Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Leukocytosis, Lipase normal, Metabolic function test, Neutrophil count, Otitis media
Clinical narrative: Initial report and medical records were received on 18 November 2008 and 20 November 2008 from an investigator participating in a trial. A five-year-old male patient was hospitalized on 28 September 2008 with chief complaint of fever of unknown origin and sickle cell anemia five days after he had received MENACTRA, lot number not reported. Prior to this hospitalization, the subject had been diagnosed with croup on 18 September 2008 following a two day history of cough with no fever. The patient had been taking PEN-V-K 250 mg and folate 1mg concomitantly at the time of vaccination. On 28 September 2008, five days after receiving the vaccine, the subject presented to the emergency room with sickle cell disease and a two week history of URI (upper respiratory infection) symptoms of cough and runny nose, and a one day history of fever. The subject was subsequently admitted. HIs parents noted that at 4pm the day before, he had a temperature of 100.4 degrees Fahrenheit and seemed more tired than usual. By the afternoon on the day of admission, his fever was 101.5 degrees Fahrenheit. His mother phoned the heme/onc clinic and brought the subject to the emergency room. The subject also complained of abdominal pain in the left upper quadrant (LUQ). According to his mother, he had been doing well at home, eating, drinking, urinating, interacting as normal. No vomiting, diarrhea or dizziness. He also had six month old sibling (brother) sick at home with a five day history of upper respiratory infection, no fever. Chest x-ray results were normal. Laboratory results: Chem7: 139/4.7/102/22/10/.39<94. CBC: 33.2 >6.9<393, 72N, 19L, 6M. LFT's: AST 24, AlkPhos 154, Lipase 93, Tbili 2.4. Retic count: 15.4%, Tbili. Blood culture results were pending and he received 1g ceftriaxone. Physical examination: temp 102.6, respiration 18, heart rate 123, BP 112/52, oxygen sat 92%, room air, up to 93-96% on subsequent observations. No rhinorrhea. Oropharynx clear, moist mucous membranes-pink, tympanic membranes within normal limits. Respiratory, abdominal, dermatological, neurological findings were all within normal limits; extremities were warm, well perfused with no cyanosis/clubbing/edema x4. Genitourinary: deferred. The medical records assessment noted the patient presented with fever, leukocytosis, borderline hypoxia, and anemia; suspect infectious trigger for splenic sequestration of RBC's, hemolysis with appropriate marrow response, slightly impaired oxygenation. Management was planned to consist of searching for infectious etiology, empiric antibiotic coverage, transfusions to keep hemoglobin from dropping further, supplemental oxygen to optimize comfort while not impairing RBC production with artificially normal saturation, monitoring for dire effects of sickle cell sequelae (sludging/infarcts/strokes/acute chest/etc), and providing environment for this patient to regain his hematological homeostatis. Treatment planned: Access - PIV, Fluids: D51/4NS, Diet: regular. HEME/ID: Impressive leukocytosis, diff somewhat suggestive of bacterial etiology. Continue to cover with ceftriaxone and modify as necessary. Currently not suspicious of meningitic/encephalitic picture. Planned to begin transfusion with packed RBCs as soon as blood products delivered; and to repeat CBC and retic count. The subject was discharged on 29 September 2008. The subject was seen for a re-check evaluation on 21 October 2008. Following his discharge from the hospital on 29 September 2008, the subject remained afebrile with no respiratory symptoms except for an occasional cough. Review of systems during this visit were positive for cough, and a grade II/VI systolic murmur. Assessment: Sickle Disease - SS resolution of lab abnormalities noted on hospitalization. Medical records indicated the subject had a history of four previous hospitalizations for fever; on 04 March 2007, 16 March 2008, 11 May 2008, and 07 July 2008 respectively. Following the hospitalization on 04 March 2007, the subject had been diagnosed with bilateral otitis media soon after he was admitted. According to the investigator, the event of fever of unknown origin and sickle cell anemia were considered to be potentially related to the study vaccine and the subject's recovery status was not reported. Documents held by sender: Medical Records.