Symptomtext
swelling in their left septic joint (knee).; swelling in their left septic joint (knee).; Initial information received on 23-Jan-2023 regarding an unsolicited valid serious case received from a nurse. This case involves a 10 months old male patient who had swelling in their left septic joint (knee) after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 19-Jan-2023, the patient received 0.25 ml(milliliter) (dose 2 ) (once) suspect influenza quadrival A-B multidose vaccine preserved, suspension for injection, (lot number: UJ899AB, expiry date:30-Jan-2023) via intramuscular route in the left thigh for Prophylactic vaccination (immunization). On 21-Jan-2023, the patient developed swelling in their left septic joint (knee) (arthritis bacterial) (joint swelling) (latency:2 days) following the administration of influenza quadrival A-B multidose vaccine preserved. It was reported that "The area was drained by an orthopedic in the hospital and the infectious disease team is involved". No lab data were reported. Action taken: not applicable. An infant received Antibiotics (intravenous) for both events as treatment. At time of reporting, the outcome was Unknown . Seriousness criteria: Medically significant for septic joint and its symptom.; Sender's Comments: Sanofi company comment dated 25-Jan-2023: This case involves a 10 months old male patient who had swelling in their left septic joint (knee) after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose].The time to onset was compatible with the role of vaccine. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based on information provided, the role of an individual vaccine cannot be assessed.