Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Urinary retention, Urine analysis
Clinical narrative: Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis; Parazlyzed from the neck down; I had spasticity in my legs; Weird sensations in my body; Pain in my arms; Retention in my bladder/overactive bladder; Lost control over bowels; Hands are weak; Chest pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis), PARALYSIS (Parazlyzed from the neck down), URINARY RETENTION (Retention in my bladder/overactive bladder), ANAL INCONTINENCE (Lost control over bowels), MUSCLE SPASTICITY (I had spasticity in my legs), FEELING ABNORMAL (Weird sensations in my body) and PAIN IN EXTREMITY (Pain in my arms) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to nuts (Tree nuts), Birch pollen allergy and Vegetable allergy. Concomitant products included LORAZEPAM for Anxiety, SERTRALINE for Depression.   On 05-Apr-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PARALYSIS (Parazlyzed from the neck down) (seriousness criteria hospitalization and medically significant), MUSCLE SPASTICITY (I had spasticity in my legs) (seriousness criterion hospitalization), FEELING ABNORMAL (Weird sensations in my body) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (Pain in my arms) (seriousness criterion hospitalization). In May 2021, the patient experienced URINARY RETENTION (Retention in my bladder/overactive bladder) (seriousness criteria hospitalization and medically significant) and ANAL INCONTINENCE (Lost control over bowels) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYELITIS TRANSVERSE (Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced MUSCULAR WEAKNESS (Hands are weak) and BACK PAIN (Back pain). an unknown date, the patient experienced CHEST PAIN (Chest pain). The patient was hospitalized for 9 days until 04-Jun-2021 due to MYELITIS TRANSVERSE, then for 9 days until 28-Jun-2021 due to ANAL INCONTINENCE, FEELING ABNORMAL, MUSCLE SPASTICITY, PAIN IN EXTREMITY, PARALYSIS and URINARY RETENTION. The patient was treated with BACLOFEN for Muscle relaxant, at a dose of 10 mg once a day; BACLOFEN for Muscle relaxant, at a dose of 10 mg and FLUDROCORTISONE for Blood pressure abnormal, at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis), PARALYSIS (Parazlyzed from the neck down), URINARY RETENTION (Retention in my bladder/overactive bladder), ANAL INCONTINENCE (Lost control over bowels), MUSCLE SPASTICITY (I had spasticity in my legs), FEELING ABNORMAL (Weird sensations in my body), PAIN IN EXTREMITY (Pain in my arms), MUSCULAR WEAKNESS (Hands are weak), CHEST PAIN (Chest pain) and BACK PAIN (Back pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Magnetic resonance imaging: abnormal (abnormal) Abnormal Diagnosed with Acute Transverse Myelitis. Spine was inflamed from C2 - C7. On an unknown date, Blood test: couldn't find anything (normal) couldn't find anything. On an unknown date, Urine analysis: couldn't find anything (normal) couldn't find anything.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that on 21-JUL-2021 neurogenic bladder test was done, results were not reported. Patient was given 5 rounds of steroids and had a lumbar puncture. The steroids were very effective in getting my paralysis down. MRI of her  thoracic spine is scheduled on August 27th because of new chest and back pain. Went back to the Urologist to have a neurogenic bladder test.  The patient reported that she was prescribed a bladder medication, Gemsa, and she also straight cath herself about 6 times or more a day.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-230242 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.