Adverse reactions following BCG vaccination are uncommon, with an estimated prevalance of 0.4 per 1000 vaccines [Lotte A, Wasz-Hockert O, Poisson N, et al. Second IUATLD study on complications induced by intradermal BCG vaccination. Bull Int Union Tuber 1988;63:47-59]. Complications include erythema, blistering, abscess formation, regional lymphadenitis and keloid formation. The onset of cutaneous tuberculosis (TB) has also been reported. We describe the case of 12-year-old girl who developed extensive primary ulceration involving most of her left upper arm at the site of a BCG vaccination. A skin graft to the arm failed to take at the periphery and the ulcerated area increased to involve most of the upper lateral arm. Over a period of 18 months, secondary lesions developed on her forehead prompting further investigation of a systemic disease process. Following extensive immunological and microbiological examination, a diagnosis of vaccine-induced granulomatous vasculitis was made and the patient responded to a combination of antituberculous therapy and steroids. Once the disease process was under control, skin grafting of the ulcerated area was successful in achieving wound closure. Non-healing ulceration may be referred to the plastic surgeon and a diagnosis of vasculitis should be considered in difficult cases. A multidisciplinary team approach involving immunologists, dermatologists and plastic surgeons provides the best opportunity for a successful long-term outcome in terms of disease control as well as immediate skin cover.

Although Kawasaki disease (KD) is a self-limiting disease, it may cause sudden cardiac death. Diagnosis of KD is principally based on clinical signs; however, some infant cases do not meet the criteria. Such cases are identified as incomplete KD. The sudden death risk in incomplete KD cases is similar to conventional KD. In our 5-month-old case, he had been admitted to a hospital for a fever and suppuration at the site of Bacille de Calmette et Guerin (BCG) vaccination. However, after discharge from the hospital, his C-reactive protein (CRP) levels declined, he got indisposed and died suddenly. A medico-legal autopsy revealed myocarditis, coronaritis, platelet-aggregated emboli in coronary arteries, and myocardial degeneration, suggesting that the fatal myocardial infarction was due to thrombus emboli in the coronary arteries. Forensic pathologists therefore should pay attention to the cardiac pathology originated from incomplete KD as a potential cause in cases of sudden infant death.

BACKGROUND: According to studies from Guinea-Bissau and Senegal, live vaccines may reduce the female-male mortality ratio (MR) whereas inactivated vaccines increase this ratio. We used data from The Gambia to examine whether similar tendencies could be found in a different setting.

SETTING: Forty villages in the Farafenni area in rural Gambia. SUBJECTS: A population of 17,000 was followed with demographic surveillance between 1998 and 2002; 537 children less than 5 years of age died in this period.

METHODS: We used two vaccination surveys and community mortality data to examine, first, the female-male mortality ratio (MR) in the age groups in which DTP and MV are recommended and have a high coverage. Second, using vaccination cards seen post-mortem, we examined the distribution of live or inactivated vaccines as last vaccination in different age groups. Third, we examined the effect of DTP and MV administered simultaneously.

MAIN OUTCOME MEASURES: The female-male MR in different age groups and for different vaccines.

RESULTS: Vaccination coverage was high for BCG, third dose of DTP (DTP3) and MV, reaching a level of 80-90% within a few months of the recommended age of vaccination. First, the female-male MR was 0.93 (0.63-1.38) in the first 2 months of life when children had received no vaccination or the combination of BCG, HBV and OPV. From 2 to 8 months of age, with DTP and HBV being the main vaccinations, the female-male MR was 1.28 (0.86-1.89). Between 9 and 17 months of age, with MV as the main vaccination, this ratio dropped to 0.73 (0.50-1.07), a significant inversion of the female-male MR (p=0.045). Second, using information from vaccination cards of dead children, boys who died at 2-4 months of age were more likely to have received live BCG and girls to have received inactivated DTP and HBV as last vaccination (p<0.001). At 5-8 months of age, essentially all dead children had received DTP as last vaccination and the female-male MR was 1.68 (0.96-2.93), whereas the MR was 0.70 (0.43-1.15) at 12-17 months of age when nearly all dead children had received MV (p=0.022). Third, compared with the general population of children who had received MV, dead children who had received MV were more likely to have received DTP3 simultaneously with MV (relative risk (RR)=5.59 (2.10-14.8)) or after MV (RR=2.61 (1.13-6.05)).

CONCLUSION: Most children dying at a specific age had received the recommended vaccines. BCG and MV as last vaccination was associated with a low female-male MR, whereas DTP as last vaccination was associated with a high female-male MR. These trends are consistent with observations from other African countries.

INTRODUCTION:BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised clinical trial of Bacille Calmette-Guérin (BCG) vaccination at birth, The Danish Calmette Study, we investigated the effect of BCG at birth on the antibody response to the three routine vaccines against DiTeKiPol/Act-Hib and Prevenar 13 in a subgroup of participants.

METHODS:Within 7days after birth, children were randomised 1:1 to BCG vaccination or to the control group (no intervention). After three routine vaccinations given at age 3, 5 and 12months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4weeks after the third vaccine dose.

RESULTS:Among the 300 included children (178 BCG; 122 controls), almost all children (>96%) had antibody responses above the protective levels. Overall BCG vaccination at birth did not affect the antibody level. When stratifying by 'age at randomisation' we found a possible inducing effect of BCG on antibodies against B. pertussis and all pneumococcal serotypes, when BCG was given after the first day of life. Girls had significantly higher antibody levels for Haemophilus influenza type b and pneumococcus than boys.

CONCLUSIONS AND RELEVANCE:Three routine vaccinations with DiTeKiPol/Act-Hib and Prevenar 13 induced sero-protective levels in almost all children. No overall effect of neonatal BCG vaccination was observed.

Kawasaki disease (KD) is an acute, self-limited, systemic vasculitis of unknown aetiology, extremely rare in infants younger than 6 months old. Younger infants are more likely to present with incomplete KD (IKD) and are at higher risk of developing coronary abnormalities. An early and specific clinical sign, not included in the classical diagnosis criteria, but that can be very useful in the diagnosis of KD, is the reaction at the Bacillus Calmette-Guérin (BCG) inoculation site. We describe a case of a 4-month-old boy, fully immunised, whose BCG scar reactivation led to the diagnosis of IKD. This case-report emphasises the importance of BCG site reactivation in establishing a diagnosis of IKD that clinicians should be aware of, especially in countries where BCG vaccination is still part of the immunisation schedule.

Mycobacterial Spindle cell Pseudotumor (MSP) is a rare complication of mycobacterial infection, especially the atypical variety. It is characterized by an exuberant spindle cell proliferation. This has been reported in the lymph nodes, skin, spleen, lungs, brain, etc. The incidence is higher in immuno-compromised patients, especially those with acquired immunodeficiency syndrome. It is rare to encounter this lesion in infants. We report a case of MSP in the axillary lymph node of a 7-month-old infant, following Bacillus Calmette Guerin (BCG) vaccination due to Mycobacterium tuberculosis complex, which was proved by PCR.

Borderline tuberculoid leprosy was diagnosed clinically and histologically in a four year-old boy about 6 months after intradermal vaccination with BCG. His mother reported that a lesion began to appear above the vaccination site on the arm 2 weeks after the vaccination, and a second lesion appeared on the chin 2 months later. Responses in the lymphocyte transformation test to sonicated Mycobacterium leprae, BCG, and to PPD were consistent with a tuberculoid leprosy infection. Precipitation of BT leprosy by intradermal BCG infection may possibly represent the overcoming of a phase of primary suppression in an individual who might otherwise have progressed toward lepromatous leprosy. The implications of this hypothesis for the planning of a controlled trial of an anti-leprosy vaccine are discussed.

A 13-year-old girl developed bilateral chronic anterior uveitis following bacille Calmette-Guérin (BCG) vaccination. HLA testing was negative for B27 but positive for DRB1 *0404, a variant of DR4 often associated with rheumatoid arthritis. The authors propose her HLA repertoire allowed for a BCG-induced abnormal autoimmune response by the mechanism of molecular mimicry.

Lupus vulgaris (LV) is a rare complication of the bacille Calmette-Guérin (BCG) vaccination, and about 65 cases of inoculation tuberculosis resembling LV have been reported in the literature. We report three cases of LV, developing many years later at the inoculation site of BCG vaccine. All three cases had a single BCG vaccination, with a LV lesion at or in the vicinity of the vaccination site, a strong positive Mantoux test, noncaseating granuloma histologically, and two of the patients had a positive PCR result for mycobacterial complex. One of the patients had an unusually delayed appearance of the LV lesion, after an interval of about 17 years, and another case was remarkable because of the large size of the lesion (210 x 110 mm).

We report a case of septic dislocation of the hip in an eight-month-old infant secondary to BCG vaccination. The usual treatment of septic arthritis with surgical drainage and broad spectrum antibiotics was unsuccessful. Cure was achieved after institution of an anti-tuberculosis treatment and a second surgical drainage. This rare complication of BCG vaccination can develop several months after administration of the vaccine. Diagnosis is often difficult to establish due to the minimal clinical and non-specific clinical expression. Early radiological signs are also non-specific. Identification of the causal agent can be most difficult. Certain diagnosis is generally achieved after biopsy and pathology examination. Despite the attenuated virulence of the vaccine, anti-tuberculosis treatment is indispensable to achieve cure. Surgery drainage alone is insufficient.

Marjolin's ulcer is an aggressive squamous cell carcinoma (SCC) found in chronically inflamed skin. SCC has been reported in smallpox vaccination sites, whereas basal cell carcinomas are more common in scar after bacille Calmette-Guérin (BCG) vaccination. A 72-year-old man presented with a chronic ulcer at the site of his childhood BCG vaccination. At the time of examination, a 3 × 1.5 cm fleshy and secreting ulcer was found on the shoulder. Biopsy revealed SCC, and the tumour was surgically removed. In conclusion, chronic ulcers, especially those originating in chronically inflamed skin, should be regularly biopsied to assure that malignant transformation has not occurred.

PURPOSE:The authors described the rare case of the progression of changes in the retina of child in course of retinopathy of prematurity. It happened after finished laser-treatment and full regression of changes of the retina. It seems that BCG vaccination done in 3-th month of life could reactivate the disease of the retina which caused total retina detachment of both eyes.

MATERIAL AND METHODS:The ophthalmologic examination included: indirect ophthalmoscopy using Fisson ophthalmoscope, slit-lamp examination and USG B-mode examination, using USG Echo Scan 3300 Oculus with the head 10 MHz--performed during all control visits.

RESULTS:The regular ophthalmologic examination enabled estimation of the dynamic of changes in the retina and correctness of treatment. In author's opinion, the secondary retina detachment in 3-th month of life could be associated with reaction post BCG vaccination.

CONCLUSIONS:Probably secondary inflammation after BCG vaccination could be the reason of reactivation of earlier treated with good results ROP Possible vision complications should incline to take special ophthalmologic care of premature infants from high risk group (very low mass of the body or fetal immaturity). Decision of changing time of BCG vaccination in such group should be made by attending physician.