Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UNK | — |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | UNK | — |
| PNC | PNEUMO (PREVNAR) | PFIZER\WYETH | UNK | UNK | — |
Allergy to vaccine/ allergic reaction; minor numbness around mouth and spreading to tongue; This serious case was reported by a other health professional via other manufacturer and described the occurrence of allergic reaction in a 76-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis, HIB vaccine conj (tet tox) (Act hib) for prophylaxis and Pneumococcal vaccine conj 7v (CRM197) (Prevenar) for prophylaxis. Concurrent medical conditions included asthma, open angle glaucoma, hypersensitivity, osteoporosis, thyroid disorder, tremor, glaucoma, dry age-related macular degeneration, neovascular age-related macular degeneration, seizure and hypothyroidism. Additional patient notes included The patient's past medical history, medical treatments, and family history were not provided.. Concomitant products included fluticasone, alendronate sodium (Alendronate), levothyroxine, primidone, folic acid, timolol maleate, astaxanthin, ascorbic acid;cupric oxide;dl-alpha tocopheryl acetate;xantofyl;zeaxanthin;zinc oxide (Preservision Areds 2), biotin, faricimab svoa (Vabysmo) and gabapentin. On 20-DEC-2023, the patient received the 1st dose of Bexsero, Menquadfi, Act hib and Prevenar. On 20-DEC-2023, less than a day after receiving Bexsero, Menquadfi, Act hib and Prevenar, the patient experienced allergic reaction (Verbatim: Allergy to vaccine/ allergic reaction) (serious criteria other: Serious as per reporter) and hypoesthesia oral (Verbatim: minor numbness around mouth and spreading to tongue). The patient was treated with diphenhydramine hydrochloride (Benadryl). On 20-DEC-2023, the outcome of the allergic reaction and hypoesthesia oral were resolved (duration 1 day). The reporter considered the allergic reaction to be possibly related to Bexsero, Menquadfi, Act hib and Prevenar. It was unknown if the reporter considered the hypoesthesia oral to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menquadfi, Act hib and Prevenar. It was unknown if the reporter considered the allergic reaction to be related to Bexsero Pre-Filled Syringe Device. The company considered the allergic reaction to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the hypoesthesia oral to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menquadfi, Act hib and Prevenar. The company considered the allergic reaction to be possibly related to Menquadfi, Act hib and Prevenar. 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: 05-SEP-2025 The nurse administered the vaccines Menquadfi, Bexsero, Prevnar, and Act HIB of an unknown dose. Reportedly, after the nurse administered the vaccines, the patient reported minor numbness around her mouth that spread to her tongue. The nurse administered Benadryl as treatment medication. The nurse monitored 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. Both events, vaccine allergy and Hypoaesthesia oral were resolved on the same day. The diagnosed events, allergy to vaccine (medically significant) was considered serious by the investigator. The causality of the allergic reaction to the vaccine, with suspects Menquadfi, Bexsero, Prevnar, and Hib, was suspected.; Sender's Comments: A case of Hypersensitivity, less than a day after receiving Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE in a 76-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly (Menquadfi, Act hib and Prevenar).
Asthma; Dry age-related macular degeneration; Glaucoma; Hypersensitivity; Hypothyroidism; Neovascular age-related macular degeneration; Open angle glaucoma; Osteoporosis; Seizure; Thyroid disorder; Tremor
Comments: The patient's past medical history, medical treatments, and family history were not provided.
FLUTICASONE; ALENDRONATE; LEVOTHYROXINE; PRIMIDONE; FOLIC ACID; TIMOLOL MALEATE; Astaxanthin; PRESERVISION AREDS 2; BIOTIN; VABYSMO; GABAPENTIN