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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective analysis of 146 children performed between January 2011 and December 2016, seven patients (three girls and four boys; aged: 1−15 years) were described, who developed anaphylaxis during antibiotic therapy with amoxicillin (two patients), amoxicillin/clavulanic-acid (four patients) and flucloxacillin (one patient) [routes and dosages not stated; not all outcomes stated].
Patient 1: A 5-year-old boy started receiving amoxicillin/clavulanic-acid for 3 days. However, one hour after treatment with amoxicillin/clavulanic-acid, he developed anaphylaxis (generalised urticaria, palpebral, lip and tongue oedema, wheezing and larynx oedema) and was hospitalised. An intradermal test showed a positive reaction to amoxicillin 25 mg/mL with wheal of 11 x 7mm. An alternate...