VAERS ID: 2331142

Description

Guillain Barre syndrome; Acute polyradiculoneuritis; distal motor deficit of the upper limbs which rapidly spreads to the 4 limbs; gait disturbances; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: FR-AFSSAPS-LY20220950 (RA). A 64-year-old female patient received BNT162b2 (COMIRNATY), on 29Jun2021 as dose 1, single (Lot number: FC3143) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: not tested; "appendectomy" (unspecified if ongoing), notes: urethral support Apr2021. The patient's concomitant medications were not reported. The following information was reported: ACUTE POLYNEUROPATHY (hospitalization, medically significant) with onset 21Jul2021, outcome "recovered with sequelae", described as "Acute polyradiculoneuritis"; MOTOR DYSFUNCTION (hospitalization) with onset 21Jul2021, outcome "unknown", described as "distal motor deficit of the upper limbs which rapidly spreads to the 4 limbs"; GAIT DISTURBANCE (hospitalization) with onset 19Aug2021, outcome "unknown", described as "gait disturbances"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "Guillain Barre syndrome". The patient was hospitalized for acute polyneuropathy, motor dysfunction, guillain-barre syndrome (start date: 28Jul2021); for gait disturbance (start date: 24Aug2021, discharge date: 07Sep2021, hospitalization duration: 14 day(s)). The patient underwent the following laboratory tests and procedures: Antibody test: (09Sep2021) anti-GT1a antibodies positive, notes: anti-GT1a antibodies; Blood creatine phosphokinase: (unspecified date) negative, notes: Blood test: 24Aug2021-07Sep2021; Blood potassium: (unspecified date) normal, notes: Blood test: 24Aug2021-07Sep2021; Blood sodium: (unspecified date) normal, notes: Blood test: 24Aug2021-07Sep2021; Blood thyroid stimulating hormone: (unspecified date) normal, notes: Blood test: 24Aug2021-07Sep2021; Coagulation test: (unspecified date) normal, notes: Blood test: 24Aug2021-07Sep2021; C-reactive protein: (unspecified date) negative, notes: Blood test: 24Aug2021-07Sep2021; Creatinine renal clearance: (unspecified date) 62 ml/min, notes: Blood test: 24Aug2021-07Sep2021; CSF glucose: (unspecified date) normal; CSF lactate: (unspecified date) 1.8, notes: Unit: mM; CSF protein: (unspecified date) 0.43 g/l; CSF test: (unspecified date) normal without albuminocytorachic dissociation, notes: Additional tests: 28Jul2021-09Aug2021; (unspecified date) nucleated element, sterile culture, glycorachia n, notes: nucleated element, sterile culture, glycorachia normal, proteinorachia 0.43 g/L, lactates 1.8 mM. Additional tests: 24Aug2021-07Sep2021; Electromyogram: (unspecified date) does not find any argument in favor of demyelinati, notes: does not find any argument in favor of demyelinating damage, all reflexes OK (during hospitalization: 28Jul2021-09Aug2021); (unspecified date) in favor of Guillain Barre syndrome with demyelina, notes: in favor of Guillain Barre syndrome with demyelinating involvement (during hospitalization: 24Aug2021-07Sep2021) all compatible with acute polyradiculoneuropathy of the Guillain Barre type of pure motor form with diffuse demyelinating involvement proximal and distal, and probable secondary axonal degeneration; (09Sep2021) overall stability of the losses of distal motor am, notes: overall stability of the losses of distal motor amplitudes, absence of sensory impairment. Partial decrease in conduction blocks. Picture compatible with table of pure acute motor polyradiculoneuritis but some signs of demyelination; Electrophoresis protein: (unspecified date) monoclonal peak, notes: Additional tests: 24Aug2021-07Sep2021; Liver function test: (unspecified date) normal, notes: Blood test: 24Aug2021-07Sep2021; Neurological examination: (unspecified date) Motor deficit: 3/5 finger flexion left and right,, notes: Motor deficit: 3/5 finger flexion left and right, hand extensor 3/5 left and right, triceps 4/5 left and right, biceps 4/5 left and right, in the lower limbs deficit of the foot elevators at 3/5 on the left and on the right and 3/5 for the extensors of the foot. Impossible to walk on heels and tiptoes, no sensory deficit Reflexes all present and symmetrical, no fascicle, walking possible with assistance, no ataxia, no widening of the support polygon; Platelet count: (unspecified date) normal, notes: Blood test: 24Aug2021-07Sep2021; Reflex test: (unspecified date) all present and symmetrical, notes: (during hospitalization 24Aug2021-07Sep2021). Therapeutic measures were taken as a result of acute polyneuropathy, motor dysfunction, gait disturbance, guillain-barre syndrome. Clinical course: On 21Jul2021, appearance of a distal motor deficit of the upper limbs which rapidly spreads to the 4 limbs. From 28Jul2021 to 09Aug2021, hospitalization in neurology for assessment which highlights a neuropathy which could correspond to an acute motor axonal neuropathy and treated by 5 plasma exchanges allowing a regression of the symptoms. Electromyogram does not find any argument in favor of demyelinating damage. On 19Aug2021, Appearance of a new distal motor deficit of the upper limbs extending rapidly to the lower limb and worsening over 5 days with gait disturbances. No sphincter disorder, no sensory paresthesia, no pain. From 24Aug2021 to 07Sep2021 hospitalization in neurology clinic, Motor deficit: 3/5 finger flexion left and right, hand extensor 3/5 left and right, triceps 4/5 left and right, biceps 4/5 left and right, in the lower limbs deficit of the foot elevators at 3/5 on the left and on the right and 3/5 for the extensors of the foot. Impossible to walk on heels and tiptoes, no sensory deficit, reflexes all present and symmetrical, no fascicle, walking possible with assistance, no ataxia, no widening of the support polygon. Electromyogram in favor of Guillain Barre syndrome with demyelinating involvement. Medical care: 4 plasma exchanges allowing a significant improvement in symptoms but persistence of a distal motor deficit of the 4 limbs predominant in the upper limbs. Follow-up care and rehabilitation guidance. Outcome, in Nov2021, change from full hospitalization in follow-up care and rehabilitation to day hospitalization, improvement with progressive recovery of muscle strength and mobilization of the 4 limbs distally, predominantly in the lower limbs. Foot lifts are recovered and quadricipital locking is good. Walking recovery, balance OK. At the level of the upper limbs, partial distal recovery with a grip strength of 3/5 and a tendency to irreducible flexion of the 3rd, 4th, and 5th fingers of both hands. no sensory disturbances, no breathing difficulties, no swallowing disorders. In total, Guillain Barre syndrome whose first symptoms occur 22 days after Dose 1 of Comirnaty initially diagnosed with acute polyradiculoneuritis type acute axonal motor neuropathies. No follow-up attempts are possible. No further information is expected.