Adverse event, adverse reaction and undesirable effect: the difference
Pharmacovigilance is a continuous process that calls into question the safety of each medicine even after its placing on the market, which takes place after the necessary tests. Coronavirus serums are not exempt from this careful surveillance, but some terms need to be clarified.
- Per adverse event we mean any unfavorable episode that occurs following the administration of a drug.
- A reaction adverse it is a harmful and unintended response to a drug, with which a causal relationship can be established.
- A undesirable effect it is related to the properties of the drug but it is not necessarily harmful. It is often a known, because it occurs commonly, and is considered acceptable.
How adverse events to Covid vaccines are classified
An adverse event following immunization, in technical language AEFI, is a medical episode that occurs after the vaccine, and therefore has a temporal relationship with it, but it was not necessarily caused by the inoculation of the serum. Many adverse events can be caused by circumstances external to taking the drug, such as pre-existing and unknown health conditions.
Particularly for younger vaccines, pharmacovigilance authorities monitor any type of adverse event. Following the introduction of new sera, reports often increase, also due to greater attention from health professionals and citizens. Collecting each report serves to better understand the relationship between the benefits and risks associated with a specific preparation.
AEFI are divided into 5 categories, based on the relationship with the vaccine.
- Reaction related to product.
- Reaction related to defects quality.
- Reaction related to mistakes of immunization.
- Reaction related to anxiety of immunization.
- Coincident event e unrelated.
Covid vaccine, how to report an adverse event and to whom
To report an adverse event that occurred after the administration of the Covid vaccine, you can contact your family doctor, vaccination center, pharmacy or health company to which you belong. The communication can be made directly by a citizen or by a health worker who observes the case, by filling in a card specific and sending it by fax or email to the local manager of the pharmacovigilance network, or directly on the Aifa website, by clicking on the item Report a suspected adverse reaction online, which leads to the platform VigiFarmaco.
This is the information needed to report an adverse event following vaccination.
- Patient personal information, ie initials of the name, age e sex.
- Description of the trend of symptoms in detail, possibly with the date and time of vaccination and the appearance of the reactions.
- Commercial name e lotto of the vaccine that was administered.
- Qualification e contacts of the person making the report.
What are the known side effects of Covid vaccines
If the pharmacovigilance bodies receive many reports regarding an adverse event, it is possible that the suspension of an anti Covid vaccine may be proceeded, especially if there is a risk that the side effects or adverse reactions outweigh the benefits of the serum. The most frequent side effects and reactions in the vaccination campaign are the following.
- Local reactions at the injection site, such as pain, swelling and redness.
- Muscle and joint pains.
- Allergic reactions which in very few cases can lead to anaphylactic shock.
- Fainting and panic attacks caused by anxiety about the injection.
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