Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Abdominal distension, Chest X-ray abnormal, Enterovirus infection, Enterovirus test positive
Clinical narrative: This 5-month-old male subject was enrolled in an open label study. The subject received the 2nd dose of Rotavirus vaccine lyophilized formulation (oral) 1 ml on 5th December 2017. The subject received the 2nd dose of DTPa-HBV-IPV vaccine (intramuscular) .5 ml on 5th December 2017. The subject received the 2nd dose of Hib vaccine (intramuscular) .5 ml on 5th December 2017. The subject received the 2nd dose of PREVENAR 13 (intramuscular) .5 ml on 5th December 2017. On 21st January 2018, 47 days after receiving Rotavirus vaccine lyophilized formulation, DTPa-HBV-IPV vaccine, Hib vaccine and PREVENAR 13, the subject developed mild - grade 1 abdominal distension. Serious criteria included hospitalization. Additional event(s) included mild - grade 1 rhinovirus infection on 21st January 2018 with serious criteria of hospitalization and mild - grade 1 enterovirus infection on 21st January 2018 with serious criteria of hospitalization and GSK medically significant. The subject was treated with ampicillin. DTPa-HBV-IPV vaccine was continued with no change. Hib vaccine was continued with no change. PREVENAR 13 was continued with no change. The outcome of abdominal distension was recovered/resolved on 22nd January 2018 12:38. The outcome(s) of the additional event(s) included rhinovirus infection (recovered/resolved on 26th January 2018 23:00) and enterovirus infection (recovered/resolved on 26th January 2018 23:00). The investigator considered that there was a reasonable possibility that the abdominal distension may have been caused by Rotavirus vaccine lyophilized formulation. The investigator considered that there was no reasonable possibility that the rhinovirus infection and enterovirus infection may have been caused by Rotavirus vaccine lyophilized formulation, DTPa-HBV-IPV vaccine, Hib vaccine and PREVENAR 13. The investigator considered that there was no reasonable possibility that the abdominal distention may have been caused by DTPa-HBV-IPV vaccine, Hib vaccine and PREVENAR 13. Relevant Tests: CXR 1/21/2018 AM: Bilateral perihilar consolidation, left great than right, findings suspicious for pneumonia. ABD 1/21/2018 AM: Colonic distention secondary to large amount of stool at the rectal vault. CXR Comparison 1/21/2018 at 0520 Hrs: Diminished perihilar patchy opacities are seen, left more than right. Diagnostic results (unless otherwise stated, normal values were not provided): On 21st January 2018, Abdominal X-ray result was see text, Abdominal X-ray result was normal, Chest X-ray result was see text, Chest X-ray result was see text, Enterovirus test result was positive, Human rhinovirus test result was positive and Oxygen saturation result was 88%. Investigator text: Subject presented at ER on 1/21/2018 with cough and abdominal distention with sick siblings at home. Abdominal xray showed colonic distention secondary to large amount of stool at the rectal vault. Surgery was contacted for concern for obstruction while subject was in the ER. Subject was transferred to a nearby hospital for further evaluation. Surgery evaluated subject as had a large stool, abdominal distention resolved, and well. Initial imaging CXR, there was concern for bilateral perihilar consolidation, left greater than right. Findings are suspicious for pneumonia. Subject was treated with 1 dose of Ampicillin. While overnight in the ED patient has desaturation to 88%. Follow up Abdominal Xray was normal which was completed on 01/21/2018. Subject tested positive on 01/21/2018 for rhino/enterovirus infection. Patient was tolerating regular diet and remained well-saturated. The hospital who admitted the subject stated in their report that the 1st hospital who transferred the subject for their initial concern for pneumonia, however upon the hospital review of the chest xray it's more consistent with viral process. Patient was discharge on 01/22/2018. Discharge Diagnosis: Rhino/Enterovirus Lower respiratory tract infection and Follow up with PCP in one week. Confirmed at today's visit by dad that symptoms did not start until around 1:00 AM on 21Jan2018. Dad states patient was feeling better and back to himself by Friday 26Jan2018. Follow up information received on 18 Apr 2018: Per discussion with PI on 18April2018: The cause is unknown but there is a possibility that the Abdominal Distension was caused by the HRV.