Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram abnormal, Fall, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: postural orthostatic tachycardia syndrome; experienced symptoms of syncope; Collapse; Heart palpitations; Dizziness; Initial information regarding an unsolicited valid serious case received from the other healthcare professional via phone at call center (Reference number: US-SANOFI-00426245) on 12-Jan-2021.  This case involved a 19-year old female patient who experienced postural orthostatic tachycardia syndrome, after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient received no concomitant medications.  On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED 0.5 mL multi-dose vial (lot number: UJ477AB, expiry date: 30-Jun-2021) via an unknown route in the right deltoid for prophylactic vaccination.  On 22-Oct-2020, 3 days following the suspect product vaccinations, the patient experienced symptoms of syncope, collapse (Fall), heart palpitations (Palpitations), and dizziness. Reporter that the patient had visited the emergency room. After being symptomatic for a while, the patient was seen at the reporting primary care practice on 12-Nov-2020, where an electrocardiogram was performed, which was abnormal. Patient was referred to a neurologist on 11-Dec-2020, Doctor who suspected postural orthostatic tachycardia syndrome (POTS), and the patient was referred to Genetics on 21-Dec-2020.   On 21-Dec-2020, 2 months 2 days following the suspect product vaccinations, at genetics, patient underwent a tilt table test, which confirmed postural orthostatic tachycardia syndrome (POTS). Patient had a follow-up appointment with neurologist on 28-Dec-2020.   Final diagnosis was postural orthostatic tachycardia syndrome.  The event of postural orthostatic tachycardia syndrome associated with accompanying symptoms of syncope, palpitations, dizziness and fall were assessed as important medical event as the accompanying symptom of syncope was assessed as medically significant as per important medical event list.  It was not reported if the patient received a corrective treatment.  Outcome of the event of postural orthostatic tachycardia syndrome with its accompanying symptoms was unknown.  The neurologist and other members of the patient's healthcare team believe that the patients POTS was related to the Fluzone vaccine the patient received.; Sender's Comments: This case involved a 19-year old female patient who presented with postural orthostatic tachycardia syndrome (POTS) accompanied with symptoms of fall, dizziness, syncope and palpitations three days (although  diagnosed on a later date) following INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE). Time to onset is compatible. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.