chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Nuclear magnetic resonance imaging normal, Oedema peripheral, Paraesthesia, Sensory loss, Thyroid function test normal
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 276617). A 16-year-old female patient with no reported medical history, developed numbness in her hand and later moved up to her arm 17 days after she had received a first intramuscular injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 30 March 2007, the patient developed numbness in her hand which later moved up her arm. On 04 April 2007, she was seen by her primary care provider due to numbness on her right side of her body which included both the upper and lower extremities which was fairly continuous. Later that day, she has additional numbness on the right side of her face. Her right index finger was noted to have been numb and swollen and her hands felt dry. The neurological examination was within normal limits; however the patient reported reduced sensations of light tough, temperature and vibration on right side of her body. Sensation was splitting right in the middle of her forehead. A differential diagnosis of demyelinating disease or other CNS abnormalities was determined. A CT Scan was negative and it was noted that there was a slight possibility that anxiety somatization disorder existed. The patient returned to the neurologic clinic on 25 April 2007 (also reported as two weeks later) and was diagnosed with hemianesthesia. Blurred vision NOS. The subjective hemianesthesia and neurologic examination "is now unremarkable", with normal symmetrical reflexes and no pronator drift. The possibility of an organic disorder was thought to be less likely. The patient was evaluated at the hospital by a neurologist (date not reported) who ordered a CT Scan, MRI, chest x-ray, thyroid panel and blood work; all with normal results. The physician diagnosed the patient with paraesthesia. The patient's recovery status was not provided at the time of thereport.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Vision blurred
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 276617). A 16-year-old female patient with no reported medical history, developed numbness in her hand and later moved up to her arm 17 days after she had received a first intramuscular injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 30 March 2007, the patient developed numbness in her hand which later moved up her arm. On 04 April 2007, she was seen by her primary care provider due to numbness on her right side of her body which included both the upper and lower extremities which was fairly continuous. Later that day, she has additional numbness on the right side of her face. Her right index finger was noted to have been numb and swollen and her hands felt dry. The neurological examination was within normal limits; however the patient reported reduced sensations of light tough, temperature and vibration on right side of her body. Sensation was splitting right in the middle of her forehead. A differential diagnosis of demyelinating disease or other CNS abnormalities was determined. A CT Scan was negative and it was noted that there was a slight possibility that anxiety somatization disorder existed. The patient returned to the neurologic clinic on 25 April 2007 (also reported as two weeks later) and was diagnosed with hemianesthesia. Blurred vision NOS. The subjective hemianesthesia and neurologic examination "is now unremarkable", with normal symmetrical reflexes and no pronator drift. The possibility of an organic disorder was thought to be less likely. The patient was evaluated at the hospital by a neurologist (date not reported) who ordered a CT Scan, MRI, chest x-ray, thyroid panel and blood work; all with normal results. The physician diagnosed the patient with paraesthesia. The patient's recovery status was not provided at the time of thereport.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood alkaline phosphatase normal, Encephalitis, Facial palsy, Full blood count, Hypoaesthesia
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 295242). A 13-year-old female patient with no reported medical history had received a first dose intramuscular injection of MENACTRA (lot number and site of administration not reported) and a second dose intramuscular injection of GARDASIL (HPV, manufacturer Merck, lot number and site of administration not reported) on 17 October 2007. On the day of vaccination (also reported as 28 October 2007), the patient complained of numbness to her hands and feet. She later developed numbness in her lower arms, lips and face. She was seen by a neurologist on 12 November 2007 and had been diagnosed with post infection "cerebellitis" and right Bell's Palsy and she was noted to be improving. Laboratory testing included CBC, Chem 16 and ESR; results were reported as lymph %51, alk phos 180 and ESR 2. According to the reporter, the current clinical events were not related to vaccination with GARDASIL. The onset date of 28 October 2007 was reported for the events of numbness to lower arms, lips and face; right Bell's Palsy, and post infection cerebellitis. The patient's recovery status was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia facial, Hypoaesthesia oral, Laboratory test, Lymphocyte percentage increased, Red blood cell sedimentation rate normal
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 295242). A 13-year-old female patient with no reported medical history had received a first dose intramuscular injection of MENACTRA (lot number and site of administration not reported) and a second dose intramuscular injection of GARDASIL (HPV, manufacturer Merck, lot number and site of administration not reported) on 17 October 2007. On the day of vaccination (also reported as 28 October 2007), the patient complained of numbness to her hands and feet. She later developed numbness in her lower arms, lips and face. She was seen by a neurologist on 12 November 2007 and had been diagnosed with post infection "cerebellitis" and right Bell's Palsy and she was noted to be improving. Laboratory testing included CBC, Chem 16 and ESR; results were reported as lymph %51, alk phos 180 and ESR 2. According to the reporter, the current clinical events were not related to vaccination with GARDASIL. The onset date of 28 October 2007 was reported for the events of numbness to lower arms, lips and face; right Bell's Palsy, and post infection cerebellitis. The patient's recovery status was not reported.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Azotaemia, Blood creatinine increased, Blood urea increased
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 295507). A 12-year-old female patient received an intramuscular first dose of MENACTRA (lot not reported) and an intramuscular first dose of GARDASIL (Merck, lot not reported) on 24 July 2007. On approximately 07 August 2007, 14 days post-vaccination, the patient began developing diplopia, ataxia, and weakness in the extremities. She was seen by a physician on 13 August 2007 and noted to have an unsteady gait and abnormal eye movements. She had reportedly began "running into things and falling", with worsening weakness and pain. Physical exam was remarkable for decreased strength in the upper and lower extremities, 1-beat clonus bilaterally, cranial nerve III palsy, and right exotropia. MRI of the brain was markedly abnormal involving midbrain and base of brain. BUN and creatinine were increased. She was admitted to the PICU on 14 August 2007 after becoming increasingly more encephalopathic during admission. She developed deteriorating renal function/azotemia, which worsened following a CT with contrast. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. No formal discharge diagnosis was noted, but a diagnosis of acute disseminated encephalomyelitis was proposed following diagnostic studies. As of a follow-up phone call on 28 December 2007, the patient still had occasional double vision when tired. Other symptoms, including ataxia, dysphagia, and renal dysfunction, had resolved. Final outcome was not reported. Follow up information was received on 10 April 2009 from the Food and Drug Administration (FDA). Per the FDA, this case did not meet probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Clonus, Diplopia, Dysphagia, Eye movement disorder, Fall
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 295507). A 12-year-old female patient received an intramuscular first dose of MENACTRA (lot not reported) and an intramuscular first dose of GARDASIL (Merck, lot not reported) on 24 July 2007. On approximately 07 August 2007, 14 days post-vaccination, the patient began developing diplopia, ataxia, and weakness in the extremities. She was seen by a physician on 13 August 2007 and noted to have an unsteady gait and abnormal eye movements. She had reportedly began "running into things and falling", with worsening weakness and pain. Physical exam was remarkable for decreased strength in the upper and lower extremities, 1-beat clonus bilaterally, cranial nerve III palsy, and right exotropia. MRI of the brain was markedly abnormal involving midbrain and base of brain. BUN and creatinine were increased. She was admitted to the PICU on 14 August 2007 after becoming increasingly more encephalopathic during admission. She developed deteriorating renal function/azotemia, which worsened following a CT with contrast. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. No formal discharge diagnosis was noted, but a diagnosis of acute disseminated encephalomyelitis was proposed following diagnostic studies. As of a follow-up phone call on 28 December 2007, the patient still had occasional double vision when tired. Other symptoms, including ataxia, dysphagia, and renal dysfunction, had resolved. Final outcome was not reported. Follow up information was received on 10 April 2009 from the Food and Drug Administration (FDA). Per the FDA, this case did not meet probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Gait disturbance, IIIrd nerve paralysis, Intensive care, Muscular weakness
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 295507). A 12-year-old female patient received an intramuscular first dose of MENACTRA (lot not reported) and an intramuscular first dose of GARDASIL (Merck, lot not reported) on 24 July 2007. On approximately 07 August 2007, 14 days post-vaccination, the patient began developing diplopia, ataxia, and weakness in the extremities. She was seen by a physician on 13 August 2007 and noted to have an unsteady gait and abnormal eye movements. She had reportedly began "running into things and falling", with worsening weakness and pain. Physical exam was remarkable for decreased strength in the upper and lower extremities, 1-beat clonus bilaterally, cranial nerve III palsy, and right exotropia. MRI of the brain was markedly abnormal involving midbrain and base of brain. BUN and creatinine were increased. She was admitted to the PICU on 14 August 2007 after becoming increasingly more encephalopathic during admission. She developed deteriorating renal function/azotemia, which worsened following a CT with contrast. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. No formal discharge diagnosis was noted, but a diagnosis of acute disseminated encephalomyelitis was proposed following diagnostic studies. As of a follow-up phone call on 28 December 2007, the patient still had occasional double vision when tired. Other symptoms, including ataxia, dysphagia, and renal dysfunction, had resolved. Final outcome was not reported. Follow up information was received on 10 April 2009 from the Food and Drug Administration (FDA). Per the FDA, this case did not meet probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pain, Renal disorder, Renal impairment, Strabismus
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 295507). A 12-year-old female patient received an intramuscular first dose of MENACTRA (lot not reported) and an intramuscular first dose of GARDASIL (Merck, lot not reported) on 24 July 2007. On approximately 07 August 2007, 14 days post-vaccination, the patient began developing diplopia, ataxia, and weakness in the extremities. She was seen by a physician on 13 August 2007 and noted to have an unsteady gait and abnormal eye movements. She had reportedly began "running into things and falling", with worsening weakness and pain. Physical exam was remarkable for decreased strength in the upper and lower extremities, 1-beat clonus bilaterally, cranial nerve III palsy, and right exotropia. MRI of the brain was markedly abnormal involving midbrain and base of brain. BUN and creatinine were increased. She was admitted to the PICU on 14 August 2007 after becoming increasingly more encephalopathic during admission. She developed deteriorating renal function/azotemia, which worsened following a CT with contrast. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. Treatment included intravenous and oral steroids, and she was discharged on hospital day 10 with aspiration precautions. No formal discharge diagnosis was noted, but a diagnosis of acute disseminated encephalomyelitis was proposed following diagnostic studies. As of a follow-up phone call on 28 December 2007, the patient still had occasional double vision when tired. Other symptoms, including ataxia, dysphagia, and renal dysfunction, had resolved. Final outcome was not reported. Follow up information was received on 10 April 2009 from the Food and Drug Administration (FDA). Per the FDA, this case did not meet probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Asthenia, Back pain, Balance disorder, Body temperature increased, CSF glucose normal
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 299604). An 18 year old male received MENACTRA and HEPTAVAX (manufacturer Merck) on 07 June 2007 (lot numbers were not reported). Late 08 June 2007 or early 09 June 2007 the patient developed a temperature of 105 degrees. He was treated and discharged in the emergency room. On 18 June 2007 the patient had lower back pain which continued through 27 June 2007. He went to a chiropractor five days prior to his hospital admission. He was experiencing shooting pain from the umbilicus to the lower extremities. On 28 June 2007 he noted that he had not urinated that day or one day prior and complained of difficulty moving his bowels. On 29 June 2007 he went to the emergency room where he was catheterized, had blood work completed, and was sent home. Results were CSF white count 264, glucose 70, protein 50, MRI of the brain normal, MRI of the thoracic and lumbar spine showed signal abnormalities of the thoracic cord from T4, T5, and T10. On 01 July 2007 he woke up with no feeling in his legs and was unable to move them and was admitted to the hospital. On 06 July 2007 he was able to ambulate using a walker and assistance. On 09 July 2007 he was able to walk independently but was very weak. On 06 July 2007 he self catheterized himself until he could urinate on his own. He was discharged on 10 July 2007 with a diagnosis of acute myelitis, neurogenic bladder and bowel dysfunction, gait and balance dysfunction. On 12 July 2007 he began physical therapy. Outcome was reported as hospitalized.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: CSF protein increased, CSF white blood cell count increased, Gait disturbance, Intestinal functional disorder, Lumbar puncture abnormal
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 299604). An 18 year old male received MENACTRA and HEPTAVAX (manufacturer Merck) on 07 June 2007 (lot numbers were not reported). Late 08 June 2007 or early 09 June 2007 the patient developed a temperature of 105 degrees. He was treated and discharged in the emergency room. On 18 June 2007 the patient had lower back pain which continued through 27 June 2007. He went to a chiropractor five days prior to his hospital admission. He was experiencing shooting pain from the umbilicus to the lower extremities. On 28 June 2007 he noted that he had not urinated that day or one day prior and complained of difficulty moving his bowels. On 29 June 2007 he went to the emergency room where he was catheterized, had blood work completed, and was sent home. Results were CSF white count 264, glucose 70, protein 50, MRI of the brain normal, MRI of the thoracic and lumbar spine showed signal abnormalities of the thoracic cord from T4, T5, and T10. On 01 July 2007 he woke up with no feeling in his legs and was unable to move them and was admitted to the hospital. On 06 July 2007 he was able to ambulate using a walker and assistance. On 09 July 2007 he was able to walk independently but was very weak. On 06 July 2007 he self catheterized himself until he could urinate on his own. He was discharged on 10 July 2007 with a diagnosis of acute myelitis, neurogenic bladder and bowel dysfunction, gait and balance dysfunction. On 12 July 2007 he began physical therapy. Outcome was reported as hospitalized.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Myelitis, Neurogenic bladder, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Pain in extremity
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 299604). An 18 year old male received MENACTRA and HEPTAVAX (manufacturer Merck) on 07 June 2007 (lot numbers were not reported). Late 08 June 2007 or early 09 June 2007 the patient developed a temperature of 105 degrees. He was treated and discharged in the emergency room. On 18 June 2007 the patient had lower back pain which continued through 27 June 2007. He went to a chiropractor five days prior to his hospital admission. He was experiencing shooting pain from the umbilicus to the lower extremities. On 28 June 2007 he noted that he had not urinated that day or one day prior and complained of difficulty moving his bowels. On 29 June 2007 he went to the emergency room where he was catheterized, had blood work completed, and was sent home. Results were CSF white count 264, glucose 70, protein 50, MRI of the brain normal, MRI of the thoracic and lumbar spine showed signal abnormalities of the thoracic cord from T4, T5, and T10. On 01 July 2007 he woke up with no feeling in his legs and was unable to move them and was admitted to the hospital. On 06 July 2007 he was able to ambulate using a walker and assistance. On 09 July 2007 he was able to walk independently but was very weak. On 06 July 2007 he self catheterized himself until he could urinate on his own. He was discharged on 10 July 2007 with a diagnosis of acute myelitis, neurogenic bladder and bowel dysfunction, gait and balance dysfunction. On 12 July 2007 he began physical therapy. Outcome was reported as hospitalized.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Sensory loss, Urinary incontinence, Walking aid user
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 299604). An 18 year old male received MENACTRA and HEPTAVAX (manufacturer Merck) on 07 June 2007 (lot numbers were not reported). Late 08 June 2007 or early 09 June 2007 the patient developed a temperature of 105 degrees. He was treated and discharged in the emergency room. On 18 June 2007 the patient had lower back pain which continued through 27 June 2007. He went to a chiropractor five days prior to his hospital admission. He was experiencing shooting pain from the umbilicus to the lower extremities. On 28 June 2007 he noted that he had not urinated that day or one day prior and complained of difficulty moving his bowels. On 29 June 2007 he went to the emergency room where he was catheterized, had blood work completed, and was sent home. Results were CSF white count 264, glucose 70, protein 50, MRI of the brain normal, MRI of the thoracic and lumbar spine showed signal abnormalities of the thoracic cord from T4, T5, and T10. On 01 July 2007 he woke up with no feeling in his legs and was unable to move them and was admitted to the hospital. On 06 July 2007 he was able to ambulate using a walker and assistance. On 09 July 2007 he was able to walk independently but was very weak. On 06 July 2007 he self catheterized himself until he could urinate on his own. He was discharged on 10 July 2007 with a diagnosis of acute myelitis, neurogenic bladder and bowel dysfunction, gait and balance dysfunction. On 12 July 2007 he began physical therapy. Outcome was reported as hospitalized.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Acoustic stimulation tests, Deafness neurosensory, Deafness unilateral, Nuclear magnetic resonance imaging
Clinical narrative: According to Dr. - sudden sensory neuro hearing loss - all hearing lost in left ear very suddenly.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Areflexia, Cerebellar syndrome, Demyelination, Electromyogram abnormal, Extraocular muscle disorder
Clinical narrative: This case was extracted on 28 March 2009 (reference number 303475). An 18-year-old female patient, with a history of Bell's Palsy, received first dose of MENACTRA (lot number U2380BA) and GARDASIL (Merck, lot number 658100/0525U) on 25 July 2007. On approximately 17 December 2007, 145 days post-vaccination, the patient developed numbness and tingling in the hand. Symptoms spread to the left arm, and she developed difficulty focusing, eye pain, ophthalmoparesis, numbness in both feet in a stocking/glove distribution, and arreflexia. She was admitted to the hospital on 31 December 2007 following an outpatient visit to a neurologist, and was diagnosed with probable Miller-Fisher variant of Guillain Barre syndrome. Upon admission she had limited extraocular movement with left lateral gaze nystagmus and dysmetria. EMG and nerve conduction studies revealed an early demyelinating process involving the left ulnar nerve. An MRI of the brain was within normal limits. She was treated with immunoglobulin G, and discharged from the hospital on 01 January 2008. Per the reporter, the patient was scheduled to follow-up as an outpatient with neurologist, and outcome was not reported. Additional doses of GARDASIL were not administered. In addition to the events noted, the following terms were also reported by the health authority: cerebellar syndrome, gait disturbance, and headache.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Eye pain, Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: This case was extracted on 28 March 2009 (reference number 303475). An 18-year-old female patient, with a history of Bell's Palsy, received first dose of MENACTRA (lot number U2380BA) and GARDASIL (Merck, lot number 658100/0525U) on 25 July 2007. On approximately 17 December 2007, 145 days post-vaccination, the patient developed numbness and tingling in the hand. Symptoms spread to the left arm, and she developed difficulty focusing, eye pain, ophthalmoparesis, numbness in both feet in a stocking/glove distribution, and arreflexia. She was admitted to the hospital on 31 December 2007 following an outpatient visit to a neurologist, and was diagnosed with probable Miller-Fisher variant of Guillain Barre syndrome. Upon admission she had limited extraocular movement with left lateral gaze nystagmus and dysmetria. EMG and nerve conduction studies revealed an early demyelinating process involving the left ulnar nerve. An MRI of the brain was within normal limits. She was treated with immunoglobulin G, and discharged from the hospital on 01 January 2008. Per the reporter, the patient was scheduled to follow-up as an outpatient with neurologist, and outcome was not reported. Additional doses of GARDASIL were not administered. In addition to the events noted, the following terms were also reported by the health authority: cerebellar syndrome, gait disturbance, and headache.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypokinesia, Immunoglobulin therapy, Miller Fisher syndrome, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This case was extracted on 28 March 2009 (reference number 303475). An 18-year-old female patient, with a history of Bell's Palsy, received first dose of MENACTRA (lot number U2380BA) and GARDASIL (Merck, lot number 658100/0525U) on 25 July 2007. On approximately 17 December 2007, 145 days post-vaccination, the patient developed numbness and tingling in the hand. Symptoms spread to the left arm, and she developed difficulty focusing, eye pain, ophthalmoparesis, numbness in both feet in a stocking/glove distribution, and arreflexia. She was admitted to the hospital on 31 December 2007 following an outpatient visit to a neurologist, and was diagnosed with probable Miller-Fisher variant of Guillain Barre syndrome. Upon admission she had limited extraocular movement with left lateral gaze nystagmus and dysmetria. EMG and nerve conduction studies revealed an early demyelinating process involving the left ulnar nerve. An MRI of the brain was within normal limits. She was treated with immunoglobulin G, and discharged from the hospital on 01 January 2008. Per the reporter, the patient was scheduled to follow-up as an outpatient with neurologist, and outcome was not reported. Additional doses of GARDASIL were not administered. In addition to the events noted, the following terms were also reported by the health authority: cerebellar syndrome, gait disturbance, and headache.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nystagmus, Ophthalmoplegia, Paraesthesia, Vision blurred
Clinical narrative: This case was extracted on 28 March 2009 (reference number 303475). An 18-year-old female patient, with a history of Bell's Palsy, received first dose of MENACTRA (lot number U2380BA) and GARDASIL (Merck, lot number 658100/0525U) on 25 July 2007. On approximately 17 December 2007, 145 days post-vaccination, the patient developed numbness and tingling in the hand. Symptoms spread to the left arm, and she developed difficulty focusing, eye pain, ophthalmoparesis, numbness in both feet in a stocking/glove distribution, and arreflexia. She was admitted to the hospital on 31 December 2007 following an outpatient visit to a neurologist, and was diagnosed with probable Miller-Fisher variant of Guillain Barre syndrome. Upon admission she had limited extraocular movement with left lateral gaze nystagmus and dysmetria. EMG and nerve conduction studies revealed an early demyelinating process involving the left ulnar nerve. An MRI of the brain was within normal limits. She was treated with immunoglobulin G, and discharged from the hospital on 01 January 2008. Per the reporter, the patient was scheduled to follow-up as an outpatient with neurologist, and outcome was not reported. Additional doses of GARDASIL were not administered. In addition to the events noted, the following terms were also reported by the health authority: cerebellar syndrome, gait disturbance, and headache.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blunted affect, Condition aggravated, Conversion disorder, Culture urine negative, Decreased eye contact
Clinical narrative: A 13-year-old female patient received MENACTRA and GARDASIL (Merck); lot numbers not reported) on 20 August 2007. On an unreported date, she developed left-sided numbness, left hand, face, and leg tremors, twitching, periodic vertigo, headache, and her left arm was "hard". Upon examination she was noted to have blunted affect, poor eye contact, slow speech, and mild decreased sensation of the left upper extremity with normal strength, tone, and reflexes. She was seen in a neurology clinic from 20 January through 21 February 2008, and during that time her tremors increased and she had begun stuttering. An EEG was abnormal, with mild encephalopathy and abnormalities suggesting a risk for focal seizures. CBC, chemistry, UA, urine culture and sensitivity, monospot, and MRI of the brain and spine were all within normal limits. The final diagnosis was stress-induced conversion reaction. The patient was referred for counseling; outcome was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dysphemia, Electroencephalogram abnormal, Encephalopathy, Full blood count normal, Headache
Clinical narrative: A 13-year-old female patient received MENACTRA and GARDASIL (Merck); lot numbers not reported) on 20 August 2007. On an unreported date, she developed left-sided numbness, left hand, face, and leg tremors, twitching, periodic vertigo, headache, and her left arm was "hard". Upon examination she was noted to have blunted affect, poor eye contact, slow speech, and mild decreased sensation of the left upper extremity with normal strength, tone, and reflexes. She was seen in a neurology clinic from 20 January through 21 February 2008, and during that time her tremors increased and she had begun stuttering. An EEG was abnormal, with mild encephalopathy and abnormalities suggesting a risk for focal seizures. CBC, chemistry, UA, urine culture and sensitivity, monospot, and MRI of the brain and spine were all within normal limits. The final diagnosis was stress-induced conversion reaction. The patient was referred for counseling; outcome was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Induration, Laboratory test normal, Mononucleosis heterophile test negative, Muscle twitching
Clinical narrative: A 13-year-old female patient received MENACTRA and GARDASIL (Merck); lot numbers not reported) on 20 August 2007. On an unreported date, she developed left-sided numbness, left hand, face, and leg tremors, twitching, periodic vertigo, headache, and her left arm was "hard". Upon examination she was noted to have blunted affect, poor eye contact, slow speech, and mild decreased sensation of the left upper extremity with normal strength, tone, and reflexes. She was seen in a neurology clinic from 20 January through 21 February 2008, and during that time her tremors increased and she had begun stuttering. An EEG was abnormal, with mild encephalopathy and abnormalities suggesting a risk for focal seizures. CBC, chemistry, UA, urine culture and sensitivity, monospot, and MRI of the brain and spine were all within normal limits. The final diagnosis was stress-induced conversion reaction. The patient was referred for counseling; outcome was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Sensory loss, Speech disorder, Tremor
Clinical narrative: A 13-year-old female patient received MENACTRA and GARDASIL (Merck); lot numbers not reported) on 20 August 2007. On an unreported date, she developed left-sided numbness, left hand, face, and leg tremors, twitching, periodic vertigo, headache, and her left arm was "hard". Upon examination she was noted to have blunted affect, poor eye contact, slow speech, and mild decreased sensation of the left upper extremity with normal strength, tone, and reflexes. She was seen in a neurology clinic from 20 January through 21 February 2008, and during that time her tremors increased and she had begun stuttering. An EEG was abnormal, with mild encephalopathy and abnormalities suggesting a risk for focal seizures. CBC, chemistry, UA, urine culture and sensitivity, monospot, and MRI of the brain and spine were all within normal limits. The final diagnosis was stress-induced conversion reaction. The patient was referred for counseling; outcome was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urine analysis normal, Vertigo
Clinical narrative: A 13-year-old female patient received MENACTRA and GARDASIL (Merck); lot numbers not reported) on 20 August 2007. On an unreported date, she developed left-sided numbness, left hand, face, and leg tremors, twitching, periodic vertigo, headache, and her left arm was "hard". Upon examination she was noted to have blunted affect, poor eye contact, slow speech, and mild decreased sensation of the left upper extremity with normal strength, tone, and reflexes. She was seen in a neurology clinic from 20 January through 21 February 2008, and during that time her tremors increased and she had begun stuttering. An EEG was abnormal, with mild encephalopathy and abnormalities suggesting a risk for focal seizures. CBC, chemistry, UA, urine culture and sensitivity, monospot, and MRI of the brain and spine were all within normal limits. The final diagnosis was stress-induced conversion reaction. The patient was referred for counseling; outcome was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Acute disseminated encephalomyelitis, Agitation, Biopsy brain abnormal, Blood creatinine normal, Blood culture negative
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood urea normal, CSF protein increased
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: CSF test normal, Candidiasis, Cardiac procedure complication, Clumsiness, Cognitive disorder
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Condition aggravated, Confusional state, Convulsion, Cough, Delirium
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Disturbance in attention, Dizziness, Endotracheal intubation, Gait disturbance, Gastrointestinal tube insertion
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.