Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Brain scan abnormal, CSF test abnormal, Decreased activity, Gait disturbance
Clinical narrative: Guillain Barre; This spontaneous case was received on 22-Sep-2020 from other non-health professional (consumer) via Communications (reference number: SEQW20-02122) and concerned a 69-year-old male patient (the patient's age was also reported as 66 years).   The patient had no medical history before receiving the vaccine. The patient's concomitant medications were not reported. Reportedly, before vaccination, the patient was playing tennis and was very active, he was healthy, and he barely even had the flu.   On 23-Sep-2012, the patient was vaccinated with Fluvirin vaccine, 5 ml multi dose vial (MDV), (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose, route of administration and anatomical location: not reported) for flu prophylaxis. The batch number was not reported.  On an unknown date, shortly after receiving Fluvirin, the patient started not feeling well. He could barely walk and since then he became "a couch potato" (as reported).  On an unspecified date in Oct-2012, about a month later after receiving Fluvirin vaccine, the patient's balance was off, and he stated that fluid was taken out of his spine and was diagnosed with Guillain Barre syndrome.  On an unknown date, the patient was hospitalized due diagnosis of Guillain Barre syndrome.   On unspecified dates, for the next 7-8 years after receiving Fluvirin vaccine, the patient was in and out of the hospitals with multiple problems. The patient had a brain scan that revealed whiteness.   At the time of initial reporting on 22-Sep-2020, the patient had not recovered from the event and he had to walk with a walker.  The reporter considered the event of 'Guillain Barre syndrome' to be related to Fluvirin. The reporter spent the last eight years researching the cause of the disease and found that it could have been caused by the flu vaccine he had received.   This case is linked to 202005002 (the same reporter).   The event of 'Guillain Barre syndrome' was considered to be serious due to hospitalization and medical significance by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Additional information received on 06-Oct-2020 from other non-health professional (consumer): Reporter's causality was provided. Narrative was amended accordingly.  Additional information received on 04-Nov-2020 from other non-health professional (consumer) via Communications (reference number: SEQW20-04768): Correspondence contact added. Date of vaccination was provided, and indication verbatim was amended from 'influenza prophylaxis' to 'flu prophylaxis'. Hospitalization added as seriousness criterion for the event. The narrative was amended accordingly.   Company comment: A 69-year-old male patient was vaccinated with Fluvirin vaccine. About a month later after receiving Fluvirin vaccine, the patient's balance was off, and he stated that fluid was taken out of his spine and was diagnosed with Guillain Barre syndrome. Chronology is plausible. More information regarding diagnostic findings, medical history and concomitant medications is needed. Reportedly, before vaccination, the patient was playing tennis and was very active. Based on provided information, causality is assessed as possibly related. Brighton collaboration criteria for Guillain Barre syndrome could not be assessed due to insufficient information provided.; Reporter's Comments: The reporter spent the last eight years researching the cause of the disease and found that it could have been caused by the flu vaccine he had received.; Sender's Comments: A 69-year-old male patient was vaccinated with Fluvirin vaccine. About a month later after receiving Fluvirin vaccine, the patient's balance was off, and he stated that fluid was taken out of his spine and was diagnosed with Guillain Barre syndrome. Chronology is plausible. More information regarding diagnostic findings, medical history and concomitant medications is needed. Reportedly, before vaccination, the patient was playing tennis and was very active. Based on provided information, causality is assessed as possibly related. Brighton collaboration criteria for Guillain Barre syndrome could not be assessed due to insufficient information provided.