Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Deafness, Ear disorder, Insomnia, Mental disorder
Clinical narrative: Issues with her ears / losing the cilia around or in the ear; An auto-immune reaction to the vaccine; Slight hearing loss/Had lost 60% of her hearing; Ringing in the ears; Felt like she was loosing her mind; it kept her up all night; This is a spontaneous report from a contactable nurse (patient's sibling). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51-years-old, via an unspecified route of administration, administered in Arm Left on 30Mar2021 16:10 (Batch/Lot Number: ER8732) as dose 1, single for COVID-19 immunization. The patient had no family or medical history. The patient had no concomitant medications. About 4 months ago the patient got the first dose of the Pfizer Covid-19 vaccine. 4 days after on 04Apr2021 (also reported as within a week) of getting the vaccine, she had an issue with her ears. She went to the ENT (ear, nose, throat) and was told she is losing the cilia around or in the ear, which they were told was probably an auto-immune reaction to the vaccine. The doctor said it was not the first time she has seen it. She had lost 60% of her hearing and they gave her oral steroids to help and an injection in the ear. The injection started to help a little with her hearing because it started slightly coming back, but she has ringing in the ear and felt like she was losing her mind and it kept her up all night. They went back in to the ENT doctor and they told her do not get the second vaccine and were concerned about that but her sister wants to get that second vaccine but it has been 4 months/16 weeks since the first dose. It was a high course dose of oral steroids and it was tapered/went progressively down and that was when they told her to wait for the second vaccine. The oral steroid was Prednisone 20mg. Patient started with (total 60mg) 3 pills a day for 7 days, then (total 40mg) 2 pills a day for 7 days, then (total 20mg) 1 pill a day for 7 days. Then she had the injection, but unsure of the name of the injection, but it was another steroid and given directly into the ear. Since after the injection a little of her hearing is coming back. Her ear was somewhat under control and she does not have the ringing as bad. They are trying to figure out if she would have to start over or even be able to get the second dose or whether its recommended or what would Pfizer say. They were asking if there is a risk of her going through this again or going deaf. They are trying to figure out what direction to go in. The patient was pretty skinny when providing weight. There were no other vaccines administered on the day of COVID-19 vaccination. The outcome of the event Ringing in the ears, Slight hearing loss was recovering, auto-immune reaction, losing the cilia around or in the ear, Felt like she was losing her mind, kept her up all night was not recovered. The events were reported as serious-disabling and related to the suspect drug.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Ear disorder, Autoimmune disorder , Deafness , Tinnitus, Mental disorder, Sleep loss cannot be 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