Age: 54.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Somatosensory evoked potentials, Treponema test negative, Urge incontinence, Urinary incontinence, Varicella virus test negative
Clinical narrative: The following is a compilation and summarization of the patient's medical records associated with the Adverse Health Event.  Patient is traditionally healthy and physically active with few medications. She is not due for any current screenings. Weight and height are good. 54 female.  The adverse event started approximately 18 days post vaccination for influenza and the COVID-19 booster.  On Sunday night, January 2, 2022, at approximately 11:00 p.m. awakened from sleep to use the bathroom. After urinating, her legs and thigh muscles felt sore and would be sore in the morning (i.e., similar to a post-workout). She proceeded to use a foam roller to roll out her muscles, but experienced pain from the pressure. Additional information for Item 18:  The pain was not similar to a post-workout.  She then became lightheaded and stumbled back to bed. When in bed, she experienced severe low back pain, the worst pain she had ever experienced which lasted 3-4 hours. She took oral naproxen, and when that did not help, she took 3 half tablets of hydrocodone over the course of those 4 hours. The hydrocodone was left over from her hysterectomy 5 years ago. She then fell asleep and when she woke up at approximately 7:00 a.m. the next morning, she had no pain, but on standing by the side of the bed, she fell over, experiencing bilateral weakness in the lower body. With difficulty, she managed to get back into bed. Because she typically has to urinate first thing in the morning, she was concerned that she did not have any such sensation, especially since she had consumed approximately 24 ounces of water during the night. With difficulty, using a type of crawl (hands and feet tepee style), she made her way to the bathroom but was unable to empty her bladder.   She and her husband then drove 2.5 hours from the location of their cabin and then proceeded to an urgent care center and then on to the emergency department of the local hospital. Her feet were numb and she was able to stand while holding on to something or someone, but unable to walk without assistance. She recalls she was catheterized for 1200 ml of urine.    The emergency room completed a workup for cauda equina. She underwent MRI imaging of the back and brain which were said to be unremarkable. The emergency room doctor expressed concern about possible GBS. She was given strict return precautions if any worsening symptoms of weakness progressed. She was given a course of oral prednisone for 7 days at approximately 30 mg for 3 days, 20 mg for 2 days and 10 mg for 2 days and prescribed hydrocodone. The emergency room performed no lumbar puncture.  Over the next several days, she began to improve but experienced difficulty urinating and incontinence. In addition, she started to experience severe leg cramps, i.e., extremely tight leg muscles, during the night hours making sleep very difficult. Prior to her scheduled office visit with her primary care physician (DO) he prescribed cyclobenzaprine (Flexeril) 5 mg and an additional course of prednisone, at a higher dose: 12 days at 60 mg for 4 days, 40 mg for the next 4 days, 20 mg for the last 4 days. He also recommended 3 ibuprofen and 2 Tylenol 3-4x/day.  On January 20, 2022, she saw her primary care physician for follow-up to the emergency room visit, as well as the scheduled annual exam. Pain was limited with only some mild pressure in the lower back. She had weakness of the lower legs and could not lift her heels while standing. She had numbness in the saddle area (back of buttocks and sides of hips, down to back of legs, including around vagina and anus. She was experiencing tightness in both legs (though more in the right hamstring and right hip, inability to feel hunger and inability to feel like she had to urinate or stool and urge incontinence when she has a full bladder or when she is experiencing pain in the low back or leg spasms. The primary care physician also noted that her left toe had 2 dots on it (petechia). He noted there is slow improvement with a tiny bit of strength coming back in both feet and legs. He also noted new hypertension and prescribed amlodipine (NORVASC) 2.5 mg; 1 tablet by mouth once daily. He recommended the patient see a neurologist and commenced a search one that was available to see her in a timely manner.   On January 24, 2022, she reported that the amlodipine was causing a very high heart rate (95 bpm at resting and 150 bpm while walking.). The primary care physician recommended discontinuing the amlodipine and thought the high blood pressure might be the result of "whatever is going on."  The primary care physician was unable to locate a neurologist within the patient's health insurance network and therefore, referred her to the Clinic due to their experience with GBS and similar conditions.  The patient was seen at the Clinic from February 15-17, 2022. At that time, she had improved to perhaps 50-60% of her nadir and the most bothersome symptoms at that time were decreased feeling in the perineum and inability to discern when she must evacuate the bladder or bowel. She has had a few episodes of incontinence of both urine and feces. She is conscientious about emptying the bladder and bowel and uses a modified credd maneuver to assist with the bladder. The toes tingle and feel "fuzzy". She cannot rise up on her tiptoes. She tried a muscle relaxant but has not used this medication for the last 2 weeks. There have been no other treatments and specifically no immunotherapies. She currently is taking no medications. She denies previous similar episodes and has never had monocular blurring of vision which lasted for hours or days or weeks with or without visual loss.  Clinic MD, with certifications in neuromuscular medicine and clinical neurophysiology since 2006 and 1996, noted the following on 2/15/2022:  Current examination findings show normal strength, sensation and reflexes (resulting in a Neuropathy Impairment Score of 0), normal straightaway gait, marked difficulty walking on toes alone but normal ability to walk on heels (Borque sign) and feet with otherwise normal foot morphology and normal pedal pulses, slightly cool temperature to the touch and otherwise normal skin. She now presents for MCA Neuromuscular evaluation.  The Clinic planned the following tests:  1) Blood tests associated with lumbar puncture  Completed 2/17/2022 2) Neurophysiology tests to include: EMG, SEP, VER and ARS  Completed 2/15 - 2/16/2022  3) Contrast imaging of the thoracic spine including the conus medullaris (Completed 3/6/2022) as well as magnetic resonance angiography for the possibility of a vascular process (Completed 5/19/2022). The clinic would also review the previous performed noncontract imaging of the spinal cord and brain.    Findings:  Neurophysiology tests   EMG (which indicated the caudal intraspinal process)   SEP (which was normal)   VAR (which was normal)   Contrast imaging of the thoracic and lumbar spine included the conus medullaris dated 3/6/2022 showed abnormal increased T2 signal within the central conus which could be sequela of a prior tiny spinal cord infarct, but was not thought by the Neuroradiologist to be specific in appearance.  Lumbar puncture results were unremarkable and did not provide convincing evidence of inflammatory and related disorders.  This may have been a small spinal stroke or acute transverse myelitis.   As of this submission (12/13/2022), while the patient has continued to slowly improve, she contineus to have decreased saddle sensation and poor sphincter and kegel control. Additionally, she remains weak in her right heel and has persistent numbness of her toes, she walks with a slight limp and occasional experiences incontinence of urine and stool.   The above compilation and summary provides compelling, reliable, valid, medical and scientific evidence that the patient's adverse health event was directly caused by the countermeasure of either the COVID-19 vaccine and/or the influenza vaccine, which were both given on the same day, 18 days prior to the patient's adverse health event.