Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Pain, Scan with contrast normal, Sudden hearing loss, Tinnitus, Tympanometry
Clinical narrative: Initial unsolicited report received from the literature on 12 July 2016. Abstract Objective. Case reports of sudden sensorineural hearing loss (SSHL) following vaccines have led to concerns that vaccines may rarely cause hearing loss. Because of this concern, we analyzed for an association between SSHL and vaccinations. Study Design. We used a case-centered method, equivalent to a case control design using immunization dates from all matched members of the population to calculate exposure to vaccines, rather than sampling. Setting. 2007 to 2013. Subjects and Methods. We searched databases from 2007 to 2013 for all first-time diagnoses of SSHL. We used the date of any hearing- or ear-related visit in the 60 days prior to the first SSHL diagnosis as the onset date. Using only SSHL cases immunized in the prior 9 months, we compared the vaccine exposure in several risk intervals prior to onset with the exposure to the same vaccine during the same time period in all membership, matched to sex and age. Results. During the study period, 20 million vaccines were administered at locations. In all risk intervals prior to onset of SSHL, we found no evidence of increased risk of immunization compared with matched controls. The odds ratios for vaccination 1 week prior to SSHL were 0.965 (95% confidence interval, 0.61-1.50) for trivalent inactivated influenza vaccine (TIV); 0.842 (0.39-1.62) for tetanus, reduced diphtheria, and reduced acellular pertussis; and 0.454 (0.08- 1.53) for zoster vaccine. Conclusion. A large-scale analysis applying a case-centered method did not detect any association between SSHL and previous receipt of TIV or other vaccines. Keywords-vaccine, immunization, adverse event, hearing loss, sensorineural, influenza vaccine. This case involves a male patient (reported as "in his 30s") who was vaccinated with a dose of Trivalent Inactivated Influenza Vaccine (TIV) (batch number, expiry date, site and route of administration was not reported) on an unspecified date. Medical history included audiology testing performed 6 years earlier was normal bilaterally and concomitant medications were not reported. On an unspecified date, 6 days following the vaccination, the patient had experienced sudden onset of right-sided tinnitus and hearing loss. On an unspecified date, following the vaccination, the patient had non-ear-related pain, slight intermittent dizziness but denied fever, congestion, or headache. The patient was referred to otolaryngology for further evaluation. The patient was diagnosed with SSHL (sensorineural hearing loss). Lab data included: Patient's head and neck examination was normal. Audiogram performed which revealed normal hearing in the right ear to 2000 Hz, then a precipitous drop to profound hearing loss in the higher frequencies. Pure tones in the left ear were normal. Word recognition scores were 100% in both ears, and tympanograms were type A. Magnetic resonance imaging (MRI) of the brain with and without gadolinium, focused on the internal auditory canal, was normal. The patient's corrective treatment included ibuprofen for 2 days for non-ear-related pain but stopped 2 days before the onset of hearing loss, decongestants which did not provide relief of symptoms, prednisone taper for SSHL and also received oral steroids. The patient was not recovered from events sensorineural hearing loss, right-sided tinnitus and hearing loss (reported as "His hearing did not improve."). The outcome of events dizziness and non-ear-related pain was not reported. Upon internal review the case was considered as serious because of important medical event: Sudden-Onset Sensorineural Hearing Loss/SSHL. List of documents held by sender: none. Sender's Comments: Patient had sudden onset of sensorineural hearing loss and pain not related to ear 6 days following TRIVALENT INACTIVATED INFLUENZA VACCINE (TIV).Time to onset is compatible but patient past medical history, recent ear infection, any history of trauma to ear, recent exposure to noise, recent neurological infection like meningitis and encephalitis and site of pain are needed to further assess the case. Based on available information role of vaccine cannot be assessed.