Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cognitive disorder, Dizziness, Fatigue, Gait disturbance, Influenza like illness
Clinical narrative: vestibular neuritis; Diagnosed with orthostatic hypotension; flu symptoms; chills; fever; body aches; fatigue; nausea; dizziness/feel as if I would faint, dizziness is getting worse, lightheadedness; vertigo; vestibular dysfunction; couldn't get up and walk around, inability to get up and walk; imbalance; brain fog  short term memory impairment, short term memory loss; slow to find words; vision impaired, visual impairment; cognitive changes, cognitive impairment; sensitivity to light; Brain fog; Inability to get up; This case was reported by a consumer and described the occurrence of vestibular neuritis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluoxetine hydrochloride (Prozac) for product used for unknown indication.   Previously administered products included shingrix with an associated reaction of fatigue (also experienced sore arm after receiving 1st dose on December 2021, refer case US2022AMR053804). Concomitant products included sertraline hydrochloride (Zoloft).   On 7th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient started Prozac at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vestibular neuritis (serious criteria GSK medically significant), orthostatic hypotension, flu symptoms, chills, fever, general body pain, fatigue, nausea, dizziness, vertigo, vestibular disorder, gait disturbance, balance difficulty, short-term memory loss, speech disorder, visual impairment, cognitive disorder, photosensitivity, foggy feeling in head and difficulty in standing. Rechallenge with Shingrix was positive. The action taken with Prozac was unknown. On an unknown date, the outcome of the vestibular neuritis, vertigo, vestibular disorder, gait disturbance, speech disorder and difficulty in standing were unknown and the outcome of the orthostatic hypotension, chills, fever, general body pain, fatigue, nausea, dizziness, balance difficulty, short-term memory loss, visual impairment, cognitive disorder, photosensitivity and foggy feeling in head were not recovered/not resolved and the outcome of the flu symptoms was recovered/resolved.   The reporter considered the vestibular neuritis, flu symptoms, chills, fever, general body pain, fatigue, nausea, dizziness, vertigo, vestibular disorder, gait disturbance, balance difficulty, short-term memory loss, speech disorder, visual impairment, cognitive disorder and photosensitivity to be related to Shingrix. It was unknown if the reporter considered the orthostatic hypotension, foggy feeling in head and difficulty in standing to be related to Shingrix.   Linked case(s) involving the same patient:US2022AMR053804   Additional Information: GSK Receipt Date: 24-MAR-2022 Reporter's Comment: The day before the patient got the Shingrix shot, he/she started taking a new antidepressant. The patient had flu symptoms for a couple of days as disclosure information described: chills, fever, body aches, fatigue, nausea and dizziness.  After the first few days, most of the symptoms went away except for the nausea and dizziness which had remained the patient's constant companions to this date.  The patient stated that what follows was a capsule of his/her life for the past several weeks. Once the initial few days of the flu symptoms (from the shot) stopped, the patient thought he/she was having a reaction to the antidepressant. The patient was on it for a week, with no improvement, so he/she cut the dosage in half the second week with still no improvement.  The patient's doctor changed prescription to a different antidepressant which he/she started immediately. After another week, there was no change. They thought that perhaps he/she had vertigo. He/she was given exercises to help with the dizziness.  The patient did those for 5 days, still with no improvement and meanwhile two weeks had elapsed on the new antidepressant with no change.  The patient had extensive blood and urine tests done which gave no indication there was any problem with his/her system.  The doctor decided it must be the medication, so she took the patient off of the antidepressant (Prozac) to get it out of my system. After a week and a half, there was no improvement. During all of this time, the nausea and dizziness were so bad that the patient could not get up and walk around. For weeks, the patient could only read or watch TV. Any other activity made the patient feel as if he/she would faint.  After that week and a half with no improvement, doctor recommended having an MRI (magnetic resonance imaging) and it resulted in no indication of any problem.  A few days later the patient went to doctor.  Follow-up information received on 08-Apr -2022. This follow-up was considered significant. Reporter's Comment:  The patient received Shingrix on unknown deltoid. Soon after she began to experience short term memory loss, chills, fever, body aches, fatigue, nausea, dizziness that is getting worse, inability to get up and walk around, feeling faint, imbalance, brain fog, visual impairment, cognitive impairment, light sensitivity, lightheadedness, and she was diagnosed with orthostatic hypotension. Less than 3 months after receiving Shingrix, the patient experienced foggy feeling in head and difficulty in standing. Less than 2 months after receiving Prozac, the patient experienced vestibular neuritis, vertigo, vestibular disorder, gait disturbance, balance difficulty, short-term memory loss, speech disorder, visual impairment, cognitive disorder, photosensitivity, orthostatic hypotension. Less than 3 months after receiving Prozac, the patient experienced foggy feeling in head and difficulty in standing. The reporter considered the vestibular neuritis, vertigo, vestibular disorder, gait disturbance, balance difficulty, short-term memory loss, speech disorder, visual impairment, cognitive disorder and photosensitivity to be related to Prozac. It was unknown if the reporter considered the orthostatic hypotension, foggy feeling in head and difficulty in standing to be related to Prozac. The patient was currently under the care of a healthcare professional. The reporter did not consent to follow up. Additional Supportive Information: The case US2022062585 was found to be duplicate of case US2022AMR053806. Hence case US2022062585 would be deleted and all the information of this case would be added in case US2022AMR053806 which was the case of record for this patient. Summary of Changes: patient demographic details were updated, product details were updated, concomitant added, new event added, events outcome updated and narrative updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053804:Same patient, 1st dose. US-GLAXOSMITHKLINE-US2022AMR053806: