Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
An HCP lets Bexsero warm up before giving to patients because otherwise it has a viscous state, if administer Bexsero in that viscous state patients reports pain in the area, swelling and redness.; swelling; redness; viscous state like honey appearance, if she administer Bexsero in that viscous; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced pain (Verbatim: An HCP lets Bexsero warm up before giving to patients because otherwise it has a viscous state, if administer Bexsero in that viscous state patients reports pain in the area, swelling and redness.), swelling (Verbatim: swelling), erythema (Verbatim: redness) and wrong technique in product usage process (Verbatim: viscous state like honey appearance, if she administer Bexsero in that viscous ). The outcome of the pain, swelling and erythema were unknown and the outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the pain, swelling and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the pain, swelling and erythema 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 01-MAY-2025: On 01/MAY/2025 a Sales representative from GSK contacted MI on behalf of an HCP with issue regarding the air bubble in the Bexsero syringe. They could not expel the air bubble, the HCP lets Bexsero warm up for 10 or 15 minutes when she takes out the vaccine from the fridge before giving to patients because otherwise it has a viscous state like honey appearance, if she administer Bexsero in that viscous state patients reports pain in the area, swelling and redness, so it is easier for them to let warm up the vaccine, this led to wrong technique in product usage process. After contacting the HCP MI letter of the Bexsero Air bubble was shared, and HCP did not mention anything about the viscous state like honey appearance of Bexsero and she did not provide anymore details about this patients who experienced pain, swelling and redness.