Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Diarrhoea, Gastroenteritis, Poor quality sleep, Rhinorrhoea
Clinical narrative: Information has been received from a consumer concerning her 3 month old son, with no medical history and no allergies, who, "four weeks ago," on approximately 11-APR-2007, was vaccinated with a first oral dose of Rotateq. Concomitant vaccines included "required vaccine." "Two days after Rotateq was administered. on approximately 13-APR-2007, the patient experienced diarrhea. The reporter indicated that her son would not complete the series. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a consumer concerning her 3 month old white son, with no medical history and no allergies, who, "four weeks ago, " on 11-APR-2007, at 10:30 a.m. , was vaccinated with a first oral dose of ROTATEQ.  Concomitant vaccines administered at the same time included a first intramuscular dose in the right thigh of PEDIARIX (Lot # AC21B090BA), a first intramuscular dose in the left thigh of ACTHIB (Lot #UF086AA), a first intramuscular dose in the right thigh of PREVNAR (Lot #B08679A).  Concomitant therapy included ZANTAC for gastroesophageal reflux disease.  There were no adverse event following prior vaccination.  "Two days after ROTATEQ was administered," no approximately 13-APR-2007, the patient experienced diarrhea.  The reporter indicated that her son would not complete the series.  At the time of the report the patient had not recovered.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Follow-up information from a person working in a physician's office indicated that the patient was seen on 18-APR-2007 for a cough and a runny nose.  The patient was diagnosed with croup and bronchitis and was given medication.  The patient was seen on 25-APR-2007 to recheck on bronchitis and croup and was diagnosed with an upper respiratory tract infection.  It was reported that on 26-APR-2007, at 9:49 a.m., the patient's mother reported to the office that the patient had diarrhea, twice per day for the "previous 2 weeks," beginning on approximately 13-APR-2007.  The patient was seen on 27-APR-2007 for the diarrhea and was diagnosed with gastroenteritis.  The patient had a normal appetite, but was not sleeping well.  The patient was to complete the medications and follow-up in 2 weeks.  The patient was seen on 14-MAY-2007 to recheck the gastroenteritis.  At that time the patient continued to have diarrhea, 2-4 times per day.  The patient had been nursing from the mother's breast for 20 minutes every 2-4 hours.  There were no new concerns or problems at that time.  The patient was seen on 08-JUN-2007 for a cough, and stuffy nose.  The patient was diagnosed with a upper respiratory tract infection.  Symptomatic care was discussed with the patient's parents and a recheck was scheduled at the patient's 4 month well-check.  At the patient's 4 month well check, on 13-JUN-2007, PEDIARIX was given.  On 21-JUN-2007 the patient received a second dose of ACTHIB.  On 28-JUN-2007 the patient was seen for a second dose of PREVNAR.  It was noted that the patient's mother signed a refusal to vaccinate with ROTATEQ.  It was reported that the patient recovered (date not reported).  Additional information is not expected.