Monitoring of possible adverse effects, in particular those considered serious or unexpected, of the Pfizer / BioNtech vaccine begins on Sunday with the first injections, underlines Thursday the Medicines Agency (ANSM).
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Identifying the possible adverse effects of Covid-19 vaccines that may not have been observed in clinical trials is “a major stake», Explains the National Agency for the Safety of Medicines and Health Products, by publishing fact sheets on this subject aimed at health professionals and patients.
The ANSM has also undertaken to publish the data collected by this pharmacovigilance on a weekly basis, with a “enhanced surveillance“. A first situation update will be published next week. But the ANSM “can communicate at any time if a safety signal is identified».
Health professionals as well as people who have been vaccinated and their family and friends can report side effects either directly to the pharmacovigilance center in their region (CRPV), or on the reporting portal. A record of adverse reactions, from the mildest to the most serious currently listed, is available on the website of the health agency.
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Most of the side effects reported during clinical trials are mild to moderate in intensity and resolve spontaneously within a few days, recalls the ANSM. They are common to other types of vaccinations: injection site pain, headache, fatigue, muscle and joint pain, chills, mild to moderate fever. Other effects of more severe intensity (hypersensitivity or allergic reactions for example) have been reported and require medical attention.
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