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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: 380132 (history)  
Form: Version 1.0  
Age: 0.37  
Gender: Male  
Location: Foreign  
Vaccinated:2008-01-24
Onset:2008-01-29
   Days after vaccination:5
Submitted: 2010-02-12
   Days after onset:745
Entered: 2010-02-12
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
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Gastrointestinal hypermotility, Haematochezia, Intestinal obstruction, Intussusception, Irritability, Laboratory test abnormal, Laparotomy, 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 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal x-ray, 30Jan2008, Abnormal
CDC Split Type: B0631993A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk); non-GSK manufacturer; intradermal; given on 12 September 2007; DTAP-IPV-HIB; manufacturer unspecified; intramuscular; given on 12 November 2007 and 24 January 2008; HEP B; manufacturer unspecified; intramuscular; given on 12 September 2007 and 12 November 2007. The subject was healthy. On 24 January 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 29 January 2008, 5 days after vaccination with ROTARIX, the subject experienced abdominal pain with bloody stools, increased peristalsis, abdominal distension and irritability. He was brought to the emergency ward. The morcilla sign was positive. On 30 January 2008, the abdomen X-ray showed fluid levels and dilated bowel loops as well as non-specific abnormalities and intestinal obstruction. A laparatomy was performed and ileocolic intussusception was found and treated by taxis without complications. The subject was hospitalised for 5 days and the physician considered the events were clinically significant (or requiring intervention). On 2 February 2008, the events were resolved and the subject was discharged from hospital in good conditions. The physician considered the events were almost certainly related to vaccination with ROTARIX. No further information was available. This case has therefore been closed.


VAERS ID: 380532 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-16
Entered: 2010-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia, Intussusception, Pneumonia, Surgery
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0631757A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a baby subject and gender unknown who was vaccinated with ROTARIX (Glaxosmithkline). On an unspecified date, at 3 and 4 months old, the subject received 2nd dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception, pneumonia and bloody stools. The subject was hospitalised due to pneumonia. During first day of hospitalization, the subject developed bloody stools and was operated for intussusception on 3rd day of hospitalization. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. Further information has been requested.


VAERS ID: 380640 (history)  
Form: Version 1.0  
Age: 0.19  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-08
Onset:2009-01-19
   Days after vaccination:42
Submitted: 2010-02-17
   Days after onset:394
Entered: 2010-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (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 X-ray, Abdominal mass, Cardiomegaly, Cyanosis, Gastrointestinal hypermotility, Haematochezia, Intussusception, Irritability, Laparotomy, Lung infiltration, Nausea, Pallor, Pneumonia, Respiratory disorder, Vomiting, X-ray abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), 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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: HEALTHY BABY
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: abdominal x-ray, 20Jan2009, see text.
CDC Split Type: B0633713A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (Glaxosmithkline). Previous and/or concurrent vaccination included PNEUMOCOCCAL vaccine; non-gsk manufacturer; intramuscular given on 8 December 2008; bacillus calmette-guerin vaccine (non-gsk); non gsk manufacturer; intradermal given on 28 September 2008; HEPATITIS B vaccine recombinant; manufacturer unspecified; intramuscular given on 28 September 2008 and 8 December 2008. The subject''s medical conditions included a healthy baby. On 8 December 2008 the subject received 1st dose of ROTARIX (oral). On 19 January 2009, 42 days after vaccination with ROTARIX, the subject experienced cyanosis, nausea and vomiting. The subject was brought to the emergency room. On 20 January 2009 she presented pallor irritability, increased of peristalsis, respiratory problems, blood stools, palpable abdominal mass. On 21 January 2009 the abdominal x-ray revealed pneumonic infiltration and cardiomegaly. Ileocolic intussusception was suspected and after confirmed. On 21 January underwent a laparotomy (no bowel resection was needed). Furthermore the subject was diagnosed with pneumonia and treated with ampicillin and furosemide without complications. On 24 January 2009 the subject was discharged in good medical conditions. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). The physician considered the events were almost certainly related to vaccination with ROTARIX.


VAERS ID: 380885 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-12-02
Submitted: 2010-02-19
   Days after onset:444
Entered: 2010-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Decreased appetite, Dehydration, Gastrointestinal hypomotility, Haematochezia, Intussusception, Irritability, Laparotomy, Nausea, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Hostility/aggression (broad), Ischaemic colitis (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Dec2008, see text
CDC Split Type: B0634572A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). Lot number not provided. On 2 December 2008, at an unspecified time after vaccination with ROTARIX, the subject experienced bloody stools, vomiting, nausea, hyporexia, irritability, abdominal distention. On 5 December 2008, the subject was taken to emergency room with dehydration, abdominal pain, morcilla sign positive and bowel peristalsis decreased. An abdominal X-ray was performed on 5 December 2008. Ileocolic intussusception was suspected and confirmed by laparotomy, performing taxis without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Plain abdominal radiograph showing fluid levels AND dilated bowel loops. Plain abdominal radiograph showing non-specific abnormalities. No abdominal scan or ultrasound was performed. On 11 December 2008, the events were resolved. The subject was discharged in good medical condition. The physician considered the events were almost certainly related to vaccination with ROTARIX.


VAERS ID: 381865 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-04
Entered: 2010-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA985A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Intussusception, Screaming
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (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: B0635460A

Write-up: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was healthy before vaccination. On an unspecified date the subject received unspecified dose of ROTARIX (oral). 6 hours after vaccination with ROTARIX, the subject experienced intussusception of the gut. The pediatric who specialized in gastro felt the limb resolved in 2 hours. During that period the baby was screaming and suffered from severe abdominal pain. The baby wasn''t suffering from anything else and after 24 hours returned to normal. They were not intend to give her the second dose. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. No further information will follow because physician said the case was resolved.


VAERS ID: 382394 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-06-06
Submitted: 2010-03-11
   Days after onset:278
Entered: 2010-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Haematochezia, Intussusception, Irritability, Laparotomy, Rhinorrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0638853A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject did not have relevant medical history. On an unspecified date, the subject received unspecified dose of ROTARIX (1 ml, oral). On 6 June 2009, at an unspecified time after vaccination with ROTARIX, the subject experienced watery thinorrhea, gastric/biliary vomiting, irritability, abdominal pain and blood stools. On 9 June 2009, the subject was admitted. The subject presented dehydration, no peristalsis and positive "morcilla" sign and suspicious probably ileocecocolic intestinal intussusception which was confirmed the same day. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). A plain abdominal radiograph was not performed. An abdominal ultrasound was not performed. An abdominal CT was not performed. The subject was treated with laparotomy and taxis on 9 June 2009 without complications and without bowel resection. After good medical conditions, the subject was discharged on 14 June 2009. On 14 June 2009, the events were resolved.


VAERS ID: 382395 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-11
Entered: 2010-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: UNK
CDC Split Type: B0636790A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received 2nd dose of ROTARIX (oral), lot number not provided. At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.


VAERS ID: 382966 (history)  
Form: Version 1.0  
Age: 0.33  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-14
Onset:2008-04-04
   Days after vaccination:112
Submitted: 2010-03-18
   Days after onset:713
Entered: 2010-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Barium double contrast, Dehydration, Faeces discoloured, Gastrointestinal motility disorder, Haematochezia, Ileocolostomy, Intestinal resection, Intussusception, Rectal examination, Sepsis, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (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 dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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, 32 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal x-ray, Apr2008, see text
CDC Split Type: B0639148A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included 10 valent pneumococcal conjugate vaccine (manufacturer unspecified, intramuscular, unknown injection site) given on 22 August 2007; BCG (non-GSK) (manufacturer unspecified, intradermal, unknown injection site) given on 15 August 2007; HEP B (manufacturer unspecified, intramuscular, unknown injection site) given on 15 August 2007, 22 October 2007 and 18 February 2008; 1st dose of ROTARIX (1 ml, oral) given on 22 October 2007. On 14 December 2007, the subject received 2nd dose of ROTARIX (1 ml, oral). On 4 April 2008, 112 days after vaccination with ROTARIX, the subject experienced abdominal pain, blood in stools, abdominal distension, biliary vomiting. The subject was admitted into emergency room same day and found abdominal distention, dehydrated, abdominal pain, no peristalsis, rectal examination with "blackcurrant" evacuations and palpate intestine in reverse. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). A plain abdominal x-Ray was performed. It did not showed a visible intussusception or soft tissue mass. It showed fluid levels and dilated bowel loops. The plain abdominal x-ray with air or liquid contrast enema did not demonstrated invagination of the intestine. The plain abdominal x-ray showed non-specific abnormalities. The result of this exam was a suspicious ileocolic invagination. An abdominal ultrasound was not performed. An abdominal CT was not performed. The subject was treated with surgery (intestinal resection and ileocolostomy) without complications. After surgery, the subject presented sepsis, recovering and was discharged on 6 May 2008. At the time of reporting the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX.


VAERS ID: 382967 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-12-12
Submitted: 2010-03-18
   Days after onset:460
Entered: 2010-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Anaemia, Collapse of lung, Diarrhoea, Gastrointestinal disorder, Ileus, Intensive care, Intussusception, Laparotomy, Septic shock, Transfusion, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Abdominal X-ray, Dec2008, see text
CDC Split Type: B0639156A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject did not have medical history. On an unspecified date, the subject received 1st dose of ROTARIX (1 ml, oral). On 12 December 2008, at an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea and abdominal distention. On 19 December 2008, the subject presented abdominal distension and intestinal ileus. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). A plain abdominal x-Ray was performed and did not showed a visible intussusceptum of soft tissue mass. The exam showed fluid levels and dilated bowel loops. The demonstration of invagination of the intestine by air or liquid contrast enema was not done. The plain abdominal x-Ray showed non-specific abnormalities. The abdominal x-Ray showed bad intestinal distribution and intestinal distension, suspicious ileosileal intussusception which was confirmed and resolved by laparotomy and taxis on 21 December 2008. After the surgery, the subject presented pulmonary collapse, septic shock, anemia and need of transfusion. The subject required intensive unit care and was transfered to another hospital. The physician does not have complete dossier and does not have more data. At the time of reporting the outcome of the events was unspecified. It was not known if the subject survived.


VAERS ID: 383928 (history)  
Form: Version 1.0  
Age: 0.14  
Gender: Unknown  
Location: Foreign  
Vaccinated:2010-01-06
Onset:2010-01-11
   Days after vaccination:5
Submitted: 2010-03-31
   Days after onset:78
Entered: 2010-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A20CA635A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D28551 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA987A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal rigidity, Blood culture, Body temperature decreased, Gastrointestinal disorder, Gastrointestinal hypomotility, Haematochezia, Hypotonic-hyporesponsive episode, Intussusception, Peritoneal disorder, Rash maculo-papular, Sepsis, Ultrasound scan abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 11Jan2010, 35.9deg. C
CDC Split Type: B0643201A

Write-up: This case was reported by a regulatory authority (PL-URPL-OCM-20100323027) and described the occurrence of suspected intussusception in a 9-week-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA and PREVNAR (non-gsk). On 6 January 2010 the subject received unspecified dose of ROTARIX (oral), unspecified dose of INFANRIX HEXA (intramuscular, unknown), unspecified dose of PREVNAR (intramuscular, unknown). On 11 January 2010, 5 days after vaccination with INFANRIX HEXA, PREVNAR and ROTARIX, the subject experienced merging maculo-papular rash and hypotonic-hyporesponsive episode. Subsequently, the child was hospitalised. On admission, the child had decreased body temperature (35.9 deg. C). An ultrasonography showed dilated intestinal loops, intestinal hypomotility and traces of fluid in the peritoneum. The child was referred to the Infectious Disease Clinic because of suspected sepsis. During the first days of admission, the child was in a serious condition and experienced hematochezia, hard abdomen and intestinal hypomotility. No pathological flora was isolated from the blood culture. Because of the vaccination with ROTARIX, the possibility of spontaneously resolved intussusception was considered. The subject was hospitalised. At the time of reporting the events were improved. The regulatory Authority has provided GSK with all the available information at this time, any further information received by the regulatory authority will be forwarded to GSK.


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