Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Weight
Clinical narrative: I have had cold and flu like symptoms; I have had cold and flu like symptoms; I was 100 percent deaf in my right ear; deafness; I do not have any hearing back yet; frightening, I was deaf; no hearing; zero; none; gone; deaf in my right ear; DOSE 5 (BOOSTER); DOSE 5 (BOOSTER); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "stomach issues" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal; FAMOTIDINE taken for abdominal discomfort. Vaccination history included: Covid-19 vaccine (Dose: 1), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2), for COVID-19 immunization; Covid-19 vaccine (Dose: 3), for COVID-19 immunization; Covid-19 vaccine (Dose: 4), for COVID-19 immunization; Flu shot (not sure of the date but patient had it as she won't do them both together so there was about a month between them ), for Immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 28Oct2022, outcome "unknown" and all described as "DOSE 5 (BOOSTER)"; DEAFNESS UNILATERAL (medically significant) with onset 31Oct2022, outcome "unknown", described as "I was 100 percent deaf in my right ear; deafness; I do not have any hearing back yet; frightening, I was deaf; no hearing; zero; none; gone; deaf in my right ear"; NASOPHARYNGITIS (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown" and all described as "I have had cold and flu like symptoms". The event "i was 100 percent deaf in my right ear; deafness; i do not have any hearing back yet; frightening, i was deaf; no hearing; zero; none; gone; deaf in my right ear" required physician office visit. Clinical course: The patient had her fifth of series on the 28Oct2022, and by the 31Oct2022, It was not a symptom. The last booster and within 3 days, She was 100 percent deaf in her right ear. She had a hearing test and she was deaf, no hearing, zero, none, gone, deaf in her right ear. That was confirmed by the doctor. She did not have any hearing back yet. She had cold and flu like symptoms since the shot. She would never have gotten that shot if she had known the side effect would be deafness. She did know that she was not the only one that has got become deaf because of this. At the time when it was looked up there were 330 people (Intent: general statement) on the 08Nov2022, She was sure there are more at the time. It was very expensive, it was very frightening. Treatment included: two shots in her inner ear of steroids. She went to her primary care on the 31Oct2022. 1 week later, she went to Ear nose and throat specialist and injected the ear with a steroid. There was no hearing back but there were sensations of touching ear where she got, she thought she could hear it so doctor said she could have the second shot, two shots. One a week after she lost the hearing, and then another week after that. Then she went back in the coming Tuesday for another hearing test to see if anything then she will do an MRI.