Posted on 03/04/2021 12:41:20 PM PST by Red Badger
In correspondence published in The New England Journal of Medicine, researchers from Massachusetts General Hospital note that Phase 3 clinical data from the Moderna vaccine trial did show delayed skin hypersensitivity in a small number of the more than 30,000 trial participants. However, the authors say the large, red, sometimes raised, itchy or painful skin reactions were never fully characterized or explained, and they warn clinicians may not be prepared to recognize them and guide patients on treatment options and completion of the second dose of the vaccine. Credit: Massachusetts General Hospital
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These reactions should not discourage patients from getting the vaccine, say researchers at Massachusetts General Hospital.
As the speed and scale of vaccinations against the SARS-CoV-2 virus ramps up globally, researchers at Massachusetts General Hospital (MGH) are calling for greater awareness and communication around a delayed injection-site reaction that can occur in some patients who have received the Moderna mRNA-1273 vaccine.
In a letter to the editor published online in The New England Journal of Medicine (NEJM), the authors note Phase 3 clinical data from the Moderna vaccine trial did show delayed skin hypersensitivity in a small number of the more than 30,000 trial participants. However, the authors say the large, red, sometimes raised, itchy or painful skin reactions were never fully characterized or explained, and they warn clinicians may not be prepared to recognize them and guide patients on treatment options and completion of the second dose of the vaccine.
“Whether you’ve experienced a rash at the injection site right away or this delayed skin reaction, neither condition should prevent you from getting the second dose of the vaccine,” says Kimberly Blumenthal, MD, MSc, lead author of the letter and co-director of the Clinical Epidemiology Program in the division of Rheumatology, Allergy and Immunology at MGH. “Our immediate goal is to make physicians and other care providers aware of this possible delayed reaction, so they are not alarmed, but instead well-informed and equipped to advise their patients accordingly.”
In the letter, Blumenthal and her co-authors also note their own clinical observations of the delayed, large, local reactions to the Moderna vaccine, and report on a series of 12 patients with the reactions. In that group, symptom onset ranged from four days after the first dose up to 11 days post-vaccination, with a median onset of symptoms on day eight. Photographs show the varied size and severity of the reactions. Most patients were treated with ice and antihistamines, although some required corticosteroids and one was erroneously treated with antibiotics.
“Delayed cutaneous hypersensitivity could be confused – by clinicians and patients alike – with a skin infection,” says letter co-author Erica Shenoy, MD, PhD, associate chief of the MGH Infection Control Unit. “These types of reactions, however, are not infectious and thus should not be treated with antibiotics.”
On average, symptoms cleared up after nearly a week for the group of 12 reported in the letter. Half of the patients went on to experience a reaction after the second dose – at or around 48 hours post-vaccination. No patient experienced a dose two reaction that was more severe than their dose one reaction.
The authors also say samples taken from skin biopsies confirmed their suspicion of a delayed allergic immune response that is commonly seen in drug reactions.
“For most people who are experiencing this, we believe it’s tied to the body’s immune system going to work,” says Esther Freeman, MD, PhD, director of Global Health Dermatology at MGH and co-author of the NEJM letter. “Overall, this data is reassuring and should not discourage people from getting the vaccine.”
Reference: “Delayed Large Local Reactions to mRNA-1273 Vaccine against SARS-CoV-2” by Kimberly G. Blumenthal, M.D.; Esther E. Freeman, M.D., Ph.D.; Rebecca R. Saff, M.D., Ph.D.; Lacey B. Robinson, M.D., M.P.H.; Anna R. Wolfson, M.D.; Ruth K. Foreman, M.D., Ph.D.; Dean Hashimoto, M.D.; Aleena Banerji, M.D.; Lily Li, M.D.; Sara Anvari, M.D. and Erica S. Shenoy, M.D., Ph.D., 3 March 2021, New England Journal of Medicine. DOI: 10.1056/NEJMc2102131
To learn more about potentially allergic reactions after COVID-19 vaccination, MGH Allergy is collecting all immediate and delayed reactions in a designated registry.
Additional co-authors of the NEJM letter were Aleena Banerji, MD, Ruth Foreman, MD, PhD, Dean Hashimoto, MD, Lacey Robinson, MD, MPH, Rebecca Saff, MD, and Anna Wolfson, MD, all from MGH; Lily Li, MD, of Brigham and Women’s Hospital; and Sara Anvari, MD, MSc, Baylor College of Medicine, Texas Children’s Hospital.
Thanks for posting Red Badger.
Health/life BUMP!
The cv19 vaccines are investigational through the end of 2023.
Anyone taking a cv19 vaccine is a trial participant. Enjoy.
Got Pfizer #1 a week ago and I haven’t noted any side effects.
And neither have I.
I just got my first shot...Moderna...about a week ago.No serious problems...some arm soreness for a day or two just like with the regular flu shot.
An excellent translation of almost anything any govt official says.
I see them giving shots on TV, local and national, and the needles look huge and long!...................
Post to me or FReep mail to be on/off the Bring Out Your Dead ping list.
The purpose of the “Bring Out Your Dead” ping list (formerly the “Ebola” ping list) is very early warning of emerging pandemics, as such it has a high false positive rate.
The false positive rate was 100%.
At some point we may well have a high mortality pandemic, and likely as not the “Bring Out Your Dead” threads will miss the beginning entirely.
*sigh* Such is life, and death...
Quarantine the sick. Protect the vulnerable. Free everyone else.
This is why the first question I have for Any Medical Professional is:
Did you get into School through an Affirmative Action Program or did you Actually Study??
My Doctors Will NOT talk in riddles to me Ever
Thanks to all posters.
Anyone choosing to not get the vaccine is just as much a participant in this experiment though.
These reactions should not discourage patients from getting the vaccine, say researchers at Massachusetts General Hospital.
Guess again.
How long before people who have reactions like that end up with anaphylaxis with their next shot, or the one after that?
Daughter got it yesterday. She said she feels like she has the flu today and the injection site looks like a bee sting.
Another daughter got the other one and felt fine - just a touch sore at the injection site.
Dang straight it is.
We have No Idea what is Happening
Isn't that reassuring? Good translation and they are the doctors. They SHOULD know.
It’s not a bug, it’s a feature!
Got my second one on Monday. Felt a bit off on Tuesday - woozy; slight headache. Nothing since.
What a joke.
I'll take my chances with being part of an *experiment* that way than being a guinea pig for Gate$ et al.
Bookmark
I took the Modera first shot and it went fine hardly felt it. Arm a little sore but not bad at all. Was dreading the second shot after I read of people getting sick 100 to 101 fever and a lot of acks and pains for 24 hours. I got the second shot and like the first didn’t feel it and only a little soreness at the shot location. For me it wasn’t near as bad. I think for some not so good.
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