Complications after BCG vaccine administration

Complications after BCG are considered as a local tuberculosis process and are subject to treatment by a pediatric phthisiatrician. Other vaccinations during treatment for complications are strictly prohibited.

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Anti-tuberculosis chemotherapy

Children with complications of BCG are prescribed three drugs:

1. streptomycin 20 mg/kg (administered as a single injection),
2. isoniazid 15-20 mg/kg (2-3 times orally before meals, after 30 minutes vitamin B6 is administered in an age-appropriate dose),
3. Pyrazinamide 25 mg/kg - one oral dose 30 minutes after a meal. (This recommendation is not indisputable, since there is evidence of BCG resistance to pyrazinamide).

The need for specific treatment of generalized complications of BCG is undoubted, however, controlled trials have shown the absence of influence of specific therapy (including macrolides) on the course of BCG lymphadenitis and the frequency of its suppuration. The recommendation to use pyrazinamide is also confusing, since the M. bovis BCG strain, as well as M. bovis, is resistant to it.

Lymphadenitis

Therapy with 3 drugs, for the fistula form in a child under 3 years of age, isoniazid 15 mg/kg/day orally, and 5 mg/kg in the form of a 10% solution is injected into the lymph node in 1 injection every other day - a total of 10 injections. Pus is sucked out with a syringe before the introduction of isoniazid. If the accumulation of pus continues after 2 weeks, the course of injections is repeated, in addition, for 5-7 days, compresses with a solution prepared from 0.45 g rifampicin, 15.0 ml dimexide and 85.0 ml distilled water are used.

After 1.5-2 months, if the lymph node has decreased, streptomycin is discontinued, and 2 drugs are administered until complete recovery. If there is no dynamics after 3 months, the issue of removing caseous-altered lymph nodes is decided. Large (>10 mm) calcification is also removed against the background of treatment with 2 drugs.

Infiltrates with ulceration in the center >20-30 mm and cold abscesses >20 mm are treated for 1 month with 3 drugs, then - with two until complete resorption. Locally, for an abscess up to 20 mm - puncture with suction of pus; streptomycin 20 mg/kg is administered. An abscess >20 mm is opened, dressings with a hypertonic solution are changed every day.

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Ulcers

Orally 2 drugs, locally for granulations sprinkle with isoniazid powder 0.1-0.3 g 2 times a day, at night - hydrocortisone ointment.

Outpatient groups for children with BCG-itis

	Type of complication	Frequency of examination	Observation period
VA	Persistent and disseminated BCG infection, including osteitis, caseous lymphadenitis (2 or more groups)	Depending on the patient's condition, but not less than once every 10 days	Unlimited
V-B	Caseous lymphadenitis of group 1, lymphadenitis without fistula, cold abscess, ulcer, infiltrate >1 cm, growing keloid	Depending on the patient's condition, but not less than once a month	Not less than 12 months.
VB	Inactive BCG infection: lymphadenitis in the calcification phase; non-growing keloid; individuals transferred from groups VA and V-B.	At least once every 6 months.	Unlimited

Keloid scars

There are no radical methods, surgical removal is strictly contraindicated, as it leads (after 3 months) to rapid growth of the keloid. Cryotherapy is also contraindicated. Resorption therapy includes intramuscular injection of pyrogenal followed by injection of lidase, as well as ultrasound (US) exposure followed by sodium thiosulfate electrophoresis. The effect of the treatment is to stop the growth of the scar.

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Outpatient observation

Outpatient monitoring of children who have complications after the BCG vaccine is carried out according to the schemes.

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Investigation of complications of BCG vaccination

The physician's algorithm of actions when investigating complications after BCG or BCG-M vaccination includes the following steps:

• Stage 1. Each vaccinated child is examined by a pediatrician at the age of 1, 3, 6 months before the local vaccination reaction has healed: the condition of the injection site and regional (axillary, supra- and subclavian, cervical) lymph nodes is noted.

Local ulceration more than 10 mm, or enlargement of more than 10 mm of a lymph node, or,

The recommendations are based on the provisions of the Order of the Ministry of Health of the Russian Federation dated 21.03.2003 No. 109, as well as the materials of the Manual for Doctors "Prevention of Complications of Anti-Tuberculosis Vaccination", Ministry of Health and Social Development of the Russian Federation, 2005. The absence of healing of a local reaction for more than 6 months is an indication for referral to a pediatrician-phthisiatrician. Additional examination is also indicated for children with lymphadenitis detected accidentally during examination due to a "turnover" of tuberculin tests, etc. In the children's clinic, blood and urine tests, the Mantoux reaction with 2TE (12 months or more after the administration of BCG), and chest X-rays are performed.

• Stage 2. The phthisiatrician determines the scope of diagnostics to confirm the diagnosis.
• Stage 3. After examination, the child with PVO is sent to the anti-tuberculosis dispensary to verify the diagnosis and prescribe treatment.

If BCG osteitis is suspected, radiography in 2 projections and/or computed tomography are performed to identify regional osteoporosis, atrophy, a focus of destruction, sequestration, narrowing of the joint space and other changes in the joints.

The diagnosis of generalized BCG infection is verified by isolating the Mycobacterium bovis BCG culture. If it is impossible to identify the strains locally, they should be sent to the St. Petersburg Research Institute of Phthisiogulmonology or the Central Research Institute of Tuberculosis of the Russian Academy of Medical Sciences (Moscow).

Hospitalization in a specialized hospital is indicated if it is impossible to adequately administer anti-tuberculosis therapy on an outpatient basis.

The final 4th stage of the algorithm after verification of the diagnosis of "complication after BCG" is informing higher authorities and drawing up an "Investigation Report on Complications after Immunization with a Tuberculosis Vaccine".

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