Report #2839755

Overview

Sex

Female

Age

12 yrs

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Merck employee with MVCC called to report an adverse event for GARDASIL-9. A pharmacy technician reported that when she was 12 years old, she received the 1st dose of GARDASIL-9 and fainted on the floor. She also reports that she almost fainted with; Almost faint with second and third dose; This spontaneous report was received from a currently 21-year-old female pharmacy technician, reporting on herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (indication, expiration date, and lot # were not reported). The patient reported that when she was 12 years old, and received the 1st dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) she fainted on the floor (syncope). She also reported that she almost fainted (presyncope) with the 2nd and 3rd doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), at unspecified age. No additional AE reported. No PQC reported. At the reporting time, the outcome of the events was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was determined as not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), was unknown. Upon internal review, the event of syncope was determined to be medically significant.