Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Nephrolithiasis, Tinnitus, Urine analysis
Clinical narrative: Developed kidney stone and diverticulitis and had to go to the hospital; it has been worse; Developed kidney stone and diverticulitis and had to go to the hospital; it has been worse; Increased tinnitus; Had tinnitus for years but it got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "tinnitus" (unspecified if ongoing). Concomitant medication(s) included: XANAX; LEXAPRO. Vaccination history included: covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Batch/Lot number: 010A21A), administration date: 03Mar2021, for COVID-19 immunisation; moderna (DOSE 2, SINGLE, Batch/Lot number: 025B21A), administration date: 31Mar2021, for COVID-19 immunisation; covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN, Batch/Lot number: 040C21A), administration date: 29Sep2021, for COVID-19 immunisation; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: 013H22A), administration date: 14Nov2022, for COVID-19 immunisation. The following information was reported: NEPHROLITHIASIS (medically significant), DIVERTICULITIS (medically significant), outcome "unknown" and all described as "Developed kidney stone and diverticulitis and had to go to the hospital; it has been worse"; TINNITUS (non-serious), outcome "recovering", described as "Increased tinnitus; Had tinnitus for years but it got worse". The events "developed kidney stone and diverticulitis and had to go to the hospital; it has been worse" and "increased tinnitus; had tinnitus for years but it got worse" required physician office visit. The patient underwent the following laboratory tests and procedures: Urine analysis: there were not any problems, notes: It was a routine one. Therapeutic measures were taken as a result of tinnitus. Clinical course: The patient had a COVID shot on 02Oct (clarified as 2023 later) at PRIVACY and she just read recently that people were reporting tinnitus effects from vaccines and that had happened to her. She had tinnitus for a while, it got worse. She could not really pinpoint exactly when because of the day after she had the shot she developed kidney stone and diverticulitis and went  to the hospital (Further not clarified, hence seriousness criteria left unchecked) but it had been worse. She went through her primary care doctor, he did flush out my ear which helped some tinnitus that she had for years and it was considerably worse then and it seemed to went inside when she got the shot. Treatment: Reporter stated, she just went to audiologist to get new hearing aids that might helped it to a certain degree. Nothing she did to her ear other than her doctor flushed out her right ear and there was wax in it so it improved her hearing and the tinnitus got a little bit better but not that much.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.