Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness bilateral, Fatigue
Clinical narrative: fatigue; severe hearing loss in both ears; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 75 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 22Oct2022 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing); "Covid-19", start date: 16May2022 (unspecified if ongoing). Concomitant medication(s) included: NEBIVOLOL taken for blood pressure abnormal, start date: 16Sep2022 (ongoing). Past drug history included: Paxlovid, start date: 16May2022, stop date: 20May2022, for COVID-19, reaction(s): "Hearing loss"; Paxlovid, start date: 16May2022, stop date: 20May2022, for COVID-19, reaction(s): "Spinning sensation"; Paxlovid, start date: 16May2022, stop date: 20May2022, for COVID-19, reaction(s): "Dizziness". Vaccination history included: BNT162b2 (Dose 1, Lot number: FL3246, Anatomical location: Left arm near shoulder, Route of administration: Intramuscular, time: 09:30), administration date: 13Jan2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot number: Fl9265, Anatomical location: Left arm near shoulder, Route of administration: Intramuscular, time: 09:30), administration date: 03Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (Booster), Lot number: FF2588, Anatomical location: Left arm near shoulder, Route of administration: Intramuscular, time: approximately 14:00), administration date: 24Sep2021, when the patient was 74-year-old, for COVID-19 Immunization. The following information was reported: DEAFNESS BILATERAL (disability, medically significant) with onset 30Oct2022, outcome "not recovered", described as "severe hearing loss in both ears"; FATIGUE (non-serious), outcome "not recovered". The event "severe hearing loss in both ears" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: severe hearing loss in both ears. Therapeutic measures were taken as a result of deafness bilateral.  Clinical course: On 30Oct2022, the patient went to haunted house with a group of friends and could hear fine before going in but could not hear when she came out and still could not hear. She had been to ENT doctor and had 2 hearing tests to learn she had severe hearing loss in both ears. No one else had any problems. She did have her 4th covid shot on 18Sep2022 and a flu shot on 22Oct2022, eight days before the sudden hearing loss. Because the hearing loss was so sudden and both ears and she had experienced a slight hearing loss after having covid in the latter part of May, she thought the noise in haunted house triggered the hearing loss. She realized there was no medical proof of this, but she knew her body and had other lingering effects of covid when hearing loss occurred. The patient had audiology hearing test and need to get hearing aids. The patient felt this uncommon event was related to either covid or paxlovid as she never had any ear problems prior to covid and doctor had no explanation for this cause. Still suffering from fatigue and fear more hearing loss.