Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood thyroid stimulating hormone, Body temperature, C-reactive protein, CSF glucose
Clinical narrative: Guillain-Barre Syndrome; Difficulty with gait especially going up a ramp or stair; Within a few days, she noticed persistent paresthesia in her feet and hands; decreased sensation in bilateral lower extremities; This is a literature report for the following literature source(s).  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 Single), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "recovering"; GAIT DISTURBANCE (medically significant), outcome "recovering", described as "Difficulty with gait especially going up a ramp or stair"; PARAESTHESIA (medically significant), outcome "recovering", described as "Within a few days, she noticed persistent paresthesia in her feet and hands"; SENSORY DISTURBANCE (medically significant), outcome "recovering", described as "decreased sensation in bilateral lower extremities". The patient underwent the following laboratory tests and procedures: Anti-aquaporin-4 antibody: unremarkable; Antinuclear antibody: unremarkable; Babinski reflex test: down-going bilaterally; Blood albumin: 86 mg/dl; Blood creatine phosphokinase: unremarkable; Blood immunoglobulin G: 0.53, notes: normal; Blood thyroid stimulating hormone: unremarkable; Body temperature: in all four extremities; C-reactive protein: unremarkable; CSF glucose: 79 mg/dl, notes: elevated; CSF immunoglobulin: 9.3 mg/dl, notes: elevated, with 4 identical gamma restrictive bands that were observed; CSF volume: significant, notes: for albuminocytologic; Electromyogram: Possible CIDP; Full blood count: unremarkable; Deep tendon reflexes: brachioradialis; unchanged; unremarkable; no dysmetria observed; unremarkable; normal bulk, notes: normal tone, and 5/5 strength in all muscle groups; Decreased, notes: noted at the fingertips and from ankle; improved, notes: only at the heels; diminished, notes: at bilateral big toes, knees, thumbs, and elbows; decreased, notes: but normal ankle and thumb; Lumbar puncture: normal, notes: opening pressure; Magnetic resonance imaging: mild thickening, notes: enhancement of the anterior; Metabolic function test: unremarkable; Neurological examination: intact mental status, notes: cranial nerves; Protein total: 112 mg/dl, notes: elevated; Red blood cell sedimentation rate: unremarkable; Serum ferritin: unremarkable; Tandem gait test: mild ataxia; Thyroxine free: unremarkable; Vitamin B12: unremarkable; Vitamin D: unremarkable.  Clinical course was reported as, a healthy and athletic 16-year-old female presented to the emergency department (ED) with three weeks of ascending numbness and paresthesia of her bilateral lower and upper extremities. She received her second dose of PfizerBioNTech COVID19 vaccine two days prior to symptom onset. Her symptoms began with intermittent paresthesia in her feet. Within a few days, she noticed persistent paresthesia in her feet and hands as well as difficulty with running while playing sports. For the next three weeks, her symptoms continued to worsen with paresthesia up to her elbows and knees, decreased sensation in bilateral lower extremities, and difficulty with gait especially going up a ramp or stairs. The progressive difficulty with ambulation prompted the patient to present to the emergency department. On neurological examination, she had intact mental status and cranial nerves. Motor exam showed normal bulk, normal tone, and 5/5 strength in all muscle groups. Deep tendon reflexes were 1 plus for brachioradialis and patellar tendon bilaterally. Reflexes at biceps, triceps, and Achilles tendons could not be elicited. Babinski reflex was down-going bilaterally. Her sensation was intact to light touch, temperature, and proprioception in all four extremities. Decreased sensation to pinprick was noted at the fingertips and from ankle to knee on the medial and lateral aspects of the shin bilaterally. Vibratory sensation was diminished at bilateral big toes, knees, thumbs, and elbows. Coordination was intact bilaterally with no dysmetria observed with finger-to-nose or heel-to-shin testing. Lastly, mild ataxia was noted on toe and tandem walking. MRI study showed mild thickening and enhancement of the anterior and posterior spinal nerve roots of the cauda equina, consistent with Guillain-Barre syndrome. Lumbar puncture was performed with normal opening pressure. Cerebrospinal fluid (CSF) study was significant for albuminocytologic dissociation with nucleated cell of 1 and elevated protein at 112 mg/dL (albumin 86 mg/dL). CSF glucose was also elevated at 79 mg/dL. CSF IgG was elevated to 9.3 mg/dL with 4 identical gamma restrictive bands that were observed both in CSF and serum, which is indicative of systemic rather than intracerebral gamma globulins. IgG index was normal at 0.53. Other lab findings including complete blood count, complete metabolic panel, creatinine phosphokinase, vitamin D, free T4, thyroid stimulating hormone, antinuclear antibody, C-reactive protein, erythrocyte sedimentation rate, ferritin, B12, Lyme antibody, anti-aquaporin-4 IgG, and GQ1b antibody were unremarkable. Her COVID19 PCR was negative. COVID-19 antibody was not tested because three weeks have passed since symptom onset and the mild severity of the symptoms, the patient did not receive intravenous immune globulin (IVIG) treatment and was discharged with continued follow-up with neurology and physical therapy treatment. One month later, the patient was seen at the outpatient clinic and reported overall improvement of symptoms. Paresthesias were no longer present; however, she continued to have intermittent numbness in her legs bilaterally below the knees which contributed to her unsteady gait. On exam, improved sensation was noted with diminished pinprick only at the heels. Vibratory sensation was decreased at the big toes, but normal ankle and thumb. Deep tendon reflexes were unchanged from initial presentation. Due to the prolonged course of the disease, electromyography/nerve conduction study was performed at 6 weeks after initial presentation to ED, to rule out possible chronic inflammatory demyelinating polyneuropathy (CIDP). There was prolonged latency and slowed conduction velocity in multiple sensory and motor nerves consistent with partially compensated demyelinating polyneuropathy without active denervation consistent with a history of GBS. She presented with a stocking-glove distribution of paresthesia and mild ataxia without any weakness or ophthalmoplegia. Initial differential also included Lyme disease, multiple sclerosis, vitamin deficiency, and Miller Fisher syndrome. Imaging and lab findings were most consistent with the diagnosis of GBS with predominantly sensory presentation. Idiopathic or asymptomatic infectious causes of GBS cannot be completely ruled out, especially in the absence of more extensive diagnostic testing; however, with the recent vaccination and absence of any other clinical signs or lab findings, the vaccine is most likely to be the trigger for our patient. It is also important to note that the patient made full functional recovery three months after initiation of symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.