Initial report received on 28 Dec 2010: This patient was enrolled in a study. Study medication was commenced on an unknown date. On 15 Oct 2010, the patient presented with hypotonia. At the time of reporting, the patient's condition was persisting. The investigator did not suspect a relationship between the event and the study vaccine. Follow-up received prior to circulation of initial on 31 Dec 2010: The patient received vaccination on 19 Feb 2010 at 11:05 hrs, 13 Apr 2010 at 17:10 hrs and on 11 Jun 2010 at 11:48 hrs. Follow-up received in 11 Jan 2011: The patient was diagnosed with motor delay / hypotonia and was referred for developmental evaluation. On 15 Nov 2010, it was confirmed that the patient was experiencing delays in gross and fine motor skills secondary to hypotonia. The results of the patient's developmental evaluation is as follows: Background information: The patient's mother reported a normal pregnancy with a c-section delivery with no complications. Developmental milestones: rolled over at 4 to 6 months, sat up at 6 months and is not yet walking or crawling. Is able to say 'mama' and 'dada'. Hearing and vision were within normal limits. One mild cold with no reported history of ear infections. The patient's behaviour was within normal levels of functioning. Developmental assessment of young children (DAYC) scores: raw score - 9, standard score - 83, age equivalent - 7 months. Patient demonstrated imitation skills by attempting to imitate scribbling and by imitating clapping hands. Requires several hand clapping demonstrations secondary to a delayed response time. Patient is able to hand a toy to an adult with increased time. Not yet repeating arm or leg movements to repeat an action. Retrieves an object, searches and retrieves a partially hidden object, holds two objects simultaneously and visually tracks a falling object. The patient presented with decreased muscle strength for her age in neck flexors, trunk musculature and lower extremities. Excessive range of motion at multiple joints and ligament laxity. Patient exhibited decreased generalised muscle tone which was impacting her skill acquisition. Demonstrated poor postural control for her age. Was able to right her head and trunk when tilted 45 degrees to the side but fatigued rapidly and had delayed reactions after one trial. Delayed reflex development for her age. Was not able to protectively place her hands forward when tipped. Attempted to place hands to the side in sitting but not to the rear, attempted to right her head forward when tipped to the rear but fatigued. Was able to remain sitting once placed for short periods of time. Was unable to transition from prone to quadraped. The patient's social/emotional score was within normal limits. The patient's fine motor ability was delayed by 54-36%. Was demonstrating visual-motor integration skills equivalent to 7 months of age. Adaptive/living skills score: 36% delay. The patient presented with tongue lateralization to both the right and left side in addition to increased tongue thrust. She demonstrated decreased jaw movement with minimal munching. Sensory processing: demonstrates poor proprioceptive processing and decreased motor planning skills which appears to be impacting her imitation skills. The patient showed strength in demonstrating normal speech and normal social emotional skills. Areas in which continued growth is required included protective responses, mobility skills, head control, strengthening, fine motor skills and adaptive/self help skills. Hypotonia is impacting her acquiring gross motor skills in a timely fashion compared to her peers. The patient's functioning was at least 33% delayed in cognition, gross motor skills, grasping, visual motor skills and adaptive skills. At the time of reporting, the patient's condition was still present and unchanged. The investigator did not suspect a relationship between the event 'hypotonia' and the study medication. In the absence of an investigator causality assessment for 'poor proprioceptive processing' and 'cognitive delay', Novartis has processed the events as suspected for reporting purposes. The case will be reassessed on receipt of follow-up information. Follow-up information on 18 Jan 2011 (prior to circulation of previous follow-up): At the time of reporting, the patient's condition was still present and unchanged.