Age: 0.51
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal faeces, Culture stool positive, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 13-SEP-2007 was vaccinated with a 2 mL first dose of ROTATEQ (lot # "0214U"), oral.  Patient received a second dose of ROTATEQ on 19-NOV-2007 (lot # 657518/1192U) and a third dose of ROTATEQ (lot # 657988/1193U) on 18-JAN-2008.  On 06-AUG-2008 the patient experienced symptoms of rotavirus.  The patient was tested and the tests came back positive for rotavirus antigen.  The patient sought unspecified medical attention.  At the time of this report the patient had recovered.  Additional information has been requested. Follow up information received on 02-MAR-2009 from a registered nurse stated that it was a patient who on an unspecified date underwent a circumsision. It was also reported that the patient born through a cesaren procedure due to mother's small pelvis, it was a full term delivery. No known drug allergies. No relevant family and social history. On 11-SEP-2007 the patient received the first dose of rotavirus (lot # 657518/1192U), oral and a third dose of ROTATEQ (lot # 657988/1193U), oral, on 18-JAN-2008 at 15:38. Concomitant therapy on 18-JAN-2008 included PEDIARIX, Hib conj vaccine (unspecified carrier), pneumococcal vaccine (unspecified) and influenza virus vaccine (unspecified). According to patient's mother, since 04-AUG-2008 at 12:30, patient had loose watery foulsmelling nonbloody stools 3 times a day, vomiting nobilious and previously ingested food several hours after, felt warm. He was able to keep down. His mother was giving him PEDIALYTE to keep well hydrated. He had good urine output; was playing at time and seems to be improving, intermittently stops playing to hold his belly and cringe a little bit as if he had abdominal cramps. No known sick contact. On 06-AUG-2008 the patient was seen in ER with vomiting, diarrhea and holding his left ear. It was stated by the patient's mother that the patient has had two days of vomiting and diarrhea, but that had stopped. Review of symptoms was unremarkable. On 07-AUG-2008 at 12:00 the patient was diagnosed per stool with rotavirus infection. The patient was seen in the pediatrician office on the same day for follow up. Physical exam showed a well appearing, not in acute cardiorespiratory distress patient. The mother was informed to increased oral fluid intake (continue PEDIALYTE with ginger ale). On 06-AUG-2008 the patient had a pulse oximetry (99%), a fundoscopic that showed normal disks, normal vessels, and ears were without external lesions and with clear auditory canals and tympanic membrane bilaterally, and a white blood cells test (not detected). Stool procedures includes a stool culture on 06-AUG-2008 that showed no bacterial enteric pathogens, heavy enteric flora and no white blood cells. A rotavirus antigen test on 07-AUG-2008 at 11:42, that was positive for rotavirus antigen. The patient sought medical attention through a ER. The patient recovered on an unspecified date. The patient's vaccination history included first, second, third and fourth doses of PEDIARIX on 13-SEP-2007, 19-NOV-2007, 18-JAN-2008 and 17-OCT-2008, respectively. First, second, third, and fourth doses of Hib conj vaccine (unspecified carrier) on 13-SEP-2007, 19-NOV-2007, 18-JAN-2008 and 17-OCT-2008 respectively. First dose of MMR on 17-JUL-2008. First dose of hepatitis A virus vaccine (unspecified) on 17-JUL-2008. First dose of varicella virus vaccine live (unspecified) on 17-JUL-2008. First, second, third, and fourth doses of pneumococcal vaccine (unspecified) on 13-SEP-2007, 19-NOV-2007, 18-JAN-2008 and 17-OCT-2008 respectively. First and second dose of influenza virus vaccine (unspecified) on 18-JAN-2008, 04-DEC-2008 respectively. this is a consolidation of two reports concerning the same patient. No additional information is available.