Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (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 / RL |
| 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 |
Respiratory syncytial virus; This 5-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (intramuscular) on 13th December 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 21st December 2018 00:01, 8 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed moderate - grade 2 respiratory syncytial virus infection. Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol Hfa), salbutamol (Albuterol) and acetaminophen. The outcome of respiratory syncytial virus infection was recovered/resolved on 31st December 2018 10:29. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Diagnostic results (unless otherwise stated, normal values were not provided): In December 2018, Chest X-ray result was no focal infiltrate and Urine analysis result was no significant results. GSK Receipt Date - 31-DEC-2018 Subject was taken to the local ED on 12/25/2018 for worsening coughing symptoms (which began on 12/21/2018). Local ED discharged patient home on 12/25/2018 with acute bronchiolitis. Patient returned to ED on 12/27/2018 and was diagnosed with acute bronchiolitis and discharged home (did not receive any medications). Patient returned to local ED on 12/30/2018 where patient was transferred to hospital and admitted for RSV bronchiolitis and monitoring. SAE paperwork has been completed and a follow up call is scheduled for later this week per study requirements. Patient was treated for RSV with albuterol inpatient. No other medications or treatment given except for supportive care. Patient discharged following day and requested to return to primary care for continuing followup. The Investigator reported the SAE as Respiratory syncytial virus. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus infection, 8 days after receiving the 2nd doses of Bexsero vs Placebo, 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 5-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering the absence of biological plausibility.
Test Date: 201812; Test Name: Chest X-ray; Result Unstructured Data: (Test Result:no focal infiltrate,Unit:unknown,Normal Low:,Normal High:); Test Date: 201812; Test Name: Urine analysis; Result Unstructured Data: (Test Result:no significant results,Unit:unknown,Normal Low:,Normal High:)