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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: 320287 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-14
Onset:2008-05-04
   Days after vaccination:20
Submitted: 2008-07-23
   Days after onset:80
Entered: 2008-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Band neutrophil count decreased, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Lymphocyte count normal, Neutrophil count increased, Pharyngeal erythema, Platelet count normal, Pyrexia, Surgery, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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)

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: Band neutrophil count, 05May2008, 2%; Hematocrit, 05May2008, 32.1%; Hemoglobin, 05May2008, 11.2g/dl; Leukocyte count NOS, 05May2008, 15500/mm3; Lymphocytes, 05May2008, 4000/mm3; Neutrophil count, 05May2008, 10500/mm3; Platelet count, 05May2008, 458000/mm3.
CDC Split Type: B0529599A

Write-up: This case was reported by a physician in the frame of a PASS 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 medications and had no relevant medical history and no allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 13 February 2008. On 14 April 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 4 May 2008, 20 days after vaccination with ROTARIX, the subject started with irritability, colic pain, vomiting (5) and fever. The subject was hospitalized on 4 May 2008 with hyperemic pharynx and without evidence of abdominal complication. Later, the patient experienced tympanic abdomen, persistent pain, abdominal distension and bloody stools. Surgery was done on 5 May 2008. Invagination ileo-ileo-colic with intestinal necrosis was found and corrected by taxis. Intestinal resection of necrosed segment and term to term anastomosis at 4 cm of ileocaecal valve was performed. Necrotic segment was 20 cm. Post surgical evolution showed cough and surgical site infection with good response to antibiotics treatment, without more complication. Laboratory tests performed on 5 May 2008 showed the following: Hemoglobin: 11.2 g/dl, hematocrit: 32.1%, leukocytes: 15500/mm3, neutrophils: 10500/mm3, lymphocytes: 4000/mm3, bands: 2%, platelets: 458000/mm3. The subject was treated with paracetamol, metronidazole and amikacin. Clinical recuperation was favorable, the subject evolved in good clinical conditions. The date of discharge was not available in the chart. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 320288 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-15
Onset:2008-07-06
   Days after vaccination:82
Submitted: 2008-07-23
   Days after onset:17
Entered: 2008-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal hypermotility, Haematochezia, Hypertrophy, Intussusception, Irritability, Pallor, Pyrexia, Surgery, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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 dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: UNK
CDC Split Type: B0529662A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of caeco-colic intussusception in a 5-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. On 15 April 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 6 July 2008, 82 days after vaccination with ROTARIX, the subject started with fever, vomiting and diarrhea. On 11 July 2008, 87 days after vaccination with ROTARIX, the patient experienced bloody stools and he was hospitalized with irritability and fever. Physical exam reported pallor, irritability, tachycardia, current jelly stool, abdominal pain and increased peristalsis. Surgery was performed on 11 July 2008. Caeco-colic invagination with multiple hypertrophy ganglions was found and correction by taxis without complication was done; intestinal exploration not evidenced vascular compromise. The post surgical evolution was favorable. The subject was treated with METAMIZOLE, RANITIDINE and AMIKACINE. On 15 July 2008, the events were resolved, the subject was discharged. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 320289 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-13
Onset:2008-05-16
   Days after vaccination:3
Submitted: 2008-07-23
   Days after onset:68
Entered: 2008-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Barium enema, Constipation, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Malaise, Pallor, 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), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0529692A

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-year-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history of allergy. On 13 May 2008, the subject received 1st dose of ROTARIX (oral, lot number not provided). On 16 May 2008, 3 days after vaccination with ROTARIX, the subject started with irritability, vomiting, constipation and malaise. On 18 May 2008, 5 days after vaccination with ROTARIX, the subject experienced bloody stools and he was hospitalized. The physical exam showed pallor, abdominal pain and bowel sounds increased. Barited enema was done on 18 May 2008 and showed ileocolic intussusception in transverse colon and reduction with pass through ileocaecal valve to ileon with success. The patient had good evolution and recuperation. The subject was discharged of emergency room on 18 May 2008 in good clinical conditions and pass to pediatric service for clinical observation. The date of hospitalization discharge was not available. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 320507 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-11
Onset:2008-06-27
   Days after vaccination:137
Submitted: 2008-07-25
   Days after onset:28
Entered: 2008-07-25
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 mass, Abdominal pain, Appendicectomy, Arachnoid cyst, Blood chloride decreased, Blood creatinine decreased, Blood glucose increased, Blood potassium normal, Blood sodium decreased, Blood urea decreased, Computerised tomogram normal, Gastrointestinal hypomotility, Haematochezia, Haematocrit increased, Haemoglobin normal, Intussusception, Irritability, Loss of consciousness, Nausea, Platelet count normal, Somnolence, Ultrasound abdomen abnormal, Ultrasound scan abnormal, Vomiting, White blood cell disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), 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), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cranial-encephalic trauma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory tests were performed on 28 June 2008 and showed the following results: Glucose: 114 mg/dl (normal range 70-110); Urea: 13 mg/dl (normal range 14-44); Creatinine: 0.3 mg/dl (normal range 0.6-1.3); Leukocytes: 6000/mm3 (normal range 4500-10000); Platelets: 19200 /mm3 (normal rang 150000-450000); Hemoglobin: 16 g/dl (normal range: 12-16); Hematocrit: 50.3 % (normal range: 38-47); Chloride: 96 mmol/1 (normal range: 100-108); Potassium: 3.8 mmol/1 (normal range: 3.6 - 5.2); Sodium: 132 mmol/l (normal range: 136-145); Abdominal ultrasound showed round image in ileocolic zone not distended of 40 x 27mm, decreased peristalsis and liquid intestinal loops. On 27 June 2008, a computerized axial tomography showed a left temporal arachnoid''s cyst not complicated without requires surgical treatment and a cranial X-ray showed no clinical alterations.
CDC Split Type: B0530201A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 8-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline) for prophylaxis. Previous vaccination included live attenuated human rotavirus vaccine (GlaxoSmithKline, oral) given on 10 December 2007. On 11 February 2008, the subject received 2nd dose of Rotarix (oral). lot number not provided. On 26 June 2008, the subject suffered cranial-encephalic trauma without loss of consciousness just drowsiness. He was admitted to Emergency room on 27 June 2008 where exams were performed. On 27 June 2008, 4 months after vaccination with Rotarix, the subject started with vomiting, nausea, decreased gastrointestinal peristalsis, and irritability. One day later, without improvement, the subject experienced abdominal pain, one bloody stool and palpable mass in abdominal area. Abdominal ultrasound showed round image in ileocolic zone not distended. The subject was hospitalized for surgery and ileo-appendiculo-colic intussusception was found and corrected by taxis and appendectomy without complications. The subject was treated with metronidazole and paracetamol. On 5 July 2008, the events were resolved. The convalescence and abdominal recuperation were gradual and neurological conditions were favorable. The patient was discharge on 05 July 2008 in good clinical conditions. The physician considered the events were unrelated to vaccination with Rotarix.


VAERS ID: 320508 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-22
Onset:2008-06-30
   Days after vaccination:129
Submitted: 2008-07-25
   Days after onset:25
Entered: 2008-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anorexia, Appendicectomy, Cough, Decreased activity, Dehydration, Gastrointestinal hypomotility, Haematochezia, Intestinal malrotation, Intussusception, Irritability, Pallor, Pharmaceutical product complaint, Pyrexia, Rhinorrhoea, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Congenital, familial and genetic disorders (narrow), 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), Hypotonic-hyporesponsive episode (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Upper respiratory tract infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0530419A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 9-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included upper respiratory tract infection on 30 June 2008 but no more information was available in the chart. Concurrent vaccination included ROTARIX (GlaxoSmithKline) given on 22 November 2007. On 22 February 2008, the subject received 2nd dose of ROTARIX (1 ml, oral). Lot number not provided. On 30 June 008, 4 months after vaccinations with RORTARIX, the subject started with fever, clear rhinorrhea, cough, 3 bloody stools, vomiting, irritability, hyporexia and abdominal pain. the subject was admitted to emergency room on 30 June 2008 with fever, pallor, pharyngeal congestion, mild dehydration, tachycardia, hypoactive, abdominal pain in the pelvic fore, decreased gastrointestinal peristalsis, positive dance sign and rectal tact with expulsion of current jelly stool. Surgery was done on 30 June 2008: ileo-ileal intussusception with intestinal malrotation was found, corrected by taxis without intestinal resection; prophylactic appendectomy was done without complications. The subject was hospitalized for 3 days. Laboratory exams and X-rays results were not available in the clinical chart. The subject was treated with metronidazole, AMIKACINE, METAMIZOLE, RANITIDINE, metoclopramide and paracetamol. Post surgical evolution was favorable. On 2 July 2008, the subject was discharged with good clinical recuperation. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 320602 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-20
Onset:2008-07-18
   Days after vaccination:59
Submitted: 2008-07-28
   Days after onset:10
Entered: 2008-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Diagnostic procedure, Haematochezia, Intussusception, Mucous stools, Surgery, Urinary tract infection, Urine analysis abnormal, Vomiting, X-ray abnormal
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? Yes
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: Proctoscopy, Jul2008, IS; Urine analysis, Jul2008, UTI; X-ray, Jul2008, IS
CDC Split Type: B0530546A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 20 May 2008, the subject received the 1st (and the unique) dose of ROTARIX (oral, lot number not provided). On 18 July 2008, 59 days after vaccination with the 1st dose of ROTARIX, the subject e4xperienced the following first symptoms (abdominal pain, vomiting, blood and mucus in feces). The subject was initially diagnosed as having a urinary tract infection thanks to a simple urine test. It was treated with ROCEPHIN. On 21 July 2008, intussusception was diagnosed. The diagnostic was made thanks to symptoms evaluation, X-ray and rectoscopy. Surgery was performed on the same day and ileo-ceco-colonic invagination (15 cm) was found. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the subject was still hospitalized and the events were improved.


VAERS ID: 320743 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-09
Onset:2008-01-15
   Days after vaccination:6
Submitted: 2008-07-30
   Days after onset:196
Entered: 2008-07-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Intestinal obstruction, Intussusception, 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? 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, Jan2008, IS; Ultrasound abdomen, Jan2008, IS
CDC Split Type: B0530263A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX. This case was collected through the Paediatric Surveillance Unit Acute Intussusception study occurring post Rotavirus vaccination. The subject was born at term. The subject''s birth weight is 3.315Kg. The subject had no family history of intussusception. Feeding history: The subject currently fed formula. The subject received no current treatment. The subject received other vaccines as per schedule. On 9 January 2008, the subject received the 1st dose of ROTARIX (unknown, lot number not provided). On 15 January 2008, 6 days after vaccination with the 1st dose of ROTARIX, the subject was admitted at hospital due to intussusception. The subject experienced intestinal obstruction, bile stained vomiting and vomiting. No faeces sample was collected. The diagnosis of intussusception was made based on abdominal ultrasound exam and abdominal X-ray. Intussusception had spontaneously reverted. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 320744 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-13
Onset:2008-05-17
   Days after vaccination:4
Submitted: 2008-07-30
   Days after onset:74
Entered: 2008-07-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Intussusception, Lethargy, Rectal haemorrhage, 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), Ischaemic colitis (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: B0530264A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case was collected through the foreign Surveillance Unit Acute Intussusception study occurring post Rotavirus vaccination. The subject was born at term. The subject''s birth weight is 3.39Kg. The subject had no history of intussusception. The subject had no previous significant illness/hospitalisations/operations. Feeding history: The subject currently fed formula. Until the age of 3 months the subject was exclusively breastfed. There was a change to the subject''s diet in the last week (change to formula). The subject had no feeding intolerance or food sensitivities. The subject received no current treatment. The subject received other vaccines as per schedule. Previous vaccination included ROTARIX (GlaxoSmithKline) given on 19 March 2008. On 13 May 2008, the subject received the 2nd dose of ROTARIX (unknown). On 17 May 2008, 4 days after vaccination with the 2nd dose of ROTARIX, the subject was admitted at hospital due to intussusception. The subject experienced passage of blood per rectum, vomiting and lethargy. No faeces sample was collected. The diagnosis of intussusception was made based on Enema (Site of intussusception: sigmoid colon). The subject was treated with guided fluoroscopy Enema. On 18 May 2008, the subject was discharged alive. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 320745 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-03
Onset:2008-04-10
   Days after vaccination:38
Submitted: 2008-07-30
   Days after onset:111
Entered: 2008-07-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Intestinal obstruction, Intussusception, Lethargy, Pallor, Surgery, Ultrasound abdomen abnormal, Virus serology test positive, Vomiting
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), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Adenovirus test, Apr2008, Positive; Ultrasound abdomen, Apr2008, IS
CDC Split Type: B0530265A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old female subject who was vaccinated with ROTARIX. This case was collected through the Paediatric Surveillance Unit Acute Intussusception study occurring post Rotavirus vaccination. The subject was born at term. The subject''s birth weight is 3.195Kg. The subject had no history of intussusception. The subject had no family history of intussusception. The subject had no previous significant illness/ hospitalisations/ operations. Feeding history: The subject currently fed formula. Until the age 1 month the subject was exclusively breast-fed. There was no change to the subject''s diet in the last week. The subject had no feeding intolerance or food sensitivities. Previous vaccination included ROTARIX (GlaxoSmithKline; unknown) given on 13 December 2007. The subject had no other vaccines within the last two weeks. The subject had no current treatment. On 3 March 2008, the subject received the 2nd dose of ROTARIX (unknown; lot number not provided). On 10 April 2008, 38 days after vaccination with the 2nd dose ROTARIX, the subject was admitted at hospital due to intussusception. The subject experienced intestinal obstruction ( no bilious vomiting), vomiting, lethargy and pallor. Faeces sample was collected; Adenovirus antigen was positive. The diagnosis of intussusception was made based on Enema, abdominal ultrasound exam and surgery (Site of intussusception: ascending colon to hepatic flexure; Type of intussusception; ileo-colic); The subject was treated with Airhydrostatic Enema but ultrasound guided was not successful. Surgery was performed; resection was done (length of bowel resected was 0 Cm). The lead point has been identified (Ileum). On 14 April 2008, the subject was discharged alive. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 320747 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-22
Onset:2008-06-15
   Days after vaccination:54
Submitted: 2008-07-30
   Days after onset:45
Entered: 2008-07-29
   Days after submission:1
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 mass, Abdominal pain, Barium enema, Barium enema abnormal, Blood sodium decreased, Crying, Dehydration, Enema administration, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal obstruction, Intussusception, Platelet count increased, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (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: Intestinal subocclusion
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 16Jun2008, see text; Barium enema, 16Jun2008, see text; Hematocrit, 18Jun2008, 26.9%; Hemoglobin, 17Jun2008, 11.7g/dl; Hemoglobin, 18Jun2008, 9.1g/dl; Leukocyte count NOS, 17Jun2008, 14700/mm3; Leukocyte count NOS, 18Jun2008, 8600/mm3; Platelet count, 17Jun2008, 593000/mm3; Platelet count, 18Jun2008, 430000/mm3; Sodium, 18Jun2008, 132mEq/1
CDC Split Type: B0530758A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 6-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. Concurrent medical conditions included intestinal sub-occlusion 15 days before, which resolved with medical treatment without surgery and without complication. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 20 February 2008. On 22 April 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 15 June 2008, 54 days after vaccination with ROTARIX, the subject experienced crying, abdominal pain, bloody stools and 5 episodes of vomiting. He was admitted to emergency room on 16 June 2008, with clinic data of intestinal obstruction. Physical exam showed dehydrated oral mucosa, painful abdomen in mesogastrium, palpable mass in left area and bowel sounds decreased. Ileocolic intussusception was suspected. The subject was hospitalized. Surgery was done on 17 June 2008; ileo-colic and colo-colic intussusception was corroborated with ischemia in descendent colon and edema in distal ileon with vascular recuperation; manual reduction of distal ileon, ileocaecal valve and descendent colon was performed without complication, without intestinal resection. During surgery, redundant colon was observed; pexy was performed on caecum, ileocaecal valve and ascendant colon without complication. Abdominal X-ray was performed on 16 June 2008 and showed distended colon with fixed loop, dilated small bowel and lack of air in colon and rectal ampulla and edema on intestinal loop. Barite enema was performed on 16 June 2008 and showed intussusception in descendent colon. Laboratory tests were performed on 17 June 2008 and showed the following results: Hemoglobin: 11.7 g/dl; Leucocytes: 14700/mm3; Platelets: 593000/mm3. Laboratory tests were performed on 18 June 2008 and showed the following results: Hemoglobin: 9.1 g/dl; Leucocytes: 8600/mm3; Platelets: 430000/mm3; Hematocrite: 26.9%; Sodium: 132 mEq/1. The subject was treated with cefotaxime, Amikacine and paracetamol. Clinical evolution after surgery was favorable. On 22 June 2008, the patient was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.


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