Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry

Sanofi Pasteur will encourage registration of pregnant women exposed to Fluzone QIV-ID in the
Sanofi Pasteur Pregnancy Registry by providing the registry's toll-free number, 1-800-VACCINE
(1-800-822-2463), in the USPI. The toll-free number will also be available through the Sanofi
Pasteur-sponsored Website for the Pregnancy Registry. Both the United States product insert
(USPI) and Website will advise health care providers to register women who are pregnant or
became aware they were pregnant at the time of Fluzone QIV-ID immunization.

Descriptive statistical methods will be the primary approach for summarizing data from the
Fluzone QIV-ID Pregnancy Registry. No vaccine products will be provided or administered as
part of this registry protocol.

Inclusion Criteria:

Pregnant women will be enrolled in the registry prospectively (after exposure to a product
but before the conduct of any prenatal tests that could provide knowledge of the outcome of
pregnancy). If the condition of the fetus has already been assessed through prenatal
testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered
retrospective reports. Retrospective reports are also eligible for the registry, but they
will be analyzed separately from prospective reports.

Exclusion Criteria: