Sex: M
Vaccine: RAB
Symptoms: Audiogram abnormal, Deafness unilateral, Sudden hearing loss, Tinnitus
Clinical narrative: Patient experienced sudden asymmetric hearing loss on left ear; Case reference number US-BN-2024-001942 is a spontaneous case report initially received from a consumer (reference number: USBAV24-1130) on 23-May-2024 and concerns 35-year-old male patient.  The patient's relevant medical history and concomitant medications were not provided.  On 16-Feb-2024, the patient was vaccinated with first dose of RabAvert vaccine (batch number: unknown), at unknown dose, intramuscularly, at unknown site of administration for indication reported as pre-exposure travel.  On 23-Feb-2024, seven days after administration of first dose of RabAvert, the patient was vaccinated with second dose of RabAvert vaccine (batch number: unknown), at unknown dose, intramuscularly, at unknown site of administration.  On unspecified date, reported as day and half after, the patient experienced bad intense ringing in the left ear. Patient was surprised and thought it was temporary, but it never stopped.  On 15-Apr-2024, five or six days after noticing, patient scheduled appointment with ear, nose, and throat (ENT) and audiometric test was performed (right ear) around 1000 Hz, and it started dropping significantly and when it reaches 2000 Hz there was significant difference from the right ear. As reported, the patient was diagnosed with sudden onset asymmetric hearing loss on left ear. Patient noticed hearing high pitched stuff in the left ear, received treatment and had five percent chance that could be tumor related but unlikely.  At the time of initial report, it was unknown if the patient recovered from event 'hearing loss unilateral'.  The reported assessed event 'hearing loss unilateral' as serious due to serious criteria of disability. Additionally, event 'hearing loss unilateral' was assessed serious due to criteria of medically significance. Causality assessment was not provided; however, it was reported that ENT drew any conclusions at all or blamed it explicitly on the administration of vaccine.  Additional information received from consumer on 23-May-2024 included RabAvert dosing information updated, serious criteria for event updated, patient information updated.; Reporter's Comments: A 35-year-old male patient experienced a serious event of bad intense ringing in the left ear, which was diagnosed as sudden onset asymmetric hearing loss (medical significance and disability) reported as day and half after the patient was vaccinated with second dose of RabAvert vaccine for indication reported as pre-exposure travel. Deafness unilateral is unlisted and unexpected for RabAvert according to the insert. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to RabAvert. This case is considered as serious due to medical significance and disability.; Sender's Comments: A 35-year-old male patient experienced a serious event of bad intense ringing in the left ear, which was diagnosed as sudden onset asymmetric hearing loss (medical significance and disability) reported as day and half after the patient was vaccinated with second dose of RabAvert vaccine for indication reported as pre-exposure travel. Deafness unilateral is unlisted and unexpected for RabAvert according to the insert. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to RabAvert. This case is considered as serious due to medical significance and disability.