chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Immunoglobulin therapy, Motor dysfunction, Nerve conduction studies abnormal, Neurological examination abnormal, Paraesthesia
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 76-year-old female patient. The patient had no clinical or laboratory evidence suggestive of precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 4 weeks after receiving H1N1 the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers and loss of balance. Motor symptoms included loss of dexterity and dysphagia and no weakness. A neurological examination revealed generalized weakness (graded to 4/5), decreased pinprick, joint position and vibration in both lower extremities, unsteady upon stance and gait, deep tendon reflexes 1+ in both upper extremities and absent patellar and ankle reflexes. The patient's cerebrospinal fluid (CSF) protein was 78mg/dl which was considered elevated. 7 weeks after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent or abnormal F responses which was highly suggestive of acute inflammatory demyelinating polyradiculoneuropathy. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. One week after receiving treatment with IVIG the patient showed improved sensations and slow improvement of weakness and dysphagia. The patient resumed their baseline level of activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.
Age: 76.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Serology normal, Vibration test abnormal
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 76-year-old female patient. The patient had no clinical or laboratory evidence suggestive of precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 4 weeks after receiving H1N1 the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers and loss of balance. Motor symptoms included loss of dexterity and dysphagia and no weakness. A neurological examination revealed generalized weakness (graded to 4/5), decreased pinprick, joint position and vibration in both lower extremities, unsteady upon stance and gait, deep tendon reflexes 1+ in both upper extremities and absent patellar and ankle reflexes. The patient's cerebrospinal fluid (CSF) protein was 78mg/dl which was considered elevated. 7 weeks after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent or abnormal F responses which was highly suggestive of acute inflammatory demyelinating polyradiculoneuropathy. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. One week after receiving treatment with IVIG the patient showed improved sensations and slow improvement of weakness and dysphagia. The patient resumed their baseline level of activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Areflexia, Asthenia, Ataxia, CSF protein increased, Decreased vibratory sense
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 61 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included hand and feet numbness and parascapular pain. Motor symptoms included weakness and gait disturbance. A neurological examination revealed proximal weakness (4+/5) in all extremities, absent vibration and joint position at bilateral toes and ankles, reduced pin-prick and light touch at bilateral feet and hands, severe sensory ataxia, generalised loss of deep tendon reflex and positive Romberg sign. The patient's cerebrospinal fluid (CSF) protein was 58mg/dl which was considered elevated. 15 days after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent F responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CEF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility the patient's gait, balance, vibration and joint position improved rapidly. The numbness in his hands and feet continued for a longer duration. The patient reached close to his baseline level activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Imaging procedure, Immunoglobulin therapy
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 61 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included hand and feet numbness and parascapular pain. Motor symptoms included weakness and gait disturbance. A neurological examination revealed proximal weakness (4+/5) in all extremities, absent vibration and joint position at bilateral toes and ankles, reduced pin-prick and light touch at bilateral feet and hands, severe sensory ataxia, generalised loss of deep tendon reflex and positive Romberg sign. The patient's cerebrospinal fluid (CSF) protein was 58mg/dl which was considered elevated. 15 days after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent F responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CEF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility the patient's gait, balance, vibration and joint position improved rapidly. The numbness in his hands and feet continued for a longer duration. The patient reached close to his baseline level activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Laboratory test normal, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal, Neurological examination abnormal
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 61 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included hand and feet numbness and parascapular pain. Motor symptoms included weakness and gait disturbance. A neurological examination revealed proximal weakness (4+/5) in all extremities, absent vibration and joint position at bilateral toes and ankles, reduced pin-prick and light touch at bilateral feet and hands, severe sensory ataxia, generalised loss of deep tendon reflex and positive Romberg sign. The patient's cerebrospinal fluid (CSF) protein was 58mg/dl which was considered elevated. 15 days after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent F responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CEF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility the patient's gait, balance, vibration and joint position improved rapidly. The numbness in his hands and feet continued for a longer duration. The patient reached close to his baseline level activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia, Positive Rombergism, Sensory loss, Serology normal, Vibration test abnormal
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 61 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included hand and feet numbness and parascapular pain. Motor symptoms included weakness and gait disturbance. A neurological examination revealed proximal weakness (4+/5) in all extremities, absent vibration and joint position at bilateral toes and ankles, reduced pin-prick and light touch at bilateral feet and hands, severe sensory ataxia, generalised loss of deep tendon reflex and positive Romberg sign. The patient's cerebrospinal fluid (CSF) protein was 58mg/dl which was considered elevated. 15 days after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent F responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CEF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility the patient's gait, balance, vibration and joint position improved rapidly. The numbness in his hands and feet continued for a longer duration. The patient reached close to his baseline level activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Areflexia, CSF protein increased, Decreased vibratory sense, Eye movement disorder, Eyelid ptosis
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 50-year-old female patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 10 days after receiving H1N1 influenza vaccine the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included numbness of both upper and lower extremities, and lower lip. Motor symptoms included generalized ophthalmoplegia. A neurological examination revealed bilateral ptosis, bilateral vertical and horizontal ophthalmoplegia, remarkably hypoactive vestibulo-ocular reflex, generalized areflexia, motor weakness in both upper and lower extremities with left side worse as compared to the right and decreased perception of sharp sensation, touch and vibration. The patient's cerebrospinal fluid (CSF) protein was 86mg/dl which was considered elevated. 4 weeks after receiving H1N1 influenza vaccine electrodiagnostic findings revealed absent sural, median and ulnar responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP), reduced motor response, absent motor units. At week 8 there was a mild improvement. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility there was a slow improvement in eye movements, motor and sensory response but persistent areflexia. At 4 months the patient had slow and incomplete recovery, she had bilateral facial and distal lower extremity weakness and sensory loss. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Imaging procedure, Immunoglobulin therapy
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 50-year-old female patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 10 days after receiving H1N1 influenza vaccine the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included numbness of both upper and lower extremities, and lower lip. Motor symptoms included generalized ophthalmoplegia. A neurological examination revealed bilateral ptosis, bilateral vertical and horizontal ophthalmoplegia, remarkably hypoactive vestibulo-ocular reflex, generalized areflexia, motor weakness in both upper and lower extremities with left side worse as compared to the right and decreased perception of sharp sensation, touch and vibration. The patient's cerebrospinal fluid (CSF) protein was 86mg/dl which was considered elevated. 4 weeks after receiving H1N1 influenza vaccine electrodiagnostic findings revealed absent sural, median and ulnar responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP), reduced motor response, absent motor units. At week 8 there was a mild improvement. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility there was a slow improvement in eye movements, motor and sensory response but persistent areflexia. At 4 months the patient had slow and incomplete recovery, she had bilateral facial and distal lower extremity weakness and sensory loss. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Motor dysfunction, Muscular weakness, Nerve conduction studies abnormal, Neurological examination abnormal, Ophthalmoplegia
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 50-year-old female patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 10 days after receiving H1N1 influenza vaccine the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included numbness of both upper and lower extremities, and lower lip. Motor symptoms included generalized ophthalmoplegia. A neurological examination revealed bilateral ptosis, bilateral vertical and horizontal ophthalmoplegia, remarkably hypoactive vestibulo-ocular reflex, generalized areflexia, motor weakness in both upper and lower extremities with left side worse as compared to the right and decreased perception of sharp sensation, touch and vibration. The patient's cerebrospinal fluid (CSF) protein was 86mg/dl which was considered elevated. 4 weeks after receiving H1N1 influenza vaccine electrodiagnostic findings revealed absent sural, median and ulnar responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP), reduced motor response, absent motor units. At week 8 there was a mild improvement. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility there was a slow improvement in eye movements, motor and sensory response but persistent areflexia. At 4 months the patient had slow and incomplete recovery, she had bilateral facial and distal lower extremity weakness and sensory loss. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia, Sensory loss, Serology normal
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 50-year-old female patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 10 days after receiving H1N1 influenza vaccine the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included numbness of both upper and lower extremities, and lower lip. Motor symptoms included generalized ophthalmoplegia. A neurological examination revealed bilateral ptosis, bilateral vertical and horizontal ophthalmoplegia, remarkably hypoactive vestibulo-ocular reflex, generalized areflexia, motor weakness in both upper and lower extremities with left side worse as compared to the right and decreased perception of sharp sensation, touch and vibration. The patient's cerebrospinal fluid (CSF) protein was 86mg/dl which was considered elevated. 4 weeks after receiving H1N1 influenza vaccine electrodiagnostic findings revealed absent sural, median and ulnar responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP), reduced motor response, absent motor units. At week 8 there was a mild improvement. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility there was a slow improvement in eye movements, motor and sensory response but persistent areflexia. At 4 months the patient had slow and incomplete recovery, she had bilateral facial and distal lower extremity weakness and sensory loss. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abasia, Areflexia, Ataxia, Axonal neuropathy, CSF protein increased
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 71 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). The patient reached nadir within 1 week. Sensory symptoms included perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx and ataxia. Motor symptoms included the rapid progression of ascending quadriparesis after admission. A neurological examination revealed reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally). Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours after admission. Deep tendon reflexes (DTRs) diminished to 1+ throughout and worsened to areflexia. Bladder and bowel control were normal at admission but progressed to complete bowel incontinence & urinary retention. The patient's cerebrospinal fluid (CSF) protein was 82mg/dl which was considered elevated. 12 days after receiving H1N1 electrodiagnostic findings were normal, however at 17 days electrodiagnostic findings were absent of F responses, A waves in all four limbs, sural and peroneal responses which were suggestive of acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. After the first course of IVIG there was an improvement in motor strength but unchanged sensory loss. Two weeks later the patient relapsed manifesting as right facial palsy in addition to increasing limb weakness. On day 50 during the relapse, electrodiagnostic findings revealed severe axonal sensorimotor polyneuropathy. The patient received a repeated course of IVIG 0.4kg/day for 5 days. Motor strength in arms significantly improved but sensory loss, bowel incontinence, and leg weakness improved very slowly. After 8 months the patient was non-ambulating with bowel incontinence. 1 year after the initial illness the patient remained non-ambulatory. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Faecal incontinence, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia, Imaging procedure
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 71 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). The patient reached nadir within 1 week. Sensory symptoms included perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx and ataxia. Motor symptoms included the rapid progression of ascending quadriparesis after admission. A neurological examination revealed reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally). Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours after admission. Deep tendon reflexes (DTRs) diminished to 1+ throughout and worsened to areflexia. Bladder and bowel control were normal at admission but progressed to complete bowel incontinence & urinary retention. The patient's cerebrospinal fluid (CSF) protein was 82mg/dl which was considered elevated. 12 days after receiving H1N1 electrodiagnostic findings were normal, however at 17 days electrodiagnostic findings were absent of F responses, A waves in all four limbs, sural and peroneal responses which were suggestive of acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. After the first course of IVIG there was an improvement in motor strength but unchanged sensory loss. Two weeks later the patient relapsed manifesting as right facial palsy in addition to increasing limb weakness. On day 50 during the relapse, electrodiagnostic findings revealed severe axonal sensorimotor polyneuropathy. The patient received a repeated course of IVIG 0.4kg/day for 5 days. Motor strength in arms significantly improved but sensory loss, bowel incontinence, and leg weakness improved very slowly. After 8 months the patient was non-ambulating with bowel incontinence. 1 year after the initial illness the patient remained non-ambulatory. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Immunoglobulin therapy, Mobility decreased, Motor dysfunction, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 71 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). The patient reached nadir within 1 week. Sensory symptoms included perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx and ataxia. Motor symptoms included the rapid progression of ascending quadriparesis after admission. A neurological examination revealed reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally). Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours after admission. Deep tendon reflexes (DTRs) diminished to 1+ throughout and worsened to areflexia. Bladder and bowel control were normal at admission but progressed to complete bowel incontinence & urinary retention. The patient's cerebrospinal fluid (CSF) protein was 82mg/dl which was considered elevated. 12 days after receiving H1N1 electrodiagnostic findings were normal, however at 17 days electrodiagnostic findings were absent of F responses, A waves in all four limbs, sural and peroneal responses which were suggestive of acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. After the first course of IVIG there was an improvement in motor strength but unchanged sensory loss. Two weeks later the patient relapsed manifesting as right facial palsy in addition to increasing limb weakness. On day 50 during the relapse, electrodiagnostic findings revealed severe axonal sensorimotor polyneuropathy. The patient received a repeated course of IVIG 0.4kg/day for 5 days. Motor strength in arms significantly improved but sensory loss, bowel incontinence, and leg weakness improved very slowly. After 8 months the patient was non-ambulating with bowel incontinence. 1 year after the initial illness the patient remained non-ambulatory. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Neurological examination abnormal, Paraesthesia, Paraesthesia oral, Peripheral sensory neuropathy, Pharyngeal hypoaesthesia
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 71 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). The patient reached nadir within 1 week. Sensory symptoms included perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx and ataxia. Motor symptoms included the rapid progression of ascending quadriparesis after admission. A neurological examination revealed reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally). Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours after admission. Deep tendon reflexes (DTRs) diminished to 1+ throughout and worsened to areflexia. Bladder and bowel control were normal at admission but progressed to complete bowel incontinence & urinary retention. The patient's cerebrospinal fluid (CSF) protein was 82mg/dl which was considered elevated. 12 days after receiving H1N1 electrodiagnostic findings were normal, however at 17 days electrodiagnostic findings were absent of F responses, A waves in all four limbs, sural and peroneal responses which were suggestive of acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. After the first course of IVIG there was an improvement in motor strength but unchanged sensory loss. Two weeks later the patient relapsed manifesting as right facial palsy in addition to increasing limb weakness. On day 50 during the relapse, electrodiagnostic findings revealed severe axonal sensorimotor polyneuropathy. The patient received a repeated course of IVIG 0.4kg/day for 5 days. Motor strength in arms significantly improved but sensory loss, bowel incontinence, and leg weakness improved very slowly. After 8 months the patient was non-ambulating with bowel incontinence. 1 year after the initial illness the patient remained non-ambulatory. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Quadriparesis, Sensory loss, Serology normal, Urinary retention, VIIth nerve paralysis
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 71 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). The patient reached nadir within 1 week. Sensory symptoms included perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx and ataxia. Motor symptoms included the rapid progression of ascending quadriparesis after admission. A neurological examination revealed reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally). Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours after admission. Deep tendon reflexes (DTRs) diminished to 1+ throughout and worsened to areflexia. Bladder and bowel control were normal at admission but progressed to complete bowel incontinence & urinary retention. The patient's cerebrospinal fluid (CSF) protein was 82mg/dl which was considered elevated. 12 days after receiving H1N1 electrodiagnostic findings were normal, however at 17 days electrodiagnostic findings were absent of F responses, A waves in all four limbs, sural and peroneal responses which were suggestive of acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. After the first course of IVIG there was an improvement in motor strength but unchanged sensory loss. Two weeks later the patient relapsed manifesting as right facial palsy in addition to increasing limb weakness. On day 50 during the relapse, electrodiagnostic findings revealed severe axonal sensorimotor polyneuropathy. The patient received a repeated course of IVIG 0.4kg/day for 5 days. Motor strength in arms significantly improved but sensory loss, bowel incontinence, and leg weakness improved very slowly. After 8 months the patient was non-ambulating with bowel incontinence. 1 year after the initial illness the patient remained non-ambulatory. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Ultrasound scan
Clinical narrative: RED, TENDER, SWOLLEN AND WARM AREA AT SITE OF polio or DTaP.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Pt received IPV, DTaP, & MMR on 4/13/12 in the am. At approximately midnight on 4/14/12 pt observed to have a generalized T-C seizure with a fever to 102 degrees.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dyspnoea, Full blood count normal, Metabolic function test normal, Vision blurred
Clinical narrative: (1) Hard to breath. (2)  Vision is foggy but she cans still see.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Head discomfort, Irritability, Pyrexia, Rash, Viral infection
Clinical narrative: Received above vaccines on 4/6/12. Infant holding head & seen in peds on 4/9/12. Peds said infant was WNLS. Rash developed on 4/11/12. Temperature from 4/6/12 - 4/9/12. Infant extremely irritable. Infant had another fever & rash - seen in peds on 4/19/12 - diagnosis - viral infection.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site erythema
Clinical narrative: Large erythema of (L) thigh. 6 cm radius. KEFLEX 250/5mL, 3/4 tsp PO QID x 5 days ordered by PA-C.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Influenza like illness
Clinical narrative: Pt states having flu like symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Injection site pain, Irritability
Clinical narrative: The baby received vaccines about 10:30 am today. Around 3pm, the baby became fussy with a sore left leg and not feeding as well. No fever or vomiting.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction, Injection site vesicles, Rash pruritic
Clinical narrative: Received shingles shot 4-20-12, per email, pt has "itchy blistering rash at injection site, plus headache."
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain, Dizziness, Face injury, Fall, Haematoma
Clinical narrative: Dizziness/black out. H/O Fall facing face. Hematoma - forehead. Abdominal pain.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Dizziness/black out. H/O Fall facing face. Hematoma - forehead. Abdominal pain.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave MENVEO, afterwards discovered child only 10 yrs old. CDC hotline called.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Oedema peripheral, Pruritus, Rash, Rash erythematous
Clinical narrative: Shot on 4/16 left arm red circular rash developed 7 days later rash is warm, semi hard, swollen was itching to start.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Shot on 4/16 left arm red circular rash developed 7 days later rash is warm, semi hard, swollen was itching to start.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised, Rash erythematous, Rash macular
Clinical narrative: C/O itching all over, blotchy red spots on chest.
Age: 43.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Computerised tomogram head normal, VIIth nerve paralysis
Clinical narrative: Member received smallpox vaccine 05Apr2012. Began with right facial paralysis on 20Apr2012. Went to ER 23Apr2012, Diagnosis: Bell's Palsy/Released on Prednisone and VALTREX.
Age: 43.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Computerised tomogram head, Computerised tomogram normal, VIIth nerve paralysis
Clinical narrative: Member received smallpox vaccine 05Apr2012. Began with right facial paralysis on 20Apr2012. Went to ER 23Apr2012, Diagnosis: Bell's Palsy/Released on Prednisone and VALTREX.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Dyspnoea, Erythema, Flushing, Lymphadenopathy
Clinical narrative: Shortness of breath, hives, chest discomfort, face red & flushed, swollen glands, arm red & pink & swollen.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Shortness of breath, hives, chest discomfort, face red & flushed, swollen glands, arm red & pink & swollen.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient came into the pharmacy with a round rash at the site of administration. Let her know to treat aches with Tylenol.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Left deltoid red, swollen and sensitive and painful to the touch.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV2, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Redness at site of injection. By the next morning progression in redness and started getting harder. Red area about 3 inches in diameter on left back arm. Diagnosed with a cellulitis and was given oral antibiotics.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Condition aggravated, Febrile convulsion, Laboratory test normal, Pyrexia, Streptococcus test negative
Clinical narrative: Sudden fever - causing febrile seizure. Patient has had 2 previous febrile seizures. The last one occurring in May 2010 after Hand, Foot and Mouth Disease.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Full blood count, Injection site erythema, Injection site induration, Laboratory test abnormal
Clinical narrative: 4/20/12 Seen at facility for Tdap reaction after vaccination 4/17/12. Reports having fever, body aches and chills starting at 8pm after vaccine administration with symptoms continuing through 4/19/12. States that she feels better today but still with sore arm and body aches. Left delt site with erythema and induration measuring 16cm x 17cm starting 4cm inferior to L acromion. No epitrochlear or auxiliary lymphedema. Temp 36.8, BP 106/80 HR 64 S1S2, RR 14 lungs CTA. Chem 7 and CBC sent stat. Evaluated by ARNP.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 4/20/12 Seen at facility for Tdap reaction after vaccination 4/17/12. Reports having fever, body aches and chills starting at 8pm after vaccine administration with symptoms continuing through 4/19/12. States that she feels better today but still with sore arm and body aches. Left delt site with erythema and induration measuring 16cm x 17cm starting 4cm inferior to L acromion. No epitrochlear or auxiliary lymphedema. Temp 36.8, BP 106/80 HR 64 S1S2, RR 14 lungs CTA. Chem 7 and CBC sent stat. Evaluated by ARNP.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Dysphagia, Endoscopy upper gastrointestinal tract abnormal, Gastrooesophageal reflux disease, Nervous system disorder
Clinical narrative: Dysphagia. Started having trouble swallowing around the end of October. No exact date. Got worse until around Nov. 23 when could hardly swallow solid food. Family Dr. sent me to Nose/Throat Dr who did scope down throat. Thought reflux. Prescribed Cooky Swallow Test. Diagnosed neurological. Sent to Neurologist who prescribed MRI of brain. No stroke. He sent me to another facility. Had a blood test which found no indications.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Dysphagia. Started having trouble swallowing around the end of October. No exact date. Got worse until around Nov. 23 when could hardly swallow solid food. Family Dr. sent me to Nose/Throat Dr who did scope down throat. Thought reflux. Prescribed Cooky Swallow Test. Diagnosed neurological. Sent to Neurologist who prescribed MRI of brain. No stroke. He sent me to another facility. Had a blood test which found no indications.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Infection, Pain, Pruritus
Clinical narrative: 4/23/2012-mother of patient calls in today to report reaction. She states that on 04/20/2012 patient c/o redness, itching and soreness and on 04/21/2012 there was increased redness, approx. 2 and 1/2 inch in diameter, mother than presented to local ER/Urgent Care, patient was diagnosed with infection and placed on oral antibiotic for five days. Mother reports that he was "doing a lot of itching". Patient with no recent illness/fever and had not had a reaction to vaccination prior to this event. Mother stated that her son has recovered and is "fine".
Age: 1.12
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Had a raised area of erythema at injection site that was hard and hot.  It measured 1 inch by 1.5 inches.
Age: 28.0
Sex: F
Vaccine: HEPA, HPV4, IPV, TDAP, HEPA, HPV4, IPV, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted.  No injury.  Patient was assisted to supine position with legs elevated.  Responded quickly.
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Arthralgia, Diarrhoea, Dizziness, Dysphonia, Headache
Clinical narrative: Dizziness, nausea, wheezing, hoarseness, racing heart, diarrhea, headache, joint aches. (3 days of nasty flu-like symptoms)
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Influenza like illness, Nausea, Palpitations, Wheezing
Clinical narrative: Dizziness, nausea, wheezing, hoarseness, racing heart, diarrhea, headache, joint aches. (3 days of nasty flu-like symptoms)
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt is reporting a 4" long and 3/4 " wide red streak at injection site not hot or bothersome just there not streaking towards heart  Was advised to call back or contact physician if symptoms worsen.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Blood gases, Cardiac enzymes, Computerised tomogram thorax, Dizziness, Drug screen
Clinical narrative: Felt faint, short of breath with hypoxia, hypotension, tachycardia, and nauseated.