Sex: F
Vaccine: FLUR4
Symptoms: Gait disturbance, Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Loss of control of legs
Clinical narrative: Initial information received on 22-May-2019 regarding an unsolicited valid serious case downloaded from the VAERS database received from a consumer/non-HCP with VAERS ID-784597. This case involves a 66 years old female patient who experienced cardiac Areflexia, Bilevel positive airway pressure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance,Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis, muscle weakness worsened, lost ability to walk, paralysis waist down, ended up on bipap (Bilevel positive airway pressure) while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 17-Sep-2018, the patient received a dose of suspect FLUBLOK QIV lot number QFAA1818 via unknown route in unknown administration site. On 30-Sep-2018, the patient developed a Areflexia, Bilevel positive airway pressure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance, Gait inability, Guillain-Barre syndrome, Hypoesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis, muscle weakness worsened, lost ability to walk, paralysis waist down, ended up on bipap (Bilevel positive airway pressure) 13 days following the administration of FLUBLOK QIV. All the events were assessed as medically significant. Final diagnosis was Areflexia, Bilevel positive airway pressure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance,Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis, muscle weakness worsened, lost ability to walk, paralysis waist down, ended up on bipap (Bilevel positive airway pressure). It was not reported if the patient received a corrective treatment. Outcome of all the events were not reported. List of documents held by send one. Sender's Comments: This case involves a 66 years old female patient presented with Areflexia, Bilevel positive airway pre ssure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance, Gait inability, Hypoaesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis and diagnosed with Guillain-Barre syndrome after vaccination with FLUBLOK QIV. Time to onset is compatible. The exact cause of Guillain-Barre syndrome is unknown. But it is often preceded by an infectious illness, recent surgery or immunization. Additional information viz. medical history, any similar episodes to previous immunization, laboratory investigations results ruling out other infectious etiology is needed to complete the assessment. Based upon the reported information, the role of the vaccine cannot be assessed.