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Smallpox Vaccine Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 20, 2024.

Applies to smallpox vaccine: injection powder for solution.

Important warnings This medicine can cause some serious health issues

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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this vaccine is working properly and to check for unwanted effects .

This vaccine may cause serious heart problems in some patients. Check with your doctor right away if you are having chest pain or discomfort; dizziness; fast or irregular heartbeat; fever and chills; shortness of breath; sweating, weakness; or trouble breathing .

Tell your doctor if you smoke cigarettes or other tobacco products. The risk of heart problems is increased in people who smoke .

You should not receive this vaccine if you are using medicines that weaken your immune system, such as steroids, radiation, or cancer medicines .

You should not become pregnant for at least 3 months after receiving this vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away .

This vaccine contains neomycin and polymyxin B. Make sure your doctor knows if you have had an allergic reaction to these medicines .

This vaccine contains a live virus. The virus can cause an infection in other parts of your body or in other people if you touch the vaccination site and then touch your body or other people. Always cover the vaccination site with a bandage. Wash your hands thoroughly after changing the bandage or after touching the vaccination site. Your doctor will tell you how to care for the vaccination site. Make sure you understand the directions and follow them carefully. Avoid contact with people who are sick or have infections until the scab falls off (usually 2 to 4 weeks after vaccination). Talk to your doctor about this if you have concerns .

You must wait at least 30 days before you can donate blood, use a hot tub or swim, handle a baby, or breastfeed .

Before you have any medical tests for syphilis or a tuberculin (TB) skin test, tell the medical doctor in charge that you have received this vaccine. The results of these tests may be affected by this vaccine .

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 side effects

  • feeling unusually cold
  • shivering
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

Less common side effects

  • 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 side effects

  • 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 adverse events

Nervous system

Other

Cardiovascular

Dermatologic

Musculoskeletal

Hematologic

Ocular

Immunologic

Gastrointestinal

Respiratory

See also:

References

1. (2020) "Product Information. ACAM2000 (smallpox vaccine)." Emergent BioSolutions Inc.

Further information

Smallpox vaccine 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.