Local and systemic adverse reactions following COVID-19 vaccine (clinical report)

Cite item

Full Text


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-Guérin (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.

About the authors

N. Yu. Zherebtsova

Belgorod National Research University, Belgorod, Russian Federation

Email: zherebtsova@bsu.edu.ru

PhD (Medicine), Head of the Department of Hygiene and Epidemiology, Institute of Medicine of Belgorod National Research University

Russian Federation

T. V. Kajdanek

Bashkir State Medical University, Ufa, Russian Federation

Author for correspondence.
Email: tkajdanek@mail.ru

PhD (Medicine), Associate Professor of the Department of Epidemiology, Bashkir State Medical University


  1. Ayantunde A.A. Delayed BCG Granulomatous Reaction in An Immunocompetent Adult: A Case Report. Clinical Practice, 2012, vol. 1, no. 1, pp. 1‒3. doi: 10.5923/j.cp.20120101.01
  2. Baden L.R., El Sahly H.M., Essink B., Kotloff K., Frey S., Novak R., Diemert D., Spector S.A., Rouphael N., Creech C. B., McGettigan J., Kehtan S., Segall N., Solis J., Brosz A., Fierro C., Schwartz H., Neuzil K., Corey L., Gilbert P., Janes H., Follmann D., Marovich M., Mascola J., Polakowski L., Ledgerwood J., Graham B.S., Bennett H., Pajon R., Knightly C., Leav B., Deng W., Zhou H., Han S., Ivarsson M., Miller J., Zaks T. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N. Engl. J. Med., 2021, vol. 384, pp. 403‒416. doi: 10.1056/NEJMoa2035389
  3. Blumenthal K.G., Freeman E.E., Saff R.R., Robinson L.B., Wolfson A.R., Foreman R.K. Delayed Large Local Reactions to mRNA-1273 Vaccine against SARS-CoV-2. N. Engl. J. Med., 2021, vol. 384, no. 13, pp. 1273‒1277. doi: 10.1056/NEJMc2102131
  4. Chavarri-Guerra Y., Soto-Perez-de-Celis E. Erythema at the bacillus Calmette-Guerin scar after influenza vaccination. Journal of the Brazilian Society of Tropical Medicine, 2020, vol. 53, e20190390. doi: 10.1590/0037-8682-0390-2019
  5. Kakisaka Y., Ohara T., Katayama S., Suzuki T., Sasai S., Hino-Fukuyo N., Kure S. Human Herpes Virus Type 6 Can Cause Skin Lesions at the BCG Inoculation Site Similar to Kawasaki Disease. Tohoku J. Exp. Med., 2012, vol. 228, no. 4, pp. 351‒353. doi: 10.1620/tjem.228.351
  6. Lopatynsky-Reyes E.Z., Acosta-Lazo H., Ulloa-Gutierrez R., Ávila-Aguero M.L., Chacon-Cruz E. BCG Scar Local Skin Inflammation as a Novel Reaction Following mRNA COVID-19 Vaccines in Two International Healthcare Workers. Cureus, 2021, 13(4): e14453. doi: 10.7759/cureus.14453
  7. Merchant H. Rapid Response: CoViD-19 post-vaccine menorrhagia, metrorrhagia or postmenopausal bleeding and potential risk of vaccine-induced thrombocytopenia in women. Letter to the Editor. B.M.J., 2021, vol. 373, no. 958 doi: 10.1136/bmj.n958
  8. Moreira T.N.F., Moraes-Pinto M.I., Costa-Carvalho B.T., Grumach A.S., Weckx L.Y. Clinical management of localized BCG adverse events in children. Rev. Inst. Med. Trop. Sao Paulo, 2016, 58(84). doi: 10.1590/S1678-9946201658084
  9. Muthuvelu S., Lim K. S.-C., Huang L.-Y., Chin S.-T., Mohan A. Measles infection causing Bacillus Calmette-Guérin reactivation: a case report. BMC Pediatrics, 2019, 19(251). doi: 10.1186/s12887-019-1635-z
  10. Yamazaki-Nakashimada M.A., Unzueta A., Gámez-González L.B., González-Saldaña N., Sorensen R.U. BCG: a vaccine with multiple faces. Hum. Vaccin. Immunother., 2020, vol. 16, no. 8. pp. 1841–1850. doi: 10.1080/21645515.2019.1706930

Supplementary files

There are no supplementary files to display.

Copyright (c) Zherebtsova N.Y., Kajdanek T.V.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies