Stroke after Vaccination in United States. A Report from the CDC/FDA Vaccine Adverse Event Reporting System. [1990–2010]

Zaid Al Qudah1, Wael Abukwaik2 and Nizar Souayah3

1 New Jersey Medical School Newark NJ
2 New Jersey Medical School Newark NJ
3 New Jersey Medical School Westfield NJ

Objective: To determine the rate and characteristics of the occurrence of acute stroke after administration of vaccination in the United States.

Background: There are several reports of stroke after vaccination.

Design/Methods: We used that data from the Vaccine Adverse Event Reporting System (VAERS) which is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of United States licensed vaccines.

Results: There were 306 cases (mean age 42 years, range 0.1 to 94 years) of stroke reported after vaccination in the United States from 1990 to 2010. The onset of stroke within 6 weeks after vaccination was reported in 300 patients (98%) and in 257 patients (83.9%) within 2 weeks of vaccination. Stroke was reported in 120 cases (39.2%) after Flue vaccination, 40 (13%) after Hepatitis B vaccination, and in 20 cases (6.5%) after Diphtheria, Tetanus, and acelluar pertussis vaccination (DTAP). The number of patients who took 2 or more vaccines and developed stroke was 12 (4%).

Conclusions: The unbalanced distribution of reports of stroke in the first 6 weeks after vaccination with a peak reporting in the first two weeks after vaccination is suggestive of the possibility that some cases may be triggered by vaccination. This warrants continuous and careful analysis stroke cases after vaccination and emphasize the need for more controlled studies to assess the risk of cereborvascular events after vaccination.

Disclosure: Dr. Al Qudah has nothing to disclose. Dr. Abukwaik has nothing to disclose. Dr. Souayah has received personal compensation for activities with Walgreens as a consultant. Dr. Souayah has received research support from Talecris.