Covid-19: First UK vaccine safety data are “reassuring,” says regulatorBMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n363 (Published 08 February 2021) Cite this as: BMJ 2021;372:n363
All rapid responses
It is curious that ipsilateral axillary lymphadenitis was observed in some cases after injection in the deltoid.
If it was a subcutaneous injection, one could readily understand that the lymph vessels would drain in to the axillary nodes.
But in this case, the injections were in the deltoid muscle. I would have thought that most of the vaccine would be absorbed into the blood stream and very little would be carried by the lymph vessels.
Could it be that some of the vaccine was accidentally injected into the subcutaneous tissues?
One would like to be reassured that the vaccinators are carefully educated.
Competing interests: Had one jab in the Vastus lateralis
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
“The benefits continue to far outweigh the risks”, says the Chief Executive of the MHRA.
1. Respectfully, I remind the CE, that she has barely a few weeks of Yellow Card Reports. These are early side-effects.
How does she jump from the early reports to the assumption that there will not be any significant severe effects in the longer term?
I suggest that the MHRA keeps its eyes on the side-effects. That it also finds out Which vaccine was administered in the 50 cases where the Yellow Card is silent. Surely the information is available from the records of the vaccine administering site? If not, somebody needs a rap on the knuckles.
I would remind her (no point in reminding the minister - who will wash his hands of the matter) that in the event of a death - say, from anaphylaxis - the Coroner will want to know these little details at the inquest.
2. If the MHRA is interested in the safety of the “VACCINES”, it needs to know the side-effects of each vaccine separately. Oranges and Satsumas ARE different.
3. Is the MHRA keeping tabs on the site of the injection?
The DELTOID, the favourite site in this mass vaccination, has a history of nerve damage.
I refused to have mine in the deltoid because of periarthritis and limited movement in the left shoulder - even a painful left shoulder because of “NORMAL” reaction would have made it difficult to get dressed. The right shoulder is, fortunately with normal range of painless movements.
My vaccinator refused to inject me in the Vastus lateralis. She had to call the doctor, who was, fortunately, open minded.
If Dr Raine believes that the vaccination site is of no concern to the MHRA, perhaps she could tell us in one word.
Enough for the moment.
Maybe one of Dr Raine’s deputies will tell us the answers?
Competing interests: Recipient of the first Jab, awaiting the second.