chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Dysphagia, Echocardiogram normal, Guillain-Barre syndrome, Haemolysis, Hyperbilirubinaemia
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Hypertension, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Lung infiltration
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Mechanical ventilation, Muscular weakness, Nasal congestion, Nausea, Nerve conduction studies abnormal
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging normal, Orchitis, Oropharyngeal pain, Paraesthesia
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Paraesthesia oral, Peripheral sensory neuropathy, Plasmapheresis, Pneumonia aspiration, Polyneuropathy idiopathic progressive
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Productive cough, Pyrexia, Respiratory failure, Respiratory tract congestion, Reticulocyte count increased
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Rhinorrhoea, Sensorimotor disorder, Tachycardia, Tracheostomy, Upper respiratory tract infection
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 336045). An 18-year-old male patient, with no reported medical history, received the following vaccinations on 22 September 2008: a left leg intramuscular dose of ADACEL (lot number C2998BA); an intramuscular dose of MENACTRA (lot number U2656AA); an intramuscular dose of BCG (lot number 52064); an intranasal dose of FLUMIST (Medimmune, lot number 500560P); MMR II (Merck, lot number 0356X); an intramuscular left leg dose of TWINRIX (GlaxoSmithKline, lot number AHAB128AB); and a subcutaneous dose of VARIVAX (lot number 0973). On 06 October 2008, 14 days post-vaccination, the patient complained of fever, chills, congestion, runny nose, sore throat, nausea, and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2009, he presented to the emergency department with complaints of numbness and tingling in both hands and feet, and in his mouth, and weakness in the lower extremities while trying to climb stairs. At that time the impression was progressive idiopathic polyneuropathy. On 16 October 2008, he began developing progressive neurologic symptoms consistent with GUILLAIN-BARRE syndrome, including aphonia, dysphagia, and acute sensorimotor neurological deficits. He progressed to respiratory failure, and required mechanical ventilation and subsequent tracheostomy. CT and MRI of the head and echocardiogram were normal. A chest x-ray showed an infiltration. Electrodiagnostic studies revealed abnormal-non-recordable latency of bilateral phrenic nerves and highly suggestive of demyelinating and axonal polyneuropathy predominantly involving motor nerves. Reticulocyte count was increased, and he developed hyperbilirubinemia. Diagnosis suggested hereditary hemolytic anemia vs. severe sepsis as cause of hemolysis. White blood count was 27.2. He was treated with intravenous immunoglobulins and plasmapheresis. During his hospitalization, he also developed orchitis, tachycardia, hypertension, and aspiration pneumonia. He remained hospitalized for 28 days and was discharged on 13 November 2008. Outcome was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and determined to meet the proposed Brighton Collaboration case definition of GUILLAIN-BARRE SYNDROME, with a level 2 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Back pain, Computerised tomogram normal, Diarrhoea, Full blood count normal, Headache
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed a severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. Follow-up information was received on 14 May 2010 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Laboratory test normal, Lumbar puncture normal, Myalgia, Nausea, Neck pain
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed a severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. Follow-up information was received on 14 May 2010 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed a severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. Follow-up information was received on 14 May 2010 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Back pain, Computerised tomogram head, Diarrhoea, Full blood count normal, Headache
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed a severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. Follow-up information was received on 14 May 2010 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. List of Documents held by Sender: none.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Areflexia, Asthenia, Ataxia, Autoantibody positive, Back pain
Clinical narrative: Initial case received from The Centers for Disease Control and Prevention (CDC) on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of GUILLAIN-BARRE SYNDROME. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Diplopia, Dysarthria, Facial nerve disorder, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial case received from The Centers for Disease Control and Prevention (CDC) on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of GUILLAIN-BARRE SYNDROME. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Headache, Hyporeflexia, Immunoglobulin therapy, Lumbar puncture normal, Migraine
Clinical narrative: Initial case received from The Centers for Disease Control and Prevention (CDC) on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of GUILLAIN-BARRE SYNDROME. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Miller Fisher syndrome, Muscular weakness, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Initial case received from The Centers for Disease Control and Prevention (CDC) on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of GUILLAIN-BARRE SYNDROME. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Paraesthesia, Sinus disorder
Clinical narrative: Initial case received from The Centers for Disease Control and Prevention (CDC) on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of GUILLAIN-BARRE SYNDROME. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Diplopia, Dysarthria, Facial paresis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial case received from The Centers for Disease Control and Prevention (CDC) on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of GUILLAIN-BARRE SYNDROME. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Paraesthesia, Paresis
Clinical narrative: Initial case received from The Centers for Disease Control and Prevention (CDC) on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of GUILLAIN-BARRE SYNDROME. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site movement impairment, Injection site pain, Musculoskeletal stiffness, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received on 15 July 2009 from a health care professional. A 32 year-old female patient, who was taking concomitant medication of DEPO-PROVERA, had received on 02 July 2009 at 08:40 am a first intramuscular left deltoid injection of ADACEL (lot number C3158AA). The patient had not received any other vaccinations within four weeks, and had not experienced any adverse events with prior vaccinations in the year. The patient called the reporter four days after receiving the ADACEL vaccine, to complain of left arm stiffness from the vaccination. The patient was advised to use ice and ibuprofen. The following day, the patient was evaluated by her primary care physician and was advised to continue the ibuprofen. The doctor's note that day stated "injection site high in deltoid." Seven days later, the patient called the reporter to report she had continued severe pain and limitation of movement. The patient reported that her primary care physician had ordered an MRI of her shoulder that was to be done on 16 July 2009. The result of that MRI was pending at the time of this report. Per the reporter, the patient has not yet recovered. Follow-up information received on 04 September 2009 from a health care professional. Per the reporter, the case was reviewed and there is "no additional information at this time." The reporter for this case is the same as for case 2009-03097. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Gait disturbance, Hot flush, Hyperhidrosis, Myalgia
Clinical narrative: Initial report received on 31 July 2009 from a consumer. A 59 year old male patient with a history of chronic back pain, hypertension, and allergies to penicillin and cephalosporins received ADACEL (lot number not reported) intramuscularly in the left hip on 26 July 2009 due to a cut on his forearm. On 27 July 2009 the patient experienced severe muscular pain and could barely walk for two days and had difficulty bending over. The patient complained of chills, hot flashes, sweating, and body aches. The patient did not have a fever, swelling, or redness. The patient improved but did not fully recover. Follow-up information was received from the consumer (who is also the patient) on 14 September 2009. ADACEL lot number was reported as UF451BA (Sanofi Pasteur Ltd. lot number C3002). No additional new information was reported. List of Documents held by Sender: none.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Initial report received on 31 July 2009 from a consumer. A 59 year old male patient with a history of chronic back pain, hypertension, and allergies to penicillin and cephalosporins received ADACEL (lot number not reported) intramuscularly in the left hip on 26 July 2009 due to a cut on his forearm. On 27 July 2009 the patient experienced severe muscular pain and could barely walk for two days and had difficulty bending over. The patient complained of chills, hot flashes, sweating, and body aches. The patient did not have a fever, swelling, or redness. The patient improved but did not fully recover. Follow-up information was received from the consumer (who is also the patient) on 14 September 2009. ADACEL lot number was reported as UF451BA (Sanofi Pasteur Ltd. lot number C3002). No additional new information was reported. List of Documents held by Sender: none.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, FLUN3, HPV4, TDAP
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Drug exposure during pregnancy, Nausea, Ovarian cancer
Clinical narrative: Initial report was received from a health care professional on 24 September 2009. A 15-year-old pregnant female patient had received a 0.5 mL intramuscular left deltoid injection of ADACEL, lot number C2773AA, and a 0.5 mL intramuscular left deltoid injection of HPV vaccine (manufacturer Merck, lot number 0653X) and a intranasal dose of FLUMIST (manufacturer MedImmune, lot number 500687P) on 17 September 2009. The vaccine was administered by a school nurse and it was unknown at the time of the vaccination that the patient was pregnant. The patient had no pre-existing medical conditions and no prior pregnancies. Her last menstrual period occurred on 01 August 2009 and her expected date of confinement was 09 May 2010. At the time of report, the patient had not experienced any adverse events since vaccination. Follow-up information was received 19 March 2010 from a health care professional. From new information received, it was reported that the patient had received ZOFRAN 4mg since 28 September 2009 for "ovarian carcinoma refractory (nausea)". Based upon this new information, this case has been upgraded from nonserious to serious. Additional maternal drug exposures included Iron 325mg beginning 16 December 2009 for anemia, and supplemental prenatal vitamins beginning 28 September 2009. The patient's last menstrual period occurred on 02 August 2009 (previously reported as 01 August 2009). Significant medical conditions were reported as "teen, anemia" and the patient was also noted to have had a family history of diabetes and HTN (hypertension). Prenatal tests included alpha feto protein on 18 November 2009 and an ultrasound on 23 December 2009, both with normal findings. An outcome was not reported for the event of ovarian carcinoma refractory nausea and anemia. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, FLUN3, HPV4, TDAP
Symptoms: Ultrasound scan normal
Clinical narrative: Initial report was received from a health care professional on 24 September 2009. A 15-year-old pregnant female patient had received a 0.5 mL intramuscular left deltoid injection of ADACEL, lot number C2773AA, and a 0.5 mL intramuscular left deltoid injection of HPV vaccine (manufacturer Merck, lot number 0653X) and a intranasal dose of FLUMIST (manufacturer MedImmune, lot number 500687P) on 17 September 2009. The vaccine was administered by a school nurse and it was unknown at the time of the vaccination that the patient was pregnant. The patient had no pre-existing medical conditions and no prior pregnancies. Her last menstrual period occurred on 01 August 2009 and her expected date of confinement was 09 May 2010. At the time of report, the patient had not experienced any adverse events since vaccination. Follow-up information was received 19 March 2010 from a health care professional. From new information received, it was reported that the patient had received ZOFRAN 4mg since 28 September 2009 for "ovarian carcinoma refractory (nausea)". Based upon this new information, this case has been upgraded from nonserious to serious. Additional maternal drug exposures included Iron 325mg beginning 16 December 2009 for anemia, and supplemental prenatal vitamins beginning 28 September 2009. The patient's last menstrual period occurred on 02 August 2009 (previously reported as 01 August 2009). Significant medical conditions were reported as "teen, anemia" and the patient was also noted to have had a family history of diabetes and HTN (hypertension). Prenatal tests included alpha feto protein on 18 November 2009 and an ultrasound on 23 December 2009, both with normal findings. An outcome was not reported for the event of ovarian carcinoma refractory nausea and anemia. Documents held by sender: None.
Age: 49.0
Sex: U
Vaccine: ANTH, FLUN3, HEP, SMALL, TDAP, TYP
Symptoms: Eczema
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 359820.  A 49 year old patient (gender unknown) received the following vaccines on 17 September 2009: a percutaneous injection of SMALLPOX (ACAM2000, lot not reported); ADACEL, (lot number C3057AA); an intramuscular injection of TYPHIM VI, (lot number E00741); ANTHRAX vaccine (manufacturer unknown, lot number FAV217); an intranasal injection of FLUMIST, (Medimmune, 500691P); and an intramuscular injection of HEPATITIS B (manufacturer unknown, lot number AHAVB632AA).  Unless specified above the routes of administration were unknown.  The sites of administration were not reported.  Seven days after vaccination the patient developed 'classic' eczema on the antecubital fossa and chest.  The patient's history is negative for atopic dermatitis but has had outbreaks of other types of rashes on the chest.  No additional information was provided.  There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported.  Latency has been calculated using the event date.  NOTE:  Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.  List of documents held by sender: none.