Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Irritability, Laboratory test normal, Laparoscopic surgery, Lethargy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 30-NOV-2011, a 0.4 year old female with excessive and unusually crying after receiving the first dose of ROTATEQ (when patient was 0.17 year old) and with no relevant medical history was vaccinated orally with a second dose of ROTATEQ (Lot# reported as 0320AA). Suspect therapy included a second dose of RECOMBIVAX HB (Lot# 669934/0571AA) given intramuscularly in left arm. Concomitant therapy included PENTACEL (Lot# C3953AA) given intramuscularly in left arm and PREVNAR 13 (Lot# F16526) given intramuscularly in right leg. On 03-JAN-2012 the patient suddenly became lethargic in the morning, and was vomiting by afternoon. The patient was taken to Emergency Room and received an abdominal x-ray - nothing was found, sent home with viral diagnosis. The patient vomited most of the night, anti-nausea medication helped, however patient was very ill through the night. The following morning the patient presented with gooey bloody poop diaper, so was taken to Pediatrician immediately. The patient was admitted to hospital by late morning for possibly dehydration, and continued to vomit and be lethargic through the day. At around 11 pm, the patient was diagnosed with intussusception, a life threatening blockage of intestine. The patient was in surgery by 2 am, and had a somewhat slow 5 day recovery in the hospital. Hospital records received for DOS 04-JAN-2012 to 08-JAN-2012 with diagnosis: intussusception, laparoscopic reduction. 03-JAN-2012 the patient to ER complaining of vomiting and diarrhea. Exam unremarkable, diagnosis with viral gastroenteritis. Patient was back home, taken care and followed up instruction. 04-JAN-2012 the patient presented 36 hr bloody stool, vomiting, diarrhea, irritable, not eating well, pale, appeared to feel uncomfortable. Physical examination included lethargy, orange-red stool in diaper. Air enema unsuccessful at reduction, patient admitted. Laparoscopic reduction attempted, converted to open reduction and appendectomy. Patient's condition improved. Patient was back home, taken care and followed up instruction. The patient had completely recovered from intussusception. 20-JUN-2012 ER records received for DOS 03-JAN-2012 with diagnosis: vomiting alone. Patient complains of vomiting, more tired than usual, fussier than normal. PE: unremarkable. Patient was able to tolerate oral intake in ER. Patient was discharged home in stable condition with care and follow-up instructions. Lab diagnostic studies performed between 03-JAN-2012 to 08-JAN-2012 included: Abdominal X-ray within normal limits. Air enema abnormal. Hemoccult +. Blood: WBC 11.3 K/uL (H), RBC 4.9 M/uL (N), MCV 78.9 fl (L), MCH 25.8 pg (L), Plt 526 K/uL (H), neutrophils 68% (H). C Diff, campylobacter, stool culture, rotavirus, giardia (-). The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 455433-1. No further information is available.