Local and Systemic Adverse Reactions Following Covid-19 Vaccine

The mass vaccination against novel coronavirus infection (COVID-19) requires to dynamically evaluate risks of adverse events following immunization to prevent them and develop vaccination tactics for various population groups. We describe a clinical case of reaction following administration of the second dose of the heterologous recombinant adenovirus based COVID-19 vaccine Gam-COVID-Vac (Sputnik V) in 48-year-old female healthcare worker. No adverse events after administration of the first dose were recorded. After vaccination, the patient complained of weakness, malaise, headache, loss of appetite, and nausea that lasted for a single day. Reaction at the injection site appeared 10 hours after vaccination manifested as pruritic erythema, induration area up to 1.5 cm size, sharp pain, which resolved within 24 hours. On the second day post-vaccination, an inflammation area up to 1.5 cm size within the Bacillus Calmette-Guerin (BCG) scar site was noted and manifested as erythema, induration, painful to palpate, pruritus located 2 cm away from the injection site. BCG scar reaction with dull pain and severe pruritus lasted for three weeks. Erythema and induration at the BCG scar site resolved two months after the onset, which were resolved by using antihistaminic agent. The patient was vaccinated according to the Russian Federation Immunization Program, not associated with any adverse events following immunization. The patient had comorbidities such as vasomotor rhinitis, urolithiasis, stomach, duodenal ulcer, type 2 diabetes, arterial hypertension, and her body mass index of 35.2. The patient permanently receives antihypertensive and antihyperglycemic drugs, and has allergic reaction in the form of urticaria to Berodual. The patient has menopause during two years, but a five-day postmenopausal bleeding three days after vaccination with the second dose was noted. Thus, a high-quality surveillance of any local and systemic reactions associated with vaccination is needed to reveal adverse events to the vaccines against COVID-19 and elaborate a safe immunization program for preventing COVID-19.

BCG Scar Local Skin Inflammation as a Novel Reaction Following mRNA COVID-19 Vaccines in Two International Healthcare Workers.

Bacillus Calmette-Guérin (BCG) local scar inflammatory reactions have been mostly associated with Kawasaki disease in children and less commonly with other viral infections (i.e., measles). BCG scar inflammation associated with or following vaccine administration has only been reported with the influenza vaccine. We describe the first reports in the literature of local BCG inflammation following two different available messenger ribonucleic acid (mRNA) anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) vaccines (mRNA-1273, and BNT162b2) in two young healthy physicians, one from Costa Rica, and another from the United States of America, with normal cell blood counts, flow cytometries, and negative for human immunodeficiency virus (HIV). In both cases, BCG scar inflammation appeared after 24 hours of vaccination of the second dose, without signs of reaction on the injection site, and resolved within four days. Dermoscopic findings in one case showed arborizing and comma-shaped vessels. Pharmacovigilance surveillance of BCG scar reactions following coronavirus disease 2019 (COVID-19) vaccines should be considered particularly in countries where BCG is part of their national immunization programs.