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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: 431419 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-30
Onset:2011-03-25
   Days after vaccination:85
Submitted: 2011-08-25
   Days after onset:153
Entered: 2011-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA175A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Computerised tomogram, Constipation, Death, Intestinal dilatation, Intussusception, Septic shock, Surgery
SMQs:, Acute pancreatitis (broad), Toxic-septic shock conditions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-04
   Days after onset: 10
Permanent Disability? No
Recovered? No
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: Computerized tomogram, 2011, see text units
CDC Split Type: B0741901A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of septic shock in a 4-month-old male subject who was vaccinated with ROTARIX (Fiocruz). On 30 December 2010, the subject received unspecified dose of ROTARIX (oral). On 25 March 2011, 85 days after vaccination with ROTARIX, the subject experienced abdominal distension and stop of stool elimination. There was no vomiting. The subject underwent surgery with intussusception reduction, with no bowel perforation. The RX showed an important bowel distension. The subject was treated with ampicillin, GENTAMICIN, metronidazole and surgery. The subject died on 4 April 2011 from septic shock. It was unknown whether an autopsy was performed.


VAERS ID: 431423 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Foreign  
Vaccinated:2011-06-27
Onset:2011-08-02
   Days after vaccination:36
Submitted: 2011-08-25
   Days after onset:23
Entered: 2011-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA299AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Diarrhoea, Diarrhoea haemorrhagic, Intensive care, Intussusception, Surgery, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Aug2011, intussusception; Ultrasound abdomen, 05Aug2011, intussusception
CDC Split Type: B0741636A

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). Previous vaccination included ROTARIX (GlaxoSmithKline; oral) 1st dose given on 25 April 2011. On 27 June 2011, the subject received 2nd dose of ROTARIX (oral). On 2 August 2011, 36 days after vaccination with ROTARIX, the subject experienced bloody mucous diarrhea. The subject was hospitalised. Abdominal x-ray and abdominal ultrasound performed on 5 August 2011 confirmed the diagnosis of intussusception. The subject was treated with surgery on 6 August 2011. There was no intestinal loop injury or perforation. The procedure was performed manually. On 8 August 2011, the subject was in recovery at ICU. At the time of reporting the events were resolved. No further information was expected; the case has been closed.


VAERS ID: 432321 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-11
Onset:2011-04-15
   Days after vaccination:63
Submitted: 2011-08-30
   Days after onset:137
Entered: 2011-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA130AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Intestinal obstruction, Intestinal resection, Intussusception, Vomiting, X-ray abnormal, X-ray gastrointestinal tract abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), 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), Noninfectious diarrhoea (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-ray, bowel resection
CDC Split Type: B0742184A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 11 February 2011, the subject received 2nd dose of ROTARIX (oral). On 15 April 2011, 63 days after vaccination with ROTARIX, the subject experienced bloody-mucous diarrhea and vomiting. The subject was hospitalised. X-ray suggested bowel obstruction. The subject was treated with surgery with manually reduction of the intussusception. At the time of reporting, the outcome of the events was unspecified.


VAERS ID: 436907 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-22
Onset:2011-09-27
   Days after vaccination:5
Submitted: 2011-10-05
   Days after onset:8
Entered: 2011-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA654A / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA381AB / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Crying, Gastrointestinal disorder, Haematochezia, Intussusception, Irritability, Pallor, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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 (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 27Sep2011, Intussusception; Ultrasound abdomen, 27Sep2011, Intussusception
CDC Split Type: B0752228A

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). Concurrent vaccination included INFANRIX PENTA (GlaxoSmithKline; route and injection site unknown) given on 22 September 2011. On 22 September 2011, the subject received 1st dose of ROTARIX (oral). On 27 September 2011, 5 days after vaccination with ROTARIX, the subject experienced bloody stools, irritability and crying. The subject was hospitalised on 27 September 2011. Clinical examination showed pallor and mildly distended abdomen. Abdomen X-ray revealed intussusception. There was a paucity of bowel gas with a loop of non-dilated bowel in the left upper abdomen. At the time of reporting the outcome of the events were was unspecified.


VAERS ID: 437096 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-24
Onset:2011-09-30
   Days after vaccination:6
Submitted: 2011-10-06
   Days after onset:6
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anal haemorrhage, Haematochezia, Intestinal operation, Intussusception
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0752640A

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 24 September 2011, the subject received 1st dose of ROTARIX (oral, batch number not provided). On 30 September 2011, 6 days after vaccination with ROTARIX, the subject was brought to hospital for fresh blood per anus and currant jelly stools. The physician considered the events were clinically significant (or requiring intervention). The subject was sent to the operating room for reduction of intussusception. At the time of reporting, the events were resolved. The physician considered the events were probably related to vaccination with ROTARIX.


VAERS ID: 437576 (history)  
Form: Version 1.0  
Age: 0.41  
Sex: Male  
Location: Foreign  
Vaccinated:2011-08-02
Onset:2011-08-07
   Days after vaccination:5
Submitted: 2011-10-07
   Days after onset:61
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA304AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Diarrhoea, Gastrointestinal necrosis, Intussusception, Small intestine operation, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0752671A

Write-up: This case was reported by a healthcare professional (case investigation unit) and described the occurrence of intussusception of small bowel in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), Hepatitis B vaccine (non-gsk), DTaP-Polio-Hib (non-gsk) and (non-gsk) PREVENAR. A physician or other health care professional has not verified this report. Historic vaccination included Hepatitis B vaccine (non-gsk); ROTARIX (GlaxoSmithKline); OPV (manufacturer unspecified) and pneumococcal vaccine (non-gsk) given on 20 April 2011. On clinical examination, the subject appeared to be healthy and had a head circumference of 45 cm. He was big for his age, drinking 180 ml/ 4 hours and eating solids. It was reported that the subject did not experience reactions to previous vaccinations. On 2 August 2011, the subject received 2nd dose of ROTARIX (oral), 2nd dose of Hepatitis B vaccine (Non-GSK) (intramuscular, unknown site of injection, batch number not provided), 1st dose of DTaP-Polio-HIB (Non-GSK) (intramuscular, unknown site of injection, batch number not provided), 2nd dose of PREVENAR (unknown route of administration, unknown site of injection, batch number not provided). On 7 August 2011, 5 days after vaccination with DTaP-Polio-HIB (Non-GSK), Hepatitis B vaccine (Non-GSK), PREVENAR and ROTARIX, the subject experienced crying, vomiting and diarrhea. The subject was brought to emergency at 17H00 and was hospitalised. At 20H45, the subject underwent surgery (dissection of 20 cm of small intestine due to intussusception. The distal part from intussusception appeared to be necrotic. At the time of reporting, the outcome of the events was unspecified. None of the 7 other subjects who were vaccinated on the same day, with the same batch and on the same circumstances, experienced event.


VAERS ID: 440876 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-10
Onset:2011-10-16
   Days after vaccination:6
Submitted: 2011-10-31
   Days after onset:15
Entered: 2011-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA419BF / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal necrosis, Intussusception, Lymphoma, Surgery, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Ischaemic colitis (narrow), Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound scan, Oct2011, pathologic
CDC Split Type: D0073107A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of very severe intussusception in an 11-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unknown date in 2011 the subject received the first dose of ROTARIX (0.5 ml, oral). At an unspecified time post vaccination with ROTARIX, on an unknown date in 2011, the subject experienced intussusception. The subject was hospitalised for an unknown period of time. At the time of reporting the outcome of the event was unspecified. On 28 October 2011 the same case was received from a foreign regulatory authority (# DE-PEI-PEI2011035259). The subject''s past medical history was not provided. No concomitant medication was reported. On 10 October 2011 the subject received the first dose of ROTARIX (0.5 ml, oral). Approximately six day post vaccination with ROTARIX, on 16 October 2011, the subject experienced very severe intussusception with colon and ileum necrosis. The subject was hospitalised for an unknown period of time. The events were assessed to be life threatening. Diagnosis of intussusception was confirmed by ultrasonography. On an unknown date between 16 October 2011 (date of first diagnosis) and 20 October 2011 (date of filling report) the subject underwent surgery during which a lymphoma was detected. Lymphoma was considered as potential causative lead point for intussusception. It was unknown whether or not lymphoma was pre-existing or developed post vaccination with ROTARIX. At the time of reporting, on 20 October 2011, the events were considered to be resolved with sequelae due to surgery. The events were assessed to be disabling (having caused permanent damage). The foreign regulatory authority has requested further information. Furthermore, follow-up information has been requested from the reporting physician.


VAERS ID: 441286 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-09-29
Onset:2011-10-01
   Days after vaccination:2
Submitted: 2011-11-03
   Days after onset:33
Entered: 2011-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Decreased activity, Frequent bowel movements, Intussusception, Pallor, Rotavirus test positive, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Diagnostic ultrasound, 11Oct2011, invagination; Rotavirus test, 11Oct2011, slightly positive; X-ray, 11Oct2011, invagination
CDC Split Type: B0757027A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of ROTARIX (administration site and route unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced invagination of intestine. The subject was hospitalised. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 24 October 2011: On 29 September 2011, the subject received 1st dose of ROTARIX (oral). Within days after vaccination with ROTARIX, the subject had frequent stool (7 to 8 times per day). The subject''s mother contacted the physician 3 days after vaccination. As the subject was breast feeded, the physician didn''t see any harm. There was no vomiting or temperature. On 11 October 2011, 12 days after vaccination with ROTARIX, the subject experienced vomiting, paleness and inactivity. The subject was hospitalised at 20.57 during 7 days, from 11 to 17 October 2011. The ultrasound and radiogram showed the invagination. In the sample of excrement, the rotavirus was slightly positive. Body temperature was normal. On 17 October 2011, the subject was discharged as he was recovered completely. The sample of excrement was negative for rotavirus on the day of discharge. It was not know if the subject''s mother allowed to vaccinate her child with the 2nd dose of ROTARIX.


VAERS ID: 442886 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-17
Entered: 2011-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea haemorrhagic, Intussusception
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0763107A

Write-up: This case was reported by a consumer and described the occurrence of bloody diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In 2008, the subject received unspecified dose of ROTARIX (oral, batch number not provided). In 2008, less than one year after vaccination with ROTARIX, the subject experienced bloody diarrhea and intussusception. The subject was then sent to local hospital for treatment and was hospitalised. At the time of reporting, the outcome of the events was unspecified. The reporter refused the identity of the subject and therefore no follow-up could be done.


VAERS ID: 443126 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-29
Onset:2011-10-01
   Days after vaccination:2
Submitted: 2011-11-18
   Days after onset:48
Entered: 2011-11-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA261CC / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, General physical health deterioration, Ileus, Intestinal operation, Intussusception, Scan abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)

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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdomen scan, 03Oct2011, pathologic
CDC Split Type: D0073464A

Write-up: This case was reported by a physician via a foreign regulatory authority (DE-PEI-PEI2011037623) and described the occurrence of ileocolic intussusception in a 10-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s past medical history was not provided. According to anamnesis the subject has not experienced recent infectious disease. No concomitant medication was reported. On 28 September 2011 the subject received the first dose of ROTARIX (1.5 ml, oral). Approximately three days post vaccination with ROTARIX, on 01 October 2011, the subject experienced intussusception and ileus of intestine. On 03 October 2011 the subject experienced vomiting and last stools. The subject did not experience bloody stools. The reporting physician considered that the events were life threatening. On 03 October 2011 the subject was hospitalised for five days for suspected intussusception. On admission to hospital the subject was in reduced general condition. The subject was crying. Abdomen could not be unambiguously diagnosed. The subject showed no signs of infection. Abdominal sonography, performed on 03 October 2011, showed and conformed ileocolic intussusception from the left mesogastric region to the middle of the transverse colon. Hydrostatic disinvagination, performed on 03 October 2011, failed. Therefore treatment included surgical disinvagination under intubation anaesthesia with laparotomy, open disinvagination and prophylactic ileopexy, performed on 03 October 2011. Surgery disinvagination and anaesthesia were performed without complications. Intussusception was easily reversed and circulation in the intestine was good. The course of hospitalisation was without complication. Post surgery stool regulation was initiated. Oral nutrition build-up was well tolerated. On 07 October 2011 the subject was discharged from hospital in good general condition for ambulatory follow-up and suture removal. At that date defecation was spontaneous again and the subject showed no signs of fever. The vaccination course with ROTARIX was discontinued. No further information will be available.


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