Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Age-related macular degeneration, Arthralgia, Audiogram abnormal, Deafness neurosensory, Deafness unilateral
Clinical narrative: Flu-like symptoms; Fever; fatigue/stayed in bed; really sick; stayed in bed; The ENT said it was called sudden ser-sensory hearing loss; lost the hearing in her left ear/20% hearing remaining in the left ear; prescribed massive doses of prednisone which causes her blood sugar level to go unbelievably high; This serious case was reported by a consumer via call center representative and described the occurrence of sensory hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blind (Legally blind for many many years). Additional patient notes included No history of hearing problems. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 01-JUN-2023, the patient received the 2nd dose of Shingrix. On 03-JUN-2023, 2 days after receiving Shingrix and 77 days after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms), fever (Verbatim: Fever), fatigue (Verbatim: fatigue/stayed in bed) and sickness (Verbatim: really sick). In JUN-2023, the patient experienced sensory hearing loss (Verbatim: The ENT said it was called sudden ser-sensory hearing loss) (serious criteria GSK medically significant), partial hearing loss (Verbatim: lost the hearing in her left ear/20% hearing remaining in the left ear), blood sugar increased (Verbatim: prescribed massive doses of prednisone which causes her blood sugar level to go unbelievably high) and bedridden (Verbatim: stayed in bed). The patient was treated with prednisone. The outcome of the sensory hearing loss, influenza-like symptoms, fever, partial hearing loss, blood sugar increased, sickness and bedridden were not reported and the outcome of the fatigue was resolved.   The reporter considered the sensory hearing loss, influenza-like symptoms, fever, fatigue and partial hearing loss to be related to Shingrix. It was unknown if the reporter considered the blood sugar increased, sickness and bedridden to be related to Shingrix.     The company considered the sensory hearing loss, influenza-like symptoms, fatigue and partial hearing loss to be related to Shingrix. It was unknown if the company considered the fever, blood sugar increased, sickness and bedridden to be related to Shingrix.   Additional Information: GSK receipt date: 11-DEC-2023 The reporter was the patient.  The patient was vaccinated with Shingrix vaccine and experienced sick with flu like symptoms including a high fever and fatigue. The patient stayed in bed until patient was able to call the physician. The patient called the ENT (ear, nose throat) physician and scheduled an appointment for 14-June-2023.  The patient said when started having the flu-like symptoms patient lost the hearing in left ear, all the sounds that she was hearing was coming from a direction that did not made sense (like there was a ventriloquist in the room).  The physician (ENT) said it was called sudden ser-sensory hearing loss. While at the doctor did an audiogram test and was told that she had profound loss of the left ear.  The patient was prescribed massive doses of prednisone (which causes her blood sugar level to go unbelievably high).  The patient was another exam with the physician (on 29-June-2023) and another audiogram test was performed which said that only has 20 percent hearing remaining in the left ear.  The ENT physician recommended (bi-monthly) ear drum injections but patient declined. The reporter stated that the CDC also had this report on file.  (She did not said if she reported it or if a healthcare reported it on her behalf).  Caller ended conversation abruptly before reporter had a chance to ask for her date of birth, MD contact information, etc.  (Also reporter did not get a chance to ask if she had/has diabetes).  The reporter did not consent to follow-up.