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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
An 8-month-old girl developed cerebral demyelination, suppurative BCG lymphadenitis, meningoencephalitis, acute disseminated encephalomyelitis and bilateral optic neuritis following vaccination with BCG vaccine. Additionally, BCG lymphadenitis worsened and she developed Mycobacterium tuberculosis complex infection following treatment with methylprednisolone for acute disseminated encephalomyelitis [not all times to reactions onsets stated].
The girl presented with right facial nerve palsy, increasing irritability and bilateral nystagmus. Six weeks prior to presentation, she had developed left axillary lymphadenopathy, which was suspected to be BCG lymphadenitis. She had been vaccinated with BCG [route not stated] at her birth.
The girl received treatment with cloxacillin for the...
- Anandakrishnan P, et al. Unusual case of cerebral demyelination and bilateral optic neuritis in an infant with suppurative BCG lymphadenitis. BMJ Case Reports 2018: 30 May 2018. Available from: URL: http://doi.org/10.1136/bcr-2018-224496 - Malaysia