Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: White blood cell count increased, X-ray gastrointestinal tract normal
Clinical narrative: Initial report received from another manufacturer (WAES0807USA02517) who received the information on request from the FDA (VAERS ID # 306668) under the Freedom of Information Act. The original reporting source was not provided. Verbatim from report: "A 4 month old male with a history of respiratory tract infection which was improving on antibiotic therapy who on 22-FEB-2008 was vaccinated with the second dose of oral ROTATEQ (659820/1665U). Suspect therapy included the second dose of COMVAX (653773/0197F), IM in the right leg. Concomitant therapy included the second dose of IPOL (UNKNOWN MANUFACTURER) (Lot # A0125-2), IM in the left leg, the second dose of DAPTACEL (SANOFI PASTEUR) (Lot # C2760AA), IM in the right leg and the second dose of PREVNAR (WYETH) (Lot # B5401SC), IM in the left leg. On 03-MAR-2008 the patient experienced abdominal mass, abdominal tenderness, barium enema, decreased activity, dehydration, diarrhea, hematochezia, intussusception, irritability, laparoscopy, small intestinal intussusception reduction, somnolence and vomiting and was hospitalized on 05-MAR-2008. 07-APR-2008 MR received for DOS 05-MAR-2008 to 07-MAR-2008 with a discharge diagnosis of intussusception and laparoscopic reduction of intussusception. The patient presented to the hospital with bilious vomiting, one bout of hematochezia, decreased activity; and he was very sleepy. The patient was recovering from a recent respiratory infection which was improving on antibiotics. Physical examination was positive for palpable bowel loop in RLQ, positive abdominal tenderness, mild moderately dehydrated and fussy. A barium enema revealed intussusception but it was reported that they were unable to reduce in radiology, so the patient was taken to the operating room for surgical laparoscopic reduction of IS. A small serosal tear was identified on the ileum. The patient tolerated surgery well and was discharged on POD# 2. KUB showed distended loop of small bowel and upper GI was WNL. Labs included CBC with WBCs of 22.2, RBC 4.97 and Hct 39.4. The original reporting source was not provided. The VAERS ID # is 306668." Additional information was obtained on 22 July 2008 from a search of the VAERS database for VAERS ID # 306668. The patient had received on 22 February 2008 a second intramuscular right leg injection of DAPTACEL (lot # C2760AA); a second intramuscular left leg injection of IPOL (lot # A0125 which is Sanofi Pasteur lot number A0125-2); a second intramuscular right leg injection of COMVAX (manufacturer Merck, lot # 653773/0197F); a second intramuscular left leg injection of PREVNAR (manufacturer Wyeth, lot # B5401SC); and a second dose oral dose of ROTATEQ (manufacturer Merck, lot # 659852/1665U). On 03 March 2008, i.e., 10 days post-vaccination, the patient developed vomiting and diarrhea and was subsequently admitted to hospital two days later on 05 March 2008. The patient, who was recovering from a recent respiratory infection which was improving on antibiotics, presented to the hospital with bilious vomiting and one bout of hematochezia. He was fussy, very sleepy and had decreased activity. Physical examination revealed palpable bowel loop in the right lower quadrant, abdominal tenderness, and mild to moderate dehydration. A KUB revealed distended loop of the small bowel, and an upper GI was within normal limits. A Complete Blood Count revealed white blood cells 22.2, red blood cells 4.97, and hematocrit 39.4. A barium enema was completed and revealed intussusception. An attempt to reduce the intussusception in radiology was unsuccessful. The patient was subsequently taken to the operating room for surgical laparoscopic reduction of the intussusception. During the procedure, a small serosal tear was identified on the terminal ileum. The patient tolerated the surgery well; and was discharged two days after admission on 07 March 2008. At the time of this report, the patient had recovered.