Information has been received from an investigator concerning the following report: AN# 101017 I BL # 0015-00035, a 1 year old female with dermatitis who has a history of secondhand tobacco smoke in home was randomized to study. On 29-JAN-2013, the patient was placed on blinded study therapy for the prophylactic treatment of Measles, Mumps, Rubella, Varicella (MMRV). The patient did not have any prior medications. Concomitant therapy included Triamcinolone Acetonide. On 29-JAN-2013, the patient was taken for a 12 month well visit to the primary care physician (PCP). The patient had a recent upper respiratory infection (URI) and bronchiolitis with symptoms resolving consistent with viral process. The patient received MMRV immunization in the right thigh. On 07-FEB-2013, the patient's platelet count was 544 10x3uL and absolute basophils were 0.2 Cells/ MCL. On 08-FEB-2013, the patient was taken the primary care physician with an inability to bear weight on the left leg since the AM. This was first noticed in the daycare and the mother denies a history of injury or fall. There was no swelling redness or bruising. An x-ray of the lower left leg tibia and fibular was normal. On 11-FEB-2013, an x-ray of the left tibia and fibula was normal. On 14-FEB-2013, the patient presented to the PCP due to a 1 week history of the patient being unable to bear weight or straighten the left leg. An x-ray of the left leg was normal. The patient held the left lower extremity in hip flexed and extremities rotated fashion for less pain and pain worsened with leg straightened or rolling femur or manipulating knee. There was no foot or ankle pain. On 15-FEB-2013, the patient was seen by the PCP. The patient had a fever from 102 to 104 Fahrenheit (F) the previous night and presented with fever of 102.1 F. The patient was coughing, congested and was sneezing upon presentation to the PCP. The patient has minimal upper respiratory infection symptoms with no excessive cough or runny nose. The patient had continued left lower extremity complaints. There was no redness or swelling. There was normal movement of all extremities, no joint swelling was seen and muscle strength and tone were normal. There was tenderness on log roll of the left lower extremity. The patient's general appearance showed no acute distress. On 15-FEB-2013, an x-ray of the hip showed a normal pelvis and no bony or soft tissue abnormalities. On 15-FEB-2013, an ultrasound showed no evidence of joint effusion. An x-ray of the left tibia and fibula was normal. On 15-FEB-2013, the PCP arranged for admission to the hospital and the patient was hospitalized. The patient had a 1 week history of refusal to bear weight on the left leg and 1 day fever with a max temperature of 103.4 F. Previously, the patient had been pulling up to stand and cruising however she stopped doing this. Two days prior to being hospitalized, the patient developed a dry cough and slight clear rhinorrhea. On the day of admission, the patient had a fever of 103.4 F, decreased oral intake (solid and fluid) and increased sleepiness and irritability. The patient had 4 wet diapers on the day of admission. The mother denied recent trauma. There was no erythema, swelling or bruising noted. There was also no vomiting, diarrhea or rash. The patient had been given TYLENOL at home (at 10:45 am) without significant improvement. The patient had been around sick contacts at the end of January 2013 (mother and friend). An x-ray of the left tibia, fibula, pelvis and left hip were normal. A bilateral hip ultrasound showed no evidence of joint effusion. There was concern for a septic hip or osteomyelitis. An MRI of the left hip was normal. The patient was diagnosed with toxic synovitis which was treated initially with TORADOL and then transitioned to oral ibuprofen. The patient was also diagnosed with bronchiolitis which was the source of the fever. The patient experienced increased work of breathing, coughing and hypoxia. The patient's oxygen saturation was 87% on room air. The patient was placed on supplemental oxygen and weaned to 0.1 L via nasal cannula. On 16-FEB-2013, an MRI of the hip showed the osseous structures of the pelvis were normal without evidence of edema or abnormal enhancement to suggest the presence of osteomyelitis. Prominent non-enlarged inguinal lymph nodes were present bilaterally. A small amount of free fluid was present within the pelvis. The ischiorectal fossae was greater on the left than the right. The soft tissues otherwise appeared normal. There was no significant joint effusion. While hospitalized, the patient was initially receiving intravenous fluids, which was transitioned to a regular diet prior to discharge. Throughout the admission, the patient had increased range of motion of the left lower extremity and bearing weight at discharge. On 17-FEB-2013, the patient was discharged home on 1.8 liters (L) oxygen via nasal cannula and NSAIDs PRN. The patient was scheduled to follow-up with their physician. On 19-FEB-2013, the patient presented to the PCP for follow-up after being hospitalized. The patient had been diagnosed with bronchiolitis and was on oxygen. Diffuse wheezing was heard on auscultation with prolonged expiratory time. There was no obvious bacterial source for the toxic synovitis. It was noted that the MMRV vaccine was provided in the right thigh with symptoms in the left hip and lower extremity. The symptoms improved with MOTRIN. The patient also had a persistent runny nose and congestion for 5 days. The patient had associated cough intermittently without respiratory distress. There was normal movement of all extremities, no joint swelling, no joint tenderness and muscle strength and tone were normal. Ortoloni and Barlow's tests were negative. On 25-FEB-2013, the patient presented to the PCP experiencing continued persistent left lower extremity symptoms consisting of left lower extremity held in flexion and external rotation, guarding with straightening and internal rotation and mild lower back guarding with palpitation without direct bony tenderness. NSAID therapy was completed. The bronchiolitis symptoms had resolved. Oxygen saturation on room air was 98%. The oxygen was discontinued. On 01-MAR-2013, C reactive protein was 3.20 mg/dL, rheumatoid factor was <8.6 ID/ml and sed rate was 42 mm/hr. An MRI of the lumbar sacral spine showed possible syrinx from L2 extending cephalad above the range of test. A bone scan was negative. On 06-MAR-2013, an MRI of the brain, cervical and thoracic spine showed possible syrinx from T6-L2 otherwise normal brain and spine MRI. An incidental finding of cystic mass spleen was also seen. A hematology consult is pending regarding the splenic cyst. On 07-MAR-2013, a neurosurgery and neurology consultation was conducted. An MRI showed findings not consistent with syrinx but more likely persistent central canal (normal for age). The neurological evaluation was normal. There was no neurologic diagnosis for cause of limb pain and non weight bearing. On 08-MAR-2013, the patient was seen by the PCP. The patient awakened with a puffy right hand at daycare after napping. The patient was not using the hand initially but the swelling decreased and afterward it was being used normally. Mild edema of the right hand and fingers remained. No fever or other symptoms were assessed. The patient was active and moving normally. On 13-MAR-2013, the patient was taken to the PCP with a contusion of the midline of the nose and epistaxis which had resolved. The patient's grandmother stated the patient fell out of her chair about 8 to 10 inches high and hit the side of her head. On 22-MAR-2013, a rheumatology consultation diagnosed the patient with monoarticular juvenile rheumatoid arthritis and not toxic synovitis. The patient was treated with NSAIDs and will be followed up in 2 weeks. No action was taken with blinded study therapy as a result of the events of toxic synovitis in left hip and monoarticular juvenile rheumatoid arthritis. Dechallenge was reported as negative. The next dose of blinded study therapy is scheduled for the time period between 06-MAY-2013 and 20-MAY-2013. The reporting investigator considered that the events of toxic synovitis in left hip and monoarticular juvenile rheumatoid arthritis were related to blinded study therapy. Additional information is expected.