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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: 392117 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2006-07-14
Onset:2006-08-20
   Days after vaccination:37
Submitted: 2010-07-06
   Days after onset:1416
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA076A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enterostomy, Explorative laparotomy, Haematochezia, Intestinal resection, Intussusception, Irritability, Polyp colorectal, Small intestinal resection, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), 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), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0662984A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 14 July 2006, the subject received 1st dose of ROTARIX (oral). On 20 August 2006, 37 days after vaccination with 1st dose of ROTARIX, the subject experienced bloody stools, vomiting and irritability. The subject was hospitalised. Exploratory laparotomy revealed Ileo-ileal intussusception leading to reduction without enterotomy. It also revealed bowel polyps leading to small intestine resection and enterostomy. At the time of reporting the events were resolved.


VAERS ID: 392118 (history)  
Form: Version 1.0  
Age: 0.41  
Sex: Male  
Location: Foreign  
Vaccinated:2006-09-12
Onset:2006-10-10
   Days after vaccination:28
Submitted: 2010-07-06
   Days after onset:1365
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA103A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Appendicectomy, Intestinal haemorrhage, Intussusception, Irritability, Laparotomy, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (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), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0662982A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; unknown route of administration) given on 12 September 2006. On 12 September 2006, the subject received 2nd dose of ROTARIX (oral). On 10 October 2006, 28 days after vaccination with 2nd dose of ROTARIX, the subject experienced irritability, bilious vomiting and enterorrhagia. The subject was hospitalised. Ileum-cecum-colon intussusception was observed. Appendectomy and intussusception correction laparotomy surgery were performed. At the time of reporting the events were resolved.


VAERS ID: 393907 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-01
Onset:2010-05-28
   Days after vaccination:57
Submitted: 2010-07-29
   Days after onset:62
Entered: 2010-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

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

Life Threatening? Yes
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: UNK
CDC Split Type: B0666868A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s medical history and concomitant medication were not reported. The subject''s medical history and concomitant medication were not reported. Previous vaccination included ROTARIX (GlaxoSmithKline; oral) st dose given on February 2010. In April 2010, the subject received 2nd dose of ROTARIX (oral). Lot number not. 28 May 2010, 1 month after vaccination with ROTARIX, the subject was taken to emergency room and diagnosed with intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). The subject was treated with liquid contrast/hydrostatic water/air enema. He was discharged from hospital with good clinical evolution. At the time of reporting the event was resolved.


VAERS ID: 394093 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2010-07-08
Onset:2010-07-09
   Days after vaccination:1
Submitted: 2010-08-02
   Days after onset:24
Entered: 2010-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB091A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal rigidity, Crying, Intussusception, Pallor, Salivary hypersecretion, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Depression (excl suicide and self injury) (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 09Jul2010, abnormal
CDC Split Type: D0068460A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2010021664) and described the occurrence of possible intussusception in an 8-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s past medical history was not provided. On 08 July 2010 the subject received the first dose of ROTARIX (0.5 ml, oral). Approximately one day post vaccination with ROTARIX, on 09 July 2010, the subject experienced diffuse abdominal rigidity, miserable abnormal crying, increased salivation and pallor. Intussusception was suspected. The subject was hospitalised for an unknown period of time. The reporter stated that the events were not life-threatening but that without medical intervention the events could have been life-threatening. On the same days, on 09 July 2010, the events were completely resolved. The vaccination course with ROTARIX was discontinued. The reporter considered that the events were possibly related to vaccination with ROTARIX. No further information will be available.


VAERS ID: 396456 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Male  
Location: Foreign  
Vaccinated:2010-08-09
Onset:0000-00-00
Submitted: 2010-08-25
Entered: 2010-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA920A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Decreased appetite, Haematochezia, Intensive care, Intussusception
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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: Tick-borne Encephalitis v
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0670572A

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). Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-gsk); non-GSK manufacturer; subcutaneous given on 8 July 2010; hepatitis B vaccine recombinant; GlaxoSmithKline; subcutaneous given on 7 May 2010 and 9 June 2010. Concurrent medications included (Non-GSK) TBE. On 9 August 2010 the subject received 1st dose of ROTARIX (oral). Three days after vaccination with ROTARIX, the subject experienced decreased appetite and bloody stools. Due to abdominal pain the subject was brought to healthcare centre and referred to surgeon. Then he was referred to hospital. The subject was hospitalized and stayed in intensive care unit for monitoring. On 13 August 2010 the subject was diagnosed with intussusception. The subject''s general conditions became better. The physician considered the events were life threatening. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 397461 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2010-08-13
Onset:2010-08-16
   Days after vaccination:3
Submitted: 2010-09-03
   Days after onset:18
Entered: 2010-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA846A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Computerised tomogram abdomen abnormal, Enema administration, Intussusception, X-ray abnormal
SMQs:, Retroperitoneal fibrosis (broad), 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: Abdominal X-ray, 16Aug2010, IS; Computerized tomography, 16Aug2010, IS
CDC Split Type: B0672647A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). No relevant medical history. Previous and/or concurrent vaccination included INFANRIX HEXA; GlaxoSmithKline; intramuscular; right thigh given on 16 July 2010; PREVENAR (non-gsk); Wyeth Labs; intramuscular; left thigh given on 16 July 2010. On 13 August 2010 the subject received 1st dose of ROTARIX (oral). On 16 August 2010, 3 days after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. Relevant test results included abdominal radiography showing non specific abnormalities and abdominal computerized tomography showing a visible intussusceptum/soft tissue. The event was resolved with enema.


VAERS ID: 397628 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-08-11
Onset:2010-08-11
   Days after vaccination:0
Submitted: 2010-09-07
   Days after onset:27
Entered: 2010-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal surgery, Ileostomy, Incorrect route of drug administration, Intussusception
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Medication errors (narrow)

Life Threatening? No
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0673083A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 11 August 2010, the subject received unspecified dose of ROTARIX (intramuscular, unknown injection site). Lot number was not provided. On 11 August 2010, during vaccination with ROTARIX, the subject experienced inappropriate route of vaccination. The subject was supposed to receive vaccine orally and not intramuscularly. On 20 August 2010, 9 days after vaccination with ROTARIX, the subject experienced intussusception. 8 days later, the subject was hospitalised and required an urgent abdominal surgery and temporarily ileosurgery. At the time of reporting, the outcome of the events was unspecified.


VAERS ID: 398767 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Female  
Location: Foreign  
Vaccinated:2010-07-19
Onset:2010-07-22
   Days after vaccination:3
Submitted: 2010-09-17
   Days after onset:57
Entered: 2010-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB091A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal tenderness, Acute abdomen, Aspartate aminotransferase normal, Bacterial test negative, Blood electrolytes normal, Blood glucose normal, Blood lactate dehydrogenase increased, Bloody discharge, Body temperature increased, C-reactive protein normal, Diarrhoea, Fluid intake reduced, Foreign travel, Gastroenteritis, Gastrointestinal motility disorder, General physical health deterioration, Ileus, Intussusception, Laboratory test normal, Neutrophil percentage, Pyrexia, Respiratory syncytial virus test negative, Rotavirus test negative, Skin turgor decreased, Surgery, Syncope, Transaminases, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Aspartate aminotransferase, 22Jul2010, 45U/l; bacteria stool test, Jul2010, normal; blood electrolytes, 22Jul2010, normal; blood glucose, 22Jul2010, normal; body temperature, 22Jul2010, 37.7degC; C-reactive protein, 22Jul2010, 0.09mg/dl; lactate dehydrogenase, 22Jul2010, 347U/l; segmented neutrophil percentag, 22Jul2010, 59%; transaminases, 22Jul2010, normal; white blood cells, 22Jul2010, 9.7/nl Laboratory of renal retention values examination on 22 July 2010: normal Examination of stool: negative for rotavirus and norovirus, negative of adenovirus; negative for respiratory syncytial viruses sonography of abdomen on 23 July 2010: wide, fluid-filled intestinal loop with very low peristalsis, partly pendulum peristalsis; unrestrained fluid in Morison pouch, Koller pouch and retrovesically. X-ray of hanging abdomen on 23 July 2010: distinct standing intestinal loop with air-fluid levels, signs of subileus to ileus, unrestrained air like perforation not detectable. Sonography on 23 July 2010: cockade in terms of ileocolic intussusception at right epigastrum and mesogastrum
CDC Split Type: D0068858A

Write-up: This case was reported by a physician and described the occurrence of acute abdomen in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Report included completed questionnaire and 2 hospital reports. According to questionnaire, concurrent medical conditions or concurrent medications were not reported. On 19 July 2010 the subject received 1st dose of ROTARIX (oral). On 22 July 2010, 4 days after vaccination with ROTARIX, the subject experienced gastroenteritis, ileus and intussusception. At an unspecified time, the subject developed syncope when travelling to foreign country. The subject was hospitalised and the physician considered the event were life threatening. On 26 July 2010, the events were resolved. The vaccination course with ROTARIX was discontinued. The physician considered gastroenteritis, ileus and intussusception were possibly related to vaccination with ROTARIX. The physician considered syncope was unlikely related to vaccination with ROTARIX. According to hospital report, signed on 23 July 2010, the subject was hospitalised by a rescue service on 22 July 2010. Acute abdomen, acute gastroenteritis, ileus symptoms and intestinal transit disorder were diagnosed. One day prior to hospitalisation, the subject developed recurrent vomiting and refused to drink (fluid intake reduced). She had fever, but no diarrhea. She was not exposed to ill peoples. Four days before, the subject received Rotavirus vaccine. On admission examination, she was in stable state. State of tension of skin was mildly reduced and mucous membrane of the mouth was still moistly. Abdomen was tender. She had no pain on pressure. Peristalsis was very lively and squeaking. Other physical examination was normally. Electrolyte values and inflammatory values were normal. At the time of reporting, there were no pathogens in stool detectably. She completely refused to drink, had recurrent vomiting and diarrhea with bloody discharge. Her general condition worsened. By sonography, wide fluid-filled intestinal loop with very low peristalsis, partly pendulum peristalsis could be shown. There was unrestrained fluid. X-ray of hanging abdomen showed air-fluid level. Due to symptoms of ileus, the subject was transferred to a paediatric surgery at another hospital on 23 July 2010. Intussusception caused intestinal transit disorder. The subject was treated with a solution containing glucose and electrolytes for parenteral rehydration. According to hospital report, signed on 02 August 2010, the subject was hospitalised from 23 to 26 July 2010. On admission examination, the subject was in table state. Abdomen was active tense and showed pain on pressure. Inflammatory values were not increased. BY sonography, cockade in terms of ileocolic intussusception at right epigastrum and mesogastrum were detected. The subject was treated with desintussusception. Fluid passed from Bahin''sche lid into small intestine. Surgery and post-operative course were unproblematically. Follow-up information has been requested.


VAERS ID: 402528 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2010-09-15
Onset:2010-09-18
   Days after vaccination:3
Submitted: 2010-10-08
   Days after onset:20
Entered: 2010-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA954A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Blood electrolytes normal, Blood lactic acid normal, Blood pH normal, C-reactive protein increased, Enema administration, Gastrointestinal disorder, General physical health deterioration, Haematocrit normal, Haemoglobin increased, Ileus, Intensive care, Intussusception, Platelet count increased, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COLECALCIFEROL
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood electrolytes, 19Sep2010, balanced; C-reactive protein, 19Sep2010, 4.6mg/l; Hematocrit, 19Sep2010, 0.365; Hemoglobin, 19Sep2010, 12.2mmol/l; Lactate, 19Sep2010, 1.7; Platelet count, 19Sep2010, 567G/l; White blood cell count, 19Sep2010, 11.2G/l; pH, 19Sep2010, 7.34
CDC Split Type: D0068981A

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). The initial report also included a questionnaire from the reporting physician received by fax. The subject has no underlying or concurrent medical conditions or other risk factors. On 15 September 2010 the subject received the first dose of ROTARIX (0.5 ml, oral). Approximately three days post vaccination with ROTARIX, on 18 September 2010, the subject experienced vomiting. On 18 September 2010 the subject was hospitalised for an unknown period of time. On the next day, on 19 September 2010, the subject was transferred to another hospital. In the paediatric surgery department of this hospital the subject was discharged with invagination (intussusception). Treatment included hydrostatic disinvagination on 19 September 2010. At the time of reporting, on 25 September 2010, the events were resolved. Follow-up information including a hospital report was received from the reporting physician. The subject has no underlying or concurrent medical conditions or other risk factors. Concomitant medications included DEKRISTOL. The subject received no other concomitant medication. On 15 September 2010 the subject received the first dose of ROTARIX (0.5 ml, oral). Approximately three days post vaccination with ROTARIX, on 18 September 2010 around noon, the subject experienced recurrent vomiting and abdominal pain. Clinical examination and initial sonography showed possible invagination. The subject was hospitalised for six days. On admission the subject was in reduced general condition and good nutritional condition. Abdominal examination showed soft abdomen but palpable resistances at the right lower abdomen. Examinations of heart and lungs, as well as further physical examinations were normal. Abdominal sonography was performed on 19 September 2010 and showed ileocolic invagination and signs of ileus. All other organs were normal. Immediate treatment included hydrostatic disinvagination on 19 September 2010. Control sonography no longer showed characteristic cocarde structure, but severe swelling of Bauhin''s valve and of terminal ileum. The subject was monitored at the paediatric intensive care ward. During course of hospitalisation these events resolved completely. The subject was transferred to the paediatric ward of the hospital. Further treatment included infusion therapy followed by stepwise oral nutrition build-up which was well tolerated. The subject did not experience further episodes of vomiting. Additionally, treatment included antibiotic prophylaxis with UNACID. The subject was always circulatory stable and free of fever. The subject resumed defecation spontaneously and started to gain weight well again. Follow-up abdominal sonography, performed on 22 September 2010, was normal. After about five days, on 22 September 2010, all events were resolved. On 23 September 2010 the subject was discharged from hospital in good general condition at home. The reporter provided the answers to a GSK targeted questionnaire for intussusception post vaccination with ROTARIX: The subject was diagnosed with intussusception. Symptoms started on 18 September 2010 with vomiting and resolved on 22 September 2010. No information was provided for plain abdominal radiography/air or liquid enema. Abdominal ultrasound showed a visible intussusception or soft tissue mass. An intra-abdominal mass with specific characteristic features was demonstrated and proven to be reduced by hydrostatic enema on post-reduction ultrasound. Abdominal computerized tomogram scan was not performed. Surgery was not performed and therefore did not demonstrate invagination. The child had no bowel resection. Family history included no intussusception or bowel abnormalities. The subject''s medical history did not include previous intra-abdominal surgery, congenital intestinal malformation, intestinal polyps, intestinal vascular malformations, cystic fibrosis, Hirschsprung disease, or other gastrointestinal malformation and dysfunction. The subject''s medical history included intussusception. No information was proved whether the subject''s medical history included Meckels diverticulum. The event did not resolve spontaneously. The event resolved by liquid contrast or hydrostatic water or air enema. The event neither required surgical disinvagination nor surgical resection. Treatment of the event was without complications. The subject survived. No further information will be available.


VAERS ID: 403181 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2010-09-18
Onset:2010-09-18
   Days after vaccination:0
Submitted: 2010-10-13
   Days after onset:25
Entered: 2010-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB054A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Barium double contrast, Intussusception, Surgery, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), 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: Ultrasound abdomen, 18Sep2010, see narrative
CDC Split Type: B0678175A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medications included (non-GSK) PREVENAR and INFANRIX-IPV/HIB, given on an unspecified date. On 18 September 2010, the subject received unspecified dose of ROTARIX (oral, lot number not provided). On 18 September 2010, less than one day after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and had surgery due to this event. At the time of reporting, the event was improved. The physician considered the event was almost related to vaccination with ROTARIX. Follow-up information received on 11October 2010: On 18 September 2010, the subject received 1st doses of ROTARIX (oral, lot number provided), INFANRIX-IPV/HIB (intramuscular, left thigh) and (non-GSK) PREVENAR (intramuscular, right thigh). On 18 September 2010, less than one day after vaccinations, the subject experienced intussusception. Follow-up information received on 12 October 2010: Concurrent medications included (non-GSK) BCG given on 10 July 2010 (subcutaneous, left upper arm). On 18 September 2010, an abdominal ultrasound was performed and revealed an intra-abdominal mass with specific characteristic features that is proven to be reduced by hydrostatic enema on post-reduction ultrasound. The event was resolved by liquid contrast / hydrostatic water / air enema.


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