Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Acute Bronchitis Due to Respiratory Syncytial Virus; This 4-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-FEB-2019, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 01-FEB-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 01-FEB-2019, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular, right thigh) on 01-FEB-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 07-FEB-2019, 6 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed severe - grade 3 respiratory syncytial virus bronchitis (Verbatim: Acute Bronchitis Due to Respiratory Syncytial Virus). Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol) and paracetamol (Tylenol). The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory syncytial virus bronchitis was resolved on 11-FEB-2019. Relevant Tests: On 07-Feb-2019 Respiratory Syncytial viral swab (RSV PCR)-positive result (normal=reference) On 08-Feb-2019 Chest X-RayResult was no acute process identified.. Diagnostic results (reference ranges are provided in parenthesis if available): Chest X-ray-In FEB-2019 negative. Oxygen saturation- 08-FEB-2019 95 percent and in FEB-2019 on room air was 95-96 percent. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchitis 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 respiratory syncytial virus bronchitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK Receipt date : 11-FEB-2019 Subject was brought to the Emergency Department on 07-Feb-2019 for fever, cough, and shortness of breath. On physical examination subject was tachypneic, had subcostal retractions, and coarse breath sounds Subject was treated with albuterol and Tylenol and nasal suctioning was performed. Subject was discharged home with albuterol nebulizer treatments, Tylenol and nasal suctioning to be performed as needed. Subject was discharged in stable condition with the final diagnosis of 'RSV Bronchiolitis'. On 08-Feb-2019 subject was brought to a MD appointment with worsening cough, congestion, and difficulty breathing.Subject had increasing tachypnea and retractions. Parents were finding it increasingly difficult to perform nasal suctioning. Subject was admitted to the pediatric unit from the MD appointment on 08-Feb-2019 with increased workof breathing, increased nasal secretions, decreased oral intake, fever and diagnosis 'Acute Bronchiolitis due to RSV (respiratory syncytial virus) '. Subject's oxygen saturation remained stable on room air. During the hospital course the subject had frequent nasal suctioning and albuterol nebulizer treatments. Subject was discharged home on 09Feb2019 in stable condition. Per parent report on 11-Feb-2019 subject has completely recovered.There was another child at Daycare who was RSV (respiratory syncytial virus) positive. Follow up information received on 12-FEB-2025 Summary of changes : Unit for treatment medication Albuterol was updated from mg/ml to mg. Upon internal review case was updated on 14-FEB-2025 lab test Respiratory Syncytial viral swab and Chest X-RayResult was added in Relevant lab test. Lab test Chest X-ray, Oxygen saturation were coded in lab data and removed from narrative. Narrative updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchitis, 6 days after receiving the 2nd doses of Bexsero vs Placebo co-administered with PCV and routine vaccines, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, Hiberix and Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 4-month-old male subject. Report is inconsistent with causal relation to the vaccine products, considering the absence of biological plausibility. Causal relation is indeterminate considering insufficient definitive evidence for DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device causing the temporaly related AE.
Test Date: 201902; Test Name: Chest X-Ray; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20190208; Test Name: Oxygen saturation; Test Result: 95 %; Test Date: 201902; Test Name: Oxygen saturation; Result Unstructured Data: (Test Result:on room air was 95-96,Unit:percent,Normal Low:,Normal High:); Comments: On 07-Feb-2019 Respiratory Syncytial viral swab (RSV PCR)-positive result (normal=reference) On 08-Feb-2019 Chest X-RayResult was no acute process identified.