chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Abasia, Aphasia, Asthenia, Computerised tomogram, Convulsion
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Echocardiogram, Electrocardiogram, Electroencephalogram, Encephalitis, Gait disturbance
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Gastrointestinal tube insertion, Lumbar puncture, Mechanical ventilation, Nuclear magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Abasia, Asthenia, Blood test, Computerised tomogram, Confusional state
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Convulsion, Dizziness, Electrocardiogram, Electroencephalogram, Headache
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Intensive care, Malaise, Mechanical ventilation, Mechanical ventilation, Nuclear magnetic resonance imaging
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Tracheostomy, Unresponsive to stimuli, X-ray
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Abasia, Aphasia, Aphasia, Asthenia, Brain oedema
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Chronic respiratory disease, Computerised tomogram, Convulsion, Echocardiogram, Electrocardiogram
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Electroencephalogram, Encephalitis, Gait disturbance, Gastrointestinal tube insertion, Hypotonia
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Intensive care, Laboratory test, Lumbar puncture, Mechanical ventilation, Neurological symptom
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Chills, Convulsion, Pyrexia, Vomiting
Clinical narrative: Mother called stated that child began with fever about 12 midnight Friday night (Feb. 13. She stated child convulsed 3 times and threw up. When asked how high the temp got she stated they could not always get the thermometer in his mouth as his teeth were chattering, but she thought it around 102-103. Mother states he took a 4 hour nap on Saturday and was better on Sunday. She did not take him to the doctor or ER as she stated he convulses from fevers and is made better with tepid baths.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Disturbance in attention, Fatigue, Insomnia
Clinical narrative: Chronic fatigue, difficulty concentrating & sleeping following vaccinations
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: pt contracted shingles 8 months s/p vaccination
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Hypoaesthesia
Clinical narrative: Mom states that 4 hours after immunization that patient complained of "butt & thighs are numb & chest feels jittery". Did not call physician and symptoms were gone in the morning.  Mother refuses future HPV.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Cough, Death, Depressed level of consciousness, Diarrhoea, Dyspnoea
Clinical narrative: He had a high fever 4 days after getting the vaccines on 11/26/2008.  He was not as alert as he usually was, he had diarrhea, acted as though he didn't know how to suck a bottle, swelled, 1 week before he died I took him to the hospital on 12/20/2008 for wheezing, hard time breathing, fever, coughing severely. They said it was a respiratory infection.  I had taken him to the hospital and doctors office for the same reasons numerous times prior to that last visit. They kept telling me there was nothing wrong with him, but I knew there was. He died 12/27/2008. 7/14/09-autopsy report received-COD-positional asphyxia.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Poor sucking reflex, Pyrexia, Respiratory tract infection, Swelling, Wheezing
Clinical narrative: He had a high fever 4 days after getting the vaccines on 11/26/2008.  He was not as alert as he usually was, he had diarrhea, acted as though he didn't know how to suck a bottle, swelled, 1 week before he died I took him to the hospital on 12/20/2008 for wheezing, hard time breathing, fever, coughing severely. They said it was a respiratory infection.  I had taken him to the hospital and doctors office for the same reasons numerous times prior to that last visit. They kept telling me there was nothing wrong with him, but I knew there was. He died 12/27/2008. 7/14/09-autopsy report received-COD-positional asphyxia.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Red swollen Left arm.  Patient came back to clinic 1 day after receiving injection.  Patient treated with Prednisone taper, benadryl OTC, and intermittent ice packs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Zostavax injection given on 2/10/2009 in the right arm subcutaneous.  On 2/17/2009 patient presented with extensive erythematous rash extending from injection site in the proximal posterior arm into the axilla.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Observed large reddened area approximately 2.5x3 inches in circumference 3 days after vaccination. Area was swollen and hot to touch. Patient reported time of onset of symptoms within 48 hours post vaccination. Patient also complained of pain that radiated down arm on day of onset, but resolved when incident reported. Dr. advised ice to site for swelling and ibuprofen.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Patient developed vesicular rash in dermatomal distribution over thoracic area, c/o pain over this area.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Patient developed vesicular rash in dermatomal distribution over thoracic area, c/o pain over this area.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Patient's mother called 2/17/09 reporting, about 2 hours after receiving MENATRA injection c/o shooting down left arm and leg 2/16/09. Today 2/17/09 reports tiredness and out of breath. No fever or nausea. 2/23/09-records received for DOS 2/17/09-returned with C/O reaction to vaccine,  hours after receiving vaccine shooting pain down left arm and leg, difficulty sleeping, headache, shaky, SOB, fatigue, no energy. Left arm red, hot and swollen.
Age: 1.8
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: C/o rash on shoulders, back, (R) side family Dr. order BENADRYL.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Swelling
Clinical narrative: Swelling, pain left index finger mcp onset 2/13/09
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Medication error
Clinical narrative: A non-serious, spontaneous report of administered expired FLUMIST in a 30 month-old female patient was received from a nurse practitioner in the United States. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 11 customers not discarding product fromt he previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 24-Mar-2009 and incorporated into the narrative lot investigation results.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 38-month-old female who received FLUMIST. The patient is one of the 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 06-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2009. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that the expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; however, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old female subsequent to FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient received FLUMIST on 05-Jan-2009 which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and on the same day, it was discovered that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter; sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 11 customers not discarding product from the previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009; product complaint investigation results.
Age: 2.7
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of hives has been received from a physician concerning a 32-month-old female, subsequently to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No past medical history nor concomitant medications were reported. The patient received the first FLUMIST dose on 27-Oct-2008 and the second FLUMIST dose on 30-Dec-2008. On 31-Dec-2008, the patient reported to the physicians office because she got hives all over. The patient was given diphenhydramine and sent home from the physicians office. The outcome was not reported.
Age: 5.7
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered of expired FLUMIST was received from a  physician concerning a 58-month-old male.  who received FLUMIST. The patient's medical history and concomitant medications were reported. On 06-Jan-2009, the child inadvertently received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medicatin errors that occurred shortly after the product expired. Additional information was received on 01-Apr-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 02-Apr-2009: Product Complaint Investigation results.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 24-month-old female subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, FLUMIST which expired on 26-Dec-2008 was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 01-Apr-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: `A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 40-month-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.  Additional information received on 30-Apr-2009 product complaint investigation results.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 38-month-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event. Additional information received on 10-Apr-2009. product complaint investigatin results.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a 24-month-old female patient subsequent to FLUMIST.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous seasaon and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow up received 30-Apr-2009L added product complaint investigation results.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a 28-month-old male patient subsequent to FLUMIST.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up received 30-Apr-2009 added product complaint investigation results.   Follow-up received 30-Apr-2009 added product complaint
Age: 2.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a 24-month-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up received 05/21/2009. Based on the result of the investigation, the root cause for the medication errors were caused by  1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occured shortly after the product expired.