Mycobacterium welchii Vaccine Granuloma - A Cautionary Tale.

Background: Mycobacterium welchii (Mycobacterium w) vaccine was one of the many strategies used to both treat and prevent coronavirus disease 2019 (COVID-19) infection. We report the results of a retrospective analysis of 15 cases with vaccine-site granulomas after administration of prophylactic Mycobacterium w vaccine as part of a trial for COVID-19 and our experience in managing those cases.

Methods: This was a retrospective analysis of 15 patients with vaccine-site granulomas who were given the vaccine as a prophylactic measure as part of a trial with informed consent.

Results: The mean average age of cases was 37 and the male-to-female ratio was 1:0.87. All of the patients developed erythematous tender nodules over the injection sites within a month of receiving the inoculations. Mycobacterial cultures and cartridge-based nucleic acid amplification tests yielded negative results. Skin biopsy revealed granulomatous dermatitis with acid-fast bacilli positivity. A diagnosis of noninfective granulomatous dermatitis was made. Treatment started with analgesics and anti-inflammatory agents. Systemic antibiotics were required in 9/15 patients. Patients are being followed up with no reported recurrence till date.

Conclusion: The possibility of injection-site granuloma should be taken into the risk-benefit analysis for the administration of Mycobacterium w vaccine and the patients should be counseled as such. Patients with persistent ulceration respond to combinations of doxycycline, ofloxacin, and clarithromycin.