COVID-19 vaccination: a possible trigger for Addisonian crisis in a patient with Addison’s disease
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20221601Keywords:
Addison’s disease, Addisonian crisis, Adverse drug reaction, COVID-19, Pharmacovigilance, VaccinationAbstract
Infection with COVID-19 disease is caused by the SARS-CoV-2 virus. Following its identification, the pursuit of the rapid development of effective vaccines became a pandemic-period international public health priority. This report describes the case of an older woman with Addison’s disease who developed acute clinical symptoms and signs indicative of an Addisonian crisis following each of two consecutive doses of the Pfizer BioNTech Covid-19 vaccines. Both presentations (with nausea, vomiting, hypotension, tachycardia, and transient hypoglycaemia) occurred within 24 hours of receipt of the vaccines. In each instance, she responded well to treatment with intravenous fluids, and temporarily changing her maintenance oral steroid regimen to higher dose intravenous steroids. She successfully completed a period of rehabilitation and was discharged home. Some pharmacokinetic and pharmacodynamic considerations of the Pfizer BioNTech COVID-19 vaccines are discussed. An overview is presented of Addison’s disease and Addisonian crisis. The discussion also applies two causality assessment systems to derive a classification of ‘probable’ adverse drug reactions for the index case report.
References
Coronovirus disease (Covid-19 pandemic). Available at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019?. Accessed on 26 March 2022.
British National Formulary. Available at: https://www.COVID-19 vaccine Drug-BNF content published by NICE. Accessed on 26 March 2022.
Origin of SARS-CoV-2. Available at: Error! Hyperlink reference not valid.. Accessed on 26 March 2022.
WHO Director General’s opening remarks at the media briefing on COVID-19 on 11th March 2020. Available at: https://www.who.int/director-general/speeches/ detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020. Accessed on 26 March 2022.
COVID-19 Immunisation against infectious disease – ‘The Green Book’. Public Health England. Available at: https://www.gov.uk/government/publications/ covid-19-the-green-book-chapter-14a. Accessed on 26 March 2022.
Summary of Product Characteristics - Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified). BioNTech-Pfizer. Available at:https://www.medicines.org.uk/ emc/product/12740/smpc. Accessed on 26 March 2022.
Yellow Card. Available at: Error! Hyperlink reference not valid.. Accessed on 26 March 2022.
Betterle C, Presotto F, Furmaniak J. Epidemiology, pathogenesis, and diagnosis of Addison's disease in adults. J Endocrinol Invest. 2019;42(12):1407-33.
Saverino S, Falorni A. Autoimmune Addison's disease. Best Pract Res Clin Endocrinol Metab. 2020;34(1): 101379.
Hahner S, Ross RJ, Arlt W, Bancos I, Burger-Stritt S, Torpy DJ, et al. Adrenal insufficiency. Nature Rev Dis Primers. 2021;7(1):19.
Bornstein SR, Allolio B, Arlt W, Barthel A, Don-Wauchope A, Hammer GD, et al. Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline. J Clinical Endocrinol Metab. 2016;101(2):364-89.
Hellesen A, Bratland E, Husebye ES. Autoimmune Addison's disease-An update on pathogenesis. Annales d'endocrinologie. 2018;79(3):157-63.
Charmandari E, Nicolaides NC, Chrousos GP. Adrenal insufficiency. Lancet. 2014;383(9935):2152-67.
Eisenbarth GS, Gottlieb PA. Medical progress: Autoimmune Polyendocrine Syndromes. The New Engl J Med. 2004;350(20):2068-79.
Husebye ES, Pearce SH, Krone NP, Kämpe O. Adrenal insufficiency. Lancet. 2021;397(10274):613-29.
Filippa MG, Tektonidou MG, Mantzou A, Kaltsas GA, Chrousos GP, Sfikakis PP, et al. Adrenocortical dysfunction in rheumatoid arthritis: Α narrative review and future directions. Eur J Clin Invest. 2022;52(1): e13635.
Hahner S. Acute adrenal crisis and mortality in adrenal insufficiency: Still a concern in 2018. Annales d'endocrinologie. 2018;79(3):164-6.
Frankel M, Feldman I, Levine M, Frank Y, Bogot NR, Benjaminov O, et al. Bilateral Adrenal Hemorrhage in Coronavirus Disease 2019 Patient: A Case Report. J Clin Endocrinol Metab. 2020;105(12):1-5.
Hashim M, Athar S, Gaba WH. New onset adrenal insufficiency in a patient with COVID-19. BMJ Case Reports. 2021;14(1):45-9.
Kumar R, Guruparan T, Siddiqi S, Sheth R, Jacyna M, Naghibi M, et al. A case of adrenal infarction in a patient with COVID 19 infection. BJR Case Rep. 2020;6(3):20200075.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.
Busto U, Naranjo CA, Sellers EM. Comparison of two recently published algorithms to assess the probability of adverse drug reactions. Br J Clin Pharmacol. 1982; 13(2):223-7.
Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR: An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA. 1979;242(7):623-32.
The use of the WHO-UMC system for standardised case causality assessment. Available at: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf Accessed on 26 March 2022.
