Applies to smallpox and monkeypox vaccine: suspension.
Serious side effects
Along with its needed effects, smallpox and monkeypox vaccine 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 smallpox and monkeypox vaccine:
More common
- Chills
Less common
- Fever
Incidence not known
- Chest tightness
- cough
- difficulty with swallowing
- dizziness
- fast heartbeat
- hives, itching, rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- trouble breathing
- unusual tiredness or weakness
Other side effects
Some side effects of smallpox and monkeypox 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:
More common
- 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
- headache
- muscle pain
- nausea
For Healthcare Professionals
Applies to smallpox and monkeypox vaccine: injectable suspension, subcutaneous suspension.
General
There were similar proportion of subjects reporting local or systemic reactions of any severity after the second dose, compared to the first dose, except for injection site pain which was more common following dose 1 (79% vs 69%).[Ref]
Cardiovascular
None of the reported cardiac AESIs causally related to vaccination were considered serious.[Ref]
Common (1% to 10%): Subcutaneous: Cardiac Adverse Events of Special Interest (AESIs - any cardiac signs or symptoms, changes in ECG, or troponin-1 elevations above 2 times the upper limit of normal)[Ref]
Gastrointestinal
Very common (10% or more): Subcutaneous: Nausea (17%); Intradermal: Nausea (23%), change in appetite (20%)[Ref]
Local
Very common (10% or more): Subcutaneous: Pain (85%), redness (60%), swelling (51%), induration (45%), itching (43%); Intradermal: Erythema (99.5%), induration (99.5%), itchiness (89%), pain at injection site (65%), underarm pain (20%), underarm swelling (10%)[Ref]
Musculoskeletal
Very common (10% or more): Subcutaneous: Muscle pain (43%); Intradermal: Muscle aches (30%), joint pain (18%)[Ref]
Nervous system
Very common (10% or more): Subcutaneous: Headache (35%); Intradermal: Headache (41%)[Ref]
Other
Very common (10% or more): Subcutaneous: Fatigue (30%), chills (10%); Intradermal: Tiredness (51%), chills (14%)
Common (1% to 10%): Subcutaneous: Fever[Ref]
