Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
Patient is pregnant; 3th dose: April 18th 2025: 28 weeks of gestation; 2nd dose: March 21st 2025: 24 weeks of gestation; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 27-year-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 18-APR-2025, the patient received the 3rd dose of Engerix B. On 21-MAR-2025, the patient received the 2nd dose of Engerix B. On 21-MAR-2025, an unknown time after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose: March 21st 2025: 24 weeks of gestation). On 18-APR-2025, the patient experienced drug dose administration interval too short (Verbatim: 3th dose: April 18th 2025: 28 weeks of gestation). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient is pregnant). The outcome of the drug dose administration interval too short, drug dose administration interval too short and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Engerix B): To mother in third trimester Pregnancy Exposure (Engerix B): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing 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 : 22-APR-2025 Registered nurse calleds to report an early third dose for a patient on ENGERIX-B. Patient was pregnant. The patient received 2nd and 3rd dose of engerix b earlier than recommended interval, which led to shortening of vaccination schedule.
ENGERIX B