BCG VACCINE for Prophylaxis: Side Effects & Safety Data

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There are 9 adverse event reports in the FDA FAERS database where BCG VACCINE was used for Prophylaxis.

Most Reported Side Effects for BCG VACCINE

Side Effect	Reports	%	Deaths	Hosp.
Disseminated bacillus calmette-guerin infection	87	20.8%	15	32
Immune reconstitution inflammatory syndrome	60	14.4%	5	13
Pyrexia	39	9.3%	5	18
Drug ineffective	35	8.4%	15	21
Off label use	35	8.4%	8	8
Granuloma	16	3.8%	1	5
Mycobacterial infection	16	3.8%	5	14
Vaccination complication	15	3.6%	0	5
Lymphadenopathy	14	3.4%	2	1
Disease progression	12	2.9%	2	0
Infection	12	2.9%	1	9
Neutropenia	12	2.9%	1	1
Skin lesion	12	2.9%	3	0
Acute kidney injury	11	2.6%	1	3
Bladder cancer	11	2.6%	0	2