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This is VAERS ID 316665

Case Details

VAERS ID: 316665 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-08
Onset:2008-05-22
   Days after vaccination:44
Submitted: 2008-06-19
   Days after onset:28
Entered: 2008-06-19
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, Appendicectomy, Crying, Dehydration, Gastrointestinal hypermotility, Haematochezia, Hyperaemia, Intussusception, Mucous stools, Oedema, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Abdominal x ray showed scarce distal air and air-fluid levels.
CDC Split Type: B0523639A

Write-up: This case was reported by a physician in the frame of 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 first dose of ROTARIX given on 8 February 2008. On 8 April 2008, the subject received 2nd dose of ROTARIX (1 ml, oral). On 22 May 2008, 44 days after vaccination with ROTARIX, the subject experienced intussusception, crying, vomiting, bloody stools, mucus in stool, fever, pharyngeal hyperemia, abdominal pain, bowel peristalsis increased, current jelly stool, abdominal mass, dehydration, edema and hyperemia. The subject was hospitalised for 5 days. Relevant test results included abdominal x ray that showed scarce distal air and air-fluid levels. The subject was treated with cefotaxime, ranitidine, metamizole, ketorolac, nalbuphine, paracetamol and surgery. Surgery was performed on 23 May 2008, ileocolic invagination was found and corrected with the pharmacologic relaxation during surgery, besides, appendectomy was also done because it has hyperemia and edema. On 27 May 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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