Rsv Vaccine, Pref A-pref B, Recombinant Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 6, 2025.

Applies to rsv vaccine, pref a-pref b, recombinant: intramuscular powder for solution, intramuscular powder for suspension.

Other side effects

Some side effects of rsv vaccine, pref a-pref b, 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 side effects

• 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
• diarrhea
• joint pain
• muscle pain

Less common side effects

• nausea

Rare side effects

• vomiting

Serious side effects

Along with its needed effects, rsv vaccine, pref a-pref b, 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, pref a-pref b, recombinant:

Less common side effects

• blurred vision
• dizziness
• fever
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

Incidence not known

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

For healthcare professionals

Applies to rsv vaccine, pref a-pref b, recombinant: intramuscular powder for injection.

General adverse events

The most common adverse reactions in pregnant patients were injection site pain, headache, muscle pain, and nausea. The most common adverse reactions in patients 60 years and older were fatigue, headache, injection site pain, and muscle pain. The most common adverse reactions in patients 18 through 59 years of age with chronic medical conditions were injection site pain, muscle pain, joint pain, and nausea.^[Ref]

Cardiovascular

• Frequency not reported: Atrial fibrillation

Dermatologic

• Frequency not reported: Urticaria

Gastrointestinal

• Very common (10% or more): Nausea (up to 20%), diarrhea (up to 11.2%)
• Common (1% to 10%): Vomiting

Systemic reactions within 7 days of vaccination in maternal participants included nausea (any severity: 20%; mild: 14.4%; moderate: 5.4%; severe: 0.2%), diarrhea (any severity: 11.2%; mild: 9.1%; moderate: 2%; severe: 0.1%), and vomiting (any severity: 7.8%; mild: 6.4%; moderate: 1.3%; severe: 0.2%).

Systemic reactions within 7 days of vaccination in participants 60 years and older included nausea (any severity: up to 3.5%; mild: up to 2.6%; moderate: 0.9%), diarrhea (any severity: up to 6%; mild: up to 4.5%; moderate: up to 1.4%; severe: 0.1%), and vomiting (any severity: 0.9%; mild: 0.7%; moderate: 0.2%).

Systemic reactions within 7 days of vaccination in participants 18 through 59 years of age at increased risk of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) included nausea (any severity: 11.8%; mild: 9.3%; moderate: 2.4%), diarrhea (any severity: 14.9%; mild: 11.1%; moderate: 3.1%; severe: 0.7%), and vomiting (any severity: 2%; mild: 1.6%; moderate: 0.4%).

Hypersensitivity

• Very rare (less than 0.01%): Hypersensitivity

Local

• Very common (10% or more): Injection site pain (up to 40.6%), vaccination site pain (up to 41%)
• Common (1% to 10%): Redness/erythema, swelling, vaccination site redness, vaccination site swelling
• Uncommon (0.1% to 1%): Severe local reactions

Local reactions within 7 days of vaccination in maternal participants included injection site pain (any severity: 40.6%; mild: 36.1%; moderate: 4.4%; severe: 0.1%), redness (any severity: 7.2%; mild: 5%; moderate: 2.1%; severe: 0.1%), and swelling (any severity: 6.2%; mild: 4.1%; moderate: 2%; severe: less than 0.1%).

Local reactions within 7 days of vaccination in participants 60 years and older included injection site pain (any severity: up to 10.7%; mild: up to 9.6%; moderate: 1.1%; severe: less than 0.1%), redness (any severity: 2.7%; mild: up to 1.6%; moderate: up to 1.1%; severe: 0.1%), and swelling (any severity: up to 2.5%; mild: 1.5%; moderate: 0.9%; severe: 0.1%).

Local reactions within 7 days of vaccination in participants 18 through 59 years of age at increased risk of LRTD caused by RSV included injection site pain (any severity: 35.3%; mild: 29.7%; moderate: 5.5%), redness (any severity: 6%; mild: 3.8%; moderate: 2.2%), and swelling (any severity: 7.1%; mild: 4%; moderate: 2.9%; severe: 0.2%).

In 1 study, this drug was coadministered with a seasonal inactivated influenza virus vaccine (with placebo administered 1 month later) or this drug was administered 1 month after the influenza vaccine (plus placebo). In the coadministration group, local adverse reactions reported with this drug included pain (any severity: 11.4%), erythema (greater than 20 mm: 3%), and swelling (greater than 20 mm: 2.9%). In the sequential-administration group, local adverse reactions reported with this drug included pain (any severity: 12.4%), erythema (greater than 20 mm: 1.6%), and swelling (greater than 20 mm: 1.9%; greater than 100 mm: 0.1%).

Musculoskeletal

• Very common (10% or more): Muscle pain/myalgia (up to 27%), joint pain/arthralgia (up to 12.4%)

Systemic reactions within 7 days of vaccination in maternal participants included muscle pain (any severity: 26.5%; mild: 17.6%; moderate: 8.6%; severe: 0.4%) and joint pain (any severity: 11.6%; mild: 6.5%; moderate: 4.9%; severe: 0.2%).

Systemic reactions within 7 days of vaccination in participants 60 years and older included muscle pain (any severity: up to 10.2%; mild: 6.5%; moderate: 3.5%; severe: 0.2%) and joint pain (any severity: up to 7.6%; mild: 4.5%; moderate: up to 3%; severe: less than 0.1%).

Systemic reactions within 7 days of vaccination in participants 18 through 59 years of age at increased risk of LRTD caused by RSV included muscle pain (any severity: 24.4%; mild: 15.7%; moderate: 8.6%) and joint pain (any severity: 12.4%; mild: 7.1%; moderate: 5.1%; severe: 0.2%).

In 1 study, this drug was coadministered with a seasonal inactivated influenza virus vaccine. Within 7 days of vaccination, myalgia (any severity) was reported in 15.8%, 12.3%, and 9.5%, respectively, and arthralgia (any severity) was reported in 11.6%, 9.2%, and 7.1%, respectively, of participants who received this drug with the influenza vaccine, this drug alone, and the influenza vaccine with placebo.

Nervous system

• Very common (10% or more): Headache (up to 31%)
• Rare (0.01% to 0.1%): Guillain-Barre syndrome
• Frequency not reported: Miller Fisher syndrome
• Postmarketing reports: Guillain-Barre syndrome

Systemic reactions within 7 days of vaccination in maternal participants included headache (any severity: 31%; mild: 20.2%; moderate: 10.4%; severe: 0.4%).

Systemic reactions within 7 days of vaccination in participants 60 years and older included headache (any severity: up to 12.9%; mild: 9%; moderate: up to 3.8%; severe: 0.1%).

Systemic reactions within 7 days of vaccination in participants 18 through 59 years of age at increased risk of LRTD caused by RSV included headache (any severity: 28.4%; mild: 20.8%; moderate: 7.3%; severe: 0.2%).

In 1 study, this drug was coadministered with a seasonal inactivated influenza virus vaccine. Within 7 days of vaccination, headache (any severity) was reported in 19.7%, 20.9%, and 16.2% of participants who received this drug with the influenza vaccine, this drug alone, and the influenza vaccine with placebo, respectively.

Other

• Very common (10% or more): Fatigue (up to 30%)
• Common (1% to 10%): Severe systemic reactions, fever, disorders of pregnancy/puerperium/perinatal conditions, pregnancy-related serious adverse events, neonatal jaundice, preterm births, low birth weight

Systemic reactions within 7 days of vaccination in maternal participants included fatigue (any severity: 46.1%; mild: 23.4%; moderate: 21.4%; severe: 1.3%) and fever (at least 38C: 2.6%; 38C to 38.4C: 1.7%; greater than 38.5C to 38.9C: 0.8%; greater than 39C to 40C: less than 0.1%; greater than 40C: less than 0.1%).

Pregnancy-related serious adverse events in pregnant patients occurring at any time after vaccination included preeclampsia (1.8%), gestational hypertension (1.1%), premature rupture of membranes (0.4%), preterm premature rupture of membranes (0.4%), hypertension (0.4%), maternal death (less than 0.1%), and fetal death (0.3%). In 1 study, eclampsia and HELLP syndrome (hemolysis, elevated liver enzymes, low platelets) occurred with this drug in 3 and 2 participants, respectively, and with placebo in 2 and 3 participants, respectively.

Systemic reactions within 7 days of vaccination in participants 60 years and older included fatigue (any severity: up to 15.7%; mild: 9.3%; moderate: up to 6%; severe: 0.3%) and fever (at least 38C: up to 1.5%; 38C to 38.4C: up to 0.7%; greater than 38.4C to 38.9C: 0.8%; greater than 38.9C to 40C: less than 0.1%).

Systemic reactions within 7 days of vaccination in participants 18 through 59 years of age at increased risk of LRTD caused by RSV included fatigue (any severity: 37.3%; mild: 18.2%; moderate: 18.2%; severe: 0.9%) and fever (at least 38C: 1.6%; 38C to 38.4C: 0.4%; greater than 38.4C to 38.9C: 1.1%).

In 1 study, this drug was coadministered with a seasonal inactivated influenza virus vaccine. Within 7 days of vaccination, fatigue (any severity) was reported in 30%, 19.1%, and 27.1%, respectively, and fever greater than 38C was reported in 1.9%, 1.4%, and 1.2%, respectively, of participants who received this drug with the influenza vaccine, this drug alone, and the influenza vaccine with placebo.

Frequently asked questions

• What is the difference between Arexvy and Abrysvo?
• What are the symptoms of RSV (respiratory syncytial virus)?

Further information

Rsv vaccine, pref a-pref b, recombinant side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer