Received Feb 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT |
she had a severe rise in blood pressure as well as tinnitus in her left ear.; she had a severe rise in blood pressure as well as tinnitus in her left ear.; LIVE TELEPHONIC VACCINE ASSESSMENT PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2021 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (disability), BLOOD PRESSURE INCREASED (disability, medically significant) all with onset 08Oct2021 at 10:00, outcome "unknown" and all described as "she had a severe rise in blood pressure as well as tinnitus in her left ear.". The event "she had a severe rise in blood pressure as well as tinnitus in her left ear." required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of blood pressure increased. Clinical course: The patient says that a day after receiving the COVID vaccine, she had a severe rise in blood pressure as well as tinnitus in her left ear. She went to her doctor the following Monday, 11Oct2021, and her doctor started her on blood pressure medicine to help control elevated blood pressure, and referred her to 2 different ENT doctors. The first one did an MRI for her, and the second measured her hearing loss due to the tinnitus, neither problem she had before the vaccination. The reporter's assessment of the causal relationship of "she had a severe rise in blood pressure as well as tinnitus in her left ear." with the suspect product(s) BNT162b2 omicron (lp.8.1) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Based on available information and close temporal association, the role of suspected drug BNT162b2 omicron (lp.8.1) causing the reported events blood pressure increased and tinnitus cannot be totally excluded, hence assessed as related to suspect drug. 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.
Test Name: Measured hearing loss; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results