Sex: F
Vaccine: MENB, UNK
Symptoms: Hypersensitivity, Paraesthesia oral, Swollen tongue, Transient ischaemic attack, Vaccine positive rechallenge
Clinical narrative: Transient ischemic attack; Swollen tongue; after the vaccine was administered subject reports tingling lips; This serious case was reported by a other health professional via other manufacturer and described the occurrence of transient ischemic attack in a 76-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included iptacopan capsule for age-related macular degeneration.   Previously administered products included Bexsero with an associated reaction of allergy to vaccine (received on 20th December 2023, refer case US2024AMR034507). Concurrent medical conditions included thyroid disorder, tremor (since 01st January 2013), osteoporosis (since 3rd March 1998), seizure (since 1st November 2023), glaucoma (since 4th June 2022), asthma, open angle glaucoma (chronic), hypothyroidism (since 1st January 2001), dry age-related macular degeneration (since 2nd November 2022), wet age-related macular degeneration (since 2nd November 2022), neovascular age-related macular degeneration, hypersensitivity (since 1st January 1998) and environmental allergy (since 1st January 1998). Concomitant products included faricimab svoa (Vabysmo), haematococcus pluvialis (Astaxanthin), gabapentine, biotin, calcium phosphate dibasic (Biotin), ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (Preservision Areds 2), fluticasone propionate (Fluticasone), alendronate sodium (Alendronate), levothyroxine sodium (Levothyroxine), primidone, folic acid and timolol maleate.   On 08-FEB-2024, the patient received Bexsero. On an unknown date, the patient started iptacopan. On 08-FEB-2024, less than a day after receiving Bexsero, the patient experienced tingling lips (Verbatim: after the vaccine was administered subject reports tingling lips) (serious criteria other: Medically significant). On 03-MAR-2024, the patient experienced transient ischemic attack (Verbatim: Transient ischemic attack) (serious criteria hospitalization, GSK medically significant and other: Medically significant). On an unknown date, the patient experienced swollen tongue (Verbatim: Swollen tongue). Rechallenge with Bexsero was positive. The action taken with iptacopan was unknown. On 08-FEB-2024, the outcome of the tingling lips was resolved.On 05-MAR-2024, the outcome of the transient ischemic attack was resolved (duration 2 days). The outcome of the swollen tongue was not reported.   It was unknown if the reporter considered the transient ischemic attack, tingling lips and swollen tongue to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the transient ischemic attack, tingling lips and swollen tongue to be related to Bexsero and Bexsero 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.   Linked case(s) involving the same patient:US2024AMR034507   Additional Information: GSK Receipt Date: 28-MAR-2024 On 08 Feb 2024, 1 month and 20 days after the first dose of the Iptacopan, the patient developed "after the vaccine was administered subject reports tingling lips. On the same day (in 1 day), the patient completely recovered from tingling lips. On 03 Mar 2024, 2 months and 13 days after receiving Iptacopan, the patient developed TIA (transient ischaemic attack). The action taken with Iptacopan was reported as no change. On 05 Mar 2024 (in 3 days) the patient completely recovered from transient ischaemic attack. The diagnosed events transient ischemic attack (hospitalization), allergy to vaccine and paraesthesia oral were considered serious by the investigator. The causality of tingling lips and transient ischemic attack with Iptacopan was reported as not suspected. As the event allergy to vaccine (allergic reaction after the vaccine administration) developed prior to the administration of Iptacopan, the causality was assessed as not suspected with Iptacopan. Considering the elderly age of the subject, inconsistency with known safety profile of Iptacopan, the causality of event transient ischemic attack was assessed as not suspected with Iptacopan.; Sender's Comments:  US-GLAXOSMITHKLINE-US2024AMR034507:same patient