Age: 2.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Red blood cell count normal, Red cell distribution width normal, Respiratory rate decreased, Streptococcal identification test negative, Tonsillar disorder
Clinical narrative: Information has been received from a nurse concerning a 24 month old male patient who on 12-JUN-2008 was vaccinated with a dose of VARIVAX 0.5 ml SQ lot# 659943/1800U.  On 20-JUN-2008 the patient developed a febrile seizure.  The patient turned blue and was transported to the emergency room.  An X Ray was done and it was positive for pneumonia.  The child was treated with ROCEPHIN.  The child was not hospitalized.  The nurse considered pneumonia and febrile seizure to be immediately life-threatening.  Follow-up information has been received from a nurse via medical records concerning this 24 month old male patient with no known pertinent medical history or drug reactions/allergies who on 12-JUN-2008 was vaccinated with a dose of VARIVAX (lot# 659943/1800U) 0.5 ml SQ in his right thigh.  On the morning of 20-JUN-2008 the patient was warm when waking up.  He was found to have a temperature of 102 F.  At 5:00pm, the patient was given some raisins while sitting on the floor.  All of a sudden, he was found in the frog position.  The patient was picked up by his parents who found he was a purplish color on the mouth and face and his eyes were rolling up.  His father did a finger sweep and didn't find any object in the mouth but the patient recovered in 2-3 minutes.  They did not witness the patient forward falling.  911 was called.  There was no witness of any shaking or seizure-like activities.  Squad measured the temperature was 104.  The parents took the patient to an emergency room.  Temperature is 101 F.  Heart rate 120 bpm.  Blood pressure is 126/79 mm Hg.  Respiratory rate is 24.  Satting was 100% on room air.  In the ER, neurologically the patient was alert.  He moved all extremities without difficulty and his behavior was age appropriate.  The patient underwent a chest x-ray which was notable for a scattered infiltrate in the right lung.  The patient was diagnosed with pneumonia.  A blood cell count was significant for a white count of 14, hemoglobin 12, hematocrit 37, and platelets of 294.  Rapid streptococcus blood and throat culture were also completed, which were both negative, also there was no growth after 5 days on a blood culture.  The patient had remained hemodynamically stable and very nontoxic appearing.  The patient received one shot of ROCEPHIN 300 mg IV and was sent to another hospital for further evaluation.  Immunization status is up to date per historian.  At the second hospital, the physical exam showed as follows:  BP 110/64 mm Hg, Pulse 126 bpm, Temperature 38.2 centigrade (100.8 F), Respiration rate 28 times.  Physical exam showed mild erythema at oropharynx with a small lesion on the left tonsil and focal lymphadenopathy on the left side of the neck.  The patient's breath sounds were clear and equal bilaterally, no respiratory distress.  At that time the patient was alert, with normal tone and no focal deficit.  On 20-JUN-2008 an X-ray was performed and indicated there were low lung volumes.  There was slight opacity in the right upper lobe which may be related to atelectasis.  Arterial blood oxygen saturation test was 97% on 21-JUN-2008.  The physician considered the fever most likely related to a viral infection and doubted aspiration based on the exam.  The patient was to be treated with MOTRIN and close outpatient follow-up.  The patient's parents were instructed to return if the child had any trouble breathing.  The patient was very well appearing at the time of discharge.  On 21-JUN-2008 the patient was discharged home.  No additional antibiotics were needed.  The patient was advised to have plenty of rest and fluids.  The patient was considered recovered.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the research center and was released.  Additional information is not expected.  All available medical records will be provided upon request.