Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
syncope after the administration/Fainting; This serious case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 34-year-old female patient who received HBV (Engerix B) (expiry date 11-JUL-2026) for prophylaxis. On 25-FEB-2025, the patient received Engerix B. In FEB-2025, less than a week after receiving Engerix B, the patient experienced syncope (Verbatim: syncope after the administration/Fainting) (serious criteria GSK medically significant). The outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to Engerix B and Engerix B Pre-Filled Syringe Device. The company considered the syncope to be unrelated to Engerix B and Engerix B 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: 26-FEB-2025 Other HCP wanted to know the percentage of patients fainting after receiving Engerix-B. Information found in the prescribing information about syncope after the administration was given and also offered to be escalated to a second line specialist, but declined it. Reporter mentioned that the vaccine was administered in a facility different than the one registered in the system and provided only the zip code of this administration site. Reporter did not knew the batch number because she was not in that facility and had nothing from the product to find out the lot number.; Sender's Comments: Syncope is a listed event which, due to the following criteria ((insufficient information provided about the clinical description, medical history, concurrent conditions, concomitant medications, lab results) is considered unrelated to GSK vaccine Engerix B and Engerix B PRE-FILLED SYRINGE DEVICE.