Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Hypoacusis, Tinnitus
Clinical narrative: Can't sleep at night; She noticed a slight ringing in the ear; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2021 as dose number unknown, single (Lot number: FF2588) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: diagnosed about 15 years ago but states she should've been diagnosed with ADHD when she was a kid.; "Anxiety" (unspecified if ongoing), notes: Anxiety Mood Disorders Caller states she was diagnosed many years ago probably 23-24 years ago.; "Mood disorder" (unspecified if ongoing), notes: Anxiety Mood Disorders Caller states she was diagnosed many years ago probably 23-24 years ago. Concomitant medication(s) included: LAMOTRIGINE taken for affective disorder; VYVANSE taken for attention deficit hyperactivity disorder; CLONAZEPAM taken for anxiety, affective disorder. The following information was reported: TINNITUS (medically significant) with onset Oct2021, outcome "not recovered", described as "She noticed a slight ringing in the ear"; SLEEP DISORDER (medically significant), outcome "unknown", described as "Can't sleep at night". The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: Fine.  Clinical course: The patient received the COVID-19 vaccine around the 9 or 10 am hour. Three weeks after receiving the vaccine, she noticed a slight ringing in the ear and it just progresses every week to the point that it still persists, at first the ringing was there intermittently but has just kept getting worse and more constant and didn't go away. She states the intensity was becoming a little higher in scale and pitch was higher. Caller clarifies the pitch was not higher just louder or volume was increased. Caller states she doesn't really know how to describe the ringing in her ears. she can't sleep at night because her ears are ringing and when she can't sleep this impacts her health and everything falls apart. Caller also went to her audiologist to get recommendations for tests and their audiologist said there was nothing they can recommend to her. She started lamotrigine a year and a half ago, vyvanse probably a year ago and clonazepam on and off for years. Caller states ebbs and flows depending on her mood. Caller states she takes clonazepam PRN. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine was reported as none.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the tinnitus, sleep disorder and the suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.