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The quality, safety, and efficacy of COVID-19 vaccines have been demonstrated in large-scale clinical trials. The most frequently reported adverse drug reactions in the studies were injection site pain, arm pain, chills, fever, fatigue, headache and muscle aches and malaise. The most common of these reactions was mild to moderate and resolved within a few days.
The SCCP recalls that the Summary of Product Characteristics and Package Leaflet for each registered COVID-19 vaccine establishes the precautions to be taken by healthcare professionals and patients to use the vaccines safely and effectively; what side effects have been seen in clinical trials and during the marketing of the vaccines. Adverse reactions are reported to healthcare professionals and the public.
Each Suspected Adverse Reaction (ADR) report for COVID-19 vaccines received by the ICD is carefully evaluated and transmitted to the European Medicines Agency safety database. Information on IRs from all EU countries is evaluated by experienced experts to determine the likelihood, dangers and risk factors of vaccines. Where necessary, appropriate measures will be taken to control risks and protect patients.
The IWT also encourages healthcare professionals (doctors, nurses) who have received information about IR from patients to notify the IWT as soon as possible, but no later than 15 days after the information was initiated and / or received.
Healthcare professionals or patients must also provide information to the ICD if the vaccine is determined to be ineffective (that is, if the person develops the disease after the time specified in the vaccine insert for protection against COVID-19) . IWT is also awaiting reports of vaccine overdoses and errors in use, whether or not this caused side effects.
You can report:
– by filling in the form directly online https://vapris.vvkt.lt/vvkt-web/public/nrvSpecialist.
– by filling in the notification form for specialists (can be found at https://www.vvkt.lt/index.php?1399030386) and sending an email. by email [email protected].
Users themselves can also record side effects of vaccines. The notification can be sent in the following ways:
– by filling in the form directly online https://vapris.vvkt.lt/vvkt-web/public/nrv;
– by filling in the notification form for patients (it can be found at https://www.vvkt.lt/index.php?4004286486) and sending it by email (to the address [email protected]);
– free phone 8800 73568.
Please note that in order to report an IRR, IWT only requires that you contact the contact information if necessary, and it is also necessary to indicate your age and gender, as this data is important to investigate and evaluate the factors that may cause some patients experience some CPR. Other personal data, such as name, profession, etc., are not collected by IWT. All information provided in the notice is secure and confidential. If a patient does not want to report CPR themselves, they can ask someone else, such as a healthcare professional or pharmacist, to do so.
It is strictly forbidden to use the information published by DELFI on other websites, in the media or elsewhere, or to distribute our material in any way without consent, and if consent has been obtained, it is necessary to indicate DELFI as the source.
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