Systemic Allergic Contact Dermatitis Post Inactivated COVID-19 Vaccine

Sir,

Vaccines are indeed a boon for tackling the present coronavirus disease 19 (COVID-19) pandemic. COVAXIN^® (BBV152) is an inactivated virus developed by Bharat Biotech and has recently received emergency use listing by the World Health Organization for worldwide use.[1] Phase 3 trial results reported the vaccine to be well tolerated with no serious adverse effects or vaccine-related deaths.[2] Here, we report the case of a young, healthy female who presented to us with features of systemic allergic contact dermatitis (SACD) following the first dose of COVAXIN administration.

A 24-year-old female presented to us with complaints of itchy, red skin lesions over the body for 5 days. The patient started experiencing itching and redness 1 hour post the first dose of COVAXIN vaccination in the left arm near the site of injection. These lesions associated with mild burning sensation and intense itching rapidly progressed within the next 24 hours to involve the rest of the upper limbs, abdomen, neck, face, and lower limbs in that order. There was no history of any allergies or intake of any other medication prior to the onset of skin lesions.

On examination, there were multiple, discrete, erythematous papules of a size of 2 to 4 mm over the trunk, extremities, and face. The papules over the face have coalesced to form crusted plaques with serous discharge [Figure 1]. A single erosion of a size of 3 × 5 cm with scaling in the periphery was present on the left medial malleolus. Her systemic examination and the routine investigations were within normal limits. A probable diagnosis of SACD secondary to COVAXIN vaccination was made using the Naranjo score (score 6), and she was administered systemic steroids (prednisolone 0.5 mg/kg/day) along with oral anti-histamines and emollients. Follow-up after 2 weeks showed a marked improvement, and systemic steroids were stopped. She had no recurrence of symptoms and was completely lesion-free by the end of 4 weeks [Figure 2]. The patient was advised to get vaccinated with alternate available COVID-19 vaccines.

Figure 1.

(a) Erythematous papules and plaques with serous discharge and crusting present over the face; erythematous papules over both upper limbs (b), popliteal fossa (c), and the trunk (d)

Figure 2.

Post-treatment pictures revealing resolution of skin lesions over the face (a), upper extremtities (b), popliteal fossa (c), and the trunk (d)

COVAXIN is a whole virion-inactivated severe acute respiratory syndrome coronavirus 2 vaccine strain NIV-2020-770 formulated with a Toll-like receptor 7/8 (TLR 7/8) agonist molecule adsorbed to alum (Algel-IMDG). Two doses of 0.5 ml each on days 0 and 28 are recommended for use in adults (>18 years of age). In the phase 3 trials, the most frequent solicited local side effect was local pain in 3.04% after the first dose and in 1.81% after the second dose. Other local adverse events were seen in less than 0.3%. The most frequent solicited systemic side effect was headache, followed by pyrexia, fatigue, and myalgia, but was less than 1%. Other expected side effects include abdominal pain, nausea and vomiting, dizziness–giddiness, tremor, sweating, cold, cough, and injection site swelling.[2]

SACD is the development of delayed type hypersensitivity (type IV) reaction upon re-exposure to the allergen systemically in a previously sensitized individual. It can also present in previously non-sensitized individuals. The sensitizing drug or chemical enters the epidermis as a prohapten, which activates dendritic and Langerhans cells; these cells subsequently migrate to lymph nodes and present as hapten-protein complexes to T cells, which are stimulated and react to induce the cytotoxic response.[3]

The ingredients of COVAXIN are the whole virion-inactivated coronavirus antigen, aluminum hydroxide gel equivalent to Al⁺³, the TLR 7/8 agonist, and 2-phenoxyethanol in phosphate buffered saline.[2] Aluminum hydroxide, a commonly used adjuvant in various vaccines including COVAXIN, has been implicated in allergic reactions. It can cause allergic reactions by two mechanisms—by attracting acidophilic cells to the injection site and inducing IgE-mediated allergies and also by acting as an antigen and eliciting a Th2 response.[4] Another excipient used in COVAXIN is 2-phenoxy ethanol, which is commonly used as a preservative in cosmetics and vaccines and is rarely reported to cause local reactions.[2,5]

Cutaneous adverse reactions reported with other COVID-19 vaccines are erythema, local swelling, generalized rashes, itching, and pernio-like lesions, but serious adverse reactions are rare.[6,7] The patient in the present case presented with sudden onset generalized eczematous eruption within hours following vaccination, extending well beyond the injection site. To the best of our knowledge, no such similar reaction to COVAXIN has been reported until now. Clinical presentation in our patient matches the description of V-REPP (vaccine-related eruption of papules and plaques) proposed by McMahon et al.[8] in their study on COVID-19 vaccine reactions.

This case recognizes the possibility of SACD in patients receiving COVAXIN. It is necessary to conduct further research to establish the safety of the second dose of vaccine in a patient who had allergic reaction to the first dose and whether dose modification or a potential alternative is required in those with confirmed allergy.

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Conflicts of interest

There are no conflicts of interest.