Fluzone Quadrivalent: side effects, ingredients & package insert

Fluzone Quadrivalent ingredients (FDA package insert, Section 11)

Per-dose composition as stated in the prescribing information; verified 2026-07-09. Click an ingredient for every vaccine that contains it.

Note: Always check vial type: preservative status differs between single-dose and multi-dose presentations.

Source: FDA package insert. Formulations change — re-verify before clinical use.

Fluzone Quadrivalent side effects: where the data is

Reported reactions for Fluzone Quadrivalent and the other influenza (flu) products are compiled on the influenza (flu) vaccine page: pre-licensure trial reactogenicity, VAERS report counts, and international databases (Canada Vigilance, EudraVigilance, Lareb, VigiAccess). Those counts are spontaneous reports with no denominator — a report does not establish that the vaccine caused the event.

• Pre-licensure clinical trial data
• Post-licensure surveillance (VAERS and international)
• Documented adverse events and causality assessment
• Vaccine Injury Table (VICP) — compensable injuries

Fluzone Quadrivalent lot number lookup

Schedule and age range

Licensed ages and the recommended series for influenza (flu) vaccines are on the influenza (flu) vaccine page; how 31 countries schedule it is on influenza (flu) schedule by country. Always confirm the product-specific age range in the current package insert.

Common questions about Fluzone Quadrivalent

What are the side effects of Fluzone Quadrivalent?

Common reactions listed in the Fluzone Quadrivalent package insert are injection-site pain, redness or swelling and short-lived systemic symptoms such as fever, tiredness or irritability. Rarer events and the reported counts from VAERS and international databases are on the influenza (flu) vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Fluzone Quadrivalent?

Fluzone Quadrivalent contains Influenza A (H1N1) hemagglutinin; Influenza A (H3N2) hemagglutinin; Influenza B (Victoria lineage) hemagglutinin; Influenza B (Yamagata lineage) hemagglutinin as antigen; adjuvant: none; it is Thimerosal. Excipients: Egg protein (ovalbumin), Formaldehyde, Octylphenol ethoxylate (Triton X-100), Sodium phosphate-buffered isotonic sodium chloride. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Fluzone Quadrivalent package insert?

The FDA-licensed prescribing information for Fluzone Quadrivalent is published by Sanofi Pasteur and the FDA; the source used for this page is https://www.fda.gov/vaccines-blood-biologics/vaccines/fluzone-quadrivalent. Formulations change, so re-verify the current insert before clinical use.