Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal X-ray, Bacterial test positive, Bronchitis, Chest X-ray abnormal, Culture urine negative
Clinical narrative: A report has been received from a Physician concerning a 1 year old, Male subject, enrolled in a study. The patient's medical history included sensorineural hearing loss, acne vulgaris, otitis media serous, drug allergy, Down's syndrome, bronchomalacia, macroglossia, glossoptosis and ear canal stenosis. Study therapy with SYNAGIS was started on 14-Oct-2014 for Down's syndrome without congential heart disease (Remarkable macroglossia/glossoptosis and respiratory tract stenosis because of diseases included respiratory tract malacia). Co-suspect Influenza HA vaccine was started on 18-Nov-2014. The patient experienced pyrexia which started on 19-Dec-2014. The patient experienced pyrexia only once 3 days after he receiving influenza vaccination. The reporting physician did not know when the event resolved. No symptomatic treatment was given in response to the event. The patient experienced bronchitis on 25-Feb-2015. The patient had animated feeling. He had no conjunctival hyperaemia, slight pharynx redness, and no neck swelling. The lung was almost clear. The abdomen was soft and slightly red. There was no oedema. RSV Serology test was performed on 25-Feb-2015 and results were not reported. The patient experienced nasal discharge and common cold were started on an unknown date. The patient had a lot of nasal discharge and sputum but he did not experience pyrexia or diarrhoea. The reporting physician comment that the both external auditory meatus was narrow. The reporting physician considered that left sensorineural hearing loss was congenital disease that developed before initiation of SYNAGIS and did not aggravate after administration of SYNAGIS. Therefore this was not an adverse event. No tests were performed. Nasal discharge developed after last administration of SYNAGIS. Hospitalization reason was bronchitis. Hospitalized ward was General private room. Admission date was 25-Feb-2015. LRI score on admission: 1, LRI score on discharge: 0. Oxygen inhalation or artificial ventilation: No. 1st administration: Patient status: Outpatient, Body weight: 8.9 kg, Injection site: NR, LRI score: 0. 2nd administration: Patient status: Outpatient, Body weight: 9.2 kg, Injection site: NR, LRI score: 0. 3rd administration: Patient status: Outpatient, Body weight: 9.5 kg, Injection site: NR, LRI score: 0. 4th administration: Patient status: Outpatient, Body weight: 9.4 kg, Injection site: NR, LRI score: 0. 5th administration: Patient status: Outpatient, Body weight: 9.5 kg, Injection site: NR, LRI score: 0. 6th administration: Patient status: Outpatient, Body weight: 9.9 kg, Injection site: NR, LRI score: 0. The patient was treated with acetaminophen, levocetirizine hydrochloride and ketotifen fumarate. The administration of SYNAGIS was discontinued due to the patient's not returning to the clinic or changing the clinic. Action taken with the influenza vaccine was not applicable. The patient recovered from the event of pyrexia on an unknown date, the patient recovered from the event of bronchitis on 05-Mar-2015. At the time of reporting, the patient recovered from the event of nasal discharge on 10-Jul-2015 and the outcome of the event of common cold was unknown. The patient was discharge on 05-Mar-2015. Lab investigations were performed during 2015 and found to be as abdominal X-Ray showed bronchitis, Chest X-ray showed Bronchitis, General Bacteria identification test was performed which showed Oral Respiratory Tract was Negative, General Bacteria identification showed Oral Respiratory Tract 2+, General Bacteria Smear (Gram Stain) showed nasal Cavity 2+, General Bacteria Smear (Gram Stain) showed Pharynx negative. The Reporting physician assessed the serious criteria for the event of bronchitis was as follows: Hospitalized. The Reporting physician assessed the serious criteria for the events of nasal discharge, pyrexia, left sensorineural hearing loss and common cold as non-serious. The Reporting physician considered that there was a causal relationship between bronchitis and SYNAGIS and pyrexia and influenza HA vaccine. The Reporting physician considered that there was no causal relationship between nasal discharge and SYNAGIS, pyrexia and SYNAGIS. Based on the information in this report, and awaiting the reporting physician's assessment, the company physician considered the event of common cold to be unrelated to the SYNAGIS. Based on the information in this report, and awaiting the reporting physician's assessment, the company physician considered the events of nasal discharge, common cold and bronchitis to be unrelated to the Influenza HA vaccine. Summary of follow-up information received by AstraZeneca/MedImmune on 26-Nov-2015: Site confirmed that the event left sensorineural hearing loss was congenital disease that developed before initiation of SYNAGIS and did not aggravate after administration of SYNAGIS. Therefore this was not an adverse event. Event left sensorineural hearing loss was deleted. Removed the stop date of the event pyrexia. Updated the dosing regimen of the suspect drug Influenza HA vaccine. Updated the lab data information. Updated narrative.