chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1), FLUX
Symptoms: Ultrasound scan
Clinical narrative: Terrible pain in right arm, at the site of injection.  I went to hand surgeon, who told me to use wet heat and Advil. I then went to my internist, who had an ultrasound performed.  Pain extended down entire arm, so I returned to hand surgeon.  He order MRI.  Too much movement for MRI, so returned for another one.  Still too much movement to read MRI.  By this time, it became extremely difficult to move entire arm.  Pain and limited movement continue to date, 3/9/2010.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1), FLUX
Symptoms: Asthenia, Nuclear magnetic resonance imaging normal, Pain in extremity, Ultrasound scan normal
Clinical narrative: Terrible pain in right arm, at the site of injection.  I went to hand surgeon, who told me to use wet heat and Advil. I then went to my internist, who had an ultrasound performed.  Pain extended down entire arm, so I returned to hand surgeon.  He order MRI.  Too much movement for MRI, so returned for another one.  Still too much movement to read MRI.  By this time, it became extremely difficult to move entire arm.  Pain and limited movement continue to date, 3/9/2010.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1), FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Ultrasound scan
Clinical narrative: Terrible pain in right arm, at the site of injection.  I went to hand surgeon, who told me to use wet heat and Advil. I then went to my internist, who had an ultrasound performed.  Pain extended down entire arm, so I returned to hand surgeon.  He order MRI.  Too much movement for MRI, so returned for another one.  Still too much movement to read MRI.  By this time, it became extremely difficult to move entire arm.  Pain and limited movement continue to date, 3/9/2010.
Sex: F
Vaccine: TYP
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: This female adult patient took the third dose of Vivotif (Batch no.: unknown) at noon, when she developed whelps and hives by evening. The patient is an ER physician and was on duty at that time. She was seen by a colleague and was given Benadryl, Pepcid and 5 day course of Prednisone. When the patient took the 4th capsule the next scheduled day, the same event occurred. She did not have diarroea or fever. The patient fully recovered and will file a VAERS report. Follow-up information was requested on 26. Jan.2009, 26.Feb.2009. Follow-up information was requested on 26.Jan.2009, 26.Feb.2009. Follow-up information received on 26.Feb.2009: Batch no. is not available. The capsules were taken in Jan.2009. The patient is early 30's and has no known allergies. She did not receive concomitant medications. A VAERS report was submitted the same day products received the initial report (19.Jan.2009). No further information can be obtained for this case.
Sex: F
Vaccine: TYP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: The patient started VIVOTIF oral vaccination (batch no: unknown) on 11.May.2009 for her trip on 25.May.2009 and administered all capsules at the scheduled times. On 22.May.2009 she developed swollen and painful lymph nodes under her arm. The symptoms were persistent at time of reporting. At the time of reporting they are still swollen, bilateral, however pain was relieving. Follow-up request was sent to the reporter on 23.Jun.2009 regarding batch no. and filling the VAERS form.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Alanine aminotransferase increased, Anaemia, Anti-cyclic citrullinated peptide antibody positive, Aspartate aminotransferase increased, Blood culture negative
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Blood lactate dehydrogenase increased, Borrelia test, C-reactive protein increased, CSF test, Chills
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Cryptococcus test, Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Exercise tolerance decreased, Fatigue
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Haematocrit decreased, Headache, Hepatitis B surface antigen negative, Hepatitis B test negative, Hepatitis C antibody negative
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Hepatitis C test negative, Influenza serology, Irritability, Laboratory test abnormal, Lumbar puncture normal
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Malaise, Mononucleosis heterophile test negative, Myalgia, Night sweats, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Parvovirus B19 test, Pyrexia, Red blood cell count normal, Sleep disorder, Smooth muscle antibody positive
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Transaminases increased, Treponema test negative, Varicella virus test, Vitamin A normal, West Nile virus test negative
Clinical narrative: Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
Age: 60.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Computerised tomogram normal, Ear, nose and throat examination normal, Epistaxis, Haematology test normal
Clinical narrative: Initial report received on 26.Aug.2009 from health professional. This 60-year old male started vaccination course with VIVOTIF (Batch no.: 3001583) on 19.Jun.2009, and took one capsule every second day. Concomitantly on 19.Jun.2009 he was vaccinated with booster vaccine i.m. On 27.Jun.2009 he developed a first episode of nose bleeding in the right nostril, followed by multiple episodes of epistaxis over the following 3 weeks until 16.Jul.2009. On 28.Jun.2009, he took oral MALARONE and started the same day his trip out of the country. He still had some bleeding, that lasted until 16.Jul.2009. Since then, he had no further symptoms. The patient had no history of previous episodes of epistaxis. A complete hematological work-up was negative, CT-scan was normal, normal ENT.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Acute disseminated encephalomyelitis, Areflexia, CSF culture negative, Central nervous system inflammation, Continuous positive airway pressure
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 272144). A 17-year-old female patient with no reported medical history, developed acute disseminated encephalomyelitis 65 days after she had received a first dose of subcutaneous injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 23 October 2006 (also reported as five days prior to presenting to transferring facility), 65 days after she received the vaccine, the patient had an upper respiratory infection, cough, coryza, and a fever of 101. Three days prior to presentation, she developed shortness of breath, left arm and back numbness which progressed to her left and right legs and her right arm; weakness ensued in all extremities, and she quickly became quadriplegic and was paralyzed from the mouth down. Her condition deteriorated where deep tendon reflexes could not be elicited and a sensory exam showed severely decreased pinprick and light touch sensation in all extremities. The patient was intubated and initially treated with IVIG (intravenous immunoglobulins). On 24 October 2006, she received a course of high dose steroids and a plasma exchange at which time, some slight improvement was noted. An MRI showed transverse myelitis at the level of medulla and upper cervical cord; as well as inflammation of pons to lower thoracic spinal cord. Additional lab results included large CSF leukocytosis with no positive viral, fungal, or bacterial cultures, HIV (negative), and CSF for PCR, West Nile, HSV, CMV, and PB PCR (results not reported). The patient received a PEG, trach, and was intubated; she remained on ventilator support for six weeks. After weaning from the ventilator, she experienced hypopnea at night during sleep requiring CPAP. She showed improvement in sensation and was transferred to rehabilitation. According to the reporter, the patient developed acute disseminated encephalomyelitis. A discharge diagnosis of Transverse Myelitis was reported for dates of service 27 October 2006 through 29 November 2006. The patient's recovery status was not reported. Follow up information was received on 10 April 2009 from the FDA. Per the FDA, this case did not meet the probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Cough, Cytomegalovirus test negative, Dyspnoea, Endotracheal intubation, Gastrostomy tube insertion
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 272144). A 17-year-old female patient with no reported medical history, developed acute disseminated encephalomyelitis 65 days after she had received a first dose of subcutaneous injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 23 October 2006 (also reported as five days prior to presenting to transferring facility), 65 days after she received the vaccine, the patient had an upper respiratory infection, cough, coryza, and a fever of 101. Three days prior to presentation, she developed shortness of breath, left arm and back numbness which progressed to her left and right legs and her right arm; weakness ensued in all extremities, and she quickly became quadriplegic and was paralyzed from the mouth down. Her condition deteriorated where deep tendon reflexes could not be elicited and a sensory exam showed severely decreased pinprick and light touch sensation in all extremities. The patient was intubated and initially treated with IVIG (intravenous immunoglobulins). On 24 October 2006, she received a course of high dose steroids and a plasma exchange at which time, some slight improvement was noted. An MRI showed transverse myelitis at the level of medulla and upper cervical cord; as well as inflammation of pons to lower thoracic spinal cord. Additional lab results included large CSF leukocytosis with no positive viral, fungal, or bacterial cultures, HIV (negative), and CSF for PCR, West Nile, HSV, CMV, and PB PCR (results not reported). The patient received a PEG, trach, and was intubated; she remained on ventilator support for six weeks. After weaning from the ventilator, she experienced hypopnea at night during sleep requiring CPAP. She showed improvement in sensation and was transferred to rehabilitation. According to the reporter, the patient developed acute disseminated encephalomyelitis. A discharge diagnosis of Transverse Myelitis was reported for dates of service 27 October 2006 through 29 November 2006. The patient's recovery status was not reported. Follow up information was received on 10 April 2009 from the FDA. Per the FDA, this case did not meet the probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: General physical health deterioration, HIV test negative, Herpes simplex serology negative, Hypoaesthesia, Hypopnoea
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 272144). A 17-year-old female patient with no reported medical history, developed acute disseminated encephalomyelitis 65 days after she had received a first dose of subcutaneous injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 23 October 2006 (also reported as five days prior to presenting to transferring facility), 65 days after she received the vaccine, the patient had an upper respiratory infection, cough, coryza, and a fever of 101. Three days prior to presentation, she developed shortness of breath, left arm and back numbness which progressed to her left and right legs and her right arm; weakness ensued in all extremities, and she quickly became quadriplegic and was paralyzed from the mouth down. Her condition deteriorated where deep tendon reflexes could not be elicited and a sensory exam showed severely decreased pinprick and light touch sensation in all extremities. The patient was intubated and initially treated with IVIG (intravenous immunoglobulins). On 24 October 2006, she received a course of high dose steroids and a plasma exchange at which time, some slight improvement was noted. An MRI showed transverse myelitis at the level of medulla and upper cervical cord; as well as inflammation of pons to lower thoracic spinal cord. Additional lab results included large CSF leukocytosis with no positive viral, fungal, or bacterial cultures, HIV (negative), and CSF for PCR, West Nile, HSV, CMV, and PB PCR (results not reported). The patient received a PEG, trach, and was intubated; she remained on ventilator support for six weeks. After weaning from the ventilator, she experienced hypopnea at night during sleep requiring CPAP. She showed improvement in sensation and was transferred to rehabilitation. According to the reporter, the patient developed acute disseminated encephalomyelitis. A discharge diagnosis of Transverse Myelitis was reported for dates of service 27 October 2006 through 29 November 2006. The patient's recovery status was not reported. Follow up information was received on 10 April 2009 from the FDA. Per the FDA, this case did not meet the probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 272144). A 17-year-old female patient with no reported medical history, developed acute disseminated encephalomyelitis 65 days after she had received a first dose of subcutaneous injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 23 October 2006 (also reported as five days prior to presenting to transferring facility), 65 days after she received the vaccine, the patient had an upper respiratory infection, cough, coryza, and a fever of 101. Three days prior to presentation, she developed shortness of breath, left arm and back numbness which progressed to her left and right legs and her right arm; weakness ensued in all extremities, and she quickly became quadriplegic and was paralyzed from the mouth down. Her condition deteriorated where deep tendon reflexes could not be elicited and a sensory exam showed severely decreased pinprick and light touch sensation in all extremities. The patient was intubated and initially treated with IVIG (intravenous immunoglobulins). On 24 October 2006, she received a course of high dose steroids and a plasma exchange at which time, some slight improvement was noted. An MRI showed transverse myelitis at the level of medulla and upper cervical cord; as well as inflammation of pons to lower thoracic spinal cord. Additional lab results included large CSF leukocytosis with no positive viral, fungal, or bacterial cultures, HIV (negative), and CSF for PCR, West Nile, HSV, CMV, and PB PCR (results not reported). The patient received a PEG, trach, and was intubated; she remained on ventilator support for six weeks. After weaning from the ventilator, she experienced hypopnea at night during sleep requiring CPAP. She showed improvement in sensation and was transferred to rehabilitation. According to the reporter, the patient developed acute disseminated encephalomyelitis. A discharge diagnosis of Transverse Myelitis was reported for dates of service 27 October 2006 through 29 November 2006. The patient's recovery status was not reported. Follow up information was received on 10 April 2009 from the FDA. Per the FDA, this case did not meet the probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Paralysis, Plasmapheresis, Polymerase chain reaction, Pyrexia, Quadriplegia
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 272144). A 17-year-old female patient with no reported medical history, developed acute disseminated encephalomyelitis 65 days after she had received a first dose of subcutaneous injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 23 October 2006 (also reported as five days prior to presenting to transferring facility), 65 days after she received the vaccine, the patient had an upper respiratory infection, cough, coryza, and a fever of 101. Three days prior to presentation, she developed shortness of breath, left arm and back numbness which progressed to her left and right legs and her right arm; weakness ensued in all extremities, and she quickly became quadriplegic and was paralyzed from the mouth down. Her condition deteriorated where deep tendon reflexes could not be elicited and a sensory exam showed severely decreased pinprick and light touch sensation in all extremities. The patient was intubated and initially treated with IVIG (intravenous immunoglobulins). On 24 October 2006, she received a course of high dose steroids and a plasma exchange at which time, some slight improvement was noted. An MRI showed transverse myelitis at the level of medulla and upper cervical cord; as well as inflammation of pons to lower thoracic spinal cord. Additional lab results included large CSF leukocytosis with no positive viral, fungal, or bacterial cultures, HIV (negative), and CSF for PCR, West Nile, HSV, CMV, and PB PCR (results not reported). The patient received a PEG, trach, and was intubated; she remained on ventilator support for six weeks. After weaning from the ventilator, she experienced hypopnea at night during sleep requiring CPAP. She showed improvement in sensation and was transferred to rehabilitation. According to the reporter, the patient developed acute disseminated encephalomyelitis. A discharge diagnosis of Transverse Myelitis was reported for dates of service 27 October 2006 through 29 November 2006. The patient's recovery status was not reported. Follow up information was received on 10 April 2009 from the FDA. Per the FDA, this case did not meet the probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Rhinitis, Sensory loss, Spinal cord disorder, Upper respiratory tract infection, Wean from ventilator
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 272144). A 17-year-old female patient with no reported medical history, developed acute disseminated encephalomyelitis 65 days after she had received a first dose of subcutaneous injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 23 October 2006 (also reported as five days prior to presenting to transferring facility), 65 days after she received the vaccine, the patient had an upper respiratory infection, cough, coryza, and a fever of 101. Three days prior to presentation, she developed shortness of breath, left arm and back numbness which progressed to her left and right legs and her right arm; weakness ensued in all extremities, and she quickly became quadriplegic and was paralyzed from the mouth down. Her condition deteriorated where deep tendon reflexes could not be elicited and a sensory exam showed severely decreased pinprick and light touch sensation in all extremities. The patient was intubated and initially treated with IVIG (intravenous immunoglobulins). On 24 October 2006, she received a course of high dose steroids and a plasma exchange at which time, some slight improvement was noted. An MRI showed transverse myelitis at the level of medulla and upper cervical cord; as well as inflammation of pons to lower thoracic spinal cord. Additional lab results included large CSF leukocytosis with no positive viral, fungal, or bacterial cultures, HIV (negative), and CSF for PCR, West Nile, HSV, CMV, and PB PCR (results not reported). The patient received a PEG, trach, and was intubated; she remained on ventilator support for six weeks. After weaning from the ventilator, she experienced hypopnea at night during sleep requiring CPAP. She showed improvement in sensation and was transferred to rehabilitation. According to the reporter, the patient developed acute disseminated encephalomyelitis. A discharge diagnosis of Transverse Myelitis was reported for dates of service 27 October 2006 through 29 November 2006. The patient's recovery status was not reported. Follow up information was received on 10 April 2009 from the FDA. Per the FDA, this case did not meet the probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: West Nile virus test negative
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 272144). A 17-year-old female patient with no reported medical history, developed acute disseminated encephalomyelitis 65 days after she had received a first dose of subcutaneous injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 23 October 2006 (also reported as five days prior to presenting to transferring facility), 65 days after she received the vaccine, the patient had an upper respiratory infection, cough, coryza, and a fever of 101. Three days prior to presentation, she developed shortness of breath, left arm and back numbness which progressed to her left and right legs and her right arm; weakness ensued in all extremities, and she quickly became quadriplegic and was paralyzed from the mouth down. Her condition deteriorated where deep tendon reflexes could not be elicited and a sensory exam showed severely decreased pinprick and light touch sensation in all extremities. The patient was intubated and initially treated with IVIG (intravenous immunoglobulins). On 24 October 2006, she received a course of high dose steroids and a plasma exchange at which time, some slight improvement was noted. An MRI showed transverse myelitis at the level of medulla and upper cervical cord; as well as inflammation of pons to lower thoracic spinal cord. Additional lab results included large CSF leukocytosis with no positive viral, fungal, or bacterial cultures, HIV (negative), and CSF for PCR, West Nile, HSV, CMV, and PB PCR (results not reported). The patient received a PEG, trach, and was intubated; she remained on ventilator support for six weeks. After weaning from the ventilator, she experienced hypopnea at night during sleep requiring CPAP. She showed improvement in sensation and was transferred to rehabilitation. According to the reporter, the patient developed acute disseminated encephalomyelitis. A discharge diagnosis of Transverse Myelitis was reported for dates of service 27 October 2006 through 29 November 2006. The patient's recovery status was not reported. Follow up information was received on 10 April 2009 from the FDA. Per the FDA, this case did not meet the probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Anaesthesia, Blood test normal, Chest X-ray normal, Computerised tomogram normal, Demyelination
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 276617). A 16-year-old female patient with no reported medical history, developed numbness in her hand and later moved up to her arm 17 days after she had received a first intramuscular injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 30 March 2007, the patient developed numbness in her hand which later moved up her arm. On 04 April 2007, she was seen by her primary care provider due to numbness on her right side of her body which included both the upper and lower extremities which was fairly continuous. Later that day, she has additional numbness on the right side of her face. Her right index finger was noted to have been numb and swollen and her hands felt dry. The neurological examination was within normal limits; however the patient reported reduced sensations of light tough, temperature and vibration on right side of her body. Sensation was splitting right in the middle of her forehead. A differential diagnosis of demyelinating disease or other CNS abnormalities was determined. A CT Scan was negative and it was noted that there was a slight possibility that anxiety somatization disorder existed. The patient returned to the neurologic clinic on 25 April 2007 (also reported as two weeks later) and was diagnosed with hemianesthesia. Blurred vision NOS. The subjective hemianesthesia and neurologic examination "is now unremarkable", with normal symmetrical reflexes and no pronator drift. The possibility of an organic disorder was thought to be less likely. The patient was evaluated at the hospital by a neurologist (date not reported) who ordered a CT Scan, MRI, chest x-ray, thyroid panel and blood work; all with normal results. The physician diagnosed the patient with paraesthesia. The patient's recovery status was not provided at the time of thereport.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dry skin, Electroencephalogram, Hypoaesthesia, Hypoaesthesia facial, Neurological examination normal
Clinical narrative: This serious case was extracted from VAERS on 28 March 2009 (VAERS reference number 276617). A 16-year-old female patient with no reported medical history, developed numbness in her hand and later moved up to her arm 17 days after she had received a first intramuscular injection of MENACTRA (lot number and site of administration not reported). No concomitant vaccines were reported. On 30 March 2007, the patient developed numbness in her hand which later moved up her arm. On 04 April 2007, she was seen by her primary care provider due to numbness on her right side of her body which included both the upper and lower extremities which was fairly continuous. Later that day, she has additional numbness on the right side of her face. Her right index finger was noted to have been numb and swollen and her hands felt dry. The neurological examination was within normal limits; however the patient reported reduced sensations of light tough, temperature and vibration on right side of her body. Sensation was splitting right in the middle of her forehead. A differential diagnosis of demyelinating disease or other CNS abnormalities was determined. A CT Scan was negative and it was noted that there was a slight possibility that anxiety somatization disorder existed. The patient returned to the neurologic clinic on 25 April 2007 (also reported as two weeks later) and was diagnosed with hemianesthesia. Blurred vision NOS. The subjective hemianesthesia and neurologic examination "is now unremarkable", with normal symmetrical reflexes and no pronator drift. The possibility of an organic disorder was thought to be less likely. The patient was evaluated at the hospital by a neurologist (date not reported) who ordered a CT Scan, MRI, chest x-ray, thyroid panel and blood work; all with normal results. The physician diagnosed the patient with paraesthesia. The patient's recovery status was not provided at the time of thereport.