Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Diplopia, Impaired driving ability, Nuclear magnetic resonance imaging brain normal, Photophobia
Clinical narrative: Initial report received on 18 October 2012 and follow up report received on 25 October 2012 from an Investigator participating in a study. A 74-year-old female subject experienced double vision on 11 October 2012 i.e. 01 day after receiving the first dose of study vaccine (FLUZONE High Dose or FLUZONE) on 10 October 2012. The subject had medical history of hypertension and neuralgia of the face since 1950. It was reported that the subject experienced double vision and photophobia on 11 October 2012, approximately 25 hours after receiving study vaccine. She was unable to drive. The subject visited an ophthalmologist on 11 October 2012 who observed no findings. The laboratory investigation included magnetic resonance imaging of brain on 15 October 2012 which showed no acute intracranial abnormality. Corrective treatments were not reported. The seriousness criterion was reported as other important medical event specified as double vision. The event of double vision along with associated symptoms of double vision and photophobia was ongoing at the time of this report. According to the investigator, the event of double vision was related to the study vaccine but not related to the trial procedures. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by the sender: None. Medical Assessment: This case of "double vision" experienced by a 74 year old subject 25 hours post vaccination, was assessed as related by the investigator due to the close temporal association with study vaccine administration. No obvious alternative explanation is evident from the information reported by the investigator. The sponsor considers that biologic mechanisms linking the vaccine effects with the occurrence of the event are unlikely. In addition, further details on the pre-existing medical history of facial neuralgia and hypertension may be informative in the assessment of alternative etiologies, including underlying conditions as well as therapies; for instance, it is described in the medical literature that some therapies used for the treatment of facial neuralgia can be associated with double vision. The sponsor assesses this event as unrelated to study vaccine. Cumulative Assessment: This is the first case of diplopia as the main manifestation reported from any clinical study of FLUZONE and/or FLUZONE High-Dose vaccine conducted by the sponsor. There were four cases of diplopia event reported as co-manifestations of other diseases (stroke, cerebrovascular accident, transient ischaemic attack and sinusitis) in the clinical studies of FLUZONE and/or FLUZONE High-Dose vaccine conducted by the sponsor. However, from almost 2 decades of post marketing experience with standard FLUZONE seasonal vaccine (from 1993 to 2012) a total of eleven (8 serious) medically confirmed cases of diplopia were received. In all serious cases, diplopia was reported as co-manifestations of other serious disease (ie: encephalitis, meningococcal infection, brain stem haemorrhage) and an alternate etiology was available for each case.