Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Nervous system disorder, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 46-year-old female patient received BNT162b2 (BNT162B2, solution for injection), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "I noticed a ringing in my ear/tinnitus"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "nerve wrecking"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty in sleeping due to the ringing". The event "I noticed a ringing in my ear/tinnitus" required physician office visit. Additional information: Caller wanted to know if Pfizer can compensate her for her medical bills if Tinnitus is a confirmed AE and if Pfizer BioNTech COVID-19 Vaccine is the cause of her tinnitus. Question: Customer asked if Pfizer will be making some changes to address concerns on tinnitus once it is an established and proven AE of the Pfizer BioNTech Covid-19 Vaccine. Question: Customer expressed disappointment over the ringing on her ears symptom and was not yet resolved even after a year. Customer also mentioned that she had some issues sending the safety report through her phone online and was only able to send it via laptop. Question: Customer Verbatim: I will like to report a side effect of the Pfizer COVID vaccine which experienced. Two days after I was vaccinated, I noticed a ringing in my ear. About 1 week later I was advised by my doctor that it should go away within 90days. Unfortunately, it has been a year and the ringing has not stop. I have visited several ENT Specialist and they have not been able to treat it. I strongly advise that your company list this side-effect. Please advise on if your company has any resolution for this issue. AE: Aside from the AE details listed on customer verbatim, patient added that the ringing in her ears have gotten worse and there are some days when the ringing would get so loud. Caller also mentioned that it was "nerve wrecking" and it started out initially mild. Patient also stated that it is causing a domino effect on her and explained that one thing triggers a bunch of other things like difficulty in sleeping due to the ringing. Caller also stated that the level of ringing is not usual and that they tried to find out the cause of the ringing in her ear by process of elimination and only thing that they think is the cause if the Pfizer BioNTech COVID-19 Vaccine. Caller got her first dose on 31Mar2021 and the second dose on 21Apr2021. Caller also got the booster on "June or July" of 2021. Age: 46 Years (turning 47 on November). Warm transferred AE. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.