Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Blood electrolytes normal, Body temperature decreased, Chest X-ray normal, Enterovirus infection, Enterovirus test positive
Clinical narrative: Enterovirus/Rhinovirus Infection; Enterovirus/Rhinovirus Infection; This 5-month-old female subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular, right thigh) on 06-JAN-2020, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 06-JAN-2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 06-JAN-2020, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular, right thigh) on 06-JAN-2020, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular, left thigh) on 06-JAN-2020, for prophylaxis.   On 23-FEB-2020, 48 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13, the subject developed severe - grade 3 enterovirus infection (Verbatim: Enterovirus/Rhinovirus Infection). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 rhinovirus infection (Verbatim: Enterovirus/Rhinovirus Infection) on 23-FEB-2020 with serious criteria of hospitalization. Bexsero vs Placebo was continued with no change. Hiberix was continued with no change. Prevnar 13 was continued with no change. The outcome of enterovirus infection was resolved on 24-FEB-2020. The outcome(s) of the additional event(s) included rhinovirus infection (resolved on 24-FEB-2020).   Relevant Tests: On an unknown date in Feb 2020, Sepsis work-up showed leukocytosis, normal electrolyte. and Respiratory virus panel was performed and the result was Positive for Enterovirus/rhinovirus RNA. On 23-FEB-2024 Chest X-Ray (chest Frontal) was performed and the result was Negative (chest Frontal) On an unknown date in Feb 2020, PCR (Polymerase chain reaction) was performed and the result was not provided.   Diagnostic results (reference ranges are provided in parenthesis if available): Body temperature- 23-FEB-2020 94.6  and 23-FEB-2020 94.2 . Lymphocyte count- 23-FEB-2020 85 (30.00-69.00). Mean cell volume- 23-FEB-2020 82 (84.00-106.00). Neutrophil count- 23-FEB-2020 9 (22.00-61.00). Platelet count- 23-FEB-2020 506 (140.00-400.00). Red cell distribution width- 23-FEB-2020 11.8 (12.00-16.50). White blood cell count- 23-FEB-2020 19.4 (6.00-17.00).                                                                                                     The investigator considered that there was no reasonable possibility that the enterovirus infection and rhinovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13.   The company considered that there was no reasonable possibility that the enterovirus infection and rhinovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13.   GSK receipt date was 29-OCT-2024  Admitted to Hospital 23FEB2020. Discharge from Hospital 24FEB2020. 1 Day onset (start 23FEB2020) of emesis and temp 94.6 rectal at home. Came to Emergency Department, temp 94.2 vitals otherwise normal and well appearing. Sepsis work-up showed leukocytosis, normal electrolyte. Chest x-ray normal. Following admission patient remained normothermic, emesis resolved. Discharged home 24FEB2020. Phone mom on 04MAR2020, Well Baby.  Follow up information received on 29-OCT-2024 Summery of changes: Hypothermia event removed and event vommiting updated to Enterovirus/Rhinovirus Infection, Narrative was updated.  Upon internal review the case was updated on 12-NOV-2024 Action taken for Bexsero vs Placebo was changed from Not applicable to No change and narrative was updated.  Upon internal review the case was updated on 26-DEC-2024 Causality updated from no to unknown for device and labs updated from narrative to lab data. Duplicate information removed from narrative.; Sender's Comments: A case of Enterovirus infection and Rhinovirus infection, 48 days after receiving 2nd dose of Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation ,Hiberix and Prevnar 13, in a 5-month-old female subject.  Report is inconsistent with causal relation to the vaccine product, considering  implausible time to onset, absence of biological plausibility and alternative etiology (Respiratory virus panel was Positive for Enterovirus/rhinovirus RNA).