Reporting side effects: A how-to guide
If you, or someone close to you, have suffered adverse effects following a “Covid vaccination”, it is essential to report them. The aim of pharmacovigilance is to identify adverse effects in order to make informed decisions about the approval, modification or suspension of medicines, or even their withdrawal from the market.
We explain the various steps to follow.
Be careful, however… it is not only up to your doctor to report adverse effects linked to the mRNA injections against Covid 19; it is crucial that YOU TOO report them to pharmacovigilance!
A tedious procedure? An obstacle course? Don’t worry… only at first sight. It is much simpler than it seems.
BAM explains the 6 steps to follow
Do it for yourself, for your children, for others, for all those who, by not reporting, prevent pharmacovigilance from being properly monitored. Do it also for… science…
Good to know beforehand: without the exact details of the vaccines received, it is impossible to submit a side-effect report.
- The details of the vaccine(s) you received are provided automatically when you insert your electronic identity card or use a digital key.
- Without a digital identity, you will need to have the document you received at your vaccination(s) to hand.
- Finally, if you are making a report for another person, their identity card or national number is required to fill in the report.
- Unvaccinated people will not be able to fill in the document without the details of a vaccination.
How to report an adverse effect linked to a vaccine on the notification form of the FAMHP (Federal Agency for Medicines and Health Products) in Belgium:
Step 1: Go to the FAMHP website |
➡️ Go to the website https://www.afmps.be/fr/effet_indesirable.
➡️ Click on “Vous êtes patient”.
Step 2: Identify yourself |
Identification with a digital ID
- In the “Vaccin contre la COVID-19” box, click on “Notifier en s’identifiant avec eID”.
- Either with an eID card reader (electronic identity card to be inserted into the card reader).
- Or via a digital key.
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Identification without a digital ID
- In the “Vaccin contre la COVID-19” box, click on “Notifier sans eID”.
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➡️ Click on “je souhaite me connecter en tant que: Citoyen”.
Step 3: VACCINES |
Specify the person in whom the adverse effect is occurring or occurred.
➡️ Yourself or another person
- Select the product type ➡️ COVID-19 Vaccin
- Select the vaccine concerned
- Specify:
- the name of the vaccine that caused the adverse effect,
- the date of vaccination,
- the batch,
- the manufacturer.
P.S.: Keep the vaccine details safe so that you can fill in the boxes concerning additional doses and/or boosters.
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➡️ Click on “Ajouter”.
Step 4: Reporting adverse effects of a COVID-19 vaccine |
- Describe precisely the symptoms experienced following vaccination.
- The onset and end (of the adverse effects).
- Any additional examinations, pregnancy, etc.
➡️ Click on “Suivant”.
Step 5: Your data |
Patient data, and any medical history and/or treatments in progress at the time of vaccination (if applicable).
-?: Specify the name of the doctor or hospital -
If the patient consulted a doctor or was hospitalised following the adverse effect, the name of the doctor or hospital concerned must be specified.
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Step 6: Reporting adverse effects |
- General information.
- Vaccine(s).
- Patient data.
- Adverse effect(s).
Click on the "Soumettre" button to send the notification form to the FAMHP.
Adverse effects are, and unfortunately will remain, a topical issue in the months and years to come…
Doctors themselves, meeting at a symposium on 4 February in Genval, acknowledged the shortcomings that have emerged in reporting to pharmacovigilance on the effects of the Covid 19 vaccines: Sortie du symposium du 4 février 2023
And even if, as for many people, the side effects seemed trivial to you, don’t hesitate… or hesitate no longer…
BAM!
Photo source: iStock