BCG VACCINE for Immunisation: Side Effects & Safety Data
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There are 98 adverse event reports in the FDA FAERS database where BCG VACCINE was used for Immunisation.
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 |
Other Indications for BCG VACCINE
Bladder cancer (135)
Bladder transitional cell carcinoma (49)
Product used for unknown indication (30)
Transitional cell carcinoma (23)
Mantle cell lymphoma (9)
Prophylaxis (9)
Bladder neoplasm (7)
Other Drugs Used for Immunisation
INFLUENZA VIRUS VACCINE (560)
PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE (281)
COVID-19 VACCINE NOS (269)
TOZINAMERAN (207)
MEASLES VIRUS STRAIN ENDERS^ ATTENUATED EDMONSTON LIVE ANTIGEN\MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN\RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (152)
TUBERCULIN PURIFIED PROTEIN DERIVATIVE (148)
PNEUMOCOCCAL VACCINE POLYVALENT (140)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (123)
AD26.COV2.S (113)
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE A (111)