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This is VAERS ID 309526

History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

VAERS ID: 309526
VAERS Form:
Age:0.3
Gender:Female
Location:Foreign
Vaccinated:2007-08-07
Onset:2007-11-21
Submitted:2008-04-15
Entered:2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abnormal faeces, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased, Parenteral nutrition, Intestinal anastomosis, Globulins decreased, Anastomotic complication, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-14
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte co
CDC 'Split Type': B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


Changed on 5/13/2013

VAERS ID: 309526 Before After
VAERS Form:
Age:0.3
Gender:Female
Location:Foreign
Vaccinated:2007-08-07
Onset:2007-11-21
Submitted:2008-04-15
Entered:2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abnormal faeces, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased, Parenteral nutrition, Intestinal anastomosis, Globulins decreased, Anastomotic complication, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-14
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte co
CDC 'Split Type': B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


Changed on 4/14/2017

VAERS ID: 309526 Before After
VAERS Form:
Age:0.3
Gender:Female
Location:Foreign
Vaccinated:2007-08-07
Onset:2007-11-21
Submitted:2008-04-15
Entered:2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abnormal faeces, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased, Parenteral nutrition, Intestinal anastomosis, Globulins decreased, Anastomotic complication, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-14
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte co count NOS, 29Nov2007, 4720mm3; Platelet count, 29Nov2007, 152000mm3; Potassium, 29Nov2007, 2.8mEg/l; Protein total, 29Nov2007, 3.2g/dl; Sodium, 29Nov2007, 117mEg/l
CDC 'Split Type': B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


Changed on 9/14/2017

VAERS ID: 309526 Before After
VAERS Form:(blank) 1
Age:0.3
Gender:Female
Location:Foreign
Vaccinated:2007-08-07
Onset:2007-11-21
Submitted:2008-04-15
Entered:2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 1 - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abnormal faeces, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased, Parenteral nutrition, Intestinal anastomosis, Globulins decreased, Anastomotic complication, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-14
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte count NOS, 29Nov2007, 4720mm3; Platelet count, 29Nov2007, 152000mm3; Potassium, 29Nov2007, 2.8mEg/l; Protein total, 29Nov2007, 3.2g/dl; Sodium, 29Nov2007, 117mEg/l
CDC 'Split Type': B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


Changed on 2/14/2018

VAERS ID: 309526 Before After
VAERS Form:1
Age:0.3
Gender:Female
Location:Foreign
Vaccinated:2007-08-07
Onset:2007-11-21
Submitted:2008-04-15
Entered:2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abnormal faeces, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased, Parenteral nutrition, Intestinal anastomosis, Globulins decreased, Anastomotic complication, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-14
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte count NOS, 29Nov2007, 4720mm3; Platelet count, 29Nov2007, 152000mm3; Potassium, 29Nov2007, 2.8mEg/l; Protein total, 29Nov2007, 3.2g/dl; Sodium, 29Nov2007, 117mEg/l
CDC 'Split Type': B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


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