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Acute demyelinating events following vaccines – a case centered analysis

  1. Nicola P. Klein1
  1. 1Northern California Kaiser Permanente Vaccine Study Center, Oakland, California, USA
  2. 2The Permanente Medical Group, Antioch, California, USA
  3. 3Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
  4. 4Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA
  5. 5Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
  1. Corresponding author: Roger Baxter, MD, Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, Phone: 510-267-7529, Fax: 510-267-7524, Email: roger.baxter{at}kp.org

Abstract

Background. Case reports have suggested that vaccines may trigger transverse myelitis (TM) or acute disseminated encephalomyelitis (ADEM), but the evidence for a causal association is inconclusive. We analyzed the association of immunization and subsequent development of TM or ADEM.

Methods. We identified all cases of TM and ADEM in the Vaccine Safety Datalink (VSD) population. Using a case centered method, we compared vaccination of each case to vaccination of all matched persons in the study population, who received the same type of vaccine, with respect to whether or not their vaccination occurred during a pre-determined exposure interval. We calculated a risk difference (excess risk) of TM and ADEM for each vaccine.

Results. Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. Based on 2 exposed cases, the OR for Tdap exposure 5-28 days prior to ADEM onset was 15.8 (95% CI 1.2-471.6, p=0.04) and the estimated excess risk was 0.385 (-0.04-1.16) cases per million doses.

Conclusions. We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered.

UNCORRECTED PROOF

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