Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Aphthous ulcer, Body temperature, Chills, Computerised tomogram
Clinical narrative: Swelling baseball size at injection site; fever; chills; Sudden loss of hearing left ear; Tinnitus; Canker sores; nose sores; weight gain; Tremors/internal vibrations at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 14:00 (Lot number: Er8729) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0161, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 17Apr2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (disability) with onset 07May2021, outcome "not recovered", described as "Swelling baseball size at injection site"; PYREXIA (disability) with onset 07May2021, outcome "not recovered", described as "fever"; CHILLS (disability) with onset 07May2021, outcome "not recovered", described as "chills"; DEAFNESS UNILATERAL (disability) with onset 07May2021, outcome "not recovered", described as "Sudden loss of hearing left ear"; TINNITUS (disability) with onset 07May2021, outcome "not recovered", described as "Tinnitus"; APHTHOUS ULCER (disability) with onset 07May2021, outcome "not recovered", described as "Canker sores"; NASAL DISORDER (disability) with onset 07May2021, outcome "not recovered", described as "nose sores"; WEIGHT INCREASED (disability) with onset 07May2021, outcome "not recovered", described as "weight gain"; TREMOR (disability) with onset 07May2021, outcome "not recovered", described as "Tremors/internal vibrations at night". The events "swelling baseball size at injection site", "fever", "chills", "sudden loss of hearing left ear", "tinnitus", "canker sores", "nose sores", "weight gain" and "tremors/internal vibrations at night" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: acoustic stimulation tests: (unspecified date) unknown results; body temperature: (07May2021) unknown results; computerised tomogram: (unspecified date) unknown results; weight: (07May2021) rapid weight gain, 30+ pounds right away. Therapeutic measures were taken as a result of vaccination site swelling, pyrexia, chills, deafness unilateral, tinnitus, aphthous ulcer, nasal disorder, weight increased, tremor. Additional information: The patient had no other vaccine in four weeks. Patient had other medication in two weeks which was Fluoxetine. On 07May2021, the patient experienced swelling baseball size at injection site, fever/chills after 2nd dose, sudden loss of hearing left ear, tinnitus both ears, canker sores 10+ at a time and nose sores, rapid weight gain, 30+pounds right away, and tremors/internal vibrations at night. The patient had no covid prior vaccination and was not tested for covid post vaccination. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.