Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Gastrointestinal tube insertion, Intussusception, Lethargy, Metabolic function test normal, Nasal congestion
Clinical narrative: Initial report received on 07 February 2007, from other manufacturer (under the reference number WAES0701USA04376). The other manufacturer received the initial information from the agency through another agency. A 17 week old male patient with no medical history or allergies who was born full term without any complications received on 18 October 2006 the following vaccines: first intramuscular dose of Daptacel (lot number unknown); first subcutaneous dose into the right thigh of IPOL (lot number 20420); first dose of Rotateq (lot number unknown); first dose of Comvax and Recombinant HB Vaccine, (lot number 654537/0500F) and first dose of Prevnar,(lot number unknown). There were no illnesses at the time of vaccination. On 11 December 2006, approximately 7 weeks post vaccination, the patient developed a small bowel obstruction possibly related to intussusception. On 11 December 2006, the patient presented to the emergency room via ambulance with the history of emesis which appeared to be bilious in nature and lethargy. He was given IV fluids in the field by paramedics and upon arrival to th emergency room appeared to be more alert and active. Her had no history of diarrhea and no previous history of fever. He had some mild nasal congestion a week or so prior to these episodes. In the emergency room he appeared to be well and not ill. A CBC at the time revealed a white count of 17.5 with 78 sega, 0 bands and the rest of the indices generally appeared to be normal. The patient was subsequently admitted for further examination. For several hours he continued to be tired and sleeping and did not nurse well. He was seen over the noon hour and he appeared non-toxic and afebrile with stable vital signs. His frontal was soft and the exam was generally otherwise unremarkable. Specifically, abdomen was soft and bowel sounds were somewhat hyperactive. No masses or hepatosplenomegly was palpated. He had a repeat KUB which revealed dome dilated small bowel loops but no free air and underwent a contrast enema x 2 and subsequent barium enema due to the possibility of intussusception. Films demonstrated a pattern of distended air filled small bowel that appeared without visible air in the colon on the plain film. According to radiology, contrast easily filled the large bowel and the appendix, but contrast could not be passed into the small bowel through the ileocecal valve. The contrast study of the colon demonstrated a normal colon including the position of the cecum and the appendix. There did not appear to suggest Hirschsprung's disease and the cecal position appeared to be normal. No specific mass effect was noted, however, given the results of this, there was concern for intussusception. He continued to have small episodes of emesis. The IV which had been placed in the emergency room infiltrated prior to the enema and he had undergone multiple attempts by anesthesia prior to the enema at this point, access remained limited. The patient had a bag specimen placed for urine which showed some leakage around the bag, but otherwise no specific urine output was noted since admission. The physician's impression was that the bag, but otherwise no specific urine output was noted since admission. The physician's impression was that the patient had an apparent small bowel obstruction with bilious emesis. Concern as to ongoing intussusception with unsuccessful reduction by enema. The patient was admitted to hospital. An upper GI with small bowel follow through was preformed which showed no malrotation, no intussusception and no volvulus. An NG was placed for decompression. By hospital day 2 the patient's abdominal exam was improved. It was soft, non-tender, non-distended and the NG was subsequently placed to gravity. He tolerated this well and was started on a general formula diet which he was taking in Ad Lib feeds currently at 3.5 ounces. After discussion the most reliable working diagnosis was that the patient had transient intussusception that was contrast enema. The patient was considered to be recovered. The patient was discharged on 13 December 2006. The patient's intussusception was considered to be another medical event.