VAERS 2530117
GLAXOSMITHKLINE BIOLOGICALS · INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) · Charge NS775
- Staat
- WA
- Alter
- 54,0
- Geschlecht
- F
- Eingang
- 13.12.2022
- Impfdatum
- 16.12.2021
- Beginn
- 02.01.2022
- Tage bis Beginn
- 17,0
- Dosis
- 1
- Route/Site
- IM / RA
Symptomtext
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.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Hypertension
- Hospital-Tage
- -
- Labordaten
- Test Short Name Result Notes Aquaporin-4 Antibody NMO/AQP4-lgG FACS,CSF Negative 2/18 Informative autoantibodies MOG FACS,S Negative A negative test does not preclude a diagnosis of an inflammatory CNS demyelinating disorder. 2/18 Cytomegalovirus PCR Negative 2/17 Lyme Disease B. burgdorferi PCR Negative 2/17 Lyme Disease B.mayonii PCR Negative 2/17 Lyme Disease B.garinii/B. Afzelii PCR Negative 2/17 Varicella-Zoster Virus PCR, V Negative 2/17 Kappa Free Light Chain, CSF Negative Value 0.0331 / standard<0.1000 mg/dL; The kappa free light concentration measures in DSF is lower than the threshold associated with demyelinating disease. 2/17 Cell Count and Differential, CSF Negative CSF was clear, colorless; cell count within normal range. 2/17 NMO/AQp4 FACS, CSF Negative 2/17 Protein, Total CSF Positive Outside average range of 15-45 (at 49) 2/17 Cryptococcus AG w/ Reflex, LFA, CSF Negative 2/17 Glucose CSF Negative Value=64; CSF glucose should be approx 60% 2/17 VDRL CSF Negative 2/21 IGG Index CSF Immunoglobulin G Negative 899; Range 767 to 1,590 2/21 IGG Index CSF Albumin Negative 4400; Range 3500 to 5000 2/21 IGG Index CSF IgG Index Negative 0.65, standard range <=0.85 2/21 IGG Index CSF IgG, CSF Negative 3.8; standard range <=8.1 2/21 IGG Index CSF Albumin Positive 30.2; standard range <=27.0 2/21 IGG Index CSF IgG/Albumin Negative 0.13; standard range <=0.21 2/21 IGG Index CSF Synthesis Rate, CSF Negative 4.16; standard range <=12 2/21 IGG Index CSF IgG/Albumin, S Negative 0.20; standard range <=0.40 2/17 Glucose Random Glucose, S Negative 98; standard range 70 to 140 2/17 Paraneoplastic Autoantibody eval AChR Ganglionic Neuronal ab, S Negative 2/17 Paraneoplastic Autoantibody eval Amphiphysin Ab, S Negative 2/17 Paraneoplastic Autoantibody eval AGNA-1, S Negative 2/17 Paraneoplastic Autoantibody eval ANNA-1, S Negative 2/17 Paraneoplastic Autoantibody eval ANNA-2, S Negative 2/17 Paraneoplastic Autoantibody eval ANNA-3, S Negative 2/17 Paraneoplastic Autoantibody eval CRMP-5-IgG,S Negative 2/17 Paraneoplastic Autoantibody eval Neuronal (V-G K+ Channel Ab, S Negative 2/17 Paraneoplastic Autoantibody eval P/Q-Type Calcium Channel Ab Negative 2/17 Paraneoplastic Autoantibody eval PCA-1, S Negative 2/17 Paraneoplastic Autoantibody eval PCA-2, S Negative 2/17 Paraneoplastic Autoantibody eval PCA-Tr, S Negative 2/18 Cyclic Citrul Peptide AB, IGG Negative <15.6; standard rang <20.0 2/16 Autonomic Reflex Negative There is no evidence of a significant generalized disorder of the autonomic nervous system (cardiovagal, cardiovascular adrenergic, or postganglionic sympathetic sudomotor pathways) 2/16 Somatosensory Test Negative The right median and tibial SEPs are normal. There is no electrophysiologic evidence of impaired conduction in central proprioceptive pathways serving the right upper or lower extremity. 2/16 Visual Evoked Potential Test Negative Normal study. There is no electrophysiologic evidence of impaired conduction in visual pathways. 2/15 EMG Positive There is EMG evidence of a subacute, evolving process involving right L5-S1 nerve roots or their anterior horn cells in a pattern that does indicate the presence of reinnervation 2/15 Copper, Serum Negative 1.4; standard range 0.75 to 1.45 2/15 MOG FACS,S Negative 2/15 Pernicious Anemia C Negative 631; standard range 180 to 914 2/15 AB to Extractable N Negative Six tests 2/15 Zinc Negative 0.73; standard range 0.66 to 1.10 2/15 Angiotensin Conveting Enzyme Positive 8; standard range 16 to 85 2/15 Syphilis screen Negative nonreactive 2/15 SARS Coronavirus 2 Negative undetect3ed ------------------------------------------ 4/1/2022 CLINIC INTERPRETATION OF OUTSIDE MR SPINE Ordering provider: MD Resulted by: MD Outside MRI Examination of the thoracic spine dated 3/6/2022 is submitted for interpretation. The examination includes T1-weighted sequences following the IV administration of gadolinium based contrast material. Comparison: Outside thoracic and lumbar spine MRI examinations from 1/3/2022. Findings: The marrow pattern is benign. There is increased T2 signal within the central conus (series 7 image 50) which is at the level of the mid L1 vertebral body. No abnormal enhancement. With the benefit of hind site bias, this finding was probably present on the outside lumbar spine MRI study of 1/3/2022 (series 6 image 8). No axial images were obtained through the conus on either the thoracic or lumbar spine MRI studies from 1/3/2022. Given the patient's clinical history, this could represent sequela of tiny spinal cord infarct but is not specific in appearance. There is no significant central canal or foraminal stenosis at any thoracic level. Degenerative changes in the lower thoracic facet joints at the T9-10 through T11-12 levels. Post gadolinium sequences are negative. ------------------------------ 5/19/2022 - Spinal Angiogram An angiogram is a diagnostic study that uses x-ray and contrast dye to visualize the blood vessels in the spine. Angiography is useful for being able to identify and visualize certain cerebrovascular abnormalities such as 1) blood vessel abnormalities, 2) Dural Arteriovenous Fistulas, 3) Arteriovenous Malformations (also known as AVM). MD, Neurosurgery - Cerebrovascular Center. I noted that spinal cord infarction in an otherwise healthy people are quite rare but that in the absence of other significant cardiovascular risk factors in the setting of her unusual pain a spinal artery dissection would be a consideration. I noted that angiography at this point would be unlikely to result in a change in management and that if there was a dissection that is may well be healed and undetectable at this point. Less likely but not impossible, if there was a dissection one might find persistent irregularity or pseudoaneurysm affecting the spinal artery that would be important to be aware of. Results: Negative
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Estradiol (ESTRACE) 0.1 mg vaginally weekly; multi-vitamin
- Allergien
- none
- Vorherige Impfungen
- -