Age: 1.1
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Irritability, Listless, Neurological symptom, Pyrexia, Rash
Clinical narrative: Initial report received from health care professional on 17/Dec/2005 A 13-month-old female with no pre-existing medical history, had received a second dose injection, (route and site of administration not reported), of FLUZONE SV '2005-'2006 manufacturer Sanofi Pasteur, lot number U1761AA on 14/Dec/2005.  Within 24 hours, she experienced a fever of 104.9 and the 102.9 degrees Fahrenheit.  The event required a doctor's visit, and she was treated with Ibuprofen.  The patient had no focal or neurological problems.  She had no vomiting or rash.  Blood cultures were negative.  At the time of the initial report, the patient had not recovered.    Follow-up information received on 21/Mar/2006 from a health care provider  The second dose FLUZONE vaccination was administered in the right thigh.  The patient had reported that three hours hours later she developed a temperature of 104 degrees Fahrenheit and was irritable  The patient was examined by a physician two days post -vaccination on 16/Dec/2005 for acute onset of fever.  The patient had received Tylenol shortly before presenting to the clinic, and at that time, her temperature was 103.6,  On exam, she was slightly listless, apathetic with no respiratory distress.  Lab Tests performed on 16/Dec/2005 showed a cath UA that was negative.  CBC-white count 10.6 (differential: 14% bands, 56% segs, 2% eosinophils, 10% monocytes, and 8% lymphocytes), hemoglobin 12.3, hematocrit 35.9, and platelets 274,000.  The patient was administered Rocephin 500 mg, intramuscularly.   One 17/Dec/2005 the patient was again examined.  Her maximum temp since receiving Rocephin had been 102.8.  Mom states that her daughter has had increasing irritability over the past eight hours, but is drinking better.  She was given Motrin, last dose at 04:00.  She has not had any vomiting or diarrhea, and had good urine output.  No other family member has been ill.  Mother stated that the day prior after her daughter was given Motrin,she did standup but had a hard time walking.  She had not observed any seizure activity or focal neurologic symptoms.  No skin rashes were noted and no meningeal signs were demonstrated.  Oxygen saturation was 97% on room air and hear rate of 140 and BP 82/56.  On 17/Dec/2006 CRP was 2.5.  White count was 2500 with 42% lymphocytes, 36% segs, and 14% bands.  Platelet count was stable at 225.   Hemoglobin was 10.4 grams, SGPT was normal at 21 and SGOT elevated at 75.  Blood and urine cultures were negative after 24 hours, and throat cultures were negative after 48 hours.  Repeat Rocephin 500 mg. was administered intramuscularly. On 19/Dec/2005, the patient's fever had subsided.  She had developed a red macular rash which did blanche.  She is very alert and playful today.  Appetite is stable.  For the reporter, the working diagnosis was systemic viral infections with viral exanthema versus vaccine induced fever and rash.  At the time of this report, the patient had recovered from the events. Prior to these events on 10/Nov/2005, the patient had received an intramuscular injection of FLUZONE (dose one) lot number 01814AA in the left thigh Measles, Mumps, and Rubella (dose one), manufacturer, Merck, lot number 0625R in the left thigh.  Following these immunizations the patient had experienced loose stools and "low-grade temperatures for five days"  The reporter for this case is the same as for case 2005-02808