Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3X937 | — |
Hives spread all over the body; Itching all over; This non-serious case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 20-year-old female patient who received HBV (Engerix B) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, 10 hrs after receiving Engerix B, the patient experienced generalized pruritus (Verbatim: Itching all over). On 30-JAN-2025, the patient experienced generalized urticaria (Verbatim: Hives spread all over the body). On 30-JAN-2025, the outcome of the generalized urticaria was resolved and the outcome of the generalized pruritus was resolved (duration 1 day). It was unknown if the reporter considered the generalized urticaria and generalized pruritus to be related to Engerix B and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the generalized urticaria and generalized pruritus to be related 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 04-FEB-2025 Nurse explained that a patient got 2 dose of Engerix-B but after the second dose, the patient experienced an adverse reaction approximately 10 hours later, the patient started itching all over and next morning she got hives on palms of her hands and then it started spread all over her body. On 30th January 2025, the patient went to an urgent care clinic and got a steroid injection, so currently symptoms were almost completely gone.
ENGERIX B