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APRIL 23, 2018
Development of Multiple Sclerosis relapse flare after Vaccination, A CDC/FDA Vaccine Adverse Event Reporting System (VAERS) Study, [1987–2017]. (P2.383)
Moamina Fakhera Eddin, Janaki Patel, Abdul Rahman Alchaki and Nizar Souayah
Abstract
Objective: To investigate the correlation between Multiple Sclerosis (MS) relapse and vaccination.
Background: There have been isolated cases reported of MS relapse following vaccination.
Design/Methods: Data from Vaccine Adverse Event Reporting System (VAERS) from 1987–2017 was used. MS relapse cases obtained from VAERS were classified as definite or probable according to strict criteria. Definite cases were defined by clinical symptoms suggestive of MS relapse and positive MRI findings. Probable cases defined by suggestive clinical presentation without supporting diagnostic results. Patients with worsening neurologic symptoms concurrent with fever were excluded.
Results: 37 cases of MS relapse (6 men, 31 women, mean age 36 years, age range 16–60 with mode 30). The reported rate of new post-vaccination MS relapse is 1.2 per year which is in the range expected in the US population. 40.5% cases reported onset within 8 weeks of vaccination and 59.5% more than 8 weeks. The onset was within 2 weeks in 64.8% of cases, 2–4 weeks in 0% of cases, 4–6 weeks in 11%, 6–8 weeks in 11%. 16.2% experienced permanent disability. 21.6% of MS relapse cases were reported following a Hepatitis B vaccination and 13.5% following a HPV4 vaccine. There is no significant difference between MS relapse cases and non-MS relapse events within 48 hours of vaccination (51.3% vs. 61.9%, p=.1843). There is a significant difference between MS relapse cases and GBS cases reported within 48 hours of vaccination (51.3% vs. 13.26%, p<.0001).
Conclusions: The reporting rate of post vaccination MS relapse is in the range expected in the general population, and there is a balanced distribution of these cases in the first 6 weeks after vaccination, suggesting that there is no association between vaccination and MS relapses.
Development of Multiple Sclerosis relapse flare after Vaccination, A CDC/FDA Vaccine Adverse Event Reporting System (VAERS) Study, [1987–2017]. (P2.383)
Moamina Fakhera Eddin, Janaki Patel, Abdul Rahman Alchaki and Nizar Souayah
Abstract
Objective: To investigate the correlation between Multiple Sclerosis (MS) relapse and vaccination.
Background: There have been isolated cases reported of MS relapse following vaccination.
Design/Methods: Data from Vaccine Adverse Event Reporting System (VAERS) from 1987–2017 was used. MS relapse cases obtained from VAERS were classified as definite or probable according to strict criteria. Definite cases were defined by clinical symptoms suggestive of MS relapse and positive MRI findings. Probable cases defined by suggestive clinical presentation without supporting diagnostic results. Patients with worsening neurologic symptoms concurrent with fever were excluded.
Results: 37 cases of MS relapse (6 men, 31 women, mean age 36 years, age range 16–60 with mode 30). The reported rate of new post-vaccination MS relapse is 1.2 per year which is in the range expected in the US population. 40.5% cases reported onset within 8 weeks of vaccination and 59.5% more than 8 weeks. The onset was within 2 weeks in 64.8% of cases, 2–4 weeks in 0% of cases, 4–6 weeks in 11%, 6–8 weeks in 11%. 16.2% experienced permanent disability. 21.6% of MS relapse cases were reported following a Hepatitis B vaccination and 13.5% following a HPV4 vaccine. There is no significant difference between MS relapse cases and non-MS relapse events within 48 hours of vaccination (51.3% vs. 61.9%, p=.1843). There is a significant difference between MS relapse cases and GBS cases reported within 48 hours of vaccination (51.3% vs. 13.26%, p<.0001).
Conclusions: The reporting rate of post vaccination MS relapse is in the range expected in the general population, and there is a balanced distribution of these cases in the first 6 weeks after vaccination, suggesting that there is no association between vaccination and MS relapses.