Spikevax PF Side Effects

Generic name: sars-cov-2 (covid-19) mrna-1273 vaccine

Medically reviewed by Drugs.com. Last updated on Jul 22, 2023.

Note: This document contains side effect information about sars-cov-2 (covid-19) mrna-1273 vaccine. Some dosage forms listed on this page may not apply to the brand name Spikevax PF.

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

Serious side effects of Spikevax PF

Along with its needed effects, sars-cov-2 (covid-19) mrna-1273 vaccine (the active ingredient contained in Spikevax PF) 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 of Spikevax PF

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, acute/delayed urticaria

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

Gastrointestinal

Very common (10% or more): Nausea (up to 29%), vomiting (up to 29%)

Postmarketing reports: Abdominal pain^[Ref]

Genitourinary

Postmarketing reports: Heavy menstrual bleeding^[Ref]

Hematologic

Very common (10% or more): Lymphadenopathy^[Ref]

Hypersensitivity

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

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

Frequency not reported: Facial swelling

Postmarketing reports: Anaphylaxis^[Ref]

Immunologic

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

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

Local

Very common (10% or more): Injection site pain (up to 97%), injection site swelling (28%), localized swelling/hardness (up to 17%), injection site erythema (up to 18.7%), 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 urticaria^[Ref]

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

Metabolic

Very common (10% or more): Appetite loss (up to 45.7%)^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 61.5%), chills (up to 49%), arthralgia (up to 41%)^[Ref]

Nervous system

Very common (10% or more): Headache (up to 78%), sleepiness (up to 51.1%)

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

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

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

Other

Very common (10% or more): Fatigue (up to 75%), pain (up to 71.4%), use of antipyretic/pain medication (up to 57.3%), axillary swelling/tenderness (up to 35%), 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]

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

Psychiatric

Very common (10% or more): Irritability/crying (up to 71%)^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer