Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | — | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Urinary Tract Infection; This 9-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 06-APR-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 06-APR-2020, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 06-APR-2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (intramuscular) on 20-JAN-2020, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 13-JUL-2020 22:38, 98 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 175 days after receiving Rotarix lyophilized formulation, the subject developed severe urinary tract infection (Verbatim: Urinary Tract Infection). Serious criteria included hospitalization. The subject was treated with ondansetron, sodium chloride (Saline), ceftriaxone and cefalexin (Cephalexin). Bexsero vs Placebo was continued with no change. The outcome of urinary tract infection was resolved on 15-JUL-2020 12:54. The investigator considered that there was no reasonable possibility that the urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. GSK Receipt Date: 16-JUL-2020, 08-SEP-2020, 09-SEP-2020, 14-SEP-2020, 23-SEP-2020, 30-SEP-2020, 14-OCT-2020, On 07.16.20 at 14:20 the subject's parent called to report the following series of events: The subject's parent stated that on the morning of 07.13.20 the subject was quite fussy and seemed to be ill (the subject was vomiting and unable to hold down any liquids). The parents were worried about dehydration as well as a spell of altered consciousness, so they took the subject to the emergency room later that night at approximately 22:38. The subject was admitted to the hospital on 07.13.20. While in the hospital the subject received 2 boluses of IVF and one dose of an IV drip of Ceftriaxone. The subject improved and was discharged on 07.15.20 at approximately 12:54. The subject was discharged on Cephalexin 250mg/5mL oral liquid 4mL QID for 8 days. The subject was currently stated to be doing well. Updated per medical records received on 09.08.20. Updated comments per request: On hospital day 2 the subject began to tolerate PO diet and had adequate UOP but developed a fever with a max of 38.8C. Physical performed on 07.14.20. Vitals were normal as well as overall function of the body. T: 37.4C HR: 146 RR: 28 BP:125/87 SpO2: 96 percent WT:7.935kg Follow-up information received on 23-OCT-2024 Summary of changes: Events Dehydration, Vomiting Bile and Spell of altered consciousness were deleted and narrative updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number of Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV was updated from World-MKT to World-INV. 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 Urinary tract infection , 98 days after receiving the 3rd dose of Bexsero vs Placebo and DTPa-HBV-IPV and 175 days after receiving the 2nd dose of Rotarix lyophilized formulation, in a 9-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility .