Age: 60.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Blood test normal, Cardiac monitoring normal, Cardiac stress test normal, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: he was driving hit a telephone poll and flipped his car; vasovagal syncope episode; lost consciousness; Initial information regarding an unsolicited valid serious case was received from a pharmacist/ veterinarian (patient's wife) via Agency (Reference number- 00362003) and transmitted to Sanofi on 17-Nov-2020.  This case involves a 60 years old male patient had vasovagal syncope episode (syncope), lost consciousness (loss of consciousness) while driving and hit a telephone pole and flipped his car (road traffic accident) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no concomitant vaccines.   On 10-Nov-2020 12:03 PM, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry date was not reported) (Strength: standard) once via an unknown route in unknown administration site.  On 10-Nov-2020 the patient developed serious vasovagal syncope episode (syncope) and lost consciousness (loss of consciousness) while driving four hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  At 4:15pm (soon after losing consciousness), the patient hit a telephone pole and flipped his car (road traffic accident) 4 hours 12 minutes following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. These events were assessed as medically significant.  The patient was hospitalized for these events for 24 hours.  Patient was being evaluated in hospital and he has 30 days of medical evaluation scheduled and also not allowed to drive for at least 30 days. Patient scheduled for a stress test too.  Patient wanted to get shingles vaccine too but she told him not to get it as that has the same side effect of vasovagal syncope.  The autobody shop person who towed her vehicle told that they have had 3 separate vehicles they have towed where the person driving had lost consciousness. The autobody shop person did not know if these were related to any vaccine or medication. But it makes her wonder as they are a very small town and to have so many of these same type of accidents.  Caller said anytime she has reported an adverse event for a patient for a vaccine, she knows those manufacturers have compensated patient. No other drug names mentioned. She does understand that other things would have to be ruled out first before Sanofi will give her compensation. Reporter relationship : Caregiver . Laboratory data was not provided   It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of events were unknown.; Sender's Comments: This case concerns 60 years old male patient who had road traffic accident, syncope and loss of consciousness same day after vaccination with FLUBLOK QIV. The time to onset is compatible. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.