chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Headache, Immunoglobulin therapy, Influenza like illness
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Intensive care, Lymphocyte percentage increased, Mean cell volume normal, Monocyte percentage increased, Neutrophil percentage
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Panic reaction, Plasmapheresis, Platelet count normal, Pneumothorax, Posturing
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Speech disorder, Urinary tract infection, Vomiting, White blood cell count normal
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770). A 12-year-old male patient received the following vaccines on 19 April 2008: an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck). Lot numbers and site of administration not reported. It was noted that the patient had received five prior doses of TDAP. On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache. He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head". He also experienced vomiting and a fever. He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis. Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2. Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos. CSF protein was also increased. A biopsy of the brain was abnormal. Blood cultures were negative. He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted. He was subsequently incubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax. He developed seizure-like spells, and required a nasogastric tube for nutrition. Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language. He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections. In July 2008 he began to show improvement, and was able to ambulate with assistance. He was discharged to rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy. Outcome was not reported. Per FDA, this case was the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abasia, Aggression, Aphasia, Asthenia, Ataxia
Clinical narrative: This serious case was extracted from VAERS database on 28 March 2009 (reference number 323080). A 15 year old male patient received MENACTRA, BOOSTRIX, VARIVAX (lot number not reported) on 04 August 2008. On 05 August 2008 the patient developed generalized muscle aches and pains. The following day his skin tone darkened significantly. In the early morning hours of 07 April 2008 the patient had a seizure and was transported to the emergency room via ambulance. The patient presented to the emergency room after having a seizure at home with subsequent post-ictal altered mental status (confusion, disorientation, combativeness). He experienced generalized weakness, paralysis of his bilateral lower extremities, was unable to bear weight or walk, unable to speak and his vision was impaired. He was admitted to the pediatric unit. The patient was treated with DILANTIN, ATIVAN, VERSED which reduced his agitation, acyclovir with improvement in his mental status. Ataxia, mild hemiparesis, and muscle pain persisted. Ataxia resolved by 19 August 2008. CSF WBC 12, 85% lymphs with normal glucose and protein. CSF gram stain, blood culture, head CT, Chest X ray were negative. Hematocrit, creatine phosphokinase, CSF white blood cell count were increased. The patient was hospitalized from 14 August 2008 to 20 August 2008. Final diagnosis was encephalitis. The outcome was reported as emergency room visit, hospitalized, and prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blood creatine phosphokinase increased, Blood culture negative, CSF glucose normal, CSF lymphocyte count increased, CSF protein normal
Clinical narrative: This serious case was extracted from VAERS database on 28 March 2009 (reference number 323080). A 15 year old male patient received MENACTRA, BOOSTRIX, VARIVAX (lot number not reported) on 04 August 2008. On 05 August 2008 the patient developed generalized muscle aches and pains. The following day his skin tone darkened significantly. In the early morning hours of 07 April 2008 the patient had a seizure and was transported to the emergency room via ambulance. The patient presented to the emergency room after having a seizure at home with subsequent post-ictal altered mental status (confusion, disorientation, combativeness). He experienced generalized weakness, paralysis of his bilateral lower extremities, was unable to bear weight or walk, unable to speak and his vision was impaired. He was admitted to the pediatric unit. The patient was treated with DILANTIN, ATIVAN, VERSED which reduced his agitation, acyclovir with improvement in his mental status. Ataxia, mild hemiparesis, and muscle pain persisted. Ataxia resolved by 19 August 2008. CSF WBC 12, 85% lymphs with normal glucose and protein. CSF gram stain, blood culture, head CT, Chest X ray were negative. Hematocrit, creatine phosphokinase, CSF white blood cell count were increased. The patient was hospitalized from 14 August 2008 to 20 August 2008. Final diagnosis was encephalitis. The outcome was reported as emergency room visit, hospitalized, and prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: CSF white blood cell count increased, Chest X-ray normal, Computerised tomogram normal, Confusional state, Convulsion
Clinical narrative: This serious case was extracted from VAERS database on 28 March 2009 (reference number 323080). A 15 year old male patient received MENACTRA, BOOSTRIX, VARIVAX (lot number not reported) on 04 August 2008. On 05 August 2008 the patient developed generalized muscle aches and pains. The following day his skin tone darkened significantly. In the early morning hours of 07 April 2008 the patient had a seizure and was transported to the emergency room via ambulance. The patient presented to the emergency room after having a seizure at home with subsequent post-ictal altered mental status (confusion, disorientation, combativeness). He experienced generalized weakness, paralysis of his bilateral lower extremities, was unable to bear weight or walk, unable to speak and his vision was impaired. He was admitted to the pediatric unit. The patient was treated with DILANTIN, ATIVAN, VERSED which reduced his agitation, acyclovir with improvement in his mental status. Ataxia, mild hemiparesis, and muscle pain persisted. Ataxia resolved by 19 August 2008. CSF WBC 12, 85% lymphs with normal glucose and protein. CSF gram stain, blood culture, head CT, Chest X ray were negative. Hematocrit, creatine phosphokinase, CSF white blood cell count were increased. The patient was hospitalized from 14 August 2008 to 20 August 2008. Final diagnosis was encephalitis. The outcome was reported as emergency room visit, hospitalized, and prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Diplegia, Disorientation, Encephalitis, Gram stain, Haematocrit increased
Clinical narrative: This serious case was extracted from VAERS database on 28 March 2009 (reference number 323080). A 15 year old male patient received MENACTRA, BOOSTRIX, VARIVAX (lot number not reported) on 04 August 2008. On 05 August 2008 the patient developed generalized muscle aches and pains. The following day his skin tone darkened significantly. In the early morning hours of 07 April 2008 the patient had a seizure and was transported to the emergency room via ambulance. The patient presented to the emergency room after having a seizure at home with subsequent post-ictal altered mental status (confusion, disorientation, combativeness). He experienced generalized weakness, paralysis of his bilateral lower extremities, was unable to bear weight or walk, unable to speak and his vision was impaired. He was admitted to the pediatric unit. The patient was treated with DILANTIN, ATIVAN, VERSED which reduced his agitation, acyclovir with improvement in his mental status. Ataxia, mild hemiparesis, and muscle pain persisted. Ataxia resolved by 19 August 2008. CSF WBC 12, 85% lymphs with normal glucose and protein. CSF gram stain, blood culture, head CT, Chest X ray were negative. Hematocrit, creatine phosphokinase, CSF white blood cell count were increased. The patient was hospitalized from 14 August 2008 to 20 August 2008. Final diagnosis was encephalitis. The outcome was reported as emergency room visit, hospitalized, and prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Hemiparesis, Mental status changes, Muscular weakness, Myalgia, Pain
Clinical narrative: This serious case was extracted from VAERS database on 28 March 2009 (reference number 323080). A 15 year old male patient received MENACTRA, BOOSTRIX, VARIVAX (lot number not reported) on 04 August 2008. On 05 August 2008 the patient developed generalized muscle aches and pains. The following day his skin tone darkened significantly. In the early morning hours of 07 April 2008 the patient had a seizure and was transported to the emergency room via ambulance. The patient presented to the emergency room after having a seizure at home with subsequent post-ictal altered mental status (confusion, disorientation, combativeness). He experienced generalized weakness, paralysis of his bilateral lower extremities, was unable to bear weight or walk, unable to speak and his vision was impaired. He was admitted to the pediatric unit. The patient was treated with DILANTIN, ATIVAN, VERSED which reduced his agitation, acyclovir with improvement in his mental status. Ataxia, mild hemiparesis, and muscle pain persisted. Ataxia resolved by 19 August 2008. CSF WBC 12, 85% lymphs with normal glucose and protein. CSF gram stain, blood culture, head CT, Chest X ray were negative. Hematocrit, creatine phosphokinase, CSF white blood cell count were increased. The patient was hospitalized from 14 August 2008 to 20 August 2008. Final diagnosis was encephalitis. The outcome was reported as emergency room visit, hospitalized, and prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Skin discolouration, Visual impairment, Weight bearing difficulty, White blood cell count increased
Clinical narrative: This serious case was extracted from VAERS database on 28 March 2009 (reference number 323080). A 15 year old male patient received MENACTRA, BOOSTRIX, VARIVAX (lot number not reported) on 04 August 2008. On 05 August 2008 the patient developed generalized muscle aches and pains. The following day his skin tone darkened significantly. In the early morning hours of 07 April 2008 the patient had a seizure and was transported to the emergency room via ambulance. The patient presented to the emergency room after having a seizure at home with subsequent post-ictal altered mental status (confusion, disorientation, combativeness). He experienced generalized weakness, paralysis of his bilateral lower extremities, was unable to bear weight or walk, unable to speak and his vision was impaired. He was admitted to the pediatric unit. The patient was treated with DILANTIN, ATIVAN, VERSED which reduced his agitation, acyclovir with improvement in his mental status. Ataxia, mild hemiparesis, and muscle pain persisted. Ataxia resolved by 19 August 2008. CSF WBC 12, 85% lymphs with normal glucose and protein. CSF gram stain, blood culture, head CT, Chest X ray were negative. Hematocrit, creatine phosphokinase, CSF white blood cell count were increased. The patient was hospitalized from 14 August 2008 to 20 August 2008. Final diagnosis was encephalitis. The outcome was reported as emergency room visit, hospitalized, and prolonged hospitalization.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Abdominal pain, Acute disseminated encephalomyelitis, Antibody test normal, Back pain, Bladder catheterisation
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324133). An 11-year-old male patient received MENACTRA (lot not reported) and VARIVAX (Merck, lot not reported) on 23 July 2008. On 01 August 2008, he developed a cough, rhinorrhea, fever (102), constipation, urinary retention and urgency. It was noted that he had a positive sick (upper respiratory infection) contact two weeks prior to presenting with symptoms. According to medical records for hospitalization occurring 02-10 August 2008, the patient presented with a two-day history of bilateral lower extremity numbness, paresis, and tingling, mid upper back pain, abdominal pain, difficulty breathing, and bowel and bladder retention. On the day of presentation, he had two episodes of emesis. A Foley catheter yielded 800cc of urine, with subsequent improvement of back and abdominal pain. Cerebrospinal fluid was notable for elevated myelin basic protein with negative oligoclonal bands and serum NMO antibody. CSF glucose was elevated at 77. Inflammatory demyelinating lesions of the brain and most of the spinal cord, from level C5 to conus, were noted. Discharge diagnosis indicated acute disseminated encephalomyelitis. The patient was treated with high dose steroids, and he subsequently recovered. Follow-up information received from the Food and Drug Administration on 10 April 2009; VAERS reference number 324133. Per the FDA, this case meets the agency collaboration probable or confirmed ADEM case definition of diagnostic certainty for Lever 1 or 2. Documents held by sender: None
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: CSF glucose increased, CSF myelin basic protein increased, CSF oligoclonal band absent, Central nervous system lesion, Constipation
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324133). An 11-year-old male patient received MENACTRA (lot not reported) and VARIVAX (Merck, lot not reported) on 23 July 2008. On 01 August 2008, he developed a cough, rhinorrhea, fever (102), constipation, urinary retention and urgency. It was noted that he had a positive sick (upper respiratory infection) contact two weeks prior to presenting with symptoms. According to medical records for hospitalization occurring 02-10 August 2008, the patient presented with a two-day history of bilateral lower extremity numbness, paresis, and tingling, mid upper back pain, abdominal pain, difficulty breathing, and bowel and bladder retention. On the day of presentation, he had two episodes of emesis. A Foley catheter yielded 800cc of urine, with subsequent improvement of back and abdominal pain. Cerebrospinal fluid was notable for elevated myelin basic protein with negative oligoclonal bands and serum NMO antibody. CSF glucose was elevated at 77. Inflammatory demyelinating lesions of the brain and most of the spinal cord, from level C5 to conus, were noted. Discharge diagnosis indicated acute disseminated encephalomyelitis. The patient was treated with high dose steroids, and he subsequently recovered. Follow-up information received from the Food and Drug Administration on 10 April 2009; VAERS reference number 324133. Per the FDA, this case meets the agency collaboration probable or confirmed ADEM case definition of diagnostic certainty for Lever 1 or 2. Documents held by sender: None
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Cough, Dyspnoea, Gastrointestinal motility disorder, Hypoaesthesia, Micturition urgency
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324133). An 11-year-old male patient received MENACTRA (lot not reported) and VARIVAX (Merck, lot not reported) on 23 July 2008. On 01 August 2008, he developed a cough, rhinorrhea, fever (102), constipation, urinary retention and urgency. It was noted that he had a positive sick (upper respiratory infection) contact two weeks prior to presenting with symptoms. According to medical records for hospitalization occurring 02-10 August 2008, the patient presented with a two-day history of bilateral lower extremity numbness, paresis, and tingling, mid upper back pain, abdominal pain, difficulty breathing, and bowel and bladder retention. On the day of presentation, he had two episodes of emesis. A Foley catheter yielded 800cc of urine, with subsequent improvement of back and abdominal pain. Cerebrospinal fluid was notable for elevated myelin basic protein with negative oligoclonal bands and serum NMO antibody. CSF glucose was elevated at 77. Inflammatory demyelinating lesions of the brain and most of the spinal cord, from level C5 to conus, were noted. Discharge diagnosis indicated acute disseminated encephalomyelitis. The patient was treated with high dose steroids, and he subsequently recovered. Follow-up information received from the Food and Drug Administration on 10 April 2009; VAERS reference number 324133. Per the FDA, this case meets the agency collaboration probable or confirmed ADEM case definition of diagnostic certainty for Lever 1 or 2. Documents held by sender: None
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Paraesthesia, Paresis, Pyrexia, Rhinorrhoea, Urinary retention
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324133). An 11-year-old male patient received MENACTRA (lot not reported) and VARIVAX (Merck, lot not reported) on 23 July 2008. On 01 August 2008, he developed a cough, rhinorrhea, fever (102), constipation, urinary retention and urgency. It was noted that he had a positive sick (upper respiratory infection) contact two weeks prior to presenting with symptoms. According to medical records for hospitalization occurring 02-10 August 2008, the patient presented with a two-day history of bilateral lower extremity numbness, paresis, and tingling, mid upper back pain, abdominal pain, difficulty breathing, and bowel and bladder retention. On the day of presentation, he had two episodes of emesis. A Foley catheter yielded 800cc of urine, with subsequent improvement of back and abdominal pain. Cerebrospinal fluid was notable for elevated myelin basic protein with negative oligoclonal bands and serum NMO antibody. CSF glucose was elevated at 77. Inflammatory demyelinating lesions of the brain and most of the spinal cord, from level C5 to conus, were noted. Discharge diagnosis indicated acute disseminated encephalomyelitis. The patient was treated with high dose steroids, and he subsequently recovered. Follow-up information received from the Food and Drug Administration on 10 April 2009; VAERS reference number 324133. Per the FDA, this case meets the agency collaboration probable or confirmed ADEM case definition of diagnostic certainty for Lever 1 or 2. Documents held by sender: None
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Vomiting
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324133). An 11-year-old male patient received MENACTRA (lot not reported) and VARIVAX (Merck, lot not reported) on 23 July 2008. On 01 August 2008, he developed a cough, rhinorrhea, fever (102), constipation, urinary retention and urgency. It was noted that he had a positive sick (upper respiratory infection) contact two weeks prior to presenting with symptoms. According to medical records for hospitalization occurring 02-10 August 2008, the patient presented with a two-day history of bilateral lower extremity numbness, paresis, and tingling, mid upper back pain, abdominal pain, difficulty breathing, and bowel and bladder retention. On the day of presentation, he had two episodes of emesis. A Foley catheter yielded 800cc of urine, with subsequent improvement of back and abdominal pain. Cerebrospinal fluid was notable for elevated myelin basic protein with negative oligoclonal bands and serum NMO antibody. CSF glucose was elevated at 77. Inflammatory demyelinating lesions of the brain and most of the spinal cord, from level C5 to conus, were noted. Discharge diagnosis indicated acute disseminated encephalomyelitis. The patient was treated with high dose steroids, and he subsequently recovered. Follow-up information received from the Food and Drug Administration on 10 April 2009; VAERS reference number 324133. Per the FDA, this case meets the agency collaboration probable or confirmed ADEM case definition of diagnostic certainty for Lever 1 or 2. Documents held by sender: None
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, CSF lymphocyte count increased, CSF white blood cell count increased, Convulsion, Decreased appetite
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324863). An 11-year-old male patient received an intramuscular dose of MENACTRA (lot number not reported) on 23 July 2008. The patient had received five previous intramuscular dose of ADACEL (lot number not reported) on 23 July 2008. The patient had received five previous doses of TDAP. On 18 August 2008, 26 days post-vaccination, he developed an upper respiratory infection with headache, fatigue, loss of appetite, and tactile temperature. On 21 August 2008 he developed difficulty urinating, with urgency. On 22 August 2008, after receiving ceftriaxone and TORADOL, he vomited and developed a rash. He later received intravenous BENADRYL, and subsequently began shaking, developed convulsions, and became delusional. According to hospital records received by the health authority, dated 25 - 28 August 2008, the patient was admitted with presumed aseptic meningitis and neurogenic bladder, and unspecified encephalomyelitis versus acute disseminated encephalomyelitis (ADEM) versus demyelinating process. Medical records received for dates of service 28 August - 02 September 2008 indicated that the final diagnosis was acute disseminated encephalomyelitis. Lumbar puncture revealed an elevated CSF white blood count (109) with 94% lymphocytes. MRI was consistent with ADEM. Treatment included high dose steroids. Outcome was not reported. Follow-up information received from the Food and Drug Administration (FDA) on 10 April 2009; VAERS referenced number 324863. Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2. Comments received by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Delusion, Dysuria, Fatigue, Headache, Lumbar puncture
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324863). An 11-year-old male patient received an intramuscular dose of MENACTRA (lot number not reported) on 23 July 2008. The patient had received five previous intramuscular dose of ADACEL (lot number not reported) on 23 July 2008. The patient had received five previous doses of TDAP. On 18 August 2008, 26 days post-vaccination, he developed an upper respiratory infection with headache, fatigue, loss of appetite, and tactile temperature. On 21 August 2008 he developed difficulty urinating, with urgency. On 22 August 2008, after receiving ceftriaxone and TORADOL, he vomited and developed a rash. He later received intravenous BENADRYL, and subsequently began shaking, developed convulsions, and became delusional. According to hospital records received by the health authority, dated 25 - 28 August 2008, the patient was admitted with presumed aseptic meningitis and neurogenic bladder, and unspecified encephalomyelitis versus acute disseminated encephalomyelitis (ADEM) versus demyelinating process. Medical records received for dates of service 28 August - 02 September 2008 indicated that the final diagnosis was acute disseminated encephalomyelitis. Lumbar puncture revealed an elevated CSF white blood count (109) with 94% lymphocytes. MRI was consistent with ADEM. Treatment included high dose steroids. Outcome was not reported. Follow-up information received from the Food and Drug Administration (FDA) on 10 April 2009; VAERS referenced number 324863. Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2. Comments received by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Meningitis aseptic, Micturition urgency, Neurogenic bladder, Nuclear magnetic resonance imaging brain abnormal, Rash
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324863). An 11-year-old male patient received an intramuscular dose of MENACTRA (lot number not reported) on 23 July 2008. The patient had received five previous intramuscular dose of ADACEL (lot number not reported) on 23 July 2008. The patient had received five previous doses of TDAP. On 18 August 2008, 26 days post-vaccination, he developed an upper respiratory infection with headache, fatigue, loss of appetite, and tactile temperature. On 21 August 2008 he developed difficulty urinating, with urgency. On 22 August 2008, after receiving ceftriaxone and TORADOL, he vomited and developed a rash. He later received intravenous BENADRYL, and subsequently began shaking, developed convulsions, and became delusional. According to hospital records received by the health authority, dated 25 - 28 August 2008, the patient was admitted with presumed aseptic meningitis and neurogenic bladder, and unspecified encephalomyelitis versus acute disseminated encephalomyelitis (ADEM) versus demyelinating process. Medical records received for dates of service 28 August - 02 September 2008 indicated that the final diagnosis was acute disseminated encephalomyelitis. Lumbar puncture revealed an elevated CSF white blood count (109) with 94% lymphocytes. MRI was consistent with ADEM. Treatment included high dose steroids. Outcome was not reported. Follow-up information received from the Food and Drug Administration (FDA) on 10 April 2009; VAERS referenced number 324863. Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2. Comments received by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin warm, Tremor, Upper respiratory tract infection, Vomiting
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 324863). An 11-year-old male patient received an intramuscular dose of MENACTRA (lot number not reported) on 23 July 2008. The patient had received five previous intramuscular dose of ADACEL (lot number not reported) on 23 July 2008. The patient had received five previous doses of TDAP. On 18 August 2008, 26 days post-vaccination, he developed an upper respiratory infection with headache, fatigue, loss of appetite, and tactile temperature. On 21 August 2008 he developed difficulty urinating, with urgency. On 22 August 2008, after receiving ceftriaxone and TORADOL, he vomited and developed a rash. He later received intravenous BENADRYL, and subsequently began shaking, developed convulsions, and became delusional. According to hospital records received by the health authority, dated 25 - 28 August 2008, the patient was admitted with presumed aseptic meningitis and neurogenic bladder, and unspecified encephalomyelitis versus acute disseminated encephalomyelitis (ADEM) versus demyelinating process. Medical records received for dates of service 28 August - 02 September 2008 indicated that the final diagnosis was acute disseminated encephalomyelitis. Lumbar puncture revealed an elevated CSF white blood count (109) with 94% lymphocytes. MRI was consistent with ADEM. Treatment included high dose steroids. Outcome was not reported. Follow-up information received from the Food and Drug Administration (FDA) on 10 April 2009; VAERS referenced number 324863. Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2. Comments received by sender: None.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Back pain, Bladder catheterisation, Bladder pain
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 334608). A 16-year-old female patient received an injection of MENACTRA (lot number not reported) on 02 September 2008. On 25 September 2008, 23 days post-vaccination, she developed a fever and tingling in the legs. The following day she complained of bladder pain and urinary retention, and was seen by her physician for a possible urinary tract infection. Later that day she presented to the emergency department with nausea, vomiting, progressive paresthesia and weakness of the lower extremities, and abnormal gait. She was catheterized for 800cc of urine, and subsequently experienced increasing toe, back, and neck pain, headache, and decreasing strength in lower extremities. By evening she experienced total paralysis of both legs with hyperreflexia and clonus. Lumbar puncture revealed the following: CSF with 70 WBCs (40 polys, 38 lymphs, 18 monos), positive RBCs, glucose 49, and protein 134. Myelin basic protein was high at 78.8. MRI of the thoracic and lumbar spine showed patchy abnormalities. Final diagnosis was acute disseminated encephalomyelitis. She was treated with two courses of SOLUMEDROL and antibiotics, and she improved and was discharged to rehab. Follow-up information was received from the FDA on 10 April 2009. This case meets the case definition of diagnostic certainty for Level 1 or 2.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose increased, CSF glucose decreased, CSF lymphocyte count abnormal, CSF monocyte count, CSF myelin basic protein increased
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 334608). A 16-year-old female patient received an injection of MENACTRA (lot number not reported) on 02 September 2008. On 25 September 2008, 23 days post-vaccination, she developed a fever and tingling in the legs. The following day she complained of bladder pain and urinary retention, and was seen by her physician for a possible urinary tract infection. Later that day she presented to the emergency department with nausea, vomiting, progressive paresthesia and weakness of the lower extremities, and abnormal gait. She was catheterized for 800cc of urine, and subsequently experienced increasing toe, back, and neck pain, headache, and decreasing strength in lower extremities. By evening she experienced total paralysis of both legs with hyperreflexia and clonus. Lumbar puncture revealed the following: CSF with 70 WBCs (40 polys, 38 lymphs, 18 monos), positive RBCs, glucose 49, and protein 134. Myelin basic protein was high at 78.8. MRI of the thoracic and lumbar spine showed patchy abnormalities. Final diagnosis was acute disseminated encephalomyelitis. She was treated with two courses of SOLUMEDROL and antibiotics, and she improved and was discharged to rehab. Follow-up information was received from the FDA on 10 April 2009. This case meets the case definition of diagnostic certainty for Level 1 or 2.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: CSF polymorphonuclear cell count increased, CSF protein increased, CSF test, CSF white blood cell count increased, Clonus
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 334608). A 16-year-old female patient received an injection of MENACTRA (lot number not reported) on 02 September 2008. On 25 September 2008, 23 days post-vaccination, she developed a fever and tingling in the legs. The following day she complained of bladder pain and urinary retention, and was seen by her physician for a possible urinary tract infection. Later that day she presented to the emergency department with nausea, vomiting, progressive paresthesia and weakness of the lower extremities, and abnormal gait. She was catheterized for 800cc of urine, and subsequently experienced increasing toe, back, and neck pain, headache, and decreasing strength in lower extremities. By evening she experienced total paralysis of both legs with hyperreflexia and clonus. Lumbar puncture revealed the following: CSF with 70 WBCs (40 polys, 38 lymphs, 18 monos), positive RBCs, glucose 49, and protein 134. Myelin basic protein was high at 78.8. MRI of the thoracic and lumbar spine showed patchy abnormalities. Final diagnosis was acute disseminated encephalomyelitis. She was treated with two courses of SOLUMEDROL and antibiotics, and she improved and was discharged to rehab. Follow-up information was received from the FDA on 10 April 2009. This case meets the case definition of diagnostic certainty for Level 1 or 2.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Diplegia, Gait disturbance, Headache, Hyperreflexia, Muscular weakness
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 334608). A 16-year-old female patient received an injection of MENACTRA (lot number not reported) on 02 September 2008. On 25 September 2008, 23 days post-vaccination, she developed a fever and tingling in the legs. The following day she complained of bladder pain and urinary retention, and was seen by her physician for a possible urinary tract infection. Later that day she presented to the emergency department with nausea, vomiting, progressive paresthesia and weakness of the lower extremities, and abnormal gait. She was catheterized for 800cc of urine, and subsequently experienced increasing toe, back, and neck pain, headache, and decreasing strength in lower extremities. By evening she experienced total paralysis of both legs with hyperreflexia and clonus. Lumbar puncture revealed the following: CSF with 70 WBCs (40 polys, 38 lymphs, 18 monos), positive RBCs, glucose 49, and protein 134. Myelin basic protein was high at 78.8. MRI of the thoracic and lumbar spine showed patchy abnormalities. Final diagnosis was acute disseminated encephalomyelitis. She was treated with two courses of SOLUMEDROL and antibiotics, and she improved and was discharged to rehab. Follow-up information was received from the FDA on 10 April 2009. This case meets the case definition of diagnostic certainty for Level 1 or 2.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 334608). A 16-year-old female patient received an injection of MENACTRA (lot number not reported) on 02 September 2008. On 25 September 2008, 23 days post-vaccination, she developed a fever and tingling in the legs. The following day she complained of bladder pain and urinary retention, and was seen by her physician for a possible urinary tract infection. Later that day she presented to the emergency department with nausea, vomiting, progressive paresthesia and weakness of the lower extremities, and abnormal gait. She was catheterized for 800cc of urine, and subsequently experienced increasing toe, back, and neck pain, headache, and decreasing strength in lower extremities. By evening she experienced total paralysis of both legs with hyperreflexia and clonus. Lumbar puncture revealed the following: CSF with 70 WBCs (40 polys, 38 lymphs, 18 monos), positive RBCs, glucose 49, and protein 134. Myelin basic protein was high at 78.8. MRI of the thoracic and lumbar spine showed patchy abnormalities. Final diagnosis was acute disseminated encephalomyelitis. She was treated with two courses of SOLUMEDROL and antibiotics, and she improved and was discharged to rehab. Follow-up information was received from the FDA on 10 April 2009. This case meets the case definition of diagnostic certainty for Level 1 or 2.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Red blood cells CSF positive, Urinary retention, Vomiting
Clinical narrative: This case was extracted from the VAERS database on 28 March 2009 (reference number 334608). A 16-year-old female patient received an injection of MENACTRA (lot number not reported) on 02 September 2008. On 25 September 2008, 23 days post-vaccination, she developed a fever and tingling in the legs. The following day she complained of bladder pain and urinary retention, and was seen by her physician for a possible urinary tract infection. Later that day she presented to the emergency department with nausea, vomiting, progressive paresthesia and weakness of the lower extremities, and abnormal gait. She was catheterized for 800cc of urine, and subsequently experienced increasing toe, back, and neck pain, headache, and decreasing strength in lower extremities. By evening she experienced total paralysis of both legs with hyperreflexia and clonus. Lumbar puncture revealed the following: CSF with 70 WBCs (40 polys, 38 lymphs, 18 monos), positive RBCs, glucose 49, and protein 134. Myelin basic protein was high at 78.8. MRI of the thoracic and lumbar spine showed patchy abnormalities. Final diagnosis was acute disseminated encephalomyelitis. She was treated with two courses of SOLUMEDROL and antibiotics, and she improved and was discharged to rehab. Follow-up information was received from the FDA on 10 April 2009. This case meets the case definition of diagnostic certainty for Level 1 or 2.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, Arthralgia, Back pain, Blood calcium decreased, Blood chloride 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.