Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | PO / MO |
Respiratory Syncytial virus; This 4-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 10-AUG-2022, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, left thigh) on 10-AUG-2022, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 10-AUG-2022, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 10-AUG-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 25-OCT-2022, 76 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed severe - grade 3 respiratory syncytial virus infection (Verbatim: Respiratory Syncytial virus). Serious criteria included hospitalization. The subject was treated with ibuprofen (Motrin), paracetamol (Tylenol) and oxygen. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory syncytial virus infection was resolved on 01-NOV-2022. Diagnostic results (reference ranges are provided in parenthesis if available): Polymerase chain reaction- 28-OCT-2022 Positive RSV detected (0.00-0.00). The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection 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 infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK receipt date: 03-NOV-2022 Subject was diagnosed with adenovirus, bronchiolitis, and rhinovirus infection. Subject was primarily treated for RSV. s/s of adenovirus, bronchiolitis, and rhinovirus were the same as RSV, with same start and stop date. Adenovirus, bronchiolitis, and Rhinovirus were diagnosed on 26Oct2022 hospital admit date 28Oct2022 hospital discharge date 01Nov2022. Follow-up information received on 10-FEB-2023, 14-FEB-2023. The case was amended on 17FEB2023: The (Product tab) was amended from (Concomitant vaccine added). Summary of changes: Investigator text updated, Lab details updated, treatment medication updated, concomitant vaccines added Follow-up information received on 23-FEB-2023 Summary of changes: Investigator text updated Follow-up information received on 26-APR-2023 and 04-MAY-2023. Co-suspect products include 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. Summary of changes: Treatment medication Dose and unit updated. Follow-up information received on 15-JUN-2023. Summary of changes: General narrative comment updated. Follow-up information received on 03-JUL-2023 Summary of changes: Frequency of Treatment drugs (motrin, Tylenol) updated. Follow-up information received on 29-MAY-2024 Summary of changes: General narrative comments were updated. Follow-up information received on 30-DEC-2024 The subject received Treatment medication oxygen high flow(dosage regimen of 28-OCT-2022) and oxygen Nasal canula(dosage regimen of 28-OCT-2022 to 01-NOV-2022) Summary of changes: Treatment medication name updated from oxygen 15L Nasal canula to oxygen Nasal canula Follow-up information received on 07-JAN-2025 Summary of changes: Treatment medication name updated from oxygen 8L high flow to oxygen high flowalso narrative was updated. Upon internal review the case was updated on 08-JAN-2025, Action taken changes from not applicable to no change for DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevenar 13. Follow-up information received on 09-JAN-2025 Summary of changes: Action taken with study drug was updated from Not applicable to no change and narrative was updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number was updated from World-MKT to World-INV for DTPa-HBV-IPV. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Respiratory syncytial virus infection ,76 days after receiving 1st dose of Bexsero vs Placebo, 1st dose of Prevnar 13, 1st dose of Hiberix, 1st dose of DTPa-HBV-IPV, 1st dose of Rotarix lyophilized formulation in a 4-month-old male subject. Report is inconsistent with causal relation to the vaccine product ,considering implausible time to onset and alternative risk factors (Subject was diagnosed with adenovirus, bronchiolitis, and rhinovirus infection) based on medical history.
Test Date: 20221028; Test Name: Polymerase Chain Reaction; Result Unstructured Data: (Test Result:Positive RSV detected,Unit:unknown,Normal Low:0.00,Normal High:0.00)