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ORIGINAL ARTICLE
Year : 2022  |  Volume : 67  |  Issue : 2  |  Page : 115-120
Spectrum of mucocutaneous reactions to COVID-19 vaccination: A report from a web-based study from India


1 From the Department of Dermatology, RG Kar Medical College, Kolkata, West Bengal, India
2 Consultant Dermatologist, Dermosphere Clinic, New Delhi, India
3 Department of Dermatology, KPC Medical College and Hospital, Kolkata, West Bengal, India
4 Department of Dermatology, Amrita Institute of Medical Sciences, Kochi, Kerala, India
5 Department of Dermatology, Sujala Polyclinic, Bengaluru, Karnataka, India

Date of Web Publication13-Jul-2022

Correspondence Address:
Anupam Das
Department of Dermatology, KPC Medical College and Hospital, Kolkata, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijd.ijd_893_21

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   Abstract 


Background: With the COVID-19 vaccination taking stride all across the globe, there are multiple reports of vaccine-induced adverse reactions (cutaneous and systemic). Objectives: To study the frequency and characteristics of mucocutaneous reactions to COVID-19 vaccines. Methods: An online questionnaire-based study was performed among the recipients of COVID-19 vaccines Results: Majority (73.6%) of the responders had received the Covishield vaccine (AstraZeneca-Oxford), while 26.4% had been vaccinated with Covaxin (Bharat Biotech-ICMR). One or more post-vaccination mucocutaneous effects were experienced in 87 (19.6%) participants. Vaccine-associated mucocutaneous changes were observed in 19.7% and 22.2% of individuals who received Covishield and Covaxin, respectively. Local injection site reaction was the predominant mucocutaneous finding, followed by urticarial rash, exacerbation of preexisting dermatoses, morbilliform rash, apthous ulcers, pityriasis rosea like eruption, telogen effluvium, herpes zoster, purpuric rash, erythema multiforme and others. Anaphylaxis was reported in three individuals. However, fatality was not reported in any of the vaccine recipients. Intergroup assessment of parameters with respect to type of vaccine was found to be insignificant. Conclusion: Majority reported mild and self-limiting reactions. This outcome should not discourage the common man in getting vaccinated.


Keywords: COVID-19 vaccination, mucocutaneous reactions, web-based study


How to cite this article:
Sil A, Jakhar D, Das A, Jagadeesan S, Aradhya SS. Spectrum of mucocutaneous reactions to COVID-19 vaccination: A report from a web-based study from India. Indian J Dermatol 2022;67:115-20

How to cite this URL:
Sil A, Jakhar D, Das A, Jagadeesan S, Aradhya SS. Spectrum of mucocutaneous reactions to COVID-19 vaccination: A report from a web-based study from India. Indian J Dermatol [serial online] 2022 [cited 2022 Aug 14];67:115-20. Available from: https://www.e-ijd.org/text.asp?2022/67/2/115/350821





   Introduction Top


India initiated its country-wide COVID-19 vaccination program on January 16, 2021. It is important to study and characterize the cutaneous effects of COVID-19 vaccines for many reasons: skin being a “window” helps better understanding of the effects of the vaccines on the entire system and a knowledge of the cutaneous adverse effects (being more visible) enables the health workers to counsel their patients better and deal with vaccine “hesitancy” more effectively.

Various cutaneous adverse effects to COVID-19 vaccines have been reported in different studies. A spectrum of cutaneous reactions ranging from local injection site reactions to specific dermatoses were reported by a US registry-based study of the mRNA vaccines.[1] Delayed large local reactions at the vaccination site were reported by Blumenthal et al.[2] Robinson et al.[3] reported a 1.9% incidence of self-reported cutaneous reactions after the first dose of an mRNA COVID-19 vaccine in a prospective cohort.


   Methodology Top


We aimed to study the frequency and characteristics of mucocutaneous side effects developing as a result of vaccination against COVID-19. An online semi-structured English questionnaire was used to collect the details of adverse reactions post-vaccination. Development of the questionnaire involved the following steps:

  1. Item selection: Items were developed by a discussion with colleagues, other experts, and targeted responders.
  2. Validity of Questionnaire: Face and Content validity were tested by a panel of experts.


    1. Content validity ratio (CVR) was determined by the formula (Ne – N/2)/(N/2), where N = total number of expert and Ne = number of expert indicating “essential.” A minimum value of CVR of 0.49 was accepted. Items with CVR ≥0.49 were retained in the final questionnaire.
    2. Content validity index (CVI) was calculated by the formula: Number of experts giving a rating of 3–4/Number of experts. After estimating the CVI for all the items, the acceptability of each item was assessed based on the following criteria:


    1. Acceptable items (scores of >0.79),
    2. Items requiring modification (scores 0.70–0.79),
    3. Unacceptable items (scores <0.7)


    The acceptable items were preserved in the questionnaire, unacceptable items were removed, and modifiable items were revised and corrected by the panel of experts.

  3. Reliability of the questionnaire:


    1. The internal consistency of the Item was tested by Cronbach's alpha coefficient (value more than 0.7 was accepted)
    2. Test-Retest reliability was measured using Pearson correlation coefficient (value more than/equal to 0.7 was considered as acceptable reliability)


  4. Response to questionnaire: The questionnaire was circulated via a link among practicing dermatologists and postgraduate dermatology residents (across India) through emails, WhatsApp messenger, Facebook messenger, Telegram and other social media to the contacts of the investigators. On receiving and clicking the link, the participants were auto directed to a set of questions. The respondents were instructed to document the demographical data, type of vaccination received, and details of mucocutaneous reactions (if any) as encountered in their clinical practice.


The confidentiality and anonymity of the respondent were strictly maintained. Data was tested for normality using Kolmogorov-Smirnov test. Numerical data were analyzed using unpaired t-test; qualitative data was compared using the Chi-square test or Fischer's exact test. The statistical software SPSS v 10.0 & Medcalc® v 9.6.4.0 was used for analysis.


   Results Top


The questionnaire was sent to 550 dermatologists (practitioners and postgraduate residents). Out of 462 responses received (response rate 84%), 19 were excluded based on incomplete parameters and exclusion criteria. Analysis of demographics of the final 443 study participants' input revealed 249 males and 194 females with a mean age of 38.82 ± 12.25 years (age range 18–76 years). Comorbidities included hypertension (80, 18.1%), diabetes mellitus (38, 8.6%), lung disease (14, 3.2%), among others. 160/443, 37.5% responders reported past or current dermatological ailment(s), namely, acne vulgaris, urticaria, contact dermatitis, androgenetic alopecia and others [Table 1]. 127 (28.7%) reported prior COVID-19 infection.
Table 1: Characteristics of study participants

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Most individuals (326, 73.6%) had received the Covishield vaccine (AstraZeneca-Oxford), while the remaining 117 (26.4%) had been vaccinated with Covaxin (Bharat Biotech-ICMR). Two doses had been administered in 348 (78.6%).

One or more post-vaccination mucocutaneous effects were experienced in 87 (19.6%) participants [Table 2]. They were commonly reported after the first dose of vaccination (67, 15.1%), followed by both doses (12, 2.7%) and second dose (8, 1.8%). The lesions predominantly occurred within 1 day (44, 9.9%), followed by 1–3 days (16, 3.6%). While resolution within a week was common (49/87, 56.3%), persistence beyond 7 days was seen in 38/87 (43.7%). Pain (61, 13.8%) was the most common symptom, followed by pruritus (10.4%), swelling (9%), erythema (5.8%), and burning sensation (3.6%). Local injection site reaction (67, 15.1%) was the predominant mucocutaneous finding, followed by urticarial rash (29), exacerbation of preexisting dermatoses (11), morbilliform rash (7), apthous ulcer (7), pityriasis rosea like eruption (6), telogen effluvium (6), herpes zoster (5), purpuric rash (4), erythema multiforme (3), and others. Systemic features included malaise (321/443, 72.4%), fever (229/443, 51.7%), headache, (28.2%), joint pain (9.5%), chills (8.3%), nausea (3.4%), vomiting (3.4%), and diarrhoea (2.3%). Anaphylaxis was reported in 3 individuals. Dermatological consultation was sought in 61/87 (70.1%) cases with mucocutaneous symptoms. Telemedicine was the preferred mode of consultation (66/87, 75.9%) in these patients. Symptomatic management was sufficient to treat the mucocutaneous reactions (37/87, 42.5%). No fatality was reported in any of the vaccine recipients. Intergroup assessment of parameters with respect to type of vaccine was found to be insignificant.
Table 2: Comparison of the mucocutaneous adverse effects to Covishield vs Covaxin

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   Discussion Top


Since the introduction of various vaccines for the COVID-19 disease, many reports have surfaced regarding the potential cutaneous adverse effects associated with these vaccines.[4],[5] Though most of the adverse effects range from mild-to-moderate, reports of severe allergic reaction, including anaphylaxis have also been found in literature.[6],[7] Vaccine-induced prothrombotic immune thrombocytopenia like serious side-effects raises concerns for the use of these vaccines.[8] Most of the available literature is based on BNT162/Comirnaty® (Pfizer®/BioNTech®, Alemania, Estados Unidos) and mRNA 1273 (Moderna®, Estados Unidos) vaccines. In this web-based study, we have outlined the possible cutaneous adverse effects associated with Covaxin® (Bharat Biotech, India) and Covishield (Oxford/AstraZeneca, Reino Unido).

In our study, we observed a broad spectrum of reactions after vaccination, ranging from injection site reactions (pain, erythema, burning sensation, swelling), urticarial, morbilliform rash, pityriasis rosea like eruption, purpura, erythema multiforme, aphthae, telogen effluvium. Exacerbation of preexisting dermatoses and reactivation of herpes zoster were also noticed. Most common adverse effect was the injection site reactions, which is similar to a previous registry.[1] Urticarial rash was the second most reported cutaneous adverse effect. Farinazzo et al.[9] speculated the urticarial manifestations to be associated with polyethylene glycol-2000(PEG-2000) present in the vaccines. The speculation was supported by other reports of anaphylaxis induced by BioNTech/Pfizer vaccine.[2] None of the vaccines in our study had PEG-2000. The urticarial rash may be attributed to viral particles or inactive constituents of these vaccines and needs further research. There was no statistical difference between Covishield and Covaxin in terms of percentage of patients showing local injection site reactions, urticarial rash, morbilliform rash, purpuric rash, and pityriasis rosea like reactions.

An interesting observation was the reoccurrence of herpes zoster, exclusively in the Covishield recipients, consistent with previous reports. The small sample size of Covaxin group prevented us to conclusively state whether they can cause herpes zoster or not. Similarly, telogen effluvium, aphthous ulcers, and erythema multiforme were also exclusively seen in Covishield recipients. Literature shows that all types of vaccines may evoke immune responses (reflecting mounting protection against specific pathogens). A robust immune response can also result in exacerbation of preexisting dermatoses and even triggering off autoimmune diseases de novo.[9] This hypothesis is supported by the report of Niebel et al.[10] (exacerbation of subacute cutaneous lupus erythematosus after receiving vaccination). Similarly, our study also demonstrates that both Covishield and Covaxin can cause exacerbation of preexisting dermatoses. In addition, we also observed de novo appearance of alopecia areata and lichen planus in two patients each among the Covishield group. None of our participants had any history of chill-blain like lesions. Recently, some reports have also described the occurrence of multisystem inflammatory syndrome in adults (MIS-A) a few weeks after a variety of COVID-19 vaccines. However, similar manifestation was not reported in our study assessment.[11]

Limitations

Being a survey-based endeavor, our study had some inherent limitations like selection bias (those with smartphones/electronic gadgets), use of snowball (non-probability) sampling technique, and subjectivity of responses. Our study lacked the denominator and, thus, incidence of cutaneous reactions could not be ascertained. A large-scale multicentric study would be the subsequent logical scientific undertaking.


   Conclusion Top


Mucocutaneous reactions to COVID-19 vaccines are minor and they should not discourage vaccination of general population. Injection site reactions (pain, erythema, burning sensation, swelling), urticarial and morbilliform rashes are among the most common mucocutaneous reactions. Reoccurrence of herpes zoster and exacerbation of preexisting dermatoses may be encountered.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
McMahon DE, Amerson E, Rosenbach M, Lipoff JB, Moustafa D, Tyagi A, et al. Cutaneous reactions reported after Moderna and Pfizer COVID-19 vaccination: A registry-based study of 414 cases. J Am Acad Dermatol 2021;85:46-55.  Back to cited text no. 1
    
2.
Blumenthal KG, Freeman EE, Saff RR, Robinson LB, Wolfson AR, Foreman RK, et al. Delayed large local reactions to mRNA-1273 vaccine against SARS-CoV-2. N Engl J Med 2021;384:1273-7.  Back to cited text no. 2
    
3.
Robinson LB, Fu X, Hashimoto D, Wickner P, Shenoy ES, Landman AB, et al. Incidence of cutaneous reactions after messenger RNA COVID-19 vaccines. JAMA Dermatol 2021;157:1000-2.  Back to cited text no. 3
    
4.
Galván-Casas C, Català A, Muñoz-Santos C. SARS-CoV-2 Vaccines and the skin. Actas Dermosifiliogr 2021;112:828-36.  Back to cited text no. 4
    
5.
Corbeddu M, Diociaiuti A, Vinci MR, Santoro A, Camisa V, Zaffina S, et al. Transient cutaneous manifestations after administration of Pfizer-BioNTech COVID-19 vaccine: An Italian single-centre case series. J Eur Acad Dermatol Venereol 2021;35:e483-5.  Back to cited text no. 5
    
6.
CDC COVID-19 Response Team; Food and Drug Administration. Allergic reactions including anaphylaxis after receipt of the first dose of moderna COVID-19 vaccine-United States. December 21, 2020-January 10, 2021. MMWR Morb Mortal Wkly Rep 2021;70:125-9.  Back to cited text no. 6
    
7.
CDC COVID-19 Response Team; Food and Drug Administration. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine - United States. December 14-23, 2020. MMWR Morb Mortal Wkly Rep 2021;70:46-51.  Back to cited text no. 7
    
8.
Bogdanov G, Bogdanov I, Kazandjieva J, Tsankov N. Cutaneous adverse effects of the available COVID-19 vaccines. Clin Dermatol 2021;39:523-31.  Back to cited text no. 8
    
9.
Farinazzo E, Ponis G, Zelin E, Errichetti E, Stinco G, Pinzani C, et al. Cutaneous adverse reactions after m-RNA COVID-19 vaccine: Early reports from Northeast Italy. J Eur Acad Dermatol Venereol 2021;35:e548-51.  Back to cited text no. 9
    
10.
Niebel D, Ralser-Isselstein V, Jaschke K, Braegelmann C, Bieber T, Wenzel J. Exacerbation of subacute cutaneous lupus erythematosus following vaccination with BNT162b2 mRNA vaccine. Dermatol Ther 2021;34:e15017.  Back to cited text no. 10
    
11.
Park JW, Yu SN, Chang SH, Ahn YH, Jeon MH. Multisystem Inflammatory Syndrome in an Adult after COVID-19 Vaccination: a Case Report and Literature Review. J Korean Med Sci 2021;36:e312.  Back to cited text no. 11
    



 
 
    Tables

  [Table 1], [Table 2]



 

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