Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | — |
syncopal episode along with loss of bladder control; syncopal episode along with loss of bladder control; This is a literature report for the following literature source(s). A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant), 2 hrs after the suspect product(s) administration, outcome "recovered", URINARY INCONTINENCE (non-serious), 2 hrs after the suspect product(s) administration, outcome "unknown" and all described as "syncopal episode along with loss of bladder control". The event "syncopal episode along with loss of bladder control" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood calcium (8.7-10.2): 22 mg/dl; Blood chloride (96-106): 103 mmol/L; Blood creatinine (0.76-1.27): 0.98 mg/dl; Blood glucose (65-99): 96 mg/dl; Blood potassium (3.5-5.2): 4.5 mmol/L; Blood sodium (134-144): 140 mmol/L; Blood thyroid stimulating hormone (0.450-4.500): 1.2 uiU/mL; Blood urea (6-20): 12 mg/dl; Carbon dioxide (20-29): 22 mmol/L; Cardiac function test: normal and unremarkable for any deficits, notes: including cognitive or mood impairment; Electrocardiogram: unremarkable; labs: unremarkable; Magnetic resonance imaging head: unremarkable, notes: other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team; unremarkable, notes: other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team; Neurological examination: normal and unremarkable for any deficits, notes: including cognitive or mood impairment; Vital signs measurement: unremarkable; Vitamin D (30.0-100.0): 20.9 ng/ml. Clinical course: A 38-year-old male with no pertinent past medical history, former high school football player and wrestler with no family history, presented to the clinic after having a syncopal episode along with loss of bladder control. The syncopal event lasted around 30 seconds, about two hours after his third Pfizer booster injection. The patient had a recollection of events prior to the event, and his wife, who witnessed this, denied any seizure-like activity or him describing chest pain or arrhythmia. His wife immediately called emergency medical services; EKG and vitals were performed on the scene, which were unremarkable, and the patient was not taken to the hospital. The patient denies palpitations prior to or after the event. The patient was seen by a neurologist where an MRI of the head was ordered with and without contrast which was unremarkable other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team. Neurological and cardiac exams were normal and unremarkable for any deficits, including cognitive or mood impairment. His labs were also unremarkable. Discussion: Syncope has diverse etiologies ranging from cardiogenic to neurally mediated. While most of the syncopal episodes in the literature following mRNA vaccination are attributed to anxiety-related events, this was not the case in this patient. The World Health Organization mentions this to be a serious neurologic adverse event warranting reporting to VAERS despite not having been done by the patient's physicians previously. A cardiogenic inflammatory response might have caused transient neurologic symptoms if myocarditis ensued, which propagated a transient arrhythmia in this 38-year-old patient, given the presence of his syncopal episode. Given that the relative risk of myocarditis in young males has shown to be higher after COVID-19 mRNA second vaccination vs. from infection, this is very troublesome given how many people are infected on top of being vaccinated and a true concern for many eligible children and adolescents. This case contributes to prior concerns of adverse events showing up only after already passing through authorization phase trials, which are defined as serious. While the pathology and location of S-spike protein deposition was also not an endpoint in any of the initial trials, the authors do know now that this has been shown to induce central nervous system (CNS) inflammation.; Sender's Comments: The event syncope is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient, concomitant medications, and/or immunization-anxiety related. 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-PV202500065305 Same article/drug; different patient/event;US-PFIZER INC-202500113628 Same article/drug; different patient/event;
Test Name: Calcium; Test Result: 22 mg/dl; Test Name: Chloride; Result Unstructured Data: Test Result:103 mmol/L; Test Name: Creatinine; Test Result: 0.98 mg/dl; Test Name: Glucose; Test Result: 96 mg/dl; Test Name: Potassium (K); Result Unstructured Data: Test Result:4.5 mmol/L; Test Name: Sodium (Na); Result Unstructured Data: Test Result:140 mmol/L; Test Name: Thyroid-stimulating hormone (TSH); Result Unstructured Data: Test Result:1.2 uiU/mL; Test Name: Blood urea nitrogen (BUN); Test Result: 12 mg/dl; Test Name: Co2; Result Unstructured Data: Test Result:22 mmol/L; Test Name: cardiac exam; Result Unstructured Data: Test Result:normal and unremarkable for any deficits; Comments: including cognitive or mood impairment; Test Name: EKG; Result Unstructured Data: Test Result:unremarkable; Test Name: labs; Result Unstructured Data: Test Result:unremarkable; Test Name: MRI of the head with contrast; Result Unstructured Data: Test Result:unremarkable; Comments: other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team; Test Name: MRI of the head without contrast; Result Unstructured Data: Test Result:unremarkable; Comments: other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team; Test Name: Neurological exam; Result Unstructured Data: Test Result:normal and unremarkable for any deficits; Comments: including cognitive or mood impairment; Test Name: vitals; Result Unstructured Data: Test Result:unremarkable; Test Name: Vitamin D; Result Unstructured Data: Test Result:20.9 ng/ml