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Found 566 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: 329844 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-08-11
Onset:2008-10-02
   Days after vaccination:52
Submitted: 2008-10-23
   Days after onset:21
Entered: 2008-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Dehydration, Gastrointestinal necrosis, Gastrointestinal sounds abnormal, Haematochezia, Intestinal anastomosis, Intussusception, Irritability, Laparotomy, Platelet count normal, Pyrexia, Vomiting, White blood cell count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Hostility/aggression (broad), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Leukocyte count NOS, Oct2008, 10.1UI/mm3; Platelet count, Oct2008, 230.000UI/mm3
CDC Split Type: B0542497A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 11 June 2008. On 11 August 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 2 October 2008, 52 days after vaccination with ROTARIX, the subject started with abdominal pain, vomiting and bloody stools. The patient was admitted to ER on 3 October 2008 and showed at physical exam irritability, fever, dehydration, palpable abdominal sausage shaped mass, bloody stools and bowel sounds decreased. The subject was hospitalised. Intussusception was diagnosed by clinical features. Laparotomy was done on 4 October 2008. Ileo-ceco-colic intussusception was found, with necrosis which required resection of 3 cm ileon and ascendant colon; term-to-term anastomosis was made without complications. The physician considered the events were clinically significant (or requiring intervention). Laboratory tests performed showed the following results: Leukocytes count: 10.1 UI/mm3; Platelets count: 230 000 /mm3. The subject was treated with Ampicillin, Amikacine, Metamizole and metoclopramide. On 15 October 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information was requested therefore the case has been closed.


VAERS ID: 330202 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-01-19
Onset:2007-01-23
   Days after vaccination:4
Submitted: 2008-10-27
   Days after onset:642
Entered: 2008-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0526919A

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 19 January 2007 the subject received unspecified dose of ROTARIX (oral). On 23 January 2007, 4 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved by taxis. The physician considered the event was almost certainly related to vaccination with ROTARIX. After several attempts no further information could be obtained. Therefore on 24 October 2008 this case has been closed.


VAERS ID: 330794 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-09-05
Onset:2008-10-02
   Days after vaccination:27
Submitted: 2008-10-30
   Days after onset:28
Entered: 2008-10-30
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 pain, Barium double contrast, Blood culture, Blood electrolytes, Blood test, Crying, Flushing, Intussusception, Laboratory test, Oral intake reduced, Rectal haemorrhage, Surgery, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), 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), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Oct2008, Abnormal unit; Air contrast barium enema, 02Oct2008, Abnormal unit; Blood test, unknown; Serum electrolytes NOS, unknown
CDC Split Type: B0541544A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 5 September 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 2 October 2008, 27 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception. The event was confirmed by clinical features, abdomen x-ray and air contrast enema which showed an ileocolic intussusception. Surgery was performed without intestine resection. The physician considered the event was life threatening. The reporter considered the events were probably related to vaccination with ROTARIX. At the time of reporting the outcome of the events was unspecified. Follow up received on 23 October 2008: The signs and symptoms were decreased oral intake for 1 day along with excessive crying and periodic abdominal pain (the subject''s face became flushing during that episode and he pulled his legs) which lasted 2-3 minutes and got resolved by itself. The subject had 4-5 episodes of rectal bleeding (typical currant jelly color). Other relevant test included CP, serum electrolytes, blood C/S. The subject was treated with FLAGYL, AMPICILLIN, GENTAMYCIN and intravenous fluids. On 02 October 2008 surgical correction (manual reduction) was done. The subject''s condition improved and he was discharged on 07 October 2008 in OPD after 1 week.


VAERS ID: 330977 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-11
Onset:2008-04-17
   Days after vaccination:6
Submitted: 2008-10-31
   Days after onset:197
Entered: 2008-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal mass, Appendicectomy, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Mucous stools, Pain, Rectal haemorrhage, Stool analysis abnormal, Surgery, Ultrasound abdomen abnormal, Vomiting
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 (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypoglycaemia (broad), 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: Stool analysis, EH+; Ultrasound abdomen, IS
CDC Split Type: B0543711A

Write-up: This case was reported by a physician in the frame of a study 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 DTaP/IPV/Hib; manufacturer unspecified; intramuscular given on 11 April 2008; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular given on 11 April 2008; ROTARIX; GlaxoSmithKline; oral given on 7 February 2008; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular given on 11 April 2008. On 11 April 2008 the subject received 2nd dose of ROTARIX (oral). On 17 April 2008, 6 days after vaccination with ROTARIX, the subject experienced irritability. The subject received Acetaminophen without improvement. Later he showed rectal bleeding with mucus. The same day the subject was hospitalized and subject''s physical examination showed gastric and biliary vomiting, dehydration, abdominal distention, pain on palpation, decreased bowel sounds, abdominal mass in right flank, persistent rectal bleeding with mucus similar to currant jelly stools. Relevant test included stool test which was positive to Entamoeba hystolitica. On 18 April 2008 the abdominal ultrasound confirmed intussusception. The diagnosis of dysentery versus intussusception was made. The same day the subject underwent a surgery in which ileocolic intussusception was found. This was reduced by taxis and prophylactic appendectomy was also performed without complications. On 22 April 2008 the subject was discharged in good clinical conditions. The subject was treated with surgery, Acetaminophen, metronidazole and Furosemide. The physician considered the events were almost certainly related to vaccination with ROTARIX.


VAERS ID: 331754 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Male  
Location: Foreign  
Vaccinated:2008-07-16
Onset:2008-10-15
   Days after vaccination:91
Submitted: 2008-11-07
   Days after onset:23
Entered: 2008-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA502A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal operation, Intussusception, Pharmaceutical product complaint, Transmission of an infectious agent via a medicinal product, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 16Oct2008, IS
CDC Split Type: B0544581A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 10-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline; oral) given on 18 March 2008. On 16 July 2008, the subject received the 2nd dose of ROTARIX (oral). On 15 October 2008, 91 days after vaccination with the 2nd dose of ROTARIX, the subject experienced intussusception. Transmission of an infectious agent via a medicinal product was suspected. The subject presented in ER. On 16 October 2008, abdominal USG was performed and showed intussusception. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 27 October 2008, emergency laparotomy was done to save life. The subject was well after surgery. On 27 October 2008, the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX. This case was associated to a product complaint.


VAERS ID: 332466 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-11
Onset:2008-10-10
   Days after vaccination:29
Submitted: 2008-11-14
   Days after onset:35
Entered: 2008-11-14
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, Haematochezia, Intussusception, Irritability, Malaise, Mucous stools, Pallor, Pyrexia, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy Baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Oct2008, see text
CDC Split Type: B0545978A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). This report involved a healthy baby. On 11 September 2008 the subject received 1st dose of ROTARIX (oral). On 10 October 2008, 29 days after vaccination with ROTARIX, the subject experienced irritability, fever, gastrobiliar vomiting and malaise. On 11 October 2008 the subject had current jelly stools and she was admitted to the emergency room presenting pallor, favorable hydration, irritability, abdominal distention, positive dance signs and one more current jelly stools was observed. Relevant test performed the same day included abdominal x-ray which showed distended loops, lack of air in distal zone and air fluid levels. Therefore the subject underwent a surgery in which intussusception in ileocecocolic position was found. Reduction by taxis was performed successfully. The subject was treated with paracetamol, metronidazole, amikacin, ranitidine, metamizole and ketoroloac. On 16 October 2008, the events were resolved and the subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 332471 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-14
Onset:2008-07-24
   Days after vaccination:132
Submitted: 2008-11-14
   Days after onset:113
Entered: 2008-11-14
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 discomfort, Dehydration, Explorative laparotomy, Gastrointestinal hypomotility, Gastrointestinal necrosis, Ileostomy, Intussusception, Pyrexia, Vitello-intestinal duct remnant, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Pulmonary Stenosis
Preexisting Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Aug2008, see text
CDC Split Type: B0545250A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 9-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s medical history included hypothyroidism, interventricular communication of travelucat type and untreated serious pulmonary stenosis. Previous and/or concurrent vaccination included DTaP and HIB (manufacturer unspecified, intramuscular) given on 10 January 2008 and 14 March 2008; hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) given on 7 November 2007 and 10 January 2008; ROTARIX (GlaxoSmithKline, oral) given on 10 January 2008; Bacillus calmette-guerin vaccine (non-GSK manufacturer, intradermal) given on 7 November 2007. On 14 March 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 24 July 2008, 4 months after vaccination with ROTARIX, the subject started with vomiting, fever and abdominal strain. She was admitted at the emergency unit at the hospital in August. The subject experienced dehydration and bowel peristalsis decreased. Abdominal x-ray was performed and showed hydroaeral levels and a poor distribution of gas. An exploring laparotomy was realized finding an ileo-ileal intussusception with a necrosis of an ileon of 40cm Meckel diverticulum. A non communicated ileostomy was done and after a good evolution patient was out from hospital on 18th August 2008. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 332472 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-09
Onset:2008-08-28
   Days after vaccination:111
Submitted: 2008-11-14
   Days after onset:78
Entered: 2008-11-14
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 mass, Chest X-ray, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Hypophagia, Intussusception, Irritability, Lymphadenitis, Lymphocyte percentage, Mucous stools, Oedema, Pain, Pallor, Platelet count normal, Pyrexia, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Hostility/aggression (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 29Aug2008, see text; Hematocrit, 29Aug2008, 26.8%; Hemoglobin, 29Aug2008, 8.8g/dl; Leukocyte count NOS, 29Aug2008, 13.9x10^3/mm3; Lymphocytes, 29Aug2008, 24.7%; Platelet count, 29Aug2008, 254000mm3; Thorax X-ray, 29Aug2008, see text
CDC Split Type: B0545930A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP, Hep B and IPV, manufacturer unspecified; intramuscular given on 10 August 2008; Hep B vaccine; manufacturer unspecified; intramuscular given on 10 August 2008; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular given on 10 August 2008. On 9 May 2008 the subject received 1st dose of ROTARIX (oral). On 28 August 2008, 111 days after vaccination with ROTARIX, the subject presented gastrobiliar vomiting, abdominal distention, pain, irritability, oral intolerance, current jelly stools and fever. The same day the subject was admitted to hospital. Subject''s physical examination included irritability, pallor, abdominal distention, generalized pain, decreased bowel sounds and abdominal mass in the right flank. Dance signs were positive and rectal tact was with current jelly stools. Relevant test includes thoracic and abdominal x-ray with distended loops and edema between loops. Intussusception was suspected. Therefore pneumoenema was performed without success. On 29 August 2008 the subject underwent a surgery in which ileocecal intussusception with mesenteric adenitis was confirmed and it reduced by taxis without complications. On 02 September 2008 the subject was discharged in good clinical conditions. The subject was treated with AMIKACIN, METRONIDAZOLE, OMEPRAZOLE, METAMIZOL, enema and surgery. On 2 September 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 332617 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-07-07
Onset:2008-10-23
   Days after vaccination:108
Submitted: 2008-11-17
   Days after onset:25
Entered: 2008-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Body temperature, Intestinal mass, Intussusception, Irritability, Lethargy, Pallor, Rectal haemorrhage, Stool analysis, Surgery, Ultrasound abdomen abnormal, Vomiting, 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), 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
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Oct2008, Abnormal; Body temperature, Oct2008, 37.2Deg C; Stool analysis, 25Oct2008, Unknown; Ultrasound abdomen, Oct2008, Abnormal
CDC Split Type: B0546156A

Write-up: This case was reported by a healthcare professional and described the occurrence of ileocolic intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was born at term, with birth weight 3.37 Kg. He had no personal or family history of intussusception. This case was collected through the Foreign Paediatric Surveillance Unit. Acute intussusception study occurring post rotavirus vaccination. Concurrent medical conditions included breast feeding. There were no change in the subject''s diet in the last week. The subject had no feeding intolerance of food sensitivities. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 6 May 2008. The subject didn''t receive any other vaccines during the last 2 weeks. He had no current treatment. On 7 July 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 23 October 2008, 108 days after vaccination with ROTARIX, the subject was admitted to hospital due to ileocolic intussusception with intestinal mass, bile stained vomiting, pallor, lethargy, irritability and blood on rectal examination. The symptoms started less than 12 hours prior to diagnosis. The subject was hospitalised for 3 days. At examination, the body temperature was 37.2 Deg C. The abdomen X-ray revealed fluid level and dilated loops. The ultrasound showed non specific bowel gas. The diagnosis of intussusception was made based on abdomen ultrasound. Surgery was performed with an intestine resection. On 25 October 2008, a stool sample was collected and the subject was discharged alive. The results remained unknown. At the time of reporting the events were resolved.


VAERS ID: 332619 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-05
Onset:2008-06-18
   Days after vaccination:44
Submitted: 2008-11-17
   Days after onset:152
Entered: 2008-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Enema administration, Haematochezia, Intestinal obstruction, Intussusception, Mucous stools, Rotavirus test negative, Ultrasound abdomen abnormal, Virus serology test positive, Vomiting
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast Feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Adenovirus test, 18Jun2008, Positive; Rotavirus test, 18Jun2008, Negative; Ultrasound abdomen, 18Jun2008, Abnormal
CDC Split Type: B0546213A

Write-up: This case was reported by a healthcare professional and described the occurrence of ileocolic intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was born at term, with birth weight 3.3 Kg. She had no personal or family history of intussusception. This case was collected through Foreign Paediatric Surveillance Unit Acute intussusception study occurring post rotavirus vaccination. Concurrent medical conditions included breast feeding. There were no change in the subject''s diet in the last the week. The subject had no feeding intolerance or food sensitivities. Previous vaccination included ROTARIX (GlaxoSmithKline) given on 6 February 2008. Within the last 2 weeks, the subject received Haemophilius influenzae type b vaccine, manufacturer unspecified; combined measles, mumps and rubella vaccine, live, attenuated (new strain) ; manufacturer unspecified; diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified; hepatitis B vaccine recombinant, manufacturer unspecified, live attenuated poliomyelitis vaccine; manufacturer unspecified; pneumococcal vaccine, unspecified; manufacturer unspecified. The subject had no current treatment. On 5 May 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 18 June 2008, the subject received 2nd dose of ROTARIX, lot number not provided. ON 18 June 2008, 44 days after vaccination with ROTARIX, the subject was hospitalised due to ileocolic intussusception with intestinal obstruction, bile stained vomiting and vomiting, red current jelly stool, abdominal pain and diarrhea. the symptoms started 24 to 48 hours before the diagnosis. The diagnosis of intussusception was made based on abdomen ultrasound. the subject was hospitalised for 1 day. The stool test was negative for rotavirus and positive for adenovirus. The subject was successfully treated with enema fluoroscopy guided. On 18 June 2008, the events were resolved and the subject was discharged from hospital alive.


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