Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Deafness unilateral, Investigation, SARS-CoV-2 antibody test negative
Clinical narrative: had no COVID-19 antibodies; catastrophic hearing loss/could not hear out of my left ear/My left ear is what 'went'; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264), via an unspecified route of administration on 09Feb2021 15:00 at single dose for COVID-19 immunisation.  Medical history included kidney transplant from an unknown date. Concomitant medication included cyclosporine (CYCLOSPORINE), mycophenolate mofetil (MYCOPHENOLATE). The patient was on the Cyclosporine 50 mg in the morning and 50 at night and Mycophenolate 180 times 3, 540 in morning and 540 at night. (Not appropriately clarified). The patient woke up at 3am in 20Feb2021 and she completely lost hearing in her left ear. She went to her ear doctor and her doctor diagnosed her with "catastrophic hearing loss" which is pretty unusual as said by her doctor. The only intervention that they could think of is getting the Pfizer COVID-19 vaccine. She wanted to know if this has been a reported adverse event with the Pfizer BioNTech COVID-19 vaccine. If so, is it permanent or temporary? She wanted to have more information so she can tell this to her doctor. She also mentioned that she found a "Pfizer worksheet" online and hearing loss was listed as an adverse event in that document. She showed it to her family doctor and her family doctor agreed that it may be associated with the Pfizer COVID-19 vaccine. Consumer stated, that she got COVID-19 Vaccine on February 9th, at 3 o'clock in the afternoon and she woke up last Saturday and she could not hear out of her left ear. She called family doctor and then called ENT doctor and went in yesterday and had some tests and some hearing tests and the doctor said it was catastrophic Hearing Loss which he sees rarely and the patient tried to look online and finally tried to look for what the heck happened because they had a lot of previous tests and her hearing was fine and all of a sudden just literally changed overnight. So, she looked up the Pfizer COVID-19 possible side effects and she did see in the COVID-19 Vaccine that it mentioned hearing loss. So, she talked to doctor and he simply said you probably have to report it. When paraphrased the above concern, consumer stated, a possible side effect. You got me, what caused it is odd and everybody said. Family doctor said it was odd. Her ear doctor said it was odd. Has anybody else reported that side effect and if so, is it permanent or temporary? When offered the number of Pfizer Medical Information, consumer stated, her left ear is what 'went'. Now she has to mess around because she has to hold the phone around her right ear and then have to use her left hand because right hand (incomplete sentence). About treatment, consumer stated, she went to the ear doctor and he ran some hearing tests and he put her on prednisone which she started last night. So, he put her through a 'regime' of prednisone, of steroids. About Laboratory work, Consumer stated, she did have some lab work prior to February 9th because she was a kidney transplant patient and she was in the Study. They are studying how the COVID-19 vaccine works on the transplantations. So, she had a blood test. The results went to facility. She did know they sent her a letter saying that she had no COVID-19 antibodies (Clarification unknown). Consumer added, she was a little concerned and would at least like to know if anybody else has reported something like this. That would be helpful. The outcome of the events was unknown.  Information about lot/batch number has been requested.