Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Sepsis
Clinical narrative: Delusion; Dysgraphia; Fine motor skill dysfunction; Mental Status Changes; Sepsis; Initial information received on 25-Oct-2024 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 79 years old female patient who experienced delusion, dysgraphia, fine motor skill dysfunction, mental status changes and sepsis after receiving varicella zoster vaccine RGE (CHO), RSV vaccine, Pneumococcal vaccine polysacch 23v [Pneumovax], COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine] and influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history included Rheumatoid arthritis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity.  Concomitant medications included Methylprednisolone aceponate (Methylprednisolone); and Leflunomide both for Product used for unknown indication.  On 16-Sep-2024, the patient received an unknown dose of Novavax COVID-19 Vaccine not produced by Sanofi Pasteur (formulation, strength, expiry date- unknown, lot 6024MF013), received an unknown dose of Pneumovax not produced by Sanofi Pasteur (formulation, strength, expiry date- unknown, lot X027348), received an unknown dose of RSV VACCINE not produced by Sanofi Pasteur (formulation, strength, expiry date- unknown, lot HN3801), received an unknown dose of varicella zoster vaccine RGE (CHO) not produced by Sanofi Pasteur formulation, strength, expiry date- unknown, lot T4HR9) and an unknown dose of influenza quadrival A-B high dose HV vaccine (formulation, strength, expiry date- unknown, lot U8249CA) all via intramuscular route in unknown administration site as prophylactic vaccination (Immunization).  On 16-Sep-2024 the patient developed delusion, dysgraphia, fine motor skill dysfunction, mental status changes and sepsis (latency same day) following the administration of influenza quadrival A-B high dose HV vaccine, Novavax COVID-19 Vaccine, Pneumovax, RSV vaccine and varicella zoster vaccine RGE (CHO).   Reportedly, The CDC's (centers for disease control and prevention) adverse event description (narrative) was provided as follows: Per conversation with daughter, patient was admitted to Medical Center emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a CT (Computerised tomogram) scan was performed.  Relevant laboratory test results included: Computerised tomogram - On 16-Sep-2024:  [unknown]  Action taken was not applicable for all.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria: All the events were assessed as medically significant. The patient was hospitalized for all the events during 2 days from an unknown date in 2024.  Sender's comment: This 79 year-old Female experienced Delusion, Dysgraphia, Fine motor skill dysfunction, Mental status changes and Sepsis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Delusion, Dysgraphia, Fine motor skill dysfunction, Mental status changes and Sepsis were reported as serious. Based on the spontaneous nature of the report, the causal relationship between Delusion, Dysgraphia, Fine motor skill dysfunction, Mental status changes and Sepsis is considered Possible.; Sender's Comments: Sanofi company comment dated 06-Nov-2024: This case involves a 79 years old female patient who experienced delusion, dysgraphia, fine motor skill dysfunction, mental status changes and sepsis after receiving varicella zoster vaccine RGE (CHO), RSV vaccine, Pneumococcal vaccine polysacch 23v [Pneumovax], COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine] and influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent]. Patient's concomitant medications included Methylprednisolone aceponate (Methylprednisolone); and Leflunomide both for Product used for unknown indication all serve as confounding factors in the events. Furthermore, patient information regarding medical history, condition at the time of vaccination, clinical course, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.