Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Alanine aminotransferase normal, Allergic colitis, Anion gap increased, Aspartate aminotransferase increased, Bilirubin conjugated increased
Clinical narrative: Initial report received on 12 October 2009 from another manufacturer (report number WAES 0908USA02573) who received the original report from a nurse. The following is verbatim from that report. "Information has been received from a nurse practitioner concerning an 87 day old fed male who on 08-JUN-2009 was vaccinated with the first dose of ROTATEQ (lot # not provided) orally. On the same day the patient experienced fever and discolored stool. On 13-JUL-2009, he was administered the second dose (lot # not provided) orally. On 24-JUL-2009 the patient experienced blood in stool on two occasions including clumps and streaks. The third dose was not given. Concomitant medication included "additional required vaccines". A culture was done and no bacteria were found. Blood work also came back normal. After stopping therapy, adverse events improved. The patient sought unspecified medical attention. As of 06-AUG-2009 the patient was believed to be recovering". "Follow-up information has been received from a nurse practitioner through a telephone call indicated that the patient did not receive concomitant vaccinations when ROTATEQ was administered. On 08-JUN-2009, the patient had discolored, green blood and mucus in the stools. The patient did not have any other symptoms. No treatment was given. The reporter felt that the patient had allergic colitic and she felt that possibly the patient's blood and mucus in the stools was food related. The nurse switched the patient's formula to NUTRAMIGEN. The patient's mother stated that she had a food allergy when she was an infant. At the time of reporting, the outcome was not reported". "Follow-up information has been received from a nurse practitioner through a telephone call indicating that the patient's birth day was 13-MAR-2009 (not 13-APR-2009 as previously reported). The patient received the first dose of ROTATEQ (lot 663359/1661X0 on 13-MAY-2009 (previously reported as 08-JUN-2009), and the second dose on 14-JUL-2009 (previously reported as 13-JUL-2009)". Follow-up information has been received from a registered nurse indicating that the male patient's suspected therapy included DAPTACEL, ACTHIB, IPOL and PREVENAR. Per his nurse practitioner, " the patient diagnosed with milk and soy allergies and colitis on 24-AUG-2009. The patient's formula was switched to MUTRAMIGEN. The patient's bloody stool stopped and he was doing well now". There was no illness at time of vaccination. Lab test included shiga toxin test which was negative. Culture result showed no salmonella, shigella, campylobacter, Plesiomonas or aeromonas isolated. Culture also showed negative for predominant amounts of staphylococcus aureus, pseudomonas aeruginosa and yeast. Serum test showed potassium 7.8 mmol/l, carbon dioxide 20 mmol/l, anion gap 21 mmol/l, alkaline phosphatase 147U/L, AST 62U/L, direct serum bilirubin 0.4mg/ml which were not in the normal range. On an unspecified date the patient recovered. Upon internal review, blood in stool was considered to be another important medical event. No further information is available". It is noted the patient's date of birth was on 13 March 2009 and he was four months old (which is 131 days) at the time of onset of serious adverse events which started on 22 July 2009. It is also noted that ACTHIB (lot number UF607AB, Sanofi Pasteur SA lot number B0624-1), DAPTACEL (lot number C3082AA) and IPOL (lot number B10902) were the second doses received on 14 July 2009. Documents held by sender: None