Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA): side effects, ingredients & package insert

Comirnaty (Pfizer-BioNTech 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.

Note: LNP lipids are the delivery system, not classical adjuvants. PEGylated lipid is structurally related to PEG.

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

Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA) side effects: where the data is

Reported reactions for Comirnaty (Pfizer-BioNTech 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

Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA) lot number lookup

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

What are the side effects of Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA)?

Common reactions listed in the Comirnaty (Pfizer-BioNTech 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 Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA)?

Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA) contains Nucleoside-modified mRNA encoding SARS-CoV-2 spike (S) glycoprotein as antigen; adjuvant: none; it is preservative-free. Excipients: Tromethamine, Tromethamine hydrochloride, Sucrose. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA) package insert?

The FDA-licensed prescribing information for Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA) is published by Pfizer Inc. / BioNTech and the FDA; the source used for this page is https://www.fda.gov/media/151707/download. Formulations change, so re-verify the current insert before clinical use.

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

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