Sex: U
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: TRANSVERSE MYELITIS DRUG-INDUCED; This spontaneous report received from a health care professional by a Regulatory Authority was received on 19-APR-2024 and concerned a patient of unspecified age and sex. This patient was also referenced in literature. The patient's weight, height, and medical history were not reported. METHOD: In a review of FDA's Vaccine Adverse Event Reporting System (VAERS), 25 patients (18 women and 7 men) aged between 34-86 years were described, who developed TM following administration of Ad26.COV2-S, elasomeran or tozinameran for immunization against COVID-19 [routes and dosages not stated; not all durations of treatments to reactions onsets and outcomes stated]. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-MAR-2021 (dose series 1), and dose was not reported, administered on 29-MAR-2021 (dose series 2) for covid-19 prophylaxis.  On an unspecified date, the patient experienced transverse myelitis drug-induced (dose series 1). RESULTS: The TM summary described as follows: numbness tingling in feet, toes progressed to waist (1 patient), numbness and needle-like pain in both feet, ascending to waistline with difficulty walking due to heavy sensation in legs and burning erythematous rash (1 patient), numbness and tingling from chest distally with girdle-like banding around trunk, hand dysfunction and impaired gait (1 patient), upper and lower extremity weakness (1 patient), tingling in both hands, paresthesias in feet, weakness in left arm and both legs with difficulty climbing ladder and fell in the home (1 patient), ascending numbness from feet to waist, hand tremors, gait ataxia and upper spine pain (1 patient), leg weakness, bladder/bowel dysfunction (1 patient), new onset seizures (1 patient), left side numb, gait unsteady and left hand dysfunction over weeks (1 patient), 1 day of severe upper extremity weakness and numbness (1 patient), left side numb and right side weak following dose1 and 2 respectively (1 patient), upper extremity proximal and distal weakness and impaired light and sharp touch, temperature, vibration and proprioception on the right with Romberg positive (1 patient), headache, cramping; chills, fatigue, leg pain and difficulty walking by the second day (1 patient), inability to walk with bowel and urinary dysfunction; left side numb from toes to breast and right side numb from toes to groin with left leg weakness (1 patient), electrical sensations, numbness and weakness lower extremities, unstable gait and sexual dysfunction (1 patient), bilateral shoulder and neck pain, lower extremity paresthesias, bilateral ataxic tremors, bilateral pruritis from wrists to elbows (1 patient), dizziness and nausea 20 minutes after first vaccination, progressing to severe left upper and lower extremity weakness with inability to walk after 2 days with intact sensation intact, urinary retention, hyperreflexia and left Babinski sign (1 patient), generalized tonic-clonic seizure, disorientation with bilateral multifocal pneumonia also diagnosed with meningoencephalitis, quadraplegic but able to follow commands with the eyes and mouth, weight loss, night sweats and one week of paresthesias in the lower extremities, neurological decline (1 patient), ascending paralysis consistent with transverse myelitis (1 patient), acute left leg weakness and sensory loss and T10 sensory level, progressing to numbness and paresthesias in the right leg with hyperreflexia n the left leg and a T5-6 sensory level (1 patient), incomplete transverse myelitis (1 patient), paresthesias and slight weakness in the right leg and onset left leg weakness and bowel and urinary retention with hydronephrosis (1 patient), headache, fatigue and cramping evening following evening chills, fatigue, pain and heaviness in lower extremities legs, progressing to inability to walk (1 patient), transverse myelitis thoracic region (1 patient), pain in the right arm which steadily intensified and spread quickly to upper torso, severe back pain with ascending numbness and paresthesias in the legs to lower abdomen, unable to stand (1 patient), numbing sensation on the left lip, numbness of the right foot travelled proximally to the waistline then the left foot and peroneal area, tiredness, sensation in the legs and slight urinary incontinence (1 patient). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of transverse myelitis drug-induced was not reported. CONCLUSION: the patients were treated with methylprednisolone, plasma exchange, dexamethasone, unspecified symptomatic treatment, methylprednisolone [Solumedrol], prednisone, unspecified corticosteroids or unspecified steroids. Eventually, 6 patients showed improvement. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Myelitis transverse. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.