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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 case report, two women were described [including one women in her fifties; ages at the time of events onsets not stated], who developed aseptic meningitis during treatment with amoxicillin/clavulanic acid and amoxicillin [not all routes, dosages, duration of treatments to reactions onset stated].
Patient 1: The woman in her 50s received amoxicillin/clavulanic acid. However, 7 days after receiving the first dose of amoxicillin/clavulanic acid, she developed fever and headache. CSF examination showed lymphocytic pleocytosis and high protein level. She was diagnosed with aseptic meningitis (first episode) secondary to amoxicillin/clavulanic acid. She again developed aseptic meningitis (second episode), 3 days after receiving amoxicillin (along with clarithromycin) for Helicobac...