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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: 334088 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-13
Onset:2008-10-15
   Days after vaccination:2
Submitted: 2008-12-05
   Days after onset:51
Entered: 2008-12-05
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
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Food intolerance, Haematochezia, Ileectomy, Intestinal anastomosis, Intussusception, Irritability, Mucous stools, Pharyngitis, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 18Oct2008, air levels
CDC Split Type: B0548929A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Previous and/or concurrent vaccination included DTAP-IPV-HIB; manufacturer unspecified; intramuscular given on 13 October 2008; HEP B vaccine recombinant; manufacturer unspecified; intramuscular given on 13 October 2008. On 13 October 2008 the subject received 1st dose of ROTARIX (oral). On 15 October 2008, 2 days after vaccination with ROTARIX, the subject started with a pharyngeal infection, intolerance to oral feeding, gastrobiliary vomiting and current jelly stools. She received ambulatory treatment (not specified) without improvement. On 18 October 2008 the subject was hospitalized. Physical examination reported abdominal pain, abdominal distention, gastrobiliar vomiting and irritability. The abdominal x-ray showed air-fluid levels. The same day the subject underwent a surgery. Ileoileal intussusception was found and it was reduced by taxis without improvement. A ileal resection was performed (length 20 cm and termino-terminal anastomosis with good evolution). On 28 October the subject was discharged in good conditions. The subject was treated with omeprazole, metronadizole, cefotaxime, amikacin, METAMIZOL, KETOROLAC, and ALBUMINE. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 334089 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-08-18
Onset:2008-10-04
   Days after vaccination:47
Submitted: 2008-12-05
   Days after onset:62
Entered: 2008-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal pain, Activated partial thromboplastin time normal, Barium enema, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Mucous stools, Pallor, Prothrombin time normal, 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Oct2008, see text; Activated partial thromboplast, 05Oct-2008, 35.1s; Hematocrit, 05Oct2008, 36.8%; Hemoglobin, 05Oct2008, 12.1g/dl; Prothrombin time, 05Oct2008, 12.5s
CDC Split Type: B0548938A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 18 June 2008. Medical conditions included a healthy baby. On 18 August 2008 the subject received 2nd dose of ROTARIX (oral). On 4 October 2008, 47 days after vaccination with ROTARIX, the subject experienced irritability, gastro alimentary vomiting, 2 current jelly stools and abdominal pain. On 05 October 2008 the subject was admitted at the emergency room with irritability, pallor, normal hydration, abdominal palpable mass, positive dance signs and rectal tact showed current jelly stools. Relevant test included abdominal x-ray, which showed small bowel loops and right colon with distention and air in rectal ampoule. Intussusception was suspected. Therefore the same day after sedation the subject was treated with barium enema. Reduction of ileocecocolic intussusception was done successfully. The subject''s clinical evolution was favorable. On 08 October 2008 the subject was discharged in good clinical conditions. The subject was hospitalized for 4 days. The subject was treated with metronidazole, amikacin, Ranitidine, Methamizole, paracetamol. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 334090 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-21
Onset:2008-11-01
   Days after vaccination:11
Submitted: 2008-12-05
   Days after onset:34
Entered: 2008-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Haematochezia, Haemoglobin normal, International normalised ratio normal, Intussusception, Irritability, Lymphocyte percentage, Neutrophil percentage, Pallor, Prothrombin time normal, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Nov2008, see text; Blood glucose, 02Nov2008, 117mg/dl; Creatinine, 02Nov2008, 0.4mg/dl; Hemoglobin, 02Nov2008, 10.8g/dl; International normalized ratio, 02Nov2008, 1.03UI; Leukocyte count NOS, 02Nov2008, 12500mm2; Lymphocytes, 02Nov2008, 36%; Neutrophils, 02Nov2008, 61%; Potassium, 02Nov2008, 4.4mEq/l; Prothrombin time, 02Nov2008, 11.7s; Sodium, 02Nov2008, 136mEq/l
CDC Split Type: B0549012A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 21 August 2008. On 21 October 2008 the subject received 2nd dose of ROTARIX (oral). On 1 November 2008, 11 days after vaccination with ROTARIX, the subject experienced gastro alimentary vomiting, gastro biliar vomiting and bloody stools. On 02 November 2008 the subject was admitted to the emergency room with pallor, irritability, abdominal mass and rectal tact with fresh blood. Abdominal x-ray showed intestinal distention. Intussusception was suspected. The same day subject underwent a surgery showing evidence of ileocecocolic position. The event was resolved with taxis without complication. The subject''s clinical evolution was favorable. On 04 November 2008 the subject was discharged in franc abdominal recuperation. The subject was hospitalized for 3 days. Relevant test results included [laboratory results/hospital investigations]. The subject was treated with metronidazole, Ranitidine, amikacin and surgery. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 334095 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-15
Onset:2008-01-14
   Days after vaccination:91
Submitted: 2008-12-05
   Days after onset:326
Entered: 2008-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Dehydration, Diarrhoea, Intussusception, Irritability, Surgery, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 14Jan2008, Abnormal
CDC Split Type: B0548673A

Write-up: This case was reported by a physician and described the occurrence of ileocecocolic intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk); manufacturer unspecified; intradermal; unknown deltoid given on 17 June 2007; combined DTaP-IPV-HIB; manufacturer unspecified; intramuscular; given on 4 August 2007, 15 October 2007 and 13 December 2007; Hep B; manufacturer unspecified; intramuscular; given on 17 June 2007, 14 August 2007 and 13 December 2007; ROTARIX; GlaxoSmithKline; oral given on 4 August 2007; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 4 August 2007 and 15 October 2007. On 15 October 2007, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 14 January 2008, 91 days after vaccination with 2nd dose of ROTARIX, the subject experienced abdominal pain and diarrhea, leading to hospitalisation. The physical examination found the subject irritable, dehydrated with Morcilla''s sign. The abdominal X-ray revealed air-fluid levels. The subject was hospitalised for 4 days and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 15 January 2008, a surgery was performed and ileocecocolic intussusception without vascular complication was found and reduced by taxis without complication. No bowel resection was performed. On 17 January 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 334096 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-08-20
Onset:2008-10-05
   Days after vaccination:46
Submitted: 2008-12-05
   Days after onset:61
Entered: 2008-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Decreased activity, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Mucous stools, Pallor, Surgery, 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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0548917A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 20 August subject received 1st dose of ROTARIX (oral). On 5 October 2008, 46 days after vaccination with ROTARIX, the subject experienced irritability, gastro alimentary vomiting. He received ambulatory treatment with erythromycin and acetaminophen without improvement. He had bloody stools (3 episodes), hypoactive and pallor. The same day the subject was hospitalized. Physical examination showed hypo activity, pallor, and abdominal pain on palpation, decreased bowel sounds and current jelly stools. The diagnosis of intussusception was made by clinical feature. The subject underwent a surgery the same day. Ileocecocolic intussusception was found and reduced by taxis without complications. On 09 October 2008 the subject was discharged in good clinical conditions. The subject was treated with acetaminophen, Ranitidine and metronidazole. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 335074 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-21
Onset:2008-07-11
   Days after vaccination:51
Submitted: 2008-12-11
   Days after onset:153
Entered: 2008-12-11
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 mass, Abdominal pain, Activated partial thromboplastin time prolonged, Blood calcium decreased, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, Gastrointestinal hypomotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Lymphocyte count increased, Mucous stools, Neutrophil count increased, Pallor, Platelet count normal, Prothrombin time prolonged, Somnolence, Surgery, Ultrasound abdomen abnormal, Vaccine positive rechallenge, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Biliary vomiting; Intussusception; Irritability
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 31Aug2008, see text unit; Abdominal X-ray, 07Oct2008, See text; Activated partial thromboplast, 30Aug2008, 40.1s; Blood glucose, Jul2008, 90mg/dl; Blood group O, 07Oct2008, Rh +; Calcium, 30Aug2008, 8.7Eq/l; Creatinine, 30Aug2008, 0.4mg/dl; Glucose, 30Aug2008, 95mg/dl; Hematocrit, Jul2008, 33%; Hematocrit, 30Aug2008, 33.5%; Hemoglobin, Jul2008, 11.4mg/dl; Hemoglobin, 30Aug2008, 11.3g/dl; Hemoglobin, 07Oct2008, 10.5g/dl; Leukocyte count NOS, Jul2008, 16900c/mm3; Leukocyte count NOS, 07Oct2008, 13 400/mm3; Lymphocytes, 30Aug2008, 5 100mm3; Neutrophil count, Jul2008, 48/mm3; Neutrophils, 30Aug2008, 10 100mm3; Partial prothrombin time, Jul2008, 33.6s; Platelet count, Jul2008, 302000 unit; Platelet count, 30Aug2008, 453000mm3; Platelet count, 07Oct2008, 295 000/mm3; Potassium, Jul2008, 4.3mEq/l; Potassium, 30Aug2008, 4.3mEq/1; Potassium, 07Oct2008, 4.6mEq/l; Prothrombin time, Jul2008, 13.7s, Prothrombin time, 30Aug2008, 13.4s; Sodium, Jul2008, 140mEq/l; Sodium, 30Aug2008, 135mEq/l; Sodium, 07Oct2008, 146mEq/l; Ultrasound abdomen, 30Aug2008, IS unit; Urea, Jul2008, 13mg/dl; Urea, 30Aug2008, 9mg/dl
CDC Split Type: B0536137A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline) for prophylaxis. Concurrent and or previous medical conditions included intussusception in May 2008 which was resolved by taxis in explorer laparotomy. Further information was not available in the file. On 21 May 2008 the subject received 1st dose of ROTARIX (oral). On 12 July 2008, 52 days after vaccination with the 1st dose of ROTARIX, the subject experienced ileocolic intussusception, which was also resolved by taxis without complications, post explorer laparotomy, intestinal resection was not performed. On 21 July 2008 the subject received 2nd dose of ROTARIX (oral). On 30 August 2008, 40 days after the 2nd dose of ROTARIX the subject presented irritability, gastrobiliar vomiting (more than 10 times), abdominal pain, and sanguinolent stools. The same day she was admitted to the emergency room with somnolence, pallor abdominal pain, decreased peristalsis, palpable abdominal mass and rectal tact with expulsion of current jelly stools. Relevant test included abdominal ultrasound which showed evidence of intussusception. The medical surgeon treated her with Diazepam for abdominal relaxation. He could palpate in ileocecal area abdominal mass which was reduced successfully and slowly with normal procedure in retrograde direction. On 31 August 2008 the subject showed clinical improvement with just slow peristalsis, without any sanguinolent stool. The subject presented a good evolution with good oral acceptance. The same day abdominal x-ray showed improvement in the intestinal air distribution. On 03 September 2008 the subject discharged in franc resolution. The subject was treated with cefotaxime, metronidazoloe, Metamizole, Ranitidine, paracetamol, Trimethoprin and diazepam. At the time of reporting the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX. In the follow up received on 23 September 2008 it was confirmed that there were relapse of intussusceptions. In May the subject had the 1st intussusception. It was unknown if the event occurred before or after vaccination. The subject showed irritability and gastrobiliar vomiting. Intussusception was resolved in another hospital. The clinical file was not available. The outcome date and laboratory tests were unknown. On 11 July 2008 the subject presented irritability, vomiting and current jelly stools. On 12 July 2008 the 2nd intussusception type ileocolic was detected and corrected by surgical taxis. On 15 July 2008 the event was resolved. On 30 August 2008, the subject presented 3rd intussusception which was resolved with external manoeuvre reduction with sedation (diazepam), surgical correction was not required. Follow up received on 05 December 2008 from the physician: On 6 October 2008, 77 days after vaccination with 2nd dose of ROTARIX, the subject started with biliary vomiting and current jelly stool. The subject was admitted at ER with abdominal pain, pallor, bowel peristalsis decreased, irritability and decreased gastrointestinal peristalsis. Abdominal x-ray showed intestinal occlusion, air-fluid levels and lack of air in rectal ampulla. The subject was hospitalized for surgery on 7 October 2008, ilecolic intussusception was found without complications. One adhesion was found (from caecum to terminal ileum) resolved by lysis. Ileocolic intussusception was resolved by taxis without intestinal resection. The physician considered the events were disabling. Relevant tests performed on 7 October 2008 showed the following results: Hemoglobin: 10.5 g/dl; Leukocytes: 13 400/mm3; Platelets: 295 000 /mm3; Potassium: 4.9 mEq/1; Sodium: 146 mEq/1; Blood group: 0+. The subject was treated with cefotaxime, metronidazole, Metamizol, Ranitidine, diazepam and Ketorolac. The subject had a goiod recuperation and was discharged on 11 October ingood clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 335078 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-11-14
Onset:2008-11-17
   Days after vaccination:3
Submitted: 2008-12-11
   Days after onset:24
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Activated partial thromboplastin time shortened, Alanine aminotransferase, Aspartate aminotransferase normal, Blood albumin decreased, Blood chloride normal, Blood creatinine increased, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea increased, Dehydration, Food intolerance, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intussusception, Irritability, Neutrophil percentage, Pallor, Platelet count increased, Protein total decreased, Prothrombin time normal, Pyrexia, Surgery, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), 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 (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (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? 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: Abdominal X-ray; 20Nov2008, See text; Activated partial thromboplast, 20Nov2008, 26.2Sec; Alanine aminotransferase, 20Nov2008, 41IU/L; Albumin, 20Nov2008, 4.2g/dL; Aspartate aminotransferase, 20Nov2008, 44U/L; Blood glucose, 20Nov2008, 99mg/dL; Blood urea nitrogen, 20Nov2008, 28mg/dL; Chloride, 20Nov2008, 99mEq/L; Creatinine, 20Nov2008, 0.7mg/dL; Hematocrit, 20Nov2008, 33%; Hemoglobin, 20Nov2008, 11g/dL; Neutrophil percentage, 20Nov2008, 59%; Platelet count, 20Nov2008, 597000/mm3; Potassium, 20Nov2008, 4.4mEq/L; Protein total, 20Nov2008, 072g/dL; Prothrombin time, 20Nov2008, 11.6Sec; Sodium, 20Nov2008, 137mEq/L; Ultrasound abdomen, 20Nov2008, See text; Urea, 20Nov2008, 60mg/dL; White blood cell count, 20Nov2008, 13900/mm3
CDC Split Type: B0549365A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant history or allergy. Concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified; intramuscular; unknown injection site) given on 14 November 2008; pneumococcal vaccine (manufacturer unspecified; intramuscular; unknown injection site) given on 14 November 2008. On 14 November 2008, the subject received 1st dose of ROTARIX (oral, lot number not provided). On 17 November 2008, 3 days after vaccination with ROTARIX, the subject experienced irritability, intolerance to oral feeding, gastro alimentary vomiting, bloody stools and fever. She received ambulatory treatment with clotrimazole, Acetaminophen and electrolytes without improvement. On 20 November 2008, the subject was hospitalised. Physical exam was with dehydration, pallor, abdominal distension and decreased bowel sounds. Lab tests were performed and showed the following: Glucose: 99 mg/dL; Urea: 60 mg/dL; Urea Nitrogen: 28 mg/dL; Creatinine: 0.7 mg/dL; Total Protein: 0.72 g/dL; Albumin: 4.2 g/dL; Alanine aminotransferase: 41 U/L; Aspartate aminotransferase: 44 U/L; Sodium: 137 mEq/L; Potassium, 4.4 mEq/L; Chloride: 99 mEq/L; Hemoglobin: 11 g/dL; Hematocrit: 33%; Platelet count: 597000/mm3; Leucocytes count: 13900/mm3; Neutrophils percentage: 59%; Prothrombin Time: 11.6 Sec; Partial Thromboplastin Time: 26.2 Sec. Abdominal X-ray was performed and showed air fluid levels and data of intestinal obstruction. Abdominal ultrasound was performed and showed right flank with tubular mass in longitudinal views (pseudo kidney) and a target appearance in transverse images probably ileocolonic intussusception, dilated bowels. On 20 November 2008, surgery was performed; ilececolic intussusception was found and reduced by taxis without complications. On 24 November 2008, the subject was discharged in good clinical conditions. On 24 November 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 335079 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-29
Onset:2008-05-30
   Days after vaccination:31
Submitted: 2008-12-11
   Days after onset:195
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Intussusception, Irritability, Laparotomy, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0549662A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline; oral) given on 28 February 2008. On 29 April 2008, the subject received 2nd dose of ROTARIX (oral, lot number not provided). On 30 May 2008, 31 days after vaccination with 2nd dose ROTARIX, the subject experienced vomiting and diarrhea. On 02 June 2008, the subject was admitted at hospital. Finding at physical examination were irritability, asthenia, adynamia, dehydration, vomiting and decreased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Intussusception was suspected and laparotomy was realised on 02 June 2008: Ileoileal intussusception was reported and resolved by taxis without complications. The subject was treated with Metoclopramid, Ampicillin and Amikacine. On 10 June 2008, the subject was discharged in good clinical conditions. On 10 June 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 335080 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-23
Onset:2008-11-20
   Days after vaccination:28
Submitted: 2008-12-11
   Days after onset:21
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Appendicectomy, Appendicitis, Haematochezia, Haemoglobin normal, Inappropriate schedule of drug administration, Intussusception, Irritability, Lymphadenitis, Pallor, Platelet count increased, Surgery, Vomiting, White blood cell count, 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), Medication errors (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 21Nov2008, see text; Hemoglobin, 21Nov2008, 10.4g/dl; Leukocyte count NOS, 21Nov2008, 17000/mm3; Platelet count, 21Nov2008, 505000/mm3
CDC Split Type: B0549709A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of 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 known allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 19 August 2008. Concurrent vaccination included combined DTaP-IPV-HIB (manufacturer unspecified) given on 23 October 2008; pneumococcal vaccine (non-GSK manufacturer) given on 23 October 2008. On 23 October 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 20 November 2008, 28 days after vaccination with ROTARIX, the subject started with irritability, abdominal pain, vomiting and bloody stools. The patient was admitted at ER on 21 November 2008 and showed at physical exam irritability, pallor, abdominal pain to palpation right side with abdominal mass, bowel sounds decreased and rectal tact with empty ampulla and bloody stains. The subject was hospitalised. Diagnosis of intussusception was made by clinical features. Surgery was performed and showed cecocolic intussusception, mesenteric adenitis and appendicitis. Intussusception was reduced by taxis with a prophylactic appendectomy without complications. Tests were performed on 21 November 2008 and showed the following results: Abdominal X-ray: air-fluid levels. Hemoglobin: 10.4 g/dl; Leukocytes: 17000/mm3; Platelets: 505000/mm3. The subject was treated with Acetaminophen, Ampicillin and amikacin. On 25 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336468 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-02
Onset:2008-10-27
   Days after vaccination:25
Submitted: 2009-01-05
   Days after onset:70
Entered: 2008-12-05
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Barium enema abnormal, Diarrhoea, Enema administration, Gastrointestinal sounds abnormal, Haematochezia, Inappropriate schedule of drug administration, Intestinal anastomosis, Intestinal perforation, Intestinal resection, Intussusception, Pyrexia, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Barium enema, 30Oct2008, see text
CDC Split Type: B0552031A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Concurrent vaccination included DTaP-IPV/Hib vaccine (manufacturer unspecified) given on 2 October 2008; pneumococcal vaccines (non-GSK manufacturer) given on 2 October 2008. On 2 October 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 27 October 2008, 25 days after vaccination with ROTARIX, the subject started with liquid stools, vomiting, bloody stools and fever. The patient was admitted at ER on 29 October 2008 and showed at physical exam abdominal pain to palpation and bowel sounds decreased. The subject was hospitalised. Intussusception was diagnosed. Barium enema was performed without success. Surgery was done on 30 October 2008. Ileo-ileal and ileo-ceco-colic intussusception with intestinal perforation in length 10 cm in ileo-cecal valve was found, reduced by taxis, intestine resection and termino-terminal anastomosis without complication. The subject was treated with midazolam and paracetamol (Acetaminophen). On 6 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


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