Cause of side effects in Sarajevo high school students after tetanus vaccination still unknown!

After the tetanus vaccine caused adverse reactions in Sarajevo high school students on Tuesday, its further use has been suspended until all circumstances that will clarify what actually happened are determined, writes the Bosnian news agency Patria.

We remind you that on the first day, 13 students had symptoms such as headache, nausea, tingling in the hands, and were provided assistance at the Infectious Disease Clinic of the University Clinical Center Sarajevo, and a day later, several more students sought help.

While on one hand there is a possibility that the cold chain (maintaining optimal temperature during transport, storage, and use of vaccines) was broken, there are still no official information.

However, on the other hand, the Agency for Medicines and Medical Devices of Bosnia and Herzegovina states that they have not received any report of suspected adverse reaction.

- Upon report of suspected adverse reaction(s), we will immediately react to assess the causal link between the reported adverse reaction and the suspected medicinal product, and in accordance with the adopted assessment, take appropriate regulatory measures - state from the Agency.

They also note that adverse reactions are expected side effects of the tetanus vaccine and are described in the summary of product characteristics and in the patient information leaflet.

As Patria previously reported, this vaccine has been used for two years, and the manufacturer is the Institute of Immunology Zagreb, which received a marketing authorization from the Agency for the BiH market.

- If the vaccine was stored under prescribed conditions (and we believe it was), there is no fear that its quality, verified at the time of the vaccine's entry into the BiH market, has been compromised. Upon request from healthcare workers or institutions, and upon receipt of the vaccine, it will immediately be taken into work to check its quality through an extraordinary control procedure - stated from the Agency.

This means that neither the Institute for Public Health of the Sarajevo Canton nor the Institute for Public Health of the Federation of Bosnia and Herzegovina have submitted a request for vaccine verification or have even commented on the course of the investigation into this unfortunate case.