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This is VAERS ID 336467

Case Details

VAERS ID: 336467 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
   Days after vaccination:68
Submitted: 2009-01-05
   Days after onset:251
Entered: 2009-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Appendicectomy, Gastrointestinal necrosis, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Mucous stools, Neutrophil count increased, Pallor, Platelet count normal, Prothrombin time prolonged, Pyrexia, Vomiting, White blood cell count normal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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 (narrow), 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: Penicillin Allergy
Preexisting Conditions:
Diagnostic Lab Data: Hematocrit, 30Apr2008, 34.8%; Hemoglobin, 30Apr2008, 11.5mg/dl; Leukocyte count NOS, 30Apr2008, 12 700/mm3; Neutrophils, 30Apr2008, 12300/mm3; Prothrombin time, 30Apr2008, 13.4sec
CDC Split Type: B0551803A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocecocolic intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history. Concurrent medical conditions included penicillin allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 1 December 2007. On 21 February 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 29 April 2008, 68 days after vaccination with ROTARIX, the subject started with bloody stools, fever, irritability, vomiting and pallor. The patient was admitted at ER on 30 April 2008 and showed at physical exam abdominal pain, fever, current jelly stool and sausage shaped abdominal mass. Intussusception was suspected. Ileocecocolic intussusception was confirmed by laparotomy, with appendix necrosis, reduced by taxis and appendectomy without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Tests were performed on 30 April 2008 and showed the following results: Hemoglobin: 11.5 mg/dl; Hematocrit: 34.8 %; Leukocytes: 12 700/mm3; Neutrophils: 12 300/mm3; Platelets: 407 000/mm3; Prothrombine time: 13.4 sec. The subject was treated with Amikacine, metronidazole, Metamizole, Ranitidine and AMBROSOL. On 6 May 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 requested therefore the case has been closed.

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