Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in
routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to
QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database
and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the
reporter at enrollment, estimated time of delivery, and six months after delivery.
Descriptive statistical methods will be the primary approach for summarizing data.

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
Quadrivalent Influenza Vaccine (QIV) 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: