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This is VAERS ID 326697

History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

VAERS ID: 326697
VAERS Form:
Age:0.4
Gender:Male
Location:Foreign
Vaccinated:2008-02-18
Onset:2008-02-28
Submitted:2008-10-01
Entered:2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal dilatation, Intestinal obstruction, Intussusception, Irritability, Pain, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal, Platelet count increased, Intestinal resection, Pharyngeal erythema, Intestinal anastomosis, Metabolic disorder, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Ma
CDC 'Split Type': B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence


Changed on 5/13/2013

VAERS ID: 326697 Before After
VAERS Form:
Age:0.4
Gender:Male
Location:Foreign
Vaccinated:2008-02-18
Onset:2008-02-28
Submitted:2008-10-01
Entered:2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal dilatation, Intestinal obstruction, Intussusception, Irritability, Pain, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal, Platelet count increased, Intestinal resection, Pharyngeal erythema, Intestinal anastomosis, Metabolic disorder, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Ma
CDC 'Split Type': B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence


Changed on 4/14/2017

VAERS ID: 326697 Before After
VAERS Form:
Age:0.4
Gender:Male
Location:Foreign
Vaccinated:2008-02-18
Onset:2008-02-28
Submitted:2008-10-01
Entered:2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal dilatation, Intestinal obstruction, Intussusception, Irritability, Pain, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal, Platelet count increased, Intestinal resection, Pharyngeal erythema, Intestinal anastomosis, Metabolic disorder, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Ma 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC 'Split Type': B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.


Changed on 9/14/2017

VAERS ID: 326697 Before After
VAERS Form:(blank) 1
Age:0.4
Gender:Male
Location:Foreign
Vaccinated:2008-02-18
Onset:2008-02-28
Submitted:2008-10-01
Entered:2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 2 - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal dilatation, Intestinal obstruction, Intussusception, Irritability, Pain, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal, Platelet count increased, Intestinal resection, Pharyngeal erythema, Intestinal anastomosis, Metabolic disorder, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC 'Split Type': B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.


Changed on 2/14/2018

VAERS ID: 326697 Before After
VAERS Form:1
Age:0.4
Gender:Male
Location:Foreign
Vaccinated:2008-02-18
Onset:2008-02-28
Submitted:2008-10-01
Entered:2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal dilatation, Intestinal obstruction, Intussusception, Irritability, Pain, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal, Platelet count increased, Intestinal resection, Pharyngeal erythema, Intestinal anastomosis, Metabolic disorder, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC 'Split Type': B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.


Changed on 6/14/2018

VAERS ID: 326697 Before After
VAERS Form:1
Age:0.4
Gender:Male
Location:Foreign
Vaccinated:2008-02-18
Onset:2008-02-28
Submitted:2008-10-01
Entered:2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal dilatation, Intestinal obstruction, Intussusception, Irritability, Pain, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal, Platelet count increased, Intestinal resection, Pharyngeal erythema, Intestinal anastomosis, Metabolic disorder, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC 'Split Type': B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.


Changed on 8/14/2018

VAERS ID: 326697 Before After
VAERS Form:1
Age:0.4
Gender:Male
Location:Foreign
Vaccinated:2008-02-18
Onset:2008-02-28
Submitted:2008-10-01
Entered:2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal dilatation, Intestinal obstruction, Intussusception, Irritability, Pain, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal, Platelet count increased, Intestinal resection, Pharyngeal erythema, Intestinal anastomosis, Metabolic disorder, Abdominal X-ray

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died:2008-03-15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC 'Split Type': B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.

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