Report #2904722

Overview

Sex

Female

Age

31 yrs

State

GA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

She felt less fetal movement after this; Pharmacist calling to report an AE. She reports that a pregnant patient was given the first dose of GARDSAIL-9 at 30 weeks gestation. Patient reported to her nurse that she felt less fetal movement after this. Consent for follow up was provided. No; This spontaneous Prospective pregnancy report was received from a Pharmacist and refers to a 31-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Z018560 confirmed as valid, expiration date: 02-Jan-2028), administered Intramuscular (IM) (anatomical location not provided) as immunization. At the time of vaccination, the patient was pregnant at 30 weeks of gestation (vaccine exposure during pregnancy). Last menstrual period was not provided; this pregnancy involved 1 fetus. After this, on unknown date, the patient reported to her health care professional that she felt less fetal movement. At the reporting time, the outcome of the events was unknown as well as pregnancy outcome or fetal outcome. The causal relationship between less fetal movement and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported. Upon internal review, the event of less fetal movement was determined to be medically significant.