Sex: F
Vaccine: FLU4
Symptoms: Spinal X-ray normal, Spinal cord injury, Swelling, Tandem gait test abnormal, Treponema test negative
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 42-year-old female patient who received FLUARIX QUADRIVALENT. Previously administered products included influenza vaccine (each of the previous 20 years and had had no adverse reactions to any of those vaccinations). Concurrent medical conditions included glaucoma, hypertension and low back pain. In November 2013, the patient received FLUARIX QUADRIVALENT. In November 2013, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced acute disseminated encephalomyelitis (serious criteria hospitalization and GSK medically significant), numbness of lower extremities (serious criteria hospitalization), skin tenderness (serious criteria hospitalization), skin warm (serious criteria hospitalization), fatigue (serious criteria hospitalization), sign Babinski present (serious criteria hospitalization), hyperreflexia (serious criteria hospitalization), urination difficulty (serious criteria hospitalization), constipation (serious criteria hospitalization), difficultly breathing (serious criteria hospitalization), hyperesthesia (serious criteria hospitalization), Lhermitte's sign (serious criteria hospitalization), spinal cord injury (serious criteria hospitalization and GSK medically significant), gait disorder (serious criteria hospitalization) and demyelination (serious criteria hospitalization and GSK medically significant). In December 2013, the patient experienced tingling of extremity (serious criteria hospitalization) and swelling (serious criteria hospitalization). The patient was treated with MIRALAX and methylprednisolone. On an unknown date, the outcome of the acute disseminated encephalomyelitis, numbness of lower extremities, skin tenderness, skin warm, fatigue, sign Babinski present, hyperreflexia, urination difficulty, constipation, difficulty breathing, hyperesthesia, Lhermitte's sign, spinal cord injury, tingling of extremity and swelling were recovering/resolving and the outcome of the gait disorder and demyelination were unknown. The reporter considered the acute disseminated encephalomyelitis, numbness of lower extremities, skin tenderness, skin warm, fatigue, sign Babinski present, hyperreflexia, urination difficulty, constipation, difficulty breathing, hyperesthesia, Lhermitte's sign, spinal cord injury, gait disorder, demyelination, tingling of extremity and swelling to be related to FLUARIX QUADRIVALENT. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis (ADEM) in a 42-year-old female patient who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). The patient had moderate glaucoma and hypertension. The patient had received an annual influenza vaccination each of the previous 20 years and had had no adverse reactions to any of those vaccinations. No information on family history was provided. On an unspecified date in November 2013, the patient received FLUARIX QUADRIVALENT, lot 5EE73 (administration route and site unspecified; dosages unknown). The age of vaccination was not provided. The vaccine contained the influenza A-H1N1 virus, the influenza A-H3N2 virus, the influenza B/Yamagata lineage virus, and the influenza B/Victoria-lineage virus. The patient's immunization records revealed that he was inadequately immunized. The patient went on a business trip. On an unspecified date in November 2013, 7 days after vaccination, the patient experienced numbness in both lower extremities. She reported this symptom to the chiropractor she was seeing for lower back pain. The chiropractor told her that the numbness was evidence that the chiropractic treatment was working. The patient also experienced abdominal skin tenderness and reported that her skin was unusually warm to the touch, although no rash or skin change was visible. She also said that she had fatigue; however, she thought that the fatigue might be due to the stress of caring for 2 young children or to stress related to her work. The lower-extremity numbness continued intermittently during the next several days. 25 days after the trip, the numbness had ascended to the patient's abdomen and right hand. She then sought help from orthopedists and had a spinal radiograph, spinal computed tomography, and needle electromyography on both hands. The test results were unremarkable. 29 days after the trip, the patient was referred to a neurology clinic. The patient was referred to the emergency department for cervical magnetic resonance imaging (MRI) because she had the Babinski sign and hyperreflexia of tendon reflexes in the limbs (3+ to 4+). The pinprick test indicated impairment below the right C3 and left T2 levels. The patient experienced difficulty urinating and passing stools. A urinary catheter was inserted and drained more than 1000 mL of yellow urine. Subsequently, in November 2013, the patient was hospitalised. After admission, the patient's numbness ascended to the chest, causing difficulty breathing. In addition, she had hyperesthesia in the right part of the scalp, the skin behind the right ear, the right upper extremity, and both lower extremities, and the numbness became more severe. She could walk with assistance; however, tandem gait and jumping on one leg were difficult. The Lhermitte sign was positive, so a lumbar puncture was performed. Analysis of the cerebrospinal fluid yielded the following results: pressure 165/125 mm Hg, with 47 white blood cells and 22 red blood cells per high-power field, protein level 58 mg/dL, and glucose level 63 mg/dL. The immunoglobulin G index was 0.39. MRI of the cervical spine revealed mild hyperintense spinal cord lesions at C2-C3 and T1-T3, and a crescentshaped lesion outside the dual sac, which corresponded to the hyperintense lesions. Brain MRI before and after injection of contrast material showed small lesions in the subcortical white matter of the left high parietal and left dorsal aspects of the pons, and the left middle part of the cerebellar peduncle had a high signal on T2-weighted images, consistent with a demyelinating process. Also, a focus of enhancement in the left middle cerebellar peduncle indicated a relatively active lesion. The cervical spine MRI showed multiple intramedullary high-signal lesions on a T2-weighted sagittal view from C3 to C4, C5 to C6, and the dorsal aspect of the pons, with mild enhancement. An autoimmune profile survey was done, and possible metabolic causes related to myelopathy were checked, including syphilis of HIV disease; all test results were within the reference range. Blood cell counts, hepatic and renal function, electrolyte levels, blood glucose level, and lipid levels were all within the reference range. At this point, ADEM was diagnosed because the patient's signs and symptoms occurred after she had received a vaccination for influenza. Differential diagnoses included multiple sclerosis, neuromyelitis optica, and spinal vascular lesion. The option of steroid treatment was discussed with the patient, and a 5-day methylprednisolone pulse therapy was started in December 2013, with a dose of 1 g/d via intravenous infusion. The patient's numbness and swelling were limited to the sole and toes of the right foot after the first 5 days of the pulse therapy. The patient's signs and symptoms improved. After the therapy, her only symptoms were tingling in the lower extremity and numbness in the toes. The patient was discharged after 10 days of hospitalization. Oral methylprednisolone were prescribed, with a tapering off in dose during a 4-week period. However, during the first week after initiation of oral therapy, she reported that numbness and swelling were returning to her right knee. After 2 weeks of oral methylprednisolone, the numbness in the right knee was gone, and the only numbness was remaining was in the sole of the right foot. However, when the dose of oral steroids was decreased again, the area of numbness expanded back to the right calf. In February 2014, during follow-up MRI was performed. No results were provided. No new symptoms developed during the first 6 months; however, the patient returned to her urologist and gastroenterologist for a follow-up on the constipation. She was encouraged to use a laxative containing MIRALAX to return her bowels to normal functioning. In addition, she was told to maintain as active a life as possible. This case has been considered serious due to hospitalisation. The author considered the event of ADEM related to FLUARIX QUADRIVALENT. The author concluded, 'Influenza vaccine is considered safe. However, adverse events do occur, and the possibility of these events (and what to do when they occur) is currently not routinely discussed by clinicians giving influenza vaccinations, except that recipients are asked about allergy to eggs, a history of Guillain-Barre syndrome, or some other indicator that an adverse event could occur. Therefore, a study of our case and of other similar cases in which a patient experienced ADEM after receiving a vaccine is useful. After 3 months of treatment, our patient had an approximately 80% recovery. Cases in which vaccines are suspected of inducing serious autoimmune illnesses are rare, but they do exist, and health care providers should be aware of the possibility. Vaccination records and patients' histories should be evaluated immediately for any patient who has signs and symptoms related to diseases of the central nervous system soon after receiving a vaccination for influenza.'