chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypoglycaemia, Platelet count increased, Pyrexia, Strabismus, White blood cell count increased
Clinical narrative: Report 20010291621 describes a seizure in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Additional information was received from manufacturer, who received it from an agency. This report has also been forwarded to a medical institution. There were no pre-existing conditions, illnesses at the time of immunization, or concurrent medications. The infant had no adverse experiences following receipt of prior immunizations and had not received any other vaccines within four weeks of 29 NOV 2001. On 29 NOV 2001, the infant received her second 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/hepatitis B vaccine, and her first injection of inactivated poliomyelitis virus vaccine. On 30 NOV 2001, one day post-immunization, she experienced a seizure characterized by her eyes rolling back and jerking of her shoulders and chest on and off for 20 minutes. She had a fever of 105.4 degrees F. She also experienced diarrhea. She was taken to the local ER and hospitalized. White blood cell count was 21,000 cells/cu mm with 58% segmented neutrophils, 16% banded neutrophils, 18% lymphocytes, and 8% atypical lymphocytes. Another white blood cell count was 30,100 cells/cu mm. Additional analyses revealed blood bicarbonate (NOS) 17 mEq/L, serum sodium 156 mEq/L, glucose 23 mg/dL, C-reactive protein 2.6 mg/dL, blood urea nitrogen 22 mg/dL, and platelets 413,000/cu mm. Urinalysis was normal and blood cultures were negative. The infant was treated with ibuprofen (Motrin), paracetamol (Tylenol), lorazepam, phenytoin, and ceftriaxone. The events resolved that day. The immunizing physician considered the events to be moderate in severeity and possibly related to Infanrix administration. The Infanrix immunization series was discontinued. This is one of two infants from this facility who experienced seizure and fever following receipt of Infanrix or the concomitant vaccines. The reporter indicated that the infants received Infanrix lot DTPA9521A2; however, this is not a valid lot number.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Eye movement disorder, Pyrexia
Clinical narrative: Report 20010291621 describes a seizure in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Additional information was received from manufacturer, who received it from an agency. This report has also been forwarded to a medical institution. There were no pre-existing conditions, illnesses at the time of immunization, or concurrent medications. The infant had no adverse experiences following receipt of prior immunizations and had not received any other vaccines within four weeks of 29 NOV 2001. On 29 NOV 2001, the infant received her second 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/hepatitis B vaccine, and her first injection of inactivated poliomyelitis virus vaccine. On 30 NOV 2001, one day post-immunization, she experienced a seizure characterized by her eyes rolling back and jerking of her shoulders and chest on and off for 20 minutes. She had a fever of 105.4 degrees F. She also experienced diarrhea. She was taken to the local ER and hospitalized. White blood cell count was 21,000 cells/cu mm with 58% segmented neutrophils, 16% banded neutrophils, 18% lymphocytes, and 8% atypical lymphocytes. Another white blood cell count was 30,100 cells/cu mm. Additional analyses revealed blood bicarbonate (NOS) 17 mEq/L, serum sodium 156 mEq/L, glucose 23 mg/dL, C-reactive protein 2.6 mg/dL, blood urea nitrogen 22 mg/dL, and platelets 413,000/cu mm. Urinalysis was normal and blood cultures were negative. The infant was treated with ibuprofen (Motrin), paracetamol (Tylenol), lorazepam, phenytoin, and ceftriaxone. The events resolved that day. The immunizing physician considered the events to be moderate in severeity and possibly related to Infanrix administration. The Infanrix immunization series was discontinued. This is one of two infants from this facility who experienced seizure and fever following receipt of Infanrix or the concomitant vaccines. The reporter indicated that the infants received Infanrix lot DTPA9521A2; however, this is not a valid lot number.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Diarrhoea, Dyskinesia, Eye movement disorder, Pyrexia
Clinical narrative: Report 20010291621 describes a seizure in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Additional information was received from manufacturer, who received it from an agency. This report has also been forwarded to a medical institution. There were no pre-existing conditions, illnesses at the time of immunization, or concurrent medications. The infant had no adverse experiences following receipt of prior immunizations and had not received any other vaccines within four weeks of 29 NOV 2001. On 29 NOV 2001, the infant received her second 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/hepatitis B vaccine, and her first injection of inactivated poliomyelitis virus vaccine. On 30 NOV 2001, one day post-immunization, she experienced a seizure characterized by her eyes rolling back and jerking of her shoulders and chest on and off for 20 minutes. She had a fever of 105.4 degrees F. She also experienced diarrhea. She was taken to the local ER and hospitalized. White blood cell count was 21,000 cells/cu mm with 58% segmented neutrophils, 16% banded neutrophils, 18% lymphocytes, and 8% atypical lymphocytes. Another white blood cell count was 30,100 cells/cu mm. Additional analyses revealed blood bicarbonate (NOS) 17 mEq/L, serum sodium 156 mEq/L, glucose 23 mg/dL, C-reactive protein 2.6 mg/dL, blood urea nitrogen 22 mg/dL, and platelets 413,000/cu mm. Urinalysis was normal and blood cultures were negative. The infant was treated with ibuprofen (Motrin), paracetamol (Tylenol), lorazepam, phenytoin, and ceftriaxone. The events resolved that day. The immunizing physician considered the events to be moderate in severeity and possibly related to Infanrix administration. The Infanrix immunization series was discontinued. This is one of two infants from this facility who experienced seizure and fever following receipt of Infanrix or the concomitant vaccines. The reporter indicated that the infants received Infanrix lot DTPA9521A2; however, this is not a valid lot number.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Eye movement disorder, Pyrexia
Clinical narrative: Report 20010291621 describes a seizure in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Additional information was received from manufacturer, who received it from an agency. This report has also been forwarded to a medical institution. There were no pre-existing conditions, illnesses at the time of immunization, or concurrent medications. The infant had no adverse experiences following receipt of prior immunizations and had not received any other vaccines within four weeks of 29 NOV 2001. On 29 NOV 2001, the infant received her second 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/hepatitis B vaccine, and her first injection of inactivated poliomyelitis virus vaccine. On 30 NOV 2001, one day post-immunization, she experienced a seizure characterized by her eyes rolling back and jerking of her shoulders and chest on and off for 20 minutes. She had a fever of 105.4 degrees F. She also experienced diarrhea. She was taken to the local ER and hospitalized. White blood cell count was 21,000 cells/cu mm with 58% segmented neutrophils, 16% banded neutrophils, 18% lymphocytes, and 8% atypical lymphocytes. Another white blood cell count was 30,100 cells/cu mm. Additional analyses revealed blood bicarbonate (NOS) 17 mEq/L, serum sodium 156 mEq/L, glucose 23 mg/dL, C-reactive protein 2.6 mg/dL, blood urea nitrogen 22 mg/dL, and platelets 413,000/cu mm. Urinalysis was normal and blood cultures were negative. The infant was treated with ibuprofen (Motrin), paracetamol (Tylenol), lorazepam, phenytoin, and ceftriaxone. The events resolved that day. The immunizing physician considered the events to be moderate in severeity and possibly related to Infanrix administration. The Infanrix immunization series was discontinued. This is one of two infants from this facility who experienced seizure and fever following receipt of Infanrix or the concomitant vaccines. The reporter indicated that the infants received Infanrix lot DTPA9521A2; however, this is not a valid lot number.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Report 20010291621 describes a seizure in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Additional information was received from manufacturer, who received it from an agency. This report has also been forwarded to a medical institution. There were no pre-existing conditions, illnesses at the time of immunization, or concurrent medications. The infant had no adverse experiences following receipt of prior immunizations and had not received any other vaccines within four weeks of 29 NOV 2001. On 29 NOV 2001, the infant received her second 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/hepatitis B vaccine, and her first injection of inactivated poliomyelitis virus vaccine. On 30 NOV 2001, one day post-immunization, she experienced a seizure characterized by her eyes rolling back and jerking of her shoulders and chest on and off for 20 minutes. She had a fever of 105.4 degrees F. She also experienced diarrhea. She was taken to the local ER and hospitalized. White blood cell count was 21,000 cells/cu mm with 58% segmented neutrophils, 16% banded neutrophils, 18% lymphocytes, and 8% atypical lymphocytes. Another white blood cell count was 30,100 cells/cu mm. Additional analyses revealed blood bicarbonate (NOS) 17 mEq/L, serum sodium 156 mEq/L, glucose 23 mg/dL, C-reactive protein 2.6 mg/dL, blood urea nitrogen 22 mg/dL, and platelets 413,000/cu mm. Urinalysis was normal and blood cultures were negative. The infant was treated with ibuprofen (Motrin), paracetamol (Tylenol), lorazepam, phenytoin, and ceftriaxone. The events resolved that day. The immunizing physician considered the events to be moderate in severeity and possibly related to Infanrix administration. The Infanrix immunization series was discontinued. This is one of two infants from this facility who experienced seizure and fever following receipt of Infanrix or the concomitant vaccines. The reporter indicated that the infants received Infanrix lot DTPA9521A2; however, this is not a valid lot number.
Age: 0.21
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Report A0361526A describes fever in a 2 month old female who received diphtheria and tetanus toxoid and acellular pertussis vaccine absorbed. Medical history , concurrent conditions, and concurrent medications were not specified. On 8/21/01, the vaccinee received her first injection of Infanrix. On 8/21/01, an unspecified time post-immunization, she experienced a fever. Outcome of the event was not provided.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: This report describes limb swelling in a 5 year old female who received an injection of Infanrix. This report was received from the child's mother and has not been verified by a physician or other healthcare professional.  On 11/06/01, the vaccinee received her fifth injection of Infanrix. On 11/06/01, an unspecified time, post-vaccination, the vaccinee developed "severe' redness at the injection site and swelling from the shoulder to the elbow. "Red mottling was present". The events resolved after approximately 30 days. A 15-day follow up report received 05/28/2003 adds: This report describes an injection site reaction in a 5-year-old female who received her 5th injection of diphtheria and tetanus toxoids and acellular persussis vaccine adsorbed, however the first with Infanrix. The reporting physician considered the events to be related to Infanrix administration.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site swelling, Livedo reticularis
Clinical narrative: This report describes limb swelling in a 5 year old female who received an injection of Infanrix. This report was received from the child's mother and has not been verified by a physician or other healthcare professional.  On 11/06/01, the vaccinee received her fifth injection of Infanrix. On 11/06/01, an unspecified time, post-vaccination, the vaccinee developed "severe' redness at the injection site and swelling from the shoulder to the elbow. "Red mottling was present". The events resolved after approximately 30 days. A 15-day follow up report received 05/28/2003 adds: This report describes an injection site reaction in a 5-year-old female who received her 5th injection of diphtheria and tetanus toxoids and acellular persussis vaccine adsorbed, however the first with Infanrix. The reporting physician considered the events to be related to Infanrix administration.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Jaundice, Malaise, Pyrexia, Vomiting
Clinical narrative: Reprot 0260599A describes an abnormal liver in a 4 year old male who received hep A vaccine inactivated. This report was received from the child's mother and has not been verified by a physician or other healthcare professional. There was not relevant medical history or concurrent conditions. Concurrent medications were not specified. On 01/25/2002, the vaccinee received his first injection of Havrix. He also received his firfth injection of Infanrix, his fourth injection of IPOL, his second injection of MMR II, and his first tuberculin skin test. Within 24 hrs, the vaccinee developed a fever and he was treated with Motirn. On 01/27/2002, two days post-vaccination, he had one episode of vomiting. His mother noted that his skin color and the "whites of his eyes" were yellow. The vaccinee reported to his mother that his urine was "black." On 01/28/2002, the vaccinee was seen by a physician, who noted that the vaccinee's liver was "slightly enlarged" and he had jaundice. The child returned to the physician on 02/20/2002; lab tests "came back okay." The physician reportedly told the vaccinee's mother that the jaundice would resolve in a "couple of weeks." All other events resolved within one to four days of their onset.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Blood bilirubin increased, Chromaturia, Eye disorder, Hepatomegaly, Jaundice
Clinical narrative: Reprot 0260599A describes an abnormal liver in a 4 year old male who received hep A vaccine inactivated. This report was received from the child's mother and has not been verified by a physician or other healthcare professional. There was not relevant medical history or concurrent conditions. Concurrent medications were not specified. On 01/25/2002, the vaccinee received his first injection of Havrix. He also received his firfth injection of Infanrix, his fourth injection of IPOL, his second injection of MMR II, and his first tuberculin skin test. Within 24 hrs, the vaccinee developed a fever and he was treated with Motirn. On 01/27/2002, two days post-vaccination, he had one episode of vomiting. His mother noted that his skin color and the "whites of his eyes" were yellow. The vaccinee reported to his mother that his urine was "black." On 01/28/2002, the vaccinee was seen by a physician, who noted that the vaccinee's liver was "slightly enlarged" and he had jaundice. The child returned to the physician on 02/20/2002; lab tests "came back okay." The physician reportedly told the vaccinee's mother that the jaundice would resolve in a "couple of weeks." All other events resolved within one to four days of their onset.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Pyrexia, Yellow skin
Clinical narrative: Reprot 0260599A describes an abnormal liver in a 4 year old male who received hep A vaccine inactivated. This report was received from the child's mother and has not been verified by a physician or other healthcare professional. There was not relevant medical history or concurrent conditions. Concurrent medications were not specified. On 01/25/2002, the vaccinee received his first injection of Havrix. He also received his firfth injection of Infanrix, his fourth injection of IPOL, his second injection of MMR II, and his first tuberculin skin test. Within 24 hrs, the vaccinee developed a fever and he was treated with Motirn. On 01/27/2002, two days post-vaccination, he had one episode of vomiting. His mother noted that his skin color and the "whites of his eyes" were yellow. The vaccinee reported to his mother that his urine was "black." On 01/28/2002, the vaccinee was seen by a physician, who noted that the vaccinee's liver was "slightly enlarged" and he had jaundice. The child returned to the physician on 02/20/2002; lab tests "came back okay." The physician reportedly told the vaccinee's mother that the jaundice would resolve in a "couple of weeks." All other events resolved within one to four days of their onset.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Report A0360245A describes seizures in a 6 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from manufacturer, who received it from a healthcare professional. This report has also been forwarded to a medical institute. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 24 JAN 2002, the infant received her second injection of Infanrix. On that date, she also received her first injection of 7 valent pneumococcal conjugate vaccine and her second injection of hepatitis B vaccine recombinant and Haemophilus influenzae type b conjugate vaccine. On 25 JAN 2002, one day post immunization, the infant developed a high fever and seizures. She was taken to the local ER and hospitalized. She recovered and was discharged from the hospital after an unspecified period of time. Follow up on 11/25/03: "From additional correspondence received at AP Inc on 02/26/2002 from WA, it was reported "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever.  The infant was brought to the hospital and was admitted.  No additional info was available as of the date of this report.  Additional info received 02/05/02 from sales representative (VAERS form).  A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), 2nd dose of Act-HIB (AP) (haemophilus B conjugate vaccine) and 2nd dose of Engerix-B (GSK) (hepatitis B vaccine) on 01/24/02.  On 01/25/02, the pt developed a "high" fever and seizures.  The infant was brought to the hospital and was admitted.  She was discharged from the hospital and she recovered.  No additional info was available as of the date of this report."
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Aspartate aminotransferase increased, Convulsion, Heart rate increased, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: Report A0360245A describes seizures in a 6 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from manufacturer, who received it from a healthcare professional. This report has also been forwarded to a medical institute. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 24 JAN 2002, the infant received her second injection of Infanrix. On that date, she also received her first injection of 7 valent pneumococcal conjugate vaccine and her second injection of hepatitis B vaccine recombinant and Haemophilus influenzae type b conjugate vaccine. On 25 JAN 2002, one day post immunization, the infant developed a high fever and seizures. She was taken to the local ER and hospitalized. She recovered and was discharged from the hospital after an unspecified period of time. Follow up on 11/25/03: "From additional correspondence received at AP Inc on 02/26/2002 from WA, it was reported "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever.  The infant was brought to the hospital and was admitted.  No additional info was available as of the date of this report.  Additional info received 02/05/02 from sales representative (VAERS form).  A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), 2nd dose of Act-HIB (AP) (haemophilus B conjugate vaccine) and 2nd dose of Engerix-B (GSK) (hepatitis B vaccine) on 01/24/02.  On 01/25/02, the pt developed a "high" fever and seizures.  The infant was brought to the hospital and was admitted.  She was discharged from the hospital and she recovered.  No additional info was available as of the date of this report."
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia, Somnolence, Tremor
Clinical narrative: Report A0360245A describes seizures in a 6 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from manufacturer, who received it from a healthcare professional. This report has also been forwarded to a medical institute. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 24 JAN 2002, the infant received her second injection of Infanrix. On that date, she also received her first injection of 7 valent pneumococcal conjugate vaccine and her second injection of hepatitis B vaccine recombinant and Haemophilus influenzae type b conjugate vaccine. On 25 JAN 2002, one day post immunization, the infant developed a high fever and seizures. She was taken to the local ER and hospitalized. She recovered and was discharged from the hospital after an unspecified period of time. Follow up on 11/25/03: "From additional correspondence received at AP Inc on 02/26/2002 from WA, it was reported "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever.  The infant was brought to the hospital and was admitted.  No additional info was available as of the date of this report.  Additional info received 02/05/02 from sales representative (VAERS form).  A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), 2nd dose of Act-HIB (AP) (haemophilus B conjugate vaccine) and 2nd dose of Engerix-B (GSK) (hepatitis B vaccine) on 01/24/02.  On 01/25/02, the pt developed a "high" fever and seizures.  The infant was brought to the hospital and was admitted.  She was discharged from the hospital and she recovered.  No additional info was available as of the date of this report."
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Report A0360245A describes seizures in a 6 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from manufacturer, who received it from a healthcare professional. This report has also been forwarded to a medical institute. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 24 JAN 2002, the infant received her second injection of Infanrix. On that date, she also received her first injection of 7 valent pneumococcal conjugate vaccine and her second injection of hepatitis B vaccine recombinant and Haemophilus influenzae type b conjugate vaccine. On 25 JAN 2002, one day post immunization, the infant developed a high fever and seizures. She was taken to the local ER and hospitalized. She recovered and was discharged from the hospital after an unspecified period of time. Follow up on 11/25/03: "From additional correspondence received at AP Inc on 02/26/2002 from WA, it was reported "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever.  The infant was brought to the hospital and was admitted.  No additional info was available as of the date of this report.  Additional info received 02/05/02 from sales representative (VAERS form).  A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), 2nd dose of Act-HIB (AP) (haemophilus B conjugate vaccine) and 2nd dose of Engerix-B (GSK) (hepatitis B vaccine) on 01/24/02.  On 01/25/02, the pt developed a "high" fever and seizures.  The infant was brought to the hospital and was admitted.  She was discharged from the hospital and she recovered.  No additional info was available as of the date of this report."
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Report A0360245A describes seizures in a 6 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from manufacturer, who received it from a healthcare professional. This report has also been forwarded to a medical institute. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 24 JAN 2002, the infant received her second injection of Infanrix. On that date, she also received her first injection of 7 valent pneumococcal conjugate vaccine and her second injection of hepatitis B vaccine recombinant and Haemophilus influenzae type b conjugate vaccine. On 25 JAN 2002, one day post immunization, the infant developed a high fever and seizures. She was taken to the local ER and hospitalized. She recovered and was discharged from the hospital after an unspecified period of time. Follow up on 11/25/03: "From additional correspondence received at AP Inc on 02/26/2002 from WA, it was reported "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever.  The infant was brought to the hospital and was admitted.  No additional info was available as of the date of this report.  Additional info received 02/05/02 from sales representative (VAERS form).  A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), 2nd dose of Act-HIB (AP) (haemophilus B conjugate vaccine) and 2nd dose of Engerix-B (GSK) (hepatitis B vaccine) on 01/24/02.  On 01/25/02, the pt developed a "high" fever and seizures.  The infant was brought to the hospital and was admitted.  She was discharged from the hospital and she recovered.  No additional info was available as of the date of this report."
Age: 0.08
Sex: M
Vaccine: DTP, HIBV, PNC, DTAP, HIBV, PNC, DTP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Gastrointestinal disorder, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: Report 2001028836-2 describes intermittent vomiting in a 6 week old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. Medical history included an "innocent ventricular heart murmur" and fever following receipt of hep B vaccine recombinant. Concurrent conditions and medications were not specified. There was no illness at the time of immunization. On 10/24/2001, the infant received his first injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, Prevnar, and Hib vaccine. The infant experienced emesis on 10/30/2001. On 11/27/2001, when the infant was 2 months old, he received his second injection of Engerix-B and an injection of IPOL. Two days later, on 11/29/2001, the infant again experienced emesis. He was seen in the physician's office, and blood was drawn for unspecified lab analyses. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/2001 and 01/03/2002. As of 01/07/2002, the infant was being evaluated for possible malrotation or volvulus of the stomach. As of 01/11/2002, the intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation, or volvulus of the stomach.
Age: 0.08
Sex: M
Vaccine: DTP, HIBV, PNC, DTAP, HIBV, PNC, DTP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Viral infection, Vomiting
Clinical narrative: Report 2001028836-2 describes intermittent vomiting in a 6 week old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. Medical history included an "innocent ventricular heart murmur" and fever following receipt of hep B vaccine recombinant. Concurrent conditions and medications were not specified. There was no illness at the time of immunization. On 10/24/2001, the infant received his first injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, Prevnar, and Hib vaccine. The infant experienced emesis on 10/30/2001. On 11/27/2001, when the infant was 2 months old, he received his second injection of Engerix-B and an injection of IPOL. Two days later, on 11/29/2001, the infant again experienced emesis. He was seen in the physician's office, and blood was drawn for unspecified lab analyses. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/2001 and 01/03/2002. As of 01/07/2002, the infant was being evaluated for possible malrotation or volvulus of the stomach. As of 01/11/2002, the intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation, or volvulus of the stomach.
Age: 0.08
Sex: M
Vaccine: DTP, HIBV, PNC, DTAP, HIBV, PNC, DTP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Report 2001028836-2 describes intermittent vomiting in a 6 week old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. Medical history included an "innocent ventricular heart murmur" and fever following receipt of hep B vaccine recombinant. Concurrent conditions and medications were not specified. There was no illness at the time of immunization. On 10/24/2001, the infant received his first injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, Prevnar, and Hib vaccine. The infant experienced emesis on 10/30/2001. On 11/27/2001, when the infant was 2 months old, he received his second injection of Engerix-B and an injection of IPOL. Two days later, on 11/29/2001, the infant again experienced emesis. He was seen in the physician's office, and blood was drawn for unspecified lab analyses. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/2001 and 01/03/2002. As of 01/07/2002, the infant was being evaluated for possible malrotation or volvulus of the stomach. As of 01/11/2002, the intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation, or volvulus of the stomach.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Somnolence, Staring
Clinical narrative: Report A0361638A describes seizures in a 6 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. There was no relevant medical history, concurrent conditions, or concurrent medications. There was a family history of seizures in children, including the vaccinee's cousin. The infant had no adverse experiences following receipt of prior immunizations. On 25 FEB 2002, the infant received his third injections of Infanrix (lot DTPA527A2) and hepatitis B vaccine recombinant. on the same date, he received injections of inactivated poliomyelitis virus vaccine and Haemophilus influenzae type b conjugate vaccine. On 26 FEB 2002, the mother reported that the infant was out of it. He eats and then falls back to sleep; he opens his eyes and just stares. The infant was seen by the physician who witnessed a seizure. The infant was immediately admitted to the hospital. An electroencephalogram, computer tomogram (CT) of the head, and MRI were performed. Results of the CT of the head were interpreted as normal; results of the other procedures were not provided. The infant was treated with phenytoin sodium and phenobarbitol. The Infanrix immunization series was discontinued. As of 10 APR 2002, the outcome of the seizures was unknown.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Convulsion
Clinical narrative: Report A0361638A describes seizures in a 6 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. There was no relevant medical history, concurrent conditions, or concurrent medications. There was a family history of seizures in children, including the vaccinee's cousin. The infant had no adverse experiences following receipt of prior immunizations. On 25 FEB 2002, the infant received his third injections of Infanrix (lot DTPA527A2) and hepatitis B vaccine recombinant. on the same date, he received injections of inactivated poliomyelitis virus vaccine and Haemophilus influenzae type b conjugate vaccine. On 26 FEB 2002, the mother reported that the infant was out of it. He eats and then falls back to sleep; he opens his eyes and just stares. The infant was seen by the physician who witnessed a seizure. The infant was immediately admitted to the hospital. An electroencephalogram, computer tomogram (CT) of the head, and MRI were performed. Results of the CT of the head were interpreted as normal; results of the other procedures were not provided. The infant was treated with phenytoin sodium and phenobarbitol. The Infanrix immunization series was discontinued. As of 10 APR 2002, the outcome of the seizures was unknown.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Convulsion, Staring, Unevaluable event
Clinical narrative: Report A0361638A describes seizures in a 6 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. There was no relevant medical history, concurrent conditions, or concurrent medications. There was a family history of seizures in children, including the vaccinee's cousin. The infant had no adverse experiences following receipt of prior immunizations. On 25 FEB 2002, the infant received his third injections of Infanrix (lot DTPA527A2) and hepatitis B vaccine recombinant. on the same date, he received injections of inactivated poliomyelitis virus vaccine and Haemophilus influenzae type b conjugate vaccine. On 26 FEB 2002, the mother reported that the infant was out of it. He eats and then falls back to sleep; he opens his eyes and just stares. The infant was seen by the physician who witnessed a seizure. The infant was immediately admitted to the hospital. An electroencephalogram, computer tomogram (CT) of the head, and MRI were performed. Results of the CT of the head were interpreted as normal; results of the other procedures were not provided. The infant was treated with phenytoin sodium and phenobarbitol. The Infanrix immunization series was discontinued. As of 10 APR 2002, the outcome of the seizures was unknown.
Age: 41.0
Sex: M
Vaccine: HEPA, YF, YF
Symptoms: CSF test abnormal, Cyst, Haematocrit decreased, Headache, Laboratory test abnormal
Clinical narrative: It was reported that a 41 year old male pt was vaccinated with Yellow Fever on 02/07/2002. On 02/11/2002, the pt developed Encephalitis. Specific IgM directed against YF in the CSF which may suggest CNS infection with 17D.
Age: 41.0
Sex: M
Vaccine: HEPA, YF, YF
Symptoms: Myalgia, Platelet count increased, Pyrexia, Red blood cell count decreased, Red blood cell sedimentation rate increased
Clinical narrative: It was reported that a 41 year old male pt was vaccinated with Yellow Fever on 02/07/2002. On 02/11/2002, the pt developed Encephalitis. Specific IgM directed against YF in the CSF which may suggest CNS infection with 17D.
Age: 41.0
Sex: M
Vaccine: HEPA, YF, YF
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: It was reported that a 41 year old male pt was vaccinated with Yellow Fever on 02/07/2002. On 02/11/2002, the pt developed Encephalitis. Specific IgM directed against YF in the CSF which may suggest CNS infection with 17D.
Age: 41.0
Sex: M
Vaccine: HEPA, YF, YF
Symptoms: CSF test abnormal, Encephalitis, Nervous system disorder
Clinical narrative: It was reported that a 41 year old male pt was vaccinated with Yellow Fever on 02/07/2002. On 02/11/2002, the pt developed Encephalitis. Specific IgM directed against YF in the CSF which may suggest CNS infection with 17D.
Age: 0.19
Sex: U
Vaccine: DTAP, HIBV, IPV, DTAP, IPV, PNC
Symptoms: Urticaria
Clinical narrative: This report described hives in a two-month old vaccine of unspecified gender who received DTaP. On 03/08/01, the vaccinee received the first intramuscular-left thigh dose of DTaP, the first dose of Haemophilus b conjugate vaccine and the first dose of IPV. Eight days later, on 03/15/01, the vaccinee developed hives. The vaccine was treated with diphenhydramine hydrochloride and recovered. As of 04/25/01, the adverse event recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Crying, Cyanosis, Loss of consciousness, Rash, Somnolence
Clinical narrative: Report 2001028435-1 describes a 2 month old male infant who turned blue after receiving Infanrix. Medical history was not specified. Concurrent conditions included an upper respiratory infection. There were no concurrent medicaitons. On 11/15/2001, the vaccinee received his first injections of Infanrix, hep B, PedvaxHIB, and IPOL. Within five minutes post-immunization, the infant began crying, turned blue, "appeared to either fall asleep or pass out," developed an urticarial rash on the face and body, experienced fussiness, and had a low-grade fever. The infant was observed in the physician's office for two hours. The rash lasted 1.5 hours. The other events had also resolved, and the infant was sent home. The reporting physician considered the events to be possibly related to Infanrix and Engerix-B administration.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Cyanosis, Irritability, Pyrexia, Somnolence, Syncope
Clinical narrative: Report 2001028435-1 describes a 2 month old male infant who turned blue after receiving Infanrix. Medical history was not specified. Concurrent conditions included an upper respiratory infection. There were no concurrent medicaitons. On 11/15/2001, the vaccinee received his first injections of Infanrix, hep B, PedvaxHIB, and IPOL. Within five minutes post-immunization, the infant began crying, turned blue, "appeared to either fall asleep or pass out," developed an urticarial rash on the face and body, experienced fussiness, and had a low-grade fever. The infant was observed in the physician's office for two hours. The rash lasted 1.5 hours. The other events had also resolved, and the infant was sent home. The reporting physician considered the events to be possibly related to Infanrix and Engerix-B administration.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: Report 2001028435-1 describes a 2 month old male infant who turned blue after receiving Infanrix. Medical history was not specified. Concurrent conditions included an upper respiratory infection. There were no concurrent medicaitons. On 11/15/2001, the vaccinee received his first injections of Infanrix, hep B, PedvaxHIB, and IPOL. Within five minutes post-immunization, the infant began crying, turned blue, "appeared to either fall asleep or pass out," developed an urticarial rash on the face and body, experienced fussiness, and had a low-grade fever. The infant was observed in the physician's office for two hours. The rash lasted 1.5 hours. The other events had also resolved, and the infant was sent home. The reporting physician considered the events to be possibly related to Infanrix and Engerix-B administration.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: The medical history, concurrent conditions and concurrent medications were not specified. On an unspecified date, the pt received an injection of Engerix-B. It was not known if the pt had received previous injections of Engerix-B. In 1 part of the claim, the attorney alleged that the pt was immunized "during the time from 3/93 and 9/94". In another part of the claim, the attorney alleged that the pt was immunized "during the period from 8/97 to 12/98". The pt also received injections of DTP vaccine adsorbed (Tri-Immunol); DTAP vaccine adsorbed (Acel-Immune; MMR; Hib type B conjugate vaccine (Hib-Titer) and Hep-B vaccine recombinant (Recombivax-HB). The pt's attorney alleged that "Through the thimerosal-containing vaccinations administered to him during the 1st 2 years of his life, (he) was poisoned by cumulative doses of mercury in the thimerosal. As a result of the thimerosal-containing vaccination received as an infant, (he) now suffers and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." This report of mercury poisoning is considered to be "Medically Serious".
Sex: U
Vaccine: FLU3
Symptoms: Multiple sclerosis, Neurological symptom
Clinical narrative: A report was received from a health professional on 10/11/2001, concerning a pt of unknown demography who developed multiple sclerosis and neurological symptoms which were disabling/incapacitating, shortly after receiving the Fluvirin vaccine on 10/21/1996. On 10/21/1996, the pt developed multiple sclerosis and neurological symptoms, shortly after receiving the Fluvirin vaccine. The pt has not received any flu vaccinations since 1996. The pt had not recovered at time of report. The reporter has assessed the relationship of study medication to the events as unknown.
Age: 71.0
Sex: M
Vaccine: YF, HEPA, TYP, YF
Symptoms: CSF test abnormal, Encephalitis, Nervous system disorder
Clinical narrative: It was reported that a 71 year old male pt received a Yellow fever vaccination on 10/04/2002. It was reported that the onset date for symptoms was 10/10/2001. Illness occurred on day 7. Pt had specific IgM directed against YF in the CSF which may suggest CNS infection with 17D. Testing to date has been inconclusive and some cultures are still pending.
Age: 71.0
Sex: M
Vaccine: YF, HEPA, TYP, YF
Symptoms: Deep vein thrombosis, Dehydration, Encephalitis, Hallucination, Pyrexia
Clinical narrative: It was reported that a 71 year old male pt received a Yellow fever vaccination on 10/04/2002. It was reported that the onset date for symptoms was 10/10/2001. Illness occurred on day 7. Pt had specific IgM directed against YF in the CSF which may suggest CNS infection with 17D. Testing to date has been inconclusive and some cultures are still pending.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Immune system disorder, Injection site swelling, Pyrexia
Clinical narrative: Arm swollen from elbow to axilla and temperature 102F. Temperature was 106F on admission to the hospital. No other pts experienced this reaction. Immunity problems and further tests are being done. A follow up report received 6/6/2002 adds: Diagnosis was cellulitis.
Age: 19.0
Sex: F
Vaccine: HEPAB, TD, YF
Symptoms: Dizziness, Dyspnoea, Hypoglycaemia, Lethargy, Muscle spasms
Clinical narrative: 5/22/02- Pt stated she felt "dizzy" all afternoon after vaccination. That evening around 9:00 pm, she "passed out". Mother states that she witnessed "posturing" or curving of the fingers for approximately 2 minutes. "Lethargic" for approximately 45 minutes. History of hypoglycemia with similar in past. 5/23/02 -  Pt c/o "cramping in fingers," dizziness and hard to breathe ,like a brick on her chest. Advised to seek medical help 5/24/02-still experiencing dizziness. Treatment recommended by physician.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Laboratory test abnormal, Pyrexia
Clinical narrative: Fever since evening of 5/6/02, Irritable crying, Temperature 104.8 rectally at noon 5/9/02, Has been treated w/Tylenol, Directed pt to other facility on 5/9/02
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes simplex, Influenza, Skin ulcer
Clinical narrative: Pt received flu vaccine 10/22/01 and experienced a flu like syndrome for a short while he has had recurrent herpes simplex lesion on her buttocks. episodes went from being very infrequent to 1-2 events every month. Clearly related to menstrual cycle Lesions respond to Denavir (topical).
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Was given the flu shot on his first day of feeling better after being ill for several weeks with a virus. By evening of the same day, he had to go to bed due to feeling ill with fever, aches and malaise for the next 48 hrs.