Table 3.
Previously reported incidence of BCG-related adverse reactions.
| Source country BCG strain age at BCGa | BCG | Injection site abscess | Regional lymphadenopathy | |||
|---|---|---|---|---|---|---|
| n/N | Risk (95% CI) | n/N | Risk (95% CI) | Comments for lymphadenopathy | ||
| Adults | ||||||
|
BRACE Australia BCG-Denmark (AJ Vaccines) 19–74 y |
All | 41/1387 | 3.0% (21/1000 to 38/1000) | 48/1387 | 3.5% (33/1000 to 36/1000) | Any size |
| V | 10/673 | 1.5% (6/1000 to 24/1000) | 18/673 | 2.7% (14/1000 to 39/1000) | All were non-suppurative | |
| R | 31/714 | 4.3% (28/1,000 to 58/1000) | 30/714 | 4.2% (27/1,000 to 57/1000) | ||
|
Hatherill et al.34, 2014 South Africa BCG-Denmark (SSI) 18–40 y |
R | NA | — | 10/72 | 14% (53/1,000 to 225/1000) | All 72 axillary and had prior positive TST >15 mm |
| All ages | ||||||
|
Product Characteristics9 BCG-Denmark (AJ vaccines) |
NA | — | <0.1% (≥0.1/1000 to <1/1000) | — | <1% (≥1/1000 to <10/1000) | Size >1.0 cm |
|
Turnbull et al.1, 2002 Australia BCG Connaught (Montreal strain) 1d–54y |
All | 23/918 | 2.5% (15/1000 to 35/1000) | 10/918 | 1.1% (4/1000 to 18/1000) | Size ≥1.5 cm |
|
Ponnighaus et al.35, 1993 Malawi BCG-Glaxo 0–71 y |
R | NA | — | 4/54,865 | 0.01% (0.001/1000 to 0.14/1000) | Only included suppurative lymphadenitis |
| Adolescents | ||||||
|
Nemes et al.15, 2018 South Africa BCG-Denmark (SSI) 12–17 y |
R | NA | — | 2/330 | 0.6% (<1/1000 to 14/1000) | — |
|
Dourado et al.37, 2003 Brazil BCG-Moreau 7–14 y |
All V R |
NA | — |
7/71347 2/11,981 5/59,366 |
0.01% (0.03/1000 to 0.17/1000) 0.02% (<1/1000 to 0.40/1000) 0.01% (0.01/1000 to 0.16/1000) |
Axillary |
|
Cunha et al.38, 2008 Brazil BCG-Moreau 7–14 y |
R | 8/47,307 | 0.02% (0.05/1000 to 0.3/1,1000) | 1/47,307 | 0.002% (<1/1000 to 0.06/1000) | Axillary |
| Children | ||||||
|
Aydinlioglu et al.39, 1993 Turkey BCG-Pasteur 3–12 m |
All | NA | — | 15/219 | 6.8% (34/1000 to 103/1000) | 4 of 15 were suppurative lymphadenitis |
|
Roth et al.11, 2010 Guinea-Bissau BCG-Denmark (SSI) 19m–5y |
All V R |
NA | — |
38/787 14/393 24/394 |
4.8% (33/1000 to 64/1000) 3.6% (17/1000 to 54/1000) 6.1% (37/1000 to 85/1000) |
Axillary LN >1.5 cm |
|
Lotte et al.5, 1984 17 countries BCG intradermal, various strains <12 m |
All | NA | — | 3/4.8mill to 9994/263,000 | Range <0.0001% (East Germany) to 3.8% (Algeria) | Only included suppurative lymphadenitis |
|
Chaves-Carballo et al.40, 1972 Panama (BCG strain NR) Children |
Vb | NA | — | 25/1295 | 1.9% (12/1000 to 27/1000) |
Size ≥1.0 cm 12 of 25 were suppurative lymphadenitis |
|
Kim et al.41, 2016 Korea BCG-Denmark Children |
Vb | NA | — | 5/721 | 0.7% (<1/1000 to 13/1000) |
Any size 3 of 5 were ≥1.5 cm |
|
Nissen et al.42, 2016 Denmark BCG-Denmark (SSI) |
V | NA | — | 13/2118 | 0.6% (3/1000 to 9/1000) |
Size >1.0 cm 10 of 13 were suppurative lymphadenitis |
| Neonates | ||||||
|
Jeena et al.36, 2001 South Africa BCG-Denmark (SSI) Neonates |
V | 123/9763 | 1.3% (10/1000 to 15/1000) | 54/9763 | 0.6% (4/1000 to 7/1000) | Size >1.5 cm |
|
Dommergues et al.6, 2009 France BCG-Denmark (SSI) 1d–6y |
Vb | 60/2435 | 2.5% (18/1000 to 31/1000) | 3/2435 | 0.1% (<1/1000 to 3/1000) |
Size >1.0 cm All three were non-suppurative lymphadenitis |
Abscess minimum diameter size only specified for BRACE Trial (≥1.5 cm) and Dommergues et al. (>1.0 cm).
BCG Bacille Calmette-Guérin, d days, SPC summary of product characteristics, SSI Statens Serum Institute, LN lymph node, m months, mill million, n number of cases, N number of vaccinees, NA not reported, R revaccinated, TST tuberculin skin test, V first BCG vaccination, y years.
aLatest dose.
bPresumed as children <6 years and revaccination not specified.