Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | — | — |
no additional AE; " Consumer confirmed that they were not pregnant when they were administered their first dose of RECOMBIVAX HB; This spontaneous prospective pregnancy report was received from a Consumer or other non health professional (patient) and refers to a(n) 39-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On Apr-2025, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose 0.5 mL (three dose series), (lot # and expiration date were not reported) as prophylaxis (Maternal exposure before pregnancy). Patient has not been able to follow up with other doses of the vaccine since. She recently found out that she was pregnant in July 2025 and I did not have any medical concerns. She confirmed that she was not pregnant when she was administered with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), as well as confirmed she had not experienced any medical concerns or symptoms as a result of this report. She confirmed she was not pregnant when they she was administered the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). The patient experienced no additional AE. This pregnancy involved 1 fetus. At the reporting time, the outcome of the events was unknown. The outcome of the pregnancy, pregnancy due date and last menstrual period were unknown. Causality was not reported.