Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Swelling face, Tinnitus
Clinical narrative: ear infection; the right side of my face swolle as well as inside my mouth; the right side of my face swolle as well as inside my mouth; severe ear ache; my hearing wasn't back to normal/hearing loss; I still have constant throbbing pain, ringing and hearing loss in both ears.; I still have constant throbbing pain, ringing and hearing loss in both ears.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Lot number: FF2589) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "covid 19" (unspecified if ongoing), notes: COVID prior vaccination: Yes. Concomitant medication(s) included: ORILISSA. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left), administration date: 15Aug2021, when the patient was 35-year-old, for COVID-19 immunization. The following information was reported: PAIN (disability), TINNITUS (disability) all with onset 16Sep2021, outcome "not recovered" and all described as "I still have constant throbbing pain, ringing and hearing loss in both ears."; EAR INFECTION (disability) with onset 16Sep2021, outcome "not recovered"; DEAFNESS (disability, medically significant) with onset 16Sep2021, outcome "not recovered", described as "my hearing wasn't back to normal/hearing loss"; EAR PAIN (disability) with onset 16Sep2021, outcome "not recovered", described as "severe ear ache"; SWELLING FACE (disability), MOUTH SWELLING (disability) all with onset 16Sep2021, outcome "not recovered" and all described as "the right side of my face swolle as well as inside my mouth". The events "ear infection", "the right side of my face swolle as well as inside my mouth", "severe ear ache", "my hearing wasn't back to normal/hearing loss" and "i still have constant throbbing pain, ringing and hearing loss in both ears." required emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (unspecified date) showing hearing loss, notes: showing hearing loss; SARS-CoV-2 test: (06Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of ear infection, swelling face, mouth swelling, deafness, pain, tinnitus. Therapeutic measures were taken as a result of ear pain.  Clinical information: About a week after getting the vaccine patient got an ear infection so bad the right side of his face swollen as well as inside mouth. He was put on antibiotics for a severe ear ache. After taking the meds he was still in pain and noticed hearing wasn't back to normal. He went to another emergency clinic who told him that he needed to see an ENT, this clinic told him they believed he was having a response to the vaccine. He made an APT for the soonest available where they conducted a hearing test showing hearing loss. He still have constant throbbing pain, ringing and hearing loss in both ears. The patient had her vaccination at Pharmacy or Drug Store. No other vaccine in four weeks.  No follow-up attempts are possible; No further information is expected.