Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
tonic-clonic seizure; received his first Pfizer-BioNTech COVID-19 vaccination 6 months prior to his second dose; This is a literature report for the following literature source(s). A 38-year-old male experienced a witnessed tonic-clonic seizure, became unresponsive, and died after failed resuscitation attempts by his wife, who was a nurse, and emergency medical services. The decedent had experienced a witnessed first onset tonic-clonic seizure 20 days earlier, at which time he was evaluated in the ED, where a head CT scan was negative, laboratory tests were non-contributory, no official explanation for the seizure was identified, and he was discharged. He was awaiting an appointment for neurologic work-up. His wife reported that the decedent had experienced unusual sensations since he received his second Pfizer-BioNTech COVID-19 vaccine and a simultaneous influenza vaccine, 14 days before his first seizure. She also reported that he had demonstrated some memory deficits since that time. He had received his first Pfizer-BioNTech COVID-19 vaccination 6 months prior to his second dose, without any reported complications. A full medicolegal autopsy was performed, which disclosed an obese male (Body Mass Index 43.7 kg/m²) with an enlarged heart (600 g) with associated cardiac myocyte hypertrophy, a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA nasal swab, but negative lung histology. A full neuropathology examination was performed by a Board-certified forensic neuropathologist, including an examination of the brain, the spinal cord, the dura mater, and the pituitary gland. No abnormalities were identified grossly or microscopically. Blood was sent for genetic arrhythmia/cardiomyopathy panel testing, which disclosed two variants of uncertain significance. Toxicology testing revealed cannabinoids within postmortem blood samples. Vitreous electrolytes were within normal limits. The COD was certified as follows: COD: seizure disorder; contributing causes: cardiomegaly; obesity; recent Pfizer-BioNTech COVID-19 vaccination and influenza vaccination. The MOD was ruled as natural. The case was referred to the VAERS.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product BNT162B2 vaccine to the reported fatal event Generalised tonic-clonic seizure cannot be excluded. This patients underlying obesity with an enlarged heart are assessed as additional contributing factors. As per the available information, cause of death was certified as "seizure disorder; contributing causes: cardiomegaly; obesity; recent Pfizer-BioNTech COVID-19 vaccination and influenza vaccination". Case will be reassessed upon receipt of additional information. 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.; Reported Cause(s) of Death: new-onset seizures; cardiomegaly; Autopsy-determined Cause(s) of Death: obese; enlarged heart; cardiac myocyte hypertrophy
Medical History/Concurrent Conditions: Tonic-clonic seizures
Test Name: complete autopsy; Result Unstructured Data: Test Result:revealed no explanation for the seizure; Comments: but cardiomegaly and obesity were documented.; Test Name: Blood; Result Unstructured Data: Test Result:disclosed two variants of uncertain significance; Comments: Blood was sent for genetic arrhythmia/cardiomyopathy panel testing; Test Name: Body Mass Index; Result Unstructured Data: Test Result:43.7; Comments: Unit: Kg/m2; Test Name: head CT scan; Test Result: Negative ; Test Name: lung histology; Test Result: Negative ; Test Name: Vitreous electrolytes; Result Unstructured Data: Test Result:within normal limits; Test Name: laboratory tests; Result Unstructured Data: Test Result:were non-contributory, no; Comments: official explanation for the seizure was identified; Test Name: neuropathological examination; Result Unstructured Data: Test Result:revealed no explanation for the seizure; Comments: but cardiomegaly and obesity were documented. No abnormalities were identified grossly or microscopically. including an examination of the brain,the spinal cord, the dura mater, and the pituitary gland.; Test Name: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA nasal swab; Test Result: Positive ; Test Name: toxicological analysis; Result Unstructured Data: Test Result:revealed no explanation for the seizure; Comments: but cardiomegaly and obesity were documented.; Test Name: Toxicology testing; Result Unstructured Data: Test Result:revealed cannabinoids within postmortem blood; Comments: samples