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Found 564 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: 335081 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-12
Onset:2008-10-29
   Days after vaccination:47
Submitted: 2008-12-11
   Days after onset:43
Entered: 2008-12-11
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 mass, Abdominal pain, Appendicectomy, Dehydration, Gastrointestinal hypomotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Lethargy, Lymphocyte percentage, Malaise, Monocyte percentage, Mucous stools, Neutrophil percentage, Pallor, Platelet count increased, Prothrombin time prolonged, Pyrexia, Rectal haemorrhage, Red blood cell count normal, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 30Oct2008, Abnormal; Hematocrit, 30Oct2008, 38.55; Hemoglobin, 30Oct2008, 13.5g/dl; Lymphocytes, 30Oct2008, 22.70%; Monocytes, 30Oct2008, 6.70%; Neutrophils, 30Oct2008, 70%; Platelet count, 30Oct2008, 719000/mm3; Prothrombin time, 30Oct2008, 14.9sec; Red blood cell count, 30Oct2008, 525000/mm3; White blood cell count, 30Oct2008, 12620/mm3
CDC Split Type: B0549716A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-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. On 12 September 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 29 October 2008, 47 days after vaccination with ROTARIX, the subject experienced bloody stools with vomiting, fever and rectorrhagia. On 30 October 2008, the subject was brought to the emergency ward. Physical examination revealed malaise, pallor, lethargy, dehydration, abdominal pain, bowel peristalsis decreased, abdominal mass in the left side and current jelly stools in the diaper. The abdomen X-ray performed showed lack of distal air and diminished in transverse colon with 1 opacity (80%). Surgery was performed and intussusception was found and reduced by taxis. An appendectomy was also performed. The subject was hospitalised for 6 days. The subject was treated with paracetamol and cefotaxime. On 4 November 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 335082 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-18
Onset:2008-10-17
   Days after vaccination:29
Submitted: 2008-12-11
   Days after onset:55
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Activated partial thromboplastin time normal, Anorexia, Blood group O, Gastrointestinal hypomotility, Haematochezia, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Mucous stools, Nausea, Platelet count increased, Prothrombin time prolonged
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), 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), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood group O, 20Oct2008, Rh+ sec; Hemoglobin, 20Oct2008, 10.8 g/dl; Partial prothrombin time, 20Oct2008, 32 sec; Platelet count, 20Oct2008, 478000/mm3; Prothrombin time, 20Oct2008, 13 sec
CDC Split Type: B0549759A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-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. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 18 July 2008. On 18 September 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 17 October 2008, 29 days after vaccination with ROTARIX, the subject started with hyporexia, bloody stools and nausea. The patient was admitted at ER on 20 October 2008 and showed at physical exam abdominal distension, irritability, impaired peristalsis and current jelly stool. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray. Laparotomy was done on 20 October 2008. Ileocecal intussusception was found, reduced by taxis without complication. The treatment given was not available in the clinical chart. Tests were performed on 20 October 2008 and showed the following results: Hemoglobin: 10.8 g/dl; Platelets count: 478000/mm3; PT: 13 sec; PTT: 32 sec; Blood group: O Rh+. On 23 October 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: 335414 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-11-29
Onset:2008-12-06
   Days after vaccination:7
Submitted: 2008-12-16
   Days after onset:10
Entered: 2008-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Colostomy, Haematochezia, Intensive care, Intestinal resection, Intussusception, Laparoscopy abnormal, Surgery
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
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: Laparoscopy, 08Dec2008, see text
CDC Split Type: B0549988A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX, (GlaxoSmithKline). On 29 November 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 6 December 2008, 7 days after vaccination with ROTARIX, the subject started with blood streaked stools progressing to bloody stools. The patient was admitted on 6 December at ER. On 8 December 2008, exploratory laparoscopy was performed. Intussusception and abdominal mass were diagnosed. Intestine resection and colostomy were done. The subject was hospitalised and the physician considered the events were life threatening. At the time of reporting the events were improved, the subject was still at ICU. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 335416 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-22
Onset:2008-10-28
   Days after vaccination:6
Submitted: 2008-12-16
   Days after onset:49
Entered: 2008-12-16
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 mass, Abdominal pain, Appendicectomy, Asthenia, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Lymphocyte count increased, Neutrophil count increased, Pallor, Platelet count increased, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CISAPRIDE; METOCLOPRAMIDE
Current Illness: Gastroesophageal Reflux
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 30Oct2008, see text; Leukocyte count NOS, 30Oct2008, 20 000 UI/dl; Lymphocytes, 30Oct2008, 8.93 UI/dl; Neutrophils, 30Oct2008, 9.94 UI/dl; Platelet count, 30Oct2008, 478 000 UI/dl
CDC Split Type: B0550034A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecocolic intussusception in a 3-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. Concurrent medical conditions included gastroesophageal reflux. Concurrent medications included Cisapride and Metoclopramide. On 22 October 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 28 October 2008, 6 days after vaccination with ROTARIX, the subject started with diarrhea, bloody stools, vomiting and adynamia. The patient was admitted at ER on 28 October 2008 and showed at physical exam pallor, dehydration, bowel sounds decreased, abdominal pain, hematochezia and sausage shaped mass. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray. Surgery was done on 30 October 2008. Ileocecocolic intussusception was found, reduced by taxis with a prophylactic appendectomy without complications. Tests were performed on 30 October 2008 and showed the following results: Leukocytes: 20 000 UI/dl; Neutrophils: 9.94 UI/dl; Lymphocytes: 8.93 UI/dl; Platelets: 478 UI/dl. On 2 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: 335532 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-20
Onset:2008-11-03
   Days after vaccination:14
Submitted: 2008-12-17
   Days after onset:44
Entered: 2008-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Diarrhoea, Food intolerance, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Intussusception, Protein total decreased, Rectal haemorrhage, Surgery, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis 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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Albumin, 04Nov2008, 1.9g/dL; Calcium, 04Nov2008, 8mg/dL; Hemoglobin, 04Nov2008, 10.4g/dL; Hemoglobin, 08Nov2008, 11.5g/dL; Protein total, 04Nov2008, 3.9g/dL
CDC Split Type: B0550031A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 13 August 2008, combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; intramuscular) given on 20 October 2008; pneumococcal vaccines (manufacturer unspecified; intramuscular) given on 20 October 2008. On 20 October 2008, the subject received 2nd dose of ROTARIX (oral, lot number not provided). On 3 November 2008, 14 days after vaccination with 2nd dose ROTARIX, the subject experienced liquid stools, bloody stools, abdominal pain, intolerance to oral feeding and gastrobialry vomiting. On 4 November 2008, the subject was hospitalised. Physical exam reported abdominal mass in mesogastrium, decreased bowel sounds and rectal blood. Lab tests were performed and showed the following: Hemoglobin: 10.4 g/dL; Albumin: 1.9 g/dL; Total protein: 3.9 g/dL; Calcium: 8 mg/dL. Diagnosis of intussusception was made by clinical features. On 04 November 2008, surgery was performed; Ileocecolic intussusception was found and resolved by taxis. Prophylactic appendectomy was done without complications. On 8 November 2008, lab tests was performed and showed the following: Hemoglobin: 11.5 g/dL. The subject was treated with KETOROLAC, CEFTRIAXONE, AMIKACIN, METRONIDAZOLE, RANITIDINE, and NALBUPHINE. The subject had good evolution; she was discharged on 9 November 2008 in good clinical conditions. On 11 November 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 335536 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-08
Onset:2008-12-09
   Days after vaccination:1
Submitted: 2008-12-17
   Days after onset:8
Entered: 2008-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA629A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Blood electrolytes normal, Diarrhoea, Diarrhoea infectious, Faeces pale, Full blood count normal, Haematochezia, Ileus, Intussusception, Lethargy, Mucous stools, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
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: Gastroenteritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 14Dec2008, bowel ileus; CBC, 14Dec2008, normal; Serum electrolytes NOS, 14Dec2008, normal
CDC Split Type: B0550437A

Write-up: This female subject was enrolled in a study 103366. On 08 December 2008, she received the 1st dose of ROTARIX (po). On 23 August 2008, the subject received a dose of ENGERIX B. On 04 September 2008, the subject received a dose of BCG (ID). On 30 October 2008, the subject received a dose of INFANRIX HEXA. Medical conditions at the time of the event included gastroenteritis. On 09 December 2008, one day after the 1st dose of ROTARIX, this three-month-old subject developed intussusception. The subject was hospitalised and the event was life-threatening. The subject was treated with Cotrimoxazole, ampicillin trihydrate, gentamicin sulphate, metronidazole and hydration therapy. The event improved on an unspecified date. The investigator considered that there was a reasonable possibility that the intussusception may have been caused by ROTARIX and that the event was possibly due to medical conditions. Investigator comments on 15 December 2008: loose bowel movement characterized as mucoid, blood streaked, yellowish occurring 8-9 episodes per day occurred 24 hours after ROTARIX administration. Consult done 3 days after ROTARIX administration, treated as infectious diarrhea given cotrimoxazole and oral rehydration solution. Current jelly stool noted few hours prior to admission. Hydration done and given oral antibiotics upon admission. 14 days prior to intussusception, the subject did not develop respiratory tract infection and had no change in feeding regimen (breast feeding). Abdominal ultrasound was not performed. On 14 December 2008, abdominal x ray showed bowel ileus. Air-fluid contrast enema and surgery were not performed. Symptoms from intussusception report form: vomiting, diarrhea, bloody stool or bright red stool, blood on rectal examination, red currant jelly stool, abdominal pain, lethargy.


VAERS ID: 335641 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-02
Onset:2008-11-11
   Days after vaccination:70
Submitted: 2008-12-18
   Days after onset:37
Entered: 2008-12-18
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, Abdominal wound dehiscence, Appendicectomy, Gastrointestinal sounds abnormal, Haematochezia, Intestinal anastomosis, Intestinal obstruction, Intussusception, Ischaemia, Mucous stools, Pallor, Rectal haemorrhage, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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)

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, 22 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 12Nov2008, abnormal
CDC Split Type: B0549773A

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 6-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. Previous and/or concurrent vaccination included diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine; manufacturer unspecified; intramuscular; given on 5 November 2008; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular; given on 5 November 2008; influenza virus vaccine; manufacturer unspecified; intramuscular; given on 5 November 2008; live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 2 July 2008. On 2 September 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided). On 11 November 2008, 70 days after vaccination with ROTARIX, the subject experienced rectal bleeding with mucus and gastroalimentary vomiting. On 12 November 2008, the subject was hospitalised. At admission, physical examination revealed pallor, abdominal distension with pain to the deep palpation, bowel sounds decreased and currant jelly stool. The abdominal ultrasound showed an intestinal obstruction and intussusception. Surgery was performed and ileocolic intussusception with appendicular ischemia was found and reduced by taxis. An appendectomy was also performed with a bad evolution. A second intestinal obstruction with multiple end to end anastomosis and dehiscent appendicular stump was diagnosed, leading to 2nd surgery on 19 November 2008. The events were resolved by anastomosis destruction, lysis and reconstruction of appendicular stump. The events were resolved by anastomosis destruction, lysis and reconstruction of appendicular stump. Intestinal resection was not performed. The subject was hospitalized for 22 days. The subject was treated with RANITIDINE, AMPICILLIN, amikacin and METAMIZOLE. On 3 December 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 335711 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-12-05
Onset:2008-12-10
   Days after vaccination:5
Submitted: 2008-12-19
   Days after onset:9
Entered: 2008-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Barium double contrast, Gastrointestinal disorder, Intussusception, X-ray abnormal
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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Dec2008, Abnormal
CDC Split Type: B0550536A

Write-up: This case was reported by a consumer and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 5 December 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 10 December 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception. On 11 December 2008, the subject was hospitalised. Abdomen X-ray was performed twice and revealed intestinal swelling. The subject was transferred to another hospital on 13 December 2008 where he was treated with air enema. The subject was hospitalised for 5 days. On 15 December 2008, the events were resolved and the subject was discharged from hospital.


VAERS ID: 335903 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-29
Onset:2008-12-03
   Days after vaccination:188
Submitted: 2008-12-22
   Days after onset:19
Entered: 2008-12-22
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 mass, Abdominal wall haematoma, Appendicectomy, Appendix disorder, Blood creatinine normal, Blood fibrinogen increased, Blood glucose normal, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileus, International normalised ratio decreased, Intestinal dilatation, Intussusception, Lymphadenitis, Pain, Pallor, Platelet count normal, Prothrombin level normal, Pyrexia, Specific gravity urine, Thrombosis, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Dec2008, see text; Abdominal X-ray, 07Dec2008, see text; Blood glucose, 05Dec2008, 82mg/dL; Creatinine, 05Dec2008, 0.4 mg/dL; Fibrinogen, 05Dec2008, 405g/L; Hematocrit, 05Dec2008, 34.8%; Hemoglobin, 05Dec2008, 11.9g/dL; International normalized ratio, 05Dec2008, 0.95; Platelet count, 05Dec2008, 359000/mm3; Prothrombin time, 05Dec2008, 11.2 Sec; Urine specific gravity, 05Dec2008, 1.010
CDC Split Type: B0551171A

Write-up: This case was reported by a physician in the frame of pass study and described the occurrence of intussusception in an 8-month-old male subject who was vaccinated with ROTARIX. The subject had no relevant medical history or allergy. Previous vaccination included ROTAVIRUS vaccine (oral) given on 29 march 2008. On 29 March 2008, the subject received a 2nd dose of ROTARIX (oral, lot number not provided). On 3 December 2008, 6 months after vaccination with 2nd dose of ROTARIX, the subject experienced gastroalimentary vomiting, liquid and bloody stools. The subject received ambulatory treatment with AMPICILLIN trihydrate (AMPICILLIN) and PARACETAMOL (acetaminophen) secondary to rhinopharyngeal infection without improvement. On 5 December 2008, the subject was hospitalised. Physical exam reported pallor, abdominal distention with mass in descendent colon and rectal tact with abundant blood and open sphincter. Lab test were performed and showed the following Glucose: 92mg/dL; Creatinine: 0.4mg/dL; Urine specific gravity: 1.010; Hemoglobin:11.9 g/dL; Hematocrit: 34.8%; Platelets count: 35900/mm3; Prothrombin time:11.2 seconds; International normalized ratio: 0.95; Fibrinogen: 405 g/dL. Abdominal X- ray was performed and showed only loops dilatation. Diagnosis of intussusception was made. Surgery was performed on 5 December 2008. Intussusception Ileocolic and congested appendix was found and resolved by taxis, appendectomy was done with adentis mesenteric findings. The subject had bad evolution, he presented intestinal occlusion with abdominal distention, pain to palpitation, decreased bowel sounds, gasrobilary vomiting and fever. On 7 December 2008, abdominal X-ray was performed and showed ileon loops dilatation and paralytic ileus. On 9 December 2008, surgery was performed again, wall hematoma, thrombosis in 6 cm length mesentery, congestion and dilatation in sigmoid and descendent colon were found. it was resolved by anterograde decompressor colonic and aspiration of coagula with good evolution. The subject was treated with AMIKACIN, RANITIDINE, METRONIDAZOLE; METOCLOPRAMIDE(METOCLOPRAMID); FRUSEMIDE (FUROSEMIDE) , CEFOTAXIME and KETOROLAC TROMETAROL ( KETOROLAC). On 16 December 2008, the subject was discharged. On 16 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 336143 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-04
Onset:2008-11-30
   Days after vaccination:271
Submitted: 2008-12-23
   Days after onset:23
Entered: 2008-12-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Dehydration, Diarrhoea, Haematochezia, Haematocrit increased, Haemoglobin decreased, Intussusception, Lymphocyte percentage increased, Mucous stools, Neutrophil percentage decreased, Pharyngeal erythema, Platelet count increased, Prothrombin level decreased, Pyrexia, Vomiting, White blood cell count increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), 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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, 03Dec2008, 100 mg/dL; hematocrit, 03Dec2008, 47%; hemoglobin, 02Dec2008, 10.6 g/dL; hemoglobin, 03Dec2008, 16 g/dL; leukocyte count NOS, 02Dec2008, 7400 mm3; lymphocyte percentage, 02Dec2008, 32%; neutrophil percentage, 02Dec2008, 2.4; platelet count, 02Dec2008, 205000 mm3; prothrombin, 03Dec2008, 12 sec
CDC Split Type: B0551667A

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 10-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. On 4 March 2008, and 6 May 2008, the subject received 1st dose and 2nd dose of ROTARIX (oral), lot numbers not provided. On 30 November 2008, 7 months after 2nd vaccination with ROTARIX, the subject experienced vomiting and liquid stools. On 2 December 2008, the subject was admitted to emergency room with dehydration, hyperemic pharynx and fever without abdominal complications. After admission, he showed one stool with mucus and blood. No more clinical data was reported in the file. On 3 December 2008, surgery was performed and ileocolic intussusception was found and reduced by taxis without complications. Relevant laboratory test showed the following; on 2 December 2008; hemoglobin: 10.6 g/dL, platelets count: 205000/mm3, leucocytes count: 7400/mm3, lymphocytes percentage: 32% and neutrophils count: 2.4%. On 3 December 2008, relevant results included; hemoglobin: 16 g/dL, hematocrit: 47%, blood glucose: 100 mg/dL and prothrombin: 12 sec. Radiologic studies were not reported in the subject''s file. The subject was treated with ranitidine hydrochloride (RANITIDINE), trimethoprim (TRIMETHOPRIM), amikacin (AMIKACINE), furazolidone (FUROXONE) and metronidazole. On 10 December 2008, since post surgical evolution was adequate, the subject discharged without pharmaos and in good clinical conditions. The physician considered the events unrelated to vaccinations with ROTARIX.


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