Post-vaccination Symptoms of Covishield Vaccine among Frontline Workers of a Tertiary Care Center in Pathanamthitta District

Abstract

Introduction: 

The COVID-19 pandemic, which began in late 2019 and is still ongoing, has affected health and life across the world. Widespread vaccination with highly effective vaccines is an important tool in the efforts to control this pandemic. To determine post-vaccination symptoms after the first dose of Covishield vaccine among health care workers at a tertiary care centre in Pathanamthitta District.

Materials and Methods: 

A descriptive cross-sectional study in a tertiary care hospital in Pathanamthitta District. Data on adverse effects following vaccination with the first dose of Covishield vaccine were collected from health care workers through online surveys and interviews. Baseline characteristics were described with frequency, percentages, and mean. Associations between categorical variables were assessed using the Chi-square test.

Results: 

Of the 1,115 health care workers who participated in the study, the majority were medical students (28.3%), followed by nurses (24.8%), and doctors (19.1%). Post-vaccination symptoms were reported by the majority of the participants (95.1%). The most common symptoms were pain at the site of injection (79.8%), followed by myalgia (67.2%), and tiredness (64.6%). Hospitalization was required for six (0.5%) of the participants.

Conclusion: 

The symptoms reported in the study were those already known to be the general side effects associated with vaccines. The information obtained from this study will aid in health promotion activities related to COVID-19 vaccination.

INTRODUCTION

The novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), is responsible for the highly infectious disease COVID-19. First identified in Wuhan, China in December 2019, it spread globally to become a pandemic.^[1] The number of new cases peaked in early January 2021 when there were just under five million cases reported in 1 week.^[2] Safe and effective vaccines are needed for both individual protection and the development of herd immunity.^[3] COVID-19 is associated with a high mortality rate in vulnerable populations,^[4] and therapeutic options are limited. Widespread vaccination with highly effective vaccines against COVID-19 is an important tool in the efforts to control this pandemic.^[5]

Worldwide, more than 120 vaccine candidates are in various preclinical and phase 1–3 clinical trials. They include inactivated, live-attenuated, viral-vectored, replicating and nonreplicating, protein and peptide-based, and nucleic acid approaches.^[6] Both Covishield® (AstraZeneca’s vaccine manufactured by Serum Institute of India) and Covaxin® (made by Bharat Biotech Limited) were approved for emergency use authorization by the Central Drugs Standard Control Organization in India. The Covishield® vaccine is a viral vector-based technology, whereas Covaxin® is a whole-virion inactivated coronavirus vaccine.^[7]

A single-blind, randomized, controlled, clinical trial conducted in 20 centers in the UK among those who received the Covishield vaccine showed reports of local and systemic reactions, such as injection-site pain, a feverish feeling, muscle aches, and headaches.^[2] The reactions were less common in older adults (those aged more than 56 years) than in younger adults. In India, the priority groups vaccinated were health care workers, those aged more than 60 years, and those between 45 and 59 years of age with co-morbid conditions.^[8] The Ministry of Health and Family Welfare recommended the strengthening of surveillance systems capable of investigating adverse events of special interest and adverse events following immunization.^[9]

Although the protective efficacy and side effects of the new vaccines are frequently discussed, little is known about their post-vaccination effects outside of clinical trial conditions. To address the issue of vaccine hesitancy among the general population and manage their post-vaccination symptoms, it is necessary to identify the symptoms immediately following COVID-19 vaccination. Hence, we conducted a study to identify the post-vaccination symptoms after the first dose of the Covishield vaccine.

SUBJECTS AND METHODS

A cross-sectional study was conducted among the health care workers of a 900-bedded tertiary hospital in South Kerala, who received their first dose of the Covishield vaccine between January 19 and February 5, 2021. The hospital is a government-designated centre for COVID-19 vaccination. In the initial phase of the vaccination drive in India, which began on January 16, 2021, health care workers were among those on the priority list. A pre-tested questionnaire was used. It was developed by the authors after reviewing previously conducted studies and WHO-reported side effects of vaccination. The questionnaire was checked and validated for content. Expert opinions were taken into consideration and used in modifying the questionnaire into an easier, simpler, and shorter version that could be filled out within 5 min. The questionnaire included the following sections: baseline demographic information, the category of the health care worker, the time of vaccination, symptoms after vaccination, duration of symptoms, information about health care utilization, and pre-existing morbidities. The questionnaire was in English. Approval for the study was obtained from the Institutional Ethics Committee and informed consent was taken from the participants before they were given the questionnaire. One week after the administration of the first dose of vaccine to all those willing to be vaccinated, questionnaires (Google forms) were sent through email and WhatsApp groups to the beneficiaries.

Statistical analysis used

The data collected were entered into a Microsoft Excel spreadsheet, analyzed using the software SPSS version 25. The baseline characteristics of the study subjects were described in terms of frequency, percentages, and mean. A Chi-square test was used to find the association between categorical variables and a P value of 0.05 was considered statistically significant.

RESULTS

Of the 2,500 health care workers who received the Covishield vaccine at the study center, 1,115 health care workers completed the questionnaire over 3 weeks from January 26 to February 11, 2021. Among those who responded, the majority were medical students (28.3%), followed by nurses (24.8%), doctors (19.2%), administrative staff (8.9%), paramedical staff (8.5%), house surgeons (6.9%), and others (3.4%), which included housekeeping staff and security staff. The mean age (SD) was 31.42 (11) years and the majority of the participants were females (75.1%).

The majority of the respondents (95.1%) reported post-vaccination symptoms. The most common symptoms were pain at the site of injection (79.8%), myalgia (67.2%), tiredness (64.6%), a feverish feeling (54.7%), fever (48.9%), headache (15%), nausea (14.7%), giddiness (13.1%), diarrhea (6.2%), and redness at the site of injection (5.3%). Rare symptoms reported included anaphylaxis, peri-orbital edema, breathlessness, vomiting, and passage of red-colored urine. The reported side effects of COVID-19 vaccinated health care workers are provided in Figure 1. Among those who reported symptoms, 87.8% noticed them within 24 h of receiving the vaccine, and 12.1% noticed them after 24 h. About 61.3% of the participants reported that their symptoms subsided after taking Tablet Paracetamol. Six of the participants (0.5%) required hospitalization for the management of their symptoms. Analysis of data regarding the duration of symptoms showed that 15.6% of participants reported that symptoms lasted for less than 24 h, 44.7% for more than 24 h, 29.5% for 2 days, 6.4% for 3 days, and 3.6% for more than 3 days. In the study, it was noted that there was a statistically significant difference in the symptoms between males and females as shown in Table 1. Symptoms such as pain at the site of injection (82.9%), myalgia (69.5%), tiredness (67.4%), headache (18.2%), nausea (17.9%), giddiness (14.8%), periorbitaledema (1.4%), and anaphylaxis (0.6%) were reported significantly more among females. A total of 115 (10.31%) participants reported having at least one non-communicable disease of which, 41 (35.6%) had hypertension, 20 (17.3%) had thyroid disease, 36 (31.3%) had type 2 diabetes, and five (4.3%) had allergies. No significant association was noted between symptomatic status and other variables in the study.

Figure 1: Side effects reported by health care workers after vaccination with Covishield

Table 1: Association between post-vaccination symptoms and various other factors

DISCUSSION

The COVID-19 pandemic has caused major disruption to health care systems, with significant socioeconomic impact. A safe and effective vaccine against COVID-19 will have a significant impact on public health.^[10] This cross-sectional study, which included 1,115 health care workers, described their immediate post-vaccination side effects following the first dose of the Covishield vaccine. The most common side effects reported were pain at the site of injection, fatigue, headache, myalgia, a feverish feeling, and fever. Most of the reported side effects occurred within the first 3 days of vaccination, and the majority resolved within 1–2 days of onset. Anaphylaxis was very rare among participants. It was noted that among both males and females, those in the age group of 21–30 years reported more side effects following vaccination.

COVID-19 vaccine recipients should be informed about the possible side effects of vaccination before the vaccine is administered. This includes local side effects such as pain, swelling, and redness at the injection site and systemic side effects such as fever, fatigue, headache, a feverish feeling, diarrhea, myalgia, and arthralgia.^[11] In the phase 3 trial of the COVID-19 vaccine Pfizer-BioNTech, the incidence of mild headache following vaccination was 42% in the vaccinated and 34% in those who received a saline placebo.^[12] The use of paracetamol for minor symptoms following vaccination is considered acceptable.^[13] A recent study from Nepal showed post-vaccination effects such as irritability in mood reported 4 h after vaccination, and complaints such as myalgia, nausea, pain at the injection site, and a feverish feeling 6 h after vaccination, which matched our findings.^[7] Muscle discomfort (68.3%) was described as the most common side effect in a study from Kabul, Afghanistan, whereas pain at the injection site was recorded as the most common adverse reaction in our study (79.8%).^[14] Although symptomatic status had no association with various other variables considered in our study, Poland GA et al. found that 80–91% of all vaccine recipients experienced at least one local symptom, and 48–91% experienced at least one systemic symptom after vaccination depending on variables such as age group.^[15]

This study had certain limitations. As it was an online survey, the rate of response from the vaccine recipients was low, and those who had experienced side effects following vaccination were more likely to complete the survey. Only the data from a beneficiary who finished the survey one week after receiving his or her first dose was used for those who were unable to respond because of the unavailability of Android phones, because they were unfamiliar with Google forms, or because they were unwilling to participate. As there is a lot of misinformation about the side effects of vaccines, the general public needs to get their information from trustworthy sources. Health care workers can play an important role in recognizing and reporting adverse events after vaccination. Mild side effects appear to be tolerable during COVID-19 immunization because the body will need time to adjust to the vaccine dose and prompt the immune system to produce protective antibodies. As a result, the general public should be aware of these minor side effects, which can be managed with symptomatic treatment such as paracetamol to resolve symptoms quickly and increase the acceptance of vaccines against COVID-19.

Furthering our knowledge about the vaccine side effects will help us educate the public and reduce vaccine hesitancy and misinformation related to vaccines. Therefore, additional independent studies on vaccine safety and post-vaccination symptoms are greatly required to strengthen the public’s confidence in accepting this new vaccine. Additionally, further studies are needed to understand the risk factors of specific vaccine side effects, and this requires the continuous monitoring of vaccinated persons for possible side effects.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.