chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Hyperglycaemia, Hyperhidrosis, Irritability, Metabolic function test normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 310715) via a healthcare provider 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), ACTHIB (Sanofi Pasteur), PREVNAR (Wyeth labs) and ROTATEQ (Merck). Medical history/pre-exisiting conditions included: 36 weeks by c-section; jaundice with phototherapy (16); slow initial weight gain. Past medical history: birth weight of 6.2 pounds and had slow weight gain. 50 percent for height and weight at four months. Sibling with holoprosencephaly with optic nerve dysplasia. On 17 April 2008 the subject received unspecified dose of PEDIARIX, (unknown), unspecified dose of ACTHIB, unspecified dose of PREVNAR, unspecified dose of ROTATEQ. On 17 April 2008, the subject experienced irritability and teething. On 20 April 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death nos. Bacterial and virus culture sensitivity (c/s) were negative. Metabolic screening was within normal limits. Toxicology was negative. Vitreous glucose was 138.8 (H). The subject died from death nos. An autopsy was performed. 07 October 2008: Autopsy stated cause of death as undetermined. Pathological diagnosis: hyperglycemia, likely related to physiological stress. 07 October 2008 autopsy report stated that the subject experienced irritability with teething at time of vaccination. Infant sleeping in car seat with cluttered closet with door partially closed and baby monitor in closet. Parents bedroom (with monitor found turned off) on another floor in house. Infant was put to sleep approximately midnight, but not checked or attempted to be fed until approximately 2pm when parent entered closet for clothing. Subject was found unresponsive, damp with sweat, with blanket partially over face. The subject was dead on arrival (DOA) in emergency room with core temperature of 85. Autopsy found no traumatic injury.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Stress, Teething, Toxicologic test normal, Unresponsive to stimuli, Viral test negative
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 310715) via a healthcare provider 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), ACTHIB (Sanofi Pasteur), PREVNAR (Wyeth labs) and ROTATEQ (Merck). Medical history/pre-exisiting conditions included: 36 weeks by c-section; jaundice with phototherapy (16); slow initial weight gain. Past medical history: birth weight of 6.2 pounds and had slow weight gain. 50 percent for height and weight at four months. Sibling with holoprosencephaly with optic nerve dysplasia. On 17 April 2008 the subject received unspecified dose of PEDIARIX, (unknown), unspecified dose of ACTHIB, unspecified dose of PREVNAR, unspecified dose of ROTATEQ. On 17 April 2008, the subject experienced irritability and teething. On 20 April 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death nos. Bacterial and virus culture sensitivity (c/s) were negative. Metabolic screening was within normal limits. Toxicology was negative. Vitreous glucose was 138.8 (H). The subject died from death nos. An autopsy was performed. 07 October 2008: Autopsy stated cause of death as undetermined. Pathological diagnosis: hyperglycemia, likely related to physiological stress. 07 October 2008 autopsy report stated that the subject experienced irritability with teething at time of vaccination. Infant sleeping in car seat with cluttered closet with door partially closed and baby monitor in closet. Parents bedroom (with monitor found turned off) on another floor in house. Infant was put to sleep approximately midnight, but not checked or attempted to be fed until approximately 2pm when parent entered closet for clothing. Subject was found unresponsive, damp with sweat, with blanket partially over face. The subject was dead on arrival (DOA) in emergency room with core temperature of 85. Autopsy found no traumatic injury.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Pyrexia, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 310806) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of sudden infant death syndrome (SIDS) in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PEDVAXHIB (Merck) and (non-gsk) PREVNAR (Wyeth Labs). On 13 August 2007 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PEDVAXHIB, 2nd dose of PREVNAR. At an unspecified time on or after 18 August 2007, 5 days after vaccination with PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced fever and SIDS. The subject experienced "at bit of a fever after vaccines" 13 August 2007 "but cleared up". The subject felt fine and ate well the day before he died. Laboratory tests may have been performed at the emergency room, but it was unknown. The subject died from SIDS. An autopsy was performed. 10 December 2008: Death certificate states cause of death as SIDS.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 310807) in response to a Freedom-of-Information request by GSK and described the occurrence of sudden infant death syndrome (SIDS) in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (Sanofi Pasteur), PREVNAR (Wyeth Labs) and ROTATEQ (Merck). Medical history/pre-existing conditions included diagnosis of thrush at one-month check-up. The subject also had "spitting up" at one-month check-up. Concurrent medications included TYLENOL. On 13 August 2007 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 18 August 2007, 5 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced possible SIDS. 25 April 2008: Cause of death: SIDS. The subject died from SIDS. Autopsy was pending.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Death, Resuscitation, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 310808) in response to a Freedom-of-Information request by GSK and described the occurrence of sids in a 3-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 36 weeks premature. Concurrent medical conditions included reflux unspecified. The subject failed a car seat test three times (lot 9 days of life). Oxygen "De sats" when sitting up. Concurrent medications included TYLENOL. On 10 August 2007 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB, unspecified dose of PREVNAR. On 12 August 2007, 2 days after vaccination with ACTHIB, PEDIARIX and PREVNAR, the subject experienced sudden infant death syndrome (SIDS). Parents found the subject blue, face down in the crib around 11:45 on 12 August 2007. Per coroner: Possibly SIDS. Cardiopulmonary resuscitation (CPR) was attempted. Infant pronounced dead at 1:30 on 12 August 2007. 27 May 2008: Records received: Cause of death: SIDS. Manner of death: natural. The subject died from SIDS. It was unknown whether an autopsy was performed.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Autopsy, Metabolic function test normal, Petechiae, Sudden death, Sudden infant death syndrome
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 311463) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of sudden unexplained death in infancy in a 7-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). There was no relevant medical history or pre-existing conditions. There were no concurrent medications. On 31 March 2008 the subject received 2nd dose of PEDIARIX (unknown), 3rd dose of PRENVAR (unknown), 3rd dose of ROTATEQ (unknown). On 24 April 2008, 24 days after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject experienced sudden unexplained death in infancy and unresponsive to stimuli. On an unspecified date after vaccination with PEDIARIX, PREVNAR, and ROTATEQ, the subject had petechiae of thymus and visceral surfaces of lungs. The subject died on 24 April 2008 from sudden unexplained death in infancy. An autopsy was performed and showed petechiae of thymus and visceral surfaces of lungs. This subject had his last set of immunizations on 31 March 2008. He did not have any reactions. He died of sudden infant death syndrome (SIDS) on 24 April 2008. On 13 June 2008, the autopsy report stated cause of death as sudden unexplained death in infancy. There was no evidence of injury; normal growth parameters; negative metabolic screen; no evidence of aspiration. The subject had been placed in crib on back with propped bottle. Found unresponsive.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 311463) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of sudden unexplained death in infancy in a 7-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). There was no relevant medical history or pre-existing conditions. There were no concurrent medications. On 31 March 2008 the subject received 2nd dose of PEDIARIX (unknown), 3rd dose of PRENVAR (unknown), 3rd dose of ROTATEQ (unknown). On 24 April 2008, 24 days after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject experienced sudden unexplained death in infancy and unresponsive to stimuli. On an unspecified date after vaccination with PEDIARIX, PREVNAR, and ROTATEQ, the subject had petechiae of thymus and visceral surfaces of lungs. The subject died on 24 April 2008 from sudden unexplained death in infancy. An autopsy was performed and showed petechiae of thymus and visceral surfaces of lungs. This subject had his last set of immunizations on 31 March 2008. He did not have any reactions. He died of sudden infant death syndrome (SIDS) on 24 April 2008. On 13 June 2008, the autopsy report stated cause of death as sudden unexplained death in infancy. There was no evidence of injury; normal growth parameters; negative metabolic screen; no evidence of aspiration. The subject had been placed in crib on back with propped bottle. Found unresponsive.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Respiratory arrest, Sudden death, Upper respiratory tract congestion
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 314113) in response to a Freedom-of-Information request by GSK and described the occurrence of sudden unexplained infant death in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (Sanofi Pasteur), PREVNAR (Wyeth labs) and ROTATEQ (Merck). There was no relevant past medical history or pre-existing conditions. Concurrent medications included clotrimazole 1% cream. On 19 May 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of ACTBIB (unknown) , 2nd dose of PREVNAR (unknown), 2nd dose of ROTATEQ (unknown). On 29 may 2008, 10 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced sudden unexplained infant death. On an unspecified date, the subject experienced chest congestion. The subject died on 29 may 2008 from sudden unexplained infant death. An autopsy was performed. The subject had immunizations on 19 May 2008 and was found dead in bed on back on 29 May 2008. On 18 July 2008, an autopsy report was received with cause of death: sudden unexplained infant death. The report stated that the subject had some chest congestion for two days for which no medication was used for treatment. The subject had been acting normally with no other recent complaints. The subject had fed at 1AM and 4AM. Parent noted the subject was not breathing.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Atelectasis, Autopsy, Bronchopneumonia, Cardiac arrest, Cell death
Clinical narrative: This report was received from the Center for Disease Control and Prevention (VAERS ID 316231) via an unspecified source in response to a Freedom-of-Information request by GSK, and described the occurrence of bronchopneumonia in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, Sanofi Pasteur, PREVNAR, Wyeth Labs and ROTATEQ, Merck. The subject's medical history included apnea, bilateral inguinal hernia, hyperbilirubinemia, murmur unspecified, neonatal respiratory distress syndrome, prematurity and rule out sepsis. Concurrent medical conditions include anemia, cholestatic jaundice, retinopathy of prematurity and scrotal hydrocele. Previous vaccination included hepatitis b vaccine (non-gsk) (Merck). On 5 June 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, unspecified dose of ROTATEQ. In June 2008, 3 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ, the subject experienced an unspecified event. On an unknown date the subject experienced bronchopneumonia. On 9 June 2008 the subject experienced cough and congestion; records indicated an upper respiratory tract infection. Later that evening the subject experienced cardiac arrest and died. Emergency Room records reported that the subject was last seen alive at 18:00 hours. Emergency Medical Services were on the scene at 22:35 hours. The subject was found cold, stiff and purple in color. Cardiopulmonary resuscitation was attempted but unsuccessful. The subject was in rigor upon arrival in the Emergency Department and was pronounced dead. The subject died on 10 June 2008 from bronchopneumonia. An autopsy was performed and reported probable cause of death acute bronchopneumonia. Per Medical Examiner's report: Diagnosis: acute bronchopneumonia, moderate. Cholestasis. Microscopic examination of the lungs reveals moderate acute bronchopneumonia present within the major and minor bronchi and alveolar spaces. Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present. Slight chronic inflammation. Severe autolysis.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cholestasis, Cough, Death, Feeling cold, Haematocrit decreased
Clinical narrative: This report was received from the Center for Disease Control and Prevention (VAERS ID 316231) via an unspecified source in response to a Freedom-of-Information request by GSK, and described the occurrence of bronchopneumonia in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, Sanofi Pasteur, PREVNAR, Wyeth Labs and ROTATEQ, Merck. The subject's medical history included apnea, bilateral inguinal hernia, hyperbilirubinemia, murmur unspecified, neonatal respiratory distress syndrome, prematurity and rule out sepsis. Concurrent medical conditions include anemia, cholestatic jaundice, retinopathy of prematurity and scrotal hydrocele. Previous vaccination included hepatitis b vaccine (non-gsk) (Merck). On 5 June 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, unspecified dose of ROTATEQ. In June 2008, 3 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ, the subject experienced an unspecified event. On an unknown date the subject experienced bronchopneumonia. On 9 June 2008 the subject experienced cough and congestion; records indicated an upper respiratory tract infection. Later that evening the subject experienced cardiac arrest and died. Emergency Room records reported that the subject was last seen alive at 18:00 hours. Emergency Medical Services were on the scene at 22:35 hours. The subject was found cold, stiff and purple in color. Cardiopulmonary resuscitation was attempted but unsuccessful. The subject was in rigor upon arrival in the Emergency Department and was pronounced dead. The subject died on 10 June 2008 from bronchopneumonia. An autopsy was performed and reported probable cause of death acute bronchopneumonia. Per Medical Examiner's report: Diagnosis: acute bronchopneumonia, moderate. Cholestasis. Microscopic examination of the lungs reveals moderate acute bronchopneumonia present within the major and minor bronchi and alveolar spaces. Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present. Slight chronic inflammation. Severe autolysis.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haemoglobin decreased, Inflammation, Lymphocyte percentage increased, Musculoskeletal stiffness, Resuscitation
Clinical narrative: This report was received from the Center for Disease Control and Prevention (VAERS ID 316231) via an unspecified source in response to a Freedom-of-Information request by GSK, and described the occurrence of bronchopneumonia in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, Sanofi Pasteur, PREVNAR, Wyeth Labs and ROTATEQ, Merck. The subject's medical history included apnea, bilateral inguinal hernia, hyperbilirubinemia, murmur unspecified, neonatal respiratory distress syndrome, prematurity and rule out sepsis. Concurrent medical conditions include anemia, cholestatic jaundice, retinopathy of prematurity and scrotal hydrocele. Previous vaccination included hepatitis b vaccine (non-gsk) (Merck). On 5 June 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, unspecified dose of ROTATEQ. In June 2008, 3 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ, the subject experienced an unspecified event. On an unknown date the subject experienced bronchopneumonia. On 9 June 2008 the subject experienced cough and congestion; records indicated an upper respiratory tract infection. Later that evening the subject experienced cardiac arrest and died. Emergency Room records reported that the subject was last seen alive at 18:00 hours. Emergency Medical Services were on the scene at 22:35 hours. The subject was found cold, stiff and purple in color. Cardiopulmonary resuscitation was attempted but unsuccessful. The subject was in rigor upon arrival in the Emergency Department and was pronounced dead. The subject died on 10 June 2008 from bronchopneumonia. An autopsy was performed and reported probable cause of death acute bronchopneumonia. Per Medical Examiner's report: Diagnosis: acute bronchopneumonia, moderate. Cholestasis. Microscopic examination of the lungs reveals moderate acute bronchopneumonia present within the major and minor bronchi and alveolar spaces. Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present. Slight chronic inflammation. Severe autolysis.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Skin discolouration, Upper respiratory tract congestion, Upper respiratory tract infection, White blood cell count decreased
Clinical narrative: This report was received from the Center for Disease Control and Prevention (VAERS ID 316231) via an unspecified source in response to a Freedom-of-Information request by GSK, and described the occurrence of bronchopneumonia in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, Sanofi Pasteur, PREVNAR, Wyeth Labs and ROTATEQ, Merck. The subject's medical history included apnea, bilateral inguinal hernia, hyperbilirubinemia, murmur unspecified, neonatal respiratory distress syndrome, prematurity and rule out sepsis. Concurrent medical conditions include anemia, cholestatic jaundice, retinopathy of prematurity and scrotal hydrocele. Previous vaccination included hepatitis b vaccine (non-gsk) (Merck). On 5 June 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, unspecified dose of ROTATEQ. In June 2008, 3 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ, the subject experienced an unspecified event. On an unknown date the subject experienced bronchopneumonia. On 9 June 2008 the subject experienced cough and congestion; records indicated an upper respiratory tract infection. Later that evening the subject experienced cardiac arrest and died. Emergency Room records reported that the subject was last seen alive at 18:00 hours. Emergency Medical Services were on the scene at 22:35 hours. The subject was found cold, stiff and purple in color. Cardiopulmonary resuscitation was attempted but unsuccessful. The subject was in rigor upon arrival in the Emergency Department and was pronounced dead. The subject died on 10 June 2008 from bronchopneumonia. An autopsy was performed and reported probable cause of death acute bronchopneumonia. Per Medical Examiner's report: Diagnosis: acute bronchopneumonia, moderate. Cholestasis. Microscopic examination of the lungs reveals moderate acute bronchopneumonia present within the major and minor bronchi and alveolar spaces. Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present. Slight chronic inflammation. Severe autolysis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Cardiac arrest, Cyanosis, Death, Muscle tightness
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 316534) via an unspecified source in response to 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), PEDVAXHIB (Merck) and PREVNAR (Wyeth Labs). The subject's mother was pre-eclampsic and a C-section had been performed due to non-reassuring fetal heart rate. The subject's mother had a positive drug screen for marijuana. There was a family history of asthma, diabetes mellitus, heart disease, cervical cancer and HIV. Concurrent medical conditions included atrial septal defect, 2/6 cardiac systolic murmur, cough, foramen ovale patent, poor weight gain, thrush, umbilical hernia and upper respiratory tract congestion. Echocardiogram performed one month prior to death had revealed atrial septal defect and patent foramen ovale, reported as probably not relevant to death. Cardiac consult had been done for atrial septal defect which was reported to be unlikely to cause signs or symptoms. The subject had taken no medications prior to the vaccinations. The subject was reported to be in usual state of health on day of vaccination. Concurrent medications included Tylenol. On 6 July 2006 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of PEDVAXHIB, 1st dose of PREVNAR. On 7 July 2006, 1 day after vaccination with PEDIARIX, PEDVAXHIB and PREVNAR, the subject experienced death (nos), apnea, unresponsive to stimuli, cyanosis, asystole and clenched jaw. On the morning of 7 July 2006, the subject was found in the bed (with parents) not breathing. He was brought to the Emergency Room via ambulance and pronounced dead. Hospital medical records revealed the subject had been fed approximately 4 hours prior to being found unresponsive, cyanotic, asystole, with jaw clenched. Emergency Medical Services unable to obtain intravenous access or intubate. Emergency Room unable to resuscitate. The subject died on 7 July 2006 from undetermined causes. An autopsy was performed and reported cause of death as undetermined and manner of death as undetermined. The report also stated that the subject was co-sleeping with parents in adult bed. Although, it was reported that it could not be determined from records if subject was in crib or bed with parents, reported in varying ways in records.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Respiratory arrest, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 316534) via an unspecified source in response to 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), PEDVAXHIB (Merck) and PREVNAR (Wyeth Labs). The subject's mother was pre-eclampsic and a C-section had been performed due to non-reassuring fetal heart rate. The subject's mother had a positive drug screen for marijuana. There was a family history of asthma, diabetes mellitus, heart disease, cervical cancer and HIV. Concurrent medical conditions included atrial septal defect, 2/6 cardiac systolic murmur, cough, foramen ovale patent, poor weight gain, thrush, umbilical hernia and upper respiratory tract congestion. Echocardiogram performed one month prior to death had revealed atrial septal defect and patent foramen ovale, reported as probably not relevant to death. Cardiac consult had been done for atrial septal defect which was reported to be unlikely to cause signs or symptoms. The subject had taken no medications prior to the vaccinations. The subject was reported to be in usual state of health on day of vaccination. Concurrent medications included Tylenol. On 6 July 2006 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of PEDVAXHIB, 1st dose of PREVNAR. On 7 July 2006, 1 day after vaccination with PEDIARIX, PEDVAXHIB and PREVNAR, the subject experienced death (nos), apnea, unresponsive to stimuli, cyanosis, asystole and clenched jaw. On the morning of 7 July 2006, the subject was found in the bed (with parents) not breathing. He was brought to the Emergency Room via ambulance and pronounced dead. Hospital medical records revealed the subject had been fed approximately 4 hours prior to being found unresponsive, cyanotic, asystole, with jaw clenched. Emergency Medical Services unable to obtain intravenous access or intubate. Emergency Room unable to resuscitate. The subject died on 7 July 2006 from undetermined causes. An autopsy was performed and reported cause of death as undetermined and manner of death as undetermined. The report also stated that the subject was co-sleeping with parents in adult bed. Although, it was reported that it could not be determined from records if subject was in crib or bed with parents, reported in varying ways in records.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 316952) in response to a Freedom-of-Information request by GSK and described the occurrence of sudden infant death syndrome 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. Concurrent medications included azithromycin. On 1 May 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 an unspecified date on or after 01 May 2008, at an unspecified time after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ, the subject experienced sudden infant death syndrome. The subject died from sudden infant death syndrome. An autopsy was performed. The subject was in bed with parents at the time of death. On 30 June 2008, an autopsy report stated the cause of death as sudden infant death syndrome. The subject was found unresponsive in bed with parents.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Blood creatine phosphokinase increased, Blood lactic acid normal, Blood pH normal, Blood potassium normal
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: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood pressure abnormal, Blood urea increased, Brain oedema, Carbon dioxide decreased, Cardiac failure congestive
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: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Death, Dehydration, Diarrhoea, Diet refusal
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: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyspnoea, Effusion, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Endotracheal intubation
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: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Feeling cold, Grunting, Hepatic congestion, Hepatic necrosis, Hepatomegaly
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: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonia, Hypoxic encephalopathy, Interstitial lung disease, Mechanical ventilation, Metabolic acidosis
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: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: PCO2 normal, Pallor, Peripheral coldness, Pulmonary oedema, Respiratory distress
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: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Resuscitation, Screaming, Skin discolouration, Tachycardia, Tachypnoea
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.