Age: 0.16
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal pain, Abnormal faeces, Haematochezia, Haematochezia, Irritability
Clinical narrative: Information received from a physician concerning a 2 month old patient with a possible milk allergy who in the first week of May 2006 was vaccinated with a dose of rotavirus G1 G2 G2 G4 P1 reassortant vaccine live (human-bovine). The physician reported that in May 2006, soon after being vaccinated, the patient had blood in the stool. Unspecified medical attention was sought.  A hemetest was performed, but the results were not known. The patient was noted to be doing fine and on 09-MAY-2006 was considered recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 5/16/2006; 5/26/2006; 6/6/2006; 6/13/2006. Information has been received from a physician concerning a 9 week old female with a possible milk allergy who in the first week of May 2006, was vaccinated with an oral dose of ROTATEQ (Lot# 652964/0145F). Concomitant vaccines administered on the same day included a first intramuscular dose in the left anterior thigh of DAPTACEL (Lot# C2431AA), a first subcutaneous dose in the left anterior thigh of IPOL (Lot# Y1067), a first intramuscular dose in the right anterior thigh of ACTHIB (Lot# UF844AA), a second intramuscular dose in the right anterior thigh of ENGERIX-B (Lot# AHBVB2H4CA) and a first intramuscular dose in the right anterior thigh of PREVNAR (Lot# B08642C). The patient was fussy, vomiting, and "cheesy" stools at the time of vaccination. There were no adverse events following prior vaccination. The physician reported that in May 2006, soon after being vaccinated, the patient had blood in the stool. Unspecified medical attention was sought. A hemetest was performed, but the results were not known. The patient was noted to be doing fine and on 09-MAY-2006 was considered to be recovered. Follow-up information was received from a RN in the physician's office regarding a 2-month-old patient with vomiting, abdominal pain and reflux ZANTAC started on 25-APR-2006) who on 28-APR-2006 was vaccinated PO with the first dose of ROTATEQ. On that same day ranitidine HCl was discontinued and REGLAN was started. The RN reported that on 05-MAY-2006, the patient was noted to have blood in the stool. At that time, the patient's stools were described as being "putty-like". An initial hemetest was negative and a second was positive. The patient's formula was subsequently changed to Nutramigen as the patient was suspected of formula intolerance (pt. previously fed with breast milk, Isomil, Similac, Carnation Good Start and Carnation Good Start (Soy)). After the formula change, the patient's symptoms improved. The RN indicated that it was not felt that the patient's blood in stool was related to vaccination with ROTATEQ. Additional follow-up was received from an RN indicating that the patient's blood in stool was not due to vaccination with ROTATEQ but from a milk protein allergy. The RN noted that the patient was now on elemental milk and was doing fine. The nurse also indicated that she planned to give the patient the second dose of ROTATEQ. Additional follow-up information from a health professional indicated the blood in the stool was noted by the patient's mother on 03-MAY-2006. It was reported that after continuing the work-up for previous/continuing gastrointestinal symptoms, the child was found to have a milk protein allergy and the bloody stools resolved on elemental formula. Hemoccult on 22-MAY-2006 was negative, and the patient was reported to have recovered that same day. No further information is available. This a follow-up to report(s) previously submitted on 5/16/2006; 5/26/2006; 6/6/2006.