Rare adverse drug reaction associated with COVID-19 vaccine case report

Sailajapriyadarsini Parlapalli a, Sekhar Babu Bandar b,*, Upendra Kumar Mudaragadda c

a,b,* Postgraduate, department of pharmacology, Siddhartha medical college, Vijayawada- 520008, India

C Postgraduate, department of dermatology, Siddhartha medical college, Vijayawada- 520008, India.

A R T I C L E  I N F O  

A B S T R A C T  

Received 25 June 2021;

Revised 12 August 2021;

Accepted 24 August 2021.

India began to administer COVID-19 vaccines on 16 January 2021. As of 31 July 2021, the number of Covid-19 vaccine doses administered in the country has crossed 46 crores. Many adverse drug reactions were reported ranging from mild to severe and common to uncommon. Here we report a case of a 50-year-old woman with erythematous macules, plaques, and multiple bullous lesions after vaccination for COVID-19. Blood investigations, histopathological examination, direct immunofluorescence tests were done and diagnosed as Urticarial Vasculitis. She was treated with steroids, antihistamines, antibiotics, and vitamin supplements. She was discharged after one week with oral drugs. As the patient was treated early with prompt medical management she was recovered without any morbidity.


COVID 19 vaccine,  adverse drug reaction, urticarial vasculitis, erythematous macules, bullous lesions.

An official publication of Global Pharmacovigilance Society This is an open-access

article under the CC BY-NC-ND license. COPYRIGHT 2021 Author(s)



Urticarial Vasculitis is a clinicopathological condition that manifests as an erythematous wheal resembling urticarial with or without pruritus lesions, may leave hyperpigmentation at affected areas. Urticarial Vasculitis lesions last for more than 24 hours associated with fever, malaise, myalgia, and specific organ involvement. (Kulthanan et al., 2009). Urticarial Vasculitis differentiated from urticarial lesions by history and clinical appearance.

Urticarial Vasculitis is due to the formation of immune complexes deposited in blood vessels. Lesions are pruritic, but more commonly asymptomatic or painful accompanied by stinging or burning sensation. Patients may or may not have systemic findings. Systemic manifestations include constitutional symptoms (like fever, malaise, and fatigue), arthralgia, arthritis, iritis, uveitis, pericarditis, pseudotumor cerebral, peripheral neuritis, pleuritis, obstructive lung disorder, glomerular nephritis, interstitial nephritis, digital infarction, and Raynaud's phenomenon (Manjaly et al., 2020).

Most cases of urticarial Vasculitis are idiopathic. The primary causes of urticarial Vasculitis are as follows: Drug-induced, such as ACE inhibitors, penicillin, sulphonamides, fluoxetine, cimetidine, diltiazem, thiazides, potassium iodide, non-steroid inflammatory drugs, and glatiramer acetate (Sun et al., 2020).

At present globally we are facing a COVID-19 pandemic, in India cases started appearing in early 2020. Millions of people were affected since then, for which there is no proper medical management protocol. Many clinical trials were done to develop a vaccine for COVID -19. Covaxin and covishield were introduced in India for vaccination after approval from WHO. Many adverse drug reactions were coming across during vaccination drive like myalgia, arthralgia, nausea, headache, fever, rash, but one patient presented with erythematous plaques, macular lesions with multiple bullae over limbs.

Case Description

This is a case of a 49-year-old female patient who got admitted to the dermatology female ward with complaints of macular, plaques all over the body except palms and soles and bullous lesions over both forearms for 2 days. There is a history of constitutional symptoms like fever, myalgia, and headache for 2 days and then subsided. There was a history of vaccination with covishield before the appearance of constitutional symptoms. Once the constitutional symptoms were reduced, the patient developed macules and plaques all over the body except sole and palm followed by bullous lesions over both forearms. She was clinically examined and investigations were done.

Fig: 1 Macular rash with papules

Fig 2 and 3: Bullous lesions over upper limbs

Investigations showed abnormal blood counts with increased neutrophils and eosinophils. Ultrasound abdomen showed grade 1 fatty liver. Histopathological examination of skin lesion showed spongiosis and vesicles composed of neutrophils along with suprabasal disruption. The dermis showed moderate perivascular collections of chronic inflammatory cells with a predominance of eosinophils. Perilesional biopsy: Direct immunofluorescence showed IgG, IgM, IgA immunoglobulin's with C3 negative, suggestive of Impetigo, Urticarial Vasculitis with bullous lesions. 

Fig 4, 5, and 6: Histopathological slides show perivascular neutrophils along with suprabasal disruption. Moderate perivascular collections of chronic inflammatory cells in the dermis.

Correlated with clinical findings and investigational reports patient was diagnosed as vaccine-induced urticarial Vasculitis with bullous lesions and treated with antihistamines, steroids both topical and parenteral, vitamin supplements for one week with close monitoring of vitals. Lesions were reduced with mild residual hyperpigmentation. The patient was discharged after one week of hospital stay.


In this case, we have suspected the covisheild vaccine to be causative for the lesions. Covisheild vaccine contains a Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells. This product contains genetically modified organisms (GMOs).s. covishield is ChAdOx1 nCoV- 19 Corona Virus Vaccine.

Covishield vaccination course consists of two separate doses of 0.5ml each. The second dose should be administered after 84-90 days of the first dose. No dosage adjustment is required for elderly individuals more than 65 years. The vaccine is for intramuscular injection only, preferably deltoid muscle.

Adverse drug reactions till now noted are:



Adverse reactions

Blood and lymphatic system disorders



Metabolism and nutrition disorders


Decreased appetite

Nervous system disorders

Very common


Gastrointestinal disorders

Very common


Skin and subcutaneous tissue disorders


Hyperhidrosis, pruritus, rash

Musculoskeletal and connective tissue disorders

Very common

Myalgia, arthralgia

General disorders and administration site conditions

Very common

Injection site tenderness, injection site pain, injection site warmth, injection site erythema, injection site pruritus, injection site swelling, injection site bruising, fatigue, malaise, pyrexia, chills, injection site induration,

Influenza-like illness.


These are adverse drug reactions ranging from common to uncommon which were published in different articles (Chang et al., 2007; Mallapaty et al., 2021; Padma et al., 2021).

In our case, as the patient have no lesions before the administration, all the symptoms and lesions appeared after the administration of the covishield vaccine. Lesions were subsided with antihistamines and steroids.

Adverse events followed by immunization are classified by the cause of events, by World Health Organisation.

l  Vaccine product-related reaction

l  Vaccine quality defect-related reaction

l  Immunization error related reaction

l  Immunization anxiety-related reaction

l  Coincidental

Our case comes under vaccine product-related reaction.


There are many myths regarding the safety of COVID-19 vaccines in India. From the time of vaccination drive started in our hospital, we confronted only mild adverse reactions which subsided with minimal intervention. Vaccines for COVID-19 are considered as safe.

Conflict of Interest

No conflict of interest


Chang, S., & Carr, W. (2007). Urticarial vasculitis. Allergy and asthma proceedings28(1), 97100. 

Kulthanan, K., Cheepsomsong, M., & Jiamton, S. (2009). Urticarial vasculitis: etiologies and clinical course. Asian Pacific journal of allergy and immunology27(2-3), 95102.

Mallapaty S. (2021). India's massive COVID surge puzzles scientists. Nature592(7856), 667668.

Manjaly Thomas, Z. R., Leuppi-Taegtmeyer, A., Jamiolkowski, D., Steveling-Klein, E., Bellutti-Enders, F., Scherer Hofmeier, K., & Hartmann, K. (2020). Emerging treatments in COVID-19: Adverse drug reactions including drug hypersensitivities. The Journal of allergy and clinical immunology146(4), 786789. 

Padma T. V. (2021). India's COVID-vaccine woes - by the numbers. Nature592(7855), 500501.

Sun, J., Deng, X., Chen, X., Huang, J., Huang, S., Li, Y., Feng, J., Liu, J., & He, G. (2020). Incidence of Adverse Drug Reactions in COVID-19 Patients in China: An Active Monitoring Study by Hospital Pharmacovigilance System. Clinical pharmacology and therapeutics108(4), 791797.