Rsv vaccine, mrna Side Effects

Applies to rsv vaccine, mrna: intramuscular suspension.

Warning

Becoming infected with respiratory syncytial virus is much more dangerous to your health than receiving this vaccine.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

The vaccination provider may want to watch you for a short time after the injection 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.

Becoming infected with RSV is much more dangerous to your health than receiving this vaccine.

Call your doctor at once if you have:

fast heartbeats;
nausea, vomiting, dizziness, weakness;
fever; or
loss of movement in your face.

Common side effects may include:

pain, bruising, swelling, irritation, or tenderness in the armpit of the arm where the vaccine was injected;
headache;
joint or muscle pain;
feeling very weak or tired; or
chills.

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

For Healthcare Professionals

Applies to rsv vaccine, mrna: intramuscular suspension.

General

The most commonly reported adverse reactions were injection-site pain, fatigue, headache, myalgia, arthralgia, axillary/underarm swelling/tenderness, and chills.^[Ref]

Dermatologic

Common (1% to 10%): Erythema/redness

Frequency not reported: Urticaria

Erythema/redness (at least 2.5 cm: 2%; grade 3 [greater than 10 cm]: 0.6%) has been reported.

Gastrointestinal

Common (1% to 10%): Nausea/vomiting

Nausea/vomiting (any grade: 7%; grade 3: 0.4%) has been reported.

Local

Very common (10% or more): Injection-site pain (up to 55.9%)

Injection-site pain (any grade: 55.9%; grade 3: 1.7%) has been reported.

Musculoskeletal

Very common (10% or more): Myalgia (up to 25.6%), arthralgia (up to 21.7%)

Myalgia (any grade: 25.6%; grade 3: 1.4%) and arthralgia (any grade: 21.7%; grade 3: 1.1%) have been reported.

Nervous system

Very common (10% or more): Headache (up to 26.7%)

Frequency not reported: Facial paralysis

Headache (any grade: 26.7%; grade 3: 1.5%) has been reported.

Other

Very common (10% or more): Fatigue (up to 30.8%), axillary/underarm swelling/tenderness (up to 15.2%), chills (up to 11.6%)

Common (1% to 10%): Swelling/hardness, fever

Fatigue (any grade: 30.8%; grade 3: 1.7%), axillary/underarm swelling/tenderness (any grade: 15.2%; grade 3: 0.8%), chills (any grade: 11.6%; grade 3: 0.6%), swelling/hardness (at least 2.5 cm: 3.7%; grade 3 [greater than 10 cm]: 0.9%), and fever (any grade [at least 38C/100.4F]: 2.7%; grade 3 [39C to 40C/102.1F to 104F]: 0.4%; grade 4 [greater than 40C/104F]: 0.2%) have been reported.