Sex: F
Vaccine: VARZOS
Symptoms: Audiogram abnormal, Cataract, Cataract operation, Deafness neurosensory, Ear discomfort
Clinical narrative: Vomiting; Unsteady gait; 10 days after experienced sudden sensorineural hearing loss; ENT examination approximately 10 days later with findings suggesting viral etiology and consistent with herpes type process; Tinnitus; fullness in the left ear; This serious case was reported by a consumer and described the occurrence of sensorineural hearing loss in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 5777F) for prophylaxis.   On 15-MAY-2023, the patient received the 2nd dose of Shingrix .5 ml. On 27-MAY-2023, 12 days after receiving Shingrix, the patient experienced sensorineural hearing loss (Verbatim: 10 days after experienced sudden sensorineural hearing loss) (serious criteria GSK medically significant and clinically significant/intervention required), viral infection (Verbatim: ENT examination approximately 10 days later with findings suggesting viral etiology and consistent with herpes type process) (serious criteria clinically significant/intervention required), tinnitus (Verbatim: Tinnitus) (serious criteria clinically significant/intervention required) and ear feels clogged (Verbatim: fullness in the left ear) (serious criteria clinically significant/intervention required). In JUN-2023, the patient experienced vomiting (Verbatim: Vomiting) (serious criteria clinically significant/intervention required) and unsteady gait (Verbatim: Unsteady gait) (serious criteria clinically significant/intervention required). The patient was treated with meclozine (Meclizine), ondansetron (Zofran), decadron (nos) (Decadron) and prednisone. On 14-JUN-2023, the outcome of the sensorineural hearing loss was resolved (duration 18 days). The outcome of the viral infection, ear feels clogged and unsteady gait were resolving and the outcome of the tinnitus and vomiting were not reported.   It was unknown if the reporter considered the sensorineural hearing loss, viral infection, tinnitus, ear feels clogged, vomiting and unsteady gait to be related to Shingrix.     It was unknown if the company considered the sensorineural hearing loss, viral infection, tinnitus, ear feels clogged, vomiting and unsteady gait to be related to Shingrix.   Additional Information: GSK Receipt Date:15-JUN-2023 The reporter stated that 10 days after the patient experienced sudden sensorineural hearing loss and ENT (Ear, nose and throat ) examination approximately 10 days later with findings suggesting viral etiology and consistent with herpes type process. The reporter's wife had OS (left eye) cataract surgery on 26th May 2023 and the following day experienced hearing loss, tinnitus and a fullness in the left ear.  In JUN-2023, less than 3 weeks after receiving Shingrix, the patient experienced vomiting and unsteady gait. One week later had severe episodes of vomiting and unsteady gait and taken by ambulance to the emergency department.  The patient received Meclizine, Zofran and the reporter requested 4mg of i.v. (Intravenous) Decadron which was administered and she was discharged home.  The following day her symptoms improved but then the next day worsened.  The patient had a ENT visit with a physician assistant and the audiogram showed severe sensorineural hearing loss (sudden).  The reporter who was retired neuro-radiologist requested a course of high dose prednisone and the physician assistant agreed, but was concerned about acoustic neuroma which the reporter said was highly unlikely.  The physician said there was no conductive hearing loss and the tympanic membrane was normal. The patient then secured an appointment several days later with an experienced otolaryngologist and MD. who found changes in the external auditory canal consistent with a possible viral etiology for sudden sensorineural hearing loss and was concerned about the recent vaccination (second dose of Shingrix 10 days prior to her cataract surgery).  The reporter could not find reported cases of sudden sensorineural hearing loss with Shingrix and certainly there were many cases reported following the Zostavax.  The reporter was not that this was a reportable side effect.  The patient was improving on steroids with better clinical hearing, less unsteadiness of gait and decreasing fullness on the left.  The reporter reported the case for knowledge that had there been any reported cases of sudden sensorineural hearing loss following the second dose of Shingrix.  The patient had the second dose within three months of the first, but could not remember the date of the first dose. The reporter consented to follow up.