chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: FLUN3, HEPAB, MMR, MNQ, TDAP
Symptoms: Nerve conduction studies abnormal, Paraesthesia, Red blood cell sedimentation rate increased, X-ray normal
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 318648. SERIOUSNESS CRITERIA: OTHER- MEDICALLY SIGNIFICANT. A 20-year-old male received an injection of MENACTRA (lot number U2409AA), ADACEL (lot number C2842AA), FLUMIST (MedImmune, lot number 500476P), MMR II (Merck, lot number 0868U), and TWINRIX (GlaxoSmithKline, lot number AHABB103AA) on 18 December 2007. He had no illness at the time of vaccination. Four days after vaccination, on 22 December 2007, the patient began experiencing weakness, paresthesias of the lower extremities, and difficulty walking. He underwent physical therapy, but did not improve, and was subsequently referred to a neurologist. His condition progressed to include weakness and paresthesias of the upper extremities and impaired activities of daily living. Diagnostic testing showed elevated CRP (7.59) and ESR, and EMG/NCV were abnormal in upper and lower extremities. Ct of the C-spine/head and foot x-ray were within normal limits. Genetic testing revealed an abnormality (gene mutation identification test positive). In June 2008 he underwent treatment with intravenous immunoglobulins, and had some improvement. He was medically separated from his occupation, and required a brace on the right foot in order to walk. Final diagnosis as of 07 July 2008 was demyelinating polyneuritis, chronic inflammatory (active). Information received from CDC stated that the patient was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). Outcome was not provided. Documents held by sender: None
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Aura, Blood creatine phosphokinase normal, Blood pressure systolic increased, Blood product transfusion, CSF glucose normal
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 324881.  A 13-year-old male patient received a first intramuscular left arm injection of MENACTRA (lot number U2686AA) and a second subcutaneous left arm injection of VARIVAX (Merck, lot number 0431X) on 21 August 2008. It was noted that the patient had traveled out of the Country on an outdoor trip in August 2008, and at the time had a viral upper respiratory infection and sore throat. On 03 September 2008, thirteen days after vaccination, the patient developed a severe headache with aura. The following day, he developed right-sided facial weakness, and his face was noted to be "droopy". Fifteen days after vaccination, on 05 September 2008, he progressed to bilateral lower extremity weakness with some intermittent blurred vision and difficulty in walking. He was initially seen by a physician on 06 September 2008, sixteen days after vaccination, and was diagnosed with Bell's Palsy. The primary symptom at that time was right facial palsy, and treatment included ACYCLOVIR, PREDNISONE, and artificial tears. His lower extremity weakness progressed, and upon re-evaluation two days later he had persistent right facial palsy, blurry vision, attention difficulty, and significant weakness of bilateral hip flexion, knee extension and flexion, great toe dorsiflexion, and plantar flexion. Systolic blood pressure was elevated. his physician consulted a neurologist via telephone, and the patient was transferred to the emergency department on 10 September 2008. A lumbar puncture showed three to four WBC's protein 373, and glucose 59. Nerve conduction studies showed absent F waves in median, ulnar, common peroneal, and tibial nerves; normal conduction velocities, but slightly prolonged distal latencies with early evidence of demyelination. CK was 63, and serum protein electrophoresis showed atypical protein pattern in gamma-globulin. He was diagnosed with Guillain-Barre Syndrome, and transferred to another hospital where he underwent intravenous immunoglobulin therapy. He remained in the hospital for 4 days, and was discharged on 13 September 2008. Final outcome was unknown. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: CSF protein increased, CSF white blood cell count negative, Demyelination, Disturbance in attention, Electrophoresis protein abnormal
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 324881.  A 13-year-old male patient received a first intramuscular left arm injection of MENACTRA (lot number U2686AA) and a second subcutaneous left arm injection of VARIVAX (Merck, lot number 0431X) on 21 August 2008. It was noted that the patient had traveled out of the Country on an outdoor trip in August 2008, and at the time had a viral upper respiratory infection and sore throat. On 03 September 2008, thirteen days after vaccination, the patient developed a severe headache with aura. The following day, he developed right-sided facial weakness, and his face was noted to be "droopy". Fifteen days after vaccination, on 05 September 2008, he progressed to bilateral lower extremity weakness with some intermittent blurred vision and difficulty in walking. He was initially seen by a physician on 06 September 2008, sixteen days after vaccination, and was diagnosed with Bell's Palsy. The primary symptom at that time was right facial palsy, and treatment included ACYCLOVIR, PREDNISONE, and artificial tears. His lower extremity weakness progressed, and upon re-evaluation two days later he had persistent right facial palsy, blurry vision, attention difficulty, and significant weakness of bilateral hip flexion, knee extension and flexion, great toe dorsiflexion, and plantar flexion. Systolic blood pressure was elevated. his physician consulted a neurologist via telephone, and the patient was transferred to the emergency department on 10 September 2008. A lumbar puncture showed three to four WBC's protein 373, and glucose 59. Nerve conduction studies showed absent F waves in median, ulnar, common peroneal, and tibial nerves; normal conduction velocities, but slightly prolonged distal latencies with early evidence of demyelination. CK was 63, and serum protein electrophoresis showed atypical protein pattern in gamma-globulin. He was diagnosed with Guillain-Barre Syndrome, and transferred to another hospital where he underwent intravenous immunoglobulin therapy. He remained in the hospital for 4 days, and was discharged on 13 September 2008. Final outcome was unknown. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Facial palsy, Facial paresis, Gait disturbance, Guillain-Barre syndrome, Headache
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 324881.  A 13-year-old male patient received a first intramuscular left arm injection of MENACTRA (lot number U2686AA) and a second subcutaneous left arm injection of VARIVAX (Merck, lot number 0431X) on 21 August 2008. It was noted that the patient had traveled out of the Country on an outdoor trip in August 2008, and at the time had a viral upper respiratory infection and sore throat. On 03 September 2008, thirteen days after vaccination, the patient developed a severe headache with aura. The following day, he developed right-sided facial weakness, and his face was noted to be "droopy". Fifteen days after vaccination, on 05 September 2008, he progressed to bilateral lower extremity weakness with some intermittent blurred vision and difficulty in walking. He was initially seen by a physician on 06 September 2008, sixteen days after vaccination, and was diagnosed with Bell's Palsy. The primary symptom at that time was right facial palsy, and treatment included ACYCLOVIR, PREDNISONE, and artificial tears. His lower extremity weakness progressed, and upon re-evaluation two days later he had persistent right facial palsy, blurry vision, attention difficulty, and significant weakness of bilateral hip flexion, knee extension and flexion, great toe dorsiflexion, and plantar flexion. Systolic blood pressure was elevated. his physician consulted a neurologist via telephone, and the patient was transferred to the emergency department on 10 September 2008. A lumbar puncture showed three to four WBC's protein 373, and glucose 59. Nerve conduction studies showed absent F waves in median, ulnar, common peroneal, and tibial nerves; normal conduction velocities, but slightly prolonged distal latencies with early evidence of demyelination. CK was 63, and serum protein electrophoresis showed atypical protein pattern in gamma-globulin. He was diagnosed with Guillain-Barre Syndrome, and transferred to another hospital where he underwent intravenous immunoglobulin therapy. He remained in the hospital for 4 days, and was discharged on 13 September 2008. Final outcome was unknown. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Lumbar puncture abnormal, Muscular weakness, Nerve conduction studies abnormal, Vision blurred
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 324881.  A 13-year-old male patient received a first intramuscular left arm injection of MENACTRA (lot number U2686AA) and a second subcutaneous left arm injection of VARIVAX (Merck, lot number 0431X) on 21 August 2008. It was noted that the patient had traveled out of the Country on an outdoor trip in August 2008, and at the time had a viral upper respiratory infection and sore throat. On 03 September 2008, thirteen days after vaccination, the patient developed a severe headache with aura. The following day, he developed right-sided facial weakness, and his face was noted to be "droopy". Fifteen days after vaccination, on 05 September 2008, he progressed to bilateral lower extremity weakness with some intermittent blurred vision and difficulty in walking. He was initially seen by a physician on 06 September 2008, sixteen days after vaccination, and was diagnosed with Bell's Palsy. The primary symptom at that time was right facial palsy, and treatment included ACYCLOVIR, PREDNISONE, and artificial tears. His lower extremity weakness progressed, and upon re-evaluation two days later he had persistent right facial palsy, blurry vision, attention difficulty, and significant weakness of bilateral hip flexion, knee extension and flexion, great toe dorsiflexion, and plantar flexion. Systolic blood pressure was elevated. his physician consulted a neurologist via telephone, and the patient was transferred to the emergency department on 10 September 2008. A lumbar puncture showed three to four WBC's protein 373, and glucose 59. Nerve conduction studies showed absent F waves in median, ulnar, common peroneal, and tibial nerves; normal conduction velocities, but slightly prolonged distal latencies with early evidence of demyelination. CK was 63, and serum protein electrophoresis showed atypical protein pattern in gamma-globulin. He was diagnosed with Guillain-Barre Syndrome, and transferred to another hospital where he underwent intravenous immunoglobulin therapy. He remained in the hospital for 4 days, and was discharged on 13 September 2008. Final outcome was unknown. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Acute respiratory failure, Alanine aminotransferase increased, Asthenia, Back pain, Blood alkaline phosphatase increased
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Blood culture negative, Blood gases abnormal, Blood product transfusion, Breath sounds abnormal, CSF culture negative
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: CSF test normal, Computerised tomogram abnormal, Cough, Culture positive, Diarrhoea
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Drug screen negative, Dyspnoea, Dysstasia, Ear pain
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Echocardiogram normal, Guillain-Barre syndrome, Head injury, Headache, Hypoventilation
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Intensive care, Lethargy, Mastoiditis, Neck pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Otitis media, Otitis media chronic, Otorrhoea, Oxygen saturation normal, Pallor
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Peak expiratory flow rate decreased, Respiratory alkalosis, Respiratory distress, Syncope, Tachypnoea
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Tympanic membrane perforation, Urine analysis abnormal, Urine ketone body present, Urine protein, quantitative, Vomiting
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Wheezing
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 325146. A 15-year-old male patient with a history of sulfa allergy (rash), irritable bowel syndrome, an appendectomy and myringotomy tubes, had received a first dose injection of MENACTRA (lot number SPU2618AA), and a second dose injection of HAVRIX (lot number AHAJB243AA, manufacturer GlaxoSmithKline) on 05 August 2008. On 09 September 2008 (also reported as 10 September 2008), 35 days after he had received the vaccine, the patient presented to the emergency room with a 24 hour history of dizziness, back pain, headache, diarrhea and a syncopal episode with a head injury. The patient also had symptoms of a cough and ear pain with a previous diagnosis of otitis media with a perforated ear drum. The patient received corrective treatment with intravenous fluids and was discharged. He returned to the emergency room on 12 September 2008 (also reported as 11 September 2008) with complaints of lethargy, a second syncopal episode, generalized weakness, shortness of breath (SOB), inability to stand, and head, neck and back pain. Physical examination noted left ear drainage, pallor, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased work of breathing (WOB), and decreased strength (3/5 upper, 2/5 lower extremities). He was admitted to the pediatric intensive care unit (PICU) in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Intravenous immune globulin's (IVIG) were administered with good response. The patient also received oxygen, Bipap, IV antibiotics, IV Fluids. According to the reporter, the patient was hospitalized for three days. Laboratory and diagnostic tests included CT head (+) for L otomastoiditis. MRI head (+) for otomastoiditis. MRI spine WNL. CSF WNL. ABGs abnormal. Alk Phos 130. ALT 103. Drug Screen (-). UA (+) for protein 20, trace ketones, rare mucous, 1-4 casts. Blood cx (-). Medical records for emergency room visit and dates of services 12 September - 15 September 2008 indicated a diagnosis of acute respiratory failure secondary to chest wall and neuromuscular weakness due to Guillain Barre Syndrome. Additional diagnosis included chronic supporative otitis media (OM); chronic mastoiditis; otitis media (OM) and central perforation of L tympanic membrane, which were consistent with the ENT consult assessment. Neurology will consider an EMG/NCS if symptoms recur. Documents held by sender: None.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site discolouration
Clinical narrative: A 6 month - old patient developed a black dot at the injection site after receiving a right thigh injection of IPOL, lot number A0169 on 08 January 2008. According to the reporter, the physician observed a black dot on the patient's right thigh on 10 March 2008 when the patient had returned for their six month well visit. At the time of the report, it was unknown if the patient recovered from the event. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used alcohol wipes and syringes which included safety glide and vanish point with with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. Follow up information was received on 14 October 2008 from a health care professional. The patient received a second dose of IPOL intramuscularly, a second right thigh intramuscular injection of Daptacel reported as "DTAP" (lot number C2765AA), a second left thigh intramuscular injection injection of ActHIB reported as "HIB" lot number UF217AB (Sanofi Pasteur SA lot number A0367), and a second left thigh intramuscular injection of PREVNAR (manufacturer Wyeth, lot number C57540) on 08 January 2008. The patient recovered from the event. No further information was provided. Documents held by sender : None. The reporter for this case is the same as for case numbers case numbers 2008-01333 (IPOL and ActHIB). 2008-01334 (IPOL), 2008-01336 (IPOL and DTAP). 2008-01338 (IPOL) and 2008-01339 (Flu zone). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Age: 0.2
Sex: U
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site discolouration
Clinical narrative: Initial report received 29 April 2008 from a health care professional.  This report (2008-01336) and case number 2008-01334 and 2008-01335 came from the same satellite location.  A 12-month-old patient (gender not reported) developed a black dot at the injection site after receiving a left thigh injection of IPOL, lot number Z0547 and a left thigh injection of DAPTACEL, lot number C2605AA on 13 June 2007 during their two month well visit.  The patient returned to their physician's office for their four month well visit on 16 August 2007, at which time the physician noticed a black dot on the patient's left thigh.  The patient subsequently received a left thigh injection of IPOL, lot number Z0812 on 16 August 2007.  When the patient returned two months later for their six month well visit (date not provided), the physician noticed the appearance of a second black dot on the child's left thigh.  Both black dots had been present at the time.  The recovery status of the patient was unknown at the time of the report.  The reporter received a cluster of reports of black dots at the injection site from multiple satellite location who were all affiliated with the reporter.  The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles.  Some of the black dots were reported to have appeared immediately with some present two months post immunization.  This event had been noticed by all health care workers at the facilities and had not been noticed in the past.  The reporter indicated follow-up information would be provided as it is obtained.  19/May/2008:  Corrective version created for the purpose of amending the lot number on the DAPTACEL product screen to C2650A (previously entered as C2605A).  Follow up information was received on 14 October 2008 from a health care professional.  The reporter clarified that the two month old patient (previously reported as twelve months old) received an initial right thigh injection of ACTHIB lot number UF101AB (SA lot number Z1101-Z) on 13 June 2007.  The reporter verified that the patient received DAPTACEL (lot number C2605AA, previously reported as C2650A).  The reporter verified that the patient's six month well visit was on 08 October 2007.  The patient recovered from the events on 07 January 2008.  Documents held by sender:  None.  The reporter for this case is the same as for case number 2008-01333 (IPOL and ACTHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01338 (IPOL) and 2008-01339 (FLUZONE).
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site discolouration
Clinical narrative: A cluster of four unidentified patients developed a black dot at the injection site after receiving an injection of IPOL, lot number A0298-2 (route/site not reported). At the time of the report, the patients had not recovered from the event. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. Additional information was received from the initial reporter on 02 May 2008. The reporter provided individual patient identifiers for the four previously unidentified patients. The information contained in this case (2008-01338) is now for a two-month-old female, whose black dot appeared on 24 March 2008. This patient's case was one of four cases which were reported from the same satellite site. The information for the other three patients is contained in cases 2008-01427, 2008-01428, 2008-01429. Follow-up information received on 17 November 2008 from the initial reporter. The patient's date of birth was provided. The patient had no medical history and no illness at the time of vaccination. Along with the IPOL, the patient had also received the following vaccines on 24 March 2008: DAPTACEL (lot number C2800AA) in the left thigh, ACT-HIB (lot number UF233AA) in the right thigh, and PREVNAR (Wyeth, lot number C49922) in the right thigh. For this patient, the black dot at the injection site was noted four days after vaccination. The patient's recovery status was not reported. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ACTHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 IPOL and DTAP), 2008-01339 (FLUZONE), 2008-01427 (IPOL), 2008-01428 (IPOL), and 2008-01429 (IPOL). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site discolouration
Clinical narrative: Information was received 02 May 2008 from a health care professional.  A 4-year-old male patient had received an injection of IPOL, lot number A0298-2 (date, route and site of administration not provided) and on 24 March 2008, he subsequently developed a black dot at the injection site.  The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter.  This patient's case was one of four cases reported from the same satellite site.  This report (2008-01427) and case number 2008-01338, 2008-01428 and 2008-01429 came from the same satellite location.  All facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles.  Some of the black dots were reported to have appeared immediately with some present two months post immunization.  This reporter indicated follow-up information would be provided as it is obtained.  Follow-up information was received from the reporter on 17 November 2008.  The patient initials were amended, and date of birth was provided.  In addition to receiving a fourth left thigh dose of IPOL, the patient also received the following vaccines on 24 March 2008: DAPTACEL (lot number C2800AA, left thigh, dose five); MMR (Merck, lot number 17460, right arm, dose two), and VARIVAX (Merck, lot number 15890, right arm, dose two).  He was not ill at the time of vaccination.  The reporter for this case is the same as for case number 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTAP), 2008-01338, 2008-01339 (FLUZONE), 2008-01428 (IPOL), and 2008-01429 (IPOL).