Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Tinnitus worsened after the second dose; This is a literature report for the following literature source(s). A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Nulliparous" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Tinnitus". Here the authors illustrate three individuals with an average age of 36 who presented with distinct neurological side effects, all within hours after the Pfizer mRNA vaccine. The fact that each presented within eight weeks of one another by Jan2022 to a small volume practice, while none of these individuals had prior vaccination adverse reactions as children, raises serious safety concerns among younger populations. All three patients are still struggling with these symptoms. A 42-year-old nulliparous female with no past medical history of illness or disease presented to the clinic six months after receiving her two doses of Pfizer COVID-19 vaccine. The patient denies having had COVID-19 previously and describes having developed mild to moderate tinnitus after the first dose. Although she felt it somewhat improving, she was still expected to receive the second shot or compromise her diplomatic status abroad despite her voiced concerns. Her tinnitus worsened after the second dose and has since been persistent. Her physical exam was unremarkable for any auricular or middle ear findings, Dix-Hallpike maneuver, as well as a complete neurological and cardiac exam. The patient was referred by the primary care physician to an otolaryngologist who performed audiometric testing, which was negative, with no subsequent blood work. She was later told that nothing else could be done, and no labs were further ordered. As people continue to ensure appropriate access to COVID-19 mRNA vaccinations, it is as important to know which groups or individuals may not be such candidates. Neurological issues from vaccination may be the direct toxic effect of S-spike proteins as it damages the blood-brain barrier and can lead to immune dysregulation processes. The authors also know tinnitus is not an exclusively auditory problem but may result from neurological changes within the auditory system and has been known to have neurological etiology from peripheral and central cytokine-mediated responses. Tinnitus is not new in the literature after COVID-19 and mRNA vaccines. In fact, recently, a case series of three patients reported tinnitus following Pfizer mRNA vaccination where two of the three people were also younger reaffirming this as a concerning risk factor. The case represents a unique scenario since the patient developed tinnitus after the first shot yet became more pronounced and persistent after the second. According to the literature search, this implies causation with a dose-dependent impact not seen before. Since S-spike protein has already been identified as causing blood-brain barrier permeability as well as promoting intestinal permeability, this may explain such an inflammatory phenomenon.These three cases in young individuals with serious neurologic sequelae may, in fact, indicate only the beginning of adverse reactions lurking in younger populations as time and proper reporting are the only way to tell in the future. This raises concern of risk vs. benefit as there is no long-term safety with rising concerns in the short run.; Sender's Comments: The event worsening of tinnitus is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient, previous vaccinations and/or concomitant medications. 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.,Linked Report(s) : US-PFIZER INC-202500113628 Same patient and product; different dose and events;
Medical History/Concurrent Conditions: Nulliparous
Test Name: Audiometric testing; Test Result: Negative ; Test Name: Cardiac exam; Result Unstructured Data: Test Result:Unremarkable for any auricular; Comments: Or middle ear findings; Test Name: Neurological exam; Result Unstructured Data: Test Result:Unremarkable for any auricular; Comments: Or middle ear findings; Test Name: Physical exam; Result Unstructured Data: Test Result:Unremarkable for any auricular; Comments: Or middle ear findings; Test Name: Dix-Hallpike maneuver; Result Unstructured Data: Test Result:Unremarkable for any auricular; Comments: Or middle ear findings