Development of Optic Neuritis after Vaccination, A CDC/FDA Vaccine Adverse Event Reporting System (VAERS) Study, 1990–2017. (P2.146)
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Abstract
Objective: To investigate the correlation between optic neuritis (ON) and vaccination.
Background: There have been isolated cases reported of ON following vaccination.
Design/Methods: Data from Vaccine Adverse Event Reporting System (VAERS) from 1990–2017 was used. Optic neuritis cases obtained from VAERS were classified as definite or probable according to strict criteria. Definite cases were defined by acute to subacute painful vision loss and positive MRI findings. Probable cases were defined by clinical presentation suggestive of ON without supporting diagnostic test results available. Patients with exacerbation of previously diagnosed ON were excluded.
Results: 187 cases of ON (49 men, 138 women, mean age 28 years, age range 6–60 with mode 16) were reported (118 definite, 69 probable). The reported rate of new post-vaccination ON is 6.93 per year which is in the range expected in the US population. 52.4% cases reported onset within 8 weeks of vaccination and 47.6% more than 8 weeks. The onset was within 2 week in 20.3 % of cases, 2–4 weeks in in 6.4% of cases, 4–6 weeks in 3.7%, 6–8 weeks in 4.3%. 34.8% experienced permanent disability. 47% of ON cases were reported following a Hepatitis B vaccination and 19.8% following a HPV4 vaccine. A significantly lower proportion of ON cases were reported to occur within 48 hours of vaccination relative to non-ON events (10.7% vs. 53.8%, p<0.0001). There is no significant difference between ON cases and GBS cases reported within 48 hours of vaccination (10.7% vs. 13.7%, p= 0.4627).
Conclusions: Although the reporting rate of post vaccination ON is in the range expected in the general population, the unbalanced distribution of these cases in the first 6 weeks after vaccination suggests that the association between vaccination and some cases may not be coincidental. Work is in progress to determine association of individual vaccine types with the course of ON.
Disclosure: Dr. Patel has nothing to disclose. Dr. Alchaki has nothing to disclose. Dr. Fakher Eddin has nothing to disclose. Dr. Souayah has nothing to disclose.
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