Table 4 Vaccine related adverse events.

From: Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial

Event Term

MIP Arm (N = 449)

Placebo Arm (N = 441)

Number of patients

Number of events

Number of patients

Number of events

Cutaneous Lesion at Injection Site (Abscess/Blister/Pappule)

309

310

10

10

Local Reaction at Injection Site (Pain, Swelling, Itching, Redness, Pus Discharge)

58

114

8

10

Scar at Injection Site

3

3

Total

370

427

18

20