Medicinal Products

Notice on the reported suspected adverse reactions to the Tetanus Vaccine, Institute of Immunology d.d. in Bosnia & Herzegovina


The Agency for Medicinal Products and Medical Devices (HALMED) has been notified by the Agency for Medicinal Products and Medical Devices of Bosina & Herzegovina (ALMBiH) about five reported suspected adverse reactions after the use of the Tetanus Vaccine (adsorbed), Institute of Immunology, batch 78/3 with the expiry date by August 2015. The tetanus vaccine is indicated for stimulating the active immunity against tetanus.

The reported suspected adverse reactions observed in five 18-year old adolescents after the use of this vaccine have been associated with an unstable walk, syncope, impulse to vomit, shuddering sensation in head and extremities, neck benumbing and heavy and rapid breathing. These symptoms may be sign of a psychogenic reaction to the vaccination itself that may appear during a group vaccination, especially in adolescents.

The Agency for Medicinal Products and Medical Devices B&H has concluded that the benefits/risks ratio for this vaccine remains positive.

According to HALMED’s data, the Tetanus Vaccine manufactured by Institute of Immunology d.d., including this batch is not on the Croatian market. The Croatian market was supplied by this vaccine by the end of 2013, or by the expiry of stocks and these adverse reactions have not been observed in Croatia.

In the case that a healthcare setting has packaging of the batch 78/3 of this vaccine, we advise healthcare professionals to temporarily suspend the use of this batch. HALMED will together with epidemiologists of the Croatian Institute for Public Health (HZJZ) continue to collaborate with ALMBiH and promptly make publicly available any new information on its webpages.