Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Viral test negative, Weight bearing difficulty, X-ray of pelvis and hip normal
Clinical narrative: A follow-up report has been received from VAERS initially received via a physician concerning a 5 years old male patient who was enrolled in a study. The patient's past medical history included an umbilical hernia which was repaired in Sep-2009. His concomitant medications were not provided. No known drug allergies. The patient received FLUMIST (intranasal) on 27-Aug-2009. In Sep-2009, the subject experienced a runny nose, cough and occasional back pain. On 20-Sep-2009, he developed fever up to 101 degrees Fahrenheit. On 21-Sep-2009, the subject was seen in the urgent clinic for fever, increased sleepiness and leg pain for the last two days. The pain started in his feet and progressed to his legs and groin area and was relieved with ibuprofen. He was also having difficulty walking. The subject was admitted to the hospital the same day. He was noted to have a temperature of 102 degrees Fahrenheit, increased warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. His cranial nerves II-XII were intact. An x-ray of the hip was normal, his sedimentation rate was 18 and CRP was elevated at 10.5. His CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A and B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus, and enteroviruses and CSF fluid was negative by PCR for enteroviruses. His CSF fluid showed no WBC, no RBC, glucose of 63 mg/dl and protein of 16.8 mg/dl and the CSF culture showed no organisms. A MRI of brain and cervical, thoracic and lumbar spine with and without contrast did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. His CK was elevated at 1094 U/ml. A nerve conduction study performed on 24-Sep-2009 demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. The subject received IVIG on 24-Sep-2009 and 25-Sep-2009. The final diagnosis was Guillain-Barre syndrome. He was discharged home on 27-Sep-2009. His discharge medications included pregabalin. A follow-up visit was scheduled at a neurology clinic in 4 weeks. Patient recovered from the event of Guillain-Barre syndrome on unknown date. The investigator assessed this event as unlikely related to FLUMIST. The sponsor assessed this event as not related to FLUMIST. The reporter considered the event of Guillain-Barre syndrome to be serious with seriousness criteria of hospitalisation. Summary of follow-up information received by AstraZeneca/MedImmune on 14-Nov-2013 from health authority: Outcome for the event updated from unknown to recovered. Reporter details updated. Dosing regimen for FLUMIST updated. Narrative updated accordingly.