Reporte zur Charge fh8028

Symptomtext

loud tinnitus/The noise in both my ears is intrusive and annoying; difficult to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Lot number: 8028) at the age of 61 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid. Concomitant medication(s) included: SYNTHROID; VALSARTAN. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin", notes: Known allergies: azithromycin; Cipro, reaction(s): "Known allergies: Cipro", notes: Known aller-gies: Cipro; Protonix, reaction(s): "Known allergies: protonix", notes: Known allergies: protonix. Vac-cination history included: BNT162b2 (Pfizer second primary, Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Pfizer first primary dose, Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 04Nov2021, outcome "not recovered", described as "difficult to concentrate"; TINNITUS (non-serious) with onset 04Nov2021, outcome "not recovered", described as "loud tinnitus/The noise in both my ears is intrusive and annoying". Therapeutic measures were not taken as a result of tinnitus, disturb-ance in attention. Additional information: Patient did not receive any other vaccine in four weeks. Patient did not had COVID prior vaccination and also not tested positive post the vaccination. It was reported that, patient had prolonged (lasting several weeks) episodes of loud tinnitus after each booster and she had recent omicron booster. The noise in both ears was intrusive and annoying, making it very difficult to concentrate. Patient did not received any treatment for AEs. Follow-up attempts are completed. No further information is expected.