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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: 342257 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2007-08-28
Onset:2007-08-31
   Days after vaccination:3
Submitted: 2009-03-20
   Days after onset:567
Entered: 2009-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Intussusception, Small intestinal resection, Surgery
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0488681A

Write-up: This case was reported by a regulatory authority (#DHH2301N2C07-36858) and described the occurrence of invagination of intestine in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 28 August 2007, the subject received 1st dose of ROTARIX intramuscular, unknown injection site instead of orally. The lot number was not provided. In August 2007, 3 days after vaccination with ROTARIX, the subject experienced ileo- ileo-colic invagination without gastroenteritis. The subject was hospitalised. The subject was treated with surgery. At the time of reporting the events were resolved with the following sequelae: resection of small intestine. Further information has been requested but could not be obtained. This case has therefore been closed. Follow-up received on 19 March 2009: The regulatory authority reported that the vaccine was administered orally.


VAERS ID: 344686 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-05
Onset:2009-02-08
   Days after vaccination:34
Submitted: 2009-04-23
   Days after onset:73
Entered: 2009-04-23
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 - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Haematochezia, 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), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0570571A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 5-month-old female subject who was vaccinated with live ROTARIX (GlaxoSmithKline). The subject had no history or family history of intussusception or bowel abnormalities. She had no congenital intestinal malformation or other gastrointestinal malformation and dysfunction. Previous and/or concurrent vaccination included bacillus calmette-guerin (non-GSK manufacturer; intradermal) given on 5 September 2008; DTAP, Polio, and HIB (manufacturer unspecified, intramuscular) given on 4 November 2008 and 5 January 2009; HEP B (manufacturer unspecified; intramuscular) given on 5 September 2008 and 4 November 2008; ROTARIX (GlaxoSmithKline, oral) given on 4 November 2008; PNEUMOVAX (non-GSK) (manufacturer unspecified; intramuscular) given on 5 January 2009 and on unspecified date. On 8 February 2009, 34 days after vaccination with the 2nd dose of ROTARIX, the subject experienced alimentary vomiting and irritability. On 09 February 2009, the subject presented abdominal distention and blood in stools. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Abdominal radiograph, abdominal ultrasound and abdominal CT were not performed. Ileocolic intussusception was suspected and confirmed by laparotomy on the same day; it was resolved without complications by taxis. With good response, subject was discharged on 12 February 2009. On 12 February 2009, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 344687 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-08-25
Onset:2009-01-01
   Days after vaccination:129
Submitted: 2009-04-23
   Days after onset:111
Entered: 2009-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Diarrhoea, Gastrointestinal hypermotility, Intussusception, Irritability, Laparotomy, Rectal haemorrhage, Vomiting, X-ray normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), 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: Abdominal X-ray, Jan2009, see text
CDC Split Type: B0570634A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 8-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included Bacillus Calmette-Guerin vaccine (non-GSK manufacturer, intradermal) given on 27 April 2008; combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified, intramuscular) given on 25 June 2008, 25 August 2008 and 27 October 2008; hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) given on 27 April 2008, 25 June 2008 and 27 October 2008; influenza virus vaccine (manufacturer unspecified, intramuscular) given on 27 October 2008 and 3 December 2008; ROTARIX (GlaxoSmithKline, oral) given on 25 June 2008; pneumococcal vaccine (manufacturer unspecified, intramuscular) given on 10 July 2008. The subject was in good health conditions. On 25 August 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 1 January 2009, 4 months after vaccination with ROTARIX, the subject experienced alimentary vomiting, diarrhea and irritability. The subject was hospitalized with 2 episodes of biliary vomiting, abdominal distension, increased peristalsis and rectal bleeding at examination. Ileocolic intussusception was suspected and confirmed by laparotomy. The laparotomy was done on 1 January 2009. Ileo-colic intussusception was resolved by taxis without intestinal resection and complication. The patient had good response and favorable evolution. Only an abdominal x-ray was performed but showed no abnormalities. An abdominal ultrasound and Ct were not done in the diagnostic procedures. The physician considered the events were clinically significant (or requiring intervention). On 5 January 2009, the events were resolved and the subject was discharged in good condition. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information has been requested; therefore this case has been closed.


VAERS ID: 344813 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-04
Onset:2008-10-24
   Days after vaccination:50
Submitted: 2009-04-24
   Days after onset:182
Entered: 2009-04-24
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, Enema administration, Hypotonia, Intussusception, Malaise, Rectal haemorrhage, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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), Generalised convulsive seizures following immunisation (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had no intestinal malformation, no medical history of abdominal surgery, no medical history of invagination of intestine. No family history of invagination of intestine.
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Oct2008, see text; Ultrasound abdomen, 25Oct2008, see text; 25 October 2008: Abdominal ultrasound: showed a visible intussusception mass at right iliac fossa level at 3.4 cm diameter with good vascularisation, associated to several small lymph nodes; liver structure normal, no vascular abnormality, no dilatation of biliary tract, biliary vesicle with thin wall without lithiasis, normal kidney, normal spleen, mild effusion between intestinal loops. Conclusion: right iliac fossa invagination. Plain abdominal X-ray without preparation: fluid levels and dilated bowel loops. Easy reduction of invagination with air. No problem during the process.
CDC Split Type: B0550021A

Write-up: This case was reported by a physician via a GSK sales representative and described the occurrence of invagination of intestine in a 6-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). Medical history and concurrent medication were unknown. In November 2008, the subject received a 2nd dose of ROTARIX (oral, batch number not available). One month after vaccination with ROTARIX, the subject developed invagination of intestine (NOS). The subject was hospitalised for an unknown time. At the time of reporting, the event was resolved (nos). Causality assessment was unspecified). Upon follow-up received on 12 February 2009: At the time of reporting the paediatrician saw the child again in consultation on 14 November 2008. Hospitalization report was not available. The subject was a 6-month-old female. She had no personal or familial medical history of invagination of intestine. She had no known intestine malformation. The second dose of ROTARIX was administered on 04 September 2008. On 26 November 2008, diagnosis of invagination of intestine was made after ultrasound (NOS). Upon follow-up received on 17 February 2009: The subject was 8-month-old, measured 65.5 cm and weighted 7.44 kg. Vaccinal history included a first dose of ROTARIX (batch number not available) on 23 July 2008. The subject had no medical history of abdominal surgery. On 27 November 2008, the subject underwent surgery, invagination of intestine was confirmed. No intestine resection was performed. The causality assessment of the reporter was unspecified. Upon follow-up received on 23 March 2009 from a new physician from the hospital where the child was admitted: The subject was hospitalized on 25 October 20008 and was diagnosed with invagination of intestine (NOS). At the time of the event, the subject was 4-month-old. The subject was efficiently treated with air enema without surgery. There was no complication; bowel movements were normal one day after enema. The subject was discharged from hospital on 27 October 2008. Causality assessment was unspecified). Upon follow-up received on 14 April 2009 from the hospital physician: The subject had no personal history of abdominal surgery. There was no family history of intestinal anomaly. From 24 to 25 October 2008, the subject developed moderate rectorragia. On an unspecified date, the subject presented with moderate abdominal pain, moderate malaise and moderate hypotonia which resolved within an unspecified period of time. No abdominal CT scan was performed. Diagnosis of right iliac fossa invagination was confirmed by abdominal ultrasound. Plain abdominal X-ray showed fluid levels and dilated bowel loops. Invagination was easily reduced with air enema on 25 October 2008. There was no complication during radiological procedures nor surgery. This case was considered as clinically significant. According to the physician, the events were unrelated to vaccination with ROTARIX and were possibly related to a viral infection. This case has been closed; no more information will be available.


VAERS ID: 345317 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2009-03-08
Onset:2009-03-16
   Days after vaccination:8
Submitted: 2009-04-30
   Days after onset:45
Entered: 2009-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA725A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Intussusception, Laparotomy, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Mar2009, see text; Ultrasound abdomen, Mar2009, see text
CDC Split Type: B0570898A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included live attenuated (GlaxoSmithKline) given on 28 January 2009. On 8 March 2009, the subject received 2nd dose of ROTARIX (oral). On 16 March 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). At the time of reporting the event was resolved. The physician considered the event was possibly related to vaccination with ROTARIX. Follow up information received on 27 April 2009: The subject received previous vaccinations according to the national schedule (BCG, oral polio vaccine, Hepatitis B vaccine and DTap vaccine). On 19 March 2009, the subject was admitted to hospital with abdominal distention and vomiting. Abdominal x-ray showed air-fluid level and abdominal ultrasound showed ileo-cecal intussusception. An exploratory laparotomy with primary reduction of intussusception was performed on 19 March 2009. The subject was treated with CEFIXIM, AMIKACINE, METROGYL, ceftriaxone and FLAGYL. The subject was hospitalized for 8 days. At the time of reporting the events were resolved. The case has been closed.


VAERS ID: 345448 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-08-30
Onset:2008-11-11
   Days after vaccination:73
Submitted: 2009-05-01
   Days after onset:170
Entered: 2009-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Culture stool negative, Enema administration, Intussusception, Laparotomy, Lethargy, Mucous stools, Pallor, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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, Nov2008, IS; Stool culture, 15Nov2008, NAD; Ultrasound abdomen, Nov2008, IS
CDC Split Type: B0571218A

Write-up: This case was reported by a physician and described the occurrence of intussusception in an 8-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case was collected through a foreign study occurring post Rotavirus vaccination. It was unknown if the subject had any family history of intussusception. It was unknown if the subject had any previous significant illness/hospitalisations/operations. Feeding history: The subject currently fed formula. The subject received no current treatment. Previous vaccination included ROTARIX (GlaxoSmithKline; unknown route of administration) given on 3 May 2008. On 30 August 2008, the subject received the 2nd dose of ROTARIX (unknown route of administration, lot number not provided). On 11 November 2008, 73 days after vaccination with the 2nd dose of ROTARIX, the subject was admitted at hospital due to intussusception. The subject experienced vomiting, lethargy and pallor (rather than 72 hours prior to diagnosis of intussusception). On 15 November 2008, faeces sample was collected: Nothing Abnormal Detected, mucoid in appearance. The diagnosis of intussusception was made based on abdominal ultrasound exam and abdominal X-ray (Site of intussusception: right lower abdominal quadrant; Type of intussusception: difficult to determine either ileoileal or ileocaecal). The subject was treated with Airhydrostatic Enema (Fluoroscopy guided); initially resolved but reoccurred again. Laparotomy (manual reduction) and appendectomy were performed. On 16 November 2008, the subject was discharged alive. At the time of reporting the outcome of the events was unspecified. No further information could be obtained due to the nature of the collaborative research trial under which the event was reported; this case has therefore been closed.


VAERS ID: 345449 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-01
Onset:2008-05-31
   Days after vaccination:30
Submitted: 2009-05-01
   Days after onset:335
Entered: 2009-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Biopsy intestine abnormal, Body temperature increased, Culture stool negative, Enema administration, Gastrointestinal necrosis, Haematochezia, Intestinal resection, Intussusception, Irritability, Lethargy, Mucous stools, Pallor, Pyrexia, Rotavirus test negative, Small intestinal haemorrhage, Surgery, Ultrasound abdomen abnormal, Virus serology test, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), 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), 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), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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, May2008, intussuscept; Biopsy intestine, May2008, necrosis; Body temperature, May2008, 37.8deg C; Diagnostic ultrasound, May2008, intussuscept; Stool culture, May2008, negative
CDC Split Type: B0571230A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case was collected through a study occurring post Rotavirus vaccination. The subject had no history and no family history of intussusception. The subject had no previous significant illness/hospitalizations/operations. Feeding history: The subject currently fed formula. The subject had no concomitant medication. Concurrent vaccination included INFANRIX HEXA (GlaxoSmithKline) given on 1 May 2008; PREVENAR (non-GSK manufacturer) given on 1 May 2008. On 1 May 2008, the subject received 1st dose of ROTARIX (unknown route). Lot number not provided. On 31 May 2008, 30 days after vaccination with ROTARIX, the subject was admitted at hospital due to ileocolic intussusception. The subject experienced abdominal pain, vomiting, lethargy, pallor, fever (37.8 deg C), irritability and currant jelly stool (48 hours prior to diagnosis of intussusception). The subject was hospitalized. On 04 June 2008, stool sample was collected and was negative for Rotavirus and Adenovirus. The diagnosis of intussusception was made based on abdominal ultrasound exam and abdominal X-ray. The intussusception was localized in the ileocecal valve. Air enema was performed but did not reduce the intussusception. A surgery was performed with an intestine resection of 5 cm and a biopsy showed hemorrhages and necrosis of the small intestine. On 5 June 2008, the subject was discharged alive. At the time of reporting the outcome of the events was unspecified. No further information could be obtained due to the nature of the collaborative research trial under which the event report was reported; this case has therefore been closed.


VAERS ID: 345814 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2009-03-30
Onset:2009-04-02
   Days after vaccination:3
Submitted: 2009-05-06
   Days after onset:34
Entered: 2009-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea haemorrhagic, Intussusception, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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? 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: B0572139A

Write-up: This case was reported by a foreign regulatory authority ( # S200904-478) and described the occurrence of intussusception of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history and was under no concomitant medication. On 30 March 2009, the subject received unspecified dose of ROTARIX (oral), lot number not provided. On 2 April 2009, 3 days after vaccination with ROTARIX, the subject experienced bloody diarrhea and vomiting. The subject was brought to hospital where an intussusception of intestine was diagnosed. The subject was hospitalised. At the time of reporting the events were improved.


VAERS ID: 346093 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-12
Onset:2009-01-01
   Days after vaccination:20
Submitted: 2009-05-11
   Days after onset:129
Entered: 2009-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Enema administration, Gastrointestinal sounds abnormal, Intestinal mass, Intestinal obstruction, Intussusception, Lethargy, Pallor, Rectal haemorrhage, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding; Cow''s milk intolerance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, Jan2009, Abnormal
CDC Split Type: B0573136A

Write-up: This case was reported by a physician and described the occurrence of ileocaecal valve intussusception in a 6-month-old female subject who was vaccinated ROTARIX (GlaxoSmithKline). This case was collected through a study occurring post ROTARIX vaccination. The subject had no medical or family history of intussusception, nor previous significant illness, hospitalisation or surgery. The subject was exclusively breast-fed until the age of 6 months. Concurrent medical conditions included breast feeding as well as cow''s milk intolerance which led to skin rash after the intake. Previous and/or concurrent vaccination included live ROTARIX; GlaxoSmithKline; oral given on 2 October 2008. On 12 December 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. The subject did not receive any other vaccine within the last 2 weeks. There has been change to the subject''s diet in the last week: solid food was started. On 31 January 2009, approximately 7 weeks after vaccination with ROTARIX, the subject was hospitalised due to bile stained vomiting, absent bowel sounds, intestinal mass, red blood per rectum, abdominal pain, lethargy, pallor and intestinal obstruction, started 12-23 hours before the diagnosis. The abdomen ultrasound revealed ileocaecal valve intussusception at the splenic flexure. It was unknown if a stool sample was collected. The subject was hospitalised for 3 days. The 1st treatment with enema was unsuccessful. The subject was then transferred to another hospital where the 2nd treatment with enema was performed with success. On 2 February 2009, the subject was discharged from hospital. At the time of reporting the events were resolved. Further information was not available. This case has therefore been closed.


VAERS ID: 346628 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-01
Onset:2008-04-25
   Days after vaccination:24
Submitted: 2009-05-19
   Days after onset:389
Entered: 2009-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Haematochezia, Intussusception, Mucous stools, Rectal haemorrhage
SMQs:, Acute pancreatitis (broad), 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? 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: B0574329A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 6-month-old female subject who was vaccinated with ROTARIX. This case was collected through a study occurring post Rotavirus vaccination. The medical history and birth details were unspecified. The subject was fed with formula; there was no further detail about her diet. Previous vaccination included ROTATEQ (Merck) given on 29 November 2007; ROTARIX (GlaxoSmithKline) given on 4 February 2008. On 1 April 2008 the subject received 3rd dose of Rotavirus vaccine (unknown route). Lot number not provided. On 25 April 2008, 24 days after vaccination with ROTARIX, the subject was admitted at hospital due to intussusception. The subject experienced abdominal pain, diarrhea, rectal blood and current jelly stool (more than 72 hours prior to diagnosis of intussusception). The diagnosis of intussusception was made based on clinical features. No treatment or procedure was performed, the intussusception reduced spontaneously. On 29 April 2008, the subject was discharged alive. At the time of reporting the outcome of the events was unspecified. No further information could be obtained due to the nature of the collaborative research trial under which the event report was reported; this case has therefore been closed.


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