Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
describes having developed mild to moderate tinnitus after the first dose; This is a literature report for the following literature source(s). A 42-year-old nulliparous White 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. Discussion: 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.; Sender's Comments: The event 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 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-202500113629 same patient/product/events, different dose;US-PFIZER INC-PV202500066251 Same article/drug; different patient/event;
Medical History/Concurrent Conditions: Nulliparous