Keywords
Ménière’s disease, COVID-19 vaccination, COVID-19, audiovestibular, vertigo, hearing loss, tinnitus
This article is included in the Emerging Diseases and Outbreaks gateway.
Ménière’s disease, COVID-19 vaccination, COVID-19, audiovestibular, vertigo, hearing loss, tinnitus
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has resulted in more than five million deaths after two years of the coronavirus disease 2019 (COVID-19) pandemic.1 Many patients with COVID-19 infections fully recover, however, a proportion experience long-term symptoms including pulmonary, cardiovascular, nervous system and psychological effects.2 Evidence for the association between COVID-19 infection and audiovestibular symptoms such as hearing loss, tinnitus and vertigo has furthermore been identified.3,4
To reduce the risk of receiving COVID-19 infection, vaccines were developed, and global vaccination implementation recommended.5 Several vaccines are approved for use and proven effective, however, post-vaccination adverse effects are also reported.6 The most common reported adverse effect are pain at the site of injection, fatigue, and headache, which generally are mild and resolve within a few days.7 Adverse audiovestibular effects such as sudden hearing loss, have also been reported in case studies or larger groups, such as sudden sensorineural hearing loss,8,9 tinnitus,10,11 and dizziness.12,13 Although recovery is often reported and incidence rates appear similar to those in the general population (e.g., Formeister et al.14; Tseng et al.15).
As with COVID-19 infection, there may be certain populations who are more at risk for developing adverse post-vaccination effects. One group may be those with pre-existing audiovestibular problems, such as patients with Ménière’s disease who experience hearing loss, tinnitus and vertigo. A study by Wichova, Miller and Derbery16 identified that 11 out of 30 patients reporting post-vaccination hearing-related symptoms had previous otologic diagnoses, including six patients with Ménière’s disease. As this possible association deserves further attention, the current study was undertaken with the aim of investigating adverse post-vaccination effects in patients with pre-existing Ménière’s Disease. The specific aims were to (i) identify the incidence of adverse effects, (ii) explore the factors associated with those reporting adverse effects, and (iii) identify the relationship between the reporting of audiovestibular and other adverse effects.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for cross-sectional studies17 was used to report the methods and results of the survey (see Extended data26).
A mixed-methods exploratory cross-sectional survey study design was used to find out about vaccinations taken and possible side effects.
This study was conducted by the Union of Finnish Ménière Association sending a questionnaire by email to the members of the Union of Finnish Ménière Association, who had a registered email address. The Union of Finnish Ménière Association is a charitable organization consisting of eight regional Ménière Associations and the main aim of the Union is to coordinate and organize peer support for Ménière patients offered by the local associations. The Union administers centrally the above-mentioned member register, and the register adheres to the GDPR (General Data Protection Regulation) of the EU. The data collection was completely voluntary and non-invasive and therefore by Finnish law did not require formal ethical committee approval, as confirmed by the Finnish law authorities (ETENE). The study was approved on 9 September 2021 by the internal ethics board of the Union of Finnish Ménière Association and was carried out according to the principles expressed in the Declaration of Helsinki. The anonymized data set was provided to the research team.
Participants provided online written, informed consent for participation by confirming they understood how their data would be used and what the study entailed.
The survey questions were developed jointly by the study authors (IP, NP) and FMF (Finnish Ménière Federation). The survey included demographic questions (i.e., gender, age, and presence of vertigo prior to the vaccination), vaccination related questions (i.e., number of COVID-19 vaccinations received, type and date of the vaccinations), and adverse vaccination effects (i.e., vertigo, imbalance, drop attacks [Tumarkin’s otolithic Crisis]), hearing loss, aural fullness, tinnitus, sinus symptoms, headaches, arm pain and/or fever). Respondents were asked to report symptoms that appeared within three weeks after vaccinations. There was also the option to include descriptions and provide more information regarding the symptoms experienced. All the questions, except the descriptions were mandatory, and participants could not continue unless they answered prior questions. This may have reduced the numbers completing the full questionnaire.
The eligibility criteria included adults aged 18 years or older who provided written electronic informed consent. The survey was distributed via email to members of the FMF who were above 18 years, who were assumed to have a history of Ménière’s disease, and who had a registered email address, which accounts for 75% of their members. The survey was lunched on October 10th, 2021 and closed on October 28th, 2021. Reporting bias was minimized by allowing anonymous responses and carefully wording to be non-leading where possible.
All analyses were completed in the Statistical Package for Social Sciences (SPSS) version 26.0. Significance was set to p ≤ .05, two-tailed. All the data was, thus using completer’s analysis. As all the questions were mandatory, there was no missing data, except for comment boxes.
Post-hoc tests were Bonferroni corrected for multiple comparisons. Continuous data are expressed as mean and standard deviation (SD). Categorical data are shown as percentages and frequencies. Initial analysis involved all the respondents (n = 333). To evaluate the vaccination effect, those who did not have the vaccination were removed (n = 6).
Subgroups were compared for those not reporting post-vaccination adverse effects and those reporting general post-vaccination effects (e.g., fever, arm pain, headaches) and those reporting vertigo-related effects (e.g., vertigo, falls, imbalance). The independent-samples t-test were used for continuous variables and the Chi-squared test for categorical variables together with adjusted standardized residual values during post-hoc testing. Spearman’s rho correlations (categorical variables) were used to estimate the strength of association between reporting vertigo-related problems and other post-vaccination-related effects. Correlation strength was categorized as very weak (.00 to .19) weak (.20 to .39), moderate (.40 to .59), strong (.60 to.79) and very strong (.80 to 1.0). Following this, hierarchical linear multiple regression models were performed with vertigo-related problems as the dependent variable and other post-vaccination-related effects as predictor variables. Due to the categorical data dummy variables were used. Qualitative data from the open questions were analyzed separately using inductive content analysis to supplement the quantitative analyses.
A total of 333 participants responded to the survey from an estimated 550 participants (60% response rate). The mean age was 63 years (SD: 11 years) with an unequal gender divide with 81% being female and 19% being male as seen in Table 1, partly representing the higher incidence of Ménière’s Disease in women.18 There were 31% reporting no history of vertigo prior to the vaccination and 69% reporting either constant (6%), episodic (47%) or a mixture of constant and episodic vertigo (16%). Those reporting no vertigo had a higher mean age (65 SD: 10 years) than those reporting constant (63 SD: 13 years) or episodic vertigo (62 SD: 12 years) or a mixture of constant and episodic vertigo (60 SD: 11 years). This may represent the progression of the Ménière’s disease that those that are older were in the later stages and hence having fewer symptoms. This indicated a significant relationship between age and type of vertigo reported (r = -.19, p = 0.002). Of those responding, 327 (98%) had the first, 313 (94%) had the second and 12 (4%) had the third vaccination as seen in Figure 1. The majority were vaccinated with Comirnaty (Pfizer/BioNTech) (69%) followed by Oxford- Astra Zeneca (15%) and then Moderna (8%) vaccinations.
Of the 327 who were vaccinated, 203 (62%) reported no vaccination adverse effects and 124 (38%) reported post-vaccination adverse effects. The most common adverse effect was injection site tenderness (38%), followed by arm pain (21%), fever (15%) and headaches (15%) as seen in Figure 2. Although differences in symptom reporting was observed, such as less fever reported by those with Comirnaty (10%) compared to those Astra Zeneca (30%) and Moderna (33%) no significant correlations were found between the symptom reported and type of vaccination received. From the open-ended responses (see supplementary information S2) most of these symptoms were short lived, expected and mild as described by these example responses: “Mild pain at the injection site that disappeared the next day,” “Mild fever the next day after the first vaccination,” and “A headache that lasted 1 day.” Post-vaccination tinnitus and vertigo (both 7%) were the most frequently reported audiovestibular-related symptoms, followed by aural fullness (6%) and hearing loss (4%).
Table 1 compares those reporting and not reporting general post-vaccination adverse effects. There were no significant associations regarding those having effects or not, based on the type of vaccination received. Age differences were present as those having vaccination effects were significantly older. Gender differences were also seen as significantly fewer females (33%) had adverse effects compared with those with no effect (67%). Significantly more males (55%) had effects compared to those with no effects (45%). The time of vaccination had no effect, except for the second vaccination, significantly fewer respondents vaccinated in April-June experienced adverse effects (55%) compared with those without effects in this period (45%). Spearman’s correlations investigated the effect of the vaccination type and the presence of symptoms. The only weak positive correlation was for local arm pain being higher for those with the Moderna injection (although this is a smaller sample: 10 not having pain and 17 having pain). Those receiving Astra Zeneca and Moderna were less likely to report injection pain.
Of the 327 who were vaccinated, 281 (86%) reported no vertigo, imbalance, swaying or drop attacks and 46 (14%) reported at least one vertigo-related post-vaccination symptom as seen in Table 2. Of these 23 (7%) reported one symptom and 23 (7%) reported two or more symptoms. There were no gender effects and no differences found related to the type of vaccination received. Those who were younger were significantly more likely to report vertigo and imbalance post-vaccination. There were also significant differences based on the presence of pre-vaccination vertigo-related problems as those reporting previous pre-vaccination vertigo were more likely to have post-vaccination vertigo. The strength of this relationship was a small positive relationship (r = .16, p = .005). When looking at the group reporting vertigo as the largest vestibular complaint (n = 23), there were no significant difference between this group and those not reporting vertigo as seen in the last column of Table 2.
There was a positive relationship between experiencing post-vaccination vertigo and experiencing post-vaccination tinnitus, hearing loss, aural fullness, headaches, and rhinitis as seen in Table 3. The correlation was strong for tinnitus, moderate for hearing loss and aural fullness and weak for headaches and rhinitis. Hierarchical linear multiple regression analysis was carried out to investigate the ability of the presence of these adverse effects to predict the presence of post-vaccination vertigo (see Table 3). All the available effects were used in the model. The model significantly improved the ability to post-vaccination vertigo and imbalance [F(8, 318) = 34.21, p = 0.001*] and 46% (Adjusted R2 = 0.63) of the variance was explained by the presence of these symptoms. Removing the non-significant variables did not improve the model. The variables making significant predictors regarding the presence of post-vaccination vertigo and imbalance were tinnitus (β = .50, p < 0.001), aural fullness (β = .19, p < 0.001), rhinitis (β = .14, p = 0.003) as seen in Table 3.
From the open-ended responses it was very difficult to identify if some participants were describing vaccination-related effects or general pre-vaccination effects due to vague comments such as “Hearing problems in my right ear,” Constant feeling of pressure,” or “headaches.” A summary of the number of open-ended responses for each symptom and information regarding the onset, duration and vaccination dosage where available is available in Underlying data. The onset of vertigo and unsteadiness was between 12 hours to two and a half weeks post-vaccination. Where reported, the duration was between a few hours to two weeks. Effects were reported for either of the vaccination doses and at times both the first and second doses. Some patients reported that they felt that their symptoms were exacerbated by the stress during the pandemic and not necessarily the vaccination.
The aim of the current study was to investigate adverse post-vaccination effects for 333 Finnish patients with an assumed history of Ménière’s disease due to recruitment through the FMF. Of the 327 who were vaccinated, 203 (62%) reported no adverse vaccination effects and 124 (38%) reported one or more adverse effect. The most common effect was injection site tenderness (38%), followed by arm pain (21%), fever (15%) and headaches (15%). Those reporting effects were more likely to be older or to be males. This is in contrast to adverse vaccination effect being higher in the female population in the general public as reported in previous studies.19 It may be that the gender imbalance of the sample size is affecting these results and they should thus be interpreted with caution. Some vaccination reports have found no age effects20 whereas others have found that young age was correlated with more effects.21 For the second vaccination, significantly fewer effects were reported for those vaccinated in April-June 2020. When comparing those who reported adverse effects and those who did not, there were no significant differences base on the type of vaccination received.
Of those vaccinated, 15% reported at least one adverse audiovestibular symptom. Post-vaccination tinnitus and vertigo (both 7%) were the most frequently reported audio-vestibular symptoms, followed by aural fullness (6%) and hearing loss (4%). There were no gender or vaccination type effects but those with previous vertigo problems and younger adults were more likely to report vertigo-related problems. From the reports the symptoms appeared to resolve within two weeks of onset, although not all participants reported the duration of the effects. There was also no clear pattern as to which vaccination could result in more effects and for one group of people it was one vaccination while others reported adverse effects after both the second and third vaccinations. These results are different to those reported by Wichova et al.16 who found that 30 (3%) of their sample of 1,325 patients reported audiovestibular effects, with hearing loss (83%) being most frequently reported, followed by tinnitus (50%), dizziness (27%) and vertigo (17%) although evidence of a correlation was not found. A further interesting difference was that the onset of audiovestibular problems was 10 days post-vaccination, which appears similar to the present study reporting onset between 12 hours to 2.5 weeks post-vaccination. Both studies suggested that previous otologic diagnoses may result in a higher incidence of post-vaccination adverse effects. A further study by Ciorba et al.22 reported a higher incidence of post-vaccination vertigo (.96%) compared with tinnitus (.11%) in Italy. Formeister et al.14 found that the incidence of sudden sensorineural hearing loss was similar post-vaccination to that expected in the general population. Further systematic reviews are required to identify wider audiovestibular adverse post-vaccination effects due to these difference across studies.
In the present study, experiencing post-vaccination tinnitus, hearing loss, and aural fullness predicted the presence of post-vaccination vertigo (explaining 46% of the variability). This indicates that likelihood that post-vaccination vertigo is more likely in the presence of other post-vaccination effects. The effect of stress during the pandemic was noted by numerous participants as contributing to their audiovestibular problems as previously found.23 Ensuring support for such individuals is available, is required.
Overall, the current exploratory study has highlighted that a small proportion of patients with a history of Ménière’s disease may experience adverse post-vaccination effects. These individuals may be more hesitant to undergo vaccinations, particularly if they had an adverse effect for one of the vaccination dosages. Further robust studies to explore this effect is required, together with systematic reviews to pool what is known regarding post-vaccination audiovestibular effects. Further research is also required to explore whether adverse post-vaccination audiovestibular effects are more prevalent in those with a history of otological disorders compared with the general population.
There were numerous limitations that should be considered when interpreting the results. Firstly, there is possible sampling bias as those responding to the survey may be patients more likely to have had post-vaccination effects. The sample was not well balanced due to an unequal gender divide, which may have affected results, although Ménière’s disease is known to be more prevalent in females.18 The survey could have been improved to ask specific questions regarding the onset, duration and dosage linked to the adverse effects. Vertigo-related problems are also frequently experienced during cardiac problems. Post-vaccination vertigo could be associated with cardiovascular problems24 and other non-auditory health conditions this association should be accounted for in future studies. Looking at the impact of comorbid health conditions on adverse vaccination effects is also required. Associations between other health conditions and audiovestibular symptom have been previously reported. Pyykkö et al.25 for instance identified that vestibular syncope (sudden and transient loss of consciousness) was associated with Tumarkin attacks, migraine and history of ischemic heart disease and history of cerebrovascular disease). It is also important to establish if there are any associations regarding previous COVID-19 infections and adverse vaccination effects. Further studies and systematic reviews are encouraged to identify the incidence and mechanisms of adverse audiovestibular vaccination effects.
Figshare: COVID 19 vaccine in Ménière's disease, https://doi.org/10.6084/m9.figshare.19519801.26
This project contains the following underlying data:
Figshare: COVID 19 vaccine in Ménière's disease, https://doi.org/10.6084/m9.figshare.19519801.26
This project contains the following extended data:
- Finnish_MD COVID Vaccination Questionnaire
- English_MD COVID Vaccination Questionnaire
- S 1S1 The STROBE Checklist
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
We would like to thank Nina Kallunki from the Finnish Ménière Federation for help with recruitment and data transfer and control for this study. Our thanks is extended to all the participants of this study for their time give to do the survey.
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Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Neurotology, neuro-ophthalmology
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Partly
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Neurotology
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Alongside their report, reviewers assign a status to the article:
Invited Reviewers | |||
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Version 1 04 Aug 22 |
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