Development of Transverse Myelitis after Vaccination, A CDC/FDA Vaccine Adverse Event Reporting System (VAERS) Study, 1985–2017. (P5.099)
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Abstract
Objective: To investigate the correlation between Transverse Myelitis (TM) and vaccination.
Background: There have been isolated cases reported of TM following vaccination.
Design/Methods: Data from Vaccine Adverse Event Reporting System (VAERS) from 1985–2017 was used. TM cases obtained from VAERS were classified as definite or probable according to strict criteria. Definite cases were defined by clinical symptoms suggestive of TM and positive MRI findings or LP. Probable cases defined by suggestive clinical presentation without supporting diagnostic results.
Results: 119 cases of TM (29 men, 90 women, mean age 32 years, age range 12–61 with mode 28) were reported (88 definite, 31 probable). The reported rate of new post-vaccination TM is 3.70 per year which is in the range expected in the US population. 40% cases reported onset within 8 weeks of vaccination and 60% more than 8 weeks. The onset was within 2 week in 36% of cases, 2–4 weeks in in 13% of cases, 4–6 weeks in 6.7%, 6–8 weeks in 6.7%. 38.7% experienced permanent disability. 47% of TM cases were reported following a Hepatitis B vaccination and 20.16% following a HPV4 vaccine. A significantly lower proportion of TM cases were reported to occur within 48 hours of vaccination relative to non-TM events (21% vs. 60.5%, p<.0001). There is no significant difference between TM cases and GBS cases reported within 48 hours of vaccination (21% vs. 12.91%, p= 0.1244).
Conclusions: Although the reporting rate of post vaccination TM 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 TM.
Disclosure: Dr. Shah has nothing to disclose. 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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