Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Sleep disorder, Tinnitus
Clinical narrative: she had very bad ringing in her ears; its affecting my job; its affecting my job and me sleeping; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202, NDC number and Expiry Date: Not Provided), via an unspecified route of administration, administered in left arm on 06Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she was on medications but believes they do not have anything to do with her reported event. The patient had not history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not receive any other additional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations, the patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to AE(s), patient believed her sister has ringing in her ears, after getting the Pfizer Covid 19 vaccine. patient declines to complete a report for her sister and states her sister can report for herself. Patient did not provide any information for her sister's report. On 26Feb2021 after the first dose of vaccination, the patient experienced she had very bad ringing in her ears, it's affecting my job and it's affecting my job and me sleeping. It was reported that patient received first dose of vaccination. The very next morning she had very bad ringing in her ears.  Patient wanted it reported that the vaccine was causing ringing in the ears. People in her family had the same effects and people online are reporting it. It was very annoying and it was affecting patient job and she sleeping. Patient wanted it noted that it is causing ringing in the ears. It was stated to patient the PI for the vaccine contains no information regarding tinnitus or ringing in the ears being reported in the clinical trial or during the post authorization period. Spoke from the attached Side Effects document.  Stated to patient that she declined to file a report however they were the one's that take the side effect reports.  Asked patient if she would like to be transferred back to Safety and she stated yes. Patient said that she just wanted to ask a question. She experienced has been reported before. The next day she woke up and had bad ringing in her ears, is that caused by the COVID vaccine. She went to the ENT and he thought that was what would of caused it but she was wondering if anyone else has complained of this before. She want to knew if this will subside or if anyone knows anything. The patient stated because people need to get the vaccine and she did not want to get sick. The patient stated she went to the ear, nose and throat doctor and she was told her hearing was normal. Outcome, the patient answered as it was getting a little better, and then on last Thursday, the ringing came back like it was when it started, and never went away. The patient stated she went to the doctor and was told that it was alright to get the second vaccine. The patient reported that the ringing was worse after the second vaccine, but started getting better until last Thursday, and then it worsened, similar to when the ringing first started. The patient did not require a visit to emergency room. Physician Office, Yes the patient stated she went for a regular check-up and made an appointment for the ear, nose and throat doctor. patient stated she was given a test and it was reported as normal. She has a small hearing loss in her left ear, but that was from age. At the time that the patient initially called into the Drug Safety Unit, she declined to file a report, but now want to complete a report. Patient reconfirmed that she was calling about the Pfizer BioNTech Covid vaccine. Patient stated she will continue a safety report, just in case someone else has the same effect. Patient stated she read about people on the internet reporting ringing in their ears, patient cannot provide any specific details. Patient stated that a person in her family, her sister, had the Pfizer Covid vaccine, and she had ringing in her ears, although not as bad. Patient stated her sister had the first vaccine and was having the second shot on Friday. No any relevant test performed. There was not reported any product complaint, not requested medical information. There was not any other report. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.