scholarly journals Case Report: ANCA-Associated Vasculitis Presenting With Rhabdomyolysis and Pauci-Immune Crescentic Glomerulonephritis After Pfizer-BioNTech COVID-19 mRNA Vaccination

2021 ◽  
Vol 12 ◽  
Author(s):  
Samy Hakroush ◽  
Björn Tampe
Keyword(s):  
Crescentic Glomerulonephritis ◽  
Current Knowledge ◽  
Herd Immunity ◽  
Disease Outbreaks ◽  
Vaccine Safety ◽  
Surveillance Systems ◽  
Vaccination Programs ◽  
Anca Associated Vasculitis ◽  
Post Marketing Surveillance ◽  
Post Marketing

As the coronavirus disease 2019 (COVID-19) pandemic is ongoing and new variants of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) are emerging, there is an urgent need for COVID-19 vaccines to control disease outbreaks by herd immunity. Surveillance of rare safety issues related to these vaccines is progressing, since more granular data emerge with regard to adverse events of COVID-19 vaccines during post-marketing surveillance. Interestingly, four cases of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) presenting with pauci-immune crescentic glomerulonephritis (GN) after COVID-19 mRNA vaccination have already been reported. We here expand our current knowledge of this rare but important association and report a case of AAV presenting with massive rhabdomyolysis and pauci-immune crescentic GN after Pfizer-BioNTech COVID-19 mRNA vaccination. As huge vaccination programs are ongoing worldwide, post-marketing surveillance systems must continue to assess vaccine safety important for the detection of any events associated with COVID-19 vaccination. This is especially relevant in complex diseases where diagnosis is often challenging, as in our patient with AAV presenting with massive rhabdomyolysis and pauci-immune crescentic GN.

scholarly journals An Overview of COVID-19 Vaccine Safety and Post-marketing Surveillance Systems

2021 ◽  
Vol 12 (4) ◽  
pp. 8
Author(s):  
Manal Mohammed Younus ◽  
Ali Azeez Al-Jumaili
Keyword(s):  
Safety Monitoring ◽  
Vaccine Safety ◽  
Lessons Learned ◽  
Surveillance Systems ◽  
Real World Data ◽  
Post Marketing Surveillance ◽  
The World ◽  
Post Marketing ◽  
Data Surveillance ◽  
Tools And Methods

The need for the safety monitoring of the COVID-19 vaccine is unprecedented. It is an ongoing process starting from different phases of clinical trials and continued to post-marketing to tackle the emergency used authorized COVID-19 vaccines across the world. Rapid detection, exchange, prioritization, and assessment of safety signals based on available real-world data, surveillance of Adverse events following immunization (AEFI), and adverse event of special interest (AESI) by studying the observed/expected cases. Enhanced collaboration, and availability of resources, tools, and methods will add to the lessons learned from previous experiences.

Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China

Vaccine ◽  
2014 ◽  
Vol 32 (44) ◽  
pp. 5875-5879 ◽  
Author(s):  
Yali Wang ◽  
Duo Dong ◽  
Gang Cheng ◽  
Shuyan Zuo ◽  
Dawei Liu ◽  
...  
Keyword(s):  
Japanese Encephalitis ◽  
Vaccine Safety ◽  
Japanese Encephalitis Vaccine ◽  
Post Marketing Surveillance ◽  
Post Marketing

scholarly journals Thrombotic events and COVID-19 vaccines

2021 ◽  
Vol 25 (9) ◽  
pp. 701-707
Author(s):  
C. Brazete ◽  
A. Aguiar ◽  
I. Furtado ◽  
R. Duarte
Keyword(s):  
Immune Thrombocytopenia ◽  
Large Scale ◽  
Viral Vector ◽  
Vaccine Safety ◽  
Severe Thrombocytopenia ◽  
The European Union ◽  
Vein Thrombosis ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Vaccination Campaigns

COVID-19 vaccines are considered promising agents in the control of the pandemic. Although their safety was assessed in randomised clinical trials, severe adverse events (AEs) have been reported after large-scale administration. This study aims to evaluate thromboembolic AEs reported after vaccination in a real-world context and how they led to the interruption of vaccination campaigns. We also review the benefits and risks of the vaccines approved in the European Union and provide recommendations. A review of the literature was performed using Medline/PubMed electronic database as well as institutional and pharmacovigilance official reports. Our findings show that vaccine-induced prothrombotic immune thrombocytopenia has been suggested as a very rare AE associated with viral vector vaccines. Unusual thrombotic events combined with moderate-to-severe thrombocytopenia were reported mainly in women under 60 years of age. As safety signals emerged, Vaxzevria and Janssen´s COVID-19 vaccine campaigns have been paused while investigations proceed. On the other hand, the number of deep vein thrombosis and pulmonary embolism reports have not increased. Post-marketing surveillance indicated that mRNA vaccines are safe and should continue to be used. The thrombotic events report rate is not increased in people over 60 years. As they are at greater risk for COVID-19 complications and death, no vaccine restrictions are recommended in this group. Risk factors for vaccine-induced prothrombotic immune thrombocytopenia should be established so that evidence-based decisions can be made. Systematic monitoring of COVID-19 vaccine safety is essential to ensure that the benefits of vaccination outweigh the risks.

Comparative Study of Medical Device Vigilance in Canada, USA, Australia

2019 ◽  
Vol 10 (03) ◽  
Author(s):  
S Sridhar ◽  
V Balamuralidhara ◽  
V Balamuralidara
Keyword(s):  
Health Professional ◽  
Information Sharing ◽  
Medical Device ◽  
Adverse Reactions ◽  
Surveillance Systems ◽  
Safety Issues ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Set Up

The medical device vigilance system was set up to minimize risks to the safety of patients, users and others by detecting the possible adverse reactions in patients, the medical device safety issues are identified and reported manufacture or health professional through identification and reporting of issues by members of the public or through information sharing with other competent authorities. Medical device reporting is important from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action, Manufacturers are obliged to maintain robust medical device vigilance and post-marketing surveillance systems for the maintenance of the marketing authorization in the country were the product is marketed.

scholarly journals What serosurveillance studies tell us about the 2009 influenza pandemic

2011 ◽  
Vol 32 (1) ◽  
pp. 18
Author(s):  
Gary K Dowse ◽  
Ian Barr
Keyword(s):  
Influenza Pandemic ◽  
Herd Immunity ◽  
Case Fatality ◽  
Antigenic Drift ◽  
Surveillance Systems ◽  
Pandemic H1n1 ◽  
Infection Rates ◽  
Vaccination Programs ◽  
Pandemic Virus ◽  
The Impact

Surveillance of the impact of pandemic (H1N1) 2009 influenza during its initial seasons in both hemispheres relied on routinely available indicators, including numbers and rates of laboratory-detected cases, hospitalisations, ICU admissions and deaths, along with monitoring of influenza-like illness (ILI) from primary care sentinel surveillance systems. Estimates of the clinical attack rate and the case fatality ratio were imperfect. Understanding of the pathogenicity of the pandemic virus and prediction of the impact in subsequent seasons was hindered by a lack of information on actual infection rates in the population. Results of a number of serosurveys conducted in Australia and overseas countries have now become available, revealing that the arrival of the pandemic virus in modern urbanised and non-immune populations resulted in relatively similar infection rates in both the southern and northern hemispheres. Around 30?50% of children and teenagers were infected during the first pandemic season, with lower rates, around 10?20%, in young and middle-aged adults, and very few infections in older adults. There were significant numbers of mild or asymptomatic infections, and case fatality and hospitalisation ratios were much lower than those contemplated in pandemic plans. Many populations, including Australia, achieved a significant level of herd immunity during the first wave, and community susceptibility was further reduced by vaccination programs, although coverage was lower than expected. In the absence of significant antigenic drift or changes in virulence, the impact of the pandemic H1N1 virus should continue to decline in future influenza seasons.

EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

1983 ◽  
Vol 22 (03) ◽  
pp. 135-148 ◽  
Author(s):  
T. Kitaguchi ◽  
T. Nojiri ◽  
S. Suzuki ◽  
T. Fukita ◽  
T. Kawana
Keyword(s):  
Data Base ◽  
Clinical Case ◽  
Drug Information ◽  
Case Record ◽  
Post Marketing Surveillance ◽  
Japanese Character ◽  
Record Data ◽  
Post Marketing ◽  
On Line ◽  
Line Drug

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Term Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Long Term Therapy
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