Spikevax (2023-2024) PF (cvx 312) Side Effects

Generic name: sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312)

Note: This document contains side effect information about sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312). Some dosage forms listed on this page may not apply to the brand name Spikevax (2023-2024) PF (cvx 312).

Applies to sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312): intramuscular suspension.

Warning

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, dizziness, weakness, fast heartbeats, difficult breathing, swelling of the face, lips, tongue, or throat.

The vaccination provider may want to watch you for a short time after the shot, to make sure you do not have an allergic reaction or faint. You will be treated quickly if there is a reaction right after receiving the vaccine.

You should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. The doctor or vaccination provider will determine if you can safely receive this vaccine.

Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

chest pain;
breathing problems; or
fast or pounding heartbeats or fluttering in your chest.

Common side effects may include:

fever, chills, swollen glands;
pain, redness or swelling where the shot was given;
nausea, vomiting, not feeling well;
feeling tired; or
headache, muscle pain, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems you have after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

For Healthcare Professionals

Applies to sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312): intramuscular suspension.

General

The most commonly reported side effects included injection site pain, headache, and fatigue.^[Ref]

Cardiovascular

Frequency not reported: Myocarditis, pericarditis^[Ref]

Dermatologic

Frequency not reported: Erythema nodosum

Postmarketing reports: Urticaria^[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 23.9%)^[Ref]

Nausea/vomiting included Grades 3 and 4 nausea/vomiting.^[Ref]

Hematologic

Frequency not reported: Lymphadenopathy^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis^[Ref]

Local

Very common (10% or more): Injection site pain (up to 93.1%), injection site swelling/hardness greater than 25 mm (up to 20.5%), localized erythema/redness greater than 25 mm (up to 19.5%)

Common (1% to 10%): Erythema at the injection site, swelling at the injection site

Frequency not reported: Injection-site lymphadenopathy, vaccination-site lymphadenopathy^[Ref]

Injection site pain included pain, Grade 3.

Localized erythema/redness greater than 25 mm included Grade 3 localized erythema/redness greater than 25 mm.^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 61.7%), arthralgia (up to 45.6%), chills (up to 49%)^[Ref]

Arthralgia included arthralgia, Grades 3 and 4.

Chills included chills, Grade 3.

Myalgia included Grade 3 myalgia.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 70.2%)

Postmarketing reports: Syncope^[Ref]

Headache included headache, Grades 3 and 4.^[Ref]

Other

Very common (10% or more): Fatigue (up to 70.1%), use of antipyretic/pain medication (up to 57.3%), axillary swelling/tenderness (up to 27.8%), fever (up to 17.4%)

Common (1% to 10%): Fever^[Ref]

Axillary swelling/tenderness included axillary swelling/tenderness, Grade 3.

Fatigue included fatigue, Grade 3 and fatigue, Grade 4.

Fever included Grades 3 and 4 fever.^[Ref]