From 7 January 2021 onwards, the FAMHP publishes a weekly overview on the adverse reactions reported in Belgium following the administration of a COVID-19 vaccine. By being fully transparent, the FAMHP aims to increase confidence in COVID-19 vaccines.
Overview from 28 December 2020 to 5 January 2021
Comirnaty (Pfizer/BioNTech)
In Belgium, vaccination with Comirnaty started on 28 December 2020.
Three notifications of adverse reactions with Comirnaty, that occurred between 28 December 2020 and 5 January 2021 in Belgium, were identified through a search in the European pharmacovigilance database EudraVigilance. None of these reactions were considered as serious.
All adverse reactions were reported by healthcare professionals.
One of the patients is 52 years old and the other two are elderly people (age not specified).
The majority of the reported adverse reactions are already known and described in the Summary of Product Characteristics and in the leaflet of Comirnaty.
The table below provides a classification of the adverse reactions reported in Belgium for Comirnaty up to 5 January 2021, per system organ class.
| System Organ Class (SOC – MedDRA terminology) | Number of cases reporting at least one adverse reaction in this category |
|---|---|
| Gastrointestinal disorders Nausea (2) |
2 |
| General disorders and administration site conditions Fatigue (1), malaise (1) |
2 |
| Investigations Increased body temperature |
1 |
| Respiratory, thoracic and mediastinal disorders Cough |
1 |
| Skin and subcutaneous tissue disorders Pruritus |
1 |
Correct interpretation
The following information is important for a correct interpretation of the data published in this overview.
- The information published in this overview is related to suspected adverse reactions, for example medical events that have been observed after vaccination, but are not necessarily related to or caused by that vaccine.
- Information on reported adverse reactions should not be interpreted as: the vaccine causes the observed adverse reaction or its use presents a risk. Only a detailed analysis and scientific evaluation of all available data make it possible to draw robust conclusions on the risks of the vaccine.
- The number of vaccines administered must be put into perspective with the number of reported adverse reactions.
- The FAMHP publishes these data so that all stakeholders, including the general public, can access the information that the European regulatory authorities use to assess the safety of COVID-19 vaccines. Transparency is a key principle of the FAMHP and the European Medicines Agency (EMA).
- The table with adverse reactions by system organ class lists the most frequently reported adverse reactions (and the number of times they were reported) and some adverse events of special interest (and the number of times they were reported). Adverse reactions and events of special interest are adverse reactions and events qualified as "sensitive" because of concerns from health professionals or users, without a causal link with the vaccine that has scientifically been proven to this date. The adverse reactions have been identified by the Brighton Collaboration. A notification can also include more than one adverse reaction belonging to different categories. Therefore, the sum of cases per category does not necessarily equal the total number of notifications.
More information
- Comirnaty is also monitored through additional pharmacovigilance activities which are described in the Risk Management Plan (RMP) for Comirnaty.
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An adverse reaction is classified as "serious" if it
-
results in death,
- is life-threatening,
- requires hospitalisation or prolongation of existing hospitalisation,
- results in persistent or significant disability/incapacity (as per reporter's opinion),
- is a congenital anomaly/birth defect, or
- results in some other medically important conditions.
-
- A notification can include more than one adverse reaction. It is considered serious if at least one of the adverse reactions are serious.
- Summary of Product Characteristics (SmPC) and leaflet, and European Public Assessment Report (EPAR) for Comirnaty
- Questions and answers on Comirnaty
Report adverse reactions
You can report adverse reactions via www.famhp.be/en/side_effect.