Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Burning Mouth Syndrome; This is a literature report for the following literature source(s). A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypoplastic right lung" (unspecified if ongoing); "attention deficit hyperactive disorder" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lithium for bipolar disorder; Oxcarbazepine for bipolar disorder. Vaccination history included: Bnt162b2 (Lot Number unknown; Dose 1), for COVID-19 immunization, reaction(s): "burning mouth syndrome". The following information was reported: BURNING MOUTH SYNDROME (medically significant), outcome "recovering". The event "burning mouth syndrome" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: which did not show any pathology., notes: normal oral mucosa confirmed on biopsy; Magnetic resonance imaging head: which was unremarkable.; Neurological examination: normal; physical exam: unremarkable, notes: normal-appearing oral mucosa without lesions or erythema (consistent with a diagnosis of BMS); severity: from a 6 to 10. Therapeutic measures were taken as a result of burning mouth syndrome. Clinical course: In the below report, we present the first known case of a male patient who presented with burning mouth syndrome subsequently after Pfizer COVID-19 vaccination, as well as a unique, multimodal approach to effective treatment. A 39-year-old male with a past medical history of hypoplastic right lung, bipolar disorder (on lithium and oxcarbazepine), attention deficit hyperactive disorder, and migraines presented to the clinic with a burning sensation located on the dorsal aspect of his tongue with an altered sensation of old food residues and xerostomia. This sensation was constant and fluctuated in severity from a 6 to 10. One year earlier, the patient received the first Pfizer COVID-19 vaccination. He noted that about 90 min after the vaccination, he began to feel a burning sensation in his feet that extended up towards his mouth and cheeks. He had an episode of presumed vasovagal syncope shortly after that resolved without treatment or further workup. The burning sensation in his mouth has persisted since. He also noted that after the second vaccination dose 1 month after the first, he developed stiffness throughout his body and could not eat for 2 days. Although the burning pain in his mouth had slightly improved since the initial onset, it still affected his ability to work. The patient subsequently underwent an MRI of the head, which was unremarkable. He also underwent a biopsy of the tongue, which did not show any pathology. Prior to presenting in our clinic, the patient tried gabapentin, Lyrica, dexamethasone oral wash, saliva supplements, and CBD with titration to maximum dosages without relief. He noted that oral lidocaine and nystatin swish and spit provided mild relief for 30 min at a time. The physical exam was unremarkable, including a normal neurologic examination as well as normal-appearing oral mucosa without lesions or erythema. At his 2-month follow-up appointment post zinc initiation, the patient reported that he started acupuncture on the tongue. This combined with zinc and oral capsaicin washes provided a near-complete resolution of his pain and xerostomia. In this case, the patient presented with a history and physical exam consistent with a diagnosis of BMS. The patient gained significant benefits from oral capsaicin, oral zinc supplementation, as well as acupuncture of the tongue. This is the first known case in which a unique, multimodal approach to treatment was effective in a patient with new-onset BMS immediately following the first dose of the Pfizer COVID-19 vaccination. This case demonstrated the successful management of post-vaccine BMS through a unique multimodal approach. Oral capsaicin 0.02% rinse provided the patient with good, transient relief. Oral daily zinc supplementation also provided the patient with significant relief of the pain symptoms. Nearly 2 months of daily acupuncture was beneficial in not only this patient's pain but xerostomia symptoms as well.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of burning mouth syndrome might not be fully ruled out, considering the temporal relationship. More epidemiologic and accumulative clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and explore the plausible physiopathologic mechanism between the vaccination and the occurrence. 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-PV202500055482 Same patient/drug; different dose;
Medical History/Concurrent Conditions: Attention deficit hyperactivity disorder; Migraine; Pulmonary hypoplasia
Test Name: biopsy of the tongue; Result Unstructured Data: Test Result:which did not show any pathology.; Comments: normal oral mucosa confirmed on biopsy; Test Name: severity; Result Unstructured Data: Test Result:from a 6 to 10; Test Name: MRI of the head; Result Unstructured Data: Test Result:which was unremarkable.; Test Name: neurologic examination; Result Unstructured Data: Test Result:normal; Test Name: physical exam; Result Unstructured Data: Test Result:unremarkable; Comments: normal-appearing oral mucosa without lesions or erythema (consistent with a diagnosis of BMS)