Applies to smallpox vaccine: injection powder for solution.
Warning
Injection route (Powder for Solution)
Myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum resulting in permanent sequelae or death, ocular complications and blindness and fetal death, have occurred following primary vaccination or revaccination. Certain individuals are at an increased risk which may lead to severe disability, permanent neurological sequelae and/or death.
Serious side effects of Smallpox vaccine
Along with its needed effects, smallpox 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 immediately if any of the following side effects occur while taking smallpox vaccine:
More common
- Feeling unusually cold
- shivering
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
Less common
- Agitation
- anxiety
- back pain
- blindness
- blistering, peeling, or loosening of skin
- blue or pale skin
- blurred vision
- changes in vision
- chest discomfort
- chest pain, possibly moving to the left arm, neck, or shoulder
- confusion
- convulsions (seizures)
- cough
- diarrhea
- difficult or labored breathing
- dizziness
- drowsiness
- fast heartbeat
- fever and chills
- hallucinations
- headache
- irritability
- itching
- joint or muscle pain
- loss of consciousness
- mood or mental changes
- red skin lesions, often with a purple center
- red, irritated eyes
- shortness of breath
- skin rash that is encrusted, scaly, and oozing
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stiff neck
- tightness in the chest
- trouble breathing
- unusual tiredness or weakness
- vomiting
- wheezing
Other side effects of Smallpox vaccine
Some side effects of smallpox 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
- Decreased ability to exercise
- difficulty having a bowel movement (stool)
- difficulty with moving
- flushing or redness of the skin
- general feeling of discomfort or illness
- itching, pain, redness, or swelling at the vaccine site
- muscle aching or cramping
- muscle stiffness
- nausea
- rash
- swollen joints
- unusually warm skin
For Healthcare Professionals
Applies to smallpox vaccine: percutaneous powder for injection.
Local
Very common (10% or more): Injection site pruritus (92%), injection site erythema (74%), injection site pain (67%), injection site swelling (48%)[Ref]
Nervous system
Very common (10% or more): Headache (50%)
Frequency not reported: Encephalitis, encephalomyelitis, encephalopathy[Ref]
Other
Very common (10% or more): Fatigue (48%), malaise (37%), feeling hot (32%), rigors (21%), exercise tolerance decreased (11%)[Ref]
Cardiovascular
Frequency not reported: Myocarditis, pericarditis, ischemic heart disease, non-ischemic dilated cardiomyopathy[Ref]
Dermatologic
Very common (10% or more): Erythema (22%), rash (11%)
Frequency not reported: Erythema multiforme major (including Stevens-Johnson syndrome)[Ref]
Musculoskeletal
Very common (10% or more): Myalgia (46%)[Ref]
Hematologic
Very common (10% or more): Lymph node pain (57%)
Common (1% to 10%): Lymphadenopathy[Ref]
Ocular
Frequency not reported: Ocular complications, blindness[Ref]
Immunologic
Frequency not reported: Generalized vaccinia, severe vaccinial skin infections, eczema vaccinatum[Ref]
Gastrointestinal
Very common (10% or more): Nausea (19%), diarrhea (16%)
Common (1% to 10%): Constipation, vomiting[Ref]
Respiratory
Common (1% to 10%): Dyspnea[Ref]
