Age: 1.58
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Febrile convulsion, Heart rate increased, Otitis media, Pyrexia, Respiratory rate increased
Clinical narrative: Initial report received from a health care professional on 06 June 2011. A 20-month-old female patient received an intramuscular thigh injection of FLUZONE, sanofi pasteur lot number U3788AA, and an intramuscular thigh injection of Hepatitis A vaccine, Merck lot number 1398Z, on 21 January 2011. The patient had a history of asthma. She was hospitalized at age 4 months for hematamosis no cause found. She was hospitalized on 22 February 2010 for urinary tract infection (UTI). She had no known allergies and took no other medications. It was not reported if the patient had any illnesses at the time of vaccination. The patient received on 08 October 2010 (dose 1) of FLUZONE, TRIPEDIA, ACTHIB and MMR. She required hospitalization for gastroenteritis and dehydration on 20 October 2010. The mother reported that the patient in the past had "minor" fevers associated with childhood vaccine series. The patient was seen in the Emergency Department (ED) on 22 February 2011 for a first diagnosis of unspecified otitis media (right otitis media) and the second diagnosis of febrile convulsions (simple), unspecified (febrile seizure). The patient started wheezing on Monday and saw her primary care physician on Tuesday where she was diagnosed with reactive airway disease. The patient had been given home nebulizer treatments since last night with no improvements per mother and also was on a steroid. On 09 March 2011, the patient was sent from the primary care physician to the hospital for evaluation for respiratory syncytial virus (RSV). On 09 March 2011, the patient presented to the hospital with wheezing. The current episode started 2 days ago and the problem occurred constantly but has gradually worsened. The patient had associated symptoms which include fever, coryza and cough. The mother felt that she was warm at home, though she was found afebrile in the hospital. The patient's pertinent negatives included no vomiting, no diarrhea, no ear pain, no rhinorrhea, no sore throat and no rash. She had tried beta-agonist inhaler for symptoms and the treatment provided no relief. Her current concomitant medications included albuterol (2.5 mg/3ml) 0.083% to be administered 2.5 mg by nebulization route once, oral ORAPRED PO, oral TYLENOL INFANTS PO take 0.8 mg by mouth and amoxicillin 250 mg/5ml PO SUSR take 0.75 tsp by mouth 3 times daily. She was slightly tachycardic and a little tachypneic. She received two treatments initially with albuterol and ATROVENT with the first treatment and then PULMICORT with the second treatment. Her respiratory rated and pulse rate increased to 62 respirations and a pulse of 137. Her pulse oximetry initially when she presented was 98% but went as low as 91%. It was noted that her respiratory rate did start to go down into the 20's. She also had her pacifier and was able to breathe with her pacifier. She was admitted to the pediatric unit for further work-up and evaluation and was in stable condition in no acute distress. Her vital signs were as follows: pulse 131, temperature 98.3 degrees Fahrenheit (axillary), respirations 30, weight 27 pounds 8 ounces, and pulse oximetry 97%. The patient had to following tests performed which were negative: resp sync rapid AG and nasal Methicillin-resistant Staphylococcus aureus test. The patient's chest x-ray on 09 March 2011 showed no pulmonary air space consolidating disease, pleural effusion or pneumothorax. Normal cardiomediastinal silhouette. Peribronchial thickening in parahiliar regions. These findings can occur with atypical pneumonia or asthma. The patient required azithromycin which was added the next day. The patient was also started on FLOVENT while in the hospital. She required oxygen for one night and was doing much better on the day of discharge. Her vital signs upon discharge were as follows: pulse 118, temperature 97.4, respiratory rate 20's and pulse oximetry 98%. Her lungs were clear to auscultation bilaterally. The patient was discharged from the hospital on 11 March 2011. The outcome was recovered on 11 March 2011. The patient had other SAE's captured in cases 2011-00986 and 2011-00987. Documents held by sender: None.