Report #2832105

Overview

Sex

Male

Age

0.3 yrs

State

—

Recovered

Recovered

Vaccinated

Jan 17, 2019

Onset

Feb 2, 2019

Days to onset

16

Hospital days

4

Symptoms (5)

Symptom narrative

RSV bronchiolitis; This 4-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 17-JAN-2019, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 17-JAN-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 17-JAN-2019, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular, right thigh) on 17-JAN-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 02-FEB-2019, 16 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed severe - grade 3 respiratory syncytial virus bronchiolitis (Verbatim: RSV bronchiolitis). Serious criteria included hospitalization and GSK medically significant. The subject was treated with salbutamol (Albuterol), prednisolone sodium phosphate (Orapred), methylprednisolone and glucose;potassium chloride;sodium chloride. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory syncytial virus bronchiolitis was resolved on 11-FEB-2019. Relevant Tests: On 04-FEB2-019 Chest X-ray showed negative results. On 04-FEB-2019 Viral PCR(polymerase chain reaction) Panel was positive for RSV(Respiratory syncytial virus) and adenovirus.. Diagnostic results (reference ranges are provided in parenthesis if available): Oxygen saturation- 04-FEB-2019 96 percent. Respiratory rate- 04-FEB-2019 66. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis 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 bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV,Rotarix lyophilized formulation and Hiberix. GSK Receipt date : 04-FEB-2019 Subject was a direct admit to hospital from office on 04-FEB-2019 with 2 days of wheezing and worsening respiratory status with respiratory rate of 66 and oxygen saturation of 96 percent. In hospital, subject responded well to albuterol and IV steroids and never had an oxygen requirement. As his respiratory status improved, he was weaned off IV fluids for nutritional support and discharged home on 08-FEB2-019 with diagnosis of RSV Bronchiolitis. Subject was stable at office follow up on 11-FEB-2019. Medication name was reported as D5 1/2 NS with 20 mEq KCl Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchiolitis, 16 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.

Lab data

Test Date: 20190204; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20190204; Test Name: respiratory rate; Result Unstructured Data: (Test Result:66,Unit:unknown,Normal Low:,Normal High:); Comments: On 04-FEB2-019 Chest X-ray showed negative results. On 04-FEB-2019 Viral PCR(polymerase chain reaction) Panel was positive for RSV(Respiratory syncytial virus) and adenovirus.