Age: 65.0
Sex: F
Vaccine: COVID19, PPV, TDAP
Symptoms: Ageusia, Anosmia, Headache, Pyrexia, Unresponsive to stimuli
Clinical narrative: unresponsive to stimuli; anosmia; ageusia; pyrexia; headache; Initial information received on 22-Jan-2024 regarding an unsolicited valid serious courtesy case received from a consumer/non-healthcare professional.  This case involves a 65 years old female patient who experienced unresponsive to stimuli, anosmia, ageusia, pyrexia and headache after receiving vaccines Pneumovax, Novavax COVID-19 vaccine and Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Hypertension, Renal disorder, Bladder disorder and Blood cholesterol increased.  Concomitant medications included atenolol (Tenolol); furosemide; Phenobarbital; Amitriptyline; and Trifluoperazine.  On 06-Nov-2023, the patient received an unknown dose (dose 1) of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot 25A2F (strength: unknown) via intramuscular route in the right arm as prophylactic vaccination (Immunization). On the same date, the patient also received 0.5 ml dose (dose 1) of NOVAVAX COVID-19 vaccine not produced by Sanofi Pasteur (formulation, lot number and expiry: unknown) not reported via unknown route in the left arm for COVID-19 immunization and an unknown dose of PNEUMOVAX not produced by Sanofi Pasteur (strength, formulation, lot number and expiry: not reported) via unknown route in the left arm as prophylactic vaccination (immunization).  On 06-Nov-2023, the patient developed unresponsive to stimuli (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine, Novavax COVID-19 vaccine and PNEUMOVAX. This event was assessed as medically significant.  On 06-Nov-2023, the patient developed anosmia, ageusia, pyrexia and headache (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine, NOVAVAX COVID-19 vaccine and PNEUMOVAX.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was recovered for all events.  Sender's comments: This 65 year-old female experienced: Unresponsive to stimuli, Ageusia, Anosmia, Headache and Pyrexia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event  unresponsive to stimuli was assessed as serious.The events Ageusia, Anosmia, headache and pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19, adjuvanted (2023-2024 formula) and the reported events in considered possible.; Sender's Comments: Sanofi company comment dated 29-Jan-2024: This case involves a 65 years old female patient who experienced unresponsive to stimuli, anosmia, ageusia, pyrexia and headache after receiving vaccines Pneumovax, Novavax COVID-19 vaccine and Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.