European Medicines Agency. COVID-19 vaccines: authorised [Internet]. 2021. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-authorised#authorised-covid-19-vaccines-section. Accessed 14 Dec 2021.

Nilsson L, Brockow K, Alm J, Cardona V, Caubet J-C, Gomes E, et al. Vaccination and allergy: EAACI position paper, practical aspects. Pediatr Allergy Immunol. 2017;28:628–40. https://doi.org/10.1111/pai.12762.

Article  PubMed  Google Scholar 

McNeil MM, Weintraub ES, Duffy J, Sukumaran L, Jacobsen SJ, Klein NP, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol. 2016;137:868–78. https://doi.org/10.1016/j.jaci.2015.07.048.

Article  PubMed  Google Scholar 

European Medicines Agency. How the safety of the new COVID-19 vaccines will be monitored [Internet]. 2021. https://www.ema.europa.eu/en/documents/presentation/presentation-how-safety-new-covid-19-vaccines-will-be-monitored-sstraus-prac_en.pdf. Accessed 14 Dec 2021.

Centers for Disease Control and Prevention. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine—United States, December 14–23, 2020 [Internet]. 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm?s_cid=mm7002e1_w. Accessed 14 Dec 2021.

World Health Organizationn (WHO). Immunization stress-related response: a manual for program managers and health professionals to prevent, identify and respond to stress-related responses following immunization [Internet]. 2019. https://www.who.int/publications/i/item/9789241515948. Accessed 14 Dec 2021.

Shimabukuro TT, Cole M, Su JR. Reports of anaphylaxis after receipt of mRNA COVID-19 vaccines in the US—December 14, 2020-January 18, 2021. JAMA. 2021;325(11):1101–2. https://doi.org/10.1001/jama.2021.1967.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Rodriguez-Nava G, Egoryan G, Trelles-Garcia DP, Yanez-Bello MA, Murguia-Fuentes R. Disproportionality analysis of anaphylactic reactions after vaccination with messenger RNA coronavirus disease 2019 vaccines in the United States. Ann Allergy Asthma Immunol. 2021;127(1):139–40. https://doi.org/10.1016/j.anai.2021.04.004.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10(6):483–6. https://doi.org/10.1002/pds.677.

CAS  Article  PubMed  Google Scholar 

Sa S, Lee CW, Shim SR, Yoo H, Choi J, Kim JH, et al. The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 vaccines: safety monitoring for adverse events using real-world data. Vaccines (Basel). 2022;10(2):320. https://doi.org/10.3390/vaccines10020320.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Rosenblum HG, Gee J, Liu R, Marquez PL, Zhang B, Strid P, et al. Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Lancet Infect Dis. 2022;S1473–3099(22):00054–8. https://doi.org/10.1016/S1473-3099(22)00054-8.

Article  Google Scholar 

Klein NP, Lewis N, Goddard K, Fireman B, Zerbo O, Hanson KE, et al. Surveillance for adverse events after COVID-19 mRNA vaccination. JAMA. 2021;326(14):1390–9. https://doi.org/10.1001/jama.2021.15072.

CAS  Article  PubMed  Google Scholar 

Brighton collaboration. BC Case Definition: Anaphylaxis (Chinese translation) [Internet]. 2020. https://brightoncollaboration.us/bc-case-definition-anaphylaxis-chinese-translation/. Accessed 14 Dec 2021.

Hwang I, Park K, Kim TE, Kwon Y, Lee Y-K. COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021. Osong Public Health Res Perspect. 2021;12(6):396–402. https://doi.org/10.24171/j.phrp.2021.0310.

Article  PubMed  PubMed Central  Google Scholar 

Ontario Agency for Health Protection and Promotion (Public Health Ontario). Reports of events managed as anaphylaxis following COVID-19 vaccines in Ontario: December 13, 2020 to March 6, 2021. 2021. https://www.publichealthontario.ca/-/media/documents/ncov/epi/covid-19-anaphylaxis-epi-summary.pdf?la=en. Accessed 14 Dec 2021.

Iguchi T, Umeda H, Kojima M, Kanno Y, Tanaka Y, Kinoshita N, et al. Cumulative adverse event reporting of anaphylaxis after mRNA COVID-19 vaccine (Pfizer-BioNTech) injections in Japan: the first-month report. Drug Saf. 2021;44(11):1209–14. https://doi.org/10.1007/s40264-021-01104-9.

CAS  Article  PubMed  Google Scholar 

Shavit R, Maoz-Segal R, Iancovici-Kidon M, Offengenden I, Haj Yahia S, Machnes Maayan D, et al. Prevalence of allergic reactions after Pfizer-BioNTech COVID-19 vaccination among adults with high allergy risk. JAMA Netw Open. 2021;4(8): e2122255. https://doi.org/10.1001/jamanetworkopen.2021.22255.

Article  PubMed  PubMed Central  Google Scholar 

Blumenthal KG, Robinson LB, Camargo CA, Shenoy ES, Banerji A, Landman AB, et al. Acute allergic reactions to mRNA COVID-19 vaccines. JAMA. 2021;325(15):1562–5. https://doi.org/10.1001/jama.2021.3976.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Sampson HA, Muñoz-Furlong A, Campbell RL, Adkinson NF, Bock SA, Branum A, et al. Second symposium on the definition and management of anaphylaxis: summary report—Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006;117(2):391–7. https://doi.org/10.1016/j.jaci.2005.12.1303.

Article  PubMed  Google Scholar 

Arroliga ME, Dhanani K, Arroliga AC, Huddleston PS, Trahan J, Aguilar T, et al. Allergic reactions and adverse events associated with administration of mRNA-based vaccines. A health-care system experience. Allergy Asthma Proc. 2021;42(5):395–9. https://doi.org/10.2500/aap.2021.42.210069.

CAS  Article  PubMed  Google Scholar 

Bae S, Lee YW, Lim SY, Lee J-H, Lim JS, Lee S, et al. Adverse reactions following the first dose of ChAdOx1 nCoV-19 vaccine and BNT162b2 vaccine for healthcare workers in South Korea. J Korean Med Sci. 2021;36(17): e115. https://doi.org/10.3346/jkms.2021.36.e115.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Alfaleh A, Alkattan A, Radwan N, Elzohri M, Alzaher A, Ibrahim M, et al. Adverse drug reactions from two COVID-19 vaccines reported in Saudi Arabia. Drugs Ther Perspect [Internet]. 2022;38:84–92. https://doi.org/10.1007/s40267-022-00893-y.

Article  PubMed  PubMed Central  Google Scholar 

World Health Organizationn (WHO). WHO Coronavirus (COVID-19) Dashboard [Internet]. 2021. https://covid19.who.int/. Accessed 14 Dec 2021.

Uppsala Medical Centre. Your window to a world of global safety insights [Internet]. https://who-umc.org/pv-products/vigilyze/. Accessed 14 Dec 2021.

Meddra.org. Introductory Guide for Standardised MedDRA Queries (SMQs) Version 24.0 [Internet]. 2021. http://alt.meddra.org/files_acrobat/SMQ_intguide_24_0_English.pdf. Accessed 14 Dec 2021.

European Medicines Agency. Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 [Internet]. 2021. https://www.ema.europa.eu/en/news/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11. Accessed 14 Dec 2021.

EudraVigilance. European database of suspected adverse drug reaction reports [Internet]. https://www.adrreports.eu/. Accessed 14 Dec 2021.

Castells MC, Phillips EJ. Maintaining safety with SARS-CoV-2 vaccines. Longo DL, editor. N Engl J Med. 2021;384(7):643–9. https://doi.org/10.1056/NEJMra2035343.

CAS  Article  PubMed  Google Scholar 

Banerji A, Wolfson AR, Wickner PG, Cogan AS, McMahon AE, Saff R, et al. COVID-19 vaccination in patients with reported allergic reactions: updated evidence and suggested approach. J Allergy Clin Immunol Pract. 2021;9(6):2135–8. https://doi.org/10.1016/j.jaip.2021.03.053.

Article  PubMed  PubMed Central  Google Scholar 

Shimabukuro T, Nair N. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine. JAMA. 2021;325(8):780–1. https://doi.org/10.1001/jama.2021.0600.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Thong BY-H, Tan T-C. Epidemiology and risk factors for drug allergy. Br J Clin Pharmacol. 2011;71(5):684–700. https://doi.org/10.1111/j.1365-2125.2010.03774.x.

Article  PubMed  PubMed Central  Google Scholar 

Eaddy Norton A, Broyles AD. Drug allergy in children and adults. Ann Allergy Asthma Immunol. 2019;122(2):148–55. https://doi.org/10.1016/j.anai.2018.11.014.

CAS  Article  PubMed  Google Scholar 

Trigunaite A, Dimo J, Jørgensen TN. Suppressive effects of androgens on the immune system. Cell Immunol. 2015;294(2):87–94. https://doi.org/10.1016/j.cellimm.2015.02.004.

CAS  Article  PubMed  Google Scholar 

Fan Z, Che H, Yang S, Chen C. Estrogen and estrogen receptor signaling promotes allergic immune responses: effects on immune cells, cytokines, and inflammatory factors involved in allergy. Allergol Immunopathol (Madr). 2019;47(5):506–12. https://doi.org/10.1016/j.aller.2019.03.001.

CAS  Article  Google Scholar 

Vasiadi M, Kempuraj D, Boucher W, Kalogeromitros D, Theoharides TC. Progesterone inhibits mast cell secretion. Int J Immunopathol Pharmacol. 2006;19(4):787–94. https://doi.org/10.1177/039463200601900408.

CAS  Article  PubMed  Google Scholar 

Hox V, Desai A, Bandara G, Gilfillan AM, Metcalfe DD, Olivera A. Estrogen increases the severity of anaphylaxis in female mice through enhanced endothelial nitric oxide synthase expression and nitric oxide production. J Allergy Clin Immunol. 2015;135(3):729-36.e5. https://doi.org/10.1016/j.jaci.2014.11.003.

CAS  Article  PubMed  Google Scholar 

Risma KA, Edwards KM, Hummell DS, Little FF, Norton AE, Stallings A, et al. Potential mechanisms of anaphylaxis to COVID-19 mRNA vaccines. J Allergy Clin Immunol. 2021;147(6):2075-2082.e2. https://doi.org/10.1016/j.jaci.2021.04.002.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Alysandratos K, Asadi S, Angelidou A, Zhang B, Sismanopoulos N, Yang H, et al. Neurotensin and CRH interactions augment human mast cell activation. Doherty TM, editor. PLoS ONE. 2012;7(11):e48934. https://doi.org/10.1371/journal.pone.0048934.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Theoharides TC. The impact of psychological stress on mast cells. Ann Allergy, Asthma Immunol. 2020;125(4):388–92. https://doi.org/10.1016/j.anai.2020.07.007.

CAS  Article  Google Scholar 

Jimenez-Rodriguez T, Garcia-Neuer M, Alenazy LA, Castells M. Anaphylaxis in the 21st century: phenotypes, endotypes, and biomarkers. J Asthma Allergy. 2018;20(11):121–42. https://doi.org/10.2147/JAA.S159411.

Article  Google Scholar 

Tanno LK, Gonzalez-Estrada A, Olivieri B, Caminati M. Asthma and anaphylaxis. Curr Opin Allergy Clin Immunol. 2019;19(5):447–55. https://doi.org/10.1097/ACI.0000000000000566.

Article  PubMed  Google Scholar 

Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343–73. https://doi.org/10.1183/09031936.00202013.

CAS  Article  PubMed  Google Scholar 

Caminati M, Guarnieri G, Senna G. Who is really at risk for anaphylaxis due to COVID-19 vaccine? Vaccines. 2021;9(1):38. https://doi.org/10.3390/vaccines9010038.

CAS  Article  PubMed  P