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Life Threatening? Yes
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 13 April 2010, the subject received 1st dose of ROTARIX (1 mg, oral, batch number not provided). On 16 April 2010, 3 days after vaccination with ROTARIX, the subject became floppy and according to mother words, experienced "perhaps convulsion". The subject was brought to healthcare center, where fluid infusions were administrated. As general condition did not get better, the boy was transported to hospital and underwent surgery. The surgery diagnosed atypical intussusception. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting, the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX. Follow-up information received on 26 May 2010: The subject''s medical history included an acute bronchitis for which he was hospitalized from 24 February 2010 to 4 March 2010. Also the neurologist consulted him on 12 February 2010 because of suspected hydrocephalic syndrome. Neurosonogram has been performed and marginal increase of lateral ventricle has been found. The subject was not treated and at the second consultation of neurologist on 7 April 2010, no pathology was found. Neither the subject nor the parents had medical history of intussusception or bowel abnormalities or other gestational dysfunction. Previous vaccination included 1st dose of ENGERIX B (GlaxoSmithKline; intramuscular, unknown gluteal) on 6 January 2010. Concomitant vaccination included 2nd dose of ENGERIX B (GlaxoSmithKline; intramuscular, unknown gluteal) and 1st of PENTAXIM (Sanofi Pasteur SA; intramuscular, unknown gluteal). Batch number and expiry date of ROTARIX was provided. The subject was hospitalized on 16 April 2010, the 1st day of illness. His condition was severe; he was somnolent, flappy, pale, between times anxious. Also he vomited many of times. Physical examination was performed and abdominal infiltrate was palpated. The infiltrate was typical for intussusception. This diagnosis has been confirmed by abdominal ultrasound. On 16 April 2010, the surgery was performed: cecocolic intussusception has been found. The intussusception was extended to sigma. The bowel has been straightened during surgery. There was no need for resection. Treatment has been continued at intensive care therapy department till 19 April 2010. After that the child was in stable condition and was transferred to Pediatric Surgery Department. The child was fed with breast milk and milk formula. The stool was normal without blood and mucus additive. The abdomen was not painful, soft. The body temperature was normal. The baby''s behaviour was as usually. There was no complication of surgery. The blood test at discharge showed following results: Hemoglobin 2%; WBC 9.8 10*9/l; C reactive protein < 8 mg/l; eosinophils 2%; lymphocytes 62%; monocytes 11%; segmented leucocytes 25%. At discharge, the events were resolved. The physician considered the events were probably related to vaccination with ROTARIX.
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