chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP
Symptoms: Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 303166) and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included HAEMOPHILIUS INFLUENZEA TYPE B vaccine; manufacturer unspecified given on 1 December 2007; ROTAVIRUS vaccine; manufacturer unspecified given on 30 November 2007 or 01 December 2007 as data is conflicting in the source document; PNEUMOCOCCAL vaccine, unspecified; Wyeth; unknown given on 1 December 2007.  On 1 December 2007 the subject received unspecified dose of PEDIARIX (unknown).  On 26 December 2007, 25 days after vaccination with PEDIARIX, the subject experienced death nos.  The subject died on 26 December 2007, cause of death was not explained.  Autopsy results were not reported.  Autopsy results not reported.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP
Symptoms: Death
Clinical narrative: This case was reported by a regulatory authority (#57696) and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline) and three unspecified vaccines.  On an unspecified date the subject received unspecified dose of PEDIARIX (unknown) and on the same day, three additional unspecified vaccines.  At an unspecified time after vaccination with PEDIARIX and the other vaccines, the subject died at two months of age.  The regulatory authority reported that the event was life threatening.  Causality could not be provided as there was no definitive causal relationship between death and PEDIARIX.  The subject died, cause of death is not specified.  It was unknown whether an autopsy was performed.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV
Symptoms: Asphyxia, Body temperature increased, Bronchopneumonia, Death, Injury
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID # 303172) via another manufacturer and described the occurrence of death nos in a 4-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent medical conditions included constipation and fever of 103 degrees Fahrenheit in August 2007, throwing up alot since the time she was born and underweight.  Previous and/or concurrent vaccination included PEDVAXHIB; Merck given on 24 October 2007 and 7 December 2007; IPV vaccine; Wyeth given on 7 December 2007.  On 7 December 2007 the subject received 2nd dose of PEDIARIX (unknown).  On 7 December 2007, less than one day after vaccination with PEDIARIX, the subject experienced being "really sick" after vaccinations.  The mother reported that the subject was given alot of other "shots" on the same day.  The subject was being seen by the health department.  Subsequently the subject died on 16 December 2007.  The subject died on 16 December 2007 from death nos.  An autopsy was performed.  The initial report from the medial examiner stated that "there was metabolized in her hair."  On 05 March 2008 the autopsy report stated the cause of death and manner of death as undetermined.  Circumstances suggested smothering and mechanical asphyxia with blunt force injuries and acute bronchopneumonia of the right upper lobe.  The initial report from the medical examiner stated "there was cocaine metabolized in her hair."  05 March 2008 autopsy report states cause of death and manner of death as undetermined.  Circumstances suggested smothering and mechanical asphyxia with blunt force injuries, acute bronchopneumonia right upper lobe.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV
Symptoms: Malaise
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID # 303172) via another manufacturer and described the occurrence of death nos in a 4-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent medical conditions included constipation and fever of 103 degrees Fahrenheit in August 2007, throwing up alot since the time she was born and underweight.  Previous and/or concurrent vaccination included PEDVAXHIB; Merck given on 24 October 2007 and 7 December 2007; IPV vaccine; Wyeth given on 7 December 2007.  On 7 December 2007 the subject received 2nd dose of PEDIARIX (unknown).  On 7 December 2007, less than one day after vaccination with PEDIARIX, the subject experienced being "really sick" after vaccinations.  The mother reported that the subject was given alot of other "shots" on the same day.  The subject was being seen by the health department.  Subsequently the subject died on 16 December 2007.  The subject died on 16 December 2007 from death nos.  An autopsy was performed.  The initial report from the medial examiner stated that "there was metabolized in her hair."  On 05 March 2008 the autopsy report stated the cause of death and manner of death as undetermined.  Circumstances suggested smothering and mechanical asphyxia with blunt force injuries and acute bronchopneumonia of the right upper lobe.  The initial report from the medical examiner stated "there was cocaine metabolized in her hair."  05 March 2008 autopsy report states cause of death and manner of death as undetermined.  Circumstances suggested smothering and mechanical asphyxia with blunt force injuries, acute bronchopneumonia right upper lobe.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abdominal X-ray, Acidosis, Arrhythmia, Blood pH increased, Cardio-respiratory arrest
Clinical narrative: This report was received from a Government Agency (VAERS ID 303292-1) via another manufacturer via a physician in response to a Freedom-of-Information request by GSK and described the occurrence of unknown congestion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ.  Concurrent vaccination included HIB (Merck & CO. INC.), 1st dose of PEDIARIX (GlaxoSmithKline) and PREVNAR (Wyeth Pharmaceuticals, INC.)   All given on unspecified dates.  In October 2007 the subject received 2nd dose of ROTATEQ (oral).  Two weeks post vaccination, on 08 November 2007, the subject was seen in the office at which time the subject was congested and vomiting on and off.  The subject presented with a good bowel movement and was given AMOXICILLIN and sent home.  Approximately 16 hours later, the subject was taken to the emergency room and he passed away due to necrotic bowel on 10 November 2007.  The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening.   It was additionally reported that on 23 October 2007 the subject received 2nd dose of PEDIARIX.  Emergency room medical records of 09 November 2007 revealed that the subject arrived in cardiopulmonary arrest having been brought to the hospital by parent.  The subject had voided and had bloody stools, possibly vomited and had been lethargic prior to coding.  He was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia and with infection.  The subject was resuscitated and transferred to a higher level of emergency room care.  The final emergency room diagnosis was abdominal catastrophe; respiratory/cardiac arrest;  and septic shock.  Hospital medical records reviewed on 01 February 2008 revealed that the subject was transferred from outlying hospital in a critical shock condition.  He was admitted 09 November 2007 to 10 November 2007 to the intensive care unit.  He had a 36 hours history of poor feeding, increased crying and developed bilious emesis and bloody stools.  The subject died on 10 November 2007 from intestinal necrosis.  It was unknown whether an autopsy was performed.  Other terms reported included:  reduced oral intake, cardioversion, disseminated intravascular coagulation, mydriasis, fixed pupils, hypercapnia, hyperaemia, intestinal ischaemia and peripheral ischae.  Labs from the emergency room were unknown.  ABG pH 6.85 (H).  A chest x-ray and abdominal x-ray revealed multiple dilated loops of air filled small bowel and free intraperitoneal air.  At the hospital the subject was intubated and emergent laparotomy and ileocecectomy was performed in the intensive care unit.  Findings at surgery:  IS extending to hepatic flexure with small area of necrosis in cecum and entire small bowel with diffusely involved ischemia thought likely secondary to shock and cardiac arrest.  Bowel remained dusky at end of procedure and the abdomen was left open with bowel wrapped in order to visualize recovery.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cardioversion, Chest X-ray abnormal, Crying, Death, Dehydration
Clinical narrative: This report was received from a Government Agency (VAERS ID 303292-1) via another manufacturer via a physician in response to a Freedom-of-Information request by GSK and described the occurrence of unknown congestion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ.  Concurrent vaccination included HIB (Merck & CO. INC.), 1st dose of PEDIARIX (GlaxoSmithKline) and PREVNAR (Wyeth Pharmaceuticals, INC.)   All given on unspecified dates.  In October 2007 the subject received 2nd dose of ROTATEQ (oral).  Two weeks post vaccination, on 08 November 2007, the subject was seen in the office at which time the subject was congested and vomiting on and off.  The subject presented with a good bowel movement and was given AMOXICILLIN and sent home.  Approximately 16 hours later, the subject was taken to the emergency room and he passed away due to necrotic bowel on 10 November 2007.  The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening.   It was additionally reported that on 23 October 2007 the subject received 2nd dose of PEDIARIX.  Emergency room medical records of 09 November 2007 revealed that the subject arrived in cardiopulmonary arrest having been brought to the hospital by parent.  The subject had voided and had bloody stools, possibly vomited and had been lethargic prior to coding.  He was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia and with infection.  The subject was resuscitated and transferred to a higher level of emergency room care.  The final emergency room diagnosis was abdominal catastrophe; respiratory/cardiac arrest;  and septic shock.  Hospital medical records reviewed on 01 February 2008 revealed that the subject was transferred from outlying hospital in a critical shock condition.  He was admitted 09 November 2007 to 10 November 2007 to the intensive care unit.  He had a 36 hours history of poor feeding, increased crying and developed bilious emesis and bloody stools.  The subject died on 10 November 2007 from intestinal necrosis.  It was unknown whether an autopsy was performed.  Other terms reported included:  reduced oral intake, cardioversion, disseminated intravascular coagulation, mydriasis, fixed pupils, hypercapnia, hyperaemia, intestinal ischaemia and peripheral ischae.  Labs from the emergency room were unknown.  ABG pH 6.85 (H).  A chest x-ray and abdominal x-ray revealed multiple dilated loops of air filled small bowel and free intraperitoneal air.  At the hospital the subject was intubated and emergent laparotomy and ileocecectomy was performed in the intensive care unit.  Findings at surgery:  IS extending to hepatic flexure with small area of necrosis in cecum and entire small bowel with diffusely involved ischemia thought likely secondary to shock and cardiac arrest.  Bowel remained dusky at end of procedure and the abdomen was left open with bowel wrapped in order to visualize recovery.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Disseminated intravascular coagulation, Feeding disorder, Gastrointestinal necrosis, Haematochezia, Hyperaemia
Clinical narrative: This report was received from a Government Agency (VAERS ID 303292-1) via another manufacturer via a physician in response to a Freedom-of-Information request by GSK and described the occurrence of unknown congestion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ.  Concurrent vaccination included HIB (Merck & CO. INC.), 1st dose of PEDIARIX (GlaxoSmithKline) and PREVNAR (Wyeth Pharmaceuticals, INC.)   All given on unspecified dates.  In October 2007 the subject received 2nd dose of ROTATEQ (oral).  Two weeks post vaccination, on 08 November 2007, the subject was seen in the office at which time the subject was congested and vomiting on and off.  The subject presented with a good bowel movement and was given AMOXICILLIN and sent home.  Approximately 16 hours later, the subject was taken to the emergency room and he passed away due to necrotic bowel on 10 November 2007.  The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening.   It was additionally reported that on 23 October 2007 the subject received 2nd dose of PEDIARIX.  Emergency room medical records of 09 November 2007 revealed that the subject arrived in cardiopulmonary arrest having been brought to the hospital by parent.  The subject had voided and had bloody stools, possibly vomited and had been lethargic prior to coding.  He was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia and with infection.  The subject was resuscitated and transferred to a higher level of emergency room care.  The final emergency room diagnosis was abdominal catastrophe; respiratory/cardiac arrest;  and septic shock.  Hospital medical records reviewed on 01 February 2008 revealed that the subject was transferred from outlying hospital in a critical shock condition.  He was admitted 09 November 2007 to 10 November 2007 to the intensive care unit.  He had a 36 hours history of poor feeding, increased crying and developed bilious emesis and bloody stools.  The subject died on 10 November 2007 from intestinal necrosis.  It was unknown whether an autopsy was performed.  Other terms reported included:  reduced oral intake, cardioversion, disseminated intravascular coagulation, mydriasis, fixed pupils, hypercapnia, hyperaemia, intestinal ischaemia and peripheral ischae.  Labs from the emergency room were unknown.  ABG pH 6.85 (H).  A chest x-ray and abdominal x-ray revealed multiple dilated loops of air filled small bowel and free intraperitoneal air.  At the hospital the subject was intubated and emergent laparotomy and ileocecectomy was performed in the intensive care unit.  Findings at surgery:  IS extending to hepatic flexure with small area of necrosis in cecum and entire small bowel with diffusely involved ischemia thought likely secondary to shock and cardiac arrest.  Bowel remained dusky at end of procedure and the abdomen was left open with bowel wrapped in order to visualize recovery.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Hypercapnia, Hypophagia, Infection, Intensive care, Intestinal ischaemia
Clinical narrative: This report was received from a Government Agency (VAERS ID 303292-1) via another manufacturer via a physician in response to a Freedom-of-Information request by GSK and described the occurrence of unknown congestion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ.  Concurrent vaccination included HIB (Merck & CO. INC.), 1st dose of PEDIARIX (GlaxoSmithKline) and PREVNAR (Wyeth Pharmaceuticals, INC.)   All given on unspecified dates.  In October 2007 the subject received 2nd dose of ROTATEQ (oral).  Two weeks post vaccination, on 08 November 2007, the subject was seen in the office at which time the subject was congested and vomiting on and off.  The subject presented with a good bowel movement and was given AMOXICILLIN and sent home.  Approximately 16 hours later, the subject was taken to the emergency room and he passed away due to necrotic bowel on 10 November 2007.  The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening.   It was additionally reported that on 23 October 2007 the subject received 2nd dose of PEDIARIX.  Emergency room medical records of 09 November 2007 revealed that the subject arrived in cardiopulmonary arrest having been brought to the hospital by parent.  The subject had voided and had bloody stools, possibly vomited and had been lethargic prior to coding.  He was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia and with infection.  The subject was resuscitated and transferred to a higher level of emergency room care.  The final emergency room diagnosis was abdominal catastrophe; respiratory/cardiac arrest;  and septic shock.  Hospital medical records reviewed on 01 February 2008 revealed that the subject was transferred from outlying hospital in a critical shock condition.  He was admitted 09 November 2007 to 10 November 2007 to the intensive care unit.  He had a 36 hours history of poor feeding, increased crying and developed bilious emesis and bloody stools.  The subject died on 10 November 2007 from intestinal necrosis.  It was unknown whether an autopsy was performed.  Other terms reported included:  reduced oral intake, cardioversion, disseminated intravascular coagulation, mydriasis, fixed pupils, hypercapnia, hyperaemia, intestinal ischaemia and peripheral ischae.  Labs from the emergency room were unknown.  ABG pH 6.85 (H).  A chest x-ray and abdominal x-ray revealed multiple dilated loops of air filled small bowel and free intraperitoneal air.  At the hospital the subject was intubated and emergent laparotomy and ileocecectomy was performed in the intensive care unit.  Findings at surgery:  IS extending to hepatic flexure with small area of necrosis in cecum and entire small bowel with diffusely involved ischemia thought likely secondary to shock and cardiac arrest.  Bowel remained dusky at end of procedure and the abdomen was left open with bowel wrapped in order to visualize recovery.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Laparotomy, Lethargy, Mydriasis, Peripheral ischaemia, Pupil fixed
Clinical narrative: This report was received from a Government Agency (VAERS ID 303292-1) via another manufacturer via a physician in response to a Freedom-of-Information request by GSK and described the occurrence of unknown congestion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ.  Concurrent vaccination included HIB (Merck & CO. INC.), 1st dose of PEDIARIX (GlaxoSmithKline) and PREVNAR (Wyeth Pharmaceuticals, INC.)   All given on unspecified dates.  In October 2007 the subject received 2nd dose of ROTATEQ (oral).  Two weeks post vaccination, on 08 November 2007, the subject was seen in the office at which time the subject was congested and vomiting on and off.  The subject presented with a good bowel movement and was given AMOXICILLIN and sent home.  Approximately 16 hours later, the subject was taken to the emergency room and he passed away due to necrotic bowel on 10 November 2007.  The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening.   It was additionally reported that on 23 October 2007 the subject received 2nd dose of PEDIARIX.  Emergency room medical records of 09 November 2007 revealed that the subject arrived in cardiopulmonary arrest having been brought to the hospital by parent.  The subject had voided and had bloody stools, possibly vomited and had been lethargic prior to coding.  He was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia and with infection.  The subject was resuscitated and transferred to a higher level of emergency room care.  The final emergency room diagnosis was abdominal catastrophe; respiratory/cardiac arrest;  and septic shock.  Hospital medical records reviewed on 01 February 2008 revealed that the subject was transferred from outlying hospital in a critical shock condition.  He was admitted 09 November 2007 to 10 November 2007 to the intensive care unit.  He had a 36 hours history of poor feeding, increased crying and developed bilious emesis and bloody stools.  The subject died on 10 November 2007 from intestinal necrosis.  It was unknown whether an autopsy was performed.  Other terms reported included:  reduced oral intake, cardioversion, disseminated intravascular coagulation, mydriasis, fixed pupils, hypercapnia, hyperaemia, intestinal ischaemia and peripheral ischae.  Labs from the emergency room were unknown.  ABG pH 6.85 (H).  A chest x-ray and abdominal x-ray revealed multiple dilated loops of air filled small bowel and free intraperitoneal air.  At the hospital the subject was intubated and emergent laparotomy and ileocecectomy was performed in the intensive care unit.  Findings at surgery:  IS extending to hepatic flexure with small area of necrosis in cecum and entire small bowel with diffusely involved ischemia thought likely secondary to shock and cardiac arrest.  Bowel remained dusky at end of procedure and the abdomen was left open with bowel wrapped in order to visualize recovery.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Respiratory tract congestion, Resuscitation, Septic shock, Shock, Vomiting
Clinical narrative: This report was received from a Government Agency (VAERS ID 303292-1) via another manufacturer via a physician in response to a Freedom-of-Information request by GSK and described the occurrence of unknown congestion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ.  Concurrent vaccination included HIB (Merck & CO. INC.), 1st dose of PEDIARIX (GlaxoSmithKline) and PREVNAR (Wyeth Pharmaceuticals, INC.)   All given on unspecified dates.  In October 2007 the subject received 2nd dose of ROTATEQ (oral).  Two weeks post vaccination, on 08 November 2007, the subject was seen in the office at which time the subject was congested and vomiting on and off.  The subject presented with a good bowel movement and was given AMOXICILLIN and sent home.  Approximately 16 hours later, the subject was taken to the emergency room and he passed away due to necrotic bowel on 10 November 2007.  The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening.   It was additionally reported that on 23 October 2007 the subject received 2nd dose of PEDIARIX.  Emergency room medical records of 09 November 2007 revealed that the subject arrived in cardiopulmonary arrest having been brought to the hospital by parent.  The subject had voided and had bloody stools, possibly vomited and had been lethargic prior to coding.  He was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia and with infection.  The subject was resuscitated and transferred to a higher level of emergency room care.  The final emergency room diagnosis was abdominal catastrophe; respiratory/cardiac arrest;  and septic shock.  Hospital medical records reviewed on 01 February 2008 revealed that the subject was transferred from outlying hospital in a critical shock condition.  He was admitted 09 November 2007 to 10 November 2007 to the intensive care unit.  He had a 36 hours history of poor feeding, increased crying and developed bilious emesis and bloody stools.  The subject died on 10 November 2007 from intestinal necrosis.  It was unknown whether an autopsy was performed.  Other terms reported included:  reduced oral intake, cardioversion, disseminated intravascular coagulation, mydriasis, fixed pupils, hypercapnia, hyperaemia, intestinal ischaemia and peripheral ischae.  Labs from the emergency room were unknown.  ABG pH 6.85 (H).  A chest x-ray and abdominal x-ray revealed multiple dilated loops of air filled small bowel and free intraperitoneal air.  At the hospital the subject was intubated and emergent laparotomy and ileocecectomy was performed in the intensive care unit.  Findings at surgery:  IS extending to hepatic flexure with small area of necrosis in cecum and entire small bowel with diffusely involved ischemia thought likely secondary to shock and cardiac arrest.  Bowel remained dusky at end of procedure and the abdomen was left open with bowel wrapped in order to visualize recovery.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: X-ray abnormal
Clinical narrative: This report was received from a Government Agency (VAERS ID 303292-1) via another manufacturer via a physician in response to a Freedom-of-Information request by GSK and described the occurrence of unknown congestion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ.  Concurrent vaccination included HIB (Merck & CO. INC.), 1st dose of PEDIARIX (GlaxoSmithKline) and PREVNAR (Wyeth Pharmaceuticals, INC.)   All given on unspecified dates.  In October 2007 the subject received 2nd dose of ROTATEQ (oral).  Two weeks post vaccination, on 08 November 2007, the subject was seen in the office at which time the subject was congested and vomiting on and off.  The subject presented with a good bowel movement and was given AMOXICILLIN and sent home.  Approximately 16 hours later, the subject was taken to the emergency room and he passed away due to necrotic bowel on 10 November 2007.  The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening.   It was additionally reported that on 23 October 2007 the subject received 2nd dose of PEDIARIX.  Emergency room medical records of 09 November 2007 revealed that the subject arrived in cardiopulmonary arrest having been brought to the hospital by parent.  The subject had voided and had bloody stools, possibly vomited and had been lethargic prior to coding.  He was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia and with infection.  The subject was resuscitated and transferred to a higher level of emergency room care.  The final emergency room diagnosis was abdominal catastrophe; respiratory/cardiac arrest;  and septic shock.  Hospital medical records reviewed on 01 February 2008 revealed that the subject was transferred from outlying hospital in a critical shock condition.  He was admitted 09 November 2007 to 10 November 2007 to the intensive care unit.  He had a 36 hours history of poor feeding, increased crying and developed bilious emesis and bloody stools.  The subject died on 10 November 2007 from intestinal necrosis.  It was unknown whether an autopsy was performed.  Other terms reported included:  reduced oral intake, cardioversion, disseminated intravascular coagulation, mydriasis, fixed pupils, hypercapnia, hyperaemia, intestinal ischaemia and peripheral ischae.  Labs from the emergency room were unknown.  ABG pH 6.85 (H).  A chest x-ray and abdominal x-ray revealed multiple dilated loops of air filled small bowel and free intraperitoneal air.  At the hospital the subject was intubated and emergent laparotomy and ileocecectomy was performed in the intensive care unit.  Findings at surgery:  IS extending to hepatic flexure with small area of necrosis in cecum and entire small bowel with diffusely involved ischemia thought likely secondary to shock and cardiac arrest.  Bowel remained dusky at end of procedure and the abdomen was left open with bowel wrapped in order to visualize recovery.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Pyrexia
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERs ID 304505) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 6-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent medical conditions included benign neoplasm, hypospadias and strawberry hemangioma.  Concurrent vaccinations received on the same day as PEDIARIX included PEDVAXHIB; Merck given on an unspecified date; PREVNAR; unspecified; Wyeth Labs given on an unspecified date.  There were no concurrent medication.  On an unspecified date the subject received 1st dose of PEDIARIX (unknown).  At an unspecified time after vaccination with PEDIARIX, the subject experienced fever and death nos.  There was no laboratory data.  The subject died, cause of death is not specified.  It was unknown whether an autopsy was performed.  There was no laboratory data.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 304745) via a healthcare professional 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).  Previous and/or concurrent vaccination included ACTHIB; Sanofi Pasteur MSD given on 25 January 2008; ROTATEQ; Merck given on 25 January 2008; PREVNAR; Wyeth Labs given on 25 January 2008.  On 25 January 2008 the subject received 1st dose of PEDIARIX (unknown).  On 28 January 2008, 3 days after vaccination with PEDIARIX, the subject experienced unexplained death which was under investigation.  The subject died on 28 January 2008, cause of death was not reported.  It was unknown whether an autopsy was performed.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 305082) 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).  Concurrent medical conditions included heart murmur heard on an unspecified date in November 2007.  Previous and/or concurrent vaccination included PEDVAXHIB; Merck given on 14 February 2008; PREVNAR; Wyeth Labs given on 14 February 2008.  On 14 February 2008 the subject received 1st dose of PEDIARIX (unknown).  On 18 February 2008, 4 days after vaccination with PEDIARIX, the subject's mother reported that the subject had died.  She stated the death occurred around 4:00am.  The subject died on 18 February 2008, cause of death was not reported.  It was unknown whether an autopsy was performed.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Death
Clinical narrative: This report was received from the Center for Disease Control and Prevention (VAERS ID 305832) in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in an approximately 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  The subject's medical history included premature baby at 32 weeks and a history of apnea.  Previous and/or concurrent vaccination included ROTATEQ; (Merck) given on 17 January 2008; pneumococcal vaccine, unspecified PREVNAR; Wyeth Labs given on 17 January 2008.  Concurrent medications included SYNAGIS and Caffeine.  On 17 January 2008 the subject received 2nd dose of PEDIARIX (unknown).  In January 2008, within 24 hours after vaccination with PEDIARIX, the subject experienced death nos.  The subject died in January 2008, cause of death was not reported.  It was unknown whether an autopsy was performed.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 306062) via a healthcare professional in response to a Freedom-of Information request by GSK and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included PEDVAXHIB; Merck given on 30 January 2008; ROTATEQ; Merck given on an unspecified date; PREVNAR; Wyeth Labs given on 30 January 2008.  On 30 January 2008 the subject received 2nd dose of PEDIARIX (unknown).  On 6 February 2008, 7 days after vaccination with PEDIARIX, the subject experienced death nos.  The subject died on 6 February 2008, cause of death was not reported.  It was unknown whether an autopsy was performed.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Constipation, Crying, Death, Diarrhoea, Hyperhidrosis
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 306386) and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included PEDVAXHIB; Merck given on 22 February 2008; ROTATEQ; Merck given on 22 February 2008; PREVNAR; Wyeth given on 22 February 2008.  Acetaminophen was given at an unknown time.  No relevant medical history or pre-existing conditions.  On 22 February 2008 the subject received 2nd dose of PEDIARIX (unknown).  On 1 March 2008, 8 days after vaccination with PEDIARIX, the subject experienced shrill screaming, arched back, fever, excessive sleeping, rigid, cried when touched; red where shots were administered, sweating, constipation, diarrhea resulting in bowel area bleeding all resulting in death nos.  Swollen and red thymus was also noted.  Laboratory results pending.  The subject died on 1 March 2008, cause of death was not reported.  It was unknown whether an autopsy was performed.  Swollen and red thymus noted.  Other laboratory results pending.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypersomnia, Injection site erythema, Muscle rigidity, Opisthotonus, Pyrexia
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 306386) and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included PEDVAXHIB; Merck given on 22 February 2008; ROTATEQ; Merck given on 22 February 2008; PREVNAR; Wyeth given on 22 February 2008.  Acetaminophen was given at an unknown time.  No relevant medical history or pre-existing conditions.  On 22 February 2008 the subject received 2nd dose of PEDIARIX (unknown).  On 1 March 2008, 8 days after vaccination with PEDIARIX, the subject experienced shrill screaming, arched back, fever, excessive sleeping, rigid, cried when touched; red where shots were administered, sweating, constipation, diarrhea resulting in bowel area bleeding all resulting in death nos.  Swollen and red thymus was also noted.  Laboratory results pending.  The subject died on 1 March 2008, cause of death was not reported.  It was unknown whether an autopsy was performed.  Swollen and red thymus noted.  Other laboratory results pending.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rectal haemorrhage, Screaming, Thymus disorder, Thymus enlargement
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 306386) and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included PEDVAXHIB; Merck given on 22 February 2008; ROTATEQ; Merck given on 22 February 2008; PREVNAR; Wyeth given on 22 February 2008.  Acetaminophen was given at an unknown time.  No relevant medical history or pre-existing conditions.  On 22 February 2008 the subject received 2nd dose of PEDIARIX (unknown).  On 1 March 2008, 8 days after vaccination with PEDIARIX, the subject experienced shrill screaming, arched back, fever, excessive sleeping, rigid, cried when touched; red where shots were administered, sweating, constipation, diarrhea resulting in bowel area bleeding all resulting in death nos.  Swollen and red thymus was also noted.  Laboratory results pending.  The subject died on 1 March 2008, cause of death was not reported.  It was unknown whether an autopsy was performed.  Swollen and red thymus noted.  Other laboratory results pending.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 306548) via a manufacturer in response to a Freedom-of-Information request by GSK and described the occurrence of sudden infant death syndrome in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), ROTATEQ and HIB vaccine, OMPC, (manufacturer unknown).  Concurrent vaccinations given on the same day as PEDIARIX, ROTATEQ, and HIB vaccine included PEDVAXHIB, (Merck) given on an unspecified date; PREVNAR; (Wyeth Labs) given on an unspecified date.  The subject had no drug allergies.  Medical history was reported as unknown.  On an unspecified date the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ROTATEQ (2 ml, oral), and unspecified dose of HIB vaccine.  This was the subject's first 2.0 ml dose of ROTATEQ.  Three days after vaccination with PEDIARIX and ROTATEQ, and HIB conjugate vaccine (OMPC), the subject experienced sudden infant death syndrome referred to as "sudden death syndrome".  Specific date of death was unknown.  The subject died from sudden death syndrome.  It was unknown whether an autopsy was performed.  This information was initially reported by a physician.  There was no product quality complaint.  It was reported that additional information had been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of excessive screaming in a 2-month-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and (PEDIARIX, GlaxoSmithKline) for prophylaxis. In March 2008, the subject received the 1st dose of PEDIARIX (.5 ml, unknown). Within one hour after vaccination with PEDIARIX, the subject experienced a screaming reaction, described as "unconsolable non-stop screaming", which lasted for a period of several hours. At the time of reporting the event was resolved. The reporting physician considered the event was probably related to vaccination with PEDIARIX. Follow-up information was received on 23 May 2008 via a registered nurse, who indicated that this case was reported to a Regulatory Agency (VAERS ID #308874). The nurse reported that the subject was a 2-month-old male who was vaccinated with PEDIARIX on 14 March 2008. Concurrent medical conditions included nasal congestion. Concurrent vaccinations given on 14 March 2008 included (ACTHIB,manufacturer); unspecified; unknown; right thigh given; (ROTATEQ, manufacturer unspecified); oral; and (PREVNAR, manufacturer unspecified); unknown; right thigh. The excessive screaming was reported to have lasted for a period of 4 to 6 hours on 14 March 2008 before improving, then resolving. The immunization series with PEDIARIX was discontinued. The reporting nurse considered the event to be related to vaccination with PEDIARIX.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP
Symptoms: Cardiac monitoring normal, Chest X-ray normal, Developmental delay, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: My daughter became pale + limp approximately 5 mins. after DTaP vaccination. She was breathing shallow & sweaty. She was transported to hospital by ambulance where she remained but has developmental delay.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP
Symptoms: Hyperhidrosis, Hypotonia, Hypoventilation, Nuclear magnetic resonance imaging brain normal, Oesophagram
Clinical narrative: My daughter became pale + limp approximately 5 mins. after DTaP vaccination. She was breathing shallow & sweaty. She was transported to hospital by ambulance where she remained but has developmental delay.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP
Symptoms: Pallor
Clinical narrative: My daughter became pale + limp approximately 5 mins. after DTaP vaccination. She was breathing shallow & sweaty. She was transported to hospital by ambulance where she remained but has developmental delay.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Joint swelling, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of knees in a 26-year-old male subject who was vaccinated with ENGERIX B. On 25 June 2008, the subject received 1st dose of ENGERIX B at 20 mcg intramuscularly in the left arm. Within 24 hours of vaccination with ENGERIX B, the subject experienced swelling and tenderness of the right arm knee to the point that he could not walk on it. A systemic reaction. The events lasted for about two days with resolution of swelling and tenderness on 27 June 2008. Follow-up information was received on 19 August 2008 via a registered nurse who reported that the subject reported the symptoms to the health department one month after the occurrence of the events. The nurse reported that the vaccination subject stated that the onset of the earliest onset of the signs and symptoms occurred on 25 June 2008. The nurse reported that the events were not serious, and were resolved as an unspecified date. In addition, the nurse indicated that he ENGERIX B immunization series was delayed pending the provider's ok to continue.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray normal, Crying, Diet refusal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: This case was reported by a physician and described the occurrence of hypotonia in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), and PREVNAR.  Concurrent vaccination included HIB vaccine given on 21 July 2008.  There were no concurrent medications.  On 21 July 2008 the subject received 1st dose of PEDIARIX at 0.5 ml in the left thigh and 1st dose of PREVNAR (unknown).  Three to four hours after vaccination with PEDIARIX, at an unspecified time after vaccination with PREVNAR, the subject experienced hypotonia, inconsolable crying, pallor and refusal to eat.  This was considered to be a systemic reaction.  Hours later the issues resolved, but the subject was taken to the local emergency room and evaluated with EEG, EKG and x-ray, all of which the physician reported were normal.  The physician questioned the lot of PEDIARIX given since she had another 2 month old with adverse events also.  This was considered to be a product complaint.  In the physician's opinion, the event of hypotonia was possibly related to treatment with PEDIARIX.  This case is linked to case A0739970A. The second case involving a 2 month old that experienced adverse events following administration of the same lot of PEDIARIX.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonia, Pallor
Clinical narrative: This case was reported by a physician and described the occurrence of hypotonia in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), and PREVNAR.  Concurrent vaccination included HIB vaccine given on 21 July 2008.  There were no concurrent medications.  On 21 July 2008 the subject received 1st dose of PEDIARIX at 0.5 ml in the left thigh and 1st dose of PREVNAR (unknown).  Three to four hours after vaccination with PEDIARIX, at an unspecified time after vaccination with PREVNAR, the subject experienced hypotonia, inconsolable crying, pallor and refusal to eat.  This was considered to be a systemic reaction.  Hours later the issues resolved, but the subject was taken to the local emergency room and evaluated with EEG, EKG and x-ray, all of which the physician reported were normal.  The physician questioned the lot of PEDIARIX given since she had another 2 month old with adverse events also.  This was considered to be a product complaint.  In the physician's opinion, the event of hypotonia was possibly related to treatment with PEDIARIX.  This case is linked to case A0739970A. The second case involving a 2 month old that experienced adverse events following administration of the same lot of PEDIARIX.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Hepatic enzyme increased, Liver function test normal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of elevated liver enzymes in a 48-year-old male subject who was vaccinated with ENGERIX B, GlaxoSmithKline.  The subject's medical history included substance abuse.  Concurrent medical conditions included viral hepatitis C.  Concurrent medications included Multivitamin and IBUPROFEN.  A pharmacist reported that the subject had hepatitis C and had a liver panel taken on 04 August 2008, ten days prior to vaccination with ENGERIX B.  The results of the liver function tests were reported to be normal at the time.  On 14 August 2008 at 15:00, the subject received the 1st dose of ENGERIX B (1 ml, unknown, right arm).  On 26 August 2008, 12 days after vaccination with ENGERIX B, the subject experienced elevated alanine aminotransferase (ALT) and elevated aspartate aminotransferase levels (AST).  A pharmacist reported that liver function tests taken on 26 August 2008 showed an ALT level of 390 (units unspecified) and an AST level of 1516 (units unspecified).  The pharmacist stated that the subject's liver enzymes remained high through a second liver panel taken on 28 August 2008, which showed an ALT level of 462 (units unspecified) and an AST level of 1400 (units unspecified).  No other symptoms were reported.  The pharmacist stated that a hepatitis panel was ordered, but results were not available at the time of this report.  This case was assessed as medically serious by GSK.  At the time of reporting the events were unresolved.  The reporting pharmacist considered the events were possibly related to vaccination with ENGERIX B.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Crying, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional, via a GSK sales representative, that described the occurrence of inconsolable crying in a 2-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and (PEDIARIX, GlaxoSmithKline) for prophylaxis. Concurrent vaccinations given on 16 June 2008 included the 1st dose of (PREVNAR, WYETH), unknown; and the 1st dose of (ROTATEQ, MERCK), unknown. On 16 June 2008, the subject received the 1st dose of PEDIARIX (.5 ml, unknown, right upper thigh). On 16 June 2008, immediately after vaccination with PEDIARIX, the subject experienced inconsolable crying. The subject was taken to the emergency room by his mother, but was not admitted to the hospital. The inconsolable crying lasted until 22:00 on the same day that the PEDIARIX vaccine was administered. The reporting healthcare professional considered the event to be disabling and clinically significant (or requiring intervention). At the time of reporting the event was resolved. The healthcare professional considered the event to be probably related to vaccination with PEDIARIX. Follow-up information was received on 03 September 2008 via a nurse, who was indicated that the previously reported concomitant vaccines PREVNAR and ROTATEQ were co-suspect for the inconsolable crying. The nurse provided the vaccination date of 16 July 2008, which conflicts with the previously reported date of 16 June 2008. In addition, the nurse indicated that the event was not disabling as was previously reported. The PEDIARIX vaccination series was neither discontinued nor delayed. The reporting nurse considered the event to be possibly related to vaccination with PEDIARIX, but also stated that the child's parent may have been overly concerned. The event was reported to be resolved as of 16 July 2008.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Axillary pain, Chest pain, Erythema, Neck pain, Oral pain
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient who on 22-DEC-2008 was vaccinated with the second dose of GARDASIL.  On 31-DEC-2008 the patient experienced red hives on inner thigh and feet.  On 02-JAN-2009 the patient also experienced severe pain in her armpits that moved to the neck and jaw.  Pain intensified in her neck, jaw and lips and moved to the back.  The physician mentioned that the symptoms resembled Kawasaki disease on a lower scale.  At the time of this report, the adverse events persisted.  The patient sought unspecified medical attention.  Upon internal review, Kawasaki disease was determined to be an other important medical event.  Additional information has been requested.