Spikevax (Moderna COVID-19 Vaccine, mRNA): side effects, ingredients & package insert

Spikevax (Moderna COVID-19 Vaccine, mRNA) 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.

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

Spikevax (Moderna COVID-19 Vaccine, mRNA) side effects: where the data is

Reported reactions for Spikevax (Moderna COVID-19 Vaccine, mRNA) and the other COVID-19 products are compiled on the COVID-19 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

Spikevax (Moderna COVID-19 Vaccine, mRNA) lot number lookup

Spikevax (Moderna COVID-19 Vaccine, mRNA) vs Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA) vs Nuvaxovid (Novavax COVID-19 Vaccine, Adjuvanted)

All licensed COVID-19 vaccine products side by side. Differences in platform, adjuvant and route are the usual reasons one is chosen over another; efficacy and safety comparisons belong to the trial and surveillance sections of the COVID-19 vaccine page.

Schedule and age range

Licensed ages and the recommended series for COVID-19 vaccines are on the COVID-19 vaccine page; how 31 countries schedule it is on COVID-19 schedule by country. Always confirm the product-specific age range in the current package insert.

Common questions about Spikevax (Moderna COVID-19 Vaccine, mRNA)

What are the side effects of Spikevax (Moderna COVID-19 Vaccine, mRNA)?

Common reactions listed in the Spikevax (Moderna COVID-19 Vaccine, mRNA) 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 COVID-19 vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Spikevax (Moderna COVID-19 Vaccine, mRNA)?

Spikevax (Moderna COVID-19 Vaccine, mRNA) contains Nucleoside-modified mRNA encoding SARS-CoV-2 spike (S) glycoprotein as antigen; adjuvant: none; it is preservative-free. Excipients: Trometamol (tromethamine), Trometamol hydrochloride, Acetic acid, Sodium acetate trihydrate, Sucrose, Water for injection. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Spikevax (Moderna COVID-19 Vaccine, mRNA) package insert?

The FDA-licensed prescribing information for Spikevax (Moderna COVID-19 Vaccine, mRNA) is published by ModernaTX, Inc. and the FDA; the source used for this page is https://www.fda.gov/media/155675/download. Formulations change, so re-verify the current insert before clinical use.

How does Spikevax (Moderna COVID-19 Vaccine, mRNA) compare with Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA)?

Spikevax (Moderna COVID-19 Vaccine, mRNA) (ModernaTX, Inc.) uses a mrna platform with adjuvant none, given intramuscular; Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA) (Pfizer Inc. / BioNTech) uses mrna with adjuvant none. Both are licensed COVID-19 vaccines; the comparison table above lists every product.