Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | SC / RA |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | UNK | IM / LL |
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | SC / LA |
septic arthritis due to kingella (left knee swelling, pain and joint effusion); This 12-month-old male subject was enrolled in a blinded study titled A Phase 3a, observer-blind, randomized, controlled study to evaluate the safety of an investigational varicella vaccine compared with Varivax, administered as a first dose to healthy children 12 to 15 months of age. The subject received the 1st dose of Varicella VNS vs Varivax (subcutaneous, left deltoid) on 05-SEP-2025 10:01, for prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) on 05-SEP-2025 10:04, for prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) on 05-SEP-2025 10:03, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) on 05-SEP-2025 10:04, for prophylaxis. Concomitant products included vancomycin, cefazolin (Cephazolin) and cefalexin (Cephalexin). On 22-SEP-2025, 17 days after receiving Varicella VNS vs Varivax, Hepatitis A vaccine, MMR vaccine and Prevnar 13, the subject developed severe - grade 3 septic arthritis (Verbatim: septic arthritis due to kingella (left knee swelling, pain and joint effusion)). Serious criteria included hospitalization. The subject was treated with paracetamol (Acetaminophen). The outcome of septic arthritis was resolved on 26-SEP-2025. Relevant Tests: On 22-SEP-2025, Imaging, including an ultrasound showed a complex, moderate-sized effusion in the left knee with surrounding hyperemia, which was concerning for a septic joint. In SEP-2025, X-rays of the left femur, tibia, and fibula on the same date confirmed a large knee joint effusion but showed no fracture or other osseous abnormalities.. Diagnostic results (reference ranges are provided in parenthesis if available): Blood creatinine- 22-SEP-2025 zero. C-reactive protein- 22-SEP-2025 4.5 mg/dL. Haemoglobin- 22-SEP-2025 12. Platelet count- 22-SEP-2025 442. Red blood cell count- 22-SEP-2025 4. Urine nitrogen- 22-SEP-2025 not reported. White blood cell count- 22-SEP-2025 10. The investigator considered that there was no reasonable possibility that the septic arthritis may have been caused by Varicella VNS vs Varivax, Hepatitis A vaccine, MMR vaccine and Prevnar 13. Other possible cause(s) of the septic arthritis included Hepatitis A vaccine PRE-FILLED SYRINGE DEVICE and MMR vaccine PRE-FILLED SYRINGE DEVICE. The company considered that there was no reasonable possibility that the septic arthritis may have been caused by Varicella VNS vs Varivax, Hepatitis A vaccine, MMR vaccine and Prevnar 13. Linked case(s) involving the same subject: US2025GSK127541 GSK Receipt date: 03-OCT-2025, 20-OCT-2025 Subject was admitted to hospital from (22-SEP-2025), to (26-SEP-2025) due to swelling of the left knee and an inability to bear weight on it. The subject was diagnosed with septic arthritis due to kingella kingae and underwent an incision and drainage procedure of the left knee. During the hospitalization, the subject received a variety of intravenous medications. Other medications used during the intervention included: acetaminophen (90 mg), bupivacaine (3 ml), and ketorolac. Upon discharge, subject was prescribed cephalexin oral suspension to be given at a dose of 9.5 ml by mouth three times daily for 11 days for a bone and/or joint infection. A follow-up appointment with infectious disease was scheduled for (06-oct-2025), at 8:30 am. The Regulatory Authority reported that there had been no complications since discharge and that the subject's mobility had improved. On 20-OCT-2025, case US2025GSK127541 was identified as duplicate of US2025136636. The case was US2025GSK127541 was prepared for deletion. All future correspondence will be added to the case US2025136636.; Sender's Comments: A case of Arthritis bacterial, 17 days after receiving 1st dose of Varicella VNS vs Varivax, 1st dose of Hepatitis A vaccine, 1st dose of MMR vaccine and 1st dose of Prevnar 13, in a 12-month-old male patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (Infectious etiology. Kingella kingae) based on medical history. US-GSK-US2025GSK127541:
Test Date: 20250922; Test Name: Clinical Chemistry - Creatinine; Result Unstructured Data: (Test Result:zero,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250922; Test Name: Clinical Chemistry - C Reactive Protein; Test Result: 4.5 mg/dl; Test Date: 20250922; Test Name: Hematology - Hemoglobin; Result Unstructured Data: (Test Result:12,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250922; Test Name: Hematology - Platelets; Result Unstructured Data: (Test Result:442,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250922; Test Name: Hematology - Erythrocytes; Result Unstructured Data: (Test Result:4,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250922; Test Name: Clinical Chemistry - Urea Nitrogen; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250922; Test Name: Hematology - Leukocytes; Result Unstructured Data: (Test Result:10,Unit:unknown,Normal Low:,Normal High:); Comments: On 22-SEP-2025, Imaging, including an ultrasound showed a complex, moderate-sized effusion in the left knee with surrounding hyperemia, which was concerning for a septic joint. In SEP-2025, X-rays of the left femur, tibia, and fibula on the same date confirmed a large knee joint effusion but showed no fracture or other osseous abnormalities.