Age: 27.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: CSF oligoclonal band absent, CSF protein normal, CSF white blood cell count increased, Computerised tomogram normal, Culture negative
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. VAERS reference number was reported as 373104. A 27-year-old female patient received FLUZONE (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1 (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptom onset. On 05 November 2009, 7 days post-vaccination with FLUZONE, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1 (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous methylprednisolone (1 g/d) and plasmopheresis for 5 days. She was discharged from the hospital on 22 December 2009. Following a slow taper over 6 weeks, she showed significant improvement of symptoms. The event was considered to be recovered on 22 December 2009, with the sequelae of neurogenic bladder. The reporter assessed the events as related to H1N1.