Report #2829095

Overview

Sex

Female

Age

54 yrs

State

WA

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

moderate hearing loss; tinnitus; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (moderate hearing loss) in a 54-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (moderate hearing loss) (seriousness criterion medically significant) and TINNITUS (tinnitus). At the time of the report, DEAFNESS (moderate hearing loss) and TINNITUS (tinnitus) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No Concomitant medications provided by the reporter. It was reported that patient was developed Tinnitus and moderate hearing loss over a period of a month. No treatment medications provided by the reporter.; Reporter's Comments: Company Comments; The benefit-risk relationship of product is not affected by this report