Human adverse reaction notification

Definition and goals

An adverse reaction is a reaction to the drug that is harmful and unintended. It is considered a serious adverse reaction if the reaction is fatal or life-threatening, requires hospitalization or prolongation of hospitalization, results in permanent or serious disability or incapacity, or is a congenital anomaly or birth defect.

For vaccines, the absence of an effect (e.g., no vaccine protection after vaccination has occurred) is also particularly relevant and should be reported in all cases.

Health care professionals, i.e. physicians, dentists, midwives, pharmacists, druggists and tradespeople who are authorized to manufacture or wholesale medicinal products pursuant to the Gewerbeordnung 1994 (Trade, Commerce and Industry Regulation Act 1994), are obliged to report adverse drug reactions occurring in Austria to the BASG pursuant to the Arzneimittelgesetz (Medicinal Products Act) and the Pharmacovigilance Ordinance (Pharmakovigilanzverordnung).  

Patients and relatives also have the option of voluntarily reporting suspected adverse drug reactions directly to the BASG.

Reporting possibilities human medicinal products

Online form for patients

https://nebenwirkung.basg.gv.at/en/

Online form for healthcare professionals

electronic form human

Paper form human

paper form human

by e-mail

nebenwirkung@basg.gv.at

by post

BASG, 1200 Wien, Traisengasse 5

by fax

+ 43 (0) 50 555 36207

telephone support:

+ 43 (0) 50 555 36600

24-hour emergency telephone number for pharmacovigilance officers or safety officers:

Tel.: +43 (0) 664 831 28 43

Please note: The emergency number is only to be used for emergencies within the meaning of § 10 Regulation on Pharmacovigilance or § 70 Austrian Medical Devices Act.

An emergency only exists if there is an immediate danger to life or a serious and considerable danger to health.

Any further questions or information should be submitted via the contacts of the Austrian Federal Office for Safety in Health Care.

Your reports will be treated confidentially. There are no negative consequences for the notifier.

By reporting adverse reactions, you can help provide more information about the safety of this medicine.

Once the Federal Office for Safety in Health Care has identified medically unacceptable risks, it can support the safe handling of medicinal products by imposing restrictions on use - possibly until the withdrawal of a marketing authorisation already granted by the authorities. The Federal Office for Safety in Health Care cooperates with the relevant authorities in other European Member States and with the European Medicines Agency.

The reporting of suspicious cases is therefore indispensable in terms of consumer protection.

We would also like to draw your attention to the European database, where you will find information on adverse reactions of medical products and active substances (at EU level).

Report templates human (only available in German)

COVID-19 vaccines: reporting of side effects or lack of effect

While vaccines are safe and effective for most patients, they can have potential side effects in addition to positive effects, which can occur in individual cases. It is therefore particularly important that side effects of vaccines are reported and evaluated. This allows the respective benefit-risk ratio to be further evaluated continuously and comprehensively even after approval, thus ensuring that all available vaccines are safe.

In Austria, adverse reactions can be voluntarily reported directly to the Federal Office for Safety in Health Care (BASG) by patients as well as their relatives. Physicians, pharmacists, and other health care professionals are required by law to report adverse reactions.

An adverse reaction is any reaction to the vaccine that is harmful and unintended. In the case of vaccines, the absence of an effect (e.g., no vaccine protection after vaccination) is also particularly relevant and should be reported in all cases.

To report adverse reactions after COVID-19 vaccination or the lack of a protective effect after vaccination has taken place, please use one of the following options:

If possible, please provide at least the following information:

  • Information about the person who experienced the side effects, including age and sex.
  • Description of the side effects, including date of occurrence
  • Name of the vaccine (brand name and active ingredient) suspected of causing the side effects
  • Lot number of the vaccine (on the package)
  • Any other medicines taken around the same time (including non-prescription medicines, herbal remedies, or contraceptives)
  • Contact person for queries (name, contact details)        

Information for marketing authorisation

Marketing authorisation holder should send all suspected serious and non-serious post-marketing case reports, which occurred within Austria, directly electronically to EVPM (EudraVigilance post-authorization module). This also includes case reports from the worldwide literature and non-interventional data collection schemes which occurred in Austria.

Medical literature monitoring – MLM Service EMA

Since September 2015 the European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database.

The MLM service currently includes 300 active substances and 100 herbals.

The results of this research is available for MAHs and member states as Individual Case Safety Reports (ICRS) in the Eudravigilance database. However, this does not release pharmaceutical companies from their obligation to monitor the literature (local literature search) with regard to their marketing authorisations.

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Further inquiry note