Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Ear discomfort, Head discomfort, Hypoacusis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 13:00 (Lot number: ER8727) at the age of 64 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Dilaudid, reaction(s): "Known allergies: Dilaudid". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0161,, Vaccine location: Right arm), administration date: 22Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 12Apr2021, outcome "not recovered", described as "hearing loss has been significant"; TINNITUS (non-serious) with onset 12Apr2021, outcome "not recovered", described as "tinnitus"; EAR DISCOMFORT (non-serious) with onset 12Apr2021, outcome "not recovered", described as "ears felt like they were under unbelievable pressure"; HEAD DISCOMFORT (non-serious) with onset 12Apr2021, outcome "not recovered", described as "my head felt like it was going to blow apart"; HYPOACUSIS (non-serious) with onset 12Apr2021, outcome "not recovered", described as "declined in hearing"; NEUROMA (non-serious) with onset 12Apr2021, outcome "not recovered", described as "MRI of head to rule out neuroma". The events "hearing loss has been significant", "tinnitus", "ears felt like they were under unbelievable pressure", "my head felt like it was going to blow apart", "declined in hearing" and "MRI of head to rule out neuroma" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: acoustic stimulation tests: (12Apr2021) showed declined in hearing; magnetic resonance imaging: (12Apr2021) unknown results. Therapeutic measures were taken as a result of deafness, tinnitus, ear discomfort, head discomfort, hypoacusis, neuroma. Clinical course: The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not tested for Covid post vaccination. "After second dose within 12 hours, my head felt like it was going to blow apart, both ears felt like they were under unbelievable pressure, from that day on, the tinnitus, and hearing loss has been significant, hearing test showed declined in hearing. I was put on prednisone, had MRI of head to rule out neuroma. Have had multiple hearing tests. The tinnitus remains, it is unbearable at times. When I tilt head backwards slightly, the tinnitus, hissing, gets louder". Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnaty in triggering the onset of deafness, tinnitus, ear discomfort, head discomfort, hypoacusis, neuroma. 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.