Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | IM |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | IM |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | UNK | IM |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM |
Pneumonia; Bronchiolitis; This 7-month-old male subject was enrolled in a study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 24-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 24-OCT-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 22-AUG-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 24-OCT-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 12-DEC-2019, 49 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 112 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 bronchiolitis (Verbatim: Bronchiolitis). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 pneumonia (Verbatim: Pneumonia) on 26-DEC-2019 with serious criteria of hospitalization. The subject was treated with amoxicillin. Bexsero vs Placebo was continued with no change. The outcome of bronchiolitis was resolved on 12-JAN-2020. The outcome(s) of the additional event(s) included pneumonia (resolved on 12-JAN-2020). Relevant Tests: On 25 DEC 2019, Respiratory Syncytial Virus was positive. On 27 DEC 2019, Chest X-Ray was and no information available about result. On 29 DEC 2019, Chest X-Ray was and no information available about result.. The investigator considered that there was no reasonable possibility that the bronchiolitis and pneumonia may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the bronchiolitis and pneumonia may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK Receipt date: 20-FEB-2020 Investigator text Mother called for safety follow up phone call 7 on 19FEB2020. She reported that the baby was hospitalized. Admission date 26DEC2019, Discharge date 28DEC2019. Mother was given call center phone advice for upper respiratory infection and fever starting on 12DEC2019. On 24DEC2019 the subject traveled for a one month family vacation. On 25DEC2019 the subject had an increase in fever and irritability. Baby was taken to a doctor where a test for RSV was done. Baby tested positive for Respiratory Syncytial Virus. Also diagnosed with Pneumonia. On 26DEC2019 the baby was hospitalized for Bronchiolitis. Treated with Amoxicillin antibiotic for 7 days. Mother reports the baby's symptoms resolved/recovered completely on 12JAN2020. SAE will be updated when more information becomes available. Records from Hospital in Brazil are not yet available. Follow up information received on 14-FEB-2025 Summary of changes: Added lab test (chest x-ray). Upon internal review, the case was updated on 17-Feb-2025: Seriousness GSK Medically Significant unticked for events pneumonia and bronchiolitis.; Sender's Comments: A case of Pneumonia and Bronchiolitis 49 days after receiving 3rd dose of Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Prevenar 13 and 112 days after receiving 2nd dose of Rotarix lyophilized formulation in a 7-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering an implausible time to onset and absence of biological plausibility and alternative etiology (Respiratory Syncytial Virus was positive) and alternative risk factor (Age).
Comments: On 25 DEC 2019, Respiratory Syncytial Virus was positive. On 27 DEC 2019, Chest X-Ray was and no information available about result. On 29 DEC 2019, Chest X-Ray was and no information available about result.