chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Thymus disorder, Use of accessory respiratory muscles, Viral myocarditis
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 316985) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of death (nos) in a 5-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-gsk, Manufacturer Unspecified) and PREVNAR (Wyeth Labs). The subject's medical history included asthma. On 11 June 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of Haemophilus influenzae type b vaccine (Non-GSK), 1st dose of PREVNAR. On 12 June 2008, 1 day after vaccination with PEDIARIX, Haemophilus influenzae type b vaccine, and PREVNAR, the subject experienced grunting and screaming. The subject also experienced difficulty breathing at an unknown time after vaccination. The subject visited the Emergency Room on 13 June 2008 and again on 20 June 2008 and was transferred to another hospital. Records as per Doctors Orders Sheet for 20 June 2008 to 21 June 2008: transferred with history of dehydration and metabolic acidosis on 14 June 2008 with subsequent Emergency Room visit on 20 June with similar symptoms. Developed difficulty breathing after 11 June 2008 vaccinations, with grunting and screaming on 12 June 2008. In Emergency Department with respiratory distress including retractions, tachypnea, heart rate at 153. On 19 June 2008 at 21:30 passed large diarrheal stool. Evening prior to admission developed limpness and refused per oral feedings. Pale, gray and cold to touch. In Emergency Department with weak cry, heart rate of 200 and unobtainable blood pressure, respirations 60. Electrocardiogram revealed wide complex tachycardia. The subject experienced massive pulmonary edema. The subject was hospitalised. The subject was treated with intubation, mechanical ventilation and resuscitation efforts. The subject died on an unknown date in June 2008 at 23:55 hours from an unspecified cause. An autopsy was performed and showed acute congestive cardiac failure with probable viral myocarditis, mild interstitial pneumonitis, hepatomegaly with centrolobular congestion and necrosis, serous effusions, stress changes in thymus, diffuse cerebral edema and hypoxic ischemic injury.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Diarrhoea, Vomiting
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERs ID 317385) in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). There was no relevant past medical history or pre-existing conditions. On 14 April 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB (unknown), 1st dose of PREVNAR (unknown), 1st dose of ROTATEQ (unknown). On 16 April 2008, 2 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ, the subject experienced vomiting and diarrhea. On 18 April 2008, 4 days after vaccination with PEDIARIX, ACTHIB, PREVNAR, and ROTATEQ, the subject experienced possible asphyxiation and death nos. The subject was treated with Pedialyte. The subject died on 18 April 2008 from death nos. It was unknown whether an autopsy was performed. Vomiting and diarrhea started on 16 April 2008 and improved on 17 April 2008. No dehydration was noted and she tolerated Pedialyte well. The subject died on morning of 18 April 2008 after the mother fell asleep while feeding the subject. On 02 July 2008, records were received - undetermined causes, no convincing cause of death could be determined. The subject may have asphyxiated by various means, including suffocation or positional asphyxia or may have died of other reasons.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 317877) in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), ActHIB, (Sanofi Pasteur), PREVNAR (Wyeth labs) and ROTATEQ, (Merck). Medical conditions included dwarfism, remote "SDH", history of c-section and premature at 37 weeks. There were no concurrent medications. On 9 June 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB, unspecified dose of PREVNAR, 1st dose of ROTATEQ. On 25 June 2008, 16 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death nos and not responding.  The subject died on 25 June 2008 from death nos. An autopsy was performed. The subject's father called on 25 June to cancel appointments for August 2008 and stated that the subject died of sudden infant death syndrome. 29 August 2009: Autopsy report also states: apparently found unresponsive at home in care seat which had been placed in crib; no evidence of acute traumatic injury; post mortem studies all negative. Autopsy states cause of death: no anatomic cause. Post mortem studies were all negative.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Laboratory test, Sudden death, Sudden infant death syndrome, Unequal limb length
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 318750) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of sudden unexpected infant death in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ActHIB (Sanofi Pasteur) and  (non-gsk) PREVNAR (Wyeth Labs). The subject's medical history included status/post inguinal hernia repair. Concurrent medications included Poly-Vi-Flor. On 7 July 2008 the subject received 3rd dose of PEDIARIX (unknown), 3rd dose of ActHIB (unknown), 3rd dose of PREVNAR (unknown). On 8 July 2008, 1 day after vaccination with ActHIB, PEDIARIX and PREVNAR, the subject experienced fussiness, sudden unexpected infant death and unresponsive to stimuli. At the time of reporting, lab data was being examined by the medical examiner. The subject died on 8 July 2008 from sudden unexpected infant death. It was unknown whether an autopsy was performed. The subject received vaccine on 07 July 2008 at approximately 3PM. Reportedly, the subject fussed til 08 July 2008 afternoon nap with the mother. When the mother awoke, the subject was unresponsive and died. On 20 October 2008, records were received and cause of death was sudden unexpected infant death. Manner of death-undetermined.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 318750) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of sudden unexpected infant death in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ActHIB (Sanofi Pasteur) and  (non-gsk) PREVNAR (Wyeth Labs). The subject's medical history included status/post inguinal hernia repair. Concurrent medications included Poly-Vi-Flor. On 7 July 2008 the subject received 3rd dose of PEDIARIX (unknown), 3rd dose of ActHIB (unknown), 3rd dose of PREVNAR (unknown). On 8 July 2008, 1 day after vaccination with ActHIB, PEDIARIX and PREVNAR, the subject experienced fussiness, sudden unexpected infant death and unresponsive to stimuli. At the time of reporting, lab data was being examined by the medical examiner. The subject died on 8 July 2008 from sudden unexpected infant death. It was unknown whether an autopsy was performed. The subject received vaccine on 07 July 2008 at approximately 3PM. Reportedly, the subject fussed til 08 July 2008 afternoon nap with the mother. When the mother awoke, the subject was unresponsive and died. On 20 October 2008, records were received and cause of death was sudden unexpected infant death. Manner of death-undetermined.
Age: 0.27
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Autopsy, Brain oedema, Contusion, Excoriation, Petechiae
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 319501) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 3-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (Sanofi Pasteur). The subject had no medical history/pre-existing conditions. On 5 May 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB. On 22 May 2008, 17 days after vaccination with ACTHIB and PEDIARIX, the subject experienced death nos. Reported to office subject deceased. The subject died from sudden unexpected infant death associated with inappropriate sleeping environment. An autopsy was performed. 22 September 2008: Autopsy report received: cause of death: sudden unexpected infant death associated with inappropriate sleeping environment. The subject was found dead while sleeping on an adult mattress on floor with pillows and blankets. Anatomical diagnosis: thymic petechiae; pulmonary edema; cerebral edema; medical intervention; facial abrasions, mild and tongue contusion.
Age: 0.27
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pulmonary oedema, Sudden death, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 319501) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 3-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (Sanofi Pasteur). The subject had no medical history/pre-existing conditions. On 5 May 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB. On 22 May 2008, 17 days after vaccination with ACTHIB and PEDIARIX, the subject experienced death nos. Reported to office subject deceased. The subject died from sudden unexpected infant death associated with inappropriate sleeping environment. An autopsy was performed. 22 September 2008: Autopsy report received: cause of death: sudden unexpected infant death associated with inappropriate sleeping environment. The subject was found dead while sleeping on an adult mattress on floor with pillows and blankets. Anatomical diagnosis: thymic petechiae; pulmonary edema; cerebral edema; medical intervention; facial abrasions, mild and tongue contusion.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Areflexia, Autopsy, Blood glucose decreased, Body temperature decreased, Brain oedema
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320329) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of myocarditis in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject had no previous medical history or concurrent conditions. On 14 May 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 15 May 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fussy and low grade fever. He was fed 4 ounces and given TYLENOL at 20:40 hours, then put in his crib, on abdomen with face turned to side. The subject was found at 21:10 hours by his mother, unresponsive, not breathing, white, lump with face buried in cover. He was taken to the Emergency Room at a local hospital where he presented in cardiopulmonary arrest and cardiopulmonary resuscitation was performed. The subject was transferred via helicopter to another hospital and placed on life support, intubation and mechanical ventilation. The subject was hypothermic on presentation with rectal temperature of 91.6, hypoglycemic with blood sugar 16, and with metabolic acidosis. Records revealed the subject had agonal respirations not compatible with life, pupils nonreactive to light and fixed, no spontaneous movements of extremities, and deep tendon reflexes absent. Electroencephalogram was abnormal with organic encephalopathy, and computed tomography of the brain showed possible diffuse cerebral edema. Additional records revealed findings of myocarditis, inflammation and necrosis of myocardium, epiglottis interstitial edema, and chronic tracheobronchitis. It was reported that the inflammatory lesions observed in the heart were consistent with either acute viral infection or post-viral syndrome. The subject's life support was stopped on 18 May 2008 and he died. An autopsy was performed and reported cause of death as myocarditis. The onset date of myocarditis was not specified.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cardio-respiratory arrest, Computerised tomogram abnormal, Death, Electroencephalogram abnormal, Encephalopathy
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320329) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of myocarditis in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject had no previous medical history or concurrent conditions. On 14 May 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 15 May 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fussy and low grade fever. He was fed 4 ounces and given TYLENOL at 20:40 hours, then put in his crib, on abdomen with face turned to side. The subject was found at 21:10 hours by his mother, unresponsive, not breathing, white, lump with face buried in cover. He was taken to the Emergency Room at a local hospital where he presented in cardiopulmonary arrest and cardiopulmonary resuscitation was performed. The subject was transferred via helicopter to another hospital and placed on life support, intubation and mechanical ventilation. The subject was hypothermic on presentation with rectal temperature of 91.6, hypoglycemic with blood sugar 16, and with metabolic acidosis. Records revealed the subject had agonal respirations not compatible with life, pupils nonreactive to light and fixed, no spontaneous movements of extremities, and deep tendon reflexes absent. Electroencephalogram was abnormal with organic encephalopathy, and computed tomography of the brain showed possible diffuse cerebral edema. Additional records revealed findings of myocarditis, inflammation and necrosis of myocardium, epiglottis interstitial edema, and chronic tracheobronchitis. It was reported that the inflammatory lesions observed in the heart were consistent with either acute viral infection or post-viral syndrome. The subject's life support was stopped on 18 May 2008 and he died. An autopsy was performed and reported cause of death as myocarditis. The onset date of myocarditis was not specified.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Endotracheal intubation, Epiglottic oedema, Hypoglycaemia, Hypothermia, Inflammation
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320329) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of myocarditis in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject had no previous medical history or concurrent conditions. On 14 May 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 15 May 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fussy and low grade fever. He was fed 4 ounces and given TYLENOL at 20:40 hours, then put in his crib, on abdomen with face turned to side. The subject was found at 21:10 hours by his mother, unresponsive, not breathing, white, lump with face buried in cover. He was taken to the Emergency Room at a local hospital where he presented in cardiopulmonary arrest and cardiopulmonary resuscitation was performed. The subject was transferred via helicopter to another hospital and placed on life support, intubation and mechanical ventilation. The subject was hypothermic on presentation with rectal temperature of 91.6, hypoglycemic with blood sugar 16, and with metabolic acidosis. Records revealed the subject had agonal respirations not compatible with life, pupils nonreactive to light and fixed, no spontaneous movements of extremities, and deep tendon reflexes absent. Electroencephalogram was abnormal with organic encephalopathy, and computed tomography of the brain showed possible diffuse cerebral edema. Additional records revealed findings of myocarditis, inflammation and necrosis of myocardium, epiglottis interstitial edema, and chronic tracheobronchitis. It was reported that the inflammatory lesions observed in the heart were consistent with either acute viral infection or post-viral syndrome. The subject's life support was stopped on 18 May 2008 and he died. An autopsy was performed and reported cause of death as myocarditis. The onset date of myocarditis was not specified.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Laryngeal oedema, Mechanical ventilation, Metabolic acidosis, Myocardial infarction
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320329) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of myocarditis in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject had no previous medical history or concurrent conditions. On 14 May 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 15 May 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fussy and low grade fever. He was fed 4 ounces and given TYLENOL at 20:40 hours, then put in his crib, on abdomen with face turned to side. The subject was found at 21:10 hours by his mother, unresponsive, not breathing, white, lump with face buried in cover. He was taken to the Emergency Room at a local hospital where he presented in cardiopulmonary arrest and cardiopulmonary resuscitation was performed. The subject was transferred via helicopter to another hospital and placed on life support, intubation and mechanical ventilation. The subject was hypothermic on presentation with rectal temperature of 91.6, hypoglycemic with blood sugar 16, and with metabolic acidosis. Records revealed the subject had agonal respirations not compatible with life, pupils nonreactive to light and fixed, no spontaneous movements of extremities, and deep tendon reflexes absent. Electroencephalogram was abnormal with organic encephalopathy, and computed tomography of the brain showed possible diffuse cerebral edema. Additional records revealed findings of myocarditis, inflammation and necrosis of myocardium, epiglottis interstitial edema, and chronic tracheobronchitis. It was reported that the inflammatory lesions observed in the heart were consistent with either acute viral infection or post-viral syndrome. The subject's life support was stopped on 18 May 2008 and he died. An autopsy was performed and reported cause of death as myocarditis. The onset date of myocarditis was not specified.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Myocarditis, Pupil fixed, Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320329) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of myocarditis in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject had no previous medical history or concurrent conditions. On 14 May 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 15 May 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fussy and low grade fever. He was fed 4 ounces and given TYLENOL at 20:40 hours, then put in his crib, on abdomen with face turned to side. The subject was found at 21:10 hours by his mother, unresponsive, not breathing, white, lump with face buried in cover. He was taken to the Emergency Room at a local hospital where he presented in cardiopulmonary arrest and cardiopulmonary resuscitation was performed. The subject was transferred via helicopter to another hospital and placed on life support, intubation and mechanical ventilation. The subject was hypothermic on presentation with rectal temperature of 91.6, hypoglycemic with blood sugar 16, and with metabolic acidosis. Records revealed the subject had agonal respirations not compatible with life, pupils nonreactive to light and fixed, no spontaneous movements of extremities, and deep tendon reflexes absent. Electroencephalogram was abnormal with organic encephalopathy, and computed tomography of the brain showed possible diffuse cerebral edema. Additional records revealed findings of myocarditis, inflammation and necrosis of myocardium, epiglottis interstitial edema, and chronic tracheobronchitis. It was reported that the inflammatory lesions observed in the heart were consistent with either acute viral infection or post-viral syndrome. The subject's life support was stopped on 18 May 2008 and he died. An autopsy was performed and reported cause of death as myocarditis. The onset date of myocarditis was not specified.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Scan brain, Skin discolouration, Tracheobronchitis, Unresponsive to stimuli, Viral infection
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320329) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of myocarditis in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject had no previous medical history or concurrent conditions. On 14 May 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 15 May 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fussy and low grade fever. He was fed 4 ounces and given TYLENOL at 20:40 hours, then put in his crib, on abdomen with face turned to side. The subject was found at 21:10 hours by his mother, unresponsive, not breathing, white, lump with face buried in cover. He was taken to the Emergency Room at a local hospital where he presented in cardiopulmonary arrest and cardiopulmonary resuscitation was performed. The subject was transferred via helicopter to another hospital and placed on life support, intubation and mechanical ventilation. The subject was hypothermic on presentation with rectal temperature of 91.6, hypoglycemic with blood sugar 16, and with metabolic acidosis. Records revealed the subject had agonal respirations not compatible with life, pupils nonreactive to light and fixed, no spontaneous movements of extremities, and deep tendon reflexes absent. Electroencephalogram was abnormal with organic encephalopathy, and computed tomography of the brain showed possible diffuse cerebral edema. Additional records revealed findings of myocarditis, inflammation and necrosis of myocardium, epiglottis interstitial edema, and chronic tracheobronchitis. It was reported that the inflammatory lesions observed in the heart were consistent with either acute viral infection or post-viral syndrome. The subject's life support was stopped on 18 May 2008 and he died. An autopsy was performed and reported cause of death as myocarditis. The onset date of myocarditis was not specified.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Anoxic encephalopathy, Brain oedema, Cerebral ischaemia, Convulsion, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320407) via an unspecified source in response to a Freedom-of-Information request by GSK, and described the occurrence of death (nos) in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PEDVAXHIB (Merck) and PREVNAR (Wyeth Labs). The subject had no prior medical history or pre-existing conditions. On 14 July 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of PEDVAXHIB, 2nd dose of PREVNAR. On 16 July 2008, 2 days after vaccination with PEDIARIX, PEDVAXHIB and PREVNAR, the subject experienced fever, seizure, bulging fontanelle, cerebral edema, anoxic brain injury and ischemia of brain. The subject presented to the Emergency Department on 16 July 2008 with seizure activity that was difficult to control after starting to have seizures at home. She was finally stabilized then transferred to the Pediatric Intensive Care Unit at hospital. Following admission she again started to have uncontrolled seizures. She was started on multiple seizure medications, but still not controlled so placed into a Phenobarbital coma and KEPPRA was added. This was again weaned with the recurrence of seizures. Her parents then decided that with the amount of brain damage noted on imaging that they would like to withdraw support. The subject then passed a few hours after support was withdrawn. Records indicated no significant trauma, no gross natural disease, brain and spinal cord retained for neuropathology examination. Records as per Doctors-Orders-Sheet of 16 July to 23 July 2008: presented to Emergency Department after seizure, had low grade fever since 2 days after immunizations. Intubation. Bulging pulsating fontanelle. Diagnosis: seizure activity with cerebral edema. The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening. The subject was treated with Phenobarbital, Fosphenytoin, pyridoxine, KEPPRA, intubation and Pentobarbital. The subject died on an unspecified date in July 2008 from unspecified cause. It was unknown whether an autopsy was performed.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Fontanelle bulging, Intensive care, Nuclear magnetic resonance imaging brain abnormal, Pyrexia
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 320407) via an unspecified source in response to a Freedom-of-Information request by GSK, and described the occurrence of death (nos) in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PEDVAXHIB (Merck) and PREVNAR (Wyeth Labs). The subject had no prior medical history or pre-existing conditions. On 14 July 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of PEDVAXHIB, 2nd dose of PREVNAR. On 16 July 2008, 2 days after vaccination with PEDIARIX, PEDVAXHIB and PREVNAR, the subject experienced fever, seizure, bulging fontanelle, cerebral edema, anoxic brain injury and ischemia of brain. The subject presented to the Emergency Department on 16 July 2008 with seizure activity that was difficult to control after starting to have seizures at home. She was finally stabilized then transferred to the Pediatric Intensive Care Unit at hospital. Following admission she again started to have uncontrolled seizures. She was started on multiple seizure medications, but still not controlled so placed into a Phenobarbital coma and KEPPRA was added. This was again weaned with the recurrence of seizures. Her parents then decided that with the amount of brain damage noted on imaging that they would like to withdraw support. The subject then passed a few hours after support was withdrawn. Records indicated no significant trauma, no gross natural disease, brain and spinal cord retained for neuropathology examination. Records as per Doctors-Orders-Sheet of 16 July to 23 July 2008: presented to Emergency Department after seizure, had low grade fever since 2 days after immunizations. Intubation. Bulging pulsating fontanelle. Diagnosis: seizure activity with cerebral edema. The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening. The subject was treated with Phenobarbital, Fosphenytoin, pyridoxine, KEPPRA, intubation and Pentobarbital. The subject died on an unspecified date in July 2008 from unspecified cause. It was unknown whether an autopsy was performed.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Cardiomegaly, Hepatomegaly, Metabolic function test normal, Otitis media
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 321634) in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB and (non-gsk) PREVNAR. Medical history/pre-existing conditions included known in utero cocaine exposure and hair testing at birth positive for cocaine. Subject was not breast fed. Subject was diagnosed with influenza A in May 2008. Previous and/or concurrent vaccination included (non-gsk) ACTHIB; Sanofi Pasteur MSD given on 20 June 2008; (non-gsk) PREVNAR; Wyeth Labs given on 20 June 2008. Concurrent medications included Amoxicillin started 18 July 2008. On 20 June 2008 the subject received 1st dose of PEDIARIX (unknown), unspecified dose of ACTHIB, unspecified dose of PREVNAR. On an unspecified date in July 2008, an unspecified time after vaccination with PEDIARIX, ACTHIB and PREVNAR, the subject experienced right otitis media. On 27 July 2008, 37 days after vaccination with PEDIARIX, ACTHIB and PREVNAR, the subject experienced death nos. This was a case of unexpected death at four and a half month of age (current coroner's case Medical Examiner's Office). The subject died on 27 July 2008, cause of death was undetermined in infant with cocaine in bloodstream. An autopsy was performed. 26 September: Autopsy report states cause of death was undetermined in infant with cocaine in bloodstream. Manner of death was undetermined. Report also stated: metabolic screening: negative; cardiomegaly; hepato/splenomegaly. The subject was placed on back and found face down in adult size bed. The subject was born precipitously at home and admitted to hospital 16 days prior to death. Mother tested positive for cocaine during pregnancy and hair testing of infant at birth was positive for cocaine. Toxicology screen at autopsy was positive for cocaine.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Splenomegaly, Sudden death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 321634) in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB and (non-gsk) PREVNAR. Medical history/pre-existing conditions included known in utero cocaine exposure and hair testing at birth positive for cocaine. Subject was not breast fed. Subject was diagnosed with influenza A in May 2008. Previous and/or concurrent vaccination included (non-gsk) ACTHIB; Sanofi Pasteur MSD given on 20 June 2008; (non-gsk) PREVNAR; Wyeth Labs given on 20 June 2008. Concurrent medications included Amoxicillin started 18 July 2008. On 20 June 2008 the subject received 1st dose of PEDIARIX (unknown), unspecified dose of ACTHIB, unspecified dose of PREVNAR. On an unspecified date in July 2008, an unspecified time after vaccination with PEDIARIX, ACTHIB and PREVNAR, the subject experienced right otitis media. On 27 July 2008, 37 days after vaccination with PEDIARIX, ACTHIB and PREVNAR, the subject experienced death nos. This was a case of unexpected death at four and a half month of age (current coroner's case Medical Examiner's Office). The subject died on 27 July 2008, cause of death was undetermined in infant with cocaine in bloodstream. An autopsy was performed. 26 September: Autopsy report states cause of death was undetermined in infant with cocaine in bloodstream. Manner of death was undetermined. Report also stated: metabolic screening: negative; cardiomegaly; hepato/splenomegaly. The subject was placed on back and found face down in adult size bed. The subject was born precipitously at home and admitted to hospital 16 days prior to death. Mother tested positive for cocaine during pregnancy and hair testing of infant at birth was positive for cocaine. Toxicology screen at autopsy was positive for cocaine.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Blood electrolytes normal, Culture negative, Death, Histology normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 323510) in response to a Freedom-of-Information requested by GSK. Initial information received described the occurrence of death nos in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. On 25 August 2008 the subject received 3rd dose of PEDIARIX (unknown), 3rd dose of ACTHIB (unknown), 3rd dose of PREVNAR (unknown), 3rd dose of ROTATEQ (unknown). One day later, on 26 August 2008, the onset of event was reported, however, no details, symptoms were provided or noted. On 27 October 2008, the subject died. An autopsy was performed and the cause of death was undetermined. No injuries or natural causes were identified. There was evidence of a resuscitation attempt.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Metabolic function test normal, Renal function test normal, Toxicologic test normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 323510) in response to a Freedom-of-Information requested by GSK. Initial information received described the occurrence of death nos in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. On 25 August 2008 the subject received 3rd dose of PEDIARIX (unknown), 3rd dose of ACTHIB (unknown), 3rd dose of PREVNAR (unknown), 3rd dose of ROTATEQ (unknown). One day later, on 26 August 2008, the onset of event was reported, however, no details, symptoms were provided or noted. On 27 October 2008, the subject died. An autopsy was performed and the cause of death was undetermined. No injuries or natural causes were identified. There was evidence of a resuscitation attempt.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Respiratory arrest
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 323974) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB and (non-gsk) PREVNAR. Medical history/pre-existing conditions included twin gestation, born at 33 5/7 weeks gestation. There were no concurrent medications. On 29 July 2008 the subject received 1st dose of PEDIARIX (unknown), unspecified dose of ACTHIB, 1st dose of PREVNAR. On 7 August 2008, 9 days after vaccination with ACTHIB, PEDIARIX and PREVNAR, a phone call was received from the subject's mother that he had stopped breathing. She called emergency medical services (EMS) and he was taken to a hospital and he was pronounced dead. The subject died on 7 August 2008, cause of death was death nos. It was unknown whether an autopsy was performed.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Cardiac arrest, Face injury, Head circumference abnormal, Pulmonary oedema
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 324291) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 5-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB and (non-gsk) PREVNAR. The subject was reported to have no medical history/pre-existing conditions. There were no concurrent medications. On 27 August 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR. Three days after vaccination with ACTHIB, PEDIARIX and PREVNAR, the subject experienced death nos. The subject was brought to the emergency department by squad. He was found unresponsive at home with no pulse. He remained in asystole throughout the resuscitation attempt. Post mortem examination pending. Toxicology screen and x-rays were negative. The subject died from death nos on 30 August 2008. An autopsy was performed. 24 October 2008: Autopsy report stated cause of death as undetermined, not consistent with sudden infant death syndrome (SIDS). Manner of death was undetermined. Report also stated pathological diagnoses: pulmonary edema, mild; minor skin injuries to face; small for developmental age by weight and head circumference; and terminal aspiration of gastric contents.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Resuscitation, Skin injury, Sudden death, Toxicologic test normal, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 324291) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 5-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB and (non-gsk) PREVNAR. The subject was reported to have no medical history/pre-existing conditions. There were no concurrent medications. On 27 August 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR. Three days after vaccination with ACTHIB, PEDIARIX and PREVNAR, the subject experienced death nos. The subject was brought to the emergency department by squad. He was found unresponsive at home with no pulse. He remained in asystole throughout the resuscitation attempt. Post mortem examination pending. Toxicology screen and x-rays were negative. The subject died from death nos on 30 August 2008. An autopsy was performed. 24 October 2008: Autopsy report stated cause of death as undetermined, not consistent with sudden infant death syndrome (SIDS). Manner of death was undetermined. Report also stated pathological diagnoses: pulmonary edema, mild; minor skin injuries to face; small for developmental age by weight and head circumference; and terminal aspiration of gastric contents.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Weight abnormal, X-ray normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 324291) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 5-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB and (non-gsk) PREVNAR. The subject was reported to have no medical history/pre-existing conditions. There were no concurrent medications. On 27 August 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR. Three days after vaccination with ACTHIB, PEDIARIX and PREVNAR, the subject experienced death nos. The subject was brought to the emergency department by squad. He was found unresponsive at home with no pulse. He remained in asystole throughout the resuscitation attempt. Post mortem examination pending. Toxicology screen and x-rays were negative. The subject died from death nos on 30 August 2008. An autopsy was performed. 24 October 2008: Autopsy report stated cause of death as undetermined, not consistent with sudden infant death syndrome (SIDS). Manner of death was undetermined. Report also stated pathological diagnoses: pulmonary edema, mild; minor skin injuries to face; small for developmental age by weight and head circumference; and terminal aspiration of gastric contents.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Nasopharyngitis, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 325016) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. The subject had no relevant medical history/pre-existing conditions. There were no concurrent medications. On 4 September 2008 the subject received unspecified dose of PEDIARIX (unknown), 1st dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. The subject's parent reported that the subject experienced cold signs/symptoms since the vaccinations were received on 04 September 2008. On 07 September 2008, three days after vaccination with PEDIARIX, ACTHIB, PREVNAR, and ROTATEQ, the subject passed away. She was diagnosed with sudden infant death syndrome (SIDS) "most likely". No other information was available at that time. The subject died from sudden unexplained death in infancy on 07 September 2008. An autopsy was performed. 12 January 2009: Autopsy report stated cause of death as sudden unexplained death in infancy. Manner of death undetermined. Report also stated that the subject was found unresponsive on her side in crib by parent in the morning. The subject had been fed and placed on side in crib approximately 1.5 hours prior to being found unresponsive.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Asphyxia, Autopsy, Death, Petechiae, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 325385) in response to a Freedom-of-Information request by GSK. Initial information received described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. On 16 July 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB (unknown), 1st dose of PREVNAR (unknown), 1st dose of ROTATEQ (unknown). No adverse events were noted at the time of injection. Thirteen days later, on 29 July 2008, the subject died. An autopsy dated 22 September 2008 stated the cause of death was asphyxia due to overlay due to co-sleeping with older sibling and parents in the same bed. It was reported as sudden infant death syndrome. Petechiae of eyes was also reported.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Adrenal insufficiency, Arterial switch operation, Autopsy, Clavicle fracture, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 325648) via healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of great arteries in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB, PREVNAR and ROTATEQ. The subject's medical history included arterial switch operation. On 5 September 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ. On 8 September 2008, at an unspecified time after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced transposition of great arteries, arterial switch operation (status post), ventricular hypertrophy, pericardial adhesions, foreign body trauma (mineralized foreign body with giant cell reaction), nodule (para aortic), discoloration (trachea and distal mainstream bronchi), exudation (frothy), inflammation, suture insertion (for para aortic nodule), adrenal insufficiency, clavicula-fracture, postoperative delayed primary wound closure and lymphopenia. The subject died from arterial switch operation, discoloration, exudation, foreign body trauma, inflammation, nodule, pericardial adhesions, suture insertion, transposition of great arteries and ventricular hypertrophy. An autopsy was performed. None. Subject scheduled for autopsy. 12 January 2009, autopsy report stated cause of death as: dextro transposition of great arteries, status post arterial switch (08 July 2008), ventricular hypertrophy, extensive pericardial adhesions, mineralized foreign body with giant cell reaction, para aortic nodule with suture, trachea and distal mainstem bronchi discoloration with frothy exudates. Report also stated subject had history of transposition of great vessels complicated by single intramural coronary artery. Autopsy revealed nodule located anterior to ascending aorta and posterior to right pulmonary artery. Histology revealed fragments of mineralized foreign body with marked inflammatory response of corresponding foreign body giant cell reaction of uncertain significance. 23 December 2008, reviewed hospital medical records of 02 to 21 July 2008. Final diagnosis: transposition of great vessels; maternal history of herpes on VALTREX; premature rupture of membranes; arterial switch procedure 08 July 2008; relative adrenal insufficiency resolved; suspected left clavicle fracture; status post delayed sternal closure; relative lymphopenia resolved.