chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Ascites, Blood bilirubin increased, Condition aggravated, Congenital absence of bile ducts, Hyperbilirubinaemia
Clinical narrative: This report describes aggravation of pre-existing biliary atresia in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received as a post marketing surveillance study of 7-valent pneumococcal conjugate vaccine. This study permitted the standard administration of childhood vaccines concurrent with Prevnar administration. Concurrent medical conditions included biliary atresia and neonatal hepatitis. Concurrent medications were not provided. The infant received her first injection of Infanrix on 5/24/00. She also received her first injections of Prevnar, Haemophilus B conjugate vaccine, inactivated poliomyelitis virus vaccine, and hepatitis B vaccine on 5/24/00. During the clinic visit, routine laboratory tests, including bilirubin level, were performed. Bilirubin level was determined to be elevated at 34.1 mg/dL; the infant was hospitalized that evening. On 5/25/00, she underwent a Kasai procedure. Post-operatively, she developed massive ascites. She was transferred to a tertiary care facility on 5/27/00 and underwent a liver transplantation. She developed unspecified post-surgical complications and died on 6/8/00. the reporter stated that the infant's death was clearly unrelated to vaccination. Cause of death was not provided.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 3 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 11/10/00, the infant received his second injection of Infanrix. On that date, he also received his second injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. He died on 11/11/00, one day post immunization. It was reported that an autopsy was performed; cause of death was reported recorded as sudden infant death syndrome.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: this report describes sudden infant death syndrome in a 3 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received as part of a post marketing safety surveillance study of 7-valent pneumococcal conjugate vaccine. Medical history included an acute life-threatening event due to gastroesophageal reflux when the infant was 12 days of age. Otherwise, the child was healthy. Concurrent medications were not specified. On 7/19/00, the infant received her first injections of Infanrix, Prevnar, Haemophilus virus vaccine. On 7/19/00, she also received her second injection of hepatitis B vaccine. On 8/27/00, the child died due to sudden infant death syndrome, 39 days post immunization. The investigator and medical monitor considered this event unrelated to vaccine administration.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 3 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medical conditions and medications were not specified. On 1/25/01, the infant received her second injection of Infanrix. That day, she also received her second injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. Four days post immunization, on the afternoon of 1/29/01, she was found dead in her crib. Autopsy results were consistent with sudden infant death syndrome.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medical conditions were not specified. There was no illness present at the time of immunization. There were no concurrent medications. On 12/12/00, the infant received his first injections of Infanrix, 7-valent pneumococcal conjugate vaccine, inactivated poliomyelitis virus vaccine, and hepatitis B/haemophilus B conjugate combination vaccine. He died 11 days later, on 12/23/00. The reported cause of death was sudden infant death syndrome.
Age: 0.88
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Apnoea, Brain oedema, Cardiac arrest, Influenza like illness, Myocarditis
Clinical narrative: This report describes acute viral myocarditis and diffuse brain swelling in an 11 month old male. The vaccinee and his family had no history of drug allergies or vaccine reactions. The vaccinee was healthy with no prior or current illness. He was taking no medications except for the vaccines listed below. On 04/05/1999, the vaccinee received vaccinations of IPV, OPV, and HIB in addition to Infanrix. On 4/5/99, the vaccinee received the unspecified dose of Infanrix. At an unspecified time thereafter, the vaccinee developed flu like symptoms. His symptoms worsened, and he was transported to the hospital on 4/11/99. During transport, the vaccinee coded and could not be resuscitated. He was pronounced dead on arrival at the hospital. An autopsy revealed acute viral myocarditis and diffuse brain swelling. Reportedly, post mortem viral titers were uninformative. The reporter indicated that he believed that the events were most likely related to the OPV/IPV vaccinations, and not to Infanrix.
Age: 0.88
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Viral infection
Clinical narrative: This report describes acute viral myocarditis and diffuse brain swelling in an 11 month old male. The vaccinee and his family had no history of drug allergies or vaccine reactions. The vaccinee was healthy with no prior or current illness. He was taking no medications except for the vaccines listed below. On 04/05/1999, the vaccinee received vaccinations of IPV, OPV, and HIB in addition to Infanrix. On 4/5/99, the vaccinee received the unspecified dose of Infanrix. At an unspecified time thereafter, the vaccinee developed flu like symptoms. His symptoms worsened, and he was transported to the hospital on 4/11/99. During transport, the vaccinee coded and could not be resuscitated. He was pronounced dead on arrival at the hospital. An autopsy revealed acute viral myocarditis and diffuse brain swelling. Reportedly, post mortem viral titers were uninformative. The reporter indicated that he believed that the events were most likely related to the OPV/IPV vaccinations, and not to Infanrix.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 4 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medical conditions and medications were not provided. On 4/25/00, the infant received his first injections of Infanrix, Prevnar, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. He died on 6/14/00, 50 days post immunization. Autopsy was performed; cause of death was determined to be sudden infant death syndrome. The investigator and medical monitor considered this event to be unrelated to vaccine administration.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Apnoea, Cardiac arrest, Coma, Sudden infant death syndrome
Clinical narrative: This report describes SIDS-like syndrome in a 15 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medical conditions and medications were not provided. On 8/7/00, the child received his third injection of Infanrix, along with his first injection of Prevnar, his second injection of hepatitis B vaccine, and his third injection of Haemophilus influenzae type B conjugate vaccine. In the morning of an unspecified date, the child was found in his crib, not breathing and in cardiac arrest. He was taken to the local emergency room, where a heart beat was re-established following a long period of cardiopulmonary resuscitation. The child was placed on mechanical ventilation. He was unresponsive to light and painful stimuli. The mechanical ventilation was removed, and the child died due to SIDS-like syndrome  on 1/11/01, five months post immunization. The investigator and medical monitor considered this event to be unrelated to vaccination.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report describes the death of a 2 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included recent bronchiolitis. There were no concurrent medications. On 2/7/01, the infant received her first injection of Infanrix. That day, she also received her first injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. Two days post immunization, on 2/9/01, she was found dead in her crib.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: this report describes possible sudden infant death syndrome in a 3 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. There were no concurrent medications. On 3/7/01, the infant received his first injection of Infanrix. That day, he also received his first injections of 7-valent pneumococcal conjugate vaccine, inactivated poliomyelitis virus vaccine, and combination hepatitis B/Haemophilus influenzae type B conjugate vaccine. Within 24 hours post immunization, on 3/8/01, the infant died. The infant's grandmother indicated that death was due to possible SIDS.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Acidosis, Apnoea, Pulse absent, Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history and concurrent conditions were unknown. There were no concurrent medications. On 12/4/00, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. He also received his second injection of hepatitis B vaccine recombinant. On 12/7/00, the infant was taken to the emergency room. On arrival, he was pulseless and had no respiratory effort. It was noted that an unspecified pH was 6.29. Resuscitative efforts were unsuccessful and the infant died. The report stated the coroner unofficially reported the cause of death was sudden infant death syndrome.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea, Pulse absent, Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history and concurrent conditions were unknown. There were no concurrent medications. On 12/4/00, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. He also received his second injection of hepatitis B vaccine recombinant. On 12/7/00, the infant was taken to the emergency room. On arrival, he was pulseless and had no respiratory effort. It was noted that an unspecified pH was 6.29. Resuscitative efforts were unsuccessful and the infant died. The report stated the coroner unofficially reported the cause of death was sudden infant death syndrome.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Acidosis, Apnoea, Pulse absent, Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 2 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medical conditions were not specified. There were no concurrent medications. On 12/4/00, the infant received his first injection of Infanrix. That day, he also received his second injection of hepatitis B vaccine recombinant and his first injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. Three days post immunization, on 12/7/00, he was taken to the local emergency room. Upon arrival, he was pulseless and had no respiratory effort. An unspecified pH was 6.29. He did not respond to resuscitative efforts and died. The coroner unofficially reported the cause of death as sudden infant death syndrome.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea, Pulse absent, Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 2 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medical conditions were not specified. There were no concurrent medications. On 12/4/00, the infant received his first injection of Infanrix. That day, he also received his second injection of hepatitis B vaccine recombinant and his first injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. Three days post immunization, on 12/7/00, he was taken to the local emergency room. Upon arrival, he was pulseless and had no respiratory effort. An unspecified pH was 6.29. He did not respond to resuscitative efforts and died. The coroner unofficially reported the cause of death as sudden infant death syndrome.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Cardiac arrest, Cough, Dyspnoea, Haematemesis, Hypoxia
Clinical narrative: This report describes a cardiac arrest in a 15 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included severe prematurity, bronchopulmonary dysplasia, reactive airway disease, pulmonary stenosis, gastroesophageal reflux disease, and insertion of a gastrostomy tube. Concurrent medications included budesonide, salmeterol, spironolactone/hydrochlorothiazide, furosemide, ranitidine, and potassium chloride. On 4/25/01, the child received her fourth injection of Infanrix. On that date, she also received her second injections of 7-valent pneumococcal conjugate vaccine and combination haemophilus influenzae type B conjugate vaccine/hepatitis B vaccine. On 4/26/01, one day post immunization, the child developed heavy breathing with cough and began pulling at her ears. On 4/27/01, two days post immunization, she developed a fever of 40.2 degrees C. She was taken to the local emergency room on 4/27/01. There, her oxygen saturation was 94%. Material removed from the child's gastrostomy tube had a coffee ground appearance and was heme positive. The child was tachycardic, with a heart rate of 190 beats/minute. Following albuterol administration, the child experienced supraventricular tachycardia, diminished respiratory effort, and a cardiac arrest. The child later died. Date and cause of death were not provided. The report listed Infanrix, Comvax and albuterol as suspects in the events leading to the child's death.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Pyrexia, Tachycardia
Clinical narrative: This report describes a cardiac arrest in a 15 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included severe prematurity, bronchopulmonary dysplasia, reactive airway disease, pulmonary stenosis, gastroesophageal reflux disease, and insertion of a gastrostomy tube. Concurrent medications included budesonide, salmeterol, spironolactone/hydrochlorothiazide, furosemide, ranitidine, and potassium chloride. On 4/25/01, the child received her fourth injection of Infanrix. On that date, she also received her second injections of 7-valent pneumococcal conjugate vaccine and combination haemophilus influenzae type B conjugate vaccine/hepatitis B vaccine. On 4/26/01, one day post immunization, the child developed heavy breathing with cough and began pulling at her ears. On 4/27/01, two days post immunization, she developed a fever of 40.2 degrees C. She was taken to the local emergency room on 4/27/01. There, her oxygen saturation was 94%. Material removed from the child's gastrostomy tube had a coffee ground appearance and was heme positive. The child was tachycardic, with a heart rate of 190 beats/minute. Following albuterol administration, the child experienced supraventricular tachycardia, diminished respiratory effort, and a cardiac arrest. The child later died. Date and cause of death were not provided. The report listed Infanrix, Comvax and albuterol as suspects in the events leading to the child's death.
Age: 0.7
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This report describes the death of an 8 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included bilateral inguinal hernias diagnosed on 11/1/00. Concurrent conditions included nasal congestion. Concurrent medications were not provided. On 11/14/00, at the age of 2 months, the infant received his first injection of Infanrix. On that date, he also received his second injection of combination Haemophilus influenzae type B conjugate vaccine/hepatitis B vaccine, as well as, his first injections of 7-valent pneumococcal conjugate vaccine and inactivated poliomyelitis virus vaccine. On 5/18/01, at the age of 8 months, the infant died of undetermined causes. The report stated however, the date of death is unclear, as the reporter also noted death within 24 hours. Comment: the report indicated that the infant received Infanrix from lot DTPA396A12; however, that is not a valid lot number.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 2001015804-1 describes the death of a 3-month-old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). This report was received from manufacturer (Ref. No. HQ1744207JUN2001), who received it from the Food and Drug Administration (VAERS ID 169933). This report has also been forwarded to and Institute (Ref. No 2825-2001). Medical history was not specified. There were no pre-existing illnesses or concurrent medications. On 15 May 2001, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenza type b conjugate vaccine hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. The office visit on 15 May 2001 was the infant's first one since birth. One day post-immunization, on the morning of 16 May 2001, the infant was found dead in his crib. The cause of death was not specified.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This report describes the death of a 3 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history was not specified. Concurrent medical conditions included otitis media. Concurrent medications included amoxicillin/clavulanate. On 4/4/01, the infant received an injection of Infanrix; it is not known if he had received previous injections of Infanrix. On that same day, he also received injections of 7 valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine; it is not known if he had received previous injections of these vaccines. The infant died 24 hours post immunization, on 4/5/01; cause of death was not reported. An autopsy was performed; results were pending at the time of the report was submitted.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This report described the death of a 2 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history and concurrent medical conditions were not specified. There were no concurrent medications. On 4/13/01, the infant received his first injection of Infanrix. On that same day, he also received his first injections of 7-valent pneumococcal conjugate vaccine, combination hepatitis B/Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. The infant died on 4/14/01; case of death was not reported. An autopsy was performed; results were pending at the time the report was submitted.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This report describes a 3 month old male who died after receiving an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history and concurrent conditions were not specified. There were no concurrent medications. The infant received his first injection of Infanrix on 6/5/01. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. On 6/15/01, 10 days post immunization, he was found dead in his crib.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report describes sudden infant death syndrome in a 2 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history and concurrent conditions were not specified. Acetaminophen was prescribed on the day of immunization; it was not specified if the acetaminophen had been administered. On 7/3/01, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. On 7/4/01, one day post immunization, the infant died as a result of sudden infant death syndrome.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma
Clinical narrative: This report describes a 3 month old male who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included premature birth at 35 weeks gestation, cystic adenoma malformation, and patent ductus arteriosus. Concurrent conditions and medications were not specified. On 7/16/01, the infant received his second injection of Infanrix. On 7/16/01, he also received his second injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. On 7/17/01, one day post immunization, the infant was found unresponsive. He was taken to the local emergency room and pronounced dead on arrival. At the time the report was submitted, the cause of death was unknown.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This report describes a 3 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed and subsequently died. Medical history, concurrent conditions, and concurrent medications were not specified. On 9/6/01, the infant received his second injection of Infanrix. On that date, he also received his second injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. On an unspecified date, the infant developed an unevaluable reaction. The infant died as a result of the adverse event.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, PNC
Symptoms: Cardiac arrest, Coma, Pallor, Pyrexia
Clinical narrative: This report described a cardiac arrest in a 13 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history and concurrent conditions were not specified. An injection of hepatitis A immunoglobulin was previously received. On 9/20/01, the child received her third injection of Infanrix. On that date, she also received her third injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. Later that day, an unspecified time post immunization, the child developed some fever. On 9/21/01, she seemed asymptomatic. She was put to bed at 20:00 on 9/21/01.  When her family checked on her at 21:00, her color was white and she was unresponsive. She was taken to the local hospital, where she experienced a cardiac arrest. She died as a result of these adverse events.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma, Cyanosis
Clinical narrative: This report describes a 3 month old female who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history was not specified. At the time of immunization, the infant had otitis media, which was being treated with amoxicillin, pseudoephedrine and paracetamol. On 5/14/01, the infant received her second injection of Infanrix. On that date, she also received her second injections of 7-valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. On 5/18/01, four days post immunization, the infant was found unresponsive and blue. Attempts at cardiopulmonary resuscitation were unsuccessful, and the infant died.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Apnoea, Diarrhoea, Fatigue, Mouth haemorrhage, Pyrexia
Clinical narrative: This report described a 4 month old male who died following receipt of an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included premature birth (six weeks premature), hypospadias, an asymmetric head, and gastroesophageal reflux disease. Concurrent conditions were not specified. There were no concurrent medications. On 10/15/01, the infant received his third injection of Infanrix. On that date, he also received his second injection of hepatitis B vaccine and his third injections of 7-valent pneumococcal conjugate vaccine and Haemophilus influenzae type B conjugate vaccine. On 10/16/01, one day post immunization, he developed a fever, was more tired that usual, and experienced three or four episodes of diarrhea. In the evening of 10/16/01, his father found with with blood from his mouth. He was not breathing. The infant died; cause of death was not reported. (OMIC)
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Death, Report 2002001711-1 describes a 2 month old female who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (Ref. No. HQ9744003JAN2002), who received it from the Food and Drug Administration (VAERS ID 178756). This report has also been forwarded to the Paul-Ehrlich-Institute (Ref. No. 0158-2002). Medical history included premature birth at 31 weeks gestational age. Concurrent conditions were not specified. There were no concurrent medications. ON 30NOVEMBER2001, the infant received her first injection of Infanrix. On that date, she also received her first injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax,Merck), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 03December 2001, three days post immunization, the infant was found dead in her crib. Emergency personnel were summoned; attempts at resuscitation were unsuccessful. An autopsy was performed; results were not available at the time of the report was submitted to the Food and Drug Administration.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP
Symptoms: Apnoea
Clinical narrative: Death, Report 2002001697-1 describes a 2 month old male who died (following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (Ref. No. HQ9747603JAN2002), who received it form the Food and Drug Administration (VAERS ID 178822). This report has also been forwarded to the Paul-Ehrlich-Instute (Ref. No. 0075-2002). Medical history, concurrent conditions, and concurrent medications were not specified. On 13JUNE2001, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), combination Haemophilus influenzae type b conjugate/ hepatitis B vaccine (Comvax, Merck), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). "Approximately one hour after being put to bed that evening, he was found not breathing. He died."
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP
Symptoms: Unevaluable event
Clinical narrative: Death, Report 2002001697-1 describes a 2 month old male who died (following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (Ref. No. HQ9747603JAN2002), who received it form the Food and Drug Administration (VAERS ID 178822). This report has also been forwarded to the Paul-Ehrlich-Instute (Ref. No. 0075-2002). Medical history, concurrent conditions, and concurrent medications were not specified. On 13JUNE2001, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), combination Haemophilus influenzae type b conjugate/ hepatitis B vaccine (Comvax, Merck), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). "Approximately one hour after being put to bed that evening, he was found not breathing. He died."
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Coma, Unevaluable event
Clinical narrative: Death, Report 20020016621 describes a 3 month old male who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (Ref. No. HQ9742703JAN2002), who received it from the Food and Drug Administration (VAERS ID 179127). This report has also been forwarded to the Paul-Ehrlich-Institute. Medical history included an upper respiratory tract infection and conjunctivitis. Approximately two or three weeks prior to immunization, the infant was taken to an emergency facility, where the diagnoses of upper respiratory tract infection and conjunctivitis were made. The infant was treated with an unspecified antibiotic; antibiotic therapy ended one week prior to immunization. There were reportedly no other pre-existing illnesses and no concurrent medications. On 27 November 2001, the infant received his first injection of Infanrix. On that date,he also received his first injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), Haemophilus influenzae type b conjugate vaccine (Act-Hib, Aventis Pasteur), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). He also received his second injection of hepatitis B vaccine (Recombivax-HB, Merck). At approximately 10:00 in the morning of 12 December 2001, 15 days post immunization, the infant was fed a bottle of infant formula. He was found unresponsive and was taken to the local hospital, where he was pronounced dead on arrival at 11:41. An autopsy was performed; results were not available at the time the report was submitted to the Food and Drug Administration.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Anorexia, Hypertonia, Rhinitis, Somnolence, Stupor
Clinical narrative: Report 2002001685-1 describes a 2 month old male who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (Ref. No. HQ9742803JAN2002), who received it from the Food and Drug Administration (VAERS ID 179128). This report has also been forwarded to Paul-Ehrlich-Institute. (Ref. No. 0072-2002). Medical history, concurrent conditions, and concurrent medications were not specified. Family history was significant for vomiting in other family members two or three days prior to the infant's death. On 28 November 2001, the infant received his first injection of Infanrix. On that date, the also received his first injections of 7-valent pneumococcal conjugate vaccine (Prevnar,Lederle Labs), Haemophilus influenzae type b conjugate vaccine (Act-Hib, Aventis Pasteur), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 28 November 2001, he also received his second injection of hepatitis B vaccine (Recombivax-HB, Merck). An unspecified time post-immunization, the infant developed anorexia, hypertonia, rhinitis, somnolence and stupor. Treatment and outcomes of these events were not provided. At 20:15 on 12 December 2001, the infant was put to sleep in his crib, on his abdomen. He was found unresponsive at 21:15. He was taken to the local hospital, where he was pronounced dead on arrival at 00:20 on 13 December 2001. An autopsy was preformed; results were not available at the time the report was submitted to the Food and Drug Administration.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: Report 2002001685-1 describes a 2 month old male who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (Ref. No. HQ9742803JAN2002), who received it from the Food and Drug Administration (VAERS ID 179128). This report has also been forwarded to Paul-Ehrlich-Institute. (Ref. No. 0072-2002). Medical history, concurrent conditions, and concurrent medications were not specified. Family history was significant for vomiting in other family members two or three days prior to the infant's death. On 28 November 2001, the infant received his first injection of Infanrix. On that date, the also received his first injections of 7-valent pneumococcal conjugate vaccine (Prevnar,Lederle Labs), Haemophilus influenzae type b conjugate vaccine (Act-Hib, Aventis Pasteur), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 28 November 2001, he also received his second injection of hepatitis B vaccine (Recombivax-HB, Merck). An unspecified time post-immunization, the infant developed anorexia, hypertonia, rhinitis, somnolence and stupor. Treatment and outcomes of these events were not provided. At 20:15 on 12 December 2001, the infant was put to sleep in his crib, on his abdomen. He was found unresponsive at 21:15. He was taken to the local hospital, where he was pronounced dead on arrival at 00:20 on 13 December 2001. An autopsy was preformed; results were not available at the time the report was submitted to the Food and Drug Administration.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Oral intake reduced, Peripheral vascular disorder
Clinical narrative: Report A0361877A describes the death of a 2 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (Ref. No. HQ0647411FEB2002), who received it from the Food and Drug Administration (VAERS ID 179926). This report has also been forwarded to the Paul-Ehrlich-Institue (Ref. Nos. 1033-2002 and 1421-2002). Medical history included prematurity, apnea, and bradycardia. Concurrent conditions were not specified. Concurrent medications included ferrous sulfate (Fer-In-Sol), multivitamin solution (Poly-Vi-Sol) and palivizumab (Synagis). On 26 December 2001, the infant received her first injection of Infanrix. On that date, she also received her first inections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), Haemophilus influenzae conjugate vaccine type b conjugate vaccine (Hib-Titer, Lederle Labs), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). At midnight on 27 December 2001, the infant "feed poorly". The infant's mother subsequently took the infant into bed with her. Upon wakening, the mother noticed that the infant was cold. The infant was taken to an emergency room via ambulance. Resuscitation was attempted; however, the infant was pronounced dead on arrival at the emergency room.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Sudden infant death syndrome: Report A0363108A describes sudden infant death syndrome in a 3 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This report was received from Wyeth-Ayerst (ref. no. HQ0646511FEB2002), who received it form the Food and Drug Administration (VAERS ID 179968). This report has also been forwarded to the Paul-Ehrlich-Institute (Ref. No. 1438-2002). Medical history and concurrent conditions were not specified. There were no concurrent medications. On 28 November 2001, the infant received his first injection of Infanrix. On that date, he also received injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), and combination Haemophilus influenzae type b conjugate/hepatitis b vaccine (Comvax, Merck) At 8:38 on 17 December 2001, 19 days post immunization, the infant died of sudden infant death syndrome. The reporter noted that the infant experienced no other adverse events post immunization. An autopsy was performed; results were not available at the time this report was submitted to the Food and Drug Administration. Autopsy: results not available.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Condition aggravated
Clinical narrative: This report described the death of a 4 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included cerebral palsy, cystic encephalomalacia, and an unspecified seizure disorder. Concurrent conditions were not specified. Concurrent medication included phenobarbital sodium. On 1/11/02, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. On 1/16/02, five days post immunization, the infant was found in his crib not breathing. His mother called an ambulance; attempts to resuscitate him were unsuccessful.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea
Clinical narrative: This report described the death of a 4 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history included cerebral palsy, cystic encephalomalacia, and an unspecified seizure disorder. Concurrent conditions were not specified. Concurrent medication included phenobarbital sodium. On 1/11/02, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. On 1/16/02, five days post immunization, the infant was found in his crib not breathing. His mother called an ambulance; attempts to resuscitate him were unsuccessful.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: This report describes a 2 month old female who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from the vaccinees mother and has not been verified by a physician or other healthcare professional. The infant's mother stated that the infant had low grade fever most of the time. Concurrent medications were not specified. On 1/22/02, the infant received her first injection of Infanrix. On that date, she also received injections of 7-valent pneumococcal conjugate vaccine, inactivated poliomyelitis virus vaccine, and Haemophilus influenzae type B vaccine. On 1/22/02, an unspecified time post vaccination, the infant reportedly experienced a temperature of 102.2 degrees F. On 1/23/02, the infant reportedly died at home. Additional information, including medical confirmation, has been requested.
Age: 0.2
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Feeling cold
Clinical narrative: This report describes the death of a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The medical history included extra digits on each hand. Concurrent conditions were not specified. There were no concurrent medications. At 11:00 on 2/6/02, the infant received his first injection of Infanrix. At that time, he also received his first injections of 7-valent pneumococcal conjugate vaccine, combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, and inactivated poliomyelitis virus vaccine. On 2/6/02, an unspecified time post immunization, the infant's mother noted that the infant was cold. He was taken to the hospital, where he died at 19:00, eight hours post immunization.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea, Asphyxia, Injury, Laboratory test abnormal, Lung disorder
Clinical narrative: Report A0368613A describes sudden unexpected death in infancy in a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The reporter submitted this report directly to VAERS (reporter's reference number: MD02-002). The vaccine provider notified Wyeth of the event (Ref. No. HQ2420023MAY2002). This report has been forwarded to the Paul-Ehrlich-Institute (Ref. No. 3606-2002). The vaccinee's medical history included one previous episode of wheezing. At the time of immunization, he had a "mild" upper respiratory infection and was taking salbutamol (Albuterol). He had experienced no adverse events following prior immunization. On 19 April 2002 at 15:00, the vaccinee received his first injection of Infanrix (lot DTPA532A2). On the same date, he also received his first injections of Haemophilus influenzae type b conjugate vaccine (PedvaxHIB, Merck), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), and his second injection of hepatitis B vaccine (Recombivax-HB, Merck). On 20 April 2002 at 06:00 the infant was found not breathing. He was taken to the emergency room, where he was pronounced dead at 07:41. Information received from Wyeth and the initial reporter on 17June2002 provided the infant's birth weight and lot numbers of vaccines administered. The vaccine provider supplied a copy of the autopsy report (available upon request) on 08 October 2002. The pathologist noted that "the pulmonary parenchyma was dark red-purple, exuding slight to moderate amounts of blood and frothy fluid; no focal lesions were noted." The pathologist's final diagnosis was recorded as "Sudden Unexpected Death in Infancy (SUDII): A. No gross or microscopic abnormalities. B. Negative toxicology. C. Deceased found unresponsive in bed with an adult. OPINION: This 2 month old black male infant....died of Sudden unexpected death in infancy (SUDII). In cases of death of an infant, once abnormalities such as congenital defects, infection or toxicology are ruled out, Sudden Infant death Syndrome (SIDS) becomes a possibility. The criteria for a diagnosis of SIDS is very strict and this by definition is a diagnosis of exclusion. As this infant was sharing a bed with an adult, while unlikely, the possibility of asphyxia due to accidental overlying cannot be definitely ruled out. The physical findings can be the same in SIDS and accidental overlying. Therefore, this death is ruled a Sudden Unexpected Death in Infancy (SUDII). The manner of death is UNDETERMINED. Alcohol or drugs were not detected on toxicologic analysis." The vaccine provider stated that SUDII was "possibly related but presumed not related" to Infanrix administration.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pulmonary haemorrhage, Sudden infant death syndrome
Clinical narrative: Report A0368613A describes sudden unexpected death in infancy in a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The reporter submitted this report directly to VAERS (reporter's reference number: MD02-002). The vaccine provider notified Wyeth of the event (Ref. No. HQ2420023MAY2002). This report has been forwarded to the Paul-Ehrlich-Institute (Ref. No. 3606-2002). The vaccinee's medical history included one previous episode of wheezing. At the time of immunization, he had a "mild" upper respiratory infection and was taking salbutamol (Albuterol). He had experienced no adverse events following prior immunization. On 19 April 2002 at 15:00, the vaccinee received his first injection of Infanrix (lot DTPA532A2). On the same date, he also received his first injections of Haemophilus influenzae type b conjugate vaccine (PedvaxHIB, Merck), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), and his second injection of hepatitis B vaccine (Recombivax-HB, Merck). On 20 April 2002 at 06:00 the infant was found not breathing. He was taken to the emergency room, where he was pronounced dead at 07:41. Information received from Wyeth and the initial reporter on 17June2002 provided the infant's birth weight and lot numbers of vaccines administered. The vaccine provider supplied a copy of the autopsy report (available upon request) on 08 October 2002. The pathologist noted that "the pulmonary parenchyma was dark red-purple, exuding slight to moderate amounts of blood and frothy fluid; no focal lesions were noted." The pathologist's final diagnosis was recorded as "Sudden Unexpected Death in Infancy (SUDII): A. No gross or microscopic abnormalities. B. Negative toxicology. C. Deceased found unresponsive in bed with an adult. OPINION: This 2 month old black male infant....died of Sudden unexpected death in infancy (SUDII). In cases of death of an infant, once abnormalities such as congenital defects, infection or toxicology are ruled out, Sudden Infant death Syndrome (SIDS) becomes a possibility. The criteria for a diagnosis of SIDS is very strict and this by definition is a diagnosis of exclusion. As this infant was sharing a bed with an adult, while unlikely, the possibility of asphyxia due to accidental overlying cannot be definitely ruled out. The physical findings can be the same in SIDS and accidental overlying. Therefore, this death is ruled a Sudden Unexpected Death in Infancy (SUDII). The manner of death is UNDETERMINED. Alcohol or drugs were not detected on toxicologic analysis." The vaccine provider stated that SUDII was "possibly related but presumed not related" to Infanrix administration.