adverse reaction reporting

anyone can report a side effect to a health or cannabis product. you should do this even if you are not sure if a particular health or cannabis product was the cause. biologics (biotechnology products and blood products) are drugs that come from living organisms or from their cells. they are used to treat medical conditions such as diabetes and some forms of cancer. they are used to treat, diagnose or prevent a disease or abnormal physical condition. they are often made from plants, but can also be made from animals, micro-organisms and marine sources. they are used to prevent or treat an illness or condition, reduce a health risk or maintain good health. vaccines are products that produce immunity to a specific disease.

cannabis refers to the plant cannabis sativa, which is used for its effects on the mind. marijuana is a slang term for the dried flowers, leaves, stems and seeds of the cannabis plant. veterinary health products (such as vitamins and minerals) are low risk drugs used to maintain or promote the health and welfare of pets and food-producing animals. they are not used to diagnose, treat or prevent diseases. all health products are carefully evaluated before they are licensed in canada. your report helps to indicate if there is an issue with a health or cannabis product (a signal). a signal is an initial indicator of an issue with the drug, health or cannabis product. we evaluate every signal to confirm or disprove a connection between the product and the reaction or problem.

the working group reports to the canadian immunization committee and it functions as a long -term task group that facilitates the development of guidelines, standards, protocols and best practices to improve f/p/t public health post-market vaccine safety surveillance in canada. hc and phac share the monitoring of the quality, safety and effectiveness of vaccines marketed in canada. the usual and preferred reporting flow of aefi reports to caefiss is from local or regional health units to central p/t immunization programs. in addition, as of december 2019, the hospitals are required to report all serious adverse drug reactions according to the food and drug regulations for adverse drug reactions requirements. the purpose of the workshop was to develop a framework for a coordinated approach to optimize vaccine post marketing surveillance in canada.

health care workers are encouraged to discuss with clients, or the clients’ caregiver, the reason for reporting the aefi and the confidentiality of all collected information. given the variation in practice between each of the provinces and territories, sections of the form may not be applicable to all settings. indicate the patient’s medical history prior to the time of aefi onset by choosing all that apply from the list provided below. provide any additional details in section 10: for a chosen event, describe the signs and symptoms by checking all that apply from the list below. indicate the section of the aefi report that the information applies to, if applicable, when recording information in section 10. this section is to be completed by the health professional. choose one of the responses as defined below to describe the outcome following the administration of the subsequent dose of vaccine and provide all pertinent details in section 10. the covishield version of this vaccine provided a temporary supply to canadians through the interim order respecting the importation, sale and advertising of drugs for use in relation to covid-19.

important: if you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. cdc and fda do not provide vaers is an early warning system used to monitor adverse events that happen after vaccination. learn how vaers reports are submitted and reviewed. vaers is the national vaccine safety monitoring system that accepts reports of adverse events after vaccination. the system can quickly detect potential, .

four faers summary statistics reports updated with data through . report serious adverse events for human medical products, including potential or actual product use errors, product quality problems, if you experience an adverse event (not a side effect) from one of our drugs, tell your doctor and then report it to us. this helps us track the safety of, .

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