Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Apnoea, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care
Clinical narrative: Guillian-Barre Syndrome; Unable to attend his daily living needs; Apneic in the evenings; This is a spontaneous case reported by other health care professional (nurse) to Med Communications (reference number: SEQ19-066005) and initially received on 13-Nov-2019, concerning a 31-year-old, male patient.  The patient's medical history was not reported  The patient did not take any concomitant medications.  On unspecified date in 2018, patient received unspecified flu vaccine with no adverse reaction reported.  On 10-Oct-2019, the patient completed a vaccine questionnaire and answered no to experiencing any numbness, weakness, allergy to egg, latex or formaldehyde after receiving vaccines.  On 22-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100123039 and expiration date: 30-Jun-2019] for influenza prophylaxis.  On 31-Oct-2019, nine days after vaccination, the patient experienced tingling in his hands.  On 06-Nov-2019, fifteen days after vaccination, the patient went to Emergency Room and was scheduled to have a magnetic resonance imaging (MRI).  On 07-Nov-2019, sixteen days after vaccination, MRI was performed but no results were available at that time.  On 08-Nov-2019, seventeen days after vaccination, the patient came back to the Emergency Room with gross motor function deterioration. A spinal tap was performed.  On an unspecified date in Nov-2019, after the spinal tap was performed, Guillian-Barre Syndrome was confirmed. Patient was admitted to intensive care unit (ICU), placed on oxygen, intravenous (IV) fluids and IV immunoglobulin (IG) were started. He was not intubated but was reported that patient was apneic in the evenings. It was reported that patient was unable to walk or attend to his daily living needs.  On-11-Nov-2019, the patient was transferred to a regular unit and some motor function had returned. It was reported that patient was able to write his name and plan was to transfer him to a skilled facility were being made. The reporter said that he was leaving in 48 hours and will be there for 9 days but will call when he receives any additional information.  At the time of initial reporting, the outcome of the events Guillian-Barre Syndrome and ' loss of personal independence in a daily activities' were not resolved and outcome of the event apnoea was not reported.  The reporter assessed the case as serious, while the causality assessment was not provided.  Company Comment: The patient experienced Guillain-Barre syndrome, apnoea and loss of personal independence in daily activities after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced Guillain-Barre syndrome, apnoea and loss of personal independence in daily activities after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.