This is VAERS ID 340281

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Blood potassium increased, Blood sodium normal, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Neutrophil percentage decreased, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (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), 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? 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC Split Type: B0558773A

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). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.