Can influenza vaccine cause ototoxicity?/nThe question concerns a 53-year-old woman who received an

Fråga: Can influenza vaccine cause ototoxicity?

The question concerns a 53-year-old woman who received an injection of influenza vaccine. The day after she noted impaired hearing and tinnitus in her right ear, which was later diagnosed as a complete hearing loss according to an audiogram. Serology for Lymes disease was negative and a brainstem audiometric examination was normal. The patient has not had any previous ear or tinnitus problems. The symptoms have not disappeared five months after exposure. The case has been reported to the regional centre for adverse drug reactions.

Sammanfattning: No published case reports concerning ototoxicity of influenza vaccine have been found in the literature. However, there are 17 cases of ototoxicity (4 hearing insufficiency, 13 tinnitus) in association with influenza vaccine reported to WHO:s adverse drug reactions database. All of these reports are not evaluated concerning causal relationship. There are several case reports in the literature ototoxicity in connection with other viral vaccines. Therefore, tinnitus and impaired auditory function could be related to the influenza vaccine.

Svar: A thorough literature search revealed no published case reports concerning ototoxicity of influenza vaccine in Drugline, Medline, Embase or other available literature.

The files of the Swedish adverse drug reactions advisory committee (SADRAC) contain no previous reports concerning hearing or vestibular disorders in association to influenza vaccine. However, the WHO adverse drug reactions-monitoring centre has received 14 reports of tinnitus and/or hearing impairment. Of these, four patients suffered from hearing impairment (1). The outcome is known in three of these case reports, where two of the patients with tinnitus and one with hearing impairment recovered without sequelae. There are no published articles showing that influenza in itself would give rise to these types of adverse effects.

There are several case reports showing that other viral vaccines can give rise to sensory neuronal hearing impairment and tinnitus (2-8). In most cases these side effects are reversible, but irreversible deafness has also been observed. In the Swedish adverse drug reaction registry there are seven reports on hearing or vestibular disorders in association to viral vaccines (2). In the literature there is a total of twelve case reports of sensory neural hearing loss in relation to MPR-vaccination, two of which cases also suffered from vertigo and tinnitus (3-5). However, sensory neural hearing loss is also a well-known complication of a measles infection. There are three cases of ototoxicity reported following hepatitis B vaccination (6-8). In two of the cases the patients experienced disabling tinnitus fullness at the time for the first injection of vaccine and later also hearing loss in association with the second injection (6,8). In the third case the patient received the same symptoms after a third injection (7). Audiogram revealed unilateral neuronal hearing loss in all cases. 1 Intdis (International Drug Information System): WHO:s adverse drug reactions database 2 Seligmann H, Podoshin L, Ben-David J, Fradis M, Goldsher M. Drug-induced tinnitus and other hearing disorders. Drug Saf 1996;14:198-212. 3 Swedis (The Swedish Drug Information System) 4 Drugline no 17124 (year 1997) 5 Brodsky L, Stanievich J. Sensorineural hearing loss following live measles virus vaccination. Int J Pediatr Otorhinolaryngol 1985;10:159-63. 6 Orlando MP, Masieri S, Pascarella MA, Ciofalo A, Filiaci F. Sudden hearing loss in childhood consequent to hepatitis B vaccination: a case report. Ann NY Acad Sci 1997;830:319-21. 7 Davanipour Z, Stewart CE, McGann DG. Hepatitis B vaccination and asymmetric tinnitus and hearing loss. Clin Res 1994;42:341A. 8 Biacabe B, Erminy M, Bonfils P. A case report of fluctuant sensorineural hearing loss after hepatitis B vaccination. Auris Nasus Larynx 1997;24:357-60.