Age: 0.51
Sex: F
Vaccine: 6VAX-F, PNC13, RVX
Symptoms: Skin warm, Specific gravity urine normal, Tachypnoea, Unresponsive to stimuli, Urine output decreased
Clinical narrative: Information has been received from an investigator concerning a 6 month old, female with congenital megaureter (22-OCT-2011) and gassiness (December 2011) who entered a study. Previous therapy history included ENGERIX-B on 23-OCT-2011. On 09-JAN-2012, the subject was consented and randomized to receive diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (+) Hib conj vaccine (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid at 2 months, 4 months, and 6 months of age. On 09-JAN-2012, 03-MAR-2012 and 26-APR-2012, the subject received the first, second and third dose respectively of IM 0.5 ml diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (+) Hib conj vaccine (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid. The subject was also vaccinated on 09-JAN-2012, 03-MAR-2012 and 26-APR-2012 with the first, second and third dose of IM 0.5 ml PREVENAR 13 and the first, second and third dose of oral 2.0 ROTATEQ as part of the study to complete childhood immunizations. There were no concomitant medications. There were no suspect therapy medications. Previously therapy included ENGERIX-B on 23 OCT-2011. On 29-APR-2012 the subject experienced bilateral pneumonia secondary to respiratory syncytial virus (severe intensity) and was hospitalized on the same day. On 28-APR-2012, the subject had a cough and runny nose. On 29-APR-2012, the subject was taken to the hospital via balance after being found with the following symptoms unresponsive, sweating, hot, eyes barely opening, limp with poor head control and dry diaper by subject's father at approximately 07:30. The subject was pink and had shallow rapid respirations (not reported as SAE/NSAE/symptom). The father reported that the subject developed a fever "overnight". In the ambulance the subject's temperature was 102F. In the emergency room fever was reported to be 101.2F. The subject received ROCEPHIN (Equivalent) 50 mg/kg bolus, 350 mg/3.5 ml IV, TYLENOL and a normal saline bolus (dose and route not reported). After receiving the bolus the subject had a "dirty bowel diaper" and started to urinate. The subject vomited twice after receiving TYLENOL. In the emergency room the subject had the following vital signs: Temp 101.7F, pulse 73, blood pressure 110's/70's, respirations 40 to 50, pulse oximetry 90% on room air and was 100% on 3L nasal cannula and weight was 7.11kg. Physical examination findings after subject received respiratory therapy (RT) albuterol 2.5 mg/0.5 ml, inhalation for bronchitis (determined to not meet SAE requirements) (29-APR-2012), were: chest had some supraclavicular retractions and abdominal breathing present, the work of breathing appeared mildly elevated, tachypnea was present but did have a regular rhythm, neurologically subject "looked normal" except for decreased head control, which was not expected. The admitting physician did not feel the chest x-ray excluded meningitis or encephalitis, therefore, the physician felt a lumbar puncture was necessary as the subject continued to have an altered mental status. The subject did receive an IV, ROCEPHIN and vancomycin (meningitis dose, actual dose not reported) prior to lumbar puncture. The subject was treated with the following therapies: acetaminophen drops 100 mg/1 ml ever four hours, as needed for fever and pain (29-APR-2012 to 30-APR-2012), RT levalbuterol inhalation solution 0.63 mg/3 ml every six hours for bronchospasm (not reported as SAE/NSAE/symptoms) (29-APR-2012 to 30-APR-2012), sodium chloride flush 2ml twice daily (29-APR-2012 to 02-MAY-2012), ibuprofen 70 mg/3.5 ml every six hours for fever (29-APR-2012 to 02-MAY-2012), JTIP lidocaine 1% 0.2 ml (xylocaine 1%) (EQ) (buffered)JTIP)) given as needed for venipuncture (30-APR-2012), ROCEPHIN (Equivalent) IV 350 mg/3.5 ml twice daily on 30-APR-2012 and once on 01-MAY-2012, vancomycin IV 100 mg/20 ml every six hours on 01-MAY-2012, Dextrose 5% and NACL 0.45% at 20 ml/hr (29-APR-2012). The subject had the following land and results: on 29-APR-2012, CT scan, axial imaging of brain without contrast, showed sinus disease as described, chest x-ray, PA and lateral view, showed bilateral perihilar pneumonia, chest x-ray, portable single view showed normal AP supine chest, urine macroscopic urinalysis showed trace protein and specific gravity 1.021, cerebrospinal fluid culture showed no growth, respiratory virus panel was positive for rhinovirus (NSAE) and positive for respiratory syncytial virus, WBC was 18, hematology-unknown 9.9, neutrophils 13, bands 11, lymphocyte 35m monocyte 24, polychromasia occasional, absolute monocyte cell count 4.32, sodium 148, chloride 116, carbon dioxide 17, BUN 29, glucose 52, calcium 7.5, CSF glucose 83, cell count CSF 613, microbiology blood culture #1 no growth after 12 hours and herpes simplex virus results unknown (previously no results at time of reporting) note in lab stated the following: this test was developed for its performance characteristics (as reported by the site); no results at time of reporting; 30-APR-2012, lymphocyte 73m polychromasia occasional, microcytes present, absolute monocyte cell count 1.47, sodium 141, potassium 3.5, carbon dioxide 20, BUN 1, creatine 0.16. On 02-MAY-2012, the subject was discharged from the hospital with a discharge diagnosis of pneumonia secondary to respiratory syncytial virus, sepsis (resolved 0n 02-MAY-2012) (NSAE) hypoxia (resolved on 08-MAY-2012) (NSAE) and dehydration (resolved on 08-MAY-2012) (NSAE). At discharge subject was given KEFLEX suspension 3ml oral (strength unknown) and VANTIN suspension 3.5ml (35mg) twice a day, oral, for four days. The subject was to follow-up with primary care physician, (date not reported). On 08-MAY-2012, the subject recovered from bilateral pneumonia secondary to respiratory syncytial virus. The action taken with study therapy was none. The reporting investigator considered that bilateral pneumonia, respiratory syncytial virus and sinusitis were "probably not related" to the following study vaccines given on 26-APR-2012 diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+)  Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) polio vaccine inactivated (Vero) (+) tetanus toxoid, PREVNAR 13 and ROTATEQ. On 08-MAY-2012, the subject was seen by her primary care physician for follow up regarding her emergency room visit (not further specified). At this visit, it was reported that all emergency room events both serious and non-serious adverse events (NSAE) were resolved. On 08-MAY-2012 during the visit, the primary care physician diagnosed the subject with acute bronchitis (NSAE). No treatment medications were prescribed. No labs and no procedures were performed for the acute bronchitis. The reporting investigator determined that sinusitis, previously reported as SAE, and did not meet SAE requirements. the investigator found it appropriate to change the 2 events, bilateral pneumonia and respiratory syncytial virus to one SAE of bilateral pneumonia secondary to respiratory syncytial virus. Follow-up information was received on 15-MAY-2012 from the investigator, the following fields were updated: source, AE information, AE/Therapy information, labs/diagnostics, episodes profile and narrative. Follow-up information was received on 18-JUN-2012 from the investigator. Follow-up information was received from the investigator on 29-JUN-2012, The following were updated: Labs/Diagnostics; stop dates of events; All events resolved and narrative update. Additional information has been requested.