Applies to sars-cov-2 (covid-19) mrna-1273 vaccine: intramuscular suspension.

Serious side effects

Along with its needed effects, sars-cov-2 (covid-19) mrna-1273 vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking sars-cov-2 (covid-19) mrna-1273 vaccine:

More common

• Chills
• difficulty in moving
• fever
• headache
• joint pain
• muscle aches, cramps, pains, or stiffness
• nausea
• swollen joints
• unusual tiredness or weakness
• vomiting

Incidence not known

• Anxiety
• blue or pale skin
• chest discomfort or tightness
• chest pain, possible moving to the left arm, neck, or shoulder
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• fainting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing

Other side effects

Some side effects of sars-cov-2 (covid-19) mrna-1273 vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to sars-cov-2 (covid-19) mrna-1273 vaccine: intramuscular suspension.

General

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

Cardiovascular

Postmarketing reports: Myocarditis, pericarditis^[Ref]

Dermatologic

Frequency not reported: Rash, urticaria

Postmarketing reports: Acute urticaria, delayed urticaria, erythema multiforme^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 24%), vomiting (up to 24%)^[Ref]

Hematologic

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

Hypersensitivity

Common (1% to 10%): Hypersensitivity events/hypersensitivity

Frequency not reported: Facial swelling

Postmarketing reports: Anaphylaxis^[Ref]

Immunologic

Common (1% to 10%): Acute otitis media^[Ref]

Acute otitis media occurred more frequently in patients 6 to 23 months of age who received this vaccine compared to placebo.^[Ref]

Local

Delayed injection site reactions included at least 1 of the following: erythema, pain, and/or swelling.

Facial swelling occurred in 2 patients on Day 1 and Day 3 with a history of injection of dermatological fillers.^[Ref]

Very common (10% or more): Injection site pain (up to 97.2%), localized swelling/hardness (up to 17%), injection site erythema (up to 13.5%), localized swelling/induration (up to 12.6%)

Common (1% to 10%): Delayed injection site reactions, injection site lymphadenopathy

Frequency not reported: Injection site pruritus, injection site rash, injection site swelling, injection site urticaria^[Ref]

Metabolic

Very common (10% or more): Appetite loss (up to 32.1%)^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 61.5%), chills (up to 45.4%), arthralgia (up to 41%)^[Ref]

Nervous system

Acute peripheral facial paralysis/palsy was reported in 3 patients who received their second dose after 22 days, 28 days, and 32 days.^[Ref]

Very common (10% or more): Headache (up to 78.4%), sleepiness (up to 37.3%)

Frequency not reported: Acute peripheral facial paralysis/palsy, Bell's palsy, febrile convulsion

Postmarketing reports: Dizziness, facial paralysis, hypoesthesia, paresthesia^[Ref]

Other

Axillary swelling and tenderness included localized axillary swelling or tenderness ipsilateral to the vaccinated arm and lymphadenopathy.^[Ref]

Very common (10% or more): Fatigue (up to 75.2%), pain (up to 71.4%), use of antipyretic/pain medication (up to 57.3%), axillary swelling (up to 28%), axillary tenderness (up to 28%), fever (up to 23.9%)

Common (1% to 10%): Axillary/groin swelling or tenderness^[Ref]

Psychiatric

Very common (10% or more): Irritability/crying (up to 67.6%)^[Ref]