chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Croup infectious, Crying, Deafness bilateral, Demyelination, Drug dependence
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Dyspepsia, Encephalopathy, Endotracheal intubation, Extracorporeal membrane oxygenation, Eye movement disorder
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Hyponatraemia, Hypoxia, IIIrd nerve paresis, Influenza, Influenza like illness
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Lethargy, Lung disorder, Meningitis pneumococcal, Otitis media
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pallor, Pneumothorax, Pupils unequal, Pyrexia, Respiratory failure
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sepsis, Strabismus, Thrombocytopenia, Torticollis, Upper respiratory tract infection
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Bacterial infection, Cerebrovascular accident, Croup infectious, Crying
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Deafness, Dyspnoea, Hypoxia, Influenza, Limb malformation
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Lung disorder, Meningitis, Nervous system disorder, Pneumonia, Pyrexia
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Respiratory distress, Respiratory failure, Screaming, Sepsis, Shock
Clinical narrative: A six month old male patient, who had a concurrent diagnosis of mild upper respiratory infection with a cough fussiness, and who was afebrile, had received a third dose of ActHib, lot number UA850AA (lot number W1231-2), a second dose of IPOL, lot number W1156-2, a third dose of Tripedia, lot number U1006BA, and a dose of Prevnar, lot number 493378 on 08 December 2003 at 11:30 am. The patients two older siblings were diagnosed with influenza around the time of the visit, both having fever of 104.0 to 105.0 degrees F. The patient went home after the immunization, and slept for approximately four hours. the mother woke the patient at around 17:00 pm, five and a half hours post immunization, and the patient was febrile. His temperature was 103.0 degrees F, and the mother called the doctors office because she was concerned. The mother was told that the fever was probably from the vaccinations the patient had received earlier, and to give him some Tylenol. Approximately four and a half hours later, around 21:30pm, the patient's fever increased to 103.3 degrees F, and he was having inconsolable crying that lasted all night ling, and he had difficulty breathing (mother stated she heard noise when the child would breath). The mother stated that she used a nebulizer to try to reduce the patients breathing difficulty. The following morning, the mother took the patient to the physicians office for evaluation. The patient was still in respiratory distress with an oxygen saturation of 90%. The patient was taken to the emergency room, and on route to the hospital he went into respiratory failure and was intubated. The patient was diagnosed with influenza type A and croup. treatment received and diagnostic performed were not reported. The following day, the patient was extubated and appeared to be doing better. Two days later, the patient still had a fever and his symptoms worsened and his lungs collapsed with Pneumococcal meningitis. Strep pneumonia and septic shock. The patient also suffered strokes. Treatments received and diagnostic performed other than the spinal tap were not reported. The patient was discharged from the hospital on 14 January 2004, 36 days after admission. Per the mother, the patient is deaf and has cochlear implants as a result of the meningitis. Three areas of his brain are affected. The left body side is affected (the mother did not specify how it was affected). The patients left leg is shouter in length then the right, and he wears a brace. At the time of this report, the patient had not recovered.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Choking, Diarrhoea, Dyspnoea, Gastroenteritis, Ileus
Clinical narrative: Information has been received from a physician concerning a 10-week-old female with no medical history or allergies who on 08-Nov-2006 was vaccinated PO with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human0bovine). Concomitant vaccinations administered on that same day included a dose of Hib conj vaccine and a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX). The physician reported that on 12-Nov-2006, about four days after being vaccinated rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine), the patient developed severe vomiting and diarrhea. She vomited 10 times in an hour. Unspecified medical attention was sought. The patient was subsequently hospitalized and was given intravenous (IV) fluid replacement. On 13-Nov-2006, the patient was discharged from the hospital. On 21-Nov-2006, the patient started to vomit again. She was again admitted to the hospital. At the time of this report, the patient was still hospitalized. A stool test for rotavirus and a complete blood count (CBC) were performed (results not provided). It was noted that the patient was recovering. The physician also considered the vomiting and diarrhea to be other important medical events due to IV fluid replacement (OMIC). Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Laboratory test abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 10-week-old female with no medical history or allergies who on 08-Nov-2006 was vaccinated PO with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human0bovine). Concomitant vaccinations administered on that same day included a dose of Hib conj vaccine and a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX). The physician reported that on 12-Nov-2006, about four days after being vaccinated rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine), the patient developed severe vomiting and diarrhea. She vomited 10 times in an hour. Unspecified medical attention was sought. The patient was subsequently hospitalized and was given intravenous (IV) fluid replacement. On 13-Nov-2006, the patient was discharged from the hospital. On 21-Nov-2006, the patient started to vomit again. She was again admitted to the hospital. At the time of this report, the patient was still hospitalized. A stool test for rotavirus and a complete blood count (CBC) were performed (results not provided). It was noted that the patient was recovering. The physician also considered the vomiting and diarrhea to be other important medical events due to IV fluid replacement (OMIC). Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 10-week-old female with no medical history or allergies who on 08-Nov-2006 was vaccinated PO with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human0bovine). Concomitant vaccinations administered on that same day included a dose of Hib conj vaccine and a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX). The physician reported that on 12-Nov-2006, about four days after being vaccinated rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine), the patient developed severe vomiting and diarrhea. She vomited 10 times in an hour. Unspecified medical attention was sought. The patient was subsequently hospitalized and was given intravenous (IV) fluid replacement. On 13-Nov-2006, the patient was discharged from the hospital. On 21-Nov-2006, the patient started to vomit again. She was again admitted to the hospital. At the time of this report, the patient was still hospitalized. A stool test for rotavirus and a complete blood count (CBC) were performed (results not provided). It was noted that the patient was recovering. The physician also considered the vomiting and diarrhea to be other important medical events due to IV fluid replacement (OMIC). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain lower, Gastrointestinal disorder, Laboratory test abnormal, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She is being referred to a specialist to rule out appendicitis. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Insomnia
Clinical narrative: Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She is being referred to a specialist to rule out appendicitis. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain, Appendicectomy, Appendicitis, Computerised tomogram
Clinical narrative: Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She is being referred to a specialist to rule out appendicitis. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count, Insomnia, Ultrasound abdomen, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She is being referred to a specialist to rule out appendicitis. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Dyspnoea, Erythema, Pain, Swelling
Clinical narrative: Redness, warmth, edema right upper arm. F/A /hand.
Age: 64.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Redness, warmth, edema right upper arm. F/A /hand.
Age: 0.21
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intestinal gangrene, Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 15 week old female who at the end of November 2006, was vaccinated PO with the first 2.0 ml dose of Rotavirus vaccine. the physician reported that in early December 2006, three days after receiving Rotavirus vaccine, the patient developed intussusception and was hospitalized. The patient underwent surgery for the intussusception over the first weekend of December 2006. At the time of this report, the outcome was unknown and it was uncertain if the patient was still hospitalized for for how long. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 15 week old female who at the end of November 2006, was vaccinated PO with the first 2.0 ml dose of Rotavirus vaccine. the physician reported that in early December 2006, three days after receiving Rotavirus vaccine, the patient developed intussusception and was hospitalized. The patient underwent surgery for the intussusception over the first weekend of December 2006. At the time of this report, the outcome was unknown and it was uncertain if the patient was still hospitalized for for how long. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an approximately 15 week old female who at the end of November 2006, was vaccinated PO with the first 2.0 ml dose of Rotavirus vaccine. the physician reported that in early December 2006, three days after receiving Rotavirus vaccine, the patient developed intussusception and was hospitalized. The patient underwent surgery for the intussusception over the first weekend of December 2006. At the time of this report, the outcome was unknown and it was uncertain if the patient was still hospitalized for for how long. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLU3, HEP, FLU3, HEP
Symptoms: Hypotonia, Injection site pain, Laboratory test abnormal, Myositis, Pyrexia
Clinical narrative: Initial report received on 06 December 2006 from a consumer and additional information provided via contact with health care professionals. A four year old female patient had received a first dose, intramuscular, left thigh injection for Fluzone,lot number U2281AA, and a first dose, intramuscular, right thigh injection of Hepatitis B vaccine, lot number 0614R, on 28 November 2006. Fluzone had been administered from a multidose viral from which no other patient developed any problems. Illness at the time of vaccination included a mild upper body rash that started approximately seven days prior to immunization. At the time of immunization, the patient had two rash spots remaining on her right underarm. Five days post immunization, the patient experienced left thigh pain, limp, and fever (temperature not specified). there was no cellulitis. WBC was 19,000 and CRP was 77.7, ESR was 24. Follow up laboratory results the next day revealed ESR was 82. MRI showed myositis. The patient was diagnosed with myositis of the left rectus femoris (initially reported as a bone infection) and was admitted to the hospital. Blood culture, urine culture, and strep culture of the throat were negative. The patient was treated with intravenous Cefazolin. Infectious disease consultant noted that there was no basis for suspecting contaminated vaccine, find no such note in the chart, and no house staff admit to saying that. The event required hospitalization for two days, and the patient subsequently recovered from the event.
Age: 4.0
Sex: F
Vaccine: FLU3, HEP, FLU3, HEP
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Initial report received on 06 December 2006 from a consumer and additional information provided via contact with health care professionals. A four year old female patient had received a first dose, intramuscular, left thigh injection for Fluzone,lot number U2281AA, and a first dose, intramuscular, right thigh injection of Hepatitis B vaccine, lot number 0614R, on 28 November 2006. Fluzone had been administered from a multidose viral from which no other patient developed any problems. Illness at the time of vaccination included a mild upper body rash that started approximately seven days prior to immunization. At the time of immunization, the patient had two rash spots remaining on her right underarm. Five days post immunization, the patient experienced left thigh pain, limp, and fever (temperature not specified). there was no cellulitis. WBC was 19,000 and CRP was 77.7, ESR was 24. Follow up laboratory results the next day revealed ESR was 82. MRI showed myositis. The patient was diagnosed with myositis of the left rectus femoris (initially reported as a bone infection) and was admitted to the hospital. Blood culture, urine culture, and strep culture of the throat were negative. The patient was treated with intravenous Cefazolin. Infectious disease consultant noted that there was no basis for suspecting contaminated vaccine, find no such note in the chart, and no house staff admit to saying that. The event required hospitalization for two days, and the patient subsequently recovered from the event.
Age: 4.0
Sex: F
Vaccine: FLU3, HEP, FLU3, HEP
Symptoms: Gait disturbance, Injection site pain, Laboratory test abnormal, Myositis, Pyrexia
Clinical narrative: Initial report received on 06 December 2006 from a consumer and additional information provided via contact with health care professionals. A four year old female patient had received a first dose, intramuscular, left thigh injection for Fluzone,lot number U2281AA, and a first dose, intramuscular, right thigh injection of Hepatitis B vaccine, lot number 0614R, on 28 November 2006. Fluzone had been administered from a multidose viral from which no other patient developed any problems. Illness at the time of vaccination included a mild upper body rash that started approximately seven days prior to immunization. At the time of immunization, the patient had two rash spots remaining on her right underarm. Five days post immunization, the patient experienced left thigh pain, limp, and fever (temperature not specified). there was no cellulitis. WBC was 19,000 and CRP was 77.7, ESR was 24. Follow up laboratory results the next day revealed ESR was 82. MRI showed myositis. The patient was diagnosed with myositis of the left rectus femoris (initially reported as a bone infection) and was admitted to the hospital. Blood culture, urine culture, and strep culture of the throat were negative. The patient was treated with intravenous Cefazolin. Infectious disease consultant noted that there was no basis for suspecting contaminated vaccine, find no such note in the chart, and no house staff admit to saying that. The event required hospitalization for two days, and the patient subsequently recovered from the event.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC, VARZOS, DTAPHEPBIP, HEPA, HIBV, PNC, VARZOS
Symptoms: Headache, Vomiting, Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a registered nurse concerning a 4.5 year old female who on 15-Nov-2006 between 1:00 PM and 4:00 PM was vaccinated SC with a 0.5 mL first dose of varicella-zoster virus vaccine live (Merck) (lot # 652946/1012F) instead of a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD). Concomitant vaccination at the same time included an IM first dose in the right deltoid of VAQTA (lot # 655301/0741F), an IM third dose in the right deltoid of PEDVAXHIB (lot # 652863/0401F), an IM third dose in the right deltoid of PREVNAR (lot # B08682E), and an IM third dose in the left deltoid of PEDIARIX (lot # AC21B070AA). There was no illness at the time of vaccination. It was noted that there was no product confusion. No medical attention was sought. Additional information was received from the administering nurse who reported that there was no confusion with the packaging. They kept measles virus vaccine Live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD), varicella virus vaccine live (Merck) (MSD), and varicella-zoster virus vaccine live (Merck) in the freezer together with an intranasal flu vaccine. Occasionally, the flu vaccine would fall onto the other small vaccine boxes. They took the top lid off of the boxes so they could easily get to the vials of vaccine. At some point, the boxes got tipped over and someone put the vaccine into the wrong box. The reporter looked for measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD) in the purple box and grabbed the vial, not realizing that the lid was the wrong color. Essentially, someone put the vaccine in the wrong box and he did not catch it. He realized a week later that the wrong vaccine was given. Additional information has been requested. Additional information has been received from the administering nurse. He noted that the parent reported that on 23-NOV-2006 the patient developed a headache and vomiting for 24 hours. No medical attention was sought and the patient recovered on an unspecified date. No further information was expected.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Skin burning sensation
Clinical narrative: Receive flu shot 10/17/06. 10/28 and 10/29 soreness at injection site Right deltoid. 10/30 noted burning sensation Left arm, left shoulder, left forearm onto L chest-continued thru today. Some days intermittent some days worse then others. To Employee Health-Emergency department to rule out cardiac, PCP
Age: 0.37
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Erythema, Injection site swelling, Lethargy, Rash macular
Clinical narrative: Within 5 minutes after administration completed of all 5 vaccines. Patient became lethargic, remarkable redness and swelling of injection sites on both legs, remarkable blotchiness of entire upper leg and scattered on torso. Upon immediate okay by myself and doctor. No respiratory distress/ B>E and clear given Zyretec syrup 2.5mg after 30-45 minutes. Reactions has resolved. Patient to be evaluated by pediatric allergist after administration of any shots.
Age: 0.19
Sex: M
Vaccine: DTAP, PNC, RV5
Clinical narrative: Pt received Daptacel, Prevnar and Rotateq on 12/04/2006. Also his twin brother received at the same time. Did not have any SX. On 12/09/06 mom fed them at 5am and found them dead at 9:00 am.   6/29/07 Received Autopsy Report which reveals COD as Undetermined & contributing condition simultaneous death of twin brother.  Pathological Dx: I. Sudden unexpected infant death     A. Twin B infant male found unresponsive in crib on stomach     B. Vitreous electrolytes, abnormal, w/decreased Na & increased Cl, urea nitrogen, calcium, carbon dioxide     C. Brain congestion & edema, neuronal heterotopia & insular micro-dysgenesis, mild focal. II. Ancillary studies, other, non-contributory. III. Simultaneous death of twin brother IV.  Fractures, ribs, anterior & lateral, w/minimal hemorrhage.
Age: 0.2
Sex: M
Vaccine: DTAP, PNC, RV5
Clinical narrative: Client received Daptacel, Prevnar, and Rotateq on 12/04/06. Twin brother received same shots on the same day. They did not have any adverse symptoms after few days. On 12/19/06, mom fed them at 5am, went to bed, then found them dead at 9:00 am.  6/29/07 Received Autopsy Report which reveals COD as Undetermined & contributing condition as simultaneous death of twin brother & tracheitis & bronchitis.  Pathological Dx: I. Sudden unexpected infant death    A. Twin A infant male found unresponsive in crib on stomach    B. Vitreous electrolytes, abnormal, w/decreased Na & increased Cl, urea nitrogen, calcium, carbon dioxide    C. Brain, congestion and neuronal heterotopis, mild    D. Tracheitis & bronchitis, chronic, mild to mod sever. II. Ancillary studies, other, non-contributory III. Simultaneous death of twin brother IV.  Fractures, ribs, anterior & lateral, w/minimal hemorrhage.