Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Drug exposure during pregnancy with no reported adverse event; Initial information received on 25-Apr-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 42 years old female patient who was exposed to vaccine influenza vaccine in context of drug exposure during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date is 01-Jul-2025. The patient's past medical history included Cholelithiasis, Cholelithiasis in AUG-2023, Caesarean section in AUG-2023, Cholecystectomy and Last menstrual period determination on 21-AUG-2024. The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy. Concomitant medications included Drospirenone (SLYND) for Contraception. On 21-Aug-2024, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and had drug exposure during pregnancy with no reported adverse event (exposure during pregnancy). Relevant laboratory test results included: Pregnancy test urine - On 05-Sep-2024: Negative; on 12-Sep-2024: Negative; on 02-Oct-2024: Negative; on 27-Mar-2025: Positive Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
Medical History/Concurrent Conditions: Cesarean section; Cholecystectomy; Cholelithiasis; Gallstones; Last menstrual period determination
SLYND
Test Date: 20240905; Test Name: Urine pregnancy test; Test Result: Negative ; Test Date: 20240912; Test Name: Urine pregnancy test; Test Result: Negative ; Test Date: 20241002; Test Name: Urine pregnancy test; Test Result: Negative ; Test Date: 20250327; Test Name: Urine pregnancy test; Test Result: Positive