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Found 568 cases where Vaccine is RV1 and Symptom is Intussusception and Appearance Date from '2008-02-01' to '2014-12-31'

Case Details

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VAERS ID: 336182 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-06-03
Onset:2008-06-11
   Days after vaccination:8
Submitted: 2008-12-29
   Days after onset:201
Entered: 2008-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, C-reactive protein normal, Echography abnormal, Intussusception, Neutrophil percentage increased, Surgery, White blood cell count increased, X-ray abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Jun2008, see text; C-reactive protein, 11Jun2008, 0.4; Echography, 11Jun2008, see text; Neutrophil count, 11Jun2008, 87%; White blood cell count, 11Jun2008, 17600/mm3
CDC Split Type: B0544840A

Write-up: This case was reported by a physician (via a sales representative) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 3 June 2008, the subject received unspecified dose of ROTARIX (unknown) lot number not provided. On 11 June 2008,8 days after vaccination with ROTARIX, the subject was hospitalized due to severe intussusception. At the time of reporting the outcome of the event was unspecified. Follow up information received on 24 December 2008 from the physician: Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given in May 2008. On 11 June 2008, 8 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception which was reduced by surgery on 11 June 2008. The subject was hospitalized and the physician considered the event was clinically significant (or requiring intervention). Laboratory tests were performed on 11 June 2008 and showed the following results: Abdominal x-ray: fluid levels and dilated bowel loops; Abdominal ultrasound: visible intussusception or soft tissue mass; White blood cells: 17 600 /mm3; Neutrophiles: 87%; CRP: 0.4. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with ROTARIX. No further information expected; the case has been closed.


VAERS ID: 336186 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-18
Onset:2008-05-11
   Days after vaccination:54
Submitted: 2008-12-29
   Days after onset:232
Entered: 2008-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Appendicectomy, Dehydration, Gastrointestinal hypomotility, Haematochezia, Hyperaemia, Hypophagia, Intestinal obstruction, Intussusception, Pyrexia, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, May 2008, see text
CDC Split Type: B0551530A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecal intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 18 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 11 May 2008, 54 days after vaccination with ROTARIX, the subject started with vomiting. The patient was admitted at ER on 11 May 2008 and showed at physical exam dehydration, hyperemic pharynx, abdominal distension, oral intake reduced. On 12 May 2008, the subject experienced bloody stools, fever, biliary vomiting and decreased gastrointestinal peristalsis. Abdominal x-ray showed distended small bowel, air-fluid levels and intestinal obstruction. Surgery was done on 13 May July 2008. Ileocecal intussusception in ileocecal valve was found, reduced by taxis with appendectomy without complications. The subject was treated with DIPHENIDOL, PARACETAMOL and TRIMETHOPRIM. On 19 May 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336187 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-10
Onset:2008-11-17
   Days after vaccination:38
Submitted: 2008-12-29
   Days after onset:42
Entered: 2008-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Appendicectomy, Dehydration, Gastrointestinal hypomotility, Haematochezia, Hypophagia, Intussusception, Irritability, Pharyngeal erythema, Pharyngeal oedema, Pyrexia, Somnolence, Surgery, Ultrasound kidney normal, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paracetamol; Chlorpheniramine
Current Illness: GRIPPE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 17Nov2008, see text; Leukocyte count NOS, 19Nov2008, high level; Ultrasound kidney, 19Nov2008, normal
CDC Split Type: B0551537A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecal intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Concurrent medical conditions included grippe treated with PARACETAMOL and CHOLPHENIRAMINE. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 1 August 2008. On 10 October 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 17 November 2008, 38 days after vaccination with ROTARIX, the subject started with 6 episodes of vomiting, fever, oral intake reduced with 1 bloody stool. The patient was admitted at ER on 17 November 2008 and showed at physical exam dehydration, somnolence, hyperemic pharynx, pharynx edema, abdominal distension and bowel peristalsis decreased. The next day the patient showed abdominal pain, irritability, more distension, absent peristalsis and rectal ampulla empty at rectal tact. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray. Surgery was done on 19 November 2008. Ileocecal intussusception was found, reduced by taxis with appendectomy without complications. Tests were performed on 17 November 2008 and showed the following results: Abdominal X-ray: dilated intestinal loops in right side abdomen, air-fluid levels and lack of air in pelvic fosse. Searching of entamoeba histolytic: positive in fresh stool with 90% polymorphonuclears and 10% monocytes Renal Ultrasound: normal; Leukocytes: high level. The subject was treated with PARACETAMOL, RANITIDINE, CO-TRIMOXAZOLE, METRONIDAZOLE and NALBUPHINE. On 24 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336189 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-01-01
Onset:2008-11-28
   Days after vaccination:332
Submitted: 2008-12-29
   Days after onset:31
Entered: 2008-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Barium enema, Enema administration, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0551651A

Write-up: This case was reported by a physician via a GSK representative and described the occurrence of invagination of intestine in a 13 month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical condition was unspecified. First dose of ROTARIX was given in December 2007. In January 2008, the subject received a 2nd dose of ROTARIX (oral, batch not available). On 28 November 2008, 10 months after the second vaccination with ROTARIX, the subject developed invagination of intestine, confirmed by unspecified investigations. The subject was treated with barium salt and event resolved without sequelae. This case was assessed as medically serious by GSK. The physician considered the event was unrelated to vaccination with ROTARIX.


VAERS ID: 336190 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-11
Onset:2008-11-26
   Days after vaccination:15
Submitted: 2008-12-29
   Days after onset:33
Entered: 2008-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Appendicectomy, Decreased activity, Gastrointestinal sounds abnormal, Haematemesis, Haematochezia, Intestinal mass, Intussusception, Irritability, Mucous stools, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 26Nov2008, showed bad air distribution and intestinal loop only, Intussusception was diagnosed by clinical features and abdominal x-ray.
CDC Split Type: B0551668A

Write-up: This case was reported by a physician in the frame a study and described the occurrence of ileocolic intussuception in a 5-month-old female subject who was vaccinated with ROTARIX. The subject was on no other medications and had no relevant medical history or allergy. Previous and/or concurrent vaccination included combined DTaP and HepB and IPV (manufacturer unspecified, intramuscular) given on 11 November 2008; ROTARIX given on 11 August 2008. On 11 November 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 26 November 2008, 15 days after vaccination with ROTARIX, the subject started with billiard vomiting, hemorrhagic residue in vomiting, fever, irritability and current jelly stool. The patient was admitted at ER on 26 November 2008 and showed at physical exam hypoactive, abdominal pain to palpation, abdominal mass, Dance sign positive, bowel sounds decreased and rectal tact with rectal mass. The subject was hospitalized. Abdominal X-ray showed bad air distribution and an intestinal loop only. Intussusception was diagnosed by clinical features and abdominal x-ray. Surgery was done on 27 November 2008. Ileocolic intussusception was found, reduced by taxis with a prophylactic appendectomy without complications. The subject was treated with Amikacine, Ranitidine, and Metamizole. On 30 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336192 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-08-13
Onset:2008-08-29
   Days after vaccination:16
Submitted: 2008-12-29
   Days after onset:122
Entered: 2008-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0551701A

Write-up: This case was reported by a regulatory authority ((clinical) # 118325347) and described the occurrence of ileocolic intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 13 August 2008, the subject received unspecified dose of ROTARIX (oral). Lot number not provided. On 29 August 2008, 16 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception. The subject was hospitalised. On 3 September 2008, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with ROTARIX. No further information was expected as this was the only information the foreign regulatory had, so the case has been closed.


VAERS ID: 336464 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-09-22
Onset:2008-12-03
   Days after vaccination:72
Submitted: 2009-01-05
   Days after onset:33
Entered: 2009-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Laparotomy, Pyrexia, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Dec2008, abnormal
CDC Split Type: B0551683A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileo-ileal intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 21 July 2008. On 22 September 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 3 December 2008, 72 days after vaccination with ROTARIX, the subject started with vomiting, bloody stools, fever and abdominal pain. The patient was admitted at ER on 4 December 2008 and showed at physical exam abdominal pain and bowel sounds decreased. Abdominal x-ray suggested intestinal obstruction. Ileo-ileal intussusception was confirmed by laparotomy and reduced by taxis without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). The subject was treated with AMIKACIN, AMPICILLIN TRIHYDRATE and PARACETAMOL. On 11 December 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336465 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-27
Onset:2008-12-07
   Days after vaccination:194
Submitted: 2009-01-05
   Days after onset:29
Entered: 2009-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Anorexia, Blood glucose increased, Blood group O, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Hyperaemia, Intussusception, Mucous stools, Neutrophil percentage, Pallor, Platelet count increased, Pyrexia, Rectal haemorrhage, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Dec2008, see text; Blood glucose, 11Dec2008, 123mg/dl; Blood group O, 11Dec2008, Rh+; Leukocyte count NOS, 11Dec2008, 9700/mm3; Neutrophils, 11Dec2008, 68%; Platelet count, 11Dec2008, 537000/mm3
CDC Split Type: B0551679A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecolic intussusception in a 1-year-old male subject who was vaccinated with ROTARIX. The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (oral) given on 27 March 2008. On 27 May the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 7 December 2008, 6 months after vaccination with ROTARIX, the subject experienced stated with vomiting, abdominal pain, hyporexia, fever and abdominal distention. The patient was admitted at ER on 11 December 2008 and showed at physical exam pallor, dehydration, vomiting, hyperemic pharynx, abdominal distention bowel sounds decreased, blood at rectal tact, and current jelly stool. Abdominal X- ray suggested intestinal obstruction and intussusception was suspected. Ileocecolic intussusception was found, reduced by taxis without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Laboratory tests were performed on 11 December 2008 and showed the following results: Blood group: o+; Leukocytes: 9700/mm3; Neutrophils: 68%; Platelets: 537 000/mm3; Blood glucose: 123 mg/dl. The subject was treated with CEFTRIXANOE, METRONIDAZOLE; AMIKACINE; CEFOTAXIME; RANITIDINE; BUPRENORPHINE; FUROSEMIDE; BUTILHOSCINE; PIPERACILLIN+ TAZOBACTAM; MEDIZYME and PYRIDOXINE. On 15 December 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336467 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-21
Onset:2008-04-29
   Days after vaccination:68
Submitted: 2009-01-05
   Days after onset:251
Entered: 2009-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Appendicectomy, Gastrointestinal necrosis, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Mucous stools, Neutrophil count increased, Pallor, Platelet count normal, Prothrombin time prolonged, Pyrexia, Vomiting, White blood cell count normal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin Allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematocrit, 30Apr2008, 34.8%; Hemoglobin, 30Apr2008, 11.5mg/dl; Leukocyte count NOS, 30Apr2008, 12 700/mm3; Neutrophils, 30Apr2008, 12300/mm3; Prothrombin time, 30Apr2008, 13.4sec
CDC Split Type: B0551803A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocecocolic intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history. Concurrent medical conditions included penicillin allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 1 December 2007. On 21 February 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 29 April 2008, 68 days after vaccination with ROTARIX, the subject started with bloody stools, fever, irritability, vomiting and pallor. The patient was admitted at ER on 30 April 2008 and showed at physical exam abdominal pain, fever, current jelly stool and sausage shaped abdominal mass. Intussusception was suspected. Ileocecocolic intussusception was confirmed by laparotomy, with appendix necrosis, reduced by taxis and appendectomy without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Tests were performed on 30 April 2008 and showed the following results: Hemoglobin: 11.5 mg/dl; Hematocrit: 34.8 %; Leukocytes: 12 700/mm3; Neutrophils: 12 300/mm3; Platelets: 407 000/mm3; Prothrombine time: 13.4 sec. The subject was treated with Amikacine, metronidazole, Metamizole, Ranitidine and AMBROSOL. On 6 May 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336621 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-13
Onset:2008-01-09
   Days after vaccination:27
Submitted: 2009-01-06
   Days after onset:363
Entered: 2009-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood potassium normal, Blood sodium normal, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Intussusception, Lymphocyte count normal, Mucous stools, Neutrophil count normal, Surgery, Vomiting, White blood cell count decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hemoglobin, 09Jan2008, 12.5mg/dl; Lymphocytes, 09Jan2008, 2500/mm3; Neutrophils, 09Jan2008, 3120/mm3; Potassium, 09Jan2008, 5.2mEq/dl; Sodium, 09Jan2008, 144mEq/dl; White blood cell count, 09Jan2008, 5800/mm3
CDC Split Type: B0552335A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. The subject was healthy. On 13 December 2007, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 9 January 2008, 27 days after vaccination with ROTARIX, the subject experienced vomiting and bloody stools. She was brought to the emergency ward where the physical examination revealed bowel sounds decreased and current jelly stools. Intussusception was suspected. On 10 January 2008, surgery was performed and ileocolic intussusception was found and reduced by taxis without complication. The subject was hospitalised for 5 days and the physician considered the events were clinically significant (or requiring intervention). On 13 January 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were possibly related to vaccination with ROTARIX.


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