Applies to rsv vaccine pref3, recombinant: intramuscular powder for suspension.

Serious side effects

Along with its needed effects, rsv vaccine pref3, recombinant 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 rsv vaccine pref3, recombinant:

Less common

• Fever

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Other side effects

Some side effects of rsv vaccine pref3, recombinant 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:

More common

• Bleeding, blistering, burning, coldness, discoloration of 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
• difficulty in moving
• headache
• joint pain
• muscle aches, cramps, pains, or stiffness
• swollen joints

For Healthcare Professionals

Applies to rsv vaccine pref3, recombinant: intramuscular powder for injection.

General

The most reported adverse reactions were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%).^[Ref]

Local

Very common (10% or more): Pain (60.9%), erythema greater than 20 mm

Common (1% to 10%): Grade 3 pain (pain at rest preventing normal daily activities), swelling greater than 20 mm

Uncommon (0.1% to 1%): Erythema greater than 100 mm, swelling greater than 100 mm^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (28.9%), arthralgia (18.1%)

Common (1% to 10%): Grade 3 myalgia (prevents normal daily activities), grade 3 arthralgia (prevents normal daily activities)^[Ref]

Nervous system

Very common (10% or more): Headache (27.2%)

Common (1% to 10%): Grade 3 headache (prevents normal daily activities)^[Ref]

Other

Very common (10% or more): Fatigue (33.6%)

Common (1% to 10%): Grade 3 fatigue (prevents normal daily activities), fever of 38C/100.4F or greater

Uncommon (0.1% to 1%): Fever greater than 39C/102.2F^[Ref]