Cutaneous adverse effects of the available COVID-19 vaccines in India: a questionnaire-based study.

Abstract

Coronavirus disease (COVID-19) is a newly discovered highly communicable disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants.1 We report diversified cutaneous side effects of the COVID-19 vaccines to describe various patterns and to understand temporal relationship between the first and second doses with cutaneous complications like local site reaction, defined as a wheal occurring at the site of immunization within 3 days from the day of immunization; delayed large local reaction, defined as wheal occurring 4 or more days post-immunization, depending on timing; and urticaria, defined as wheals distributed beyond the site of injection. Pain other than at the site of injection was defined as somatic pain in the peripheral region 2 cm away from injection site. From 16 January 2021 to 16 August 2021, single or more cutaneous reactions to Covishield or Covaxin COVID-19 vaccines were studied in 1029 healthcare workers, which was first target population in vaccination drive, immunized at institutional vaccination centre of central India, where one or more cutaneous reactions developed in 418 (86.7%) and 72 (13.3%) of the subjects in each group, respectively. The most common reaction, local injection site reaction, occurred primarily after the Covaxin vaccination (50.8%) more than the Covishield (34.93%) at a median of 1 day (inter quartile range – IQR 0–1) after the second dose and lasted for a median of 3 days (IQR 1–3). Delayed local arm reactions occurred primarily after the Covishield vaccination (1.4%) more than the Covaxin (0.7%) at a median of 4 days (IQR 1–7) after the first vaccine and lasted for a median of 1.5 days (IQR 1–3). Urticaria occurred primarily after the Covishield vaccination at a median of 1 day after the first dose and earlier, that is <1 day (IQR 0–1) after the second dose. Pain other than at the site of injection occurred primarily after the Covishield vaccination (10.3%) more than the Covaxin (4.4%) at a median of 1 day (IQR < 1–3) after the second vaccine and lasted for a median of 3 days (IQR 1–10). Other cutaneous findings, which were less commonly seen with both vaccines, included are 18 reports of swelling at other sites, 3 pityriasis rosea-like reactions, 3 morbilliform rash, 1 petechiae, 1 pernio-like rash, and 1 urticarial vasculitis (Fig. 1) and hairfall in 94 patients (9.1%). The data for post-vaccination systemic reactions from various studies showed fever, fatigue, myalgia and headache to be most common,2 which match our study – fever (49%), no reaction (37.4%), bodyache (31%), headache (23.2%), arthralgia (12%), myalgia (9.1%), chills (9%) being more common than sore throat (6%) and diarrhoea (1.6%; Table 1; Fig. 1). Exact aetiology of immediate local reactions due to both vaccines is unclear. Excipients like polyethylene glycol3, 4 have been attributed to cause immediate hypersensitivity reactions and urticaria. Delayed large local reactions were the most common, followed by local injection site reactions, urticarial eruptions, and morbilliform eruptions, according to Devon E. McMahon et al. study, which registered 414 cutaneous reactions to mRNA COVID19 vaccines from Moderna (83%) and Pfizer (17%).5 A study by Georgi Bogdanov et al. showed similar results, with injection-site reactions amongst the most frequent adverse events, which were mostly mild, usually self-limited and without serious consequences.6 Although aetiology of delayed local reactions due to the Covishield vaccine is unclear, a delayed-type hypersensitivity reaction to the excipient polysorbate 80 might be the potential aetiology, similar to that seen in the study by Georgi Bogdanov et al.6 Serious adverse events did not occur in any vaccine. Limitations include incomplete follow-up, delayed injection site reactions that needed long-term follow-ups and data were entered at one point of time only. As per data collected from our study, we conclude that cutaneous reactions to COVID-19 vaccines Covishield and Covaxin are benign and self-limited and should not hamper vaccination. The patients in this study have given written informed consent to the publication of their case details. None. None. The data that support the findings of this study are available from the corresponding author upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request.