Safety Surveillance After Immunization With IXIARO

• Detection of non-predefined Adverse Events overrepresented after IXIARO [ Time Frame: 42 days after each dose of IXIARO ] [ Designated as safety issue: Yes ]
  Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group
• Occurrence of complications during pregnancy [ Time Frame: Up to delivery ] [ Designated as safety issue: Yes ]
  Detect and describe pregnancy complications following inadvertent vaccination in pregnant women
• Occurrance of infant health complications [ Time Frame: up to 3 months after birth ] [ Designated as safety issue: Yes ]
  Detect and describe infant health complications following inadvertent vaccination in pregnant women

This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military, to detect adverse events that occur more frequently after IXIARO and to electronically follow up pregnancies during or shortly before which IXIARO was administered.

There will be no intervention and no individuals contacted.

Active duty military personnel (Army, Navy, Air Force, and Marines) who are ≥17 years of age and received at least one dose of Japanese encephalitis vaccine.

• IXIARO exposed group
  Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO
  Intervention: Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed
• Comparison group
  Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of JE-VAX

Inclusion Criteria:

• Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO (IXIARO exposed group) or at least one dose of JE-VAX (comparison group).

Exclusion Criteria:

• Individuals who have an ICD-9-CM code suggestive of one of the predefined adverse events screened for in IC51-401 prior to vaccination with IXIARO cannot with certainty be classified as being "disease free" at study entry and will be excluded for that adverse event.