Symptomology Following First Dose of COVID-19 Vaccination in Healthy Subjects without Comorbidities

Introduction

Every person experiences diverse reactions on administration of COVID-19 (Corona virus disease of 2019) vaccine. Most people during clinical trials experienced only mild side effects, and some of them with no side effects at all showed a strong immune response to the vaccine. With or without side effects, vaccination protects everyone from severe COVID-19 infection.¹

COVID-19 vaccination helps guard people against COVID-19 infection. As body is in the process of building protection, some may exhibit side effects which are routine signs and symptoms, and these should disappear in few days. In this process, they do hamper daily activities of a person. Few may not show any side effects and rarely anybody experience allergic reactions.¹

Any vaccination rarely causes adverse effects that could result in long-term health problems and COVID-19 vaccine is no exception to this. If at all any adverse effects are seen, they occur within six weeks of receiving vaccination. Hence the U.S. Food and Drug Administration (FDA) collected data during clinical trials for a minimum period of eight weeks (two months) on each of the authorized COVID-19 vaccines after the final dose.¹

For the same reason, CDC, FDA, and other federal agencies have extended to monitor the safety of COVID-19 vaccines even after the vaccines have been in use.²

The symptoms developed after vaccinations are as follows:

On the arm at the site of vaccination: Pain, redness and swelling

The rest of the body: Tiredness, headache, muscle pain, chills, fever, nausea1

Occurrence of mild to moderate side effects after being vaccinated against COVID-19 is a normal sign of the body developing protection. Fever, tiredness, headache, muscle ache, chills, diarrhoea and pain or redness at the injection site are common side effects of COVID-19 vaccine which subside within few days on their own.

However, grave or long-term side effects of COVID-19 vaccines are not impossible even though they are rare. As long as vaccines are in use, they are continually monitored to perceive and react any rare adverse events.

In order to protect against virus, vaccines stimulate immune system. In this process, sometimes causes side effects like fever, chills or headache, in a few. Immune response to vaccine is not predicted by the presence or magnitude of the reaction after vaccination.

Rarely in some cases, a severe allergic reaction like anaphylaxis may be experienced after being vaccinated against COVID-19. This is an unusual side effect of any vaccine.³

After the 1^st or 2^nd dose of COVID-19 vaccine, mild to moderate side effects are observed including: fatigue, headache, joint pain, swollen lymph nodes, along with above stated symptoms.⁴ The side effects are observed within the primary three days after vaccination, typically lasting only 1 to 2 days.⁴

A cross sectional observational study conducted in Goa Medical College (Feb 2021-May 2021) found that incidence of adverse events after COVID-19 vaccination (Covishield) was 54.31%. Fever, fatigue and headache were the most commonly reported systemic adverse events and majority of vaccine recipients developed symptoms within 24 hours of receiving 1st dose of vaccine.⁵

In the US, especially in males aged 12 through 17 years, an increase in reported cases of myocarditis and pericarditis were seen after mRNA COVID-19 vaccination.⁶ Janssen/ Johnson & Johnson COVID-19 vaccine showed serious side effects which needed emergency care and these can occur within three weeks of vaccination.⁷

Possible symptoms include: Shortness of breath, persistent stomach pain, severe or persistent headaches or blurred vision, chest pain, leg swelling, easy bruising or tiny red spots on the skin beyond the injection site. Within three days after receiving vaccination, mild to moderate headaches and muscle aches are common.

Guillain-Barre syndrome was observed in Janssen/ Johnson & Johnson COVID-19 vaccine, though the occurrence was low. This disorder was most often reported about two weeks after vaccination, and mostly in men aged 50 years and above.⁸ The side effects of COVID-19 vaccines are not observed in everyone. Side effects do not last more than a week and are usually mild. Very rare side effects include allergic reactions, blood clotting, heart inflammation (myocarditis).⁹

Need for the study

When this vaccine was introduced, many speculations were made on its effect as it was a new vaccine without much of clinical confirmation compared to other known vaccines. Hence it was important to know the possible adverse effects of the vaccine once administered, as initially it was recommended only for ages above 40 years. This age group was the vulnerable group having co-morbidities. Later it was extended to lower age groups as well. The present study was taken up during the time when vaccine drive had just started to take its course (first time COVID-19 vaccination in India started in Jan 2021).

One study conducted in Bangladesh (305 subjects) in May 2021 among adults receiving Covishield vaccination reported the rate of adverse events as 54.1% after the 1st dose and as 41.3% after 2nd dose of vaccination.10

Our aim was to assess the impact of 1st dose of COVID-19 vaccine on subjects without co-morbidities.

Methodology

Type of research: Observational study

Duration of study: From October 2021 to September 2022

Data collection: Data was collected using an online questionnaire link for Google form through Whatsapp

Tool: Self-constructed questionnaire with closed end questions, validated by face validity

Sampling method: Random sampling method

Ethical clearance from IEC was obtained before beginning the study.

The Google form was sent via Whatsapp to students and practitioners along with subjects who visited our hospital after obtaining consent for voluntarily participation in the survey.

Subjects were asked to give the retrospective information on the symptoms experienced after 1st dose of COVID-19 vaccination, if they had received 2nd dose of vaccination.

Discussion

This study was a novel attempt to understand the symptoms developed after 1^st dose of COVID-19 vaccination as there is no available data. Studies showed minimal adverse reactions after 1^st dose of vaccination. Subjects in the age group of 18-67 years and above, without any co-morbidities were selected for the study.

In our study, the commonest symptoms reported were body ache 55 (14%), fever and body ache 52 (14.5%), fever 38 (10.6%), fever, joint pain & body ache 20 (5.3%).

One of the study conducted in India in a tertiary care center by Parida et al., on adverse events after COVID 19 (Covaxine) vaccination concluded that 29.8% of the participants reported at least one symptom, 14.6% reported pain at the injection site, 9.7% reported fever, and 5.9% reported myalgia. The incidence of symptoms developed after Covaxine administration were higher after 1^st dose (38.1%) compared to 2nd dose (26.4%) of vaccination.¹¹

According WHO, most common symptoms expected were fever, tiredness, headache, muscle ache, chills, diarrhoea and pain or redness at the injection site.¹²

According to study done by Hamed Zare et al., minimum one side effect was observed in individuals vaccinated with Sputnik-V, AZD1222, and Covaxin vaccines (81.9%, 88.8%, and 92.9%, respectively). ¹³

In our study, we have not segregated symptoms developed according to Covishield, Covaxine.¹³

In our study, pain at injection site (83%), fever with other symptom combination were found in majority of the participants.

According to study done by Hamed Zare et al., injection site pain (62.1%), fatigue (43.9%), muscle pain (42.5%), and fever (40.6%) were the most common side effects observed for all the three vaccines.¹³

Side effect frequency was higher in the female group (90.6%) compared to the male group (79.5%).¹³

In our study, frequency of symptoms developed in female was 63%, was 37% in males.

The prevalence of side effects with Covaxin vaccines was reduced in the elderly.¹³

After the 1^st dose of COVID-19 vaccine, 9.8% of elderly participants (53 years & above) reported symptoms.

Maximum symptoms were observed in age group of 23- 27 years (32%), followed by 18-22 years 93 (25%).

Majority of the subjects developed symptoms on 1st day of vaccination 164 (43.7%), followed by day 0 (31%).

Limitations

• The severity of pain at the injection site was not measured (pain assessment).

• The options for the type of vaccine administered were Covaxine & Covishield. Hence, we cannot conclude that only these two vaccines develop symptoms.

• Sample size was small to derive a significant conclusion.

• The subjects already with symptoms and worsened after vaccination could not be differentiated.

• Female respondents were more (236/375) and thus cannot be stated that symptoms developed more in females.

• Recently vaccination has been extended to individuals below 18 years; the symptoms may vary in these subjects which was not assessed.

• Some of the questions were confusing for the subjects (questionnaire limitation).

Recommendations for further studies

Future studies with large sample size must be conducted to estimate the long term effects of vaccination. Also, effects in subjects with co-morbidities and subjects below 18 years of age can be studied in depth.

Conclusion

As per today, 164 crore vaccinations are given and it is claimed to provide effective protection against COVID-19 virus and its variant strains. Much research is being conducted to assess symptoms developing after vaccination. In this current study, 164/375 (44%) subjects developed symptoms after 1st day of vaccination. This rate of development of symptoms was maximum in the age group of 23-27 years and minimum in individuals above 58 years. In the present study, fever (216-57.6%) was the commonest symptom observed along with pain at the site of injection (310). However, it is too early to conclude that vaccine has any long-term effects.

Conflicts of Interest

None

Acknowledgement

To my Guru Late Dr. G.M.Moogi Principal, Dean faculty of homoeopathy, who inspired, guided & encouraged us always. Dr. Kiran Patil  Professor Organon dept who always enlightens us about the intricacies of research. Staff, P.G's of A.M.Shaikh homoeopathic medical college and the study participants.