Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Nuclear magnetic resonance imaging thoracic normal, Red blood cell sedimentation rate increased
Clinical narrative: Case number PHHY2011US37118 is an initial spontaneous report received from a consumer (patient) in the form of a claim on 28 Apr 2011 with a combined follow-up received from a physician on 02 Sep 2011 and 06 Sep 2011. This report concerns a female patient. Her past medical history included chronic sinusitis, hypothyroidism, diverticulitis, and obesity, GERD, hearing loss, hypertension, hyperlipidemia, asthma and diabetes. She had undergone a tonsillectomy and an unspecified eye surgery. She was taking AVAPRO at a dose of 300 mg tablet once daily, metoprolol 100 mg tablet once daily, levothyroxine 137 mcg QD, vitamin D and baby aspirin. She had no known drug allergies and was not a smoker or drinker. She was vaccinated with FLUVIRIN 2010/2011 (batch number: 111824P1) on 07 Dec 2010. She experienced an upper respiratory infection in the early Dec 2010 but no gastrointestinal issue. She developed leg paralysis over a period of day or two at the end of Dec 2010. On 25 Dec 2010, she woke up feeling like her normal self hence had no difficulties whatsoever. But earlier that morning she noted slight back pain and weakness in her legs and within an hour she could not move. She was unable to move her legs. The nadir of her weakness occurred easily within one hour. The back pain was subtle. This frightened her greatly. She got weak and fell down and was transferred to a hospital. There it was obvious that she was weak and she was admitted into an intensive care unit of another hospital with the presumption of Guillain-Barre syndrome. There were thoughts about multiple sclerosis, transverse myelitis but the discharge diagnosis was made as Guillain-Barre syndrome. She was given intravenous immunoglobulin (IV Ig) which helped her condition to improve. There was no sphincter abnormality, visual disturbances, dysarthria or dysphagia, and throughout her hospitalization there was no neurologic problem above the waist. Her weakness was solely confined to her legs. She underwent extensive routine testing such as complete blood count (CBC), and comprehensive metabolic panel (CMP) were all normal, although there was slight hyponatremia at one point (no values provided). Erythrocyte sedimentation rate (ESR) was 30 (no units and normal range mentioned), vitamin B12 was normal. C-reactive protein showed high sensitivity with a value of 112 (no units and normal range mentioned) and lyme serology was negative. She had a CMV and HSV-1 and 2 serology done on spinal fluids which was negative. Spinal tap was carried out and the protein as 37. There were no cells and no oligoclonal bands. A limited viral serology versus CMV and HSV-1 and 2 were negative. Magnetic resonance imaging (MRI) scan of the cervical spine disclosed disc herniation at three levels. At the C6-7 level, by report, there was some impingement of the cord, but there was abnormality of the cord signal. MRI of the brain on the other hand disclosed multiple white matter abnormalities   [Due to memory limitations, the remainder of this text could not be compared.]  alities in both hemispheres. A thoracic MRI with and without contrast was unremarkable. The lumbar MRI disclosed disc protrusions at two levels. Upper extremity strength was normal, but the strength in the lower extremity was 2/5. There was no mention of the reflexes but according to the patient they were absent. After few days in the hospital she was transferred to a rehabilitation center for 45 days and since her hospitalization until on 26 Apr 2011 she was 60% better. From not being ambulatory at all she could now ambulate with a cane but did so in a very unsteady fashion. Her blood pressure was high at a value of 180/100 and she had hearing loss. Besides leg weakness and unsteadiness she had some difficulty in falling and maintaining sleep. Short of that there were no sphincter abnormalities. On neurologic examination it was found that she was overweight but her attention and concentration was normal. She showed marked stiffness of her legs. The diagnosis of Guillain-Barre syndrome was ruled out and she was assessed to have myelopathy likely in the thoracic spine, probably very caudal. She had spasticity of legs with very brisk reflexes and bilateral Babinsky, and there appeared to be a sensory level in addition. A comprehensive myelopathy was ruled out by structural imaging of the neural axis. The cerebrospinal fluid (CSF) formula was benign therefore a disease associated with transverse myelitis related to multiple sclerosis was suspected, but the other possibilities of post-infectious state and post-vaccination state could not be avoided. A spinal cord infarction was also considered a possibility but it was very rare as she had no cardiovascular risk factors. A metabolic myelopathy was also considered a possibility but her B12 was normal. She was recommended to undergo a diagnostic imaging 3T MRI for the spine with and without gadolinium. The final assessment was made that of unspecified acute myelitis. She was consulted on 16 May 2011 for a second opinion regarding the possible transverse myelitis. Her history and physical examination were suggestive of spinal cord pathology rather than a nerve disorder such as Guillain-Barre syndrome or a chronic inflammatory demyelinating polyneuropathy. She had hyperreflexia in the lower extremities, sustained clonus at the ankles and bilateral plantar responses with the sensory level just above the umbilicus. For this reason the localization of her problem was most likely the thoracic spinal cord, although a more cephalad lesion in the cord could explain her problem. She was showing improvement and her history was consistent with a diagnosis of transverse myelitis. She had occasional pain in the left hip region and had twitching in her legs, as they tend to spasmed toward her chest. She occasionally wheezed and had some heartburn and abdominal pain. There was no rash or heat and cold intolerance. She had low back pain but no depressive symptoms. Her blood pressure was 164/102 and pulse was 100. Her appearance, attention, language, memory and speech were unimpaired; she was well nourished and well hydrated. Occasionally, she also had urinary bladder incontinence. She had no peripheral edema nd palpable peripheral pulses. Her visual fields were intact. Fundoscopic examination was benign and pupils were reactive. Extra ocular movements were full and cranial nerves were unimpaired. Motor systems had normal limb, muscle strength and tone in upper extremities. There was no nystagmus or dysmetria. There was no dysarthria or gait ataxia. She was able to stand from a chair and walked without assistance. Her gait was paraparetic. No information regarding causality was reported. Combined follow-up received from a physician on 02 Sep 2011 and 06 Sep 2011: Updated information about medical history, concomitant medications, events and outcome.