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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 2-month-old girl developed Takayasu arteritis following vaccination with Bcg-vaccine, hepatitis-b-vaccine and poliovirus-vaccine-inactivated [poliomyelitis vaccine].
The 3-month-old girl was hospitalised with one-month history of increased levels of acute phase reactants after cough in February 2015. She was a full-term baby with a body weight of 4200g and 54cm of length. In January 2015, when she was about 2 months old, she suffered from cough after she received treatment with poliovirus-vaccine-inactivated, hepatitis-B-vaccine and Bcg vaccine [dosages and routes not stated]. Her cough was not severe, and her fever was gradually increased to 37.8°C. Laboratory examination revealed haemoglobin 129 g/L, WBC count 28 x 109/L, platelet 766 x 109/L, neutrophil 62.5% and there was...
- Liu H, et al. Case report: Takayasu arteritis in a 3-month-old Chinese girl. Medicine 97: e12637, No. 41, Oct 2018. Available from: URL: http://doi.org/10.1097/MD.0000000000012637 - China