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.
Cumulative overview of notifications
In Belgium, vaccination with Comirnaty started in Belgium on 28 December 2020. Until 12 January 2021, 34,979 doses of this vaccine have been registered in our country (figures from the Government Commissioner for COVID-19).
Ten notifications of suspected adverse reactions with Comirnaty in Belgium were identified through a search in the European pharmacovigilance database EudraVigilance.
One of these notifications is considered to be serious. This notification involved dizziness, followed by raised blood pressure, contractions of the respiratory muscles with reduced blood oxygen levels and chest pain within fifteen minutes of vaccination. Medical care and follow-up were required. After a few hours, there was a positive recovery.
A notification is considered serious if at least one of the listed adverse reactions is serious.
The 10 Belgian notifications were made by healthcare professionals.
In seven notifications, the patients were younger than 65 years.
The majority of the adverse reactions reported were already known side effects and are described in the Summary of Product Characteristics and in the leaflet of Comirnaty.
Other reported adverse reactions were isolated, for example, contractions of the respiratory muscles and increased blood pressure.
On 14 January 2021 (i.e. outside the period covered by this bulletin), the FAMHP was informed of the death of an 82-year-old with health problems, five days after vaccination. This case will be investigated further to see if there is a causal link between the vaccination and the death. It has been decided to carry out an autopsy, among other things. In the at-risk target group currently being vaccinated, the occurrence of serious health problems and deaths must be taken into account regardless of vaccination. Further research is essential to determine if there is a link between the vaccination and deaths. FAMHP experts are currently collecting all relevant data. More information on this notification will be provided in our next bulletins.
Overview per system organ class (SOC – MedDRA terminology)
Below table gives a breakdown of the adverse reactions per system organ class for Comirnaty reported in Belgium up to 12 January 2021.
|System Organ Class (SOC – MedDRA terminology)||Number of cases reporting at least one adverse reaction in this category*|
|General disorders and administration site conditions||5|
|Nervous system disorders||3|
|Respiratory, thoracic and mediastinal disorders||2|
|Skin and subcutaneous tissue disorders||1|
|Ear and labyrinth disorders||1|
*Based on search in Eudravigilance on 12.01.2021.
Overview per reported adverse reaction
Overview of all adverse reactions reported in Belgium for Comirnaty that are registered in the EudraVigilance database until 12 January 2021. This document indicates whether the adverse reaction was reported as serious or not, according to the WHO criteria described above.
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 reaction 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 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.
- Comirnaty is also monitored through additional pharmacovigilance activities which are described in the Risk Management Plan (RMP) for Comirnaty.
- 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.