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CNAA / Theses / 2007 / June /

Epidemiological characteristic and perfecting surveillance sistem of the adverse reactions in the Republic of Moldova

Author: Laura Ţurcan
Degree:doctor of medicine
Speciality: 14.00.30 - Epidemiology
Scientific adviser: Victoria Bucov
doctor habilitat, professor, National Center of Public Health
Scientific council:


The thesis was presented on the 20 June, 2007
Approved by NCAA on the 20 September, 2007


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125 pages


Adverse events following immunization, adverse reactions to vaccines, epidemiological surveillance, standard definitions of case, population study


The work includes a systematization and summarization of the results of post-immunization complications analysis, found in the Republic of Moldova in 1995-2006 in the conditions of planned immunization and in during the immunization campaign against measles and rubella, and data concerning the evaluation of immunization service security and the efficiency of post-immunization complications registration on the basis of the passive principle is provided.

The evaluation of the post-immunization complications surveillance was conducted on the basis of no. 5-san annual reports and 1228 Post-immunization complications case investigation questionnaires. The frequency of various post-immunization complications cases, their territorial distribution, the causes of their apparition and the clinical forms most often observed, were determined. The visits to 261 medical institutions and the examination of 255 child’s individual development cards (F. 112) provided information about medical worker’s level of knowledge about safe immunization practices and about the authenticity of the post-immunization complications reports.

Summarizing the materials about the characteristics of post-immunization complications cases, registered in the analyzed period, it can be remarked that out of the total number of post-immunization complications confirmed (1123) cases, the largest part was found after the immunization with BCG vaccine. (987 – 87,9% out of total number of post-immunization complications cases). During the first analyzed period (1995-1997), a major part of reactions, linked with the use of BCG vaccine was observed after immunization with this vaccine, but later (1998-2002) – after re-immunization. In 66,5±3,0% cases, post-immunization complications registered after the introduction of the BCG vaccine were a result of its influence, and in 33,5±3,2% cases, post-immunization complications was caused by the mistakes committed during the immunization process and wrong care applied to the vaccine administration site. After DTP immunization, 115 post-immunization complications cases were registered (10,2%) and another 5 cases after DTP/DTP-m. Out of the rest of the cases 4 were found after the immunization with measles or ROR vaccine, 6 cases for mumps vaccine, 3 cases after poliomyelitis vaccine and 2 cases after Hepatitis B. In different periods the number of post-immunization complications cases varied, in dynamics, a gradual overall reduction of post-immunization complications cases resulting from incorrect BCG vaccine introduction and care for the inoculation site was observed.

A prognostic analysis of the annual number of possible post-immunization complications cases, it was established that in Moldova, in comparison with other territories, post-immunization complications cases are registered more often after the introduction of the BCG vaccine and less often after immunization with other vaccines, included into the immunization calendar.

It was determined, that most children (98,2 - 99,3%) are examined before immunization. The surveillance of children in post-immunization period is insufficient – only 46,7±6.4% who received DTP I-IV vaccine were under surveillance, including only a one tenth part of those who received DTP IV. For ROR vaccination the value of this index equals only 7% of the children. The surveillance pointed out that the older the child, the lesser is the index of the post-immunization surveillance.

The results of the conducted studies showed the efficiency of the registration of post-vaccination syndrome cases, organized on the basis of the passive principle.

The number of post-immunization complications cases during the national immunization campaign against measles and rubella (2,02 for 100000 vaccine doses) was much smaller, than that observed in other countries.

It was found that 3-15% of the immunization service workers do not have the knowledge necessary for working with vaccines. The regime of the vaccine storage was not respected in 51% of the medical institutions that were examined, especially in maternity hospital and medical aid station.

A methodology for the creation of the post-immunization complications surveillance in the republic of Moldova, a Post-immunization complications case investigation questionnaire and standard post-immunization complications case definitions were created. The post-immunization complications surveillance must be organized according to the hierarchic principle, based on a standard case definition, passive reporting wit the filling in of a Post-immunization complications case investigation questionnaire and the registration of the cases in 5-san report.