Sex: F
Vaccine: FLUA4
Symptoms: Condition aggravated, Postoperative wound infection, Skin graft, Tendonitis, Tenoplasty
Clinical narrative: Worsening of Right Foot Tendonitis; This clinical trial case, initially received on 20-Aug-2024, with additional follow up on 21-Aug-2024 was reported by a health professional and concerns an adult female subject.  Weight: 75.7 kg; Height: 171 cm  The subject was enrolled in the study  Past medical history included Cholecystectomy, Cholelithiasis, Right Dislocated shoulder, Right shoulder bone spurs, Arthroscopic Shoulder surgery, Pinched Nerve in Neck, Cervical Foraminotomy, Pig Skin Xenograft, Hidradentis Suppurativa, Right Foot Tendon reconstruction, Right Foot Tendon reconstruction, Bilateral Tubal Ligation.  At the time of the event the subject had Acid Reflux, Postmenopausal, Tobacco Abuse, Urinary Incontinence, Mold Allergy, Dust Allergy, Right Foot Tendonitis, Depression, Bipolar disorder, Seasonal Allergies, Generalized osteoarthritis, Fibromyalgia, Post Traumatic Stress disorder.  Administration of company suspect drug: On 28-Nov-2023 11:39, the subject received aQIVc HD  vs QIVr vs aQIV for Influenza prophylaxis., dosage, 0.5 ml, Route of administration: Intramuscular.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 05-Jun-2024, the subject experienced Worsening of Right Foot Tendonitis (Hospitalized, outcome: Recovered / Resolved, stop date: 26-Aug-2024).  The subject stated they had a right foot reconstruction surgery done on 05-Jun-2024 and was discharged from the hospital on 07-Jun-2024. The subject states the wound became infected and broke open, so the subject had to have another surgery on 24-Jul-2024, where a skin graft was placed. The subject verbalized this was a same day surgery and they did not need to spend the night. The subject mentioned they started taking Hydrocodone/ Acetaminophen 5/325 mg PRN on 05-Jun-2024. The subject also mentioned they had a skin graft placed on 24-Jul-2024 and was going to have it removed on 19-Aug-2024. Subject has had right foot tendonitis ongoing since 1983, along with 2 other right foot reconstructions in 1983 and 2004. The subject stated nothing has been helping to fix it, but it is now resolved after his last reconstruction on 05-Jun-2024 and after the infection clean up on 24-Jul-2024.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Treatment medication: Hydrocodone/acetaminophen 1 DF As needed  Reporter's assessment: The investigator assessed the event  Worsening of Right Foot Tendonitis as moderate and serious due to seriousness criteria of Hospitalization and assessed the event as not related to the administration of the investigational drug and alternative cause of event was Musculoskeletal.  The subject remained blinded in the study.  Follow-up (26-Sep-2024) received from an Investigator: Alternative cause of event updated, narrative updated accordingly.  Follow-up (28-Sep-2024) received from  investigator: The event outcome was updated, event stop date provided. Fields and narrative updated.  Follow-up (26-Oct-2024) received from an Investigator. Query response received, Updated narrative accordingly; Reporter's Comments: Six months and 7 days after receiving the study vaccine (aQIVc HD vs QIVr vs aQIV), the subject experienced worsening of right foot tendonitis. The Sponsor agreed with Investigator's causality assessment and assessed the event as not related due to biological and chronological implausibility. The event is attributed to the natural progression of underlying condition. The subject had a past medical history of right foot tendonitis with multiple reconstructive surgeries. Listedness was assessed using IB version 4.