chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Foreign body, Inflammation, Lymphopenia, Nodule, Pericarditis adhesive
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 325648) via healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of great arteries in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB, PREVNAR and ROTATEQ. The subject's medical history included arterial switch operation. On 5 September 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ. On 8 September 2008, at an unspecified time after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced transposition of great arteries, arterial switch operation (status post), ventricular hypertrophy, pericardial adhesions, foreign body trauma (mineralized foreign body with giant cell reaction), nodule (para aortic), discoloration (trachea and distal mainstream bronchi), exudation (frothy), inflammation, suture insertion (for para aortic nodule), adrenal insufficiency, clavicula-fracture, postoperative delayed primary wound closure and lymphopenia. The subject died from arterial switch operation, discoloration, exudation, foreign body trauma, inflammation, nodule, pericardial adhesions, suture insertion, transposition of great arteries and ventricular hypertrophy. An autopsy was performed. None. Subject scheduled for autopsy. 12 January 2009, autopsy report stated cause of death as: dextro transposition of great arteries, status post arterial switch (08 July 2008), ventricular hypertrophy, extensive pericardial adhesions, mineralized foreign body with giant cell reaction, para aortic nodule with suture, trachea and distal mainstem bronchi discoloration with frothy exudates. Report also stated subject had history of transposition of great vessels complicated by single intramural coronary artery. Autopsy revealed nodule located anterior to ascending aorta and posterior to right pulmonary artery. Histology revealed fragments of mineralized foreign body with marked inflammatory response of corresponding foreign body giant cell reaction of uncertain significance. 23 December 2008, reviewed hospital medical records of 02 to 21 July 2008. Final diagnosis: transposition of great vessels; maternal history of herpes on VALTREX; premature rupture of membranes; arterial switch procedure 08 July 2008; relative adrenal insufficiency resolved; suspected left clavicle fracture; status post delayed sternal closure; relative lymphopenia resolved.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Postoperative wound complication, Skin discolouration, Suture insertion, Transposition of the great vessels, Ventricular hypertrophy
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 325648) via healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of great arteries in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB, PREVNAR and ROTATEQ. The subject's medical history included arterial switch operation. On 5 September 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ. On 8 September 2008, at an unspecified time after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced transposition of great arteries, arterial switch operation (status post), ventricular hypertrophy, pericardial adhesions, foreign body trauma (mineralized foreign body with giant cell reaction), nodule (para aortic), discoloration (trachea and distal mainstream bronchi), exudation (frothy), inflammation, suture insertion (for para aortic nodule), adrenal insufficiency, clavicula-fracture, postoperative delayed primary wound closure and lymphopenia. The subject died from arterial switch operation, discoloration, exudation, foreign body trauma, inflammation, nodule, pericardial adhesions, suture insertion, transposition of great arteries and ventricular hypertrophy. An autopsy was performed. None. Subject scheduled for autopsy. 12 January 2009, autopsy report stated cause of death as: dextro transposition of great arteries, status post arterial switch (08 July 2008), ventricular hypertrophy, extensive pericardial adhesions, mineralized foreign body with giant cell reaction, para aortic nodule with suture, trachea and distal mainstem bronchi discoloration with frothy exudates. Report also stated subject had history of transposition of great vessels complicated by single intramural coronary artery. Autopsy revealed nodule located anterior to ascending aorta and posterior to right pulmonary artery. Histology revealed fragments of mineralized foreign body with marked inflammatory response of corresponding foreign body giant cell reaction of uncertain significance. 23 December 2008, reviewed hospital medical records of 02 to 21 July 2008. Final diagnosis: transposition of great vessels; maternal history of herpes on VALTREX; premature rupture of membranes; arterial switch procedure 08 July 2008; relative adrenal insufficiency resolved; suspected left clavicle fracture; status post delayed sternal closure; relative lymphopenia resolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Atrial septal defect, Autopsy, Blood culture negative, Brain malformation, Cardio-respiratory arrest
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 326199) in response to a Freedom-of Information request by GSK and described the occurrence of multiple congenital abnormalities in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, (non-gsk) (ACTHIB), (non-gsk) (PREVENAR) and (non-gsk) (ROTATEQ). Concurrent medical conditions included atrial septal defect, chromosome abnormality, colpocephaly, foramen ovale patent, hydrocephalus and ventricular septal defect. On 19 September 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 19 September 2008, 12 hours after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever. Two days after vaccination with PEDIARIX, the subject experienced cardiac respiratory arrest. At an unknown time after vaccination with PEDIARIX, the subject experienced multiple congenital abnormalities, urinary tract infection, sepsis and lobar pneumonia. The subject was hospitalised. The subject was treated with antibiotics. The subject died from death from natural causes and multiple congenital abnormalities. An autopsy was performed. Infant presented to emergency room with fever approximately 12 hours after vaccinations. Admitted and started on empiric antibiotics. Two days later, lumbar puncture attempted with subsequent cardio-respiratory arrests. 07 April 2009, Autopsy report stated cause of death as complications of multiple congenital abnormalities and manner of death as natural. Report also states multiple congenital abnormalities of: normal pressure hydrocephalus; patent foramen ovale; ventricular septal defect (VSD); mildly atretic right dominant coronary artery system. Also had urinary tract infection with enterococcus faecalis, sepsis and lobar pneumonia. Tox screen negative.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram abnormal, Congenital anomaly, Culture urine negative, Death, Enterococcal infection
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 326199) in response to a Freedom-of Information request by GSK and described the occurrence of multiple congenital abnormalities in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, (non-gsk) (ACTHIB), (non-gsk) (PREVENAR) and (non-gsk) (ROTATEQ). Concurrent medical conditions included atrial septal defect, chromosome abnormality, colpocephaly, foramen ovale patent, hydrocephalus and ventricular septal defect. On 19 September 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 19 September 2008, 12 hours after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever. Two days after vaccination with PEDIARIX, the subject experienced cardiac respiratory arrest. At an unknown time after vaccination with PEDIARIX, the subject experienced multiple congenital abnormalities, urinary tract infection, sepsis and lobar pneumonia. The subject was hospitalised. The subject was treated with antibiotics. The subject died from death from natural causes and multiple congenital abnormalities. An autopsy was performed. Infant presented to emergency room with fever approximately 12 hours after vaccinations. Admitted and started on empiric antibiotics. Two days later, lumbar puncture attempted with subsequent cardio-respiratory arrests. 07 April 2009, Autopsy report stated cause of death as complications of multiple congenital abnormalities and manner of death as natural. Report also states multiple congenital abnormalities of: normal pressure hydrocephalus; patent foramen ovale; ventricular septal defect (VSD); mildly atretic right dominant coronary artery system. Also had urinary tract infection with enterococcus faecalis, sepsis and lobar pneumonia. Tox screen negative.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hydrocephalus, Lobar pneumonia, Lumbar puncture, Multiple congenital abnormalities, Pyrexia
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 326199) in response to a Freedom-of Information request by GSK and described the occurrence of multiple congenital abnormalities in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, (non-gsk) (ACTHIB), (non-gsk) (PREVENAR) and (non-gsk) (ROTATEQ). Concurrent medical conditions included atrial septal defect, chromosome abnormality, colpocephaly, foramen ovale patent, hydrocephalus and ventricular septal defect. On 19 September 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 19 September 2008, 12 hours after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever. Two days after vaccination with PEDIARIX, the subject experienced cardiac respiratory arrest. At an unknown time after vaccination with PEDIARIX, the subject experienced multiple congenital abnormalities, urinary tract infection, sepsis and lobar pneumonia. The subject was hospitalised. The subject was treated with antibiotics. The subject died from death from natural causes and multiple congenital abnormalities. An autopsy was performed. Infant presented to emergency room with fever approximately 12 hours after vaccinations. Admitted and started on empiric antibiotics. Two days later, lumbar puncture attempted with subsequent cardio-respiratory arrests. 07 April 2009, Autopsy report stated cause of death as complications of multiple congenital abnormalities and manner of death as natural. Report also states multiple congenital abnormalities of: normal pressure hydrocephalus; patent foramen ovale; ventricular septal defect (VSD); mildly atretic right dominant coronary artery system. Also had urinary tract infection with enterococcus faecalis, sepsis and lobar pneumonia. Tox screen negative.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sepsis, Toxicologic test normal, Urinary tract infection, Ventricular septal defect
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 326199) in response to a Freedom-of Information request by GSK and described the occurrence of multiple congenital abnormalities in a 2-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, (non-gsk) (ACTHIB), (non-gsk) (PREVENAR) and (non-gsk) (ROTATEQ). Concurrent medical conditions included atrial septal defect, chromosome abnormality, colpocephaly, foramen ovale patent, hydrocephalus and ventricular septal defect. On 19 September 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 19 September 2008, 12 hours after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever. Two days after vaccination with PEDIARIX, the subject experienced cardiac respiratory arrest. At an unknown time after vaccination with PEDIARIX, the subject experienced multiple congenital abnormalities, urinary tract infection, sepsis and lobar pneumonia. The subject was hospitalised. The subject was treated with antibiotics. The subject died from death from natural causes and multiple congenital abnormalities. An autopsy was performed. Infant presented to emergency room with fever approximately 12 hours after vaccinations. Admitted and started on empiric antibiotics. Two days later, lumbar puncture attempted with subsequent cardio-respiratory arrests. 07 April 2009, Autopsy report stated cause of death as complications of multiple congenital abnormalities and manner of death as natural. Report also states multiple congenital abnormalities of: normal pressure hydrocephalus; patent foramen ovale; ventricular septal defect (VSD); mildly atretic right dominant coronary artery system. Also had urinary tract infection with enterococcus faecalis, sepsis and lobar pneumonia. Tox screen negative.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Blood glucose increased, Cardiac arrest, Crying, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 326959) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of asystole in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. There was no previous relevant medical history or pre-existing conditions. There were no concurrent medications. On 3 September 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 6 September 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced crying and pain. At an unspecified time on or after 06 September 2008, the subject experienced asystole, intestinal ischemia, blood glucose increased, increased heart rate, pallor and small intestinal perforation. Test results included hemoglobin of 10.6 and glucose of 320. The subject died from asystole. An autopsy was performed and showed intestinal ischemia and small intestinal perforation. On morning of 6 September 2008, the subject was crying with different cry "painful". On the way to the office, the subject was noted to be pale. In the office, the subject's heart rate of 110, increased to 190 in ten minutes. An ambulance was called. In route to the emergency room, the subject experienced asystole. Code lasted for 30 minutes, but no heart rate. Autopsy showed entire bowel ischemia and true knot in small intestine.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haemoglobin normal, Heart rate increased, Intestinal ischaemia, Pain, Pallor
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 326959) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of asystole in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. There was no previous relevant medical history or pre-existing conditions. There were no concurrent medications. On 3 September 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 6 September 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced crying and pain. At an unspecified time on or after 06 September 2008, the subject experienced asystole, intestinal ischemia, blood glucose increased, increased heart rate, pallor and small intestinal perforation. Test results included hemoglobin of 10.6 and glucose of 320. The subject died from asystole. An autopsy was performed and showed intestinal ischemia and small intestinal perforation. On morning of 6 September 2008, the subject was crying with different cry "painful". On the way to the office, the subject was noted to be pale. In the office, the subject's heart rate of 110, increased to 190 in ten minutes. An ambulance was called. In route to the emergency room, the subject experienced asystole. Code lasted for 30 minutes, but no heart rate. Autopsy showed entire bowel ischemia and true knot in small intestine.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Small intestinal perforation
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 326959) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of asystole in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. There was no previous relevant medical history or pre-existing conditions. There were no concurrent medications. On 3 September 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 6 September 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced crying and pain. At an unspecified time on or after 06 September 2008, the subject experienced asystole, intestinal ischemia, blood glucose increased, increased heart rate, pallor and small intestinal perforation. Test results included hemoglobin of 10.6 and glucose of 320. The subject died from asystole. An autopsy was performed and showed intestinal ischemia and small intestinal perforation. On morning of 6 September 2008, the subject was crying with different cry "painful". On the way to the office, the subject was noted to be pale. In the office, the subject's heart rate of 110, increased to 190 in ten minutes. An ambulance was called. In route to the emergency room, the subject experienced asystole. Code lasted for 30 minutes, but no heart rate. Autopsy showed entire bowel ischemia and true knot in small intestine.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Analgesic drug level increased, Autopsy, Bacterial test negative, Blood creatinine increased, Bronchial disorder
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 329869) via a healthcare provider in response to a Freedom-of Information request by GSK and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-GSK) ACTHIB, (non-GSK) PREVNAR and (non-GSK) ROTATEQ. Previous medical history included an uncomplicated term delivery, 40 weeks gestation, normal growth and no congenital anomalies. On 22 April 2008 the subject unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 22 April 2008, the same day as vaccinations with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever. At an unspecified time on or after 22 April 2008, the subject experienced death nos, acetaminophen high, increased bronchial mucus, blood creatinine increased, chronic cystitis, and unresponsive to stimuli. Test results included negative bacterial and viral cultures, negative metabolic screening, high acetaminophen level, and high vitreous creatinine. The subject was treated with TYLENOL. The subject died from death nos. The autopsy report was performed and stated the cause of death and manner of death as undetermined. Autopsy findings also included viscous bronchial mucus and chronic cystitis. The 2-month-old subject died following routine vaccinations. Medical examiner was a physician. On 28 October 2008, an autopsy report stated cause of death and manner of death as undetermined. The autopsy report also stated that the subject was found lying on his side unresponsive in adult bed two hours status/post laid down for a nap. The subject had fever status/post vaccination and received PARACETAMOL.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cystitis noninfective, Death, Metabolic function test normal, Pyrexia, Unresponsive to stimuli
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 329869) via a healthcare provider in response to a Freedom-of Information request by GSK and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-GSK) ACTHIB, (non-GSK) PREVNAR and (non-GSK) ROTATEQ. Previous medical history included an uncomplicated term delivery, 40 weeks gestation, normal growth and no congenital anomalies. On 22 April 2008 the subject unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 22 April 2008, the same day as vaccinations with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever. At an unspecified time on or after 22 April 2008, the subject experienced death nos, acetaminophen high, increased bronchial mucus, blood creatinine increased, chronic cystitis, and unresponsive to stimuli. Test results included negative bacterial and viral cultures, negative metabolic screening, high acetaminophen level, and high vitreous creatinine. The subject was treated with TYLENOL. The subject died from death nos. The autopsy report was performed and stated the cause of death and manner of death as undetermined. Autopsy findings also included viscous bronchial mucus and chronic cystitis. The 2-month-old subject died following routine vaccinations. Medical examiner was a physician. On 28 October 2008, an autopsy report stated cause of death and manner of death as undetermined. The autopsy report also stated that the subject was found lying on his side unresponsive in adult bed two hours status/post laid down for a nap. The subject had fever status/post vaccination and received PARACETAMOL.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Viral test negative
Clinical narrative: This case was received from the Centers for Disease Control and Prevention (VAERS ID 329869) via a healthcare provider in response to a Freedom-of Information request by GSK and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-GSK) ACTHIB, (non-GSK) PREVNAR and (non-GSK) ROTATEQ. Previous medical history included an uncomplicated term delivery, 40 weeks gestation, normal growth and no congenital anomalies. On 22 April 2008 the subject unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 22 April 2008, the same day as vaccinations with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever. At an unspecified time on or after 22 April 2008, the subject experienced death nos, acetaminophen high, increased bronchial mucus, blood creatinine increased, chronic cystitis, and unresponsive to stimuli. Test results included negative bacterial and viral cultures, negative metabolic screening, high acetaminophen level, and high vitreous creatinine. The subject was treated with TYLENOL. The subject died from death nos. The autopsy report was performed and stated the cause of death and manner of death as undetermined. Autopsy findings also included viscous bronchial mucus and chronic cystitis. The 2-month-old subject died following routine vaccinations. Medical examiner was a physician. On 28 October 2008, an autopsy report stated cause of death and manner of death as undetermined. The autopsy report also stated that the subject was found lying on his side unresponsive in adult bed two hours status/post laid down for a nap. The subject had fever status/post vaccination and received PARACETAMOL.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: This case was received from the Center's for Disease Control and Prevention (VAERS ID 330055) 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), (non-gsk) ACTHIB and (non-gsk) PREVNAR. There was no relevant medical history or pre-existing conditions. The subject started on PROSOBEE at the mother's request. There were no concurrent medications. On 20 October 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of ACTHIB (unknown), 2nd dose of PREVNAR (unknown). On 20 October 2008, less than one day after vaccination with ACTHIB, PEDIARIX and PREVNAR, the subject experienced death nos. The subject died on 20 October 2008 from death nos. It was unknown whether an autopsy was performed. A call was received from the nurse at medical center that the subject had died at the emergency room around 4PM the date of vaccination. The subject appeared well and healthy at the time of vaccination.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Autopsy, Respiratory arrest, Resuscitation, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 333759) in response to the Freedom-of-Information request by GSK. The report described the occurrence of sudden infant death syndrome in a 6-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), FLUZONE (non-gsk), PREVNAR (non-gsk) and ROTATEQ (non-gsk). The subject's medical history included antibiotic therapy for a recent throat problem and prematurity of 4 weeks. Concurrent medical conditions included gastroesophageal reflux disease, sleep apnea since birth and occasional snoring. Concurrent medications included ZANTAC. On 21 November 2008 the subject received 3rd dose of PEDIARIX (unknown), 1st dose of PEDIARIX, 3rd dose of PREVNAR, and 3rd dose of ROTATEQ On 26 November 2008, 5 days after vaccination with FLUZONE, PEDIARIX, PREVNAR and ROTATEQ, the subject was found face down in crib and not breathing. Resuscitation was not successful. There were no other signs of illness. Presumed sudden infant death syndrome versus suffocation. The subject died on 26 November 2008. An autopsy was performed and confirmed cause of death as sudden infant death syndrome.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cerebral ischaemia, Child maltreatment syndrome, Coagulopathy, Death, Hyperaemia
Clinical narrative: This report was received from the Centers of Disease Control and Prevention (VAERS ID 334930) in response to a Freedom-of-Information requested by GSK. The report described the occurrence of hypoxic-ischemic encephalopathy in a 1-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, PREVNAR, and ROTATEQ. The subject's medical history included jaundice. On 14 December 2006 the subject received 1st dose of PEDIARIX (unknown), 2nd dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 15 December 2006, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced eye hyperemia in both eyes. On an unknown date the subject experienced coagulopathy, liver disorder, hypovitaminosis, whiplash injury and child maltreatment syndrome. On 18 December 2006, the subject experienced respiratory arrest, hypoxic encephalopathy and cerebral ischemia. The subject was hospitalised. The subject died on 18 December 2006. The death certificate states cause of death as hypoxic-ischemic encephalopathy due to whiplash shaking injuries of head and spinal cord. It was unknown whether an autopsy was performed.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypovitaminosis, Hypoxic encephalopathy, Liver disorder, Respiratory arrest, Whiplash injury
Clinical narrative: This report was received from the Centers of Disease Control and Prevention (VAERS ID 334930) in response to a Freedom-of-Information requested by GSK. The report described the occurrence of hypoxic-ischemic encephalopathy in a 1-month-old male subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, PREVNAR, and ROTATEQ. The subject's medical history included jaundice. On 14 December 2006 the subject received 1st dose of PEDIARIX (unknown), 2nd dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 15 December 2006, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced eye hyperemia in both eyes. On an unknown date the subject experienced coagulopathy, liver disorder, hypovitaminosis, whiplash injury and child maltreatment syndrome. On 18 December 2006, the subject experienced respiratory arrest, hypoxic encephalopathy and cerebral ischemia. The subject was hospitalised. The subject died on 18 December 2006. The death certificate states cause of death as hypoxic-ischemic encephalopathy due to whiplash shaking injuries of head and spinal cord. It was unknown whether an autopsy was performed.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Pneumonia, Sudden death, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 335418) in response to a Freedom-of-Information request by GSK, and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk), PREVNAR (non-gsk) and ROTATEQ (non-gsk). On 4 December 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 6 December 2008, 2 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death (nos) and unresponsive to stimuli. The subject had been put to bed on her stomach and was found unresponsive two hours later. The subject died on 6 December 2008. Cause of death was not specified. An autopsy was performed and showed sudden unexplained infant death, prone sleeping position and minute foci of pneumonia.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Respiratory arrest, Resuscitation
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 337670) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of death nos in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-GSK) ACTHIB, (non-GSK) PREVNAR and (non-GSK) ROTATEQ. The subject received no concomitant medications. Concurrent medical conditions included heart murmur. On January 2009 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 10 January 2009, 2 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death and respiratory arrest. The subject was found by his father not breathing. Resuscitation at home was attempted by police and Emergency Medical Services. The subject was taken to hospital and resuscitation efforts were continued for approximately one hour with no results. The subject died on 10 January 2009, cause of death was not reported. An autopsy report was pending.
Age: 0.17
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 342046) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PEDVAXHIB (non-gsk), PREVNAR (non-gsk) and ROTATEQ (non-gsk). There were no concomitant medications and no medical history or pre-existing conditions. On 13 March 2009 the subject received 1st dose of PEDIARIX (unknown), 1st dose of PEDVAXHIB, unspecified dose of PREVNAR, 1st dose of ROTATEQ. The PEDIARIX lot number was reported as AX21B143AA. On 17 March 2009, 4 days after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject died. Cause of death was unknown and under investigation at the time of reporting. It was unknown whether an autopsy was performed.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Biopsy, Rash, Skin discolouration
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 26-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccination included HIB (non-gsk) (Merck) given on an unspecified date.  On an unspecified date the subject received 3rd dose of PEDIARIX (unknown route, left thigh).  7 months after vaccination with PEDIARIX, the subject experienced rash and skin discoloration.  The subject saw a dermatologist and a biopsy was performed.  At the time of reporting the rash was improved on an unknown date and the outcome of the skin discoloration was unspecified.  Follow up received from physician on 11 May 2009:  The results of the biopsy were pending.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood alkaline phosphatase increased, Blood calcium normal, Blood chloride normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 344796) in response to a Freedom-of-Information request by GSK, and described the occurrence of complications of prematurity in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR and ROTATEQ. The subject's medical history included premature separation of placenta with delivery by Caesarean section at 24 weeks gestation. On 2 September 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PREVNAR, 1st dose of ROTATEQ. On 2 September 2008, approximately 12 hours after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject developed hypophagia, and became limp and unresponsive. Cardiopulmonary resuscitation was initiated. He did not have any fevers, vomiting or diarrhea. The subject was hospitalised in the Pediatric Intensive Care Unit and placed on nasal continuous positive airways pressure and oxygen. Laboratory tests on 16 September 2008 revealed decreased hemoglobin (9.7, unspecified units). Approximately 2 days prior to death, while on the ventilator, the subject experienced 2-3 episodes of seizure-like activity, but remained stable on the ventilator. On the day of his death (date not specified), the subject experienced a sudden drop in heart rate to 40 and was unresponsive. Cardiopulmonary resuscitation was performed, but a heart rate or rhythm could not be obtained. There were no signs of seizure before this last event. The subject died on an unknown date from complications of prematurity. An autopsy was performed. The autopsy report revealed a final diagnosis of: I. complications of prematurity A. Chronic lung disease B. Gilosis, medullary nuclei. II. History of maternal abruption placenta and delivery by Caesarean section. Cause of death: complications of prematurity. Manner of death: natural.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Blood creatinine decreased, Blood glucose increased, Blood magnesium normal, Blood phosphorus normal, Blood potassium normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 344796) in response to a Freedom-of-Information request by GSK, and described the occurrence of complications of prematurity in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR and ROTATEQ. The subject's medical history included premature separation of placenta with delivery by Caesarean section at 24 weeks gestation. On 2 September 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PREVNAR, 1st dose of ROTATEQ. On 2 September 2008, approximately 12 hours after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject developed hypophagia, and became limp and unresponsive. Cardiopulmonary resuscitation was initiated. He did not have any fevers, vomiting or diarrhea. The subject was hospitalised in the Pediatric Intensive Care Unit and placed on nasal continuous positive airways pressure and oxygen. Laboratory tests on 16 September 2008 revealed decreased hemoglobin (9.7, unspecified units). Approximately 2 days prior to death, while on the ventilator, the subject experienced 2-3 episodes of seizure-like activity, but remained stable on the ventilator. On the day of his death (date not specified), the subject experienced a sudden drop in heart rate to 40 and was unresponsive. Cardiopulmonary resuscitation was performed, but a heart rate or rhythm could not be obtained. There were no signs of seizure before this last event. The subject died on an unknown date from complications of prematurity. An autopsy was performed. The autopsy report revealed a final diagnosis of: I. complications of prematurity A. Chronic lung disease B. Gilosis, medullary nuclei. II. History of maternal abruption placenta and delivery by Caesarean section. Cause of death: complications of prematurity. Manner of death: natural.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Blood sodium normal, Blood urea decreased, Bronchopulmonary dysplasia, Carbon dioxide increased, Condition aggravated
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 344796) in response to a Freedom-of-Information request by GSK, and described the occurrence of complications of prematurity in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR and ROTATEQ. The subject's medical history included premature separation of placenta with delivery by Caesarean section at 24 weeks gestation. On 2 September 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PREVNAR, 1st dose of ROTATEQ. On 2 September 2008, approximately 12 hours after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject developed hypophagia, and became limp and unresponsive. Cardiopulmonary resuscitation was initiated. He did not have any fevers, vomiting or diarrhea. The subject was hospitalised in the Pediatric Intensive Care Unit and placed on nasal continuous positive airways pressure and oxygen. Laboratory tests on 16 September 2008 revealed decreased hemoglobin (9.7, unspecified units). Approximately 2 days prior to death, while on the ventilator, the subject experienced 2-3 episodes of seizure-like activity, but remained stable on the ventilator. On the day of his death (date not specified), the subject experienced a sudden drop in heart rate to 40 and was unresponsive. Cardiopulmonary resuscitation was performed, but a heart rate or rhythm could not be obtained. There were no signs of seizure before this last event. The subject died on an unknown date from complications of prematurity. An autopsy was performed. The autopsy report revealed a final diagnosis of: I. complications of prematurity A. Chronic lung disease B. Gilosis, medullary nuclei. II. History of maternal abruption placenta and delivery by Caesarean section. Cause of death: complications of prematurity. Manner of death: natural.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Convulsion, Death, Dyskinesia, Gliosis, Haematocrit decreased
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 344796) in response to a Freedom-of-Information request by GSK, and described the occurrence of complications of prematurity in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR and ROTATEQ. The subject's medical history included premature separation of placenta with delivery by Caesarean section at 24 weeks gestation. On 2 September 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PREVNAR, 1st dose of ROTATEQ. On 2 September 2008, approximately 12 hours after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject developed hypophagia, and became limp and unresponsive. Cardiopulmonary resuscitation was initiated. He did not have any fevers, vomiting or diarrhea. The subject was hospitalised in the Pediatric Intensive Care Unit and placed on nasal continuous positive airways pressure and oxygen. Laboratory tests on 16 September 2008 revealed decreased hemoglobin (9.7, unspecified units). Approximately 2 days prior to death, while on the ventilator, the subject experienced 2-3 episodes of seizure-like activity, but remained stable on the ventilator. On the day of his death (date not specified), the subject experienced a sudden drop in heart rate to 40 and was unresponsive. Cardiopulmonary resuscitation was performed, but a heart rate or rhythm could not be obtained. There were no signs of seizure before this last event. The subject died on an unknown date from complications of prematurity. An autopsy was performed. The autopsy report revealed a final diagnosis of: I. complications of prematurity A. Chronic lung disease B. Gilosis, medullary nuclei. II. History of maternal abruption placenta and delivery by Caesarean section. Cause of death: complications of prematurity. Manner of death: natural.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Haemoglobin decreased, Heart rate decreased, Hypophagia, Hypotonia, Intensive care
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 344796) in response to a Freedom-of-Information request by GSK, and described the occurrence of complications of prematurity in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR and ROTATEQ. The subject's medical history included premature separation of placenta with delivery by Caesarean section at 24 weeks gestation. On 2 September 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PREVNAR, 1st dose of ROTATEQ. On 2 September 2008, approximately 12 hours after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject developed hypophagia, and became limp and unresponsive. Cardiopulmonary resuscitation was initiated. He did not have any fevers, vomiting or diarrhea. The subject was hospitalised in the Pediatric Intensive Care Unit and placed on nasal continuous positive airways pressure and oxygen. Laboratory tests on 16 September 2008 revealed decreased hemoglobin (9.7, unspecified units). Approximately 2 days prior to death, while on the ventilator, the subject experienced 2-3 episodes of seizure-like activity, but remained stable on the ventilator. On the day of his death (date not specified), the subject experienced a sudden drop in heart rate to 40 and was unresponsive. Cardiopulmonary resuscitation was performed, but a heart rate or rhythm could not be obtained. There were no signs of seizure before this last event. The subject died on an unknown date from complications of prematurity. An autopsy was performed. The autopsy report revealed a final diagnosis of: I. complications of prematurity A. Chronic lung disease B. Gilosis, medullary nuclei. II. History of maternal abruption placenta and delivery by Caesarean section. Cause of death: complications of prematurity. Manner of death: natural.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Platelet count normal, Premature baby, Unresponsive to stimuli, White blood cell count normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 344796) in response to a Freedom-of-Information request by GSK, and described the occurrence of complications of prematurity in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR and ROTATEQ. The subject's medical history included premature separation of placenta with delivery by Caesarean section at 24 weeks gestation. On 2 September 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PREVNAR, 1st dose of ROTATEQ. On 2 September 2008, approximately 12 hours after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject developed hypophagia, and became limp and unresponsive. Cardiopulmonary resuscitation was initiated. He did not have any fevers, vomiting or diarrhea. The subject was hospitalised in the Pediatric Intensive Care Unit and placed on nasal continuous positive airways pressure and oxygen. Laboratory tests on 16 September 2008 revealed decreased hemoglobin (9.7, unspecified units). Approximately 2 days prior to death, while on the ventilator, the subject experienced 2-3 episodes of seizure-like activity, but remained stable on the ventilator. On the day of his death (date not specified), the subject experienced a sudden drop in heart rate to 40 and was unresponsive. Cardiopulmonary resuscitation was performed, but a heart rate or rhythm could not be obtained. There were no signs of seizure before this last event. The subject died on an unknown date from complications of prematurity. An autopsy was performed. The autopsy report revealed a final diagnosis of: I. complications of prematurity A. Chronic lung disease B. Gilosis, medullary nuclei. II. History of maternal abruption placenta and delivery by Caesarean section. Cause of death: complications of prematurity. Manner of death: natural.
Age: 1.26
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Erythema, Rash, Reaction to previous exposure to any vaccine
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 15-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). There were no reported concomitant medications. The subject had experienced rash with previous unspecified vaccinations. Concurrent vaccination included ACTHIB(Sanofi) given on 6 July 2009. On 6 July 2009 at 11:45 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 7 July 2009, 1 day after vaccination with PEDIARIX, the subject experienced rash and erythema. On 8 July 2009, the events were resolved. The physician considered the events were possibly related to vaccination with PEDIARIX. The subject received PEDIARIX and HIB on the same day. Twenty-four hours later, the subject's mother called the office reporting rash and redness on subject's body. The subject was seen in the office. No limitations on play and subject did not appear uncomfortable per the reporter. Hydrocortisone was recommended, but on the next day mother returned, rash and redness had resolved and no cream had to be used. The physician reported the case to VAERS and called the CDC for recommendations on revaccination. CDC provided that if not an anaphylactic reaction and with vaccines rash was possible. Subject was behind in vaccinations per the reporter and PEDIARIX was used as all the components were needed.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Edema, tissue induration, redness, swelling, tenderness, heat, approx 4 inches at vaccine site on right arm.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Edema, tissue induration, redness, swelling, tenderness, heat, approx 4 inches at vaccine site on right arm.