chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperventilation, Hypotonia, Muscle twitching, Mydriasis, Unresponsive to stimuli
Clinical narrative: Patient was given vaccine while seated in venipuncture chair by medical assistant who then stepped away from patient for a minute.  A thump was heard, pt was found slumped in corner of room next to chair - was unresponsive to voice.  Laid out onto floor & legs elevated.  Had strong pulse at radial artery of 60.  Pupils were dilated.  After a minute or two, patient was noted to have twitching of lips; limbs were flaccid.  Intermittently followed commands; then seemed to hyperventilate and did not respond to commands anymore.  Rescue squad was called & arrived within 10 minutes of onset of symptoms.  Pt was taken to ER; ER staff thought symptoms were psychiatric.  Pt says she does not recall anything up til point she was in ER.
Age: 13.0
Sex: F
Vaccine: HEPA, HPVX, HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Developed hives all over neck and arms approximately 4 hours after the shot.  Benadryl was administered and the hives subsided.  They returned the next day and were treated again with Benadryl
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Computerised tomogram, Cough, Headache, Pain, Pain in extremity
Clinical narrative: Severe headache and sore arm.  I have had this headache for almost 10 months.  I have recently started to have a ringing in my ears.  Dr thought I had a sinus infection.  I have taken 5 rounds of antibiotics, the last one I finished a week ago.  They have had no effect. There is a feeling of "fullness" in my head.  My nose, the areas around my eyes and my forhead hurts.  It is a throbbing pain.  When I cough or sneeze, I have a sharp pain in the right top of my head that brings tears to my eyes!  I had a CT scan in May.  It showed nothing unusual.  I saw an EN&T doctor on Friday 9/7/07.  She ran a tube with a light on the end up my nose and did not see anything unusual.  I want to find out if this is a result of the vaccine before I have anymore tests done.  I am thinking about requesting a referral to a neurologist and a diagnostic MRI.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Sneezing, Tinnitus
Clinical narrative: Severe headache and sore arm.  I have had this headache for almost 10 months.  I have recently started to have a ringing in my ears.  Dr thought I had a sinus infection.  I have taken 5 rounds of antibiotics, the last one I finished a week ago.  They have had no effect. There is a feeling of "fullness" in my head.  My nose, the areas around my eyes and my forhead hurts.  It is a throbbing pain.  When I cough or sneeze, I have a sharp pain in the right top of my head that brings tears to my eyes!  I had a CT scan in May.  It showed nothing unusual.  I saw an EN&T doctor on Friday 9/7/07.  She ran a tube with a light on the end up my nose and did not see anything unusual.  I want to find out if this is a result of the vaccine before I have anymore tests done.  I am thinking about requesting a referral to a neurologist and a diagnostic MRI.
Age: 48.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Blood culture, Chills, Pyrexia, White blood cell count increased
Clinical narrative: Fevers up to 103.7 for 4 days, chills and rigors Pt took all 4 doses, after each dose, he experienced mild side effects which subsided in a day or 2.  After the 4 dose, fevers began 2 days later and have persisted since (peaking and wanning).  We are continuing to treat for the fevers.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Developmental delay, Fatigue, Gastrointestinal disorder, Immunodeficiency, Irritability
Clinical narrative: Irritable, low-grade fever, tired.  09/17/2007 MR received from PCP with DX of Speech Delay dated 10/2003 and DX Mild PDD (verified with PCP) dated 5/2004 on cover sheet.  6yr old WCC on 1/18/2007 with Assessment:  Well child.  Autistic Disorder. Esophagitis, unspecified. Completed chelation therapy 4/2007 for Autism. Homeopathic MD reports child has yeast overgrowth in bowel./pc 10/01/2007 MR received from MD for visits beginning 12/14/06 through 8/20/2007 with intial dx of regressive autism with very little language  from age 13-15 mon.  Regression noted after MMR and antibiotics.  Esophagitis on Prevacid.  Diarrhea resolved.  Had chelation tx with increased connecting and cuddling w/ parents.   Dx of ADHD noted on 3/25/07 as well as reflux, malabsorbtion, yeast overgrowth. Per 60 day follow up: Heavy metal poisoning, autism, compromised immune system, GI tract issues, speech delay, global developmental delays. We parents need the government agencies to support us in recovering our children! Our children deserve the quality of life they were ment to have. Please correct the vaccine program so the next generation will be protected from this medical vaccine tragedy which affects 1 out of 9 vaccinated boys and 1 out of 150 vaccinated girls. Please help these affected children my child was born normal!
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Malabsorption, Metal poisoning, Pyrexia, Speech disorder
Clinical narrative: Irritable, low-grade fever, tired.  09/17/2007 MR received from PCP with DX of Speech Delay dated 10/2003 and DX Mild PDD (verified with PCP) dated 5/2004 on cover sheet.  6yr old WCC on 1/18/2007 with Assessment:  Well child.  Autistic Disorder. Esophagitis, unspecified. Completed chelation therapy 4/2007 for Autism. Homeopathic MD reports child has yeast overgrowth in bowel./pc 10/01/2007 MR received from MD for visits beginning 12/14/06 through 8/20/2007 with intial dx of regressive autism with very little language  from age 13-15 mon.  Regression noted after MMR and antibiotics.  Esophagitis on Prevacid.  Diarrhea resolved.  Had chelation tx with increased connecting and cuddling w/ parents.   Dx of ADHD noted on 3/25/07 as well as reflux, malabsorbtion, yeast overgrowth. Per 60 day follow up: Heavy metal poisoning, autism, compromised immune system, GI tract issues, speech delay, global developmental delays. We parents need the government agencies to support us in recovering our children! Our children deserve the quality of life they were ment to have. Please correct the vaccine program so the next generation will be protected from this medical vaccine tragedy which affects 1 out of 9 vaccinated boys and 1 out of 150 vaccinated girls. Please help these affected children my child was born normal!
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Disseminated intravascular coagulation, Dysuria
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Ear pain, Encephalitis, Flank pain, Headache, Hypokinesia
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Infection, Lethargy, Multi-organ failure, Otitis media, Pyrexia
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Viral infection, Vomiting
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abdomen scan normal, Abdominal pain, Acute haemorrhagic leukoencephalitis, Antinuclear antibody positive, Bacterial culture negative
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Blood test normal, Brain oedema, Computerised tomogram abnormal, Culture negative, Death
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Dysuria, Extubation, Eye movement disorder, Gastroenteritis viral
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Gaze palsy, Gram stain negative, Headache, Intensive care, Intubation
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Leukoencephalomyelitis, Lumbar puncture abnormal, Otitis media, Prothrombin time prolonged, Pupils unequal
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pyrexia, Renal failure, Urine analysis normal, Vomiting
Clinical narrative: Initial report received on 18 April 2007 from the FDA, VAERS # 270289. A healthy 11-year-old male patient, with no reported medical history, or use of other medications had received a first, right arm, intramuscular injection of Menactra, lot number U1853AA, on 11 July 2006. While fishing on 07 August 2006, seven days post-vaccination, the patient "experienced abdominal pain, emesis, and a headache. His pediatrician saw him on 10 August 2006 and diagnosed viral gastroenteritis. On 11 August 2006, the boy presented again and was found to have bilateral otitis media, and he was treated with ear drops. By August 13 2006. He developed fever and dysuria and went to the emergency department, where a CT of the abdomen was negative and his urine and blood work were reportedly normal. He went home, but by 15 August 2006, he was dizzy and had a severe headache. He went to the hospital and was found to have a left preference and "rowing eyes." LP showed 1500 WBC (95% polys). Gram stain was negative, and a head CT showed thalamic edema. He was intubated, given broad spectrum antibiotics and glucocorticoids, and transferred to the PICU of a tertiary care center. He was minimally responsive and had anicocoria. Acyclovir was added. The CDC was consulted and ruled out anoebic infection. All viral, bacterial, fungal, and mycobacterial cultures were negative. Serial CTs revealed edema of the thalami, basal ganglia, brainstem, and cerebellar peduncles. Prothrombin time ratio was slightly elevated, and ANA was low-positive. The patient developed obstructive hydrocephalus, and his status declined, despite decompression procedures. He developed renal-failure, and the parents consented to extubation. The patient died on 21 August 2006." An autopsy was performed and states that the clinical and postmortem findings are most consistent with acute hemorrhagic leukoencephalitis, which is a rare and fulsinant form ADEM. The pathologist believes the patient's gastroenteritis likely led to an acute autoimmune reaction as demyelination.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TD, YF, FLUX, HEP, HEPA, IPV, MNQ, YF
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Neuropathy, Paraesthesia
Clinical narrative: Initial report received on 08 May 2007 from the Centers for Disease Control and Prevention. VAERS ID # 275138. A 19-year-old male patient, was vaccinated on 13 July 2006 with Poliomyelitis vaccine inactivated, Diphtheria and Tetanus Toxoids vaccine, and Yellow Fever vaccine. The tradenames, manufacturer's names, lot numbers, routes and sites of administration were not reported. The patient had also received Influenza vaccine, Menactra vaccine (lot number U2057AA), Hepatitis A (vaccine, Hepatitis B vaccine, MMR II and Pneumococcal vaccine on 13 June 2006 that are also considered suspect vaccines. The trade names, manufacturer's names, lot numbers, routes and sites of administration were not reported for any of these vaccines except the Menactra vaccine. Three days after receiving the vaccinations on 13 July 2006, the patient experienced numbness, tingling, and weakness in his calves, ankles and feet. This progressed to a diagnosis of "GBS" (Guillain-Barre syndrome). Treatments received and diagnostic tests performed were not reported. The recovery status of the patient was not reported. Follow-up information received on 27 June 2007 from the Centers for Disease Control and Prevention, VAERS# 27513B. Per the reporter, this case meets criteria for Guillain-Barre syndrome. No other relevant medical information was provided.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TD, YF, FLUX, HEP, HEPA, IPV, MNQ, YF
Symptoms: Yellow fever
Clinical narrative: Initial report received on 08 May 2007 from the Centers for Disease Control and Prevention. VAERS ID # 275138. A 19-year-old male patient, was vaccinated on 13 July 2006 with Poliomyelitis vaccine inactivated, Diphtheria and Tetanus Toxoids vaccine, and Yellow Fever vaccine. The tradenames, manufacturer's names, lot numbers, routes and sites of administration were not reported. The patient had also received Influenza vaccine, Menactra vaccine (lot number U2057AA), Hepatitis A (vaccine, Hepatitis B vaccine, MMR II and Pneumococcal vaccine on 13 June 2006 that are also considered suspect vaccines. The trade names, manufacturer's names, lot numbers, routes and sites of administration were not reported for any of these vaccines except the Menactra vaccine. Three days after receiving the vaccinations on 13 July 2006, the patient experienced numbness, tingling, and weakness in his calves, ankles and feet. This progressed to a diagnosis of "GBS" (Guillain-Barre syndrome). Treatments received and diagnostic tests performed were not reported. The recovery status of the patient was not reported. Follow-up information received on 27 June 2007 from the Centers for Disease Control and Prevention, VAERS# 27513B. Per the reporter, this case meets criteria for Guillain-Barre syndrome. No other relevant medical information was provided.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TD, YF, FLUX, HEP, HEPA, IPV, MNQ, YF
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received on 08 May 2007 from the Centers for Disease Control and Prevention. VAERS ID # 275138. A 19-year-old male patient, was vaccinated on 13 July 2006 with Poliomyelitis vaccine inactivated, Diphtheria and Tetanus Toxoids vaccine, and Yellow Fever vaccine. The tradenames, manufacturer's names, lot numbers, routes and sites of administration were not reported. The patient had also received Influenza vaccine, Menactra vaccine (lot number U2057AA), Hepatitis A (vaccine, Hepatitis B vaccine, MMR II and Pneumococcal vaccine on 13 June 2006 that are also considered suspect vaccines. The trade names, manufacturer's names, lot numbers, routes and sites of administration were not reported for any of these vaccines except the Menactra vaccine. Three days after receiving the vaccinations on 13 July 2006, the patient experienced numbness, tingling, and weakness in his calves, ankles and feet. This progressed to a diagnosis of "GBS" (Guillain-Barre syndrome). Treatments received and diagnostic tests performed were not reported. The recovery status of the patient was not reported. Follow-up information received on 27 June 2007 from the Centers for Disease Control and Prevention, VAERS# 27513B. Per the reporter, this case meets criteria for Guillain-Barre syndrome. No other relevant medical information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Blood test normal, Computerised tomogram head, Computerised tomogram normal, Headache
Clinical narrative: Initial report received on 08 May 2007 from the Center for Disease Control and Prevention, VAERS# 275804. A 17-year-old female patient had received an injection of Menactra, lot number U1874AA, on 29 March 2007. The next day, she experienced a headache that increased in intensity over eight days. On 05 April 2007, she experienced weakness in her knees, an inability to control her limbs, tingling on her right side, garbled speech with some conversation that was not understandable or correct in nature for 45-60 minutes. The patient was hospitalized from 05 April 2007 to 06 April 2007 for onset of expressive aphasia, bilateral arm weakness, and facial numbness. It was reported, "Transient expressive aphasia with neurological deficits. Possible variant of Guillain Barre." The Clinical Immunization Safety Assessment network (CISA) is in the process of following-up on this report. Follow-up information received from the CDC (Centers for Disease Control and Prevention). Evaluation by the Clinical Immunization Safety Assessment Network (CISA) has determined that this case does not meet the criteria for GBS (Guillain-Barre syndrome). No other relevant medical information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Loss of control of legs, Paraesthesia, Repetitive speech, Speech disorder, Transient ischaemic attack
Clinical narrative: Initial report received on 08 May 2007 from the Center for Disease Control and Prevention, VAERS# 275804. A 17-year-old female patient had received an injection of Menactra, lot number U1874AA, on 29 March 2007. The next day, she experienced a headache that increased in intensity over eight days. On 05 April 2007, she experienced weakness in her knees, an inability to control her limbs, tingling on her right side, garbled speech with some conversation that was not understandable or correct in nature for 45-60 minutes. The patient was hospitalized from 05 April 2007 to 06 April 2007 for onset of expressive aphasia, bilateral arm weakness, and facial numbness. It was reported, "Transient expressive aphasia with neurological deficits. Possible variant of Guillain Barre." The Clinical Immunization Safety Assessment network (CISA) is in the process of following-up on this report. Follow-up information received from the CDC (Centers for Disease Control and Prevention). Evaluation by the Clinical Immunization Safety Assessment Network (CISA) has determined that this case does not meet the criteria for GBS (Guillain-Barre syndrome). No other relevant medical information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Aphasia, Dyskinesia, Headache, Hypoaesthesia facial, Muscular weakness
Clinical narrative: Initial report received on 08 May 2007 from the Center for Disease Control and Prevention, VAERS# 275804. A 17-year-old female patient had received an injection of Menactra, lot number U1874AA, on 29 March 2007. The next day, she experienced a headache that increased in intensity over eight days. On 05 April 2007, she experienced weakness in her knees, an inability to control her limbs, tingling on her right side, garbled speech with some conversation that was not understandable or correct in nature for 45-60 minutes. The patient was hospitalized from 05 April 2007 to 06 April 2007 for onset of expressive aphasia, bilateral arm weakness, and facial numbness. It was reported, "Transient expressive aphasia with neurological deficits. Possible variant of Guillain Barre." The Clinical Immunization Safety Assessment network (CISA) is in the process of following-up on this report. Follow-up information received from the CDC (Centers for Disease Control and Prevention). Evaluation by the Clinical Immunization Safety Assessment Network (CISA) has determined that this case does not meet the criteria for GBS (Guillain-Barre syndrome). No other relevant medical information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Paraesthesia
Clinical narrative: Initial report received on 08 May 2007 from the Center for Disease Control and Prevention, VAERS# 275804. A 17-year-old female patient had received an injection of Menactra, lot number U1874AA, on 29 March 2007. The next day, she experienced a headache that increased in intensity over eight days. On 05 April 2007, she experienced weakness in her knees, an inability to control her limbs, tingling on her right side, garbled speech with some conversation that was not understandable or correct in nature for 45-60 minutes. The patient was hospitalized from 05 April 2007 to 06 April 2007 for onset of expressive aphasia, bilateral arm weakness, and facial numbness. It was reported, "Transient expressive aphasia with neurological deficits. Possible variant of Guillain Barre." The Clinical Immunization Safety Assessment network (CISA) is in the process of following-up on this report. Follow-up information received from the CDC (Centers for Disease Control and Prevention). Evaluation by the Clinical Immunization Safety Assessment Network (CISA) has determined that this case does not meet the criteria for GBS (Guillain-Barre syndrome). No other relevant medical information was provided.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Urticaria
Clinical narrative: Hives
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Convulsion, Eye rolling, Syncope
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no medical history or drug allergies who on 21-AUG-2007 was vaccinated with a 0.5mL first dose of Gardasil (Lot # not provided). Concomitant vaccination included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified). On 21-AUG-2007 the patient fainted and experienced seizure like activity after receiving the Gardasil. It was noted by the reporter that the patient received the vaccination on an empty stomach. The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. On 21-AUG-2007, the patient recovered. No product quality complaint was involved. Upon internal review, seizure like activity was considered to be an other important medical event. Additional information has been requested. Follow up information received 06/11/2009: I would like to add to this report that my daughter was not on any medications. Thank You.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no medical history or drug allergies who on 21-AUG-2007 was vaccinated with a 0.5mL first dose of Gardasil (Lot # not provided). Concomitant vaccination included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified). On 21-AUG-2007 the patient fainted and experienced seizure like activity after receiving the Gardasil. It was noted by the reporter that the patient received the vaccination on an empty stomach. The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. On 21-AUG-2007, the patient recovered. No product quality complaint was involved. Upon internal review, seizure like activity was considered to be an other important medical event. Additional information has been requested. Follow up information received 06/11/2009: I would like to add to this report that my daughter was not on any medications. Thank You.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Eye rolling, Pallor, Syncope, Tremor
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no medical history or drug allergies who on 21-AUG-2007 was vaccinated with a 0.5mL first dose of Gardasil (Lot # not provided). Concomitant vaccination included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified). On 21-AUG-2007 the patient fainted and experienced seizure like activity after receiving the Gardasil. It was noted by the reporter that the patient received the vaccination on an empty stomach. The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. On 21-AUG-2007, the patient recovered. No product quality complaint was involved. Upon internal review, seizure like activity was considered to be an other important medical event. Additional information has been requested. Follow up information received 06/11/2009: I would like to add to this report that my daughter was not on any medications. Thank You.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Eye rolling, Hypotonia, Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Initial report received on 30 August 2007 from a nurse. A five year-old male patient, with no past medical history, had received a fifth intramuscular "right" dose of Daptacel, lot number C2657AA; a fourth "right" subcutaneous dose of IPOL, lot number Z1009; a second left forearm intradermal dose of Tubersol, lot number C2680AA; and a second left subcutaneous dose of another manufacturer's MMR II, (Merck), lot number 0426V (diluent lot number 3071U) on 30 August 2007 at 12:30 p.m. Within one to two minutes post-vaccination, the patient turned pale, his eyes rolled up in his head, his body stiffened, and the he went limp and unresponsive. The patient was laid flat with his legs elevated. An "MD" evaluated the patient by which time the patient was responding appropriately to questions. The patient's heart rate was 70, and a pulse oximeter reading was 97-96% oxygen saturation. The patient was observed for 15 minutes with no further episodes. He was discharged to home alert and playful with a heart rate of 98-100's, pulse oximetry reading was 94% and blood pressure was 90/50. No relevant diagnostic testing was performed. The status of the patient was reported as recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Gaze palsy, Hypotonia, Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Initial report received on 30 August 2007 from a nurse. A five year-old male patient, with no past medical history, had received a fifth intramuscular "right" dose of Daptacel, lot number C2657AA; a fourth "right" subcutaneous dose of IPOL, lot number Z1009; a second left forearm intradermal dose of Tubersol, lot number C2680AA; and a second left subcutaneous dose of another manufacturer's MMR II, (Merck), lot number 0426V (diluent lot number 3071U) on 30 August 2007 at 12:30 p.m. Within one to two minutes post-vaccination, the patient turned pale, his eyes rolled up in his head, his body stiffened, and the he went limp and unresponsive. The patient was laid flat with his legs elevated. An "MD" evaluated the patient by which time the patient was responding appropriately to questions. The patient's heart rate was 70, and a pulse oximeter reading was 97-96% oxygen saturation. The patient was observed for 15 minutes with no further episodes. He was discharged to home alert and playful with a heart rate of 98-100's, pulse oximetry reading was 94% and blood pressure was 90/50. No relevant diagnostic testing was performed. The status of the patient was reported as recovered.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: Initial report received on 05 September 2007 from a health care professional . A 60-year-old female patient, with a history of mitral valve prolapse, hypertension, and hyperlipidemia, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2644AA, on 03 July 2007. Concomitant medications included Lipitor, aspirin, and hydrochlorothiazide. Seventeen days post-vaccination, the patient experienced numbness in her hands and feet. She subsequently went to the hospital where she was diagnosed with Guillain Barre Syndrome. The patient was hospitalized for 21 days and then admitted to an inpatient rehabilitation facility for two weeks. Per the reporter, "The patient continues with outpatient rehabilitation therapy and continues with numbness and difficulty walking." The reporter noted that the seriousness of the event had also included a prolongation of hospitalization and a permanent disability. The reporting facility indicated that they had no lab reports on file and provided the contact information for the admitting hospital. At the time of this report, the patient had not recovered.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial report received on 05 September 2007 from a health care professional . A 60-year-old female patient, with a history of mitral valve prolapse, hypertension, and hyperlipidemia, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2644AA, on 03 July 2007. Concomitant medications included Lipitor, aspirin, and hydrochlorothiazide. Seventeen days post-vaccination, the patient experienced numbness in her hands and feet. She subsequently went to the hospital where she was diagnosed with Guillain Barre Syndrome. The patient was hospitalized for 21 days and then admitted to an inpatient rehabilitation facility for two weeks. Per the reporter, "The patient continues with outpatient rehabilitation therapy and continues with numbness and difficulty walking." The reporter noted that the seriousness of the event had also included a prolongation of hospitalization and a permanent disability. The reporting facility indicated that they had no lab reports on file and provided the contact information for the admitting hospital. At the time of this report, the patient had not recovered.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a health professional concerning a 19 week old male, with no medical history and no allergies, who on 30-MAY-2007 was vaccinated with a dose of Rotateq (Lot# 656385/0030U). On 04-AUG-2007 the patient had surgery for intussusception and was hospitalized. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. The patient's experience was considered to be immediately life-threatening, disabling, and an other important medical event by the reporter. Additional information has been requested.  9/28/07 Received hospital medical records which reveal patient experienced vomiting, irritability, restlessness, abdominal distention & bloody stools x 2 days.  Seen in outlying ER & transferred to higher level of care.  Admitted 8/4-8/7/2007.  IS was nonreducible by air contrast enema & taken to OR for exp lap w/reduction of IS & open appendectomy.  Progressed well but continued to have bloody stools throughout hospitalization but lessened w/more formed stools.  D/C to home w/pcp & surgical f/u. FINAL DX: Intussusception, surgically reduced.