Review

The Side Effects and Adverse Clinical Cases Reported after

COVID-19 Immunization
Roshina Rabail 1 , Waqar Ahmed 1 , Madiha Ilyas 2 , Muhammad Shahid Riaz Rajoka 3 , Abdo Hassoun 4,5 ,
Abdur Rauf Khalid 6 , Moazzam Rafiq Khan 1 and Rana Muhammad Aadil 1, *

1 National Institute of Food Science and Technology, University of Agriculture, Faisalabad 38000, Pakistan;
roshina.rabail@gmail.com (R.R.); 729waqar@gmail.com (W.A.); mrkhan_ft@yahoo.com (M.R.K.)
2 Department of Nutritional Sciences, Government College Women University, Madina Town,
Faisalabad 38000, Pakistan; madihailyasrana@hotmail.com
3 Food and Feed Immunology Group, Laboratory of Animal Food Function, Graduate School of Agricultural
Science, Tohoku University, Sendai 980-8572, Japan; shahidrajoka@yahoo.com
4 Sustainable AgriFoodtech Innovation & Research (SAFIR), 62000 Arras, France; a.hassoun@saf-ir.com
5 Syrian Academic Expertise (SAE), Gaziantep 27200, Turkey
6 Department of Livestock and Poultry Production, Faculty of Veterinary Sciences, Bahauddin Zakariya
University, Multan 60800, Pakistan; dr.abdurrauf@hotmail.com
* Correspondence: muhammad.aadil@uaf.edu.pk

Abstract: COVID-19 remains a deadly disease that poses a serious threat to humanity. COVID-
19 vaccines protect the public and limit viral spread. However, public acceptance is significantly
dependent on the efficacy and side effects (SEs) of the vaccinations being produced. Four important
mechanisms have been examined for COVID-19 vaccines: DNA-based, mRNA-based, protein-based,
and inactivated viruses. Vaccination safety research was formerly limited to manufacturer-sponsored



studies, but numerous additional cross-sectional survey-based studies conducted globally have

 contributed to the generation of vaccine-related safety data reports. Twenty-seven studies and
Citation: Rabail, R.; Ahmed, W.; Ilyas, twenty-four case reports published-up till 2021 were overviewed for the presentation of SEs and their
M.; Rajoka, M.S.R.; Hassoun, A.; severity. Injection site pain remained the most dominant localized SE, while headache and fatigue
Khalid, A.R.; Khan, M.R.; Aadil, R.M. were the most prevalent systemic SEs. Most studies reported that all vaccinations were safe, with
The Side Effects and Adverse Clinical
very little or no adverse effects, but the nature of SEs was reported to be more persistent in DNA- and
Cases Reported after COVID-19
mRNA-based vaccines, while inactivated viral vaccines were associated with longer-duration SEs.
Immunization. Vaccines 2022, 10, 488.
Overall, SEs were found to be more dominant in women and youngsters. Case reports of adverse
https://doi.org/10.3390/
reactions have also been documented, but there is still a need to find out their pathological linkage
vaccines10040488
with the COVID-19 vaccination.
Academic Editor: Giuseppe La Torre

Received: 8 February 2022

Keywords: COVID-19 vaccination side effects; AstraZeneca side effects; Pfizer side effects; Moderna
Accepted: 16 March 2022 side effects; Sinopharm side effects; Sputnik V side effects
Published: 22 March 2022

Publisher’s Note: MDPI stays neutral

with regard to jurisdictional claims in
1. Need for Vaccination against COVID-19
published maps and institutional affil-
iations. Vaccines can be used to control infectious diseases, and are well known to be effective
in fostering a long-lasting immune memory. Vaccines currently save the lives of 2–3 million
people each year. When recommending or rejecting vaccinations, the adverse effects on
people’s trust in healthcare professionals should be considered [1]. Severe acute respiratory
Copyright: © 2022 by the authors. syndrome-coronavirus-2 (SARS-CoV-2) triggered a pandemic. The first cases were reported
Licensee MDPI, Basel, Switzerland. in Asia, which were then spread to other parts of the globe [2]. The COVID-19 infection
This article is an open access article is caused by SARS-CoV-2, against which immunity can be obtained either by natural
distributed under the terms and or preventative immunization of the population at the mass level [3]. The COVID-19
conditions of the Creative Commons pandemic has introduced a challenge never before seen in the history of humankind for a
Attribution (CC BY) license (https://
secure and fearless existence [4], as it has directly afflicted millions of people around the
creativecommons.org/licenses/by/
globe. International agencies have recently discovered that poverty and hunger may kill
4.0/).

Vaccines 2022, 10, 488. https://doi.org/10.3390/vaccines10040488 https://www.mdpi.com/journal/vaccines

Vaccines 2022, 10, 488 2 of 25

far more people than COVID-19 victims [5]. However, COVID-19 remains a lethal disease
that poses a significant threat to humanity. Many significant pharmaceutical and non-
pharmaceutical companies have spent significant effort and money in the fight against this
disease in recent years [6], as there was an immediate need to find a long-term therapeutic
strategy, such as immunization [2]. Since the start of the coronavirus pandemic, experts
have been working diligently to discover a way to stop the virus from spreading. The
most pressing objective in the aftermath of such a public health crisis was the development
of an effective vaccination [7], as vaccinating the global population is the most effective
strategy to combat the COVID-19 pandemic. The promotion of these preventative methods,
such as vaccination, is ethical and cost-effective and should be actively pursued by all
physicians, particularly in the case of immune-compromised patients, e.g., patients with
systemic sclerosis, who should be provided with the means to better protect their quality of
life [8]. However, the public’s apprehension regarding the available vaccines is a significant
obstacle in the fight against the spread of COVID-19 [9].
Vaccines against COVID-19 protect the general public and limit viral spread [2]. The
four key mechanisms investigated in this paper for the COVID-19 vaccines are inactivated
virus, DNA, mRNA, and protein-based vaccines. DNA-based vaccinations transfer the
DNA coding for the SARS-CoV-2 spike protein using viral vectors into cells; mRNA
vaccines typically deliver mRNA into the cells via a lipid nanoparticle; protein vaccines
are based on the spike proteins or their particles, and certain other vaccinations are based
on inactivated viruses [10]. Vaccines are one of the most effective therapies for combating
COVID-19, saving millions of lives each year. However, the ideal option is a vaccine
that is efficacious, safe and does not cause serious adverse responses. Due to the lack of
viable and licensed COVID-19 treatments, a vaccination development race has started, with
259 COVID-19 vaccine projects beginning on 11 November 2020. The fast development
of vaccines has increased the possibility of vaccine-related safety concerns [11]. Many
countries are developing vaccines in the aftermath of the COVID-19 pandemic to protect
their populations [12]. Many vaccines have been made available earlier than planned due to
their pressing need. New technology has also aided the development of far more effective
vaccines; however, their potential adverse effects must be considered [6].

2. Side Effects (SEs) and COVID-19 Vaccination Resistance

The development of a COVID-19 vaccine was viewed as a critical strategy for ending
the pandemic. Public acceptance, on the other hand, is based on people’s ideas and percep-
tions of the vaccination [13]. The rates of vaccine hesitation and rejection are still higher,
which may require legislative changes to make the vaccination program profitable [12].
One possible cause behind neglecting immunization could be the negative emotions such
as anxiety, depression, anger, and irritability which have already been observed in many
studies during quarantine periods. This occurs because psychosocial disturbances, such
as relational loss and social rejection, cause changes in mind–body interplay [14]. Such
hesitation has been linked to more negative beliefs that the vaccination would cause SEs
or be unsafe [15]. The COVID-19 vaccine’s adverse effects play a critical role in public
trust in the vaccination and its administration technique [3]. An online self-administered
questionnaire, completed in May 2020 among the Saudi population regarding vaccination
views and the potential barriers preventing people from becoming vaccinated against
COVID-19, cited SEs as major obstacles to vaccine uptake [13]. Similarly, in another study,
seven attributes were evaluated to create vaccine choice sets: vaccine effectiveness, SEs,
accessibility, number of doses, vaccination sites, length of vaccine protection, and a fraction
of acquaintances vaccinated. Although all seven factors were found to have a substantial
impact on respondents’ vaccination decisions, and vaccination SEs were among the most
relevant factors [16,17], the likelihood of a serious adverse SE was found to be a modest but
significant cause of vaccination rejection. In comparison to rates of 1/1,000,000 general SEs,
a significant adverse SE rate of 1/100,000 was more likely to discourage vaccine usage [18].
COVID-19 vaccinations have been expedited through the review process due to the lack of
Vaccines 2022, 10, 488 3 of 25

safety data. COVID-19 vaccines had a low level of public acceptance of 37.4%. Therefore
public health officials must implement systematic interventions to reduce vaccine hesitancy
and improve vaccine acceptance [19] and more studies are required to identify the benefits
and SEs.

3. Selection and Collection of Data

The latest current available literature on COVID-19 immunization, COVID-19 vacci-
nation updates, the studies on their reported SEs, updates on case reports presented with
serious adverse SEs, their approval, authorization, and clinical phases were explored on
Google scholar, Scopus, and Science Direct using the keywords “COVID-19 vaccination” or
“COVID_19 immunization” or “SARS-CoV-2 vaccination” or “SARS-CoV-2 immunization”
and “Side effects” or “Adverse effects” or “Safety studies”, available up to November 2021.

4. COVID-19 Vaccinations’ Approval/Authorization

Scientists across the world are working faster than ever to design and create vaccina-
tions that can prevent the spread of COVID-19, with 21 vaccines already being distributed
in countries around the world [20]. COVID-19 vaccines were previously available in three
forms: messenger RNA-based vaccinations, adenoviral vector vaccines, and inactivated
whole-virus vaccines. Some of them have passed phase 3 safety and efficacy trials and are
now commonly utilized for COVID-19 infection prophylaxis [21], but now protein subunit
forms of COVID-19 vaccines are also under consideration [22,23]. Thus far, the US Food and
Drug Administration (FDA) has granted emergency use approval for three new COVID-19
vaccines: two messenger RNA-based vaccines (Pfizer and Moderna), and one adenoviral
vector vaccine (Janssen) has received FDA approval [24]. In the event of a public health
emergency, emergency use authorization (EUA) is provided for unlicensed medications
and vaccines. The FDA Director General is authorized to issue the EUA under Executive
Order No. 121; the following vaccinations have received this license: Pfizer, AstraZeneca,
Coronavac/Sinovac, Sputnik V, Janssen, Covaxin, Moderna, and Sinopharm [25]. Seven
vaccinations are listed on the WHO emergency use listing (EUL). These include Moderna,
Pfizer, Janssen, AstraZeneca, Covishield, Sinopharm, and Sinovac [26]. Two vaccines
(Moderna and Janssen) have launched successful phase 4 clinical trials. The United States
authorizes Moderna for use on anyone over the age of 18, while the European Medicines
Agency has given approval for youngsters aged 12 to 17 in July 2021. Four vaccinations
(AstraZeneca (Cambridge, United Kingdom), Pfizer (New York, United States), Sinovac
(Beijing, China), and Cansino (Tianjin, China) have advanced to phase 3 as part of the
WHO’s vaccine solidarity study. There are now 128 COVID-19 vaccine candidates in clinical
trials and 194 candidates in pre-clinical research across the world [20]. Eleven vaccines
based on their authorization, approval, efficacy level, and utilization have been listed in
Table 1.
Vaccines 2022, 10, 488 4 of 25

Table 1. Most-utilized vaccinations against COVID-19.

Local/Given Origin: Com- Efficacy Trials

Codename Type Approval/Authorization References
Name pany/Country Phase II/III/IV
Uridine
nucleoside BioNTech 95% efficacy.
FDA-approved; FDA
modified mRNA (Germany) in Safe during
Emergency Use
(encodes the collaboration pregnancy.
Authorization (EUA);
BNT162b2 receptor-binding with Fosun 38 trials in
Pfizer WHO-approved in 103 [6,20,25–30]
Vaccine domain or Pharmaceuticals 20 countries.
countries; among first
full-length (Shanghai, China) Phase IV
vaccines to get EUA in
version of and Pfizer registered on 27
December 2020
SARS-CoV-2 (Canada) September 2021
spike protein)
Massachusetts
(the United States)
along with the 94% efficacy; safe
National Institute FDA-approved; FDA during pregnancy.
mRNA-based
of Allergy and (EUA); 31 trials in
vaccine designed
mRNA-1273 Infectious WHO-approved in 7 countries; phase
Moderna to express the [6,20,25–30]
Vaccine Diseases and 76 countries; among II in August 2021;
coronavirus spike
Biomedical first vaccines to get phase IV
protein
Advanced EUA in December 2020 launched in June
Research and 2021
Development
Authority
13 trials in
Johnson and FDA-approved; FDA
Adenoviral- 3 countries.
Johnson/the (EUA);
Janssen Ad26.COV2.S based Phase IV [6,20,25,26,28]
United States, the WHO-approved in
vaccine launched in June
Netherlands. 75 countries
2021
70% efficacy.
46 trials in
Oxford 3 countries.
Chimpanzee FDA (EUA); WHO
University under Phase II/III was
AstraZeneca/ AZD1222 Vac- Adenovirus- emergency use listing
British completed in June [4,16,21–24,26]
Vaxzevria cine/ChAdOx1 Vectored (EUL) WHO-approved
pharmaceutical 2021; Phase IV
vaccine in 124 countries
company was registered on
27 September
2021 [26]
Gamaleya
National
Adenoviral-
Gam-COVID- Research Centre
Sputnik V based FDA (EUA) 91.6% efficacy; [25,27,28,30]
Vac of Epidemiology
vaccine
and Microbiology
(Moscow, Russia)
Tianjin, China in
The recombinant
collaboration
vaccine which
with the Beijing 90% efficacy.
involves
Convidecia/ Ad5-nCoV Institute of Phase IV
replication- - [20,27,30]
CanSino Vaccine Biotechnology in registered in May
defective
the Academy of 2021
adenovirus type 5
Military Medical
as vector
Sciences
Bharat Biotech
(India) in
collaboration
Inactivated with Thomas
vaccine candidate; Jefferson
deactivated rabies University of
Covaxin
BBV152 vaccine as a Philadelphia, FDA (EUA) - [25,27]
Vaccine
vehicle for Indian Council of
coronavirus Medical Research
proteins (ICMR) and
National Institute
of Virology
(Pune, India)
Vaccines 2022, 10, 488 5 of 25

Table 1. Cont.

Local/Given Origin: Com- Efficacy Trials

Codename Type Approval/Authorization References
Name pany/Country Phase II/III/IV
FDA (EUA); WHO
New Crown Wuhan Institute 79.34% efficacy.
Inactivated (EUL);
Sinopharm COVID-19 of Biological 15 trials in [20,25–28,30]
vaccine candidate WHO-approved in
Vaccine Products, (China) 9 countries
68 countries
Sinovac Life 65% efficacy;
Sciences Co. Ltd. WHO emergency use 22 trials in
Adsorbed
Sinovac/ CoronaVac (China) in listing (EUL); 2 countries.
(inactivated) [20,26,27,30]
CoronaVac Vaccine collaboration WHO-approved in Phase IV
vaccine
with Instituto 41 countries registered on 27
Butantan September 2021
(Oxford/
Serum Institute of WHO-approved in 2 trials in
Covishield AZD1222 AstraZeneca [26]
India 46 countries? 1 country
formulation)
Antigenic
components
Novavax NVX-CoV2373 (spike (S) protein) - - - [30,31]
generated in vitro
(Viral subunit)

5. Studies Reporting SEs of COVID-19 Immunizations

Previously, vaccination safety research only came from manufacturer-sponsored stud-
Vaccines 2022, 10, x FOR PEER REVIEW
ies, but many other cross-sectional survey-based studies around the world have helped 6 of in
25

the generation of vaccine-related safety data reports [3]. COVID-19 vaccine types and their
SEs are illustrated in Figure 1.

Figure 1. Most-utilized COVID-19 vaccinations and their frequently reported SEs.

Figure 1. Most-utilized COVID-19 vaccinations and their frequently reported SEs.

5.1. Messenger RNA Based COVID-19 Immunization

The FDA granted Emergency Use Authorization (EUA) to two two-dose mRNA vac-
cines: BNT162b2 from Pfizer–BioNTech, for people aged ≥16 years; and mRNA-1273
Moderna for people aged ≥18 years [32]. Both vaccines employ either lipid nanoparticle
delivery technology or a modified mRNA-delivery mechanism. Modified mRNA is used
Vaccines 2022, 10, 488 6 of 25

5.1. Messenger RNA Based COVID-19 Immunization

The FDA granted Emergency Use Authorization (EUA) to two two-dose mRNA
vaccines: BNT162b2 from Pfizer–BioNTech, for people aged ≥16 years; and mRNA-1273
Moderna for people aged ≥18 years [32]. Both vaccines employ either lipid nanoparticle
delivery technology or a modified mRNA-delivery mechanism. Modified mRNA is used
to encode the COVID-19 spike proteins, with mutant mRNA being added to lock them
into the three-dimensional structure required to cause an interaction between the spike
proteins and virus-neutralizing antibodies. They have a higher safety profile than other
viral vaccines since they are not created with actual infections and are not incorporated into
host DNA [28]. Both have been considered safe during pregnancy [29]. Messenger RNA
vaccinations generate milder, less-frequent systemic adverse effects, but more localized
SEs [9,33].

5.1.1. Pfizer–BioNTech (BNT162b2) COVID-19 Vaccination

Millions of people worldwide have been immunized with the Pfizer–BioNTech vacci-
nation [24]. The Pfizer–BioNTech (BNT162b2) vaccine has shown good safety and efficacy
in phase 3 trials and reduces the chances of SARS-CoV-2 infection after approximately
12 days of vaccination [34]. The Pfizer–BioNTech vaccine was associated with considerably
greater rates of all forms of adverse reactions [35]. A selection of the minor SEs, which
have been highlighted in ten studies on the Pfizer–BioNTech vaccine, is listed in Table 2.
Among these eleven studies on Pfizer, eight studies reported headache; seven studies
reported weakness/fatigue and myalgia/muscle/body pain; six studies reported local
injection site/shoulder pain, chills/feeling cold, and fever; four studies reported enlarged
lymph nodes and joint pain/arthralgia; three studies reported nausea/vomiting/GIT dis-
turbances; one study reported cutaneous urticarial/morbilliform eruptions, weakness,
hand numbness, mucosal lesions, taste disturbances, skin burning, rash, allergic reactions,
dry cough, sore throat, brain fog, and decreased sleep quality. On the other hand, the
prevalence of major or complex SEs has also been reported in these nine studies, including
one study which reported adverse skin reactions, i.e., chilblains; zoster, herpes simplex,
pityriasis rosea, etc.; two studies, which reported severe allergic responses such as anaphy-
laxis; one study which reported thromboembolic events such as a cerebrovascular accident,
myocardial infarction, pulmonary embolism, acute hypertension (over 210/105mm Hg),
and Bell’s palsy. While exploring the data, available in the form of clinical case reports in
Table 3, a total of twenty cases reported clinical complications which may have been linked
with the Pfizer vaccination. Among these cases, eight belong to the onset of acute zoster
ophthalmicus/varicella-zoster virus reactivation/shingles (herpes zoster); three belong
to the lymphoproliferative disease and autoimmune adverse reactions (antineutrophil
cytoplasmic autoantibody and severe immune thrombocytopenia); two cases pertain to
acute immune thrombocytopenia; and one involves a clinical complication for takotsubo
cardiomyopathy, multiple cranial neuropathies, and Guillain-Barré Syndrome. Some of the
reported clinical cases for the COVID-19 vaccine and their SEs are illustrated in Figure 2.
Vaccines 2022, 10, 488 7 of 25

Table 2. COVID-19 vaccinations and their reported SEs.

Participant/ Concluding
Vaccine Name Methodology Date/Duration Minor Side Effects Major Side Effects Duration References
Area Remarks
The presence of a
A collaborative
cutaneous reaction to
study between the
Pfizer– Local injection site Pernio/chilblains, the first vaccine dose,
American
BioNTech COVID-19 reactions, urticarial cosmetic filler when it appears 4 h
Academy of 414 cutaneous December
(17%) eruptions, reactions, zoster, - after injection, is not [36]
Dermatology and the reaction cases 2020–February 2021
and morbilliform herpes simplex flares, a contraindication to
International League
Moderna (83%) eruptions. pityriasis rosea. receiving the second
of Dermatological
dose of the Pfizer or
Societies
Moderna vaccine.
Injection site pain,
headaches, flu-like
symptoms, fever,
Google 455 individuals Bell’s palsy, lymph
Pfizer–BioNTech tiredness, fast
Form-questionnaire Saudi Arabia 10–21 January 2021 node swelling and - - [37]
COVID-19 heartbeat, whole-body
(online survey) inhabitants tenderness.
aches, difficulty
breathing, joint pain,
chills, drowsiness.
Pharmaceutical and
181 suspected event
Medical Devices
reports of anaphylaxis In 171 of these
Agency (PMDA)
Pfizer–BioNTech February–March and anaphylactoid 181 cases, women
reported adverse 578,835 doses - - [38]
COVID-19 2021 symptoms (reporting developed these
events following
rate: symptoms.
immunization
8.1/100,000 doses)
(AEFI)
Soreness, fatigue,
myalgia, headache,
chills, fever, joint pain,
nausea, muscle spasm,
sweating, dizziness,
Pfizer–BioNTech
Cross-sectional trial flushing, feelings of
COVID-19 (64.5%) 24 January–10 March
with an independent 1245 HCWs relief, brain fogging, - - - [39]
and 2021
online questionnaire anorexia, localized
Moderna (35.5%)
swelling, decreased
sleep quality, itching,
tingling, diarrhea,
nasal stuffiness,
palpitations.
Vaccines 2022, 10, 488 8 of 25

Table 2. Cont.

Participant/ Concluding
Vaccine Name Methodology Date/Duration Minor Side Effects Major Side Effects Duration References
Area Remarks
68 thromboembolic
events
Vaccine Adverse (1 case per
Event Reporting 222,951 vaccinated)
Pfizer–BioNTech System (VAERS); Women aged thromboembolic
COVID-19 Food and Drug ≤50 years with events under 1–6 days after
19 March 2021 - - [40]
and Administration hormonal investigation: vaccination
Moderna Adverse Event contraceptive use thrombosis,
Reporting System cerebrovascular
(FAERS) accident, myocardial
infarction, pulmonary
embolism.
SEs more prevalent
Injection site pain,
Pfizer–BioNTech Cross-sectional HCW in the Czech January–February among the
fatigue, headache, - 1 or 3 days [7]
COVID-19 survey-based study Republic 2021 ≤43-year-old age
muscle pain, chills.
group.
Pruritus, rash, itchy 10 cases of
108 case reports of sensations in the anaphylaxis
21 December
Moderna COVID-19 CDC report severe allergic mouth (2.5 anaphylaxis 7–30 min after
2020–10 January - [41]
vaccine (VAERS) reaction, including and throat, sensations cases/million vaccination
2021
anaphylaxis of throat closure, and Moderna COVID-19
respiratory symptoms. vaccine doses.
Injection site pain,
shoulder pain, muscle
aches, headaches, fever,
chills, weakness,
nausea, vomiting,
AstraZeneca causes
diarrhea in both
more SEs.
vaccines.
Pfizer had the same
General stomach
AstraZeneca Total 705: or more adverse
problems,
and Online survey Pfizer 196. - - - reactions after the [42]
osteoarticular pain,
Pfizer–BioNTech AstraZeneca 509 second dose;
back pain, neck pain,
AstraZeneca’s
drowsiness, feeling
second dose caused
cold, fast heart rate
even stronger SEs.
and palpitations in
AstraZeneca.
Hand numbness,
enlarged lymph nodes
in Pfizer.
Vaccines 2022, 10, 488 9 of 25

Table 2. Cont.

Participant/ Concluding
Vaccine Name Methodology Date/Duration Minor Side Effects Major Side Effects Duration References
Area Remarks
Injection site pain, mRNA-based
headache, fatigue, vaccines: more local
muscle pain, malaise, SEs.
chills, joint pain. More Viral vector-based
Pfizer-BioNTech, 599 HCWs in the than one-sixth vaccine: higher
Moderna and Online questionnaire Federal Republic of February–April 2021 participants reported - 1–3 days systemic SEs. [9]
AstraZeneca Germany at least one oral side Females and the
effect, including younger age groups
mucosal lesions, oral are more associated
paresthesia, taste with an increased
disturbance. risk of SEs.
Headache, fatigue,
chills, shivering,
diarrhea, fever,
Adverse effects are
arthralgia, myalgia,
more frequently
nausea, pain, swelling,
Pfizer- reported in younger
COVID symptom 282103 individuals 8 December 2020–10 tenderness, itch,
BioNTech and - 1–2 days individuals, women, [34]
study app (aged 16–99 years) March 2021 swollen armpit glands,
AstraZeneca and among those
redness,
who previously had
warmth, bruising,
COVID-19.
allergic reactions, rash,
skin burning, red welts
on face and lip.
Fatigue, body pain,
Six cases: (four- Pfizer
headache, muscle pain,
and two AstraZeneca)
fever, gastrointestinal
admitted into the
effects (nausea,
hospital due to severe
vomiting, anorexia,
hypotension,
and diarrhea) in all
An interactive generalized body Signs and symptoms
1736 (18–86 years three vaccines;
web-based aches, shortness of are more persistent
Pfizer-BioNTech, age). tenderness or swollen
system interview 1 January–10 April breath, and fever of for AstraZeneca
AstraZeneca, Pfizer 700. lymph nodes in Pfizer; 1–2.5 days [43]
with an electronic 2021 more than 39 ◦ C. followed by Pfizer
and Sinopharm AstraZeneca 696; sweating, dizziness,
version of the Four cases (2 swelling and less adverse
Sinopharm 340 dry cough, anxiety,
questionnaire and severe allergic with Sinopharm.
shortness of breath,
reaction of eyelids
tachycardia,
and 2 acute
abdominal pain, sore
hypertension—over
throat, joint pain, nasal
210/105 mm Hg) in
discharge in
Pfizer vaccine.
AstraZeneca
Vaccines 2022, 10, 488 10 of 25

Table 2. Cont.

Participant/ Concluding
Vaccine Name Methodology Date/Duration Minor Side Effects Major Side Effects Duration References
Area Remarks
SEs more persistent
Injection site pain, in female; Sputnik V
AstraZeneca,
503 HCWs in Birjand 21 February–7 March fatigue, muscle pain, and Covaxin
Sputnik-V and - - [44]
(Iran) 2021 fever in all three reported lower SE
Covaxin
vaccines. occurrence in the
elderly.
Local and systemic Pfizer was associated
Sinopharm (51.1%) 1004 Jordanian effects: with greater rates,
Semi-structured
and adults with no 10 March–2 April pain at the injection No serious cases of while Sinopharm
interviews on a - [35]
Pfizer–BioNTech history of previous 2021 site, fatigue, headaches, hospitalization. was associated with
phone call
(48.9%) allergies myalgia, arthralgia, a longer duration of
fever, rigors. SEs.
583 Iranian multiple Malaise, fatigue, fever,
Five recipients (0.9%)
Sinopharm Google form sclerosis (MS) 1 May–22 May 2021 shivering, body pain, - - [45]
reported MS relapse.
patients headache.
injection site
Chronic diseases
92 HCWs/Germany discomfort, fatigue, No serious cases of
Cross-sectional were not associated
AstraZeneca and the Czech March 2021 muscle pain, chills, hospitalization/no - [7]
survey-based study with an increased
Republic feeling unwell, nausea, blood disorder.
risk of SE.
headache
tachycardia (rapid
heart rate),
hyperventilation
(rapid breathing),
dyspnea (difficulty
17 reports of syncope
breathing), chest pain,
64 anxiety-related (fainting): Immediately after
Janssen VAERS 7–9 April 2021 paresthesia (numbness - [46]
events 8.2 episodes per vaccination.
or tingling),
100,000 doses.
light-headedness,
hypotension (low
blood pressure),
headache, pallor, or
syncope
pain in the injection
site, fatigue, body pain, SEs more frequent in
3236 reports out of
Sputnik V Observational study February–April 2021 headache, fever, joint - - females and younger [47]
13,435 HCW
pain, chilling, individuals.
drowsiness.
Vaccines 2022, 10, 488 11 of 25

Table 2. Cont.

Participant/ Concluding
Vaccine Name Methodology Date/Duration Minor Side Effects Major Side Effects Duration References
Area Remarks
Local site pain,
Sputnik V shows a
nodules, swelling,
2558 people from strong tolerance
warmth, asthenia,
Sputnik V E-questionnaire San Marino; aged 4 March–8 April 2021 - - profile in the [48]
headache, joint pain,
18-89 years population aged
muscle pain, chills,
≥60 years.
malaise, fever.
An observational
Injection site pain,
cohort study by the 707 HCWs in
redness, swelling.
Sputnik V Ministry of Health of Hospital Italiano de 5–20 January 2021 - - - [49]
Fever, diarrhea, muscle
Buenos Aires City Buenos Aires
pain.
(CABA)
Injection site pain,
fever, fatigue,
headache, insomnia,
LabelStudio data
December nausea, vomiting,
Sputnik V labeling tool to label 4579 entities - - - [50]
2020–April 2021 redness, pruritus,
the dataset
swelling, lymph nodes
enlargement, diarrhea,
chills.
Injection site pain, SEs are more
Cross-sectional The United Arab fatigue, headache, No serious cases of common in
Sinopharm January–April 2021 - [11]
survey Emirates lethargy, fatigue, hospitalization. ≤49 years of age and
tenderness. females.
Fever, muscle pain,
chills, arm pain,
breathlessness,
diarrhea, cough, flu,
Web-based ≥18 years of age
11 April–23 April fatigue, chest pain,
Sinopharm cross-sectional 2000 resident of - - - [51]
2021 headache, abdominal
survey. Karachi
pain, swelling in the
legs and arms,
multiple bruises,
productive bleeding.
155/400 Healthcare More SE in the
Pain at the injection
workers (HCWs) 24–42-year age
site, weariness,
Sinopharm Closed-ended >18 years old; No serious cases of group; Sinopharm
March 2021 headache, - [52]
COVID-19 questionnaire Khyber Teaching hospitalization. vaccine has no or
light-headedness,
Hospital, Peshawar, minor negative
myalgia.
Pakistan effects.
Vaccines 2022, 10, 488 12 of 25

Table 2. Cont.

Participant/ Concluding
Vaccine Name Methodology Date/Duration Minor Side Effects Major Side Effects Duration References
Area Remarks
Mild fever, myalgia,
Web-based
cold, cough, headache,
self-report
16 January–6 local pain, swelling,
Covishield submission or 5637 HCWs in India - - - [53]
February 2021 fatigue, diarrhea,
vaccine event
rigors, joint pain,
reporting system
nausea
fatigue, headache,
arthritis, sore throat,
nausea, fever, vertigo,
nasal flow, appetite
changes, diarrhea,
Sinovac Questionnaire 355 nurses in Turkey - - - - [54]
itchiness, abdominal
pain, cough,
changes in the mucosa,
changes in taste
sensation.
Few serious adverse
mRNA vaccines
Fever, dyspnea, flu-like effects such as
linked with higher
Different/Others Online poll 2002 February 2021 illness, weariness, local anaphylaxis, in viral - [33]
but milder incidence
reactions. vector-based
of any side effect.
immunizations.
Stroke (17), GBS (32), The rare occurrence
facial palsy (190), of tinnitus,
Dizziness, headaches,
9442 reports of transverse myelitis dysphonia,
discomfort, muscular
Different/Others VAERS adverse events in the March 2021 (9 cases), acute - convulsions, and [10]
spasms, myalgia,
United States disseminated herpes zoster
paresthesia.
encephalomyelitis recurrence was
(6 cases). reported.
Vaccines 2022, 10, 488 13 of 25

Table 3. Case studies with reported SEs of COVID-19 vaccinations.

Complication/Side
Vaccine Cases Patient Date/Duration References
Effects
Case I Acute zoster
16 days after the
(Pfizer 73-year-old female ophthalmicus (HZO) in
first dose
BioNTech) right V1 dermatome
mRNA-based
COVID-19 Case II
10 days after the HZO in left V1 [55]
immunization (Pfizer 69-year-old female
first dose dermatome
BioNTech)
Case II 13 days after the An eruption in the left V1
72-year-old female
(Moderna) first dose dermatome
Ocular adverse effects:
episcleritis, anterior
Inactivated 7 cases
30–55 year seven Within 15 days of scleritis, acute macular
COVID-19 (Sinopharm [56]
patients (3 males) first dose neuroretinopathy, acute
immunization COVID-19)
middle maculopathy,
subretinal fluid
mRNA-based One case 80-year-old female on Takotsubo
4 days after the
COVID-19 (Pfizer hemodialysis for two cardiomyopathy with LV [57]
first dose
immunization BioNTech) and half years outflow tract obstruction
mRNA-based One case
6 days after the Multiple cranial
COVID-19 (Pfizer 29-year- old male [58]
first dose neuropathy
immunization BioNTech)
Inactivated One case Anterior uveitis
5 days after
COVID-19 (Sinopharm 18-year-old female associated with juvenile [59]
second dose
immunization COVID-19) idiopathic arthritis (JIA)
Transverse myelitis is a
neurological disorder;
viral vector-based Two cases
unlikely to be related to
COVID-19 (AstraZeneca - - [10]
the vaccine as the patient
immunization vaccine)
already had multiple
sclerosis
Autoimmune side effect:
antineutrophil
mRNA-based One case
16 days after the cytoplasmic autoantibody
COVID-19 (Pfizer- 29-year-old female [60]
second dose (ANCA)-associated
immunization BioNTech)
vasculitis of acute kidney
injury
Case I Severe immune
53-year-old male
(Pfizer- 8 days after the thrombocytopenia (ITP);
with no previous
BioNTech COVID-19 second dose platelet count of
mRNA-based history
vaccine) 2 × 109 /L
COVID-19
immunization Case II 67-year-old male
(Pfizer- previous chronic ITP 2 days after the Severe ITP; platelet count [61]
BioNTech COVID-19 patient but no history first dose of 2 × 109 /L
vaccine) of recent flares of ITP
Viral vector-based 59-year-old female
Case III (Janssen 2 days after the Severe ITP; platelet count
COVID-19 with a history of
COVID-19 vaccine) first dose of 64 × 109 /L
immunization chronic ITP
One case Guillain-Barré syndrome
mRNA-based
(Pfizer- 2 weeks after the (GBS) with generalized
COVID-19 82-year-old female [62]
BioNTech COVID-19 first dose body aches, paresthesia,
immunization
vaccine) and difficulty walking
Vaccines 2022, 10, 488 14 of 25

Table 3. Cont.

Complication/Side
Vaccine Cases Patient Date/Duration References
Effects
Lympho-proliferative
Case I disease: left
(Pfizer- 15 days after first infra-clavicular
47-year-old female
BioNTech COVID-19 dose non-painful lump along
vaccine) with fatigue, myalgia,
and mild pyrexia to 38 ◦ C
mRNA-based
Left supraclavicular and
COVID-19 Case II
axillary painful multiple [63]
immunization (Pfizer-
46-year-old female 5 days after first dose enlarged lymph nodes,
BioNTech COVID-19
along with
vaccine)
headaches, chills.
Case III
(Pfizer- 18 days after the Left axillary lymph nodes
42-year-old female
BioNTech COVID-19 first dose up to 2 cm in diameter
vaccine)
Hypersensitivity reaction
Case I 64 -year-old female
Within 10 min of the with generalized pruritus,
(Moderna COVID-19 with a history of
first dose urticaria, and
mRNA-based vaccine) shellfish allergy
self-reported tachycardia
COVID-19
[64]
immunization Hypersensitivity reaction
Case II 39-year-old female
Within 15 min of the with chest and neck
(Moderna COVID-19 with history of
first dose urticarial and mild facial
vaccine) allergic rhinitis
angioedema
18-year-old female
with a history of
Inactivated One case antinuclear antibody Bilateral anterior uveitis
5 days after the
COVID-19 (Sinopharm positive with reduced visual [59]
second dose
immunization COVID-19) oligoarticular acuity in both eyes
juvenile idiopathic
arthritis (JIA)
Severe cutaneous adverse
reaction with
panhypopituitarism
Viral vector-based One case secondary to
COVID-19 (Janssen COVID-19 74-year-old male 3 days after the dose craniopharyngioma [65]
immunization vaccine) resection, vision loss of
the left eye, neurogenic
bladder, and obstructive
sleep apnea
Viral vector-based One case
41-year-old morbidly Within four weeks of Guillain-Barré syndrome
COVID-19 (Janssen COVID-19 [66]
obese gentleman dose (GBS)
immunization vaccine)
Idiopathic
thrombocytopenic
mRNA-based One case 1 day purpura with a rash,
COVID-19 (Moderna COVID-19 72-year-old female after receiving the spontaneous oral [67]
immunization vaccine) first dose bleeding, headache and
easy bruising or
abnormal bleeding.
Vaccines 2022, 10, 488 15 of 25

Table 3. Cont.

Complication/Side
Vaccine Cases Patient Date/Duration References
Effects
COVID arm: pruritic,
erythematous plaque
Case I
8 days after the with mild scaling on her
(Moderna COVID-19 74-year-old female
first dose left upper arm, rash
vaccine)
spread to 15 cm in
diameter over 10 days
COVID arm: Pruritic
Case II erythematous rash on her
8 days after the
(Moderna COVID-19 62-year-old female left deltoid, began as a
first dose
mRNA-based vaccine) maculopapular eruption [68]
COVID-19 over the injection site
immunization COVID arm:
Case III
7 days after the Erythematous, non-scaly
(Moderna COVID-19 54-year-old female
first dose patch on her left
vaccine)
upper arm
COVID arm:
Erythematous patch on
Case IV left deltoid surrounding
10 days after the
(Moderna COVID-19 72-year-old female the injection site, pruritic,
first dose
vaccine) warm to the touch, and
measured 14 cm in
diameter
77-year-old male Shingles (herpes zoster)
Case I
with a history of 2 days after the with severely painful,
(Moderna COVID-19
Psoriasis and Crohn’s first dose unilateral dermatomal
mRNA-based vaccine)
Disease herpetiform eruptions
COVID-19 [69]
immunization Shingles (herpes zoster)
Case II
with painful,
(Pfizer-
65-year-old male After second dose erythematous, clustered
BioNTech COVID-19
skin eruptions and
vaccine)
pruritus
Varicella-zoster virus
Case I
reactivation: herpetiform
(Pfizer-
58-year-old male 1 day after first dose umbilicated vesicle with
BioNTech COVID-19
fever and cervical
vaccine)
lymphadenopathy
Case II Varicella-zoster virus
(Pfizer- 5 days after the reactivation: herpetiform
47-year-old female
BioNTech COVID-19 first dose umbilicated vesicle with
vaccine) fever and dysesthesia
mRNA-based Case III Varicella-zoster virus
COVID-19 (Pfizer- 3 days after the reactivation: painful [70]
immunization 39-year-old male
BioNTech COVID-19 first dose Herpetiform umbilicated
vaccine) vesicles
Case IV Varicella-zoster virus
(Pfizer- 2 days after the reactivation: herpetiform
56-year-old female
BioNTech COVID-19 second dose umbilicated vesicle with
vaccine) fever and dysesthesia
Case V Varicella-zoster virus
(Pfizer- 16 days after the reactivation: herpetiform
41-year-old female
BioNTech COVID-19 second dose umbilicated vesicle with
vaccine) fever and dysesthesia
Vaccines 2022, 10, 488 16 of 25

Table 3. Cont.

Complication/Side
Vaccine Cases Patient Date/Duration References
Effects
Anti-neutrophil
Case I
2 weeks after cytoplasmic antibody
(Moderna COVID-19 52-year-old male
the dose (ANCA)
vaccine)
glomerulonephritis
mRNA-based
COVID-19 Case II Acute kidney injury (AKI) [71]
Immediately after
immunization (Moderna COVID-19 39-year-old male with nephritic syndrome,
second dose
vaccine) de novo vasculitis
Case III Mild after the first
AKI, proteinuria, de novo
(Moderna COVID-19 81-year-old male dose, worsened after
vasculitis
vaccine) the second dose
Encephalopathy
associated with
non-convulsive status
Case I
epilepticusat, poor
(Moderna COVID-19 86-year-old female 7 days after the dose
neurological function,
vaccine)
acute confusion, Visual
mRNA-based
hallucinations, Left
COVID-19 [72]
frontal headache
immunization
Encephalopathy
associated with
Case II
7 days after the non-convulsive status
(Moderna COVID-19 73-year-old male
first dose epilepticusat, staring
vaccine)
episodes, restlessness,
cognitive deficits.
64-year-old woman
Case I Acute immune
with chronic
(Pfizer- 2 days after the first thrombocytopenia with
idiopathic
BioNTech COVID-19 dose oral bleeding and
thrombocytopenic
vaccine) generalized petechiae.
purpura (ITP)
mRNA-based
COVID-19 Case II Acute immune
(Pfizer- 61-year-old woman thrombocytopenia with [73]
immunization After the second dose
BioNTech COVID-19 with scleroderma petechiae on both legs
vaccine) after.
Case III Acute immune
11 days after the
(Moderna COVID-19 73-year-old woman thrombocytopenia with
first dose
vaccine) generalized petechiae.
CNS demyelination: New
35-year-old neurologic symptoms
Caucasian woman, with ataxia/dysmetria in
Case I
stable history of Twenty-one days the right upper extremity,
(Moderna COVID-19
clinically isolated after the second dose and mild gait ataxia, with
vaccine)
demyelinating an Expanded Disability
syndrome (CIS), Status Scale (EDSS) score
of 2.5.
CNS demyelination: New
visual symptoms
26-year-old white
mRNA-based Case II involving the right eye,
Hispanic woman no Fourteen days after
COVID-19 (Moderna COVID-19 mild blurring, progressed [74]
significant past the second dose
immunization vaccine) to worsening blurriness
medical history
and pain with eye
movement OD.
CNS demyelination:
Presented with new onset
left eye vision changes;
Case III
visual symptoms in the
(Pfizer- 24-year-old One day after the
right eye with blurred
BioNTech COVID-19 Vietnamese woman second dose
vision and pain on eye
vaccine)
movement with
monocular decreased
visual acuity.
Vaccines 2022, 10, 488 17 of 25

Table 3. Cont.

Complication/Side
Vaccine Cases Patient Date/Duration References
Effects
CNS demyelination: Pain
and paresthesia in his
upper abdomen
progressed to right lower
Case IV 64-year-old
extremity numbness,
(Pfizer- Caucasian man with Eighteen days after
weakness, pain and
BioNTech COVID-19 no history of the first dose
numbness in the bilateral
vaccine) neurologic diseases,
lower extremities, saddle
anesthesia, sphincter
dysfunction, and
balance/gait difficulty.
CNS demyelination:
Unilateral painless
Case V 33-year-old blurring of vision with
(Pfizer- Caucasian man with One day after the visual acuity of 20/50 OS
BioNTech COVID-19 no significant past second dose and multiple T2
vaccine) medical history hyperintense white
matter lesions on brain
MRI.
CNS demyelination:
Transient low-grade fever
with new neurological
symptoms including
44-year-old
numbness that ascended
Case VI Caucasian woman
Six days after the from her feet to the
(Moderna COVID-19 with a medical
second dose middle of her waist
vaccine) history of MS at age
without any bowel or
20 when
bladder incontinence.
EDSS score of 1.5 with
mild right deltoid and
iliopsoas weakness.
CNS demyelination:
developed with a painful
48-year-old sensation behind her
Case VII Caucasian woman right eye, worsening with
(Pfizer- with a history of the 15 days after the eye movement; Brain
BioNTech COVID-19 Clinically isolated first dose MRI showed three new
vaccine) demyelinating T2 hyperintense white
syndrome (CIS) matter lesions compared
to prior imaging 2 years
earlier.
Acute asthma
exacerbation with
Inactivated
One case 1 day after multiple infiltrations in
COVID-19 A 76-year-old female [75]
(CoronaVac, Sinovac) vaccination both lungs and
immunization
ground-glass shadows in
both lung fields.
 Vaccines2022,
Vaccines 10,x488
2022,10, FOR PEER REVIEW 1818ofof25
25

Figure 2. Clinical cases for adverse effects after COVID-19 vaccinations.

Figure 2. Clinical cases for adverse effects after COVID-19 vaccinations.
5.1.2. Moderna (mRNA-1273) COVID-19 Vaccination
5.1.2. Moderna
The Moderna (mRNA-1273) COVID-19
vaccine, similar to theVaccination
Pfizer vaccine, received FDA approval in its
early clinical
The efficacy
Moderna trials similar
vaccine, [29,63]. toThe theSEs recorded
Pfizer for this
vaccine, vaccination
received are reasonably
FDA approval in its
similar
early to those
clinical reported
efficacy trials for otherThe
[29,63]. vaccines [63]. The
SEs recorded forminor SEs of Moderna
this vaccination has been
are reasonably
highlighted
similar to thosein reported
the five studies
for other listed in Table
vaccines [63].2.The
The mostSEs
minor reported SEs include
of Moderna has beeninjection
high-
site pain, headache, fatigue, muscle pain, malaise, chills, joint pain,
lighted in the five studies listed in Table 2. The most reported SEs include injection site mucosal lesions, oral
paresthesia, taste disturbance, pruritus, rash, itchy sensations in the
pain, headache, fatigue, muscle pain, malaise, chills, joint pain, mucosal lesions, oral par- mouth and throat,
sensations
esthesia, of disturbance,
taste throat closure, musclesrash,
pruritus, spasms,
itchyanorexia,
sensationsdecreased sleep and
in the mouth quality diarrhea,
throat, sen-
flushing,
sations of nasal
throatstiffness,
closure,and respiratory
muscles spasms, symptoms.
anorexia,Local injection
decreased sitequality
sleep reactions, such as
diarrhea,
urticarialnasal
flushing, eruptions and and
stiffness, morbilliform
respiratory eruptions,
symptoms. have also injection
Local been reported. While exploring
site reactions, such as
the data available in the form of clinical case reports in Table 3, a total
urticarial eruptions and morbilliform eruptions, have also been reported. While exploring of fifteen cases have
been reported thus far, which report complaints of clinical complications
the data available in the form of clinical case reports in Table 3, a total of fifteen cases have associated with
the Moderna vaccination. Among these, there are two cases of
been reported thus far, which report complaints of clinical complications associated with severe hypersensitivity
reactions
the Moderna with generalized
vaccination. pruritus,
Among urticaria,
these, there are tachycardia,
two cases chest, andhypersensitivity
of severe neck urticarial, and
re-
mild facial angioedema; two complications of herpes zoster ophthalmicus
actions with generalized pruritus, urticaria, tachycardia, chest, and neck urticarial, (HZO) reacti-
and
vation;
mild oneangioedema;
facial case of idiopathic thrombocytopenic
two complications purpura;
of herpes zosterfour cases of COVID
ophthalmicus (HZO) arm with
reacti-
erythematous plaques; three acute kidney complications with
vation; one case of idiopathic thrombocytopenic purpura; four cases of COVID arm with glomerulonephritis and
proteinuria; two cases of encephalopathy; and one case of acute immune thrombocytopenia
erythematous plaques; three acute kidney complications with glomerulonephritis and
with generalized petechiae.
proteinuria; two cases of encephalopathy; and one case of acute immune thrombocytope-
nia
5.2.with
Viralgeneralized
Vector-Basedpetechiae.
COVID-19 Immunization
TheVector-Based
5.2. Viral non-replicating adenoviruses
COVID-19 used in viral vector-based vaccines are safe for
Immunization
humans. This vaccine’s technique has been in use for decades. Two distinct adenoviruses
(AD16Theand
non-replicating adenoviruses
AD5) are employed, used
one in indose
each viralof
vector-based vaccines
vaccine, with are interval
a 21-day safe for hu-
[76].
mans. This vaccine’s technique has been in use for decades. Two distinct adenoviruses
Vaccines 2022, 10, 488 19 of 25

The prevalence of systemic SE was higher in the AZD-1222 vaccine than in the Sputnik V
and Covaxin vaccines [44].

5.2.1. AstraZeneca (ChAdOx1 nCoV-19) COVID-19 Vaccination

The AstraZeneca (ChAdOx1 nCoV-19) vaccine has shown good safety and efficacy
in phase 3 trials and reduces the chances of SARS-CoV-2 infection after about 12 days of
vaccination [34]. The AstraZeneca ChAdOx1 nCoV-19 (AZD1222) vaccine has been linked
to thrombosis with thrombocytopenia syndrome (TTS) in 3/100,000 people, with high
fatality rates reported in many countries. In Australia, the potential risks of the AZD1222
vaccine in younger adults who are unlikely to die from COVID-19 may outweigh the
benefits [77]. A selection of the minor SEs that have been highlighted in five studies on
the AstraZeneca vaccine is listed in Table 2. All five studies reported headache and myal-
gia/muscle/body pain; four studies reported weakness/fatigue, chills, nausea, diarrhea;
three studies reported local injection site/shoulder pain and fever; two studies reported
joint pain and tachycardia; and one study reported dry cough, shortness of breath, nasal
discharge, swollen armpit, bruising, rash, allergic reactions, red felts on face, skin, oral
mucosal lesions, and taste disturbances. The severe SEs reported in these studies were
severe hypotension, generalized body aches, shortness of breath, and fever with a temper-
ature greater than 39◦ C. One study presented two clinical cases of transverse myelitis, a
neurological disorder that might have been linked to the AstraZeneca vaccination.

5.2.2. Covishield (AZD1222)

Covishield is a COVID-19 vaccine developed in India. Covishield is currently in
use and has nearly 90% effectiveness. It was developed by Oxford–AstraZeneca and is
manufactured by the Serum Institute of India (SII) in Pune, Maharashtra. It employs the
same technology that was used to develop vaccines for viruses such as Ebola, a chimp
adenovirus, namely, ChAdOx1. This technology has been modified to carry the COVID-
19 spike protein into human cells. A web-based survey study reported the SEs of the
Covishield vaccine. The prominent SEs were mild fever (28.91%), myalgia (26.43%), cold
and cough (8.16%), headache (6.74%), and local injection site pain (3.37%). Less-prevalent
SEs included fatigue, diarrhea, rigors, joint pain, and nausea. Only 0.70% of recipients
claimed severe symptoms with admission and observation in clinical setups [53].

5.2.3. Janssen (Ad26.COV2.S) COVID-19 Vaccination

The Janssen vaccine is based on the genetic modification of inactivated adenoviruses
by the deletion of the E1 gene, which is replaced with the spike gene [78]. A VAERS-based
study reported 64 anxiety-related events, as elaborated in Table 2. Other SEs included
tachycardia, hyperventilation, dyspnea, chest pain, paresthesia, light-headedness, hypoten-
sion, headache, pallor or syncope, and fainting. Three clinical cases of severe immune
thrombocytopenia (ITP), severe cutaneous adverse reaction, and Guillain-Barré syndrome
(GBS) have been reported in its major complications, as shown in Table 3.

5.2.4. Sputnik V (Gam-COVID-Vac) COVID-19 Vaccination

Russia’s first authorized vaccination was developed and manufactured wholly in the
country, and its name alludes to the 1950s space race. To create the vaccine, the adenoviruses
are mixed with the SARS-CoV-2 spike protein, which causes the body to respond with an
immunological response [79]. Sputnik V was registered as Gam-COVID-Vac by the Russian
Ministry of Health in August 2020, and it has been delivered in 61 countries globally since
December 2020 [48]. A total of five studies have been added here; the SEs of Sputnik V
are reported in Table 2. All five studies reported injection site pain; three studies reported
fatigue, headache, swelling, and chills; four studies reported muscle or body pain and
fever; two studies reported joint pain nodules or lymph nodes, diarrhea, and redness; and
one study reported drowsiness, warmth, asthenia, malaise, insomnia, nausea, vomiting,
and pruritus.
Vaccines 2022, 10, 488 20 of 25

5.3. Inactivated COVID-19 Immunization

5.3.1. Covaxin Vaccine (BBV152)
India has produced a COVID-19 vaccine—namely, COVAXIN—that is an inactivated
vaccine produced by Whole-Virion Inactivated Vero Cell-derived platform technology. It
does not require reconstitution or sub-zero storage and comes in ready-to-use multi-dose
vials that are stable between 2 and 8 ◦ C. It cleared Phase I and II human clinical trials in
July 2020. Vaccine-induced antibodies, according to the National Institute of Virology, can
neutralize the UK variant strains as well as other heterologous strains. The effectiveness of
the Covaxin vaccine is nearly 81% [53]. Local injection site pain, fatigue, muscular pain,
and fever were described in a single investigation on the SEs of a Covaxin dose [44].

5.3.2. Sinovac
The most common local SE 54.6% was pain, while the most common systemic SEs
were fatigue 39.2% and headache 34.1%. Two-thirds of individuals who were vaccinated
reported at least one local or systemic SE, with women and people under the age of 35
being the most affected. Individuals who worked more than 8 h a day felt the vaccine’s
local adverse effects, such as increased hunger and weariness, more acutely [54]. A clinical
case for severe acute asthma exacerbation was reported as a possible adverse effect of the
Sinovac COVID-19 vaccination (Table 3).

5.3.3. Sinopharm (BBIBP-CorV/Vero Cells) COVID-19 Vaccination

The Sinopharm vaccine is a complete viral inactivated vaccine manufactured from
Vero cells. These cells replicate the SARS-CoV-2 virus, which is subsequently treated with
beta-propiolactone, which deactivates the virus by binding to its genes [28]. Sinopharm
post-vaccination SEs remain modest and predictable for the first and second doses, with no
cases of hospitalization, which help to reduce vaccine hesitancy [51,80]. Sinopharm vaccine
recipients had a longer duration of adverse effects. The majority of these adverse effects
are minor and curable [35]. A total of six studies have been documented here for SEs of
Sinopharm in Table 2. All six studies reported headache; five studies reported fatigue; three
studies reported injection site pain, body, or muscle pain; five studies reported headache;
four studies reported fever; two studies reported myalgia, cough, flu, or nasal discharge,
shortness of breath, abdominal pain, and diarrhea; one study reported lightheadedness,
weariness, multiple bruises with productive bleeding; swelling in the legs and arms;
chest pain, chills, arm pain, tenderness, lethargy, shivering, and rigors; malaise, myalgia,
arthralgia, joint pain, sore throat, nausea, anxiety, and dizziness. Seven clinical cases of
ocular adverse effects (episcleritis, anterior scleritis, acute macular neuroretinopathy, acute
middle maculopathy, subretinal fluid); one case for anterior uveitis associated with juvenile
idiopathic arthritis (JIA); and one case for bilateral anterior uveitis with reduced visual
acuity in both eyes has been documented in the literature, as shown in Table 3.

6. COVID-19 Vaccinations’ Reported Minor Side Effects

As elaborated in Table 1, the most-prevalent minor SE reported after COVID-19
vaccinations were localized reactions in the form of local injection site reactions, injec-
tion site/shoulder pain swelling, and soreness surrounding the area, whereas the most-
prevalent generalized SEs were headache, fever, sweating, chills, tiredness, and fatigue.
There were minor SEs in the nose, throat, and oral cavity, including throat infection or
irritations, breath tightness, nasal stuffiness, flu-like symptoms, sensations of throat closure,
oral mucosal lesions, paresthesia, and taste disturbance. The minor SEs of musculoskeletal
symptoms included joint pain, muscular spasm, whole-body aches/myalgia, osteoarticular
pain, back pain, and neck pain. The SEs of skin included skin rashes or allergic responses
of urticarial eruptions, morbilliform eruptions, and pruritus. The minor SEs of the gastroin-
testinal system included nausea, vomiting, and diarrhea, while other SEs reported include
fast heartbeat, dizziness, flushing, palpitations, brain fogging, mental confusion, anorexia,
decreased sleep quality, drowsiness, hand numbness, enlarged lymph nodes, etc.
Vaccines 2022, 10, 488 21 of 25

7. COVID-19 Vaccinations’ Reported Major Side Effects

The adverse or major-severity SEs in Tables 1 and 2 reported from COVID-19 vac-
cinations on skin included zoster or herpes simplex flares such as varicella-zoster virus
reactivation, chilblains, cosmetic filler reactions, and pityriasis rosea. The major SEs of the
cardiovascular system (CVS) reported in studies include thromboembolic events such as
thrombosis, cerebrovascular accidents, myocardial infarction, takotsubo cardiomyopathy,
and pulmonary embolism. The major SEs of the central nervous system (CNS) included
CNS demyelination, multiple sclerosis, syncope, transverse myelitis, encephalopathy,
stroke, and acute disseminated encephalomyelitis. The major SEs of musculoskeletal
system included Guillain-Barré syndrome, Bell’s palsy and facial palsy. Ocular adverse
effects included episcleritis, anterior scleritis, acute macular neuroretinopathy, acute mid-
dle maculopathy, subretinal fluid, and anterior uveitis associated with juvenile idiopathic
arthritis (JIA). Severe immune system disturbances and autoimmune side effects were also
observed, such as antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis
of acute kidney injury, severe immune thrombocytopenia, lympho-proliferative disease,
hypersensitivity reaction, and severe cutaneous adverse reaction with panhypopituitarism
secondary to craniopharyngioma resection. Furthermore, among adverse reactions, COVID
arm with pruritic, erythematous plaques were reported. However, the link between the
mildness and severity of SEs, along with the mechanism involved and other risk factor
associations, is still under debate and requires proper investigative studies.

8. Conclusions
Twenty-seven studies on SEs and twenty-four case reports reporting fifty-six various
clinical adverse effects of various COVID-19 vaccines have been overviewed in this study.
Conclusive outcomes for local and systemic SEs revealed that the mRNA-based vaccines
were more likely to be linked with localized adverse effects (e.g., injection site discomfort),
while viral vector-based vaccines were found to be more common in imparting systemic
SEs (e.g., headache/fatigue). Individuals who received Pfizer and AstraZeneca vaccines
exhibited higher overall local site reactions when compared to those who received the
Sinopharm vaccine. Regarding the SE severity, persistency, and duration, the AstraZeneca
vaccine was found to have more persistent and severe SEs compared to other vaccines
such as Pfizer; additionally, Pfizer’s SEs were dominant in comparison to the Sinopharm
vaccine. Overall, the vaccinations from Pfizer, AstraZeneca, and Sinopharm were judged to
be safe, with Sinopharm having a lower number of adverse effects than the other vaccines.
Pfizer was associated with greater rates, while Sinopharm was associated with longer-
duration SEs. On the other hand, the outcomes for age and gender revealed that females
and youngsters, particularly individuals ≤ 43 years old, were found to be linked with a
higher risk of adverse effects by both mRNA-based and viral vector-based immunizations.
Sputnik V and Covaxin reported fewer SEs and better tolerance levels in the elderly.
Injection site pain, fatigue, headache, muscle or body pains, and fever were the most
reported SEs. Certain adverse effects, such as cutaneous reactions, herpes reactivation,
ocular adverse effects, Bell’s palsy, lymph nodes, anaphylaxis, thrombosis, myocardial
infarction, cardiomyopathy, severe hypotension, multiple sclerosis relapse, syncope, stroke,
GBS, facial palsy, myelitis, autoimmune SEs, acute disseminated encephalomyelitis, and
multiple cranial neuropathies, were also reported in these studies. Overall, studies found
that all immunizations were safe, with very few or no SEs; however, the form of SEs was
shown to be more persistent in DNA- and mRNA-based vaccines, whereas inactivated viral
vaccines were associated with longer-duration SEs. Overall, SEs were shown to be more
prevalent in women and youngsters. Certain instances of adverse responses have also been
observed, although their pathological relationship with COVID-19 immunization has yet
to be determined.
Vaccines 2022, 10, 488 22 of 25

Author Contributions: Conceptualization, R.R. and R.M.A.; reviewed and refined tables and figures,
W.A.; R.M.A., M.S.R.R., A.H., M.I. and A.R.K.; writing—original draft preparation, R.R. and W.A.;
writing—review and editing, M.I., M.R.K., M.S.R.R., A.R.K. and R.M.A.; supervision, R.M.A. All
authors have read and agreed to the published version of the manuscript.
Funding: This study received no external funding.
Data Availability Statement: Not applicable.
Acknowledgments: The authors are grateful to University of Agriculture, Faisalabad, Pakistan, for
their support.
Conflicts of Interest: The authors declare no conflict of interest.

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