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.
Applies to sars-cov-2 (covid-19) mrna-1273 vaccine: intramuscular suspension.
Serious side effects of Spikevax
Along with its needed effects, sars-cov-2 (covid-19) mrna-1273 vaccine (the active ingredient contained in Spikevax) 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
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]
