chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Blood culture negative, Blood immunoglobulin G, Blood immunoglobulin G decreased, C-reactive protein normal, CSF protein increased
Clinical narrative: This case was extracted from VAERS on 28 March 2008 (reference number 335367). An 18-year-old male patient, who had reported to boot camp on 18 August 2008, received the following vaccinations on 20 August 2008: ADACEL, MENACTRA, and TWINRIX (GlaxoSmithKline). Lot numbers, route, and site of administration were not reported. On 02 September 2008, the patient began experiencing cold symptoms; it was noted that other platoon members were ill with similar symptoms at the time. On 19 September 2008 he presented to health care professional and was diagnosed with an upper respiratory infection. Treatment included Tylenol, Mucinex, Cepacol, and Pseudoephedrine. He was evaluated again on 23 September 2008 with a two-day history of right hip pain, left leg weakness, and upper back pain. He did not report bilateral hand tremors. Laboratory work-up at that time revealed the following: hematocrit 39.6 (low), calcium 1.1 (high), and erythrocyte sedimentation rate 11 (high). All other laboratory results were within normal limits. The following day his symptoms worsened and he required crutches to ambulate. He was seen on 25 September 2008 with "near complete paresis of his left foot, right leg weakness, and worsening back pain". He was sent to the emergency room and underwent a CBC, CMP, urinalysis, CRP, and INR. Results were within normal limits, except for the following: chloride 96, platelets 440 (high), and lymphocytes 26.3 (low). A blood culture showed no growth. On 26 September 2008 the patient received his second set of immunizations (specific products not reported), and later that day his primary care provider noted severe left leg weakness, right leg numbness, left foot drop, and grossly abnormal gait, noted as significant changes in status. He was transferred to the emergency department where he complained of mild urinary hesitancy, a vague sense of constipation, and continued "flu symptoms". He was admitted for a lumbar puncture and a course of high dose steroids for presumed transverse myelitis. After four days the patient showed improvement, and on 30 September 2008 was transferred to acute rehab with significant weakness of the left leg, sensory changes to the right leg, and mild to moderate depressive symptoms. Additionally, reported reactions indicated increased CSF protein and white blood cell count, decreased blood immunoglobulin G, and decreased Fibrin D dimer. Additional diagnoses included acute disseminated encephalomyelitis, and conjunctival hyperaemia. The patient was reported to have recovered. Follow-up information was received from the FDA on 10 April 2009. This case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Conjunctival hyperaemia, Constipation, Depressive symptom, Fibrin D dimer decreased, Full blood count
Clinical narrative: This case was extracted from VAERS on 28 March 2008 (reference number 335367). An 18-year-old male patient, who had reported to boot camp on 18 August 2008, received the following vaccinations on 20 August 2008: ADACEL, MENACTRA, and TWINRIX (GlaxoSmithKline). Lot numbers, route, and site of administration were not reported. On 02 September 2008, the patient began experiencing cold symptoms; it was noted that other platoon members were ill with similar symptoms at the time. On 19 September 2008 he presented to health care professional and was diagnosed with an upper respiratory infection. Treatment included Tylenol, Mucinex, Cepacol, and Pseudoephedrine. He was evaluated again on 23 September 2008 with a two-day history of right hip pain, left leg weakness, and upper back pain. He did not report bilateral hand tremors. Laboratory work-up at that time revealed the following: hematocrit 39.6 (low), calcium 1.1 (high), and erythrocyte sedimentation rate 11 (high). All other laboratory results were within normal limits. The following day his symptoms worsened and he required crutches to ambulate. He was seen on 25 September 2008 with "near complete paresis of his left foot, right leg weakness, and worsening back pain". He was sent to the emergency room and underwent a CBC, CMP, urinalysis, CRP, and INR. Results were within normal limits, except for the following: chloride 96, platelets 440 (high), and lymphocytes 26.3 (low). A blood culture showed no growth. On 26 September 2008 the patient received his second set of immunizations (specific products not reported), and later that day his primary care provider noted severe left leg weakness, right leg numbness, left foot drop, and grossly abnormal gait, noted as significant changes in status. He was transferred to the emergency department where he complained of mild urinary hesitancy, a vague sense of constipation, and continued "flu symptoms". He was admitted for a lumbar puncture and a course of high dose steroids for presumed transverse myelitis. After four days the patient showed improvement, and on 30 September 2008 was transferred to acute rehab with significant weakness of the left leg, sensory changes to the right leg, and mild to moderate depressive symptoms. Additionally, reported reactions indicated increased CSF protein and white blood cell count, decreased blood immunoglobulin G, and decreased Fibrin D dimer. Additional diagnoses included acute disseminated encephalomyelitis, and conjunctival hyperaemia. The patient was reported to have recovered. Follow-up information was received from the FDA on 10 April 2009. This case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Gait disturbance, Haematocrit decreased, Hypoaesthesia, Influenza, International normalised ratio normal
Clinical narrative: This case was extracted from VAERS on 28 March 2008 (reference number 335367). An 18-year-old male patient, who had reported to boot camp on 18 August 2008, received the following vaccinations on 20 August 2008: ADACEL, MENACTRA, and TWINRIX (GlaxoSmithKline). Lot numbers, route, and site of administration were not reported. On 02 September 2008, the patient began experiencing cold symptoms; it was noted that other platoon members were ill with similar symptoms at the time. On 19 September 2008 he presented to health care professional and was diagnosed with an upper respiratory infection. Treatment included Tylenol, Mucinex, Cepacol, and Pseudoephedrine. He was evaluated again on 23 September 2008 with a two-day history of right hip pain, left leg weakness, and upper back pain. He did not report bilateral hand tremors. Laboratory work-up at that time revealed the following: hematocrit 39.6 (low), calcium 1.1 (high), and erythrocyte sedimentation rate 11 (high). All other laboratory results were within normal limits. The following day his symptoms worsened and he required crutches to ambulate. He was seen on 25 September 2008 with "near complete paresis of his left foot, right leg weakness, and worsening back pain". He was sent to the emergency room and underwent a CBC, CMP, urinalysis, CRP, and INR. Results were within normal limits, except for the following: chloride 96, platelets 440 (high), and lymphocytes 26.3 (low). A blood culture showed no growth. On 26 September 2008 the patient received his second set of immunizations (specific products not reported), and later that day his primary care provider noted severe left leg weakness, right leg numbness, left foot drop, and grossly abnormal gait, noted as significant changes in status. He was transferred to the emergency department where he complained of mild urinary hesitancy, a vague sense of constipation, and continued "flu symptoms". He was admitted for a lumbar puncture and a course of high dose steroids for presumed transverse myelitis. After four days the patient showed improvement, and on 30 September 2008 was transferred to acute rehab with significant weakness of the left leg, sensory changes to the right leg, and mild to moderate depressive symptoms. Additionally, reported reactions indicated increased CSF protein and white blood cell count, decreased blood immunoglobulin G, and decreased Fibrin D dimer. Additional diagnoses included acute disseminated encephalomyelitis, and conjunctival hyperaemia. The patient was reported to have recovered. Follow-up information was received from the FDA on 10 April 2009. This case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Laboratory test normal, Lymphocyte count normal, Metabolic function test normal, Muscular weakness, Myelitis transverse
Clinical narrative: This case was extracted from VAERS on 28 March 2008 (reference number 335367). An 18-year-old male patient, who had reported to boot camp on 18 August 2008, received the following vaccinations on 20 August 2008: ADACEL, MENACTRA, and TWINRIX (GlaxoSmithKline). Lot numbers, route, and site of administration were not reported. On 02 September 2008, the patient began experiencing cold symptoms; it was noted that other platoon members were ill with similar symptoms at the time. On 19 September 2008 he presented to health care professional and was diagnosed with an upper respiratory infection. Treatment included Tylenol, Mucinex, Cepacol, and Pseudoephedrine. He was evaluated again on 23 September 2008 with a two-day history of right hip pain, left leg weakness, and upper back pain. He did not report bilateral hand tremors. Laboratory work-up at that time revealed the following: hematocrit 39.6 (low), calcium 1.1 (high), and erythrocyte sedimentation rate 11 (high). All other laboratory results were within normal limits. The following day his symptoms worsened and he required crutches to ambulate. He was seen on 25 September 2008 with "near complete paresis of his left foot, right leg weakness, and worsening back pain". He was sent to the emergency room and underwent a CBC, CMP, urinalysis, CRP, and INR. Results were within normal limits, except for the following: chloride 96, platelets 440 (high), and lymphocytes 26.3 (low). A blood culture showed no growth. On 26 September 2008 the patient received his second set of immunizations (specific products not reported), and later that day his primary care provider noted severe left leg weakness, right leg numbness, left foot drop, and grossly abnormal gait, noted as significant changes in status. He was transferred to the emergency department where he complained of mild urinary hesitancy, a vague sense of constipation, and continued "flu symptoms". He was admitted for a lumbar puncture and a course of high dose steroids for presumed transverse myelitis. After four days the patient showed improvement, and on 30 September 2008 was transferred to acute rehab with significant weakness of the left leg, sensory changes to the right leg, and mild to moderate depressive symptoms. Additionally, reported reactions indicated increased CSF protein and white blood cell count, decreased blood immunoglobulin G, and decreased Fibrin D dimer. Additional diagnoses included acute disseminated encephalomyelitis, and conjunctival hyperaemia. The patient was reported to have recovered. Follow-up information was received from the FDA on 10 April 2009. This case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Nasopharyngitis, Paresis, Peroneal nerve palsy, Platelet count increased, Red blood cell sedimentation rate increased
Clinical narrative: This case was extracted from VAERS on 28 March 2008 (reference number 335367). An 18-year-old male patient, who had reported to boot camp on 18 August 2008, received the following vaccinations on 20 August 2008: ADACEL, MENACTRA, and TWINRIX (GlaxoSmithKline). Lot numbers, route, and site of administration were not reported. On 02 September 2008, the patient began experiencing cold symptoms; it was noted that other platoon members were ill with similar symptoms at the time. On 19 September 2008 he presented to health care professional and was diagnosed with an upper respiratory infection. Treatment included Tylenol, Mucinex, Cepacol, and Pseudoephedrine. He was evaluated again on 23 September 2008 with a two-day history of right hip pain, left leg weakness, and upper back pain. He did not report bilateral hand tremors. Laboratory work-up at that time revealed the following: hematocrit 39.6 (low), calcium 1.1 (high), and erythrocyte sedimentation rate 11 (high). All other laboratory results were within normal limits. The following day his symptoms worsened and he required crutches to ambulate. He was seen on 25 September 2008 with "near complete paresis of his left foot, right leg weakness, and worsening back pain". He was sent to the emergency room and underwent a CBC, CMP, urinalysis, CRP, and INR. Results were within normal limits, except for the following: chloride 96, platelets 440 (high), and lymphocytes 26.3 (low). A blood culture showed no growth. On 26 September 2008 the patient received his second set of immunizations (specific products not reported), and later that day his primary care provider noted severe left leg weakness, right leg numbness, left foot drop, and grossly abnormal gait, noted as significant changes in status. He was transferred to the emergency department where he complained of mild urinary hesitancy, a vague sense of constipation, and continued "flu symptoms". He was admitted for a lumbar puncture and a course of high dose steroids for presumed transverse myelitis. After four days the patient showed improvement, and on 30 September 2008 was transferred to acute rehab with significant weakness of the left leg, sensory changes to the right leg, and mild to moderate depressive symptoms. Additionally, reported reactions indicated increased CSF protein and white blood cell count, decreased blood immunoglobulin G, and decreased Fibrin D dimer. Additional diagnoses included acute disseminated encephalomyelitis, and conjunctival hyperaemia. The patient was reported to have recovered. Follow-up information was received from the FDA on 10 April 2009. This case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Sensory disturbance, Tremor, Upper respiratory tract infection, Urinary hesitation, Urine analysis normal
Clinical narrative: This case was extracted from VAERS on 28 March 2008 (reference number 335367). An 18-year-old male patient, who had reported to boot camp on 18 August 2008, received the following vaccinations on 20 August 2008: ADACEL, MENACTRA, and TWINRIX (GlaxoSmithKline). Lot numbers, route, and site of administration were not reported. On 02 September 2008, the patient began experiencing cold symptoms; it was noted that other platoon members were ill with similar symptoms at the time. On 19 September 2008 he presented to health care professional and was diagnosed with an upper respiratory infection. Treatment included Tylenol, Mucinex, Cepacol, and Pseudoephedrine. He was evaluated again on 23 September 2008 with a two-day history of right hip pain, left leg weakness, and upper back pain. He did not report bilateral hand tremors. Laboratory work-up at that time revealed the following: hematocrit 39.6 (low), calcium 1.1 (high), and erythrocyte sedimentation rate 11 (high). All other laboratory results were within normal limits. The following day his symptoms worsened and he required crutches to ambulate. He was seen on 25 September 2008 with "near complete paresis of his left foot, right leg weakness, and worsening back pain". He was sent to the emergency room and underwent a CBC, CMP, urinalysis, CRP, and INR. Results were within normal limits, except for the following: chloride 96, platelets 440 (high), and lymphocytes 26.3 (low). A blood culture showed no growth. On 26 September 2008 the patient received his second set of immunizations (specific products not reported), and later that day his primary care provider noted severe left leg weakness, right leg numbness, left foot drop, and grossly abnormal gait, noted as significant changes in status. He was transferred to the emergency department where he complained of mild urinary hesitancy, a vague sense of constipation, and continued "flu symptoms". He was admitted for a lumbar puncture and a course of high dose steroids for presumed transverse myelitis. After four days the patient showed improvement, and on 30 September 2008 was transferred to acute rehab with significant weakness of the left leg, sensory changes to the right leg, and mild to moderate depressive symptoms. Additionally, reported reactions indicated increased CSF protein and white blood cell count, decreased blood immunoglobulin G, and decreased Fibrin D dimer. Additional diagnoses included acute disseminated encephalomyelitis, and conjunctival hyperaemia. The patient was reported to have recovered. Follow-up information was received from the FDA on 10 April 2009. This case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Walking aid user, White blood cell count decreased
Clinical narrative: This case was extracted from VAERS on 28 March 2008 (reference number 335367). An 18-year-old male patient, who had reported to boot camp on 18 August 2008, received the following vaccinations on 20 August 2008: ADACEL, MENACTRA, and TWINRIX (GlaxoSmithKline). Lot numbers, route, and site of administration were not reported. On 02 September 2008, the patient began experiencing cold symptoms; it was noted that other platoon members were ill with similar symptoms at the time. On 19 September 2008 he presented to health care professional and was diagnosed with an upper respiratory infection. Treatment included Tylenol, Mucinex, Cepacol, and Pseudoephedrine. He was evaluated again on 23 September 2008 with a two-day history of right hip pain, left leg weakness, and upper back pain. He did not report bilateral hand tremors. Laboratory work-up at that time revealed the following: hematocrit 39.6 (low), calcium 1.1 (high), and erythrocyte sedimentation rate 11 (high). All other laboratory results were within normal limits. The following day his symptoms worsened and he required crutches to ambulate. He was seen on 25 September 2008 with "near complete paresis of his left foot, right leg weakness, and worsening back pain". He was sent to the emergency room and underwent a CBC, CMP, urinalysis, CRP, and INR. Results were within normal limits, except for the following: chloride 96, platelets 440 (high), and lymphocytes 26.3 (low). A blood culture showed no growth. On 26 September 2008 the patient received his second set of immunizations (specific products not reported), and later that day his primary care provider noted severe left leg weakness, right leg numbness, left foot drop, and grossly abnormal gait, noted as significant changes in status. He was transferred to the emergency department where he complained of mild urinary hesitancy, a vague sense of constipation, and continued "flu symptoms". He was admitted for a lumbar puncture and a course of high dose steroids for presumed transverse myelitis. After four days the patient showed improvement, and on 30 September 2008 was transferred to acute rehab with significant weakness of the left leg, sensory changes to the right leg, and mild to moderate depressive symptoms. Additionally, reported reactions indicated increased CSF protein and white blood cell count, decreased blood immunoglobulin G, and decreased Fibrin D dimer. Additional diagnoses included acute disseminated encephalomyelitis, and conjunctival hyperaemia. The patient was reported to have recovered. Follow-up information was received from the FDA on 10 April 2009. This case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Blood culture positive, Meningococcal infection, Vaccination failure
Clinical narrative: Information was initially provided from the Centers for Disease Control (CDC) which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS database and had previously been entered in the sanofi pasteur Pharmacovigilance database (sanofi pasteur case reference numbers 2007-03425, 2007-03383, 2008-00387, 2008-00531, and 2008-02355. On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these case is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017 and 2009-00018. On 03 February 2009 additional information was provided for the thirteenth patient, which is contained in this case (2009-00381). This serious report was received from the Centers for Disease Control and Prevention (CDC) on 03 February 2009, under VAERS number 335756. A male patient who was reported as a college student with a history of pulmonary embolism and deep vein thrombosis received MENACTRA (lot number U1639A) on 14 June 2005. On 17 September 2006 culture confirmed meningococcal disease and a blood culture was positive for Neisseria meningitis serogroup C. The specific strain was identified as ST-11/ET-37. The patient was hospitalized. Dates of hospitalization were not reported. The patient was reported as recovered. The patient was 19 years of age at the time of the event. List of Documents by Sender: None.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL, BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Aphonia, Axonal neuropathy, Chest X-ray abnormal, Chills, Computerised tomogram normal
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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: Demyelinating polyneuropathy, Dysphagia, Echocardiogram normal, Electrocardiogram abnormal, Electromyogram abnormal
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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: Guillain-Barre syndrome, Haemolysis, Hyperbilirubinaemia, Hypertension, Hypoaesthesia
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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: Hypoaesthesia oral, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Nasal congestion
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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: Nausea, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal, Orchitis, Oropharyngeal pain
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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, Paraesthesia oral, Plasmapheresis, Pneumonia aspiration, Polyneuropathy
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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: Polyneuropathy idiopathic progressive, Productive cough, Pyrexia, Respiratory failure, Reticulocyte count increased
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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, Sepsis, Tachycardia, Tracheostomy
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed 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: Upper respiratory tract congestion, White blood cell count increased
Clinical narrative: Initial report received from the Centers for Disease Control (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 and a productive cough. He was diagnosed with an upper respiratory infection at that time, and symptoms resolved in four days. On 15 October 2008, 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 the 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 predominately 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 network and determined to meet the proposed case definition of GUILLAIN-BARRE syndrome, with a level 2 of diagnostic certainty. Documents held by sender: None.