Age: 76.0
Sex: F
Vaccine: HIBV, MEN, MENB, PNC
Symptoms: Allergy to vaccine, Hypersensitivity, Hypoaesthesia oral, Paraesthesia oral, Swollen tongue
Clinical narrative: transient ischaemic attack; tingling lips; numbness around mouth and spreading to tongue; swollen tongue; Allergic reaction after the vaccine administration; This serious case was reported by a consumer 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 Hib UNK (Hib vaccine) for prophylaxis, Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for prophylaxis and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   Concurrent medical conditions included thyroid disorder, tremor, osteoporosis, seizure, glaucoma, asthma, open angle glaucoma, environmental allergy, hypothyroidism, dry age-related macular degeneration and wet age-related macular degeneration. Concomitant products included fluticasone propionate (Fluticasone), alendronate sodium (Alendronate), levothyroxine sodium (Levothyroxine), primidone, folic acid, timolol maleate, haematococcus pluvialis (Astaxanthin), ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (Preservision Areds 2), biotin, calcium phosphate dibasic (Biotin), gabapentin and faricimab svoa (Vabysmo).   On 20-DEC-2023, the patient received Bexsero, Hib vaccine, Prevnar and Menquadfi. On 20-DEC-2023, less than a day after receiving Bexsero and Hib vaccine, the patient experienced allergy to vaccine (Verbatim: Allergic reaction after the vaccine administration) (serious criteria other: serious as per reporter). On an unknown date, the patient experienced transient ischemic attack (Verbatim: transient ischaemic attack) (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), tingling lips (Verbatim: tingling lips) (serious criteria other: serious as per reporter), numbness oral (Verbatim: numbness around mouth and spreading to tongue) and swollen tongue (Verbatim: swollen tongue). The patient was treated with acrivastine (Benadryl). On 05-MAR-2024, the outcome of the transient ischemic attack was resolved. The outcome of the allergy to vaccine and tingling lips were resolved and the outcome of the numbness oral and swollen tongue were not reported.   It was unknown if the reporter considered the transient ischemic attack, tingling lips, numbness oral and swollen tongue to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Hib vaccine. The reporter considered the allergy to vaccine to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Hib vaccine.     It was unknown if the company considered the transient ischemic attack, tingling lips, numbness oral and swollen tongue to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Hib vaccine. The company considered the allergy to vaccine to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Hib vaccine.   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: 14-MAR-2024 The nurse administered vaccines Menquadfi, Bexsero (meningococcal vaccine b rfhbp/nada/nhba omv), Prevnar (pneumococcal vaccine conj 7v (crm197)) and Hib (hib vaccine) and developed allergic reaction after the vaccine administration. Reportedly, the patient received vaccines and after the nurse administered vaccines, the patient reported minor numbness around mouth and spreading to tongue. The nurse administered Benadryl. The nurse was monitoring the patient and the patient reported that the symptoms were going away. The nurse did not leave the patient's home until the patient was free from symptoms. On 20-Dec-2023 (in 1 day), the patient completely recovered from allergy to vaccine. On 08-Feb-2024, 1 month and 20 days after the first dose of the study medication, the patient developed after the after the vaccine was administered patient reports tingling lips. On the same day (in 1 day), the subject completely recovered from paraesthesia oral. On 03 Mar 2024, 2 months and 13 days after the first dose of the study medication, the patient developed TIA (transient ischaemic attack). On 05-Mar-2024 (in 3 days), the subject completely recovered from transient ischaemic attack. The diagnosed events transient ischaemic attack (hospitalization), allergy to vaccine and paraesthesia oral (medically significant) were considered serious by the investigator.