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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This case was reported by a physician via a sales representative and described the occurrence of invagination of intestine in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 28 February 2008, the same case was reported by via regulatory authority ((vaccines, biologicals) #DE-PEI-PEI2008001865). The subject has no underlying or concurrent medical conditions or other risk factors. On 08 February 2008 the subject received the first dose of ROTARIX (1 ml, oral). Approximately five days post vaccination with ROTARIX, on 13 February 2008, the subject experienced invagination of intestine. The subject was hospitalised for an unknown period of time. The reporting physician considered that the event was life threatening. Invagination was confirmed by sonography. Treatment in hospital included disinvagination by giving an enema. After about six hours, on 13 February 2008 or 14 February 2008, the event was resolved. The vaccination course with ROTARIX was discontinued. According to the information received by PEI the reporter considered that the event was probably related to vaccination with ROTARIX. Follow-up information was received on 06 March 2008 by the reporting physician including the hospital report. The subject has no underlying or concurrent medical conditions or other risk factors. The subject received no concomitant medication. On 08 February 2008 the subject received the first dose of ROTARIX (1 ml, oral). On 13 February 2008, the subject experienced invagination of intestine. The subject was hospitalised this event for two days. Anamnesis, according to hospital report: On day prior to invagination of intestine, on 12 February 2008, the subject showed increased restlessness. During night from 12 February 2008 to 13 February 2008 the subject experienced a single episode of splash-like vomiting. The subject was examined by the reporting physician and hospitalised. On admission to hospital, on 13 February 2008, the subject was in satisfactory general condition, experienced no fever (body temperature was 37.0 degC) and showed rosy complexion. Abdominal examination was soft on palpation, showed no pain on pressure and no pathologic resistances. Throat examination was normal. The eardrums were covered with earwax both sides. Lung examination showed vesicular breathing sounds both sides. Heart examination showed clear and rhythmic heart sounds. Laboratory examinations showed C-reactive protein (CRP) of 0.2 mg/dl and white blood cell count of 11.0 /nl. All other laboratory examinations for liver enzymes, blood electrolytes, blood coagulation and blood count were normal. Blood gas analysis showed pH of 7.415, pCO2 of 31.5 mmHg, pO2 of 70.7 mmHg, HCO3 of 19.8 mmol/l, base excess of -3.5 mmol/l, well-balanced electrolytes and blood glucose level of 102 mg/dl. Invagination was confirmed by abdominal sonography. Treatment in hospital included disinvagination by giving an enema with water (pre-warmed NaCl solution). The event resolved without complications. Post disinvagination the subject discharged lots of faeces. Abdominal sonography, performed on 14 February 2008, showed normal intestinal structures except mild oedematous changes, no signs of re-invagination and no ileus. On 14 February 2008, the subject was discharged from hospital in good general condition. No further information will be available. Case D0057465A was identified as a duplicate of case D0056291A and will be voided. All future correspondence will be submitted to the case of Record D0056291A. This subject was enrolled in an epidemiological study to gather epidemiological back-ground data on the incidence of intussusception in foreign country.
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