Age: 69.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Olfactory test abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 69 year-old female patient. On an unspecified date, the patient received influenza vaccine (Influenza virus vaccine, manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 16/40 which was not suggestive of malingering (<6).  The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test score was -2.00 bilateral. The Whole-Mouth test identification test score was 80% correct. The outcome was not reported. Case correction (11-Sep-2015): Assessment for AE#5 (rhinorrhoea) changed to listed. Reporter's Comments: Reporter's comments: The authors reported that the smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. According to the CCDS for CSL Inactivated Influenza Virus Vaccine, anosmia, smell and chemosensory dysfunction, rhinorrhoea are unlisted. Flu like symptoms and other events are consistent Influenza like illness which is listed. According to the Afluria PI, anosmia, smell and chemosensory dysfunction are unlisted. Rhinorrhoea, Flu like symptoms and other events are consistent Influenza like illness which is listed. Causality: Unassessable.  Flu-like symptom can be attributable to vaccination as onset was within a week after inoculation. Causality is unassessable for anosmia. The retrospective study largely depended on identification of patients who self-attributed symptoms to vaccination. Causality attribution by authors was based on analyses of covariance of association (age as main covariate, sex and etiology as additional factors) between Influenza vaccination histories and Chemosensory Test Scores and not real time diagnosis following vaccination. In addition there was limitation of the study such as recall bias. Further information such as time to onset of anosmia, preceding viral or bacterial infections and investigation to investigate and exclude other causes are not provided. Hence causality is unassessable.