Sex: F
Vaccine: PNC13
Symptoms: Meningitis pneumococcal, Motor dysfunction, Seizure, Streptococcus test positive, Vasculitis
Clinical narrative: strep pneumo meningitis; strep pneumo meningitis; epilepticus; bacteremia; Positive strep pneumo culture on CSF and blood.; seizure; multifocal infarcts (left MCA and left vertebral artery occlusion (secondary to suspected vasculitis); multifocal infarcts (left MCA and left vertebral artery occlusion (secondary to suspected vasculitis); Left sided motor deficits; bilateral sensorineural hearing loss (R >>>L); severe oropharyngeal dysphagia requiring NG feed; areas of ischemic injury/volume loss; multiple sinus venous thromboses; progressive arterial occlusive disease; labyrinthitis; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 month-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPILEPSY (hospitalization, life threatening), outcome "unknown", described as "epilepticus"; MENINGITIS (hospitalization, life threatening), outcome "unknown", described as "strep pneumo meningitis"; BACTERAEMIA (hospitalization, life threatening), outcome "unknown", described as "bacteremia"; BACTERIAL TEST POSITIVE (hospitalization), outcome "unknown", described as "Positive strep pneumo culture on CSF and blood."; SEIZURE (hospitalization), outcome "unknown", described as "seizure"; INFARCTION (hospitalization), VASCULITIS (hospitalization), outcome "unknown" and all described as "multifocal infarcts (left MCA and left vertebral artery occlusion (secondary to suspected vasculitis)"; MOTOR DYSFUNCTION (hospitalization), outcome "unknown", described as "Left sided motor deficits"; DEAFNESS NEUROSENSORY (hospitalization), outcome "unknown", described as "bilateral sensorineural hearing loss (R >>>L)"; DYSPHAGIA (hospitalization), outcome "unknown", described as "severe oropharyngeal dysphagia requiring NG feed"; HYPOXIC-ISCHAEMIC ENCEPHALOPATHY (hospitalization) with onset Nov2019, outcome "unknown", described as "areas of ischemic injury/volume loss"; VENOUS THROMBOSIS (hospitalization) with onset Nov2019, outcome "unknown", described as "multiple sinus venous thromboses"; ARTERIAL OCCLUSIVE DISEASE (hospitalization) with onset Nov2019, outcome "unknown", described as "progressive arterial occlusive disease"; LABYRINTHITIS (hospitalization) with onset Nov2019, outcome "unknown", described as "labyrinthitis". The patient underwent the following laboratory tests and procedures: csf white blood cell count positive: (unspecified date) positive; magnetic resonance imaging head: (Nov2019) evolving areas of ischemic injury/volume loss, notes: evolving areas of ischemic  injury/volume loss, multiple venous thromboses, progressive arterial occlusive disease, and labyrinthitis.  The lot number for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: The association between the event lack of effect (Strep pneumo meningitis) with PREVENAR 13 can not be fully excluded. Based on the temporal relationship, the association between the other events with PREVENAR 13 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.