Age: 0.17
Sex: F
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Blood culture negative, C-reactive protein normal, Culture urine negative, Full blood count normal, Pyrexia
Clinical narrative: Information has been received from an investigator concerning an 8 week old female with gastrooesophageal reflux disease and a history of right lacrimal duct obstruction congenital and toxic erythema who entered a study. Previous vaccine history included 0.5 ml IM injection, one dose on 02-NOV-2011 of ENGERIX-B. On 03-Jan-2012 the subject was randomized to receive DTaP-HepB-Hib-IPV at 2 months, 4 months and 6 months. On 03-JAN-2012 the subject was vaccinated with the first in series of IM 0.5 ml (injection site not reported) DTaP-HepB-Hib-IPV. Additional vaccine therapy on 03-Jan-2012 included oral 2.0 ml ROTATEQ and IM 0.5 ml PREVNAR 13 as part of the childhood series. Concomitant therapy included TRI-VI-SOL. On 03-JAN-2012 the subject experienced fever (moderate intensity) and was hospitalized on 04-Jan-2012. The subject presented to the local ER on 03-JAN-2012 reporting a fever of 102.2 degrees Fahrenheit (previously unit of measure not provided) taken rectally at home. Temperature taken in the ER was 100.8 degrees Fahrenheit (previously unit of measure not reported) rectally after TYLENOL had been given at home. The subject was admitted for observation and to rule out infection only and discharged on the same day (04-Jan-2012) in stable condition, (previously reported as remained hospitalized at time of reporting). No medications given during hospitalization. The lab/diagnostic results (previously reported as unknown) revealed the following: 03-Jan-2012 urine culture negative, 03-Jan-2012 blood culture negative, 03-Jan-2012 urinalysis WBC 5-10 (units unknown), otherwise normal urine, on 03-Jan-2012 (day approximate) CBC negative and CRP normal. On 04-Jan-2012, lumbar puncture was attempted but was unsuccessful during hospitalization (date not reported). The action taken with the study vaccine therapy was none. On 04-JAN-2012, the fever resolved (previously at the time of initial reporting, the subject had not recovered from the fever). The subject was discharged from the hospital on 04-JAN-2012. The hospital discharge diagnosis was fever, no other etiology was determined for fever. No discharge summary was available as the hospitalization was for observation only. The history and physical were reviewed by the investigator and no other diagnosis was given other than fever. The reporting investigator considered that the fever was possibly related to all three study vaccines. Follow up information was received from the investigator on 06-Jan-2012 and the following fields were update: AE screen, episodes profile, lab/diagnostic screen and the narrative. Follow up information was received from the investigator on 10-Jan-2012 and the following fields were updated: episode profile and the narrative. Follow-up information was received on 12-JAN-2012 from the investigator. The following field was updated: narrative. Additional information is not expected. This is an amended report, it was requested to provide the relationship to ROTATEQ and Pneumococcal 13 as related.