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Covid-19: First UK vaccine safety data are “reassuring,” says regulator

BMJ 2021; 372 doi: (Published 08 February 2021) Cite this as: BMJ 2021;372:n363

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Ipsilateral axillary lymphadenopathy following Covid-19 vaccination: recommendations for referral.

Dear Editor,

We were pleased to read “Covid-19: First UK vaccine safety data are reassuring”, but would like to draw attention to our and others observations regarding the increase in ipsilateral axillary lymphadenopathy following Covid-19 vaccination.

We have noted women are being referred to breast units with clinically enlarged axillary nodes (usually painful) from primary care or with image detected (mammogram, CT scan etc) lymphadenopathy from the NHSBSP or radiology departments, with or without an explicit link to recent COVID vaccination.

Ipsilateral axillary lymphadenopathy is a recognised adverse event in up to 0.3% of Pfizer-BioNTech and AstraZeneca Covid-19 vaccines (1)(2) , and is being reported at higher rates than for other vaccines such as BCG and influenza (3). This is attributed to a ‘robust vaccine-elicited immune response’ (4) with typical ultrasound appearance of reactive nodes, including preserved fatty hilum and ovoid shape (5).

Current NICE guidance for assessment of enlarged axillary nodes suggests a “watch and wait” approach, with referral at 6 weeks if persistent and for otherwise healthy individuals with ipsilateral lymphadenopathy after COVID vaccination this remains appropriate and reasonable. However in women with a current or past history of breast cancer, new axillary lymphadenopathy maybe the first sign of local-regional relapse so prompt action is required and we would advocate referral to breast clinic for assessment without delay.

1. Polack, Fernando P., et al. "Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine." New England Journal of Medicine (2020): 2603-2615.
2. Department of Health and Social Care (DHSC) AstraZeneca AB, 2021. Public Assessment Report Authorisation for Temporary Supply, COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]). MHRA.
3. Lars Grimm, S. D., et al. "SBI Recommendations for the Management of Axillary Adenopathy in Patients with Recent COVID-19 Vaccination". Society of Breast Imaging. (2021).
4. Polack, Fernando P., et al. "Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine." New England Journal of Medicine (2020): 2603-2615.
5. Mehta, Nishi, et al. "Unilateral axillary Adenopathy in the setting of COVID-19 vaccine." Clinical imaging 75 (2021): 12-15.

Competing interests: No competing interests

01 March 2021
Fiori Teklebrhan
Clinical Fellow in Breast Surgery
Ms Rachel Rolph, Post-CCT Breast Fellow, Ms Fiona MacNeill, Consultant Oncoplastic Breast Surgeon
The Royal Marsden NHS Foundation Trust
203 Fulham Road, Chelsea, London, SW3 6JJ