Sex: M
Vaccine: COVID19, FLU4
Symptoms: Skin ulcer, Wound
Clinical narrative: very painful; sores; prone to infection; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; Rash vesicular/Blistery rash; rash; WOUND; This non-serious case was reported by a consumer via regulatory authority and described the occurrence of loss of personal independence in daily activities in a 33-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) for prophylaxis.   Co-suspect products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for prophylaxis.   The patient's past medical history included generalized anxiety disorder, post-traumatic stress disorder, post-acute covid-19 syndrome and major depressive disorder. Concurrent medical conditions included drug allergy (allergy to cehlore, gabapentin, propanalol). Concomitant products included bupropion, lamotrigine (Lamictal), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall) and formoterol fumarate, mometasone furoate (Dulera).   On 22-OCT-2024, the patient received the 1st dose of FluLaval Quadrivalent 2024-2025 season (intramuscular) and the 1st dose of Novavax COVID-19 Vaccine (intramuscular). On 02-NOV-2024, 11 days after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced loss of personal independence in daily activities (Verbatim: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES), vesicular rash (Verbatim: Rash vesicular/Blistery rash), rash (Verbatim: rash) and wound (Verbatim: WOUND). On an unknown date, the patient experienced pain (Verbatim: very painful), skin ulcer (Verbatim: sores) and infection (Verbatim: prone to infection). The outcome of the loss of personal independence in daily activities, vesicular rash, rash and wound were not resolved and the outcome of the pain, skin ulcer and infection were not reported.   It was unknown if the reporter considered the loss of personal independence in daily activities, vesicular rash, rash, wound, pain, skin ulcer and infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the loss of personal independence in daily activities, vesicular rash, rash, wound, pain, skin ulcer and infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-DEC-2024 The patient experienced loss of personal independence in daily activities, rash, rash vesicular and wound after receiving Flulaval and Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 12 Day. Experienced blistering rash that spread throughout right armpit and left open sores on torso, in armpit and up the inside of right bicept. The sores were very painful, prone to infection and significantly adversely impacted ability to function normally. The causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and events loss of personal independence in daily activities, rash, rash vesicular and wound was considered possible.