chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Ophthalmoplegia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03172. A 59-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Two weeks after vaccination, the patient developed diplopia, imbalance and gait ataxia. He experienced "right ptosis, bilateral vertical (upward and downward) and horizontal (abduction and adduction) ophthalmoplegia, absent vestibulo-ocular reflex, generalized areflexia, severe ataxia on finger-to-nose and heel-to-shin maneuvers." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 48 mg/dl. Electrodiagnostic testing on day 18 revealed "normal nerve conduction studies of the upper and lower extremities, the facial nerve and blink reflexes." The patient was diagnosed with Miller Fisher variant of Guillain-Barre syndrome. The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient showed "slow improvement in eye movements, ataxia of gait and hands, persistent areflexia at the end of one week after IVIG." He resumed his "baseline level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that this patient who developed Miller Fisher variant of GBS fulfilled level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group. Documents held by sender: None.
Age: 1.06
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Blood creatinine, Blood culture, Blood electrolytes, Blood glucose, Blood urea
Clinical narrative: Diarrhea, vomiting x4 days, weight loss.
Age: 1.06
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Culture stool, Diarrhoea, Full blood count, Vomiting, Weight decreased
Clinical narrative: Diarrhea, vomiting x4 days, weight loss.
Age: 1.52
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Injection site warmth, Skin lesion
Clinical narrative: Left leg noted 3 inch x 2 1/2 inch round, red, warm to touch lesion surrounding injection site. Blister like appearance noted on inner part of lesion-closer to injection site. Ice applied. KEFLEX prescribed.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Areflexia, CSF protein increased, Electromyogram abnormal, Eye movement disorder, Eyelid ptosis
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03171. A 50-year-old female patient received an injection of INFLUENZA (manufacturer and lot number unknown, route, site and date not reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1." Ten days after vaccination, the patient developed "numbness of both upper and lower extremities, and lower lip, generalized ophthalmoplegia, 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." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 86 mg/dl, electrodiagnostic testing on week 4 was "highly suggestive of Acute Inflammatory Polyradiculopathy (AIDP) (sural sparing, median ulnar responses)." Electromyography (EMG) showed "reduced motor response, absent motor units." At week eight, Electrodiagnostic testing showed mild improvement. The patient had been diagnosed with Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN) and ophthalmoplegia." The patient was hospitalized and treatment included intravenous immunoglobulin" (IVIG) (0.4g/kg/day x 5days). " The patient showed "slow improvement in eye movements, motor and sensory response," but had persistent areflexia. She "did not show any signs of improvement by two months." At four months, the patient still had "bilateral facial and distal lowe extremity weakness and sensory loss." The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, this patient met level 1 diagnostic certainty criteria outline by Collaboration Working Group because of quadriparesis. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Hypokinesia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03171. A 50-year-old female patient received an injection of INFLUENZA (manufacturer and lot number unknown, route, site and date not reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1." Ten days after vaccination, the patient developed "numbness of both upper and lower extremities, and lower lip, generalized ophthalmoplegia, 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." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 86 mg/dl, electrodiagnostic testing on week 4 was "highly suggestive of Acute Inflammatory Polyradiculopathy (AIDP) (sural sparing, median ulnar responses)." Electromyography (EMG) showed "reduced motor response, absent motor units." At week eight, Electrodiagnostic testing showed mild improvement. The patient had been diagnosed with Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN) and ophthalmoplegia." The patient was hospitalized and treatment included intravenous immunoglobulin" (IVIG) (0.4g/kg/day x 5days). " The patient showed "slow improvement in eye movements, motor and sensory response," but had persistent areflexia. She "did not show any signs of improvement by two months." At four months, the patient still had "bilateral facial and distal lowe extremity weakness and sensory loss." The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, this patient met level 1 diagnostic certainty criteria outline by Collaboration Working Group because of quadriparesis. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Hyporeflexia, Immunoglobulin therapy, Laboratory test abnormal, Muscular weakness, Ophthalmoplegia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03171. A 50-year-old female patient received an injection of INFLUENZA (manufacturer and lot number unknown, route, site and date not reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1." Ten days after vaccination, the patient developed "numbness of both upper and lower extremities, and lower lip, generalized ophthalmoplegia, 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." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 86 mg/dl, electrodiagnostic testing on week 4 was "highly suggestive of Acute Inflammatory Polyradiculopathy (AIDP) (sural sparing, median ulnar responses)." Electromyography (EMG) showed "reduced motor response, absent motor units." At week eight, Electrodiagnostic testing showed mild improvement. The patient had been diagnosed with Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN) and ophthalmoplegia." The patient was hospitalized and treatment included intravenous immunoglobulin" (IVIG) (0.4g/kg/day x 5days). " The patient showed "slow improvement in eye movements, motor and sensory response," but had persistent areflexia. She "did not show any signs of improvement by two months." At four months, the patient still had "bilateral facial and distal lowe extremity weakness and sensory loss." The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, this patient met level 1 diagnostic certainty criteria outline by Collaboration Working Group because of quadriparesis. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Peripheral sensory neuropathy, Sensory disturbance
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03171. A 50-year-old female patient received an injection of INFLUENZA (manufacturer and lot number unknown, route, site and date not reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1." Ten days after vaccination, the patient developed "numbness of both upper and lower extremities, and lower lip, generalized ophthalmoplegia, 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." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 86 mg/dl, electrodiagnostic testing on week 4 was "highly suggestive of Acute Inflammatory Polyradiculopathy (AIDP) (sural sparing, median ulnar responses)." Electromyography (EMG) showed "reduced motor response, absent motor units." At week eight, Electrodiagnostic testing showed mild improvement. The patient had been diagnosed with Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN) and ophthalmoplegia." The patient was hospitalized and treatment included intravenous immunoglobulin" (IVIG) (0.4g/kg/day x 5days). " The patient showed "slow improvement in eye movements, motor and sensory response," but had persistent areflexia. She "did not show any signs of improvement by two months." At four months, the patient still had "bilateral facial and distal lowe extremity weakness and sensory loss." The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, this patient met level 1 diagnostic certainty criteria outline by Collaboration Working Group because of quadriparesis. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Areflexia, Asthenia, Balance disorder, CSF protein increased, Dysphagia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03171, and 2012-03172. A 76-year-old female patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Four weeks after vaccination, the patient developed "paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers;" and she also had loss of balance. Her motor symptoms were noted as "loss of dexterity and dysphagia." Neurological exam noted "generalized weakness (graded 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; absent patellar and ankle reflexes." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 78 mg/dl. Electrodiagnostic testing on Week 7: was "highly suggestive of Acute inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed as having Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN)." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient experienced improved sensation but had "slow improvement of weakness and dysphagia on week after the course of IVIG." The patient resumed her "base line level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Laboratory test abnormal
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03171, and 2012-03172. A 76-year-old female patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Four weeks after vaccination, the patient developed "paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers;" and she also had loss of balance. Her motor symptoms were noted as "loss of dexterity and dysphagia." Neurological exam noted "generalized weakness (graded 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; absent patellar and ankle reflexes." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 78 mg/dl. Electrodiagnostic testing on Week 7: was "highly suggestive of Acute inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed as having Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN)." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient experienced improved sensation but had "slow improvement of weakness and dysphagia on week after the course of IVIG." The patient resumed her "base line level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Motor dysfunction, Neurological examination abnormal, Paraesthesia, Peripheral sensory neuropathy, Sensory loss
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03171, and 2012-03172. A 76-year-old female patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Four weeks after vaccination, the patient developed "paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers;" and she also had loss of balance. Her motor symptoms were noted as "loss of dexterity and dysphagia." Neurological exam noted "generalized weakness (graded 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; absent patellar and ankle reflexes." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 78 mg/dl. Electrodiagnostic testing on Week 7: was "highly suggestive of Acute inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed as having Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN)." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient experienced improved sensation but had "slow improvement of weakness and dysphagia on week after the course of IVIG." The patient resumed her "base line level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
Age: 1.07
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, PNC13, VARCEL
Symptoms: Laboratory test normal, Rash generalised, Roseola, Streptococcus test
Clinical narrative: Multiple immunization administered 3/19/12. Body rash has now developed over the past 24 hrs. Examined in office 3/30/12. Copy of examine is attached. Rapid strep negative. ATARAX Rx 1D. DDX: Roseola secondary to MMR vaccine.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Erythema, Swelling face
Clinical narrative: Swelling and redness of face and both lower legs & feet, excessive. Crying.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Areflexia, Asthenia, Ataxia, Autonomic nervous system imbalance
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03170, 2012-03171, and 2012-03172. A 71-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed "perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx, and ataxia." The patient had "rapidly progressive ascending quadriparesis" with "reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally)" after admission to hospital. "Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours (h) after admission; deep tendon reflexes (DTRs) diminished to 1+ throughout, worsened to areflexia. Bladder and bowel control, normal at admission, progressed to complete bowel incontinence and urinary retention." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 82 mg/dl. Electrodiagnostic testing on Day 12 was normal, but on day 17: was "suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP), (Absent F waves, A waves in all four limbs, absent sural and peroneal responses)." The patient had been diagnosed with Guillain-Barre syndrome and "acute motor sensory axonal neuropathy (AMSAN) and dysautonomia." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5days)." The patient experienced "improvement in motor strength, but unchanged sensory loss after first course of IVIG. A relapse two weeks later manifested as right facial palsy in addition to increasing limb weakness." During relapse on day 50, the patient developed "severe axonal sensorimotor polyneuropathy" and was treated with a repeated course of "IVIG (0.4g/kg/day x 5days)" after relapse. The patient showed significant improvement motor strength of arms, but still had sensory loss, with bowel incontinence and leg weakness improving very slowly. At eight months, he still had bowel incontinence and was not ambulatory. The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, and bowel incontinence and urinary retention, this patient met level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group because of quadriparesis. Documents held by sender: None.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: CSF protein increased, Electromyogram abnormal, Faecal incontinence, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03170, 2012-03171, and 2012-03172. A 71-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed "perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx, and ataxia." The patient had "rapidly progressive ascending quadriparesis" with "reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally)" after admission to hospital. "Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours (h) after admission; deep tendon reflexes (DTRs) diminished to 1+ throughout, worsened to areflexia. Bladder and bowel control, normal at admission, progressed to complete bowel incontinence and urinary retention." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 82 mg/dl. Electrodiagnostic testing on Day 12 was normal, but on day 17: was "suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP), (Absent F waves, A waves in all four limbs, absent sural and peroneal responses)." The patient had been diagnosed with Guillain-Barre syndrome and "acute motor sensory axonal neuropathy (AMSAN) and dysautonomia." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5days)." The patient experienced "improvement in motor strength, but unchanged sensory loss after first course of IVIG. A relapse two weeks later manifested as right facial palsy in addition to increasing limb weakness." During relapse on day 50, the patient developed "severe axonal sensorimotor polyneuropathy" and was treated with a repeated course of "IVIG (0.4g/kg/day x 5days)" after relapse. The patient showed significant improvement motor strength of arms, but still had sensory loss, with bowel incontinence and leg weakness improving very slowly. At eight months, he still had bowel incontinence and was not ambulatory. The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, and bowel incontinence and urinary retention, this patient met level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group because of quadriparesis. Documents held by sender: None.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Hyporeflexia, Immunoglobulin therapy, Motor dysfunction, Muscular weakness, Paraesthesia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03170, 2012-03171, and 2012-03172. A 71-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed "perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx, and ataxia." The patient had "rapidly progressive ascending quadriparesis" with "reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally)" after admission to hospital. "Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours (h) after admission; deep tendon reflexes (DTRs) diminished to 1+ throughout, worsened to areflexia. Bladder and bowel control, normal at admission, progressed to complete bowel incontinence and urinary retention." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 82 mg/dl. Electrodiagnostic testing on Day 12 was normal, but on day 17: was "suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP), (Absent F waves, A waves in all four limbs, absent sural and peroneal responses)." The patient had been diagnosed with Guillain-Barre syndrome and "acute motor sensory axonal neuropathy (AMSAN) and dysautonomia." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5days)." The patient experienced "improvement in motor strength, but unchanged sensory loss after first course of IVIG. A relapse two weeks later manifested as right facial palsy in addition to increasing limb weakness." During relapse on day 50, the patient developed "severe axonal sensorimotor polyneuropathy" and was treated with a repeated course of "IVIG (0.4g/kg/day x 5days)" after relapse. The patient showed significant improvement motor strength of arms, but still had sensory loss, with bowel incontinence and leg weakness improving very slowly. At eight months, he still had bowel incontinence and was not ambulatory. The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, and bowel incontinence and urinary retention, this patient met level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group because of quadriparesis. Documents held by sender: None.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia oral, Peripheral sensory neuropathy, Quadriparesis, Sensory loss, Urinary retention
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03170, 2012-03171, and 2012-03172. A 71-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed "perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx, and ataxia." The patient had "rapidly progressive ascending quadriparesis" with "reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally)" after admission to hospital. "Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours (h) after admission; deep tendon reflexes (DTRs) diminished to 1+ throughout, worsened to areflexia. Bladder and bowel control, normal at admission, progressed to complete bowel incontinence and urinary retention." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 82 mg/dl. Electrodiagnostic testing on Day 12 was normal, but on day 17: was "suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP), (Absent F waves, A waves in all four limbs, absent sural and peroneal responses)." The patient had been diagnosed with Guillain-Barre syndrome and "acute motor sensory axonal neuropathy (AMSAN) and dysautonomia." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5days)." The patient experienced "improvement in motor strength, but unchanged sensory loss after first course of IVIG. A relapse two weeks later manifested as right facial palsy in addition to increasing limb weakness." During relapse on day 50, the patient developed "severe axonal sensorimotor polyneuropathy" and was treated with a repeated course of "IVIG (0.4g/kg/day x 5days)" after relapse. The patient showed significant improvement motor strength of arms, but still had sensory loss, with bowel incontinence and leg weakness improving very slowly. At eight months, he still had bowel incontinence and was not ambulatory. The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, and bowel incontinence and urinary retention, this patient met level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group because of quadriparesis. Documents held by sender: None.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03170, 2012-03171, and 2012-03172. A 71-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed "perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx, and ataxia." The patient had "rapidly progressive ascending quadriparesis" with "reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally)" after admission to hospital. "Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours (h) after admission; deep tendon reflexes (DTRs) diminished to 1+ throughout, worsened to areflexia. Bladder and bowel control, normal at admission, progressed to complete bowel incontinence and urinary retention." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 82 mg/dl. Electrodiagnostic testing on Day 12 was normal, but on day 17: was "suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP), (Absent F waves, A waves in all four limbs, absent sural and peroneal responses)." The patient had been diagnosed with Guillain-Barre syndrome and "acute motor sensory axonal neuropathy (AMSAN) and dysautonomia." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5days)." The patient experienced "improvement in motor strength, but unchanged sensory loss after first course of IVIG. A relapse two weeks later manifested as right facial palsy in addition to increasing limb weakness." During relapse on day 50, the patient developed "severe axonal sensorimotor polyneuropathy" and was treated with a repeated course of "IVIG (0.4g/kg/day x 5days)" after relapse. The patient showed significant improvement motor strength of arms, but still had sensory loss, with bowel incontinence and leg weakness improving very slowly. At eight months, he still had bowel incontinence and was not ambulatory. The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, and bowel incontinence and urinary retention, this patient met level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group because of quadriparesis. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Areflexia, Arthropathy, Asthenia, Ataxia, Balance disorder
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03169, 2012-03170, 2012-03171, and 2012-03172. A 61-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except for history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed hand and feet numbness, gait disturbance, weakness and parascapular pain. 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, generalized loss of deep tendon reflex, and positive Romberg sign." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 58 mg/dl. Electrodiagnostic testing on Day 15 was "highly suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed with Guillain-Barre syndrome with sensory ataxic variant. The patient was hospitalized and treatment included intravenous Immunoglobulin" (IVIG) (0.4g/kg/day x 5days)". The patient showed "rapid improvement of gait and balance, vibration and joint position. Numbness in hands and feet continued for a longer duration." The patient's outcome was not recovered. Authors indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: CSF protein increased, Decreased vibratory sense, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03169, 2012-03170, 2012-03171, and 2012-03172. A 61-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except for history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed hand and feet numbness, gait disturbance, weakness and parascapular pain. 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, generalized loss of deep tendon reflex, and positive Romberg sign." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 58 mg/dl. Electrodiagnostic testing on Day 15 was "highly suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed with Guillain-Barre syndrome with sensory ataxic variant. The patient was hospitalized and treatment included intravenous Immunoglobulin" (IVIG) (0.4g/kg/day x 5days)". The patient showed "rapid improvement of gait and balance, vibration and joint position. Numbness in hands and feet continued for a longer duration." The patient's outcome was not recovered. Authors indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Immunoglobulin therapy, Laboratory test abnormal, Muscular weakness, Musculoskeletal pain, Neurological examination abnormal
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03169, 2012-03170, 2012-03171, and 2012-03172. A 61-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except for history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed hand and feet numbness, gait disturbance, weakness and parascapular pain. 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, generalized loss of deep tendon reflex, and positive Romberg sign." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 58 mg/dl. Electrodiagnostic testing on Day 15 was "highly suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed with Guillain-Barre syndrome with sensory ataxic variant. The patient was hospitalized and treatment included intravenous Immunoglobulin" (IVIG) (0.4g/kg/day x 5days)". The patient showed "rapid improvement of gait and balance, vibration and joint position. Numbness in hands and feet continued for a longer duration." The patient's outcome was not recovered. Authors indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Positive Rombergism, Sensory loss
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03169, 2012-03170, 2012-03171, and 2012-03172. A 61-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except for history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed hand and feet numbness, gait disturbance, weakness and parascapular pain. 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, generalized loss of deep tendon reflex, and positive Romberg sign." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 58 mg/dl. Electrodiagnostic testing on Day 15 was "highly suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed with Guillain-Barre syndrome with sensory ataxic variant. The patient was hospitalized and treatment included intravenous Immunoglobulin" (IVIG) (0.4g/kg/day x 5days)". The patient showed "rapid improvement of gait and balance, vibration and joint position. Numbness in hands and feet continued for a longer duration." The patient's outcome was not recovered. Authors indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Blood pressure increased, Cold sweat, Hyperhidrosis, Throat irritation
Clinical narrative: Initial report received from a health care professional on 20 March 2012. This reporter also reported other adverse events, which captured in case number 2012-02851 and 2012-03162. A female patient (age not reported) received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number C4063 and sanofi pasteur Inc. lot number U4308BA, on an unknown date. The patient became diaphoretic, cold, clammy, blood pressure elevated, throat itching and narrowing and was anxious. The outcome was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Initial report received from a health care professional on 20 March 2012. This reporter also reported other adverse events, which captured in case number 2012-02851 and 2012-03162. A female patient (age not reported) received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number C4063 and sanofi pasteur Inc. lot number U4308BA, on an unknown date. The patient became diaphoretic, cold, clammy, blood pressure elevated, throat itching and narrowing and was anxious. The outcome was not reported. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Laboratory test abnormal, Pneumonia, Polymerase chain reaction
Clinical narrative: Initial report was received from a health care professional on 20 March 2012. A 5-year-old male patient had received the following vaccinations on 26 May 2010: a dose five intramuscular injection in the left arm of DAPTACEL, sanofi pasteur Ltd., lot number C3082AA, an intramuscular injection in the left arm of IPOL, sanofi pasteur SA, lot number B1090, an injection in the right arm of MMR and an injection in the right arm of VARIVAX (Merck). On 27 February 2012, the patient developed a cough and low grade pneumonia. On 15 March 2012, the patient had a positive PCR test. Illness at the time of vaccination was reported as none. The patient had no known allergies (NKA) and no reported adverse events following prior vaccinations. No additional information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Had varicella and flu in (R) arm on 3-13-12, developed redness, warmth, pain following day that got worse. Came in to office 3-15-12 to be seen.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Shingles vaccine given on 3-20-12 and she was fine until the following day - she then noted her arm was warm/red, this got worse and worse. BENADRYL did not help. Came in office to be seen 3-22-12.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised bump. (L) thigh noticed 1-2 days per Mom. Nickel sized. Noticed 3/26/12.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt complained (L) arm pain within 48 hours of receiving vaccination. Currently pain still exists. More pronounced in the evening.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: 1 1/2 day later noticed itching at site on (R) arm. This progressed to redness & some mild swelling. The next day (2 days after imm) redness worsened & she came in with blister in area. Tx'd with ABX for cellulitis & advised to continue ZYRTEC OTC & RTC for recheck after 24hrs.
Sex: U
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report was received on 19 March 2012 from a health care professional. A cluster of two unidentified patient's who had no illness at the time of vaccination had received in March 2012 an intramuscular injection of ADACEL, lot number C4008BA (site and exact date of administration not reported) and an unspecified amount of time later developed cellulitis at the injection site with swelling, redness and pain. Both patients were evaluated in the emergency room (ER). One patient had been seen in follow-up and was "improving". No further information was available at the time of report. One patient was reported to have recovered and the other patient's recovery status was unknown. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Blister, Dyspnoea, Erythema, Fatigue
Clinical narrative: After receiving varicella vaccine - felt feverish, fatigue, cold like symptoms with some shortness of breath. Approximately 10 days later (L) arm became swollen, red, sore to touch, "hard like a ball" and "skin was bubbly".
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Nasopharyngitis, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: After receiving varicella vaccine - felt feverish, fatigue, cold like symptoms with some shortness of breath. Approximately 10 days later (L) arm became swollen, red, sore to touch, "hard like a ball" and "skin was bubbly".
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test
Clinical narrative: After receiving varicella vaccine - felt feverish, fatigue, cold like symptoms with some shortness of breath. Approximately 10 days later (L) arm became swollen, red, sore to touch, "hard like a ball" and "skin was bubbly".