Age: 1.24
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Gastroenteritis, Hypovolaemia, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received from an investigator concerning a 15 month old female who received her fourth dose of Prevnar on 1/14/02 as part of a trial. On 1/15/02, she was hospitalized for hypovolemia. She recovered. The investigator considers hypovolemia to be "possibly related" to the vaccine administration. The medical monitor's assessment is unknown.  Reported on 04/03/2003: "Additional information received on 03/24/2003 from an investigator provided additional event, description of the event, concomitant vaccines and test results.  Information has been received from an investigator concerning a 15-month-old female who received her fourth dose of Prevnar on 01/14/2002 as part of a trial.  Concomitant therapy included Hb0C and MMR vaccines.  On 01/15/2002, she was hospitalized for high fever and grunting respiration.  Chest X-ray showed subtle patchy consolidation in left lower lobe for impression of "probable left lower lobe pneumonia."  However, the discharge diagnosis was hypovolemia and acute gastroenteritis.  She recovered.  The investigator considered hypovolemia (not expected per the agency) and acute gastroenteritis (expected per the agency) to be "possibly related" to Prevnar administration.  The medical monitor's assessment was unknown.  Follow up on 08/09/04 states: "As a result of follow up information received from the investigator, this case has been reclassified as a serious, not related event. Follow up information included a final diagnosis of acute gastroenteritis and pneumonia, updated relatedness assessment, hospitalization details including further diagnosis tests and treatment and discharge information, treatment and follow up. Information has been received from an investigator concerning a 14 month old female, with a past history at 8 months of bilateral otitis medial who "examined well" at her well baby check on 01/14/02.  On the same day, she received her fourth dose of Prevnar, as part of the non-interventional post marketing safety surveillance trial. Concomitant therapy included Hib-Titer vaccine and MMR vaccine. On the night of 01/14/02 she began vomiting and did so approximately 15 times prompting her parents to bring her to the ER where IV fluids were administered and a CBC with manual differentiation was performed. The test revealed that her WBC count was elevated at 21.3K/ul, high segmented neutrophils 78% and low lymphocytes 17%. She was discharged to home. On the morning of 01/15/02, she continued to vomit 3 times without diarrhea. She was lethargic and had little interest in drinking and began to run a fever that reached a peak of 103 degrees Fahrenheit. She was brought back to clinic for evaluation, where she was referred to the ER due to her lethargy, "upper respiratory infection symptoms" and slight intermittent grunting. A chest x-ray was obtained which revealed a subtle patchy consolidation in left lower lobe for impression of "probable left lower lobe pneumonia." A urine specimen was obtained which revaled "many bacteria" on microscopic examination, but "none grew when cultured". The child was admitted to the hospital with a differential diagnosis of "fever, vomiting and pneumonia" versus "urinary tract infection", versus "viral etiology". During her hospitalization, there was "fever on and off, to a peak of 102.2 degrees Fahrenheit but no vomiting was noted.  She had no interest in drinking, some watery stools and good urinary output and although she was "fussy" she was consolable. Physical exam was reported as normal. Treatment included IV fluid, Ceftriaxone, and "fever management". A final diagnosis of "mild" viral acute gastroenteritis-positive fecal rotavirus and pneumonia was assigned.  The pt's discharge treatment included Amoxicillin 200mg twice a day for 10 days and to "push fluids". The pt was noted to be in "good condition" upon discharge from the hospital. After discharge, fecal studies were positive for rotavirus. The child was seen in clinic on 01/18/04 and diagnosed with acute gastroenteritis. There was no change in the pt's medication. The reporter indicated that the child made a "full recovery". The investigator(s) and medical monitors(s) considered gastroenteritis rotavirus and pneumonia not related to the study product."