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Awareness and Utilization of Reporting Pathways for Adverse Events Following Immunization: Online Survey Among Pediatricians in Russia and Germany



Vaccine safety surveillance is highly dependent on accurate reporting of adverse events following immunization (AEFI). An online survey was conducted to assess the utilization of AEFI reporting standards and pathways among pediatricians in Germany, and in Russia where pediatric specialization begins in medical school.


In May 2011, a 31-item online questionnaire was sent to members of the German Professional Association for Pediatricians (BVKJ) and the Union of Pediatricians of Russia (UPR), capturing information on vaccine safety training, awareness of AEFI reporting pathways, and use of standardized case definitions for the ascertainment of AEFI. A convenience sample of 1,632 completed online surveys was analyzed.


Participating pediatricians reported spending approximately 50 min per 8-hour workday on vaccine safety consultations, but only 42 % (56 % UPR, 26 % BVKJ) have ever received any formal vaccine safety training. Two-thirds reported having observed AEFI in their practice, but only one-third utilized standardized case definitions for case ascertainment. Only 35 % of participants named accurate AEFI reporting pathways. Every second pediatrician would report AEFI to institutions that are not primarily in charge of vaccine safety surveillance; the remaining reports would either be lost or delayed. Pediatricians who had received formal vaccine safety training were significantly more likely to apply international safety standards and to report adequately, both at the p < 0.05 level.


Pediatricians play a key role in the post-marketing surveillance of vaccine safety. The lack of training represents a missed opportunity. There may be a role for professional societies to improve vaccine safety training.

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Fig. 1
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Advisory Committee on Immunization Practices


Adverse Event


Adverse Event Following Immunization


Adverse Drug Reaction


Brighton Collaboration


German Professional Association for Pediatricians (association for pediatricians in private practice in Germany; Berufsverband der Kinder- und Jugendärzte e.V.)


US Centers for Disease Control


Drug Commission of the German Medical Association (Ärztekammer der Deutschen Ärzteschaft)


Department of Health


European Center for Disease Prevention and Control


European Medicines Agency


Health care professional


Ministry of Health


Objective structured clinical examination


Paul Ehrlich Institute


Public Health Agency of Canada


Patient-Reported Outcomes Safety Event Reporting


United Nations


Union of Pediatricians of Russia


Vaccine Adverse Event Reporting System


World Health Organization

ГИCК им Tapaceвичa:

Russian Federal State Institution for Scientific Research, the Institute for Standardization and Control of Medical and Biological Preparations “L. A. Tarasevich”


Sanitary-Epidemiological Commission


Federal Centre of Hygiene and Epidemiology


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The authors kindly thank the participating pediatric professional societies as well as their members for their participation in the online survey. The authors also express their gratitude to Olga Komarova for organizing the survey in Russia and to members of the Vienna Vaccine Safety Initiative Think Tank (, who provided feedback to the concept and design of the survey.

L. Namazova-Baranova has received grant funding from Pfizer, payment for board activities from Pfizer and GSK, and payment for lectures from MSD, GSK, Pfizer and sanofi-pasteur. S. Muehlhans, M. von Kleist, T. Gretchukha, M. Terhardt, U. Fegeler, W. Maurer, G. Gaedicke, A.A. Baranov, and B.A. Rath declare that they have no conflicts of interest.

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Correspondence to Barbara Rath.

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Muehlhans, S., von Kleist, M., Gretchukha, T. et al. Awareness and Utilization of Reporting Pathways for Adverse Events Following Immunization: Online Survey Among Pediatricians in Russia and Germany. Pediatr Drugs 16, 321–330 (2014).

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  • Aseptic Meningitis
  • Objective Structure Clinical Examination
  • Vaccine Safety
  • Vaccine Adverse Event Reporting System
  • Adverse Event Follow Immunization