Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y007991 | — |
no adverse event; vaccine exposure during pregnancy; This prospective spontaneous report has been received from a health professional regarding a 31-year-old female patient. The patient's medical history included rash due to handling bleach. Information regarding concurrent conditions and concomitant therapies was not reported. On 08-JAN-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis , lot number Y007991 which has been verified to be valid, expiration date reported and validated as 18-JUN-2026. (strength, dose, scheme, route of administration, and anatomical site not reported) On 12-NOV-2024, the patient's pregnancy test resulted negative. On an unknown date, the caller stated during ultrasound, patient was about 6 weeks and 3 days pregnant when she received vaccine (conflicting information, the reporter stated the patient was "unknowingly pregnant" when she received the vaccine) (vaccination exposure during pregnancy). On 28-JAN-2025, the patient's pregnancy test was positive. No additional information provided, no adverse event. The pregnancy and fetal outcome was unknown.
Medical History/Concurrent Conditions: Rash (rash due to handling bleach.)
Test Date: 20241112; Test Name: pregnancy test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20250128; Test Name: pregnancy test; Test Result: Positive ; Result Unstructured Data: positive