Complications associated with the bacille Calmette-Guérin vaccination in Ireland.
BACKGROUND
BCG vaccination is currently recommended for all newborns in Ireland except where specifically contraindicated. This paper describes a marked increase in the number of referrals of patients with localised complications after vaccination to two Dublin paediatric hospitals. This increase coincided with the introduction of a new strain of BCG vaccine


METHODS
A population surveillance study was undertaken to determine the frequency and spectrum of complications associated with the new strain of BCG vaccine introduced in Ireland. Patients were identified though review of the infectious disease service case records and microbiology laboratory culture reports for the two year period from August 2002 to July 2004. Prospectively gathered data were supplemented by retrospective chart review. All infants who had inoculation site abscesses, suppurative adenopathy, or non-suppurative adenopathy with nodes > or =2 cm were included.


RESULTS
Fifty eight patients presented a median of 13 weeks post-inoculation: 32 with suppurative adenitis, 17 with inoculation site abscess, three with both inoculation site abscess and suppurative adenitis, and six with non-suppurative adenopathy. The overall complication rate was estimated at 1/931 vaccinees with 1/1543 developing suppurative adenitis. Twenty six infants required surgery.


CONCLUSIONS
This series illustrates the role of hospitals in sentinel surveillance and highlights the importance of having a well functioning and responsive system of adverse event reporting. These events raise a serious question as to the suitability of this vaccine strain for use in a national immunisation programme in a country where the prevalence of tuberculous disease is 10.4/100,000.
Our Lady's Hospital for Sick Children, Dublin, Eire. turloughbolger@yahoo.co.uk
T
T
Bolger
M
M
O'Connell
A
A
Menon
K
K
Butler
D000038:Abscess / Q000139:chemically induced* / Q000453:epidemiology; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001365:Axilla; D001500:BCG Vaccine / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007494:Ireland / Q000453:epidemiology; D008199:Lymphadenitis / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D011446:Prospective Studies; D013492:Suppuration / Q000139:chemically induced / Q000453:epidemiology
D000900:Anti-Bacterial Agents; D001500:BCG Vaccine