Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Aphasia, Asthenia, Burning sensation, CSF protein increased
Clinical narrative: A report has been received from a physician concerning, female patient of an unknown age. The patient's relevant medical history or concomitant medications were not reported. The patient had been receiving FLUMIST started during Sep-2012. The health professional reported that the patient was diagnosed with the Guillain-Barre syndrome (GBS), which she said she got after receiving FLUMIST. The physician reported that the patient received FLUMIST in mid Sep-2012 and within 2 weeks she experienced headaches and eye problems which improved as she did not seek medical help. On or around Halloween 2012 she sought medical help for tingling of her feet, her symptoms progressed. The reporter reported that the patient was admitted to a hospital as the notes in the database are very scant and it did not appear that their office was notified of this event. The patient was admitted on 09-Nov-12 to the ICU, she had paralysis of her arms and legs for 3 to 4 days but she did not need a ventilator. She was discharged at a later date to intensive rehabilitation. Her arms and hands were now fine but her legs continued to experience some numbness and she had gait issues and she also had eye problems. The physician reported that she may possibly have the Miller Fischer variant of GBS/GBS. It was reported that a few days before the patient went home on leave, she received FLUMIST. When the patient got to her home she began to notice symptoms, but initially brushed them off. She noticed her feet were becoming numb and felt like they were being stuck with pins and needles. Then the patient had neck problem and her tongue started to go numb, and then the entire mouth. Then her hands felt like pins and needles, and next night it got worse. The patient began to feel weak and she could barely pick up a 20 pound bag of mulch. Her calves felt like they were on fire. The pain was moving up her legs and her feet were hurting. The patient was admitted to emergency room. It was noticed that she was walking weird and she needed a wheel chair. She could not do the paperwork or hold a pen. Her condition continued to deteriorate at alarming pace. Along with other symptoms her speech started slurring badly. She was transported by ambulance to a hospital where neurologist gave her spinal tap and found extreme amounts of proteins in her spine. She was transferred to intensive care unit, where she learned she had contracted Guillain-Barre syndrome. It was reported that the patient was paralyzed from head to toe and lost her ability to talk or to do any thing at her own. She was declared critical patient. It was reported that the patient had slowly and steadily progressed on the road to recovery. The action taken on influenza vaccine was unknown. The patient was recovered from the event of headache and the patient was recovering from the event of Miller Fischer variant of GBS/GBS. At the time of reporting, the events of eye problems, leg numbness and gait issues were ongoing. The reporter assessed the event of Miller Fischer variant of GBS/GBS to be serious with the criteria of important medical event. The company physician assessed the event of Miller Fischer variant of GBS/GBS to be serious with the criteria of hospitalization and the events of eye problems, leg numbness, gait issues and headache to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 11-Feb-2013 from physician: Added non-serious events of eye problems, leg numbness, gait issues and headache to the case. Start date of suspect updated as mid Sep-2012. Updated reporter details. Previously reported serious event GBS was captured with changed verbatim Miller Fischer variant of GBS/GBS and with outcome as recovering. Case narrative updated. Corrected report 19-Feb-2013: New reporters mandatory for vaccine added.