chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Blood glucose increased, Blood potassium increased, Culture urine negative
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Haematochezia, Intestinal dilatation, Intestinal resection
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Intussusception, Lethargy, Leukocytosis, Lymphocyte count normal, Mass excision
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Neutrophil percentage increased, Pyrexia, Skin haemorrhage, Skin lesion, Small intestinal obstruction
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system X-ray, Vitello-intestinal duct remnant, Vomiting, White blood cell count increased
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Haematochezia, Haemorrhage, Intestinal dilatation
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Intussusception, Lethargy, Leukocytosis, Lymphocyte count increased, Mass
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Mass excision, Neutrophil count increased, Skin lesion, Small intestinal obstruction, Ultrasound abdomen abnormal
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Urinary system X-ray, Vitello-intestinal duct remnant, White blood cell count increased, X-ray abnormal
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: HEP, RUB, HEP, MMR
Symptoms: Asthenia, Burning sensation, Dizziness, Headache, Oedema peripheral
Clinical narrative: 7/08/11 Returned to clinic c/o of the following S headache & dizziness evening of 7/05/11. Developed itchy red rash on left hand & arm also swelling. O noted concentrated macular rash between left thumb and first digit. Diffuse rash left forearm, mild swelling. A P client went to PCP prescribed unknown medication. Advised to continue f/u with PCP/ER PRN. 7/12/11 Received PC from client. Worsening rash & itchy, darkening of fingers. Advised to f/u with PCP/ER. Verbalized understanding.
Age: 23.0
Sex: F
Vaccine: HEP, RUB, HEP, MMR
Symptoms: Urticaria
Clinical narrative: 7/08/11 Returned to clinic c/o of the following S headache & dizziness evening of 7/05/11. Developed itchy red rash on left hand & arm also swelling. O noted concentrated macular rash between left thumb and first digit. Diffuse rash left forearm, mild swelling. A P client went to PCP prescribed unknown medication. Advised to continue f/u with PCP/ER PRN. 7/12/11 Received PC from client. Worsening rash & itchy, darkening of fingers. Advised to f/u with PCP/ER. Verbalized understanding.
Age: 23.0
Sex: F
Vaccine: HEP, RUB, HEP, MMR
Symptoms: Dizziness, Headache, Oedema peripheral, Rash, Rash erythematous
Clinical narrative: 7/08/11 Returned to clinic c/o of the following S headache & dizziness evening of 7/05/11. Developed itchy red rash on left hand & arm also swelling. O noted concentrated macular rash between left thumb and first digit. Diffuse rash left forearm, mild swelling. A P client went to PCP prescribed unknown medication. Advised to continue f/u with PCP/ER PRN. 7/12/11 Received PC from client. Worsening rash & itchy, darkening of fingers. Advised to f/u with PCP/ER. Verbalized understanding.
Age: 23.0
Sex: F
Vaccine: HEP, RUB, HEP, MMR
Symptoms: Rash macular, Rash pruritic, Sinus headache, Skin discolouration, Swelling
Clinical narrative: 7/08/11 Returned to clinic c/o of the following S headache & dizziness evening of 7/05/11. Developed itchy red rash on left hand & arm also swelling. O noted concentrated macular rash between left thumb and first digit. Diffuse rash left forearm, mild swelling. A P client went to PCP prescribed unknown medication. Advised to continue f/u with PCP/ER PRN. 7/12/11 Received PC from client. Worsening rash & itchy, darkening of fingers. Advised to f/u with PCP/ER. Verbalized understanding.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Amino acid level normal, Ammonia, Blood electrolytes, Blood lactic acid increased, Blood pyruvic acid
Clinical narrative: The morning following the Dtap vaccine, patient screamed at 6:00 AM. I couldn't calm her and I noticed her eyes were arching up and over to the left. I noticed it a few times in the 2 weeks following the vaccine. Then, they started to appear in clusters. On the day of admission at the hospital, she had 11 clusters and 2 days before the admission, she had  approx. 4 to 5 clusters and I noticed that her legs were going limb (or at least she was losing control of her legs. The clusters were increasing. She was admitted overnight and the next morning they tested her. The EEG showed hypsarrhythmia. She got diagnosed with Infantiles Spams with no known etiology.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: CSF cell count, CSF glucose, CSF lactate, CSF protein, CSF test
Clinical narrative: The morning following the Dtap vaccine, patient screamed at 6:00 AM. I couldn't calm her and I noticed her eyes were arching up and over to the left. I noticed it a few times in the 2 weeks following the vaccine. Then, they started to appear in clusters. On the day of admission at the hospital, she had 11 clusters and 2 days before the admission, she had  approx. 4 to 5 clusters and I noticed that her legs were going limb (or at least she was losing control of her legs. The clusters were increasing. She was admitted overnight and the next morning they tested her. The EEG showed hypsarrhythmia. She got diagnosed with Infantiles Spams with no known etiology.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Chromosome analysis normal, Electroencephalogram abnormal, Emotional distress, Full blood count, Gaze palsy
Clinical narrative: The morning following the Dtap vaccine, patient screamed at 6:00 AM. I couldn't calm her and I noticed her eyes were arching up and over to the left. I noticed it a few times in the 2 weeks following the vaccine. Then, they started to appear in clusters. On the day of admission at the hospital, she had 11 clusters and 2 days before the admission, she had  approx. 4 to 5 clusters and I noticed that her legs were going limb (or at least she was losing control of her legs. The clusters were increasing. She was admitted overnight and the next morning they tested her. The EEG showed hypsarrhythmia. She got diagnosed with Infantiles Spams with no known etiology.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Hypotonia, Infantile spasms, Laboratory test normal, Liver function test, Loss of control of legs
Clinical narrative: The morning following the Dtap vaccine, patient screamed at 6:00 AM. I couldn't calm her and I noticed her eyes were arching up and over to the left. I noticed it a few times in the 2 weeks following the vaccine. Then, they started to appear in clusters. On the day of admission at the hospital, she had 11 clusters and 2 days before the admission, she had  approx. 4 to 5 clusters and I noticed that her legs were going limb (or at least she was losing control of her legs. The clusters were increasing. She was admitted overnight and the next morning they tested her. The EEG showed hypsarrhythmia. She got diagnosed with Infantiles Spams with no known etiology.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Lumbar puncture, Mycobacterium tuberculosis complex test negative, Nuclear magnetic resonance imaging normal, Screaming, Thyroid function test normal
Clinical narrative: The morning following the Dtap vaccine, patient screamed at 6:00 AM. I couldn't calm her and I noticed her eyes were arching up and over to the left. I noticed it a few times in the 2 weeks following the vaccine. Then, they started to appear in clusters. On the day of admission at the hospital, she had 11 clusters and 2 days before the admission, she had  approx. 4 to 5 clusters and I noticed that her legs were going limb (or at least she was losing control of her legs. The clusters were increasing. She was admitted overnight and the next morning they tested her. The EEG showed hypsarrhythmia. She got diagnosed with Infantiles Spams with no known etiology.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urine analysis, Urine analysis normal
Clinical narrative: The morning following the Dtap vaccine, patient screamed at 6:00 AM. I couldn't calm her and I noticed her eyes were arching up and over to the left. I noticed it a few times in the 2 weeks following the vaccine. Then, they started to appear in clusters. On the day of admission at the hospital, she had 11 clusters and 2 days before the admission, she had  approx. 4 to 5 clusters and I noticed that her legs were going limb (or at least she was losing control of her legs. The clusters were increasing. She was admitted overnight and the next morning they tested her. The EEG showed hypsarrhythmia. She got diagnosed with Infantiles Spams with no known etiology.
Sex: U
Vaccine: HPV4
Symptoms: Autism, Drug exposure during pregnancy
Clinical narrative: Information has been received from immunization coordinator concerning a child patient whose mother on unspecified date was vaccinated with 1 dose of GARDASIL, (lot number, dose and site of administration not reported) while pregnant. The child now had autism. At the time of the report the patient's outcome was unknown. Upon internal review, autism was determined to be an other important medical event. The mother's experience has been captured in WAES # 1107USA00366. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site discharge, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 25 May 2011. A 4-year-old child (gender not reported) had received on 23 May 2011 an intramuscular right deltoid injections of DAPTACEL and IPOL (lot numbers C3449AA, and D1086-1 respectively); and subcutaneous left deltoid injections of MMR and VARIVAX (manufacturer Merck, lot numbers 0743Z and 1474Z, respectively) and overnight, the patients arm became red, swollen, and the skin in the affected area was weeping. The patient required a doctors visit; however no relevant diagnostic tests and/or laboratory data were performed. It was also not reported whether the patient had required any treatments. The patient had no concurrent illnesses, pre-existing medical conditions or use of other medications at the time of the vaccinations; and had not received any other vaccinations with 4 week prior to 23 May 2011. It was noted the patient had not experienced any adverse events with past vaccinations. At the time of this report, the patient had not recovered. Follow-up information was received from a health care professional on 05 July 2011. The birth weight of this male patient was 6 pounds 12 ounces and he has 3 siblings. It was confirmed that the patient was vaccinated on 23 May 2011 at about 12:30 PM and on 24 May 2011 (previously reported as 23 May 2011) at about 3:00 PM the whole right arm became swollen, red and weeping. On 25 May 2011 at about 11:00 AM he was seen by a physician. He was instructed to continue taking BENADRYL and apply cool compresses. The event was considered serious by the physician. It took 5 days for him to fully recover. The outcome was reported as recovered on 28 June 2011. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Secretion discharge
Clinical narrative: Initial report received from a health care professional on 25 May 2011. A 4-year-old child (gender not reported) had received on 23 May 2011 an intramuscular right deltoid injections of DAPTACEL and IPOL (lot numbers C3449AA, and D1086-1 respectively); and subcutaneous left deltoid injections of MMR and VARIVAX (manufacturer Merck, lot numbers 0743Z and 1474Z, respectively) and overnight, the patients arm became red, swollen, and the skin in the affected area was weeping. The patient required a doctors visit; however no relevant diagnostic tests and/or laboratory data were performed. It was also not reported whether the patient had required any treatments. The patient had no concurrent illnesses, pre-existing medical conditions or use of other medications at the time of the vaccinations; and had not received any other vaccinations with 4 week prior to 23 May 2011. It was noted the patient had not experienced any adverse events with past vaccinations. At the time of this report, the patient had not recovered. Follow-up information was received from a health care professional on 05 July 2011. The birth weight of this male patient was 6 pounds 12 ounces and he has 3 siblings. It was confirmed that the patient was vaccinated on 23 May 2011 at about 12:30 PM and on 24 May 2011 (previously reported as 23 May 2011) at about 3:00 PM the whole right arm became swollen, red and weeping. On 25 May 2011 at about 11:00 AM he was seen by a physician. He was instructed to continue taking BENADRYL and apply cool compresses. The event was considered serious by the physician. It took 5 days for him to fully recover. The outcome was reported as recovered on 28 June 2011. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Dehydration, Pertussis, Post-tussive vomiting
Clinical narrative: Initial case received from a consumer on 06 July 2011. A 19-year-old female patient, with no reported medical history, received an injection of ADACEL (lot not reported) on 25 February 2008. Three years post-vaccination, on 20 June 2011, the patient presented to her physician with a 3-week history of coughing. She returned to her physician on 22 June 2011 with ongoing symptoms, and was prescribed Z-PAK. Laboratory testing at that time serologically confirmed pertussis. She was subsequently admitted to the hospital due to dehydration secondary to post-tussive vomiting. Outcome was not reported.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Biopsy, Culture, Drug administered at inappropriate site, Injection site cyst, Injection site discharge
Clinical narrative: Initial case received from a dermatologist on 08 July 2011. A 31-year-old female, with a history of erythromycin sensitivity, received an intramuscular right hip injection of ADACEL (lot number C3518AA) on 18 March 2011. Of note, the recommended site of vaccination for ADACEL is the deltoid; the gluteal muscle is not recommended for administration. The patient subsequently developed a rash at the injection site in March 2011. On 24 June 2011 she was noted to have a 3cm bleeding, draining cyst on her right hip. She underwent a biopsy and culture; results were pending. The patient was diagnosed with "atypical bacterial rash'. The event remained ongoing at the time of the report.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haemorrhage, Injection site rash, Skin bacterial infection
Clinical narrative: Initial case received from a dermatologist on 08 July 2011. A 31-year-old female, with a history of erythromycin sensitivity, received an intramuscular right hip injection of ADACEL (lot number C3518AA) on 18 March 2011. Of note, the recommended site of vaccination for ADACEL is the deltoid; the gluteal muscle is not recommended for administration. The patient subsequently developed a rash at the injection site in March 2011. On 24 June 2011 she was noted to have a 3cm bleeding, draining cyst on her right hip. She underwent a biopsy and culture; results were pending. The patient was diagnosed with "atypical bacterial rash'. The event remained ongoing at the time of the report.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Aches and pains (ribs, breast, shoulder) started June 21 in PM. Pain kept getting worse, felt like broken rib and breast surgery. Shingles rash presented June 25 in PM. Went to doctor June 27 - insurance would only pay for 3 days of 7 day prescription of valacyclovir then got another 7 day prescription for acyclovir. Final med taken 7-6 in PM. Pain was severe June 23 to July 5.
Age: 1.54
Sex: M
Vaccine: PNC13
Symptoms: Abscess drainage, Abscess sterile, Culture negative, Erythema, Haematoma infection
Clinical narrative: 1. Severe pain at time of injection 2. Local redness noted same day 3. Development over time of knot at injection site 06/08/2011 4. Increase in size of knot 06/27/2011 5. Pus drained from site 07/01/2011 6. Referred for ID consultation 07/11/011--diagnosis sterile abscess vs infected hematoma
Age: 1.54
Sex: M
Vaccine: PNC13
Symptoms: Injection site discharge, Injection site nodule, Injection site pain
Clinical narrative: 1. Severe pain at time of injection 2. Local redness noted same day 3. Development over time of knot at injection site 06/08/2011 4. Increase in size of knot 06/27/2011 5. Pus drained from site 07/01/2011 6. Referred for ID consultation 07/11/011--diagnosis sterile abscess vs infected hematoma
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Convulsion, Dizziness, Musculoskeletal stiffness, Syncope, Vertigo
Clinical narrative: Patient recieved the Menactra vaccine. Within approx. 3 minutes she had mini seizure and had an episode of syncope that lasted approx. 1 minute. Patient stiffened up and slid out of a chair from a sitting position and was lowered to the floor. Dizziness and vertigo lasted for about 20 minutes after and then started to ease.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Differential white blood cell count, Full blood count, Metabolic function test, Petechiae
Clinical narrative: Petechiae - Rash to body - Platelet count 39 (7/5/11) down from 453 6/17/11.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Platelet count decreased, Rash generalised
Clinical narrative: Petechiae - Rash to body - Platelet count 39 (7/5/11) down from 453 6/17/11.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Enema administration, Haematochezia, Intussusception, Lethargy
Clinical narrative: Sx: Bilious emesis, currant jelly stools, lethargy. Dx: Intussusception.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Sx: Bilious emesis, currant jelly stools, lethargy. Dx: Intussusception.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Blood urea nitrogen/creatinine ratio increased, Eating disorder
Clinical narrative: Sx: Bilious emesis, currant jelly stools, lethargy. Dx: Intussusception.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Hypophagia, Intussusception, Irritability
Clinical narrative: Sx: Bilious emesis, currant jelly stools, lethargy. Dx: Intussusception.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Lethargy, Pallor, Pyrexia, Somnolence, Vomiting
Clinical narrative: Sx: Bilious emesis, currant jelly stools, lethargy. Dx: Intussusception.