Sex: M
Vaccine: COVID19-2, FLUA4, COVID19, FLU4
Symptoms: Acute respiratory failure, Angiogram, COVID-19, Encephalopathy, Pneumonia
Clinical narrative: Sepsis / Appeared septic; Acute respiratory failure with hypoxia and hypercapnia; Acute encephalopathy; Multifocal pneumonia; Covid-19; This spontaneous case from the United States was retrieved on 07-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2713263-1) reported by other healthcare professional and concerned a male patient of unspecified age (discrepantly reported as 64 and 4-years-old).  The patient's concurrent condition included unspecified mood disorder, essential (primary) hypertension, non-insulin-dependent type 2 diabetes, arteriovenous malformation (AVM), unspecified brain neurocognitive disorder, anxiety with agitation, paroxysmal atrial fibrillation, tremor, and benign prostatic hyperplasia (BPH). The patient's concomitant medications included Tylenol (paracetamol), Pacerone (amiodarone hydrochloride), Amoxil (amoxicillin), aspirin, Plavix (clopidogrel bisulfate), and cyanocobalamin, all used for unreported indications. The patient's historical condition included hemorrhagic stroke (cerebrovascular accident (CVA) due to intracerebral hemorrhage) with subsequent tremor. The patient's historical procedure included Watchman procedure. The patient had no allergies.   It was reported that on 14-Nov-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number reported was AS3705B (reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent (influenza vaccine inact split 4v) instead of reported suspect product Fluad Quadrivalent). Based on the reported batch number, the suspect product was changed to Afluria Quadrivalent.  On the same date, the patient was vaccinated with non-company, co-suspect Covid-19 vaccine reported as Pfizer BioNTech COVID-19 vaccine, bivalent (active ingredient not specified; dose reported as '5', route of administration, anatomical location, and indication: not reported). The batch number reported was GJ6665.  On an unspecified date in 2023, reported as about ten days prior 08-Sep-2023, an unknown amount of time after receiving Afluria Quadrivalent and non-company, co-suspect Covid-19 vaccine, the patient was diagnosed with Covid-19.  On 08-Sep-2023, nine months and 25 days, after receiving Afluria Quadrivalent and non-company, co-suspect Covid-19 vaccine, the patient was brought to the emergency department (ED) and was admitted to hospital with concerns of acute encephalopathy and he appeared septic.  On an unspecified day in Sep-2023, computed tomography angiography (CTA) of chest was performed and revealed concerning for extensive bilateral nodularity, ground-glass, areas of multifocal consolidation consistent with multifocal pneumonia. The patient was diagnosed with severe sepsis and acute respiratory failure with hypoxia and hypercapnia. The patient had been residing in a skilled nursing facility on hospice care. The patient had court-appointed guardian and emergency department physician was able to get in touch with her, and she agreed that patient would want to revoke his hospice for hospitalization, but with no aggressive measures. The patient was treated with unspecified broad-spectrum antibiotics and was placed on positive airway pressure therapy (BiPAP) for increase of breathing. During next 24 hours the patient showed very minimal improvement.  On 10-Sep-2023, after discussion with his guardian, the patient was made comfort measures.  On 11-Sep-2023, nine months and 28 days after receiving Afluria Quadrivalent and non-company, co-suspect Covid-19 vaccine, the patient died. The causes of death were sepsis, acute respiratory failure, Covid-19, encephalopathy acute, and pneumonia. It was unknown if an autopsy was performed.   The reporter did not provide a causality assessment.   The events of sepsis, acute respiratory failure, Covid-19, encephalopathy acute, and pneumonia were assessed as serious due to the seriousness criterion of fatal outcome and hospitalization. Additionally, the events of sepsis, encephalopathy acute, acute respiratory failure, and pneumonia were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  Company comment: On 14-Nov-2022, a male patient of unspecified age (discrepantly reported as 64 and 4-years-old) was vaccinated with Fluad Quadrivalent and non-company, co-suspect Covid-19 vaccine. On 08-Sep-2023, the patient was brought to the emergency department (ED) and was admitted to hospital with concerns of acute encephalopathy and he appeared septic. Ten days before admission, the patient was diagnosed with Covid-19. Computed tomography angiography (CTA) of chest was performed and revealed concerning for extensive bilateral nodularity, ground-glass, areas of multifocal consolidation consistent with multifocal pneumonia. The patient was diagnosed with severe sepsis and acute respiratory failure with hypoxia and hypercapnia. On 11-Sep-2023, the patient died. The causes of death were sepsis, acute respiratory failure, Covid-19, encephalopathy acute, and pneumonia. It was unknown if an autopsy was performed. Causal role of the suspect vaccine is assessed as not related for all events, based on biological and chronological implausibility.; Sender's Comments: On 14-Nov-2022, a male patient of unspecified age (discrepantly reported as 64 and 4-years-old) was vaccinated with Fluad Quadrivalent and non-company, co-suspect Covid-19 vaccine. On 08-Sep-2023, the patient was brought to the emergency department (ED) and was admitted to hospital with concerns of acute encephalopathy and he appeared septic. Ten days before admission, the patient was diagnosed with Covid-19. Computed tomography angiography (CTA) of chest was performed and revealed concerning for extensive bilateral nodularity, ground-glass, areas of multifocal consolidation consistent with multifocal pneumonia. The patient was diagnosed with severe sepsis and acute respiratory failure with hypoxia and hypercapnia. On 11-Sep-2023, the patient died. The causes of death were sepsis, acute respiratory failure, Covid-19, encephalopathy acute, and pneumonia. It was unknown if an autopsy was performed. Causal role of the suspect vaccine is assessed as not related for all events, based on biological and chronological implausibility.; Reported Cause(s) of Death: Sepsis / Appeared septic; Acute respiratory failure with hypoxia and hypercapnia; Covid-19; Acute encephalopathy; Multifocal pneumonia