Healthcare professionals can report adverse drug reactions from human vaccines by using the Danish e-form below. Please read the text below before you proceed to report an adverse drug reaction.
E-form
Report an adverse drug reaction from a human vaccine - for healthcare professionals (e-form)
Getting started
We use the details you provide to build a clear picture of the adverse drug reaction you have reported. You must fill in the fields marked with a red star in the e-form, but it is of great help to us, if you fill in as many fields as possible.
By law, an adverse reaction report must contain information about at least the following:
- the adverse drug reaction
- the suspected vaccine
- the patient
- your name
- your workplace
If you have any questions along the way, please ring +45 4488 9757.
We may need additional information
In some cases, we may need to obtain additional information on the adverse drug reaction you have reported. If so, we will contact you to obtain the necessary information.
What happens after you have reported an adverse drug reaction?
We register the information in our database of adverse drug reactions, and pass on the information to the company responsible for the vaccine you suspect to have caused the adverse drug reaction. The information is anonymised so that the company cannot see the name and address of the patient. The company responsible receives all the information about the vaccine and the adverse drug reaction, as well as the patient's date of birth and intials. Therefore, the company can neither identify nor contact the patient. Moreover, the company is not permitted to contact you about the report.
We also send the data to the shared EU database under the European Medicines Agency and to a global database under WHO, so that medicines agencies in other countries may benefit from the information.
The company must evaluate the vaccine's safety on the basis of all the adverse reaction data, collected worldwide.
The Danish Medicines Agency assesses whether the new information on adverse drug reactions should lead to changes in, e.g. summaries of product characteristics and/or package leaflets.
Summaries of product characteristics and package leaflets
www.produktresume.dk offers you access to summaries of product characteristics of vaccines authorised to be sold in Denmark. You can find summaries of product characteristics for vaccines authorised through the centralised EU procedure at the EMA website.
Find Danish package leaflets at www.indlaegsseddel.dk.
