Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood glucose increased, Blood sodium increased, Blood urine present, C-reactive protein increased, Clostridium difficile toxin test positive
Clinical narrative: Initial information received on 17 May 2007 from another manufacturer, report number WAES0703USA05645. This manufacturer had received the initial report from a nurse practitioner and a physician. Verbatim from report: "Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies, a cardiac murmur and with a history of fevers (on and off), jaundice neonatal and bronchitis who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and 655864/1082F, respectively). Concomitant vaccination on 01-NOV-2006 included: a second dose of Pediarix (lot # AC21B070AA), a second dose of Prevnar (B08683R) and a second dose of Prevnar (B08683R) and a second dose of ActHib 9lot # UE930AA). Concomitant vaccination on 09-JAN-2007 included: a third dose of Pediarix (lot # AC21B073AA), a third dose of Prevnar (B08670K) and a third dose of ActHib (lot # UE991AA). On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussuception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. A standard lot check investigation was performed. All in-process quality checks for the lot numbers in question (654352/0410F and 655864/1082F) were satisfactory. The lot met the requirements and was released. The physician indicated that the intussusception was not related to vaccination with Rotateq. Follow-up information medical records indicated that on 10-FEB-2007 the patient experienced nausea and vomiting. On 12-FEB-2007 the patient was taken to the clinic for evaluation and subsequently admitted to the hospital for IV hydration and further management with a diagnosis of acute gastroenteritis and mild dehydration. The patient was not able to hold any liquids down. The patient had lost 2 pounds. She was evaluated and CBC, chemistry and stool was ordered. Initially it was thought to be gastroenteritis so no other focus of infection except gastroenteritis was noted. The bowel sounds were audible. The patient was alert, well oriented and good capillary refill but mild signs of dehydration were seen so the decision was made to administer an IV saline bolus on admission and repeat another after a few hours. UA and urine culture was ordered. Patient's white cell count was 19.4, neutrophils 79%, bands 2, lymph 18 and mono 1. C-reactive protein was positive. The urine done showed specific gravity of 1.025 with a PH of 6. Leukocytes were 500. Ketones were 50. There was positive blood and WBCs. Urine culture had been set up and her electrolytes. Sodium was 145, potassium was 4.29, chloride was 109, glucose was 110 and Bicarb was 22. Alkaline phosphatase of 173, AST and ALT were well within normal limits. A stool specimen was obtained and it was sent out for stool culture, C.difficile. The patient was transferred to another office for a second opinion. It was reported that plain films of the abdomen were done and consistent with small bowel obstruction. The patient was diagnosed with incarcerated intussusception. A barium enema was obtained which demonstrated intussusception which could only be partially reduced. It was therefore elected to take the patient to the operating room for laparoscopic reduction of the intussusception. The surgery was performed on 14-FEB-2007. Additional information has been requested."