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Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.
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