Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Eye pruritus, Hypersensitivity, Lacrimation increased, Swelling, Upper-airway cough syndrome
Clinical narrative: Hospitalisation; Hypersensitivity; Eye pruritus; Lacri mation increased; Upper-airway cough syndrome; Swelling; This serious case was reported by a consumer via other manufacturer and described the occurrence of hospitalization in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3L620Z, expiry date 31-OCT-2026) for prophylaxis.   Co-suspect products included dupilumab for prophylaxis.   Concurrent medical conditions included asthma, allergy (At the time of event, the patient had ongoing allergy) and drug allergy (penicillin vk 500 mg tablet). Concomitant products included semaglutide.   On an unknown date, the patient received Arexvy and dupilumab (subcutaneous) 300 mg. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hospitalization (Verbatim: Hospitalisation) (serious criteria hospitalization), allergy (Verbatim: Hypersensitivity), eye pruritus (Verbatim: Eye pruritus), watering eyes (Verbatim: Lacri mation increased), upper-airway cough syndrome (Verbatim: Upper-airway cough syndrome) and swelling (Verbatim: Swelling). The patient was treated with ibuprofen. Dupilumab was discontinued. The outcome of the hospitalization, allergy and swelling were unknown and the outcome of the eye pruritus, watering eyes and upper-airway cough syndrome were not reported.   It was unknown if the reporter considered the hospitalization, allergy, eye pruritus, watering eyes, upper-airway cough syndrome and swelling to be related to Arexvy.     The company considered the hospitalization to be unrelated to Arexvy. It was unknown if the company considered the allergy, eye pruritus, watering eyes, upper-airway cough syndrome and swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-JAN-2025 Initial information received on 01-May-2023 regarding an unsolicited valid serious case received from Patient. This case involved a 61 years old female patient who was hospitalized and had allergy symptoms and swelling while being treated with Dupilumab [Dupixent] delivered via pre-filled syringe and Respiratory Syncytial Virus (RSV) vaccine prot. subunit PreF3 [Arexvy]. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing allergy: penicillin vk 500 mg tablet (Drug hypersensitivity). It was unknown if the patient had any additional medical history, concomitant disease or risk factor. Concomitant medications included semaglutide ( wegovy). On an unknown date, the patient started taking Dupilumab Solution for injection at dose of 300 mg QO W subcutaneous (strength: 300mg/2ml for severe persistent asthma uncomplicated via pre-filled syringe.  On an unknown date on 15-December, the patient start taking Arexvy (RSV vaccine prot. subunit PreF3) (Unknown dosage, unknown: formulation, strength, frequency, route and indication). Patient reported she was experienced allergy (hypersensitivity) (onset date and latency unknown) symptoms-itchy watery eyes (eye pruritus) (lacrim ation increased) and drainage in her throat (Upper-airway cough syndrome) (onset date and latency unknown).  no head congestion. Also mentioned she was hospitalized last year (hospitalization) (onset date: 2022) (unknown latency) (Batch number: 3L620Z and expiry date: 31-Oct-2026).  Patient missed a dose due to being at (in) hospital.  Patient reported swelling (onset: unknown, latency: unknown) (Batch number: 3L620Z and expiry date: 31-Oct-2026) after receiving the respiratory syncytial virus vaccine, arexvy, on 15-December. It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available. It was unknown if the reporter considered the hospitalization, allergy, eye pruritus, watering eyes, upper-airway cough syndrome and swelling to be related to Dupilumab.; Sender's Comments: Hospitalisation is an unlisted event which is considered unrelated to GSK drug Arexvy.