Received Apr 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | LA |
cellulitis; This non-serious case was reported by a physician via other manufacturer and described the occurrence of cellulitis in a 16-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. On an unknown date, the patient received Bexsero (left arm) and Menquadfi (left arm). On an unknown date, less than a day after receiving Bexsero, the patient experienced cellulitis (Verbatim: cellulitis). The patient was treated with ibuprofen (Advil), paracetamol (Tylenol) and cephalexin. The outcome of the cellulitis was not resolved. It was unknown if the reporter considered the cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the cellulitis 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. Additional Information: GSK Receipt Date: 20-MAR-2025 The patient received Bexsero and Menquadi administered and after injection site was wiped with alcohol swab. The patient experienced significant pain started in left arm less than 5 hours after shot, advil provided around 8pm due to pain. Pain continued 16-March-2025, advil administered around 6am, alieve around 11am, and tylenol around 3pm. Touching/bumping arm caused significantly more pain. Rash, that was swollen, pink, and hot to the touch noted on arm around 8pm approximately 2cm below the injection site. On 15-March-2025, 8 am pain persisted, rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before. On 15-March-2025 at 11am, diagnosed with cellulitis. Rash measured approximately 8 cm by 6cm. Oral cephalexin prescribed. It was unknown if the reporter considered the cellulitis to be related to Menquadfi.