Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Body mass index, Cardiac hypertrophy, Cardiomegaly, Computerised tomogram head, Generalised tonic-clonic seizure
Clinical narrative: tonic-clonic seizure; he experienced another witnessed seizure; enlarged heart (600 g); cardiac myocyte hypertrophy; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); This serious case was reported in a literature article and described the occurrence of tonic-clonic seizures in a 38-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for an unknown indication. Literature Reference.   Co-suspect products included Tozinameran (Pfizer BioNTech COVID-19 vaccine) for prophylaxis and Tozinameran (Pfizer BioNTech COVID-19 vaccine) for prophylaxis.   Concurrent medical conditions included obesity.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, the 2nd dose of Pfizer BioNTech COVID-19 vaccine and the 1st dose of Pfizer BioNTech COVID-19 vaccine. On an unknown date, 14 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tonic-clonic seizures (Verbatim: tonic-clonic seizure) (serious criteria death and GSK medically significant), seizure (Verbatim: he experienced another witnessed seizure) (serious criteria death and GSK medically significant), heart enlarged (Verbatim: enlarged heart (600 g)) (serious criteria death), cardiac hypertrophy (Verbatim: cardiac myocyte hypertrophy) (serious criteria death) and severe acute respiratory syndrome (Verbatim: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) (serious criteria death and GSK medically significant). The reported cause of death was tonic-clonic seizures, seizure, heart enlarged, cardiac hypertrophy and severe acute respiratory syndrome. An autopsy was performed.   The reporter considered the tonic-clonic seizures, seizure, heart enlarged, cardiac hypertrophy and severe acute respiratory syndrome to be related to Influenza vaccine Quadrivalent unspecified season.   The company considered the tonic-clonic seizures, seizure, heart enlarged, cardiac hypertrophy and severe acute respiratory syndrome to be unrelated to Influenza vaccine Quadrivalent unspecified season.   Additional Information: GSK receipt date: 20-DEC-2024  This case corresponds to a patient mentioned in the case-2 of the literature article.  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 patient was evaluated in the emergency department (ED). His wife reported that the decedent had experienced unusual sensations since patient received his second Pfizer-BioNTech COVID-19 vaccine and a simultaneous influenza vaccine, 14 days before his first seizure. Patient wife also reported that patient had demonstrated some memory deficits since that time. Patient had received his first Pfizer-BioNTech COVID-19 vaccination 6 months prior to his second dose, without any reported complications. The cause of death (COD) was certified as follows: COD was seizure disorder; contributing causes were cardiomegaly; obesity; recent Pfizer-BioNTech COVID-19 vaccination and influenza vaccination. The mode of death (MOD) was ruled as natural. The case was referred to the VAERS. In this case, the temporal association between the vaccines and the new-onset seizures, the lack of another satisfactory explanation for seizure activity, the fact that the decedent experienced sudden death during a witnessed seizure, the lack of another, more adequate explanation for death, and the available medical and scientific literature which proposes a link between the vaccinations and seizures, all led the forensic pathologist to the conclusion that death was the result of a seizure, with contributing factors of cardiomegaly, obesity, and recent COVID-19 and influenza vaccination.   This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Sender's Comments: Generalised tonic-clonic seizure, Seizure, Cardiomegaly, Cardiac hypertrophy and  Severe acute respiratory syndrome are unlisted events which are considered unrelated to GSK vaccine Influenza vaccine Quadrivalent unspecified season.; Reported Cause(s) of Death: tonic-clonic seizure; he experienced another witnessed seizure; enlarged heart (600 g); cardiac myocyte hypertrophy; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)