BCG Vaccine

BCG vaccine provides immunity or protection against tuberculosis (TB).

BCG vaccine is administered by multiple needle-puncture of the skin (percutaneously with a multiple puncture device). 

Common side effects include slight tenderness, itching, and red papules (a small, raised, solid pimple or swelling) at the puncture site. 

BCG vaccine provides immunity or protection against tuberculosis (TB) in persons not previously infected with TB who are at high risk for exposure to TB. 

BCG vaccination should be considered for:

• TB exposed tuberculin skin test-negative infants and children
• TB exposed health care workers (HCW) in high risk settings

BCG vaccination is reserved for persons who have a reaction of less than 5mm after a TB skin test. 

This vaccine may be used for other purposes. Ask you doctor or pharmacist for more information. 

BCG vaccine is given by multiple needle-puncture of the skin (percutaneously with a multiple puncture device) on the deltoid region (upper) arm. 

• A vaccinated person should be tuberculin skin tested 2–3 months after BCG administration. Vaccination should be repeated for those who test negative after 2–3 months.
• In infants less than 1 month old, the dosage of BCG vaccine should be reduced by one-half. If a vaccinated infant remains tuberculin negative on skin testing, and if indications for vaccination persist, the infant should receive a full dose after 1 year of age.

Serious side effects have been reported with the BCG vaccine including the following:

• more severe reactions at the injection site which might occur up to 5 months after vaccination and could persist for several weeks:
  • formation of ulcers (a sore) at the injection site
  • cuts or pus filled lesions at the injection site
• pus formation and inflammation of the lymph nodes with a runny nose (suppurative lymphadenitis with draining sinuses)
• BCG infection 

Do not take the BCG vaccine if you:

• have  a weakened immune system due to medical conditions such as the following HIV infections, congenital immunodeficiency such as chronic granulomatous disease or interferon gamma receptor deficiency, leukemia, lymphoma, or generalized malignancy
• have a weakened immune system due to certain drugs such as steroids, alkylating agents, antimetabolites, or radiation
• are HIV-infected or immunocompromised include children with a family history of immune deficiency disease

Serious side effects have been reported with the BCG vaccine. See the "BCG Vaccine Precautions" section.

Common side effects of the BCG vaccine include the following:

• skin reactions. Following vaccination with BCG, initial skin lesions usually appear within 10–14 days and consist of small red papules (a small, raised, solid pimple or swelling) at the vaccination site. The papules reach a maximum diameter (about 3 mm) after 4 to 6 weeks, after which they may scale and slowly subside. Six months afterwards there is usually no visible sign of the vaccination, though on occasion, a faintly discernable pattern of the points from the multiple puncture device may be visible
• Patients may experience "flu-like" symptoms for 24–48 hours following BCG vaccination. However, the patient should consult with their physician immediately if they experience fever of 103°F or greater, or acute local reactions persisting longer than 2–3 days.
• swollen lymph nodes (lymphadenopathy)

This is not a complete list of BCG vaccine side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

• antibiotics
• cancer chemotherapy agents
• steroids
• tuberculosis medications
• vitamins

This is not a complete list of BCG vaccine drug interactions. Ask your doctor or pharmacist for more information. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications and vaccines based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

BCG vaccines falls into category C. There are not well controlled studies that have been done in pregnant women. BCG vaccine should be used during pregnancy only if the possible benefit outweighs the potential risks to the unborn child. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if BCG vaccine crosses into human milk. Because some vaccines can cross into human milk and becuase of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using BCG vaccine.