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 Table of Contents  
CASE REPORT
Year : 2022  |  Volume : 3  |  Issue : 3  |  Page : 90-92

“COVID Arm” in the family medicine setting: Moderna vaccine hypersensitivity reaction


1 University of Miami Miller School of Medicine, Miami, Florida, USA
2 Department of Family Medicine, University of Miami, Miami, Florida, USA

Date of Submission17-Sep-2021
Date of Decision25-Dec-2021
Date of Acceptance05-Feb-2022
Date of Web Publication14-Sep-2022

Correspondence Address:
Dr. Bryan W Pardo
8932 SW 97th Ave, UHealth at Kendall, Miami, FL 33176
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jphpc.jphpc_26_21

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  Abstract 


The Moderna COVID-19 vaccination has been widely distributed since authorized for emergency use. Phase 3 clinical trial data reported that 1.5% of recipients experienced hypersensitivity reactions after vaccination. The resulting erythematous rash, termed “COVID arm,” has been described in isolated case reports. To our knowledge, existing literature has not presented this diagnosis in the family medicine setting. This study was exempt from Institutional Review Board approval. An 85-year-old female presented to our family medicine clinic with a rash at injection site 15 days after receiving the Moderna vaccine. She endorsed pruritus and allodynia. She was afebrile. The rash measured 8 cm (height) × 9 cm (width) and was erythematous, without edema or warmth. We determined the rash was a “COVID arm” hypersensitivity reaction. Family medicine physicians are newly responsible for providing education and care related to COVID-19 vaccination. This case provides a unique opportunity to review the suspected pathology of “COVID arm” and describe management in an outpatient setting. Patients without severe allergic reactions should proceed with the second dose in their other arm, anticipating possible repeat “COVID arm.”

Keywords: Coronavirus disease-19, exanthema, hypersensitivity, injection site reaction


How to cite this article:
Cohen LL, Suarez AJ, Pardo BW. “COVID Arm” in the family medicine setting: Moderna vaccine hypersensitivity reaction. J Public Health Prim Care 2022;3:90-2

How to cite this URL:
Cohen LL, Suarez AJ, Pardo BW. “COVID Arm” in the family medicine setting: Moderna vaccine hypersensitivity reaction. J Public Health Prim Care [serial online] 2022 [cited 2022 Oct 1];3:90-2. Available from: http://www.jphpc.org/text.asp?2022/3/3/90/354817




  Introduction Top


The Moderna COVID-19 vaccination is not to be administered to people with a history of severe allergic reactions to vaccine ingredients.[1],[2],[3] The vaccine contains polyethylene glycol (PEG) 2000 dimyristoyl glycerol, a rare but high-risk allergen.[4],[5],[6],[7] Other ingredients have not been identified as allergens in the literature.

Moderna's Phase 3 clinical trial reported that 1.5% of vaccine and 1.1% of placebo recipients experienced hypersensitivity reactions. Reactions in the vaccine cohort included rash and urticaria. The placebo vaccine contained 0.9% sodium chloride.[8] A review of hypersensitivity reactions to the Moderna vaccine coined the term “COVID arm,” an erythematous rash around the injection site. Wei et al. reported four patients who experienced “COVID arm” rashes 7–10 days after first vaccination.[9]


  Methods Top


This report was exempt from Institutional Review Board approval. The patient provided informed consent.


  Results Top


Case presentation

An 85-year-old female presented to a family medicine clinic complaining of a rash on her left arm at injection site, 15 days after she received the first dose of the Moderna vaccine. She described the rash as “red” and “itchy.” She denied any symptoms immediately after the vaccine, denying arm soreness, fatigue, or fever. She stated that she began to experience pruritus at the injection site 3 days after vaccination. The pruritus progressively worsened, and the site became tender with itching. Six days after vaccination, the injection site became erythematous. She endorsed allodynia, experiencing pain when she touched or itched the rash. She quantified the pain as a 4 out of 10. She denied swelling, warmth to touch, or pain at rest. She stated that the rash progressively grew in size, causing her to seek medical treatment. Before presenting to our clinic, she began applying over-the-counter hydrocortisone cream, which decreased pruritus. The patient had no related medical history and denied prior hypersensitivity reactions to vaccinations or medications.

Physical examination

The patient's vital signs were stable: heart rate 90 beats per minute, temperature 98.4°F, and blood pressure 137/70. On examination, there was an oval patch with irregular borders over the left deltoid muscle. The rash measured 8 cm (height) × 9 cm (width). The area surrounding the injection site was erythematous without edema or warmth. The injection site was visible and located within the patch [Figure 1].
Figure 1: The patient presented 15 days after the first Moderna COVID-19 vaccine with an erythematous patch measuring 8 cm (height) × 9 cm (width). The injection site is seen within the patch (arrow)

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Treatment

We determined that the rash was a hypersensitivity reaction to the Moderna COVID-19 vaccine, given its similarity to existing descriptions of “COVID arm.”[9],[10] The patient endorsed topical cortisone gradually resolving symptoms. We advised her to continue using the medication. The Centers for Disease Control and Prevention (CDC) suggests that patients with “COVID arm” that experience pruritus and pain use antihistamines and acetaminophen or nonsteroidal anti-inflammatory drugs, respectively.[10]

The CDC advises patients who have experienced adverse reactions to the COVID-19 vaccine to proceed with a second dose on schedule, unless they experienced a severe (i.e., anaphylaxis) or immediate (within 4 h) reaction. We encouraged the patient to continue with her second shot, scheduled 4 weeks from her first dose, in the opposite arm. We counseled her that the rash may recur and reviewed aforementioned treatments.[10]

The patient reported that the erythema slowly subsided over the course of a week. In total, the patient had resolution of vaccine-related symptoms 22 days post-vaccination, including a rash of 16 days duration. At last follow-up, she described a hyperpigmented patch where the rash previously was. The visit was virtual, so we were unable to examine it.


  Discussion Top


Family medicine physicians are responsible for providing information on and care related to COVID-19 vaccination. This case provides an opportunity to learn about “COVID arm” and its management. The Moderna and Pfizer-BioNTech vaccines are formulated with PEG, a rare allergen not previously used in vaccines.[3],[4],[5],[6],[7],[11] Although over-the-counter food and drug products contain PEG (i.e., laxatives), its molecular weight and coformulation is different in these vaccines.[3],[6],[7] Immediate-type hypersensitivity reactions to PEG have been reported, typically within 24 h of use.[5]

A case series of immediate-type PEG hypersensitivity reactions found that 54% occurred after laxative use. Seventy-six percent of reactions involved anaphylaxis, but pruritus was common. One case of “pruritic maculopapular rash” similar to the presentation we described was detailed, although it occurred within minutes of topical PEG use versus several days.[5]

The four cases first reported as “COVID arm” experienced rashes 7–10 days after vaccination.[9] The dissimilarity of rash onset between a patient with a known PEG allergy and those who received the Moderna vaccine may suggest that other vaccine ingredient (s) are allergens.[5],[9] The CDC suggests that “COVID arm” rashes can begin “a few days to more than a week” after vaccination.[10]

The treatment of “COVID arm” depends on the severity of symptoms and can range from observation to symptomatic care.[9] Topical steroids, topical and oral antihistamines, acetaminophen, and non-steroidal anti-inflammatory drugs can be used as necessary.[10] Patients should contact their physician if they develop a rash at the injection site that worsens after 24 h.[12] Adverse effects should be reported to the vaccination provider.[10] It is important to remind patients of this before their vaccination and at the vaccination site.

We recommend that patients with a known PEG allergy consider the AstraZeneca or Johnson & Johnson vaccines if available, as neither contain PEG.[3] If “COVID arm” patients experience relief of symptoms after their first vaccination without serious adverse effects, we recommend second vaccination in the opposite arm.[10]

We recommend future research on potential allergens in these vaccines, especially PEG. The majority of published cases of PEG allergy involve anaphylaxis.[5] It is unclear if there are fewer cases of topical PEG reaction compared to anaphylaxis, or they are just published infrequently. A retrospective review of topical PEG reactions would be useful for physicians trying to prevent and treat “COVID arm.”

Family medicine physicians should anticipate patients experiencing “COVID arm” as vaccination becomes more widespread. We agree with the CDC's recommendation to proceed with second vaccination in the opposite arm.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given her consent for her images and other clinical information to be reported in the journal. The patient understands that her name and initials will not be published and due efforts will be made to conceal identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Hinton DM. Emergency Use Authorization: Pfizer-BioNTech COVID-19 Vaccine. US Food and Drug Administration Website. Available from: https://www.fda.gov/media/144412/download. [Last accessed on 2021 Apr 13; Last updated on 2021 Feb 25].  Back to cited text no. 1
    
2.
Hinton DM. Emergency Use Authorization: Moderna COVID-19 Vaccine. US Food and Drug Administration Website. Available from: https://www.fda.gov/media/144636/download. [Last accessed on 2021 Apr 13; Last updated on 2021 Feb 25].  Back to cited text no. 2
    
3.
Banerji A, Wickner PG, Saff R, Stone CA Jr., Robinson LB, Long AA, et al. mRNA vaccines to prevent COVID-19 disease and reported allergic reactions: Current evidence and suggested approach. J Allergy Clin Immunol Pract 2021;9:1423-37.  Back to cited text no. 3
    
4.
Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older. US Food and Drug Administration Website. Available from: https://www.fda.gov/media/144638/download. [Last accessed on 2021 Apr 13; Last updated on 2021 Mar 26]  Back to cited text no. 4
    
5.
Wenande E, Garvey LH. Immediate-type hypersensitivity to polyethylene glycols: A review. Clin Exp Allergy 2016;46:907-22.  Back to cited text no. 5
    
6.
Cabanillas B, Akdis CA, Novak N. Allergic reactions to the first COVID-19 vaccine: A potential role of polyethylene glycol? Allergy 2021;76:1617-8.  Back to cited text no. 6
    
7.
Garvey LH, Nasser S. Anaphylaxis to the first COVID-19 vaccine: Is polyethylene glycol (PEG) the culprit? Br J Anaesth 2021;126:e106-8.  Back to cited text no. 7
    
8.
Clinical Trial Results. Moderna Website. Available from: https://www.modernatx.com/covid19vaccine-eua/providers/clinical-trial-data. [Last accessed on 2021 Apr 13; Last updated on 2020 Nov 25].  Back to cited text no. 8
    
9.
Wei N, Fishman M, Wattenberg D, Gordon M, Lebwohl M. “COVID arm”: A reaction to the Moderna vaccine. JAAD Case Rep 2021;10:92-5.  Back to cited text no. 9
    
10.
What to Do if You Have an Allergic Reaction after Getting A COVID-19 Vaccine. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html. [Last accessed on 2021 Apr 13; Last updated on 2021 Mar 04].  Back to cited text no. 10
    
11.
Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of Pzifer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 16 Years of Age and Older. Available from: https://www.fda.gov/media/144414/download. [Last accessed on 2021 Apr 13; Last updated on 2021 Apr 06].  Back to cited text no. 11
    
12.
Possible Side Effects after Getting a COVID-19 Vaccine. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html. [Last accessed on 2021 Apr 13; Last updated on 2021 Mar 16].  Back to cited text no. 12
    


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