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Temporal association between serious bleeding and immunization: vitamin K deficiency as main causative factor.
Susi Susanah1,2, Eddy Fadlyana3, Meita Dhamayanti3
1Department of Child Health, Dr. Hasan Sadikin General Hospital/Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia. susi_rshs@yahoo.co.id.
BMC Pediatrics
|February 23, 2020
Summary
Bleeding events reported as adverse events following immunization (AEFI) in Indonesian children were mostly vitamin K deficiency bleeding (VKDB), unrelated to vaccination. Improved AEFI surveillance and routine vitamin K prophylaxis for newborns are recommended.
Area of Science:
- Pediatrics
- Immunology
- Hematology
Background:
- Bleeding is a rare but concerning adverse event following immunization (AEFI) in children.
- Bleeding episodes can stem from various acquired or hereditary disorders.
- This study investigates the causal association between immunization and bleeding episodes in children recorded as AEFIs.
Purpose of the Study:
- To analyze bleeding episodes in children reported as AEFIs.
- To determine the etiological factors of these bleeding episodes.
- To assess the causal relationship between immunization and bleeding events.
Main Methods:
- A cross-sectional study of 388 AEFI cases in children in West Java, Indonesia (2000-2017).
- Case findings and confirmation were conducted.
- Causality assessment using the World Health Organization classification.
Main Results:
- 55 children (14%) presented with bleeding as an AEFI.
- 32 cases were attributed to acquired prothrombin complex deficiency (APCD), with 30 suspected as vitamin K deficiency bleeding (VKDB).
- Most bleeding cases were deemed coincidental events with a temporal association to immunization, causally unrelated.
Conclusions:
- The majority of bleeding AEFIs in this cohort were identified as VKDB, coincidental with immunization.
- A causal relationship between immunization and these bleeding events was not established.
- Recommendations include vitamin K administration to all newborns and improved AEFI surveillance in Indonesia.
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