Age: 76.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injection site erythema, Post procedural erythema, Procedural site reaction, Pruritus, Rash
Clinical narrative: High Blood Pressure; Redness at injection Site; Total Body Rash/ rash on a surgical scar/ polka dots; Red rash/ pale pink; raised bumps of all different diameters; This rash started like "polka dots" that were red/ bigger spots; Itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) for prophylaxis.   The patient's past medical history included lumpectomy and aneurysm (previous aneurysm (pre existing Fluarix)). Concurrent medical conditions included surgical scar and allergy to antibiotic (Aminoglycosides, Neomycin). Concomitant products included fluticasone and azelastine.   On 17-AUG-2023, the patient received Fluarix Tetra 2023-2024 season (intramuscular, left arm) .5 ml. In AUG-2023, less than a week after receiving Fluarix Tetra 2023-2024 season, the patient experienced pruritus (Verbatim: Itching). On 18-AUG-2023, the patient experienced generalized rash (Verbatim: Total Body Rash/ rash on a surgical scar/ polka dots), red rash (Verbatim: Red rash/ pale pink), papular rash (Verbatim: raised bumps of all different diameters) and spot-like rash (Verbatim: This rash started like "polka dots" that were red/ bigger spots). On 19-AUG-2023, the patient experienced injection site erythema (Verbatim: Redness at injection Site). On 22-AUG-2023, the patient experienced blood pressure high (Verbatim: High Blood Pressure).  The patient was treated with prednisone, benadryl (nos) (Benadryl) and cetirizine hydrochloride (Zyrtec). The outcome of the injection site erythema, generalized rash, red rash, spot-like rash and blood pressure high were not resolved and the outcome of the papular rash and pruritus were not reported.   It was unknown if the reporter considered the injection site erythema, generalized rash, red rash, papular rash, spot-like rash, pruritus and blood pressure high to be related to Fluarix Tetra 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema, generalized rash, red rash, papular rash, spot-like rash, pruritus and blood pressure high to be related to Fluarix Tetra 2023-2024 season and Fluarix 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: 23-Aug-2023 The patient reported that she received Fluarix in her left shoulder (arm) from her pharmacist and almost exactly 24 hours later, the patient started developing a rash on a surgical scar from a previous double lumpectomy surgery she underwent on 3-AUG-2023. The patient reported that the rash as a total body rash because it had spread everywhere from her clavicle down to her knees.  This rash started like polka dots that were red, and today (on the day of reporting) were pale pink, bigger spots. Patient reported that the rash was red, raised bumps of all different diameters, and she got new ones every day. Patient still had that rash today (on the day of reporting). Patient also reports that she had injection site redness and is 4 inches long and 2 inches wide and still had that redness on the day of reporting. Patient did go to Urgent Care twice for the rash and injection site redness on 19-AUG-2023 and 21-AUG-2023. Patient was given treatment with Prednisone dose pack decreasing dose (unknown product information), Benadryl 25mg every 4 hours, and Zyrtec 10mg 24 hour once daily, all for itching, and reported this treatment was not helping. Patient also reported that she used Fluticasone Nasal Spray (unknown product information) and Azelastine Nasal Spray (unknown product information) which were pre existing Fluarix.  It was not confirmed if she used them the day she received the Fluarix. Patient also reports that her blood pressure was sky high at 180/70 today (on the day of reporting) and her cardiologist monitored this due to a previous aneurysm (pre existing Fluarix), and told her the high blood pressure was a natural reaction to this rash. Patient also reported that her allergic to Neomycin, and she was also allergic to all aminoglycosides (both allergies are pre existing Fluarix). The reporter was unable to find the Fluarix Quadrivalent for the 2023-2024 season in the product list, so chose the 2022-2023 Season option. The reporter consented to follow up with HCP