indistinguishable multiple other viruses and even bacteria acting as infective agents...
May 18, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28516208/safety-and-efficiency-of-active-immunization-with-detoxified-antigen-against-scorpion-venom-side-effect-evaluation
#5
Nassrine Bachsais, Lila Boussag-Abib, Fatima Laraba-Djebari
OBJECTIVE: The efficiency and safety of vaccine are the most important properties, however, as any medication, it can induce side effects. This prophylactic therapy could be used to prevent the lethal and pathophysiological effects induced after scorpion envenomation. METHODS: In this study, detoxified venom associated to alum adjuvant (V*alum) is used as a vaccine against scorpion venom for immunization of mice. We evaluate the safety and the inflammatory response of this vaccine...
May 17, 2017: Inflammation Research: Official Journal of the European Histamine Research Society ... [et Al.]
https://www.readbyqxmd.com/read/28515627/frequently-asked-questions-on-seven-rare-adverse-events-following-immunization
#6
REVIEW
G L D'alò, E Zorzoli, A Capanna, G Gervasi, E Terracciano, L Zaratti, E Franco
Routine mass immunization programs have contributed greatly to the control of infectious diseases and to the improvement of the health of populations. Over the last decades, the rise of antivaccination movements has threatened the advances made in this field to the point that vaccination coverage rates have decreased and outbreaks of vaccine-preventable diseases have resurfaced. One of the critical points of the immunization debate revolves around the level of risk attributable to vaccination, namely the possibility of experiencing serious and possibly irreversible adverse events...
March 2017: Journal of Preventive Medicine and Hygiene
https://www.readbyqxmd.com/read/28515198/post-authorisation-passive-enhanced-safety-surveillance-of-seasonal-influenza-vaccines-protocol-of-a-pilot-study-in-england
#7
Simon de Lusignan, Gaël Dos Santos, Ana Correa, François Haguinet, Ivelina Yonova, Florence Lair, Rachel Byford, Filipa Ferreira, Karen Stuttard, Tom Chan
AIM: To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season's vaccine. STUDY DESIGN: A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data...
May 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28512074/an-idea-whose-time-has-come-compensation-for-vaccine-related-injuries-and-death-in-india
#8
Sarojini Nadimpally, Sneha Banerjee, Deepa Venkatachalam, Divya Bhagianadh
This paper emphasises the urgent need for a compensation policy for those affected by adverse events following immunisation in India. In the absence of such a mechanism in the country, people claim compensation by taking recourse to tort law and have to face the ensuing uncertainty and challenges with regard to the award of compensation. The paper argues that people should be provided compensation in the event of death and serious adverse events following compulsory immunisation, irrespective of whether there is a causal association between the adverse event and the vaccine, on the basis of no fault compensation...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512073/identifying-ethical-issues-in-the-development-of-vaccines-and-in-vaccination
#9
Veena Johari
Vaccines are a widely accepted public health intervention. They are also a profitable tool for pharmaceutical companies manufacturing vaccines. There are many vaccines in the pipeline, for various diseases, or as combination vaccines for several diseases. However, there is also a growing concern about vaccines and the manner in which they are developed and approved by the authorities. Approvals are fast tracked and adverse events and serious adverse events following vaccination are seldom reported once the vaccine gets its marketing approval...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512072/lessons-learnt-in-japan-from-adverse-reactions-to-the-hpv-vaccine-a-medical-ethics-perspective
#10
Hirokuni Beppu, Masumi Minaguchi, Kiyoshi Uchide, Kunihiko Kumamoto, Masato Sekiguchi, Yukari Yaju
The human papillomavirus (HPV) vaccine has been linked to a number of serious adverse reactions. The range of symptoms is diverse and they develop in a multi-layered manner over an extended period of time. The argument for the safety and effectiveness of the HPV vaccine overlooks the following flaws: (i) no consideration is given to the genetic basis of autoimmune diseases, and arguments that do not take this into account cannot assure the safety of the vaccine; (ii) the immune evasion mechanisms of HPV, which require the HPV vaccine to maintain an extraordinarily high antibody level for a long period of time for it to be effective, are disregarded; and (iii) the limitations of effectiveness of the vaccine...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28507496/safety-and-efficacy-of-venom-immunotherapy-a-real-life-study
#11
Agnieszka Kołaczek, Dawid Skorupa, Monika Antczak-Marczak, Piotr Kuna, Maciej Kupczyk
INTRODUCTION: Venom immunotherapy (VIT) is recommended as the first-line treatment for patients allergic to Hymenoptera venom. AIM: To analyze the safety and efficacy of VIT in a real life setting. MATERIAL AND METHODS: One hundred and eighty patients undergoing VIT were studied to evaluate the safety, efficacy, incidence and nature of symptoms after field stings and adverse reactions to VIT. RESULTS: Significantly more patients were allergic to wasp than bee venom (146 vs...
April 2017: Postȩpy Dermatologii i Alergologii
https://www.readbyqxmd.com/read/28506538/epitope-specific-immunotherapy-targeting-cd4-positive-t-cells-in-coeliac-disease-two-randomised-double-blind-placebo-controlled-phase-1-studies
#12
Gautam Goel, Tim King, A James Daveson, Jane M Andrews, Janakan Krishnarajah, Richard Krause, Gregor J E Brown, Ronald Fogel, Charles F Barish, Roger Epstein, Timothy P Kinney, Philip B Miner, Jason A Tye-Din, Adam Girardin, Juha Taavela, Alina Popp, John Sidney, Markku Mäki, Kaela E Goldstein, Patrick H Griffin, Suyue Wang, John L Dzuris, Leslie J Williams, Alessandro Sette, Ramnik J Xavier, Ludvig M Sollid, Bana Jabri, Robert P Anderson
BACKGROUND: A gluten-free diet is the only means to manage coeliac disease, a permanent immune intolerance to gluten. We developed a therapeutic vaccine, Nexvax2, designed to treat coeliac disease. Nexvax2 is an adjuvant-free mix of three peptides that include immunodominant epitopes for gluten-specific CD4-positive T cells. The vaccine is intended to engage and render gluten-specific CD4-positive T cells unresponsive to further antigenic stimulation. We assessed the safety and pharmacodynamics of the vaccine in patients with coeliac disease on a gluten-free diet...
May 11, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28504837/immunotherapy-for-metastatic-renal-cell-carcinoma
#13
REVIEW
Susanne Unverzagt, Ines Moldenhauer, Monika Nothacker, Dorothea Roßmeißl, Andreas V Hadjinicolaou, Frank Peinemann, Francesco Greco, Barbara Seliger
BACKGROUND: Since the mid-2000s, the field of metastatic renal cell carcinoma (mRCC) has experienced a paradigm shift from non-specific therapy with broad-acting cytokines to specific regimens, which directly target the cancer, the tumour microenvironment, or both.Current guidelines recommend targeted therapies with agents such as sunitinib, pazopanib or temsirolimus (for people with poor prognosis) as the standard of care for first-line treatment of people with mRCC and mention non-specific cytokines as an alternative option for selected patients...
May 15, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28498925/a-case-report-of-anaphylaxis-to-typhoid-vaccine-live-oral-ty21a-vivotif
#14
Nathan L Haas, Mary R C Haas, Charmaine Gregory
Typhoid Vaccine Live Oral Ty21a (Vivotif) is typically well tolerated, and adverse events are infrequent and mild. To the best of the authors' knowledge, only one prior anaphylactic reaction has previously been reported. We present a case of anaphylaxis related to Vivotif, in which a 66-year-old male with no medical comorbidities developed anaphylaxis following the third of a four-dose course (in the absence of concomitant vaccination administration), which consisted of tongue swelling, difficulty breathing, abdominal discomfort and rash...
September 1, 2017: Journal of Travel Medicine
https://www.readbyqxmd.com/read/28498853/safety-and-immunogenicity-of-an-inactivated-whole-cell-tuberculosis-vaccine-booster-in-adults-primed-with-bcg-a-randomized-controlled-trial-of-dar-901
#15
C Fordham von Reyn, Timothy Lahey, Robert D Arbeit, Bernard Landry, Leway Kailani, Lisa V Adams, Brenda C Haynes, Todd Mackenzie, Wendy Wieland-Alter, Ruth I Connor, Sue Tvaroha, David A Hokey, Ann M Ginsberg, Richard Waddell
BACKGROUND: Development of a tuberculosis vaccine to boost BCG is a major international health priority. SRL172, an inactivated whole cell booster derived from a non-tuberculous mycobacterium, is the only new vaccine against tuberculosis to have demonstrated efficacy in a Phase 3 trial. In the present study we sought to determine if a three-dose series of DAR-901 manufactured from the SRL172 master cell bank by a new, scalable method was safe and immunogenic. METHODS: We performed a single site, randomized, double-blind, controlled, Phase 1 dose escalation trial of DAR-901 at Dartmouth-Hitchcock Medical Center in the United States...
2017: PloS One
https://www.readbyqxmd.com/read/28498618/phase-i-clinical-trial-of-cell-division-associated-1-cdca1-peptide-vaccination-for-castration-resistant-prostate-cancer
#16
Wataru Obara, Fuminori Sato, Kazuyoshi Takeda, Renpei Kato, Yoichiro Kato, Mitsugu Kanehira, Ryo Takata, Hiromitsu Mimata, Tamotsu Sugai, Yusuke Nakamura, Tomoaki Fujioka
We screened cell division associated 1 (CDCA1) as an oncogene that is overexpressed on several cancers, including prostate cancer. We also identified a highly immunogenic HLA-A*2402-restricted epitope peptide corresponding to part of the CDCA1 protein. We conducted a phase I clinical trial for patients with castration resistant prostate cancer (CRPC) using a CDCA1 peptide vaccination. Twelve patients having HLA-A*2402 with CRPC after failure of docetaxel chemotherapy were enrolled. They received subcutaneous administration of the CDCA1 peptide as an emulsion with Montanide ISA51VG once a week in a dose-escalation manner (doses of 1...
May 12, 2017: Cancer Science
https://www.readbyqxmd.com/read/28495398/true-and-false-contraindications-to-vaccines
#17
R Opri, G Zanoni, C Caffarelli, P Bottau, S Caimmi, G Crisafulli, F Franceschini, L Liotti, F Saretta, M Vernich, D G Peroni
Nowadays, the awareness of risks related to infectious diseases has decreased, whereas THE perception of risks related to vaccination is growing. Therefore, it may be difficult for health care providers to convince people of the importance of vaccination and adherence to the immunisation schedule. Selected situations that might raise uncertainties about vaccine recommendations are discussed in order to help health care providers to identify real and perceived contraindications to vaccines, and cases to be referred to specialised pre-vaccination consultation due to an increased risk of adverse events to vaccines...
May 8, 2017: Allergologia et Immunopathologia
https://www.readbyqxmd.com/read/28495264/community-engagement-and-integrated-health-and-polio-immunisation-campaigns-in-conflict-affected-areas-of-pakistan-a-cluster-randomised-controlled-trial
#18
Muhammad Atif Habib, Sajid Soofi, Simon Cousens, Saeed Anwar, Najib Ul Haque, Imran Ahmed, Noshad Ali, Rehman Tahir, Zulfiqar A Bhutta
BACKGROUND: Pakistan faces huge challenges in eradicating polio due to widespread poliovirus transmission and security challenges. Innovative interventions are urgently needed to strengthen community buy-in, to increase the coverage of oral polio vaccine (OPV) and other routine immunisations, and to enhance immunity through the introduction of inactivated polio vaccine (IPV) in combination with OPV. We aimed to evaluate the acceptability and effect on immunisation coverage of an integrated strategy for community engagement and maternal and child health immunisation campaigns in insecure and conflict-affected polio-endemic districts of Pakistan...
June 2017: Lancet Global Health
https://www.readbyqxmd.com/read/28494274/personalized-t-cell-mediated-cancer-immunotherapy-progress-and-challenges
#19
REVIEW
Michael T Bethune, Alok V Joglekar
Immunotherapies are yielding effective treatments for several previously untreatable cancers. Until recently, vaccines and adoptive cell therapies have been designed to target public tumor antigens common to multiple patients rather than private antigens specific to a single patient. Due to the difficulty of identifying public antigens that are expressed exclusively on tumor cells, these studies have yielded both clinical successes and serious immune-related adverse events. Multiple avenues of research now underscore the centrality of tumor-specific mutated private antigens to endogenous anti-tumor immunity...
May 8, 2017: Current Opinion in Biotechnology
https://www.readbyqxmd.com/read/28493930/clinical-laboratory-reference-values-amongst-children-aged-4-weeks-to-17-months-in-kilifi-kenya-a-cross-sectional-observational-study
#20
Jesse Gitaka, Caroline Ogwang, Moses Ngari, Pauline Akoo, Ally Olotu, Christine Kerubo, Greg Fegan, Patricia Njuguna, Godfrey Nyakaya, Tuda Otieno, Gabriel Mwambingu, Ken Awuondo, Brett Lowe, Roma Chilengi, James A Berkley
Reference intervals for clinical laboratory parameters are important for assessing eligibility, toxicity grading and management of adverse events in clinical trials. Nonetheless, haematological and biochemical parameters used for clinical trials in sub-Saharan Africa are typically derived from industrialized countries, or from WHO references that are not region-specific. We set out to establish community reference values for haematological and biochemical parameters amongst children aged 4 weeks to 17 months in Kilifi, Kenya...
2017: PloS One
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