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Scotland ( The National Records of Scotland): In the week ending 19 February 2023, 1,263 deaths were registered; of these deaths, 48 cited COVID-19, accounting for 3.8% of all deaths. Reporting has helped identify many new safety issues that were previously unknown until they were reported as a Yellow Card. For example: If this card comes up as the first card when the game begins, the player on the dealer’s left must draw a card then skip their turn. 5. Skip The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse drug reactions (ADRs).
Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020 and an autumn booster campaign for eligible patients was deployed from September 2022. It is important that everyone submits a report to the Yellow Card scheme as soon as they suspect a side effect from a medicine or adverse incident associated with a medical device. This ensures that actions to reduce harm are based on the best available evidence and can improve safety for as many people as possible.
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The Yellow Card scheme enables the MHRA to monitor safety concerns such as suspected side effects or adverse incidents involving healthcare products. These include medicines, vaccines, blood factors and immunoglobulin products, medical devices, e-cigarettes and complementary therapies such as homeopathies. The scheme also collates information about suspected safety concerns involving defective, falsified or fake healthcare products. Every report helps the MHRA identify and response to safety issues to minimise the risk of harm. Since its establishment in 1964 the scheme has identified numerous safety issues to the benefit of many, thanks to individual reports from the UK public and healthcare professionals. Reporting suspected side effects using the Yellow Card scheme helps ensure vaccines, medicines and medical devices continue to be used in the best way and adds to the known safety information about healthcare products. Notes to Editor If you’re playing on the Light Side and the Flip Card is played, all cards should now be flipped over to the Dark Side. The MHRA closely monitors the safety of COVID-19 vaccine exposures in pregnancy, including published information as well as Yellow Card reports for COVID-19 vaccines used in pregnancy. These reports have been reviewed by the independent experts of the CHM’s Medicines for Women’s Health Expert Advisory Group (MWHEAG).
Public Health Scotland, COVID-19 Statistical report: https://publichealthscotland.scot/publications/covid-19-statistical-report/covid-19-statistical-report-11-may-2022/ ↩ As with any vaccine, COVID-19 vaccines will cause side effects in some people. The total number and the nature of the majority of Yellow Cards reports received so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction. Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors. All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness. The MHRA has received 30 UK reports of suspected ADRs with a fatal outcome to the bivalent COVID-19 Pfizer/BioNTech vaccine and 42 reports of suspected ADRs with a fatal outcome for the bivalent COVID-19 vaccine Moderna. The MHRA has received no UK reports with a fatal outcome for COVID-19 Vaccine Novavax.
Please note:
The MHRA takes all reports with a fatal outcome in patients who have received a COVID-19 vaccine very seriously and every report with a fatal outcome is reviewed carefully. All reports with a fatal outcome regardless of the time period between receiving the suspect vaccine and the reported death are reviewed. All available information is assessed to consider whether the vaccine may have caused the reported death. Cumulatively, the Yellow Card data is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the reported death alongside data available from international sources. This is further considered by the Commission on Human Medicines and its Expert Advisory Groups. Reporting helps to make medicines and medical devices safer for all patients. In doing so, you are helping those who are most vulnerable and at risk of potential harm. All reports go onto our specialised database that allows us to process and analyse the reports rapidly to make them available to detect new safety issues. Every report therefore could be a potential safety issue or ‘signal’. Potential signals are evaluated and triaged to identify previously unidentified potential hazards, and new information including on recognised effects or safety issues. Your Yellow Card report will be considered in the context of all other reports received from patients or healthcare professionals. If someone decides to challenge and finds you guilty, you’ll have to draw the cards until you get the color you chose. However, if you are innocent, your challenger will have to draw cards until they get the chosen color plus additional 2 cards. No differences in safety are expected for the bivalent vaccines. Nevertheless, the MHRA will continue to closely monitor safety data following use of the COVID-19 vaccines in pregnancy, including through evaluation of electronic healthcare record data. Safety of COVID-19 vaccines in those breastfeeding
div class = "card" style = "width: 18rem;" > < div class = "card-body" > < h5 class = "card-title" >Special title treatment < p class = "card-text" >With supporting text below as a natural lead-in to additional content. < a href = "#" class = "btn btn-primary" >Go somewhere < div class = "card text-center" style = "width: 18rem;" > < div class = "card-body" > < h5 class = "card-title" >Special title treatment < p class = "card-text" >With supporting text below as a natural lead-in to additional content. < a href = "#" class = "btn btn-primary" >Go somewhere < div class = "card text-end" style = "width: 18rem;" > < div class = "card-body" > < h5 class = "card-title" >Special title treatment < p class = "card-text" >With supporting text below as a natural lead-in to additional content. < a href = "#" class = "btn btn-primary" >Go somewhere Navigation Events occurring following vaccination but may or may not be caused by the vaccine. Third dose/vaccination Given the huge scale of the COVID-19 immunisation programme, with many millions of doses of vaccines administered over a relatively short time period, vigilance needs to be continuous, proactive and as near real-time as is possible. The importance of this is two-fold. First, we need to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals.
If necessary, we may take action to ensure that the product is used in a way which minimises risk, and maximises benefits to the patient or user. Previous summaries of Yellow Card reporting covering the primary and Autumn 2021 booster vaccination campaigns presented tabulated summaries of reports with a fatal outcome stratified by vaccine brand, age and sex. With respect to the use of bivalent COVID-19 vaccines and the Autumn 2022 booster campaign these tables have now been replaced with an interactive search tool to allow readers to view the total number of reports with a fatal outcome received by the MHRA across the UK primary and booster vaccination programmes. The tool presents data by vaccine brand, age and sex with respect to these reports with a fatal outcome. div class = "card mb-3" > < img src = "..." class = "card-img-top" alt = "..." > < div class = "card-body" > < h5 class = "card-title" >Card title < p class = "card-text" >This is a wider card with supporting text below as a natural lead-in to additional content. This content is a little bit longer. < p class = "card-text" >< small class = "text-muted" >Last updated 3 mins ago < div class = "card" > < div class = "card-body" > < h5 class = "card-title" >Card title < p class = "card-text" >This is a wider card with supporting text below as a natural lead-in to additional content. This content is a little bit longer. < p class = "card-text" >< small class = "text-muted" >Last updated 3 mins ago < img src = "..." class = "card-img-bottom" alt = "..." > Image overlays
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