Received Jul 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z018560 | OT |
She reports that a pregnant patient was given the first dose of GARDSAIL-9 at 30 weeks gestation; she felt less fetal movement after this; This spontaneous prospective pregnancy has been received from a pharmacist, regarding to a 31-years-old female adult patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unknown date (at 30 weeks gestation), the patient was vaccinated with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) suspension for injection (GARDASIL 9) at a dose of 0.5 milliliter (ml), (lot number Z018560 which has been verified to be valid, expiration date reported and established as 02-JAN-2028) as treatment of Immunization (Exposure during pregnancy). On an unknown date (also reported as after the vaccination), the patient felt less fetal movement (Foetal hypokinesia). The outcome of the event of Foetal hypokinesia was not provided. The pregnancy outcome was unknown as well the fetal outcome. The causality assessment between Foetal hypokinesia and the suspect vaccine was not provided. Upon internal review, the event Foetal hypokinesia was determined to be Medically Significant.