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\begin{document}

\title{Toxic epidermal necrosis following Sinopharm COVID-19 vaccine
(BBIBP-CorV): A case report and literature review}



\author[1]{Safoura Shakoei}%
\author[1]{Alireza hadizadeh}%
\affil[1]{Tehran University of Medical Sciences}%


\vspace{-1em}



  
  \date{June 03, 2024}


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\selectlanguage{english}
\begin{abstract}
This study reports a patient developing TEN after the first dose of
(BBIBP-CorV). He developed numerous purpuric and dusky patches with
flaccid bullae and areas of epidermal detachment covered more than 30\%
of the body area within 6 days. After treatment with dexamethasone and
cyclosporin, he recovered within 14 days.%
\end{abstract}%



\sloppy


\textbf{Introduction}

In 2019 the novel coronavirus started a pandemic and ever since millions
have been affected in the respiratory system and other organs like the
skin. Ever since the first vaccines got authorized for use, many people
have become immune to severe forms of infection and many lives have been
saved {[}1{]}. However, complications and side effects of the vaccines
were also reported {[}2{]}. Even though cutaneous reaction to vaccines
is not a novel concept and many reactions are known to have happened,
some reactions are more severe and require intensive care. COVID-19
Vaccine-induced TEN is a rare incidence on its own and only a few cases
have been reported {[}3{]}.

Toxic epidermal necrolysis is an idiosyncratic drug reaction that is
associated with high mortality and morbidity rates {[}4 5{]}. This
spectrum of diseases is heralded by an acute fever which is followed by
a generalized dusky rash, crusting, extensive erosion, conjunctivitis,
necrolysis of the epidermis, mucositis, In both the pulmonary and
gastrointestinal tract {[}5{]} {[}6{]}. It is estimated that the
mortality of TEN is around 30\%. Several drugs such as sulfonamides,
anti-convulsive medications, and even influenza vaccines are known to be
chiefly associated with this reaction; however, vaccines are among the
least associated causes {[}5{]} {[}7{]}.

In this article, we report a case of TEN following the administration of
the Sinopharm COVID-19 vaccine. TEN is an important entity even though
it has rarely been reported with COVID-19 vaccines. The current report
will also provide a brief review of the literature concerning the
reported TEN/SJS cases that are induced by a COVID-19 vaccine.

\textbf{Case presentation}

Our patient is a 67-year-old man with a history of hypertension who
presented to our clinic with a history of fever and cutaneous eruptions.

He had received the first dose of Sinopharm COVID-19 vaccine
(BBIBP-CorV) with a dose of 0.5 mL given intramuscularly six days before
the development of his lesions. His manifestations started with fever
and erythema patches on his back followed by bullous lesions on the
lower extremities. He was seen in another health care center and was
given acetaminophen, cetirizine, and vitamines and did not notice any
improvement. Seven days after vaccination, lesions developed on his
body, and the genital mucosa was involved.

He had no history of taking any new medication in the past one month
before the development of the skin lesions and he had a history of
COVID-19 infection 3 months ago.

On physical examination, all mucosal surfaces were involved. Bilateral
conjunctivitis with purulent and oral and genital ulceration and
hemorrhagic crusting over his lips.

He had numerous purpuric and dusky patches involving the back, chest,
abdomen, both extremities, and face, with flaccid bullae and areas of
epidermal detachment. He had positive Nikolsky's sign. His body surface
area (BSA) involvement is estimated to be more than 30\%. Laboratory
findings showed elevated D-dimer {[}2626{]}, erythrocyte sedimentation
rate~(ESR){[}64 mm/h{]}, C-reactive protein (CRP)levels {[}70 mg/l{]}.
(Figure 1)

The Severity-of-Illness Score for Toxic Epidermal Necrolysis (SCORTEN)
score was two on the day of her admission since she was older than 40
and detached body surface more than 10\%. Viral markers and COVID-19 (
polymerase chain reaction) PCR was negative. He has been treated with
dexamethasone 4 mg twice daily and cyclosporine 200 mg daily for 6 days.
His lesions stopped developing after four days, and complete healing was
noted after 14 days.

Ophthalmic antibiotics and corticosteroids eye drop was used for
conjunctivitis treatment. On the other hand, elevated D-Dimer levels
prompted the clinicians to evaluate and rule out Deep vein thrombosis
(DVT) and pulmonary thromboembolism (PTE). No signs of DVT were found in
ultrasonographic evaluations of lower limbs, PTE was also ruled out as
ventilation and perfusion scan was carried out. The patient is currently
under observation and the lesions have been completely cured.

(Figure 1)

\textbf{Discussion}

This study reports a case who suffered from toxic epidermal necrolysis
following COVID-19 vaccination with Sinopharm COVID-19 vaccine
(BBIBP-CorV). It is highly suspected that the offending agent is the
vaccine since other causes such as medications couldn't cause this
phenomenon in the aforementioned timetable.

SJS/TEN is a spectrum of delayed hypersensitivity skin reactions that
are potentially fatal. The most prominent cause for these reactions is
medications and drugs such as sulfonamides and antiepileptics such as
lamotrigine. Infectious diseases such as mycoplasma pneumonia and HIV
infections are also known to have caused this reaction. Vaccine-related
TEN/SJS is a relatively rare concept and even though multiple cases of
MMR, DTP, and influenza vaccine-induced TEN/SJS have been reported, the
relation between the vaccines and TEN/SJS has not been established
{[}7{]}.TEN/SJS usually starts the presentation with flu-like symptoms
which are consecutively followed by a dusky rash, crusting, targetoid
lesions, purpuric macules with full-thickness epidermal necrosis, and
extensive erosion. This spectrum of reaction can involve mucus membranes
which could impair oral intake. It has been suggested by several studies
that a hypersensitivity reaction with cytotoxic T cells which is
mediated by CD8+ lymphocytes could be the cause. It has been suggested
that the cytotoxic T cells cause the damage by releasing enzymes such as
granulysin and perforin {[}5{]}.

COVID-19 vaccines are designed to combat the infection via different
methods. Some such as the AstraZeneca vaccine uses vectors while the
Pfizer vaccine uses mRNAs to introduce spike proteins to immune cells.
In this case, the Sinopharm vaccine is an inactivated virus vaccine
{[}1{]}. Up to now, COVID-19 vaccine-related SJS and TEN have also been
reported (Table 1). The majority of cases are women with 6 cases.
Reactions occurred after both the first dose and second (6 and 3 cases),
respectively (in one case it was not defined as to whether the first or
the second dose was responsible for the reaction). The mean age of
patients was 56.5 (sd:13.23) years old. Meanwhile, the time to the onset
of the presentation ranged from 6 hours to two weeks but most of them
happened within 4.32 (SD:4.05) days. The reaction resolved on average in
21.3 (SD:14.14) days.

COVID-19 vaccinations are widely used and are proved to protect against
severe infection and such instances are considered rare complications.
However, reporting these severe side effects should not prevent the
vaccine from being injected, and the fact that should be mentioned is
doctors and health care providers should be vigilant to such adverse
outcomes and must provide immediate care.

(Table 1)

\textbf{Key clinical message}

COVID-19 vaccinations are safe and effective methods for prevention of
infection albeit with few instances of complication. The patients who
develop TEN/SJS following vaccination which might have led to mortality
if they were misdiagnosed.

\textbf{Declarations}

\textbf{Ethics approval and consent to participate}

This study was approved by the research and ethics committee of Tehran
University of Medical Sciences. The patients and their families have
given their informed consent to publish this case.

\textbf{Consent for publication}

Written informed consent was obtained from the patients and their next
of kin for publication of this case series and any accompanying images.
A copy of the written consent is available

\textbf{Availability of data and materials}

Data sharing is not applicable to this article as no datasets were
generated or analyzed during the current study.

\textbf{Competing interests}

The authors have no conflict of interest to declare.

\textbf{Funding}

None

\textbf{References:}

1. Xia S, Duan K, Zhang Y, et al. Effect of an inactivated vaccine
against SARS-CoV-2 on safety and immunogenicity outcomes: interim
analysis of 2 randomized clinical trials. Jama 2020;\textbf{324}
(10):951-60

2. Saeed BQ, Al-Shahrabi R, Alhaj SS, Alkokhardi ZM, Adrees AO. Side
effects and perceptions following Sinopharm COVID-19 vaccination.
International Journal of Infectious Diseases 2021;\textbf{111} :219-26

3. Riad A, Hockov\selectlanguage{ngerman}á B, Kantorová L, et al. Side Effects of mRNA-Based
COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in
Slovakia. Pharmaceuticals 2021;\textbf{14} (9):873

4. \selectlanguage{polish}Ł\selectlanguage{english}oboda J, Dudzik A, Chomyszyn-Gajewska M. Stevens-Johnson Syndrom and
Toxic Epidermal Necrolysis--based on literature. Przeglad lekarski
2015;\textbf{72} (1):35-37

5. Schwartz RA, McDonough PH, Lee BW. Toxic epidermal necrolysis: Part
II. Prognosis, sequelae, diagnosis, differential diagnosis, prevention,
and treatment. Journal of the American Academy of Dermatology
2013;\textbf{69} (2):187. e1-87. e16

6. Fernando SL. The management of toxic epidermal necrolysis.
Australasian journal of dermatology 2012;\textbf{53} (3):165-71

7. Grazina I, Mannocci A, Meggiolaro A, La Torre G. Is there an
association between Stevens-Johnson syndrome and vaccination? A
systematic review. Ann. Ig 2020;\textbf{32} :81-96

8. Mansouri P, Chalangari R, Martits-Chalangari K, Mozafari N.
Stevens-Johnson Syndrome due to COVID-19 vaccination. Clinical Case
Reports 2021;\textbf{9} (11):e05099

9. Elboraey MO, Essa EESF. Stevens-Johnson syndrome post second dose of
Pfizer COVID-19 vaccine: a case report. Oral surgery, oral medicine,
oral pathology and oral radiology 2021;\textbf{132} (4):e139-e42

10. Boualila L, Mrini B, Tagmouti A, El Moubarik N, Boutimzine N,
Cherkaoui L. Sinopharm COVID-19 vaccine-induced Stevens-Johnson
syndrome. Journal Francais D'ophtalmologie 2022

11. Dash S, Sirka C, Mishra S, Viswan P. COVID-19 vaccine-induced
Stevens--Johnson syndrome. Clinical and Experimental Dermatology
2021;\textbf{46} (8):1615-17

12. Bakir M, Almeshal H, Alturki R, Obaid S, Almazroo A. Toxic Epidermal
Necrolysis Post COVID-19 Vaccination-First Reported Case. Cureus
2021;\textbf{13} (8)

13. Kherlopian A, Zhao C, Ge L, Forward E, Fischer G. A case of toxic
epidermal necrolysis after ChAdOx1 nCov-19 (AZD1222) vaccination. The
Australasian Journal of Dermatology 2021

14. Mardani M, Mardani S, Asadi-Kani Z, Hakamifard A. An Extremely Rare
Mucocutaneous Adverse Reaction Following COVID-19 Vaccination: Toxic
Epidermal Necrolysis. Dermatologic Therapy 2022:e15416

15. Aimo C, Mariotti E, Corr\selectlanguage{ngerman}à A, et al. Stevens\selectlanguage{english}-Johnson syndrome induced
by Vaxvetria (AZD1222) COVID\selectlanguage{english}-19 vaccine. Journal of the European Academy
of Dermatology and Venereology 2022

16. Mansouri P, Farshi S. A case of Steven\selectlanguage{english}-Johnson syndrome after
COVID\selectlanguage{english}-19 vaccination. Journal of cosmetic dermatology 2022

\textbf{Table 1. Cases of COVID-19 vaccine-induced TEN/SJS}\selectlanguage{english}
\begin{longtable}[]{@{}lllllllll@{}}
\toprule
\begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{author}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{country}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{Vaccine}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{Age}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{sex}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{onset}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{First or second dose}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{resolution of lesions}\strut
\end{minipage} & \begin{minipage}[b]{0.08\columnwidth}\raggedright\strut
\textbf{treatment}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
P. mansouri{[}8{]}\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Iran\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Sinopharm\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
49\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
woman\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
3 d\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
second dose\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
2 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Fexofenadine Topical violet gentian\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
M. Elboraey{[}9{]}\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Saudi Arabia\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Pfizer\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Middle-aged\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
woman\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
5 d\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
first dose\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
2 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
prednisolone (30 mg/d), Oral corticosteroids in the form of a
mouthwash.\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
L. Boualila{[}10{]}\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
morocco\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Sinopharm\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
32\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
man\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
6 hours\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
second dose\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
30 days\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
eye drops and ointment, oral doxycycline.\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
S. Dash{[}11{]}\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
India\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
AstraZeneca\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
49\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
woman\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
3 d\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
First dose\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
7 days\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Cyclosporine 300 mg\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
M. Bakir{[}12{]}\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Iran\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Pfizer\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
60\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
woman\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
7 d\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
First dose\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
22 days\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Etanercept 50 mg/ml, 2 doses on the first and second day of admission
marked healing in 22 days\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
A. Kherlopian {[}13{]}\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Australia\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
AstraZeneca\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
48\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Woman\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
14 d\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
First dose\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
28 days\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
adalimumab\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
M. Mardani {[}14{]}\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Iran\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
Sinopharm\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
76\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
man\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
1 d\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
First dose\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
2 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.11\columnwidth}\raggedright\strut
prednisolone and prepared mouthwash.\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
C. Aimo {[}15{]}\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Italy\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
AstraZeneca\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
65\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Man\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
3 d\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Second dose\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
8 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
prednisolone 1mg/Kg/day\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
P. Mansouri {[}16{]}\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Iran\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Sinopharm\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
63\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Woman\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
1 d\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
N/A\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
2 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Oral prednisolone (40mg) daily\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
s.shakoei\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Iran\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Sinopharm\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
67\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
man\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
6 d\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
First dose\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
2 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.08\columnwidth}\raggedright\strut
Dexamethasone, Cyclosporine\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

Figure 1. 1a: Bilateral conjunctivitis with purulent secretion, and 1b:
oral lesions and hemorrhagic crusting over his lips. 1c: Numerous
purpuric and dusky patches involving the chest, abdomen, both
extremities, and face, with flaccid bullae and areas of epidermal
detachment.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/unnamed/unnamed}

\end{center}
\end{figure}

\selectlanguage{english}
\FloatBarrier
\end{document}

