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This is VAERS ID 312402

Case Details

VAERS ID: 312402 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-14
Onset:2008-04-29
   Days after vaccination:46
Submitted: 2008-05-15
   Days after onset:16
Entered: 2008-05-15
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 pain, Abdominal tenderness, Appendicectomy, Body temperature increased, Gastrointestinal hypomotility, Haematochezia, Intussusception, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (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 (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 30Apr2008 see text unit; Body temperature 29Apr2008 38.8deg C
CDC Split Type: B0519432A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 15 January 2008. On 14 March 2008 the subject received 2nd dose of ROTARIX (oral). On 29 April 2008, 46 days after vaccination with ROTARIX, the subject presented abdominal pain, vomiting (2 episodes), bloody stools (2 times) and fever. On 30 April 2008 the subject was taken to the emergency room. Physical examination included fever 38.8 deg C, tender abdomen with decreased peristalsis and no abdominal mass. She had bloody stool in her diaper. Relevant test included abdominal x-ray which showed distended loops in upper left quadrant. The same day the subject underwent surgery in which ileoceco-colic intussusception was confirmed and resolved by taxis. Also appendectomy was done. The event was resolved without complication and good clinical evolution. On 02 May the subject was discharged in good condition. The subject was treated with metronidazole, amikacin and ranitidine hydrochloride (Ranitidine). The physician considered the events were unrelated to vaccination with ROTARIX.


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