Based on additional information on 14 September 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 5 June 2015. A 81-year-old female patient, whose and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number- U5016AA) and a dose of ADACEL (batch number- U4963AA) both vaccines via intramuscular route (site of administration was not reported for both vaccines) on 24 September 2014. The patient previously used NORVASC, CARTIA XT, ALTACE and MERIDIA. The patient has allergy of adhesive tape. She has a history of Hypothyroidism, Diabetes type 2, low risk hyperlipidemia, mitral valve regurgitation, aortic sclerosis, stage 3 chronic kidney disease, Hypertension and arthritis. Patient has no illness at the time of vaccination. On 8 October 2014, two weeks after vaccination, the patient woke in the middle of the night to use the restroom, she fell. Patient has no feeling sensation in her lower extremities and feeling below the umbilicus. She also experienced Transverse myelitis. Patient needs a walker to ambulate. All other causes have been ruled out and it is thought this is a result of vaccination. Laboratory investigations and corrective treatments were not reported. Patient required ER/doctor visit. At the time of this report, the patient was not recovered from the event. Upon medical review, the case was considered as serious due to important medical event: myelitis transverse, numbness and fall. Documents held by sender: none. Follow up information received from a physician on 14 September 2015. The expiry date of FLUZONE HD was reported as 29 March 2015. Medical history were patient had spinal fusion on 13 April 2005, urinary loss of control, spinal stimulator and up to date on cancer screening, Cataracts, Hypertension, Heart murmur, Back/neck pain, Numbness/Tingling, Paralysis/weakness, Arthritis, Sciatica, Artificial joint replacement, Physical limitations, Diabetes, Thyroid disorder, Bladder surgery, cesarean section, D and C (Dilation and curettage), tubal ligation, spinal fusion, hysterectomy, bilateral salpingo-oophorectomy (BSO), lymph node resection, right hip replacement. The patient had a history of multiple back surgeries with a spinal stimulator, so was unable to had an MRI. Patient had no known allergies. Concomitant medication were glipizide 10 mg tablet, Lisinopril 20 MG tablet once a day, levothyroxine sodium 125 MCG capsule once a day, AMARYL 1 MG tablet once a day, Simvastatin 40 MG tablet once a day, Hydrochlorothiazide 25 MG tablet once a day, Aspirin 81 MG tablet, Calcium 600 MG, CENTRUM SILVER, Fish oil 1000 MG capsule Delayed release twice a day, Zolpidem Tartrate 10 MG tablet once a day, Gabapentin 300 MG tablet, Amoxicillin 500 MG tablet 4 capsules one time prior to invasive procedures, Vitamin D3, AMBIEN 10 MG tablet once a day, medication list reviewed and reconciled with the patient. On 8 October 2015, two weeks following vaccination sudden onset of numbness from her waist down, severe right shoulder pain, right shoulder pain/ piercing pain right shoulder/ located in the right trapezius muscle/ left forearm pain/ musculoskeletal pain. On an unspecified date, following vaccination patient had lower back pain, muscle spasm still with the bear hug which moves around her abdominal region, difficulty with balance and in the house can walk without the walker, needs a walker to ambulate, absent lower extremity reflexes, spinal stenosis lumbar, sensory disturbances having some pain radiating from the sciatic notch down the back of the left leg, band like sensation left ankle/ couldn't feel her legs, electrical impulses are being felt throughout lower body, more than R heaviness/ heaviness of her left leg, difficulty with balance/ disturbance of gait/ ataxic gait, neck pain, neck stiffness, and feeling of bloating with baclofen. The patient continues in physical therapy and feels her strength is improving. The patient was hospitalized on an unspecified date. EMG of her lower extremities which revealed a moderate to severe polyneuropathy and chronic right LS reinnervation changes consistent with right LS radiculopathy. Patient other laboratory investigations on 13 August 2015 (03:39 pm) BP-sitting: 165/80 mmHg, height 62 inch, weight 200 lbs, body mass index: 36.6 kg/m2, body surface area: 1.91 m2 and patient also presented with obese. Temporal arteries was normal, eyes: extraocular movements was normal, visual field normal, cardiovascular: auscultation and heart rate and rhythm was normal. Musculoskeletal system a five finger dexterity exam was performed normally bilaterally. Neurological physical examination were estimated intelligence was normal, oriented to time, place, and person. Speech: Normal. No language abnormalities were demonstrated. Cranial Nerves: Optic nerve was not impaired. Oculomotor nerve was not impaired. Trochlear nerve was not impaired. No trigeminal neuropathy. Abducens nerve was normal. No facial nerve palsy was noted. Vestibulocochlear nerve was not impaired. Glossopharyngeal nerve was not impaired. Vagus nerve was not impaired. Cranial and spinal accessory nerves were normal. Hypoglossal nerve was not impaired. Sensation: decreased response to pain and temperature stimulation just above ankle right and mid-calf left. Decreased response to stimulation by vibration absent toes and decreased ankles and knees. Decrease in proprioception decreased in left great toe. No decreased response to tactile stimulation. Motor: Muscle bulk was normal. Muscle tone was normal. Strength was normal. Preference for right-handedness. No paresis was seen. No paralysis. No bradykinesia was noted. No Involuntary movements were seen. No fine, rapid tremor of both hands was seen. Coordination/Cerebellum: impaired heel-to-shin movement was seen. No Coordination/Cerebellum abnormalities were noted. No impairment of finger-to-nose movement was seen. Balance: impaired balance. Normal. Gait and Stance: Abnormal dragging is and unsteady. Arm swing was normal. Reflexes: Right biceps reflex: value 2, left biceps reflex: value 2, right brachioradialis reflex: value 2, left brachioradialis reflex: value 2, right knee jerk reflex: value 0.5, left knee jerk reflex: value 0.5, right ankle jerk reflex value 0, left ankle jerk reflex: value 0. Psychiatric. Appearance: Normal, Attitude: Not abnormal, Mood: euthymic, Affect: Normal, thought processes. Not impaired, thought content: Revealed no impairment. Patient had CAT scans of her brain, thoracic and lumbar spine all of which were fairly unremarkable. She had a lumbar puncture which was unremarkable. She had blood work to look for metabolic causes of the numbness, which were unremarkable as well. She had no further left forearm pain or numbness of her fingers in her left hand. Her physical therapist feels that the pain is due to the use of her walker. She continues with a heaviness of her left leg. She was slowing getting some feeling back in her trunk. She continued with numbness in her left leg, but her right leg has improved. Physical Findings Vitals taken 2 April 2015, (03:19 pm). BP-sitting: 165/80 mmHg, height 62 inch, weight 200 lbs, body mass index: 36.6 kg/m2, body surface area: 1.91 m2. On 14 January 2015, patient had EMG/NCS test and the result are the right radial SNAP demonstrated normal peak latency, and moderately reduced amplitude, bilateral sural and superficial peroneal SNAPS were unobtainable, the left peroneal CMAP demonstrated normal distal latency, severely reduced, amplitude and normal conduction velocity. The right peroneal CMAP demonstrated normal distal latency, moderately reduced amplitude and normal conduction velocity, the left tibia CMAP demonstrated normal distal latency, severely reduced, amplitude and normal conduction velocity. The right tibia CMAP demonstrated normal distal latency, normal amplitude distally, and normal conduction velocity, Bilateral tibia H-reflexes were normal, the right anterior tibialis demonstrated fibrillation potentials with reduced, recruitment of large amplitude MUAPs. The peroneus longus and posterior tibialis also demonstrated reduced recruitment of mildly enlarged MUAPs. Blood Analysis: Hematology-erythrocyte test, reviewed erythrocyte sedimentation rate: value 13. Blood Chemistry: Blood vitamin levels: Value. Reviewed serum vitamin B12 value: 552 pg/ml. Reviewed serum vitamin levels - Mate greater than 19, 9. Laboratory-based Chemistry; Immunology Studies: Reviewed antibody, Borrelia burgdorferi negative. Reviewed serum ANA neg. Microbiology Studies were performed. Microbiology - serum: value. Reviewed a serum C-reactive protein value 0.8 ng/ml. SSA/SSB negative. Test: CSF Analysis Report Date: 28 November 2014. CSF appearance clear: Normal, CSF Color colorless normal, CSF RBC 0/mm3: Normal, CSF tube Number TUBE 3#: Normal, CSF WBC 0/mm3 Normal, Glucose CSF 78 mg/dL High, Total Protein CSF 50.7 mg/dL. Test: Multiple Sclerosis Panel Report Date: 12 April 2014. Albumin, CSF 40.9 mg/dL Normal, Albumin, Serum TNP Normal, IgG, CSF 4.1 mg/dl normal, IgG index TNP Normal, CSF IgG synthesis rate TNP normal, myelin basic protein less than 2.0 mcg/L normal. CSF oligoclonal bands. Test: Angiotensin Convert Enz, CSF Report Date: 12 April 2014. Angiotensin Convert Enz, CSF 7 U/L Normal, Test; VDRL, CSF Report Date: 12 April 2014. VDRL, CSF Nonreactive Normal. Test B burgdorferi IgG IgM Ab, CSF Report. B burgdorferi IgG IgM Ab, CSF: Normal. Test: Varicella Zoster, PCR. VZV DNA, QL PCR Not Detected Normal. Source CSF Normal. Physical Findings Vitals taken 12 November 14 (08:49 pm) BP-Sitting 180/100 mmHg, height 62 in, weight 206 lbs, body Mass Index 37.7 kg/m2, and Body Surface Area 1.94 m2. Reflexes: Right biceps reflex: value 2, left biceps reflex: value 2, right brachioradialis reflex: value 2, left brachioradialis reflex: value 2, right knee jerk reflex: value 0, left knee jerk reflex: value 0.5, right ankle jerk reflex value 0, left ankle jerk reflex: value 0. Lumbar puncture under fluoroscopy, blood work to look for autoimmune common metabolic causes of transverse myelitis, CAT scan of the chest abdomen and pelvis to rule out tile possibility of a metastatic lesion, also need to rule out a possible thoracic aortic aneurysm which can cause a stroke to the artery of Adamkiewicz. Scan of the thoracic spinal cord. Patient was counseled and will need a CT myelogram to definitively make a diagnosis however this was very painful procedure and I would prefer to hold off on doing this until we've done the other workup. Her symptoms had been going on for 5 weeks and so I think it's reasonable to see whether her response to IV steroids and et the results of the spinal tap and CAT scans prior to putting her through a myelogram. Patient had very low suspicion for spinal cord compression as an etiology for symptoms as they are purely sensory in the compressive lesion would affect posterior column or motor as well. On 24 November 2014, CT scan of the brain was performed from the skull base through the higher convexities. The ventricles and position. There is no hemorrhage, mass lesion, or mid line shift, no extra-axial fluid collections are visualized. There is no evidence of acute infarction. The visualized paranasal sinuses are clear. The osseous structures are normal. Impression: Normal non-contrast CT scan of the brain. On 24 November 2014, CT scan of the thoracic spine with contrast performed. Reformatted coronal and sagittal images reviewed. Findings: Vertebral body heights are maintained. There is a mild levoconvex curvature the spine which may be positional. There is multilevel mild degenerative disc disease with disc space narrowing and endplate productive change. There are prominent flowing osteophytes along the right side of the thoracic spine which could represent DISH or degenerative change. There is multilevel facet hypertrophy. There is multilevel costovertebral hypertrophy. This is prominent on the right at T5 and T8. There are multilevel moderate to severe degenerative productive changes between the spinal processes of flic thoracic spine. There are 2 posterior central canal spinal stimulators a left sided-stimulator has its tip at the level of T7. This stimulator slightly projects to the right side of the posterior central canal. A right-sided stimulator has its tip at the level of T8. The 2 spinal stimulator wires enter from the right side. T1-T2, there is a posterior disc osteophyte complex. There is a mild central canal stenosis. There is moderate bilateral neural foraminal narrowing. T2-T3: there is bilateral facet hypertrophy. There is moderate mild bilateral neural foraminal narrowing. No central canal stenosis. T475: There is mild bilateral neural foraminal narrowing secondary to facet hypertrophy. No central canal stenosis. T8-T9, there is mild bilateral neural foraminal narrowing. No central canal stenosis. T9-T10, there is mild left neural foraminal narrowing. No central canal stenosis. T10-T11: there is mild bilateral neural foraminal narrowing. No central canal stenosis. On 21 October 2014, indication pain in right shoulder, two view examination of the right shoulder shows no evidence of fracture or dislocation. No other significant bone abnormalities are seen. The shoulder and acromioclavicular joint spaces are well maintained. No significant soft tissue abnormalities are noted. On 21 October 2014, indication pain in left shoulder, Findings: Two view examination of the left shoulder shows calcification in the region of the lateral left shoulder joint consistent with calcific bursitis/calcific tendinitis. There is no evidence of fracture or dislocation. No other significant bone abnormalities are seen. The shoulder and acromioclavicular joint spaces are well maintained, No significant soft tissue abnormalities are noted. IMPRESSION: No acute fracture. Calcific bursitis/tendinitis. On 28 November 2014, CSF analysis (28 November 2014, 1:32 pm). CSF analysis. CSF color: colorless, CSF appearances clear, CSF WBC 0, CSF RBC 0, Glucose, CSF. Protein. Myelin Basic protein result is less than 2.0, Interpretation Negative, Result: 4.1-6.0 mcg/L, Interpretation Weakly positive, Greater than 6.0 mcg/L, positive. Albumin, CSF result is 40.9, IgG, CSF result is 4.1, Oligoclonal Band: no Oligoclonal bands were identified in the patient's CSF when compared to the serum control. CT off the lumbar spine was performed with 3 mm axial and 2 mm sagittal and coronal sections. There are postsurgical changes of 8 laminectomy and posterior fusion. At T12-L1 the disc normal there is facet arthropathy. There is no stenosis or foraminal narrowing, a lead enters the spinal canal for a dorsal column stimulator. At L1-2 there is no disc bulging or herniation there is facet arthropathy. There is no central stenosis or foraminal narrowing. A second lead enters the spinal canal for a second dorsal column stimulator. At L3-4 there is severe disc degeneration with a vacuum phenomenon. There is a grade 1 spondylolisthesis. There is marked facet arthropathy, there is disc bulging, and hypertrophy of the ligamentum. This is resulting in severe central stenosis with mark rectal narrowing of the thecal sacs. There is mild bilateral foraminal narrowing. There is mild laminectomy defect from L3 through L5. At L3 4 there is disc degeneration and mild disc bulging. There is a mild grade 1 spondylolisthesis. There is no foraminal narrowing. At L4-5 there is reversal of the normal fidotic nerve. There is severe degenerative disc disease with, marked narrowing of the discs with a vacuum phenomenon. There are large osteonriytas. There is moderate disc protrusion. There is facet arthropathy. There is mild foraminal narrowing and severe foraminal narrowing on the left. There was no foraminal L4 and L5. Corrective treatment was 5 days of IV steroids with some relief. Continue MOBIC 7.5 mg tablet, 1 orally 30 days, 3 refills, baclofen 10 mg tablet, 1 gram SOLUMEDROL x 5 days for transverse myelitis. Outcome of event needs a walker to ambulate, numbness of BLE l more than R/ numbness waist down/ numbness from T8 distally left greater than the right/ axillary numbness/ numbness of fingers/ genital numbness, sensory disturbances/ band like sensation left ankle/ couldn't feel her legs, l more than R heaviness/ heaviness of her left leg, lower back pain/ muscle spasm still with the bear hug which moves around her abdominal region/ lumbago, right shoulder pain/ piercing pain right shoulder/ located in the right trapezius muscle/ left forearm pain/ musculoskeletal pain was recovering, absent lower extremity reflexes, moderate to severe polyneuropathy, neck pain, neck stiffness, feeling of bloating with baclofen and blurry vision after a dose of baclofen was unknown, spinal stenosis lumbar, electrical impulses are being felt throughout lower body, pain radiating from sciatic notch down the back of the left leg, difficulty with balance/ disturbance of gait/ ataxic gait was not recovered. Patient was discharged on 17 April 2015.