Ons Reporting Requirements

* Vermont has an individual state mandate, but currently has no employer reporting requirements. The overall reporting rate for the first, second and third doses or booster doses is in the range of 2 to 5 yellow cards per 1,000 doses administered for Pfizer/BioNTech monovalent and bivalent COVID-19 vaccine, AstraZeneca COVID-19 vaccine and Moderna monovalent and bivalent COVID-19 vaccine. Experience with the Novavax COVID-19 vaccine is insufficient to make similar estimates of reporting rates. Clinical trials know that the most common side effects can occur with all vaccines at a rate greater than one in 10 doses (e.g., local reactions or symptoms similar to transient flu-like symptoms). The MHRA has thoroughly reviewed UK and international reports of suspected myocarditis and pericarditis following COVID-19 vaccination. There has been a consistent trend towards higher reporting of these suspected events with the Pfizer/BioNTech monovalent COVID-19 vaccine and the Moderna COVID-19 vaccine, which are more common in men. These reports were also analyzed by the government`s independent advisory body, the CHM and its expert working group on the benefits of COVID-19 vaccines. As a result of their advice, product information for Moderna`s monovalent COVID-19 vaccine and Pfizer/BioNTech COVID-19 vaccine has been updated to inform healthcare professionals and patients of these reports and to provide guidance for identifying key symptoms of myocarditis and pericarditis. This notice was also included in the product information for bivalent (original/Omicron BA.1) COVID-19 vaccines for Moderna and Pfizer/BioNTech. We will continue to inform discussions on the development of the new Statistical Business Register (SBR), taking into account user feedback to inform the requirements. In addition to the specific safety issues summarized in this report, a number of other isolated events or a number of serious and non-fatal ADR reports have been reported.

All of these elements are subject to ongoing review, including an in-depth analysis of expected rates without a vaccine. There is currently no evidence of specific trends or reporting rates that would suggest that the vaccine played a role. Based on reports of suspected adverse reactions in the UK, the overall reporting rate in all age groups for suspected myocarditis (including viral myocarditis) after the first, second and booster dose or third dose is 10 reports per million doses of the Pfizer/BioNTech COVID-19 monovalent vaccine and for suspected pericarditis (including viral pericarditis and infectious pericarditis), The overall reporting rate is 7 reports per million doses. For Moderna`s monovalent COVID-19 vaccine, the overall reporting rate for suspected myocarditis (including hypersensitive myocarditis and viral myocarditis) is 18 per million doses and for suspected pericarditis (including plaeuropericarditis and gonococcal pericarditis) is 11 per million doses. For AstraZeneca COVID-19 vaccine, the overall reporting rate for suspected myocarditis (including viral myocarditis and infectious myocarditis) is 5 per million doses and for suspected pericarditis (including viral pericarditis) is 5 per million doses. Note that a single report can contain more than one event and therefore the total number of reports is not equal to the number of events. Bell`s palsy (PA) is a temporary weakness or paralysis that affects one side of the face and develops gradually; Most people recover from this condition within a few months. BP is known to be linked to a number of infectious diseases, including the SARS-CoV-2 virus.

Reports of suspected cases of BP following COVID-19 vaccination have been continuously reviewed by the MHRA. While it is rare to report BP after COVID-19 vaccination, evidence based on the latest available evidence shows that there may be an increased risk of BP after COVID-19 vaccination. In order to raise awareness among healthcare professionals and patients about this potential adverse event, facial paralysis has been included in the product information for the AstraZeneca COVID-19 vaccine, the Pfizer/BioNTech monovalent and bivalent COVID-19 vaccine, and the Moderna monovalent and bivalent COVID-19 vaccine. We will continue to monitor these events following the COVID-19 vaccination. International data have shown that these suspicions most often occur approximately 3 days after the first vaccination and 2 days after the second vaccination, and UK and international data have shown that the vast majority of suspected cases occur within 7 days of vaccination. In the UK, data show that there is a similar frequency of notification after the first and second dose. This publication is available at www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting Second, we need to determine very quickly whether serious vaccine-related medical events are just an incidental link. These associations are likely while we are still in the midst of a large national vaccination program, and because many of the millions of people who offered the vaccine in the early stages of a vaccination campaign were older and/or had underlying conditions, increasing the likelihood of unrelated diseases occurring shortly after vaccination. As mentioned above, the yellow card type means that reported events are not always proven side effects, and some may have occurred independently of vaccination. These reporting rates may also change as experience in the UK increases. *Data are currently insufficient to calculate a reliable estimate of the reporting rate in the UK due to the relatively limited exposure and low number of suspicious activity reports among these individuals. Nurses play a key role in identifying adverse events that occur in patients, not only for fast-track approval drugs, but for all drugs.

The nurse is often the front-line staff who administers medications and is in an excellent position to quickly detect adverse events and perform a thorough assessment of the patient. This printable resource highlights the importance of oncology nurses – Detect adverse events – Classify symptoms – Communicate with the healthcare team – Report the adverse event As an ideal resource for printing and viewing in oncology care units, nurses can learn more about the FDA`s Medwatch program and how to detect and report adverse events.