chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.8
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Hepatitis A given to 9 month old child.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability
Clinical narrative: persistent severe irritability, 4-6 hrs immunization  for several days
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper leg Swelling, warmth redness
Age: 46.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: 12/20 1 1/2 area of redness with elevated temp and soreness at injection site. 12/25 redness and elevated temp resolved, quarter" sized knot at site 1/7 soreness right elbow, lump "nickel sized" elevated d pain- saw MD- nodule aspirated- clear serousang. Fluid. Prophylactic antibiotic Bactrim DS 1/1 bid po #14 prescribed 1/8 lump "dime sized" decreased d pain. See attached progress note from doctor.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Left upper arm - redness and swelling, mild rash redness used Benadryl 2t sp Q60 until redness gone.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea, Vision blurred, Vital capacity normal
Clinical narrative: C/O light headedness and inability to focus visually 5 minutes after 3rd rabies Vac. administered . Vital sighs remained stable. Some nausea. All Sx subsided in 1 1/2 hr. Then O/C to home.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Client given Tdap - recommended for ages 11-64 only. ADACEL- lot # C3027AA in right deltoid.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Grip strength decreased, Injection site pain, Pain in extremity
Clinical narrative: Complained of pain radiating from injection site in left deltoid down to her hand diminished grip strength, normal sensation.  No s/s inflammation.  Ibuprofen 400 mg of 8 hrs next 24 hrs.  Follow up sooner if worsening pain or increasing weakness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Five inch red circle around administration site that was hard to touch, 0 itching. Area was tender to touch. Began 2 days after administration and lasted approx 1 week. No treatment required.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis, Erythema multiforme, Rash generalised
Clinical narrative: SM changed bandage over SPV site and approx.  3-4 days later develop a localized rash that became generalized over several days.  SM received primary SPV on 09/30/07.  Symptom:  Dermatitis, diffuse, generalized Start: 10/16/2007; 11/01/07: erythema multiforme
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Rash erythematous
Clinical narrative: 1/12/09- Area swelled red raised.  Very sore.  Mom gave BENADRY & ice to area - still present 1/15/09-
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site induration, Rash, Rash macular
Clinical narrative: Child came to appointment for 4 mo WCC on Amoxil started on 1-6-09.  Appoint date 1-12-09.  Had dry rash primarily on Abd. & torso.  Dr. instructed mom to use hydrocortisone cream up to bid for few days.  Today 1-14-09 appears with bright red blotchy rash to cheeks with widely scattered dotted rash to Abd / legs / arms / head etc.  Local site to RT where PCV given "hardened lump.  Dr. unsure of rash cause by PCV or Amoxil.  Thinking ? Amoxil? or the Pentacil?
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site swelling
Clinical narrative: Abnormal sounding cry, crying consistently, not consolable, after receiving immunization  0n 1/8/09. Had swelling at injection site of DTAP for 1-2 days. Cried for 31/2 hours. Seen in ER, given TYLENOL, observed and sent home.
Age: 0.9
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Bacteria urine, Blood creatinine increased, Blood creatinine normal, Chest X-ray normal, Convulsion
Clinical narrative: On 1-14-09 per mother at 10:30 pm she felt infant & he was hot.  She gave Tylenol and child had seizure.  Child taken to ER by ambulance with temp of 102.3 F, pulse 157, R 28, 99% O2 RA.  Tylenol given in ER.  Seizure lasted approximately 3 minutes.  Child delivered to home at 01:39 AM.  Temp 99.9 F.  Mom called me on 1-15-09.  This sibling's fraternal twin was vaccinated at same time with same vaccines and had no difficulties.  Mom said no redness at sites and no other s/s.
Age: 0.9
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Feeling hot, Haematocrit normal, Haemoglobin normal, Pyrexia, Red blood cell count normal
Clinical narrative: On 1-14-09 per mother at 10:30 pm she felt infant & he was hot.  She gave Tylenol and child had seizure.  Child taken to ER by ambulance with temp of 102.3 F, pulse 157, R 28, 99% O2 RA.  Tylenol given in ER.  Seizure lasted approximately 3 minutes.  Child delivered to home at 01:39 AM.  Temp 99.9 F.  Mom called me on 1-15-09.  This sibling's fraternal twin was vaccinated at same time with same vaccines and had no difficulties.  Mom said no redness at sites and no other s/s.
Age: 0.9
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Urine analysis abnormal, White blood cell count normal
Clinical narrative: On 1-14-09 per mother at 10:30 pm she felt infant & he was hot.  She gave Tylenol and child had seizure.  Child taken to ER by ambulance with temp of 102.3 F, pulse 157, R 28, 99% O2 RA.  Tylenol given in ER.  Seizure lasted approximately 3 minutes.  Child delivered to home at 01:39 AM.  Temp 99.9 F.  Mom called me on 1-15-09.  This sibling's fraternal twin was vaccinated at same time with same vaccines and had no difficulties.  Mom said no redness at sites and no other s/s.
Sex: U
Vaccine: RAB
Symptoms: No adverse event
Clinical narrative: None stated
Age: 35.0
Sex: F
Vaccine: FLU3, JEV, TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Within 2 hours of vaccination Pt experienced generalized ache ness that lasted 3 days. Itching was significant enough to require antihistamines. No respiratory involvement, angioedema or other S/ Sx. Pt also reported area of redness, swelling and warmth at site of yellow fever injection, lasting 3 days
Age: 29.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 11-14-09 back of neck began to itch in the PM.  Then when woke up 11-15-09 legs and arms were itching resemoline hives, welts/redness on bilateral legs & arms.  On CTD use BENADREL to control itching & to call physician if become worse or no improvement
Age: 58.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Chills, Fatigue, Myalgia, Tremor
Clinical narrative: Severe Shaking Chills myalgias for several hours. Resolved spontaneously. Fatigued the next day.
Age: 1.5
Sex: F
Vaccine: MMR, PNC
Symptoms: Abnormal faeces, Decreased appetite, Diarrhoea, Hyperaesthesia, Irritability
Clinical narrative: Here with both parents for rash, Friday had a few spots on chest, has spread entire body and Saturday had fever to 102.  Received MMR 12/18/08, also was started on Amoxicillin for sinus symptoms.  Skin seems sore, does not want to be touched.  Fussy, irritable, decreased appetite and foul smelling diarrhea.  No further fever.  Rash is continuing to worsen.  Luride 0.5 mg/ml.  No allergies.  Denies symptoms other than stated above.  Denies eye symptoms.  Reports clear discharge from the nostrils.  Denies cough, dyspnea and wheezing.  Reports diarrhea, but denies vomiting.
Age: 1.5
Sex: F
Vaccine: MMR, PNC
Symptoms: Pain, Pyrexia, Rash, Rash generalised
Clinical narrative: Here with both parents for rash, Friday had a few spots on chest, has spread entire body and Saturday had fever to 102.  Received MMR 12/18/08, also was started on Amoxicillin for sinus symptoms.  Skin seems sore, does not want to be touched.  Fussy, irritable, decreased appetite and foul smelling diarrhea.  No further fever.  Rash is continuing to worsen.  Luride 0.5 mg/ml.  No allergies.  Denies symptoms other than stated above.  Denies eye symptoms.  Reports clear discharge from the nostrils.  Denies cough, dyspnea and wheezing.  Reports diarrhea, but denies vomiting.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Apnoea, Cyanosis, Death, Endotracheal intubation, Hypothermia
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 290655-1) via another manufacturer via an investigator in charge of a PREVNAR clinical trial in response to a Freedom-of-Information request by GSK.  The report described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), and unspecified PREVNAR.  Concurrent vaccination included ACTHIB, (Sanofi Pasteur) given on an unspecified date.  On 30 August 2007 the subject (a participant in a PREVNAR clinical trial study) received 1st dose of PEDIARIX (unknown) and 1st dose of PREVNAR (unknown).  On 11 September 2007, 12 days after vaccination with PEDIARIX and PREVNAR, the subject was found in his crib at day care, on his back, unresponsive, blue and not breathing.  Day care workers initiated cardiopulmonary resuscitation and contacted 911 emergency response.  Upon emergency medical response arrival, the child was noted to be apneic and pulseless.  The subject was intubated without difficulty and cardiopulmonary resuscitation was continued.  An intraosseous line was placed in the left lower extremity that was infusing well.  A total of 4 doses of epinephrine were given without any response.  The child remained apneic and pulseless.  Upon arrival to the emergency room the child had blood pooling on the posterior back and neck area.  On physical examination, the pupils were fixed at approximately 2-3 mm bilaterally and no pulse was noted.  The physician also noted hypothermia and stiffness.  The subject was pronounced dead at 12:42 in the afternoon at the hospital.  The cause of death was reported as unknown.  The parent reported that the child had been healthy up to that point.  The investigator considered the death possibly related to PREVNAR.  No relationship to PEDIARIX was mentioned.  The subject died on 11 September 2007, cause of death was not reported.  It was unknown whether an autopsy was performed.  Other terms included: decreased body temperature; unresponsive to stimuli and cyanosis.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Musculoskeletal stiffness, Pulse absent, Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 290655-1) via another manufacturer via an investigator in charge of a PREVNAR clinical trial in response to a Freedom-of-Information request by GSK.  The report described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), and unspecified PREVNAR.  Concurrent vaccination included ACTHIB, (Sanofi Pasteur) given on an unspecified date.  On 30 August 2007 the subject (a participant in a PREVNAR clinical trial study) received 1st dose of PEDIARIX (unknown) and 1st dose of PREVNAR (unknown).  On 11 September 2007, 12 days after vaccination with PEDIARIX and PREVNAR, the subject was found in his crib at day care, on his back, unresponsive, blue and not breathing.  Day care workers initiated cardiopulmonary resuscitation and contacted 911 emergency response.  Upon emergency medical response arrival, the child was noted to be apneic and pulseless.  The subject was intubated without difficulty and cardiopulmonary resuscitation was continued.  An intraosseous line was placed in the left lower extremity that was infusing well.  A total of 4 doses of epinephrine were given without any response.  The child remained apneic and pulseless.  Upon arrival to the emergency room the child had blood pooling on the posterior back and neck area.  On physical examination, the pupils were fixed at approximately 2-3 mm bilaterally and no pulse was noted.  The physician also noted hypothermia and stiffness.  The subject was pronounced dead at 12:42 in the afternoon at the hospital.  The cause of death was reported as unknown.  The parent reported that the child had been healthy up to that point.  The investigator considered the death possibly related to PREVNAR.  No relationship to PEDIARIX was mentioned.  The subject died on 11 September 2007, cause of death was not reported.  It was unknown whether an autopsy was performed.  Other terms included: decreased body temperature; unresponsive to stimuli and cyanosis.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Bronchopneumonia, Capillary disorder, Choking, Cough
Clinical narrative: This report was received form a Government Agency (VAERS ID 290672) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of acute bronchopneumonia in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  The subject's medical history inlcluded  respiratory syncytial virus bronchiolitis and respiratory syncytial virus pneumonia, which required hospitalization for five or six days from approximately 15 March 2007 to 19 March 2007.  According to the subject's mother, she had been hospitalized from 15 March 2007 to 19 March 2007 with a diagnosis of viral pneumonia.  Previous and /or concurrent vaccination included ACTHIB; Sanofi Pateur MSD; unknown given on 22 March 2007; PREVNAR Wyeth Labs; unknown given on 22 March 2007.  On 22 March 2007 the subject received unspecified dose of PEDIARIX (unknown).  According to the medical records reviewed on 25 September 2007, the subject was in good health on the day of vaccination.  On 22 March 2007, the same day as vaccination with PEDIARIX, the subject experienced acute bronchopneumonia due to viral respiratory infection which led to respiratory arrest.  The subject's mother reported she "gave breathing medicine to my baby at 5PM Friday and baby began to choke and cough.  Took baby to the emergency room with difficulty breathing and vomiting.  Treatment included nebulization treatment and supplemental oxygen with initial improvement, but then her condition worsened again.  Examination included mottle cool skin with sluggish capillary refill, tachycardic, prolonged expiratory phase respiration, trahcheal tugging, intercostal and subcostal retractions, and fever of 105 degrees.  Multiple attempts to establish intravenous access and to obtain arterial blood gases were unsuccessful.  She was intubated emergently.  Chest compressions secondary to electromechanical dissociation had to be started.  EPINEPHRINE was administered via interosseous access, as well as, endotracheal without initiation of perfusing rhythm or spontaneous breathing.  The reporter notes indicated the subject expired with diagnosis of respiratory infection.  The manner of death was natural.  Findings at autopsy included:  chronic inflammation of upper and lower airways, acute and chronic otitis media, and acute bronchopneumonia.  Autopsy report received on 12 April 2007 stated cause of death as acute bronchopneumonia due to viral respiratory infection.  Manner of death:  natural.  Findings at autopsy included chronic inflammation, upper and lower airways; acute and chronic otitis media; and acute bronchopneumonia.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Dyspnoea, Endotracheal intubation, Inflammation, Intercostal retraction
Clinical narrative: This report was received form a Government Agency (VAERS ID 290672) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of acute bronchopneumonia in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  The subject's medical history inlcluded  respiratory syncytial virus bronchiolitis and respiratory syncytial virus pneumonia, which required hospitalization for five or six days from approximately 15 March 2007 to 19 March 2007.  According to the subject's mother, she had been hospitalized from 15 March 2007 to 19 March 2007 with a diagnosis of viral pneumonia.  Previous and /or concurrent vaccination included ACTHIB; Sanofi Pateur MSD; unknown given on 22 March 2007; PREVNAR Wyeth Labs; unknown given on 22 March 2007.  On 22 March 2007 the subject received unspecified dose of PEDIARIX (unknown).  According to the medical records reviewed on 25 September 2007, the subject was in good health on the day of vaccination.  On 22 March 2007, the same day as vaccination with PEDIARIX, the subject experienced acute bronchopneumonia due to viral respiratory infection which led to respiratory arrest.  The subject's mother reported she "gave breathing medicine to my baby at 5PM Friday and baby began to choke and cough.  Took baby to the emergency room with difficulty breathing and vomiting.  Treatment included nebulization treatment and supplemental oxygen with initial improvement, but then her condition worsened again.  Examination included mottle cool skin with sluggish capillary refill, tachycardic, prolonged expiratory phase respiration, trahcheal tugging, intercostal and subcostal retractions, and fever of 105 degrees.  Multiple attempts to establish intravenous access and to obtain arterial blood gases were unsuccessful.  She was intubated emergently.  Chest compressions secondary to electromechanical dissociation had to be started.  EPINEPHRINE was administered via interosseous access, as well as, endotracheal without initiation of perfusing rhythm or spontaneous breathing.  The reporter notes indicated the subject expired with diagnosis of respiratory infection.  The manner of death was natural.  Findings at autopsy included:  chronic inflammation of upper and lower airways, acute and chronic otitis media, and acute bronchopneumonia.  Autopsy report received on 12 April 2007 stated cause of death as acute bronchopneumonia due to viral respiratory infection.  Manner of death:  natural.  Findings at autopsy included chronic inflammation, upper and lower airways; acute and chronic otitis media; and acute bronchopneumonia.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Livedo reticularis, Otitis media chronic, Oxygen supplementation, Pneumonia viral, Pyrexia
Clinical narrative: This report was received form a Government Agency (VAERS ID 290672) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of acute bronchopneumonia in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  The subject's medical history inlcluded  respiratory syncytial virus bronchiolitis and respiratory syncytial virus pneumonia, which required hospitalization for five or six days from approximately 15 March 2007 to 19 March 2007.  According to the subject's mother, she had been hospitalized from 15 March 2007 to 19 March 2007 with a diagnosis of viral pneumonia.  Previous and /or concurrent vaccination included ACTHIB; Sanofi Pateur MSD; unknown given on 22 March 2007; PREVNAR Wyeth Labs; unknown given on 22 March 2007.  On 22 March 2007 the subject received unspecified dose of PEDIARIX (unknown).  According to the medical records reviewed on 25 September 2007, the subject was in good health on the day of vaccination.  On 22 March 2007, the same day as vaccination with PEDIARIX, the subject experienced acute bronchopneumonia due to viral respiratory infection which led to respiratory arrest.  The subject's mother reported she "gave breathing medicine to my baby at 5PM Friday and baby began to choke and cough.  Took baby to the emergency room with difficulty breathing and vomiting.  Treatment included nebulization treatment and supplemental oxygen with initial improvement, but then her condition worsened again.  Examination included mottle cool skin with sluggish capillary refill, tachycardic, prolonged expiratory phase respiration, trahcheal tugging, intercostal and subcostal retractions, and fever of 105 degrees.  Multiple attempts to establish intravenous access and to obtain arterial blood gases were unsuccessful.  She was intubated emergently.  Chest compressions secondary to electromechanical dissociation had to be started.  EPINEPHRINE was administered via interosseous access, as well as, endotracheal without initiation of perfusing rhythm or spontaneous breathing.  The reporter notes indicated the subject expired with diagnosis of respiratory infection.  The manner of death was natural.  Findings at autopsy included:  chronic inflammation of upper and lower airways, acute and chronic otitis media, and acute bronchopneumonia.  Autopsy report received on 12 April 2007 stated cause of death as acute bronchopneumonia due to viral respiratory infection.  Manner of death:  natural.  Findings at autopsy included chronic inflammation, upper and lower airways; acute and chronic otitis media; and acute bronchopneumonia.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Respiratory arrest, Respiratory tract infection, Tachycardia, Tracheal disorder, Vomiting
Clinical narrative: This report was received form a Government Agency (VAERS ID 290672) via a healthcare professional in response to a Freedom-of-Information request by GSK and described the occurrence of acute bronchopneumonia in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  The subject's medical history inlcluded  respiratory syncytial virus bronchiolitis and respiratory syncytial virus pneumonia, which required hospitalization for five or six days from approximately 15 March 2007 to 19 March 2007.  According to the subject's mother, she had been hospitalized from 15 March 2007 to 19 March 2007 with a diagnosis of viral pneumonia.  Previous and /or concurrent vaccination included ACTHIB; Sanofi Pateur MSD; unknown given on 22 March 2007; PREVNAR Wyeth Labs; unknown given on 22 March 2007.  On 22 March 2007 the subject received unspecified dose of PEDIARIX (unknown).  According to the medical records reviewed on 25 September 2007, the subject was in good health on the day of vaccination.  On 22 March 2007, the same day as vaccination with PEDIARIX, the subject experienced acute bronchopneumonia due to viral respiratory infection which led to respiratory arrest.  The subject's mother reported she "gave breathing medicine to my baby at 5PM Friday and baby began to choke and cough.  Took baby to the emergency room with difficulty breathing and vomiting.  Treatment included nebulization treatment and supplemental oxygen with initial improvement, but then her condition worsened again.  Examination included mottle cool skin with sluggish capillary refill, tachycardic, prolonged expiratory phase respiration, trahcheal tugging, intercostal and subcostal retractions, and fever of 105 degrees.  Multiple attempts to establish intravenous access and to obtain arterial blood gases were unsuccessful.  She was intubated emergently.  Chest compressions secondary to electromechanical dissociation had to be started.  EPINEPHRINE was administered via interosseous access, as well as, endotracheal without initiation of perfusing rhythm or spontaneous breathing.  The reporter notes indicated the subject expired with diagnosis of respiratory infection.  The manner of death was natural.  Findings at autopsy included:  chronic inflammation of upper and lower airways, acute and chronic otitis media, and acute bronchopneumonia.  Autopsy report received on 12 April 2007 stated cause of death as acute bronchopneumonia due to viral respiratory infection.  Manner of death:  natural.  Findings at autopsy included chronic inflammation, upper and lower airways; acute and chronic otitis media; and acute bronchopneumonia.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cyanosis, Death, Irritability
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 290946) 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 PEDVAXHIB, (Merck) given on 19 September 2007; ROTATEQ (Merck) given on 19 September 2007; PREVNAR (Wyeth) given on 19 September 2007.  No history or pre-existing conditions.  Two month physical examination was within normal limits.  On 19 September 2007 the subject received 1st dose of PEDIARIX (unknown) between 11:30 and 12:00 AM.  Subject was seen three hours later by the physician and the subject appeared well.  The parents noted that between 6:00 pm and 8:00 pm the infant was fussy.  On 20 September 2007 in the morning, 1 day after vaccination with PEDIARIX, the subject was found "blue".  Paramedics were called but the subject died.  The subject died on 20 September 2007, cause of death was not reported.  It was unknown whether an autopsy was performed.  Two month old complete physical examination was within normal limits.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Blood culture positive, Death, Pneumonia klebsiella, Sepsis
Clinical narrative: This report was received and described the occurrence of death Nos in a male subject of unspecified age who was vaccinated with PEDIARIX. Previous and/ or concurrent vaccination included pneumococcal vaccine, unspecified; Wyeth given on 19 October 2006. On 19 October 2006 the subject received unspecified dose of PEDIARIX . At an unspecified time after vaccination with PRDIARIX, the subject experienced death Nos and sepsis due to Klebsiella pneumoniae. The subject died from sepsis blood culture positive for Klebsiella pneumoniae per the autopsy report. Per the source document, it was noted that a physician reported this case to the immunization staff. A mother refused vaccine due to a death that the mother heard about. Autopsy report stated cause of death as sepsis, blood culture positive for Klebsiella pneumonia.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Sudden death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 291338) and described the occurrence of sudden death in a 2-month-old male subject who was vaccinated with PEDIARIX, (manufacturer unspecified).  Previous and/or concurrent vaccination included HIB vaccine; manufacturer unspecified; unknown given on 9 August 2007; PNEUMOCOCCAL POLYVALENT vaccine; manufacturer unspecified given on 9 August 2007.  On 9 August 2007 the subject received unspecified dose of PEDIARIX (unknown).  At an unspecified time after vaccination with PEDIARIX, the subject experienced sudden death.  The subject died at an unspecified time, cause of death was reported to be sudden unexplained and unexpected death in infancy.  It was reported that the manner of death was undetermined (co-sleeping).  Per the source document, the case was reported from a physician with a mother who refused vaccination due to two deaths she had heard about after children received vaccines.  Autopsy report states cause of death as sudden unexplained and unexpected death in infancy.  Manner of death as undetermined (co-sleeping).
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Death, Feeling cold, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for disease Control and Prevention (VAERS ID # 291476) and described the occurrence of sids in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PEDVAXHIB and ROTATEQ.  Birth history included an emergent c-section at 41 weeks of gestation.  Birthweight was 7 pounds and 14 ounces.  Jaundice was noted.  It was noted that the primary care physician revealed that the subject was in good health on the day of vaccinations.  Concurrent medical conditions included cephalohematoma, circumcised and penile adhesion.  Previous and/or concurrent vaccination included PNEUMOCOCCAL vaccine, unspecified; Wyeth; unknown given on 12 September 2007.  On 12 September 2007 the subject received 2nd dose of PEDIARIX (unknown), On an unspecified date the subject received unspecified dose of PEDVAXHIB (unknown).  On 12 September 2007 the subject received 1st dose of ROTATEQ.  On 14 September 2007, the parents put the infant to sleep on his back.  The infant had a pacifier and no blankets in the crib.  At midnight, when the parents checked on him, he was fine.  When the parents checked on him at 6:00 am on 15 September 2007, 3 days after after vaccination with PEDIARIX, 3 days after vaccination with ROTATEQ and at an unspecified time after vaccination with PEDVAXHIB, the subject was unresponsive, and cold.  Paramedics were called and the baby was coded.  The infant was dead on arrival to the hospital.  The cause of death was sudden infant death syndrome.  Sudden infant death syndrome was considered disabling and life-threatening.  The subject died on 15 September 2007 from sids.  The cause of death was sudden infant death syndrome.  Autopsy report stated cause of death as sudden unexplained death in infancy.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Atrial septal defect, Haemorrhage, Pulmonary congestion, Sudden infant death syndrome, Thymus disorder
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 291677) and described the occurrence of sids in a 3-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included PEDVAXHIB; (Merck) given on 11 September 2007; PREVNAR vaccine, unspecified; Wyeth; given on 11 September 2007.  On 11 September 2007 the subject received 1st dose of PEDIARIX (unknown).  On 12 September 2007, 1 day (within 24 hours) after vaccination with PEDIARIX, the subject experienced sids.  The subject died on 12 September 2007 from sids.  An autopsy was performed.  Findings on autopsy included severe congestion in lungs, petechial hemorrhages of thymus gland and probe patent foramen ovale.  Autopsy report listed SIDS as the cause of death.  Findings on autopsy included severe congestion in lungs, petechial hemorrhages of thymus gland and probe patent foramen ovale.  Autopsy report stated SIDS as the cause of death.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal distension, Cardio-respiratory arrest, Cardiomegaly, Chest X-ray abnormal, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAES ID 291803) and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  The subject's medical history included premature birth. Birthweigh was 4 pounds. Results of a chest -x-ray done on 20 September 2007 showed enlarged heart, enlarged left ventricular and prominent and distended abdomen.  Previous and/or concurrent vaccination included PEDVAXHIB; Merck; given on 21 September 2007; ROTATEQ; Merck; given on 21 September 2007; PERVNAR, unspecified; Wyeth; given on 21 September 2007.  On 21 September 2007 the subject received 1st dose of PEDIARIX (unknown).  On 22 September 2007, 1 day after vaccination with PEDIARIX, the subject was brought to the emergency room in full arrest.  In the early morning of 23 September the subject experienced death nos.  The subject died on 23 September 2007, cause of death was not reported.  An autopsy was performed and results are pending.  Results:  CXR on 20 September 2007 showed enlarged heart, enlarged left ventricular prominent/distended abdomen.  Autopsy pending.
Age: 0.3
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 293421) 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 1 October 2007; ROTATEQ; Merck; unknown; unknown  given on 1 October 2007; PREVNAR unspecified; Wyeth; unknown given on 1 October 2007.  On 1 October 2007 the subject received 2nd dose of PEDIARIX (unknown).  On 4 October 2007, 3 days after vaccination with PEDIARIX, the subject experienced death nos.  The subject died on 4 October 2007, cause of death was not reported.  It was unknown whether as autopsy was performed.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Death, Pulse absent, Respiratory arrest
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 294509) in response to a Freedom-of-Information request by GSK and described the occurrence of in a 2-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccination included ACTHIB; (Sanofi Pasteur) MSD given on 8 October 2007; ROTATEQ; (Merck) given on 8 October 2007; PREVNAR; (Wyeth Labs) given on 8 October 2007.  The subject had no medical history or pre-existing conditions.  On 8 October 2007 the subject received 1st dose of PEDIARIX (unknown).  Acetaminophen 40 mg was given immediately after the vaccinations.  By report, the family gave the same amount again at about 7:00pm on 8 October 2007.  On 9 October 2007, 1 day after vaccination with PEDIARIX, the subject's mother awakened in the early morning and noticed that the subject was not breathing or moving.  Resuscitation was attempted by the subject's father and by emergency medical services (EMS) personnel and hospital personnel.  By report, the first recorded temperature during resuscitation was 102 degrees Fahrenheit.  Pulse was never reported to have been attained.  The subject experienced death nos.  The subject died on 9 October 2007 from death nos.  An autopsy was performed.  Autopsy results were pending.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Meningitis pneumococcal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 294789) via a manufacturer in response to a Freedom-of Information request by GSK and described the occurrence of pneumococcal meningitis in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline) and PREVNAR.  Concurrent vaccination included PEDVAXHIB, Merck given on 23 July 2007.  The subject's relevant medical history was not provided.  The subject's concomitant medications were not reported.  On 23 July 2007 the subject received 1st dose of PEDIARIX (unknown) and 1st dose of PREVNAR.  Information regarding PREVNAR was received from a healthcare professional regarding a subject who was reported to be three-months-old who experienced pneumococcal meningitis.  The subject had received a dose in 2007.  In 2007, at an unspecified time after vaccination with PEDIARIX and PREVNAR, the subject experienced pneumococcal meningitis.  It was reported that the subject expired close to 01 September 2007.  The cause of death was reported as meningitis pneumococcal.  It was reported that on 18 December 2007, vaccination records were received.  It was reported that on 18 January 2008, the autopsy report was reviewed which stated cause of death as bacterial meningitis "(days)".
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 296797-1) 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).  Concurrent vaccination included HIB vaccine (manufacturer unspecified) and PREVNAR, (Wyeth Pharmaceuticals, Inc.) given on unspecified dates.  On 7 May 2007 the subject received 3rd dose of PEDIARIX (unknown) as part of his 4 month shots and check-up.  The baby was described as fussy and he spit up, but nothing out of the normal was noted at that time.  The baby was found to be healthy.  Six days later, on 13 May 2007, the baby died at 12:59 due to death nos.  Another term included irritability.  An autopsy report dated 16 November 2007 revealed the cause of death as sudden infant death syndrome.  A vax record dated 27 November 2007 confirmed this report.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cyanosis, Death, Fatigue, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 297526) and described the occurrence of sids in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  The subject's medical history included small macular vsd.  Previous and/or concurrent vaccination included ACTHIB vaccine; (Sanofi Pasteur); given on 17 October 2007; ROTATEQ vaccine; (Merck); given on 17 October 2007; PREVNAR vaccine, unspecified; (Wyeth); given on 17 October 2007.  On 17 October 2007 the subject received 2nd dose of PEDIARIX (unknown).  For two days after the vaccinations, the subject was noted to be extra tired.  No other symptoms.  On the second day after the vaccinations, the subject was found non responsive, cyanotic and face down.  In October 2007, two days after vaccination with PEDIARIX, the subject experienced sids.  Autopsy stated that the cause of death was sids.  Other autopsy finding was probe patent foramen ovale.  Autopsy report stated cause of death as SIDS.  Other findings on autopsy was probe patent foramen ovale.
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 298067) and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent medical conditions included left cephalhematoma and cerebral palsy of the left arm.  Previous and/or concurrent vaccination included PEDVAXHIB; Merck; given on 20 November 2007; ROTATEQ; Merck; given on 20 November 2007; PREVNAR, unspecified; Wyeth; given on 20 November 2007.  On 20 November 2007 the subject received 1st dose of PEDIARIX (unknown).  On 25 November 2007, five days after vaccination with PEDIARIX, the subject experienced death nos.  The subject died on 25 November 2007, cause of death was not reported.  It was unknown whether an autopsy was performed.  No lab data.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 299556) and described the occurrence of death nos in a 1-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Pervious and/or concurrent vaccination included PEDVAXHIB; (Merck) given on 29 November 2007, ROTATEQ; (Merck) given on 29 November 2007; PREVNAR, unspecified; Wyeth given on 29 November 2007.  Subject was born at 36 weeks of gestation and birthweight of 5 pounds, 6 ounces.  On 29 November 2007 the subject received 1st dose of PEDIARIX on 30 November 2007 in the morning, 1 day after vaccination with PEDIARIX, the subject was found non-responsive, not breathing and expired.  The subject died on 30 November 2007, cause of death was not reported.  It was unknown whether an autopsy was performed.
Age: 0.2
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 299918) and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent medical conditions included second had exposure to smoke and possible reflux unspecified.  Previous and/or concurrent vaccination included HIB vaccine; Merck; given on 5 December 2007.  On 5 December 2007 the subject received 1st dose of PEDIARIX (unknown).  On 8 December 2007, 3 days after vaccination with PEDIARIX and a check-up, the subject was reportedly found dead in the bed by the parents.  The subject died on 8 December 2007, cause of death was not reported.  It was unknown whether an autopsy was performed.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Death, Respiratory distress, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 300036-1) in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 4-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccination included HIB, (Merck & Co. Inc.) and ROTATEQ, ( Merck & Co. Inc.).  On 19 September 2007 the subject received 2nd dose of PEDIARIX (unknown).  On 20 September 2007, 16 hours after vaccination with PEDIARIX, the subject experienced death nos.  The infant had been sleeping on the sofa with her mother.  The mother felt that the child was warm and gave TYLENOL.  The subject's mother noted respiratory distress.  Emergency medical services was notified and CPR was initiated, however, the child was pronounced dead upon arrival at medical center.  Unsafe sleeping conditions was documented.  A distinction between SIDS and subtle forms of asphyxia could not be made by autopsy alone.  Among terms documented included sudden infant death syndrome, autopsy, toxicologic test, resuscitation and body temperature increased.  Autopsy did not reveal any signs of adverse reaction.  Cause of death was reported as sudden unexpected death in infancy.  An investigation, autopsy and toxicology were completed.  Results not provided.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Asphyxia, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 300760) and described the occurrence of death nos in a 1-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included ACTHIB, (Sanofi Pasteur; given on 6 December 2007; ROTATEQ; Merck; given on 6 December 2007; PREVNAR, unspecified; Wyeth given on 6 December 2007.  On 6 December 2007 the subject received 1st dose of PEDIARIX (unknown).  On 8 December 2007, 2 days after vaccination with PEDIARIX, the subject expired after an accidental suffocation at home.  The subject died on 8 December 2007, cause of death was reported as accidental suffocation.  It was unknown whether an autopsy was performed.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Otitis media acute, Sudden infant death syndrome, Unevaluable event
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 300774) and described the occurrence of sids in a 3-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  The subject was a 37 week gestation twin.  Previous and/or concurrent vaccination included PEDVAXHIB; Merck; given on 11 December 2007; PREVNAR vaccine, unspecified; Wyeth; given on 11 December 2007.  On 11 December 2007 the subject received 1st dose of PEDIARIX (unknown).  On 13 December 2007, 2 days after vaccination with PEDIARIX, the subject experience unspecified event.  On 27 February 2008, 78 days after vaccination with PEDIARIX, the subject was found dead in his crib.  Per an autopsy, cause of death was reported to be sids and a contributing factor was noted to be acute bilateral otitis media.  Autopsy results listed SIDS as cause of death.  Acute bilateral otitis media was noted to be contributing.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abdominal distension, Cardiac arrest, Death, Diarrhoea, Melaena
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 300934) 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 male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  The subject's medical history included Down's Syndrome, grade 5 reflux, hypothyroidism and duodenal atresia.  It was reported that on 07 January 2008, records were received; The subject had a history of duodenal atresia status post repair and Trisomy 21.  Previous and/or concurrent vaccination included PEDVAXHIB; (Merck) given on 17 December 2007; ROTATEQ; (Merck) given on 17 December 2007; PREVNAR; (Wyeth Labs) given on 17 December 2007.  Concurrent medications included SYNTHROID and AMOXICILLIN.  On 17 December 2007 the subject received 1st dose of PEDIARIX (unknown).  One day after vaccination with PEDIARIX, the subject experienced an unspecified event.  It was reported that vomiting started after vaccination (date unspecified).  The subject had no fever for two days.  On an unspecified date, the subject had "soft stools tarry".  Oral hydration was performed at the hospital with PEDIALYTE.  It was reported that on 07 January 2008, record were received for doctor's order sheet (DOS) : 23 December 2007- The subject presented to the emergency department with cardiac arrest.  The subject was found by family in cardiac arrest, unresponsive, and abdomen was distended.  The subject had vomiting the day before.  On an unspecified date, an unspecified time after vaccination with PEDIARIX, the subject experienced death nos.  The regulatory authority reported that the events were life threatening.  The subject died on an unspecified date from death nos.  It was unknown whether an autopsy was performed.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event, Unresponsive to stimuli, Vomiting
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 300934) 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 male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  The subject's medical history included Down's Syndrome, grade 5 reflux, hypothyroidism and duodenal atresia.  It was reported that on 07 January 2008, records were received; The subject had a history of duodenal atresia status post repair and Trisomy 21.  Previous and/or concurrent vaccination included PEDVAXHIB; (Merck) given on 17 December 2007; ROTATEQ; (Merck) given on 17 December 2007; PREVNAR; (Wyeth Labs) given on 17 December 2007.  Concurrent medications included SYNTHROID and AMOXICILLIN.  On 17 December 2007 the subject received 1st dose of PEDIARIX (unknown).  One day after vaccination with PEDIARIX, the subject experienced an unspecified event.  It was reported that vomiting started after vaccination (date unspecified).  The subject had no fever for two days.  On an unspecified date, the subject had "soft stools tarry".  Oral hydration was performed at the hospital with PEDIALYTE.  It was reported that on 07 January 2008, record were received for doctor's order sheet (DOS) : 23 December 2007- The subject presented to the emergency department with cardiac arrest.  The subject was found by family in cardiac arrest, unresponsive, and abdomen was distended.  The subject had vomiting the day before.  On an unspecified date, an unspecified time after vaccination with PEDIARIX, the subject experienced death nos.  The regulatory authority reported that the events were life threatening.  The subject died on an unspecified date from death nos.  It was unknown whether an autopsy was performed.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 302724) and described the occurrence of death nos in a 3-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included ACTHIB; Sanofi Pasteur; given on 11 January 2008; PREVNAR vaccine, unspecified; Wyeth given on 11 January 2008.  On 11 January 2008 the subject received 1st dose of PEDIARIX (unknown).  On 13 January 2008, approximately 48 hours after vaccination with PEDIARIX, the subject died in bed.