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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: 445375 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-16
Onset:2011-06-01
   Days after vaccination:16
Submitted: 2011-12-13
   Days after onset:195
Entered: 2011-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA262AG / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Adenovirus test, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood creatinine normal, Blood electrolytes normal, Blood urea normal, C-reactive protein normal, Crying, Diarrhoea, Enema administration, Full blood count normal, Infantile colic, Intussusception, Mucous stools, Pallor, Protein total normal, Restlessness, Rotavirus test negative, Tremor, Ultrasound abdomen abnormal, Ultrasound scan abnormal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Akathisia (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Swelling of legs; Vaccination complication
Allergies:
Diagnostic Lab Data: Adenovirus test, 14Jun2011, stool: negative; Alanine aminotransferase, 14Jun2011, normal; Aspartate aminotransferase, 14Jun2011, normal; Blood creatinine, 14Jun2011, normal; Blood electrolytes, 14Jun2011, normal; Blood urea, 14Jun2011, normal; C-reactive protein, 14Jun2011, 0.4mg/dl; Full blood count, 14Jun2011, normal; Protein total, 14Jun2011, normal; Rotavirus test, 14Jun2011, stool: negative; Ultrasound scan, 14Jun2011, pathologic; Ultrasound scan, 15Jun2011, improved; Ultrasound scan, 16Jun2011, normalised. Abdominal ultrasonography, performed on 14 June 2011, was pathologic in the right lower abdomen. Urinary bladder was filled, no free fluid was detectable. In the left lower abdomen fluid and stool filled intestinal loops with normal peristalsis. In the right lower abdomen imaging of cocarde-like intestinal structures with lack of peristalsis. No enlarged mesenteric lymph nodes. Hydrostatic disinvagination with Ringer solution followed by imaging with abdominal ultrasonography, performed on 14 June 2011. The fluid passed quickly from large intestine to small intestine. Subsequently all intestinal loops were ubiquitous filled with fluid and cocarde-like intestinal structures were no longer detectable. However, imaging showed on intestinal loop in the right lower abdomen with thickened intestinal wall. Abdominal ultrasonography, performed on 15 June 2011, showed improved condition. Urinary bladder was filled, no free fluid was detectable. In the left lower abdomen fluid and stool filled intestinal loops with slow peristalsis. In the right lower abdomen intestinal loops with thickened intestinal wall and hardly any peristalsis. No enlarged mesenteric lymph nodes. Abdominal ultrasonography, performed on 16 June 2011, showed normalising condition. Distinctly more peristalsis all over intestine was observed. Not any longer signs of intestinal loops with thickened intestinal wall in the right lower abdomen. No signs of cocarde-like intestinal structures.
CDC Split Type: D0073734A

Write-up: This case was reported by a physician via a Foreign regulatory authority (DE-PEI-PEI201104083) and described the occurrence of ileocolic intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The Foreign regulatory authority has received this case via the foreign agency. Otherwise the subject has no known underlying or concurrent medical conditions or other risk factors. Analysis of social contacts for transmissible disease was normal. The subject has received all vaccinations as recommended. The subject''s medical history included swelling of legs after a previous vaccination. On 11 April 2011 the subject received the first dose of ROTARIX (1.5 ml, oral). On 16 May 2011 the subject received the second dose of ROTARIX (1.5 ml, oral). Less than one month post vaccination with ROTARIX and about five days prior to diagnosis of intussusception, on an unknown date in June 2011, the subject experience abdominal cramps with pallor with explosive defecation of thin stool in the end. Approximately 27 days post vaccination with ROTARIX, on 12 June 2011, the subject experienced mild restlessness. Approximately 28 days post vaccination with ROTARIX, on 13 June 2011 in the afternoon, the subject experienced severe colic-like pain, pallor, tremor and loud crying. On 13 June 2011 the subject also experienced for the last time stool which was reported as severe diarrhea of a bulky amount of mushy stools. The subject did not experience blood in stools, vomiting or fever. The subject was eating and drinking well. Approximately 29 days post vaccination with ROTARIX, on 14 June 2011, the subject experienced a single episode of mucus defecation. The subject was active and showed no signs of malaise. On 14 June 2011 the subject was hospitalised for three days. The reporting physician considered that the events probably had been life threatening. On admission to hospital the subject was in good general condition. The subject was awake and active. Heart and lung examinations were normal. Abdominal examinations were normal except palpable resistances in the right lower abdomen. Bowel sounds were present. Dermatologic examinations were normal. Mucous membranes were humid. C-reactive protein (CRP) was 0.4 mg/dl. All laboratory examinations were normal. Stool examinations showed no signs of Rotavirus or Adenovirus. Abdominal ultrasonography post hospitalisation, performed on 14 June 2011, was suspicious in the right lower abdomen. Ileocolic intussusception was suspected, but imaged cocarde-like intestinal structures were not completely conclusive. Due to lack to peristalsis conservative repositioning by hydrostatic disinvagination was followed by abdominal ultrasonography. Disinvagination was performed without complications. Ultrasonography, performed on the next day, showed thickened intestinal wall in the right lower abdomen consistent with intussusception. Clinical and ultrasonographic condition improved. Treatment with charcoal was hesitantly discontinued and oral nutrition build-up was started slowly without complications. On 16 June 2011 the subject was discharged from hospital without complaints in good medical condition for ambulatory follow-up. No further information will be available.


VAERS ID: 445727 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-02-17
Onset:2011-02-21
   Days after vaccination:4
Submitted: 2011-12-16
   Days after onset:298
Entered: 2011-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA270BA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Abdominal tenderness, Enema administration, General physical health deterioration, Haematochezia, Intussusception, Pallor, Somnolence, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound scan, 22Feb2011, pathologic; Ultrasound scan, 23Feb2011, improved; Ultrasound scan, 25Feb2011, normal; Ultrasonography of abdomen, performed on 22 February 2011: Ileocolic intussusception found up to the traverse colon; free fluid retrovesical and in the right lower abdomen. Ultrasonography of abdomen, performed on 22 February 2011: Ileocecal valve was still swollen with lymph node swelling and minimal amount of free fluid. No detectable signs of recurrent ileocolic intussusception.
CDC Split Type: D0073668A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of ileocolic intussusception in an 11-week-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received an unspecified dose of ROTARIX (oral). At an unspecified time post vaccination with ROTARIX, on an unknown date, the subject experienced intussusception. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the event was unspecified. Follow-up information including a hospital report was received on 13 December 2011 from the reporting physician. The subject has no underlying or concurrent medical condition or other risk factors. The subject received no concomitant medication. On 17 February 2011 the subject received the first dose of ROTARIX (1.5 ml, oral). Approximately four days post vaccination with ROTARIX, on 21 February 2011 in the afternoon, the subject experienced intermittent abdominal pain, bilious vomiting and intermittent sleepiness. Approximately five days post vaccination with ROTARIX, on 22 February 2011 in the morning, the subject experienced bloody stools (hematochezia). Approximately four days post vaccination with ROTARIX, on 21 February 2011, the subject experienced ileocolic intussusception, intermittent abdominal pain, bilious vomit, and intermittent sleepiness. The subject was hospitalised for four days. In hospital the subject was diagnosed with ileocolic intussusception. The reporting physician considered that this event was life threatening. On admission to hospital the subject was in reduced general condition, pale, with very wide abdomen, lively peristalsis in the upper two quadrants, a palpable resistance in the right lower abdomen, pain on pressure in lower abdomen, but no guarding. Genitals, groin and all other physical examinations were normal. Ultrasonography of abdomen performed on 22 February 2011, was pathologic and showed ileocolic intussusception up to the transverse colon. Treatment included hydrostatic disinvagination on 22 February 2011 controlled by ultrasonography. On the same day oral nutrition build up was started. Both hydrostatic disinvagination and oral nutrition build up were performed without complications. Ultrasonography of abdomen performed on 23 February 2011, showed improved conditions and resolved ileocolic intussusception without signs of recurrence. During course of hospitalisation hematochezia was resolved and oral nutrition build up was completed. On 25 February 2011 the subject was discharged from hospital after final examinations without pathologic findings and normal abdominal ultrasonography results. The vaccination course with ROTARIX was discontinued. The reporting physician also provided the answers to a GSK targeted questionnaire for intussusception post vaccination with ROTARIX: The subject was diagnosed with intussusception on 22 February 2011. The symptoms started about five days post vaccination with the first dose of ROTARIX on 22 February 2011. The symptoms were completely resolved on 23 February 2011. Plain abdominal radiography/air or liquid contrast enema was not performed. 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. No surgical intervention was needed. Family history did not include intussusception or bowel abnormalities. The subject''s medical history did not include previous intra-abdominal surgery, congenital intestinal malformation, intestinal polyps, Meckels diverticulum, intestinal vascular malformations, cystic fibrosis, Hirschsprung disease, other gastrointestinal malformation and dysfunction or intussusception. The event did not resolve spontaneously. The event resolved by liquid contrast of hydrostatic water or air enema. The subject had no bowel reduction without bowel resection. The subject had no bowel resection. Radiological procedure was without complications. The subject survived. No further information will be available.


VAERS ID: 446692 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-22
Onset:2010-04-30
   Days after vaccination:8
Submitted: 2012-01-03
   Days after onset:613
Entered: 2012-01-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB081A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Ileus, Intussusception, Mechanical ileus, Surgery
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastroschisis
Preexisting Conditions: Cryptorchidism
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0073693A

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). On an unspecified date the subject received an unspecified dose of ROTARIX (oral). At an unspecified time post vaccination with ROTARIX, in an unknown date, the subject experienced intussusception. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the event was unspecified. Written follow-up information was received on 29 December 2011 from physician. The subject''s medical history included left-sided cryptorchidism with state after surgery after birth. Concurrent medical conditions included gastroschisis. First dose of ROTARIX was well tolerated. On 22 April 2010 the subject received 2nd dose of ROTARIX (oral). On 30 April 2010, 8 days after vaccination with ROTARIX, the subject experienced symptoms of ileus. On 03 May 2010, the subject received emergency surgery due to ileus. At the time of reporting the events were resolved. According to targeted follow-up questionnaire, the subject developed mechanical ileus 8 days after 2nd dose of ROTARIX. No further information will be available.


VAERS ID: 447125 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-28
Onset:2012-01-01
   Days after vaccination:4
Submitted: 2012-01-10
   Days after onset:9
Entered: 2012-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB259B / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Hypotonia, Intussusception, Pallor, Ultrasound abdomen abnormal
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 01Jan2012, normal; Ultrasound scan, 01Jan2012, Intussusception.
CDC Split Type: B0773738A

Write-up: This case was reported by a pediatrician and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical conditions and concurrent medications, if any, were unspecified. On 28 December 2011, the subject received a 1st dose of ROTARIX (oral, batch A41CB259B). On 01 January 2012, 4 days after vaccination with ROTARIX, the subject presented with pallor and atonia. He was hospitalized. Ultrasound scan showed intussusception at small intestine level. On 02 January 2012, intussusception was reduced without sequelae by enema. At the time of reporting, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 447404 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-01-16
Entered: 2012-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

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: A0960812A

Write-up: This case was reported by a physician via representative and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (unknown). Two days after vaccination with ROTARIX, the subject experienced intussusception. The representative reported a pediatric in a clinic reported a subject was vaccinated by a family physician and was diagnosed with intussusception two days after receiving the first dose of ROTARIX. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the intussusception was unspecified.


VAERS ID: 447486 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-01-06
Onset:2012-01-09
   Days after vaccination:3
Submitted: 2012-01-17
   Days after onset:8
Entered: 2012-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Haematochezia, Intussusception, Nausea, Rotavirus test negative, Viral test negative, 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pranlukast; Oxatomide; Mequitazine
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0775003A

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 6 January 2012, the subject received unspecified dose of ROTARIX (1.5 ml, oral, batch number not provided). On 9 January 2012, 3 days after vaccination with ROTARIX, the subject experienced diarrhea. On 10 January 2012, 4 days after vaccination with ROTARIX, the subject had bloody stools. Intussusception was suspected and the subject was admitted to hospital A. It was revealed that the symptom was not intussusception. Simple test showed negative for both rotavirus and norovirus. On 12 January 2012, the second test was performed at Hospital A and the subject was diagnosed as having intussusception. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. Additional information received on 12 January 2012: The subject''s medical condition included asthma. Concomitant medications included DTP vaccine, ACTHIB, PREVENAR, Onon, Celtect and Zesulan. On 6 January 2012, the subject received ROTARIX (batch number provided). On 09 January 2012, the subject experienced queasy feeling. On 10 January 2012, the subject experienced vomiting. At time of reporting, the outcome of the event diarrhea was unknown, the other events were unresolved. The physician considered the event as related to vaccination with ROTARIX.


VAERS ID: 447913 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-01-24
Entered: 2012-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Intussusception
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0776847A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX (oral, lot number not provided). At an unspecified time after vaccination with ROTARIX, the subject experienced very tensed abdomen for 3 days. An intussusception was suspected. At the time of reporting the events were resolved. The physician considered the events were clinically significant (or requiring intervention).


VAERS ID: 448528 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Foreign  
Vaccinated:2012-01-14
Onset:2012-01-17
   Days after vaccination:3
Submitted: 2012-02-01
   Days after onset:15
Entered: 2012-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Intussusception, Mood altered, Ultrasound scan abnormal
SMQs:, Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (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: Ultrasound scan, 17Jan2012, Invagination of intestine
CDC Split Type: B0777794A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 0-year-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 14 January 2012, the subject received unspecified dose of ROTARIX (1.5 ml, oral, batch number not provided). On 17 January 2012, 3 days after vaccination with ROTARIX, the subject experienced intussusception. Abdominal ultrasonography performed on 17 January 2011 showed invagination of intestines. The subject was hospitalised. On 20 January 2012, the event was resolved. The physician considered the event was related to vaccination with ROTARIX. Follow-up information received on 27 January 2012: On 17 January 2012, 3 days after vaccination with ROTARIX, the subject also experienced bad mood. She intermittently had intussusception from around 15:00 on 17 January 2011 and she visited pediatric clinic at around 17:00. No blood stool was observed by enema and her symptom was diagnosed by abdominal ultrasound. She was referred to the department of pediatric surgery of university and the event was reportedly reducted by high enema. On 20 January 2012, the events were resolved. The physician considered the events were related to vaccination with ROTARIX.


VAERS ID: 449130 (history)  
Form: Version 1.0  
Age: 0.29  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-29
Onset:2012-01-28
   Days after vaccination:30
Submitted: 2012-02-07
   Days after onset:10
Entered: 2012-02-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA297AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia, Intussusception, Laparoscopy, Laparotomy, Ultrasound abdomen abnormal, Vomiting
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? 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: Laparoscopy, 29Jan2012, unknown; Ultrasound abdomen, 29Jan2012, intussusception
CDC Split Type: B0778936A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 31 October 2011. On 29 December 2011, the subject received 2nd dose of ROTARIX (oral). On 28 January 2012, 30 days after vaccination with ROTARIX, the subject experienced bloody stools and vomiting. On 29 January 2012, 31 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised. On 29 January 2012, the abdominal ultrasound showed an intussusception. A laparatomy was performed. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with ROTARIX.


VAERS ID: 449553 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2012-02-06
Onset:2012-02-10
   Days after vaccination:4
Submitted: 2012-02-14
   Days after onset:4
Entered: 2012-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405CA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Intussusception, Pallor, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (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: Unknown
Current Illness: Atopic dermatitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound scan, 10Feb2012, invagination of
CDC Split Type: B0781313A

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). Concurrent medical conditions included atopic dermatitis. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine (manufacturer unspecified, given on 6 February 2012), SYNFLORIX (manufacturer unspecified, given on 6 February 2012). Concurrent medications included Unknown medication (Unknown drug). On 6 February 2012, the subject received unspecified dose of ROTARIX (1.5 ml, oral). The subject was vaccinated with diphtheria pertussis tetanus vaccine, pneumococcal vaccine and ACTHIB simultaneously. On 10 February 2012, at 10:30, 4 days after vaccination with ROTARIX, after feeding, the subject experienced 4 episodes of vomiting and ill complexion, for which he visited his family doctor. He was referred to the reporting physician''s hospital shortly after 12:00. On 10 February 2012, shortly after 13:00, the subject was given a diagnosis of invagination of intestine by ultrasonography. He underwent air reduction at the department of X-ray and was admitted to the hospital. On 10 February 2012, at around 14:00, the subject''s condition became stable. The subject was hospitalised. At the time of reporting the outcome of the event invagination of intestine was resolved and the outcome of the other events was unspecified.


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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=41&SYMPTOMS[]=Intussusception_%2810022863%29&VAX[]=RV1&REPORT_YEAR_LOW=2008&REPORT_MONTH_LOW=02&REPORT_YEAR_HIGH=2014&REPORT_MONTH_HIGH=12


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