Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | IM / LA |
I am Pregnant, Gave Me HEPLISAV-B; Initial report received on 15-Aug-2025. Additional information received on 29-Aug-2025 from the reporter that included the patient's last menstrual period date, estimated date of delivery, and concomitant medications. A physician reported that she, a 37-year-old female, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 12 weeks pregnant. No medical history was reported. Concomitant medications included prenatal vitamins, aspirin, rizatriptan, and TYLENOL (acetaminophen). On 11-Jul-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available) intramuscularly in the left deltoid. The patient presented to the pharmacy, filled out her paperwork, and notified staff that she was pregnant. The patient later found out she was given HEPLISAV-B. The patient was 12 weeks gestation at the time of injection. Her last menstrual period (LMP) was 18-Apr-2025. Her due date is 23-Jan-2026. No side effects were reported. She has had an uncomplicated pregnancy so far. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.