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Life Threatening? No
Write-up: This case was reported by a foreign regulatory authority (reference PV20080062) and described the occurrence of intussusception of intestine in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline, PREVENAR, non-gsk and PENTAVAC, non-gsk. The subject was born at 40 weeks and 4 days of amenorrhea (birth weight 3.27 kg, birth height 49.5 cm and birth cranial perimeter 34.5 cm). She had no known allergy. Medical condition included unspecified reflux. At the time of the events, there were gastroenteritis cases in the subject''s family. The subject weighted 7.18 kg. On 11 December 2007, the subject received an unspecified dose of ROTARIX (batch A41CA392A oral), a 2nd dose of PREVENAR (intramuscular, batch and injection site unknown), and a 2nd dose of PENTAVAC (intramuscular, batch and injection site unknown). On 08 January 2008, a physician was consulted for acute diarrhea with several vomiting and fever at 38.7 degrees Celsius. Diarrhea had become a mucous bloody diarrhea (10 liquid stools per day; with a weight loss of four percent (incidental events). TIORFAN, ADVIL, DOLIPRANE and oral rehydration solution were prescribed. Vomiting and diarrhea persisted. On 09 January 2008, 29 days after vaccination with PENTAVAC, PREVENAR and ROTARIX, the subject was admitted to emergency service for bloody diarrhea and pain. On admission, blood pressure was at 107/77, heart rate at 156 bpm and body temperature was normal. The subject was irritable and tired. There was no sign of dehydration. The rest of physical examination was normal. At abdominal ultrasound scan, acute intussusception of intestine was suspected. The subject was hospitalized and intussusception was reduced by hydrosoluble enema. Intussusception of intestine resolved at an unspecified date. Outcome of pain, blood in stool, irritability and fatigue was unspecified. According the foreign method of assessment, the relationship between vaccinations with ROTARIX, PREVENAR and PENTAVAC and intussusception was dubious.
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