Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Osteomyelitis, Red blood cell sedimentation rate increased, Skin discolouration
Clinical narrative: A serious clinical trial report of osteomyelitis has been received from an investigator concerning a 29-month-old female, subject number 28398632, who is enrolled in study.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On the day of vaccination and for several days prior to vaccination, the subject's right foot was noticeably swollen and tender: and she walked with a limp despite no known injury.  The subject had no concomitant medications and no known allergies.  The subject received FLUMIST on 26-Nov-2007 intranasally for influenza vaccination.  On 26-Nov-2007, the day she received the FLUMIST vaccine, it was noticed that the right foot was swollen, tender, and the subject was limping.  The subject was seen in the ER and a slight improvement was noted since a previous ER visit.  On examination at the ER, slight swelling of the dorsum foot was noted with some limping, no ankle swelling and normal ROM.  Her axillary temperature was 98.4 degrees Fahrenheit.  X-rays of the right foot were taken on 18-Nov-2007 and 11-Dec-2007, both showed no overt fracture, no malaligment and no emphysema.  On 12-Dec-2007, an office visit revealed continued swelling and limping, discoloration of dorsum of right foot, no fever or other symptoms.  The subject was referred to podiatry.  On 14-Dec-2007, a MRI revealed an aggressive lesion in the medial cuneiform, concerning for infection.  However, given the relative lack of elevated white count and other clinical symptoms of infection, other neoplastic etiologies such as leukemia, eosinophilic granuloma, or sarcoma could not be excluded.  There was guestionanle edema in the ascending cuneiform and involvement of the bone was not excluded.  On 22-Dec-2007, the subject was admitted to the hospital for the management and treatment of a presumed right foot cateomyelitis.  On the date of admission, the subject had the following laboratory results: neutrophils 31% (80-70%); eosinophils 5% (0-4%), and ESR 25 mm/Hr (0-20 mm/Hr).  Upon admission, an IV was started for antibiotics after a debridement of her right cuneiform bone.  The cultures were negative.  The subject was started on CELAZOLIN IV which was continued for seven days.  The hospital stay was without complications.  The subject was discharged from the hospital on 28-Dec-2007, after seven days of IV antibiotics then ordered to complete a two week course of CEPHALEXIN orally.  The subject was doing well at discharge.  On 28-Jan-2008, the subject presented for an office visit to follow up the CETEOMYELITIS of the right medial cuneiform.  The subject was noted to be doing well, no limp or complications of pain, no fever or swelling.  The right medial foot had healed well with no signs of infection or swelling.  New X-rays revealed all foot bones to be normal.  The assessment showed the osteomyclitic of the right medial cuneiform to be resolved.  The event was resolved on 28-Jan-2008.  The investigator assessed the osteomyelitis as not related to FLUMIST.  The sponsor assessed the relationship to FLUMIST as not related.  Follow-up information received 20-Oct-2008 and incorporated into the narrative: D/C summary and laboratory results.