Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | DD72H | — |
Pain injection site; Migraine; Lightheadedness; tingling right arm; pain up right arm, shoulder ear; both hands throbbing and pulsating; pulsating in pain; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number DD72H) for prophylaxis. On 05-MAY-2025, the patient received Bexsero. On 05-MAY-2025, several hours after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain injection site), migraine (Verbatim: Migraine), light headedness (Verbatim: Lightheadedness), tingling of extremity (Verbatim: tingling right arm), pain in arm (Verbatim: pain up right arm, shoulder ear), throbbing pain (Verbatim: both hands throbbing and pulsating) and sensation of blood flow (Verbatim: pulsating in pain). The outcome of the injection site pain, migraine and light headedness were resolved and the outcome of the tingling of extremity, pain in arm, throbbing pain and sensation of blood flow were unknown. It was unknown if the reporter considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow 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: 28-MAY-2025 Other Health Professional reported that patient received Bexsero vaccine on 5-MAY-2025, a few hours later, he was lightheaded, right arm tingly and pain at injection site that migrated up arm shoulder to ear and Hands throbbing and pulsating in pain, He had migraine later that evening. This case US2025066674 reported by same reporter.; Sender's Comments: US-GSK-US2025066674:1 of 2 report