Hospital Pharmacy - February 2018 - 15

739727
research-article2017

HPXXXX10.1177/0018578717739727Hospital PharmacyMancano

ISMP Adverse Drug Reactions
Hospital Pharmacy
2018, Vol. 53(1) 15-17
© The Author(s) 2017
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https://doi.org/10.1177/0018578717739727
DOI: 10.1177/0018578717739727
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ISMP Adverse Drug Reactions:

Influenza Vaccine-Induced Stevens-Johnson Syndrome
Vilazodone-Induced Nightmares
Dabigatran-Induced Pustular Eruptions
Neurotoxic and Cardiotoxic Symptoms After Cannabis Concentrate Exposure
Rosuvastatin-Induced Skin Eruption
Michael A. Mancano1
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our
readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail:
mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided
by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

Influenza Vaccine-Induced
Stevens-Johnson Syndrome
A 75-year-old male in Japan reported erythematous papules
2 days after receiving his 2015 influenza injection. He
reported he has received seasonal influenza vaccine every
year since 2014. After receiving his 2016 influenza injection,
he noticed erythema on his trunk and extremities 1 day after
administration. Two days later, he developed lesions of the
eye and oral mucosa. A medication history revealed that the
patient does not receive any other medications, and an allergy
history revealed the patient is not allergic to eggs. The patient
had a low-grade fever of 37.7°C (99.9°F), and a skin biopsy
of the lesions on his trunk revealed dyskeratotic keratinocytes in the epidermis and lymphocytic infiltration in the epidermis and dermis. Eosinophils also infiltrated the dermis.
On physical exam, the patient had a positive Nikolsky sign.
Nikolsky sign is present when slight rubbing of the skin
results in exfoliation of the outermost layer. A typical example would be to place the eraser of a pencil on the roof of a
lesion and spin the pencil in a rolling motion between the
thumb and forefinger. If the lesion is opened (ie, skin
sloughed off), then the Nikolsky sign is present/positive.
Nikolsky sign is almost always present in Stevens-Johnson
Syndrome/toxic epidermal necrolysis.
Detailed laboratory analysis ruled out herpes simplex
virus, Epstein-Barr virus, and mycoplasma as possible infectious causes of the patient's condition. Stevens-Johnson syndrome was suspected due to the patient's influenza vaccination
as he was not exposed to any other medications. He was

prescribed prednisone 30 mg daily, and the eruption resolved
completely after 1 month of treatment.
The authors could not obtain the patient's consent for skin
patch testing to confirm the allergy using influenza vaccine.
However, he was able to perform patch testing using the additives in the vaccine, which included formalin and thimerosal.
Results of the patch testing with these agents were negative.
Therefore, the authors hypothesized that the patient developed
Stevens-Johnson Syndrome due to the influenza vaccine itself.
Since the patient first developed the skin eruption after the
2015 seasonal influenza vaccine injection, a common antigen
in the 2014 and 2015 seasonal influenza vaccine could have
been the causative agent. The authors speculated that a causative agent might have been A/California/7/2009(X-179A)
(H1N1)pdm09, which was a common antigen in seasonal
influenza vaccine from 2014 to 2016.
In closing, the authors state, "Clinicians should bear in
mind that not only the vaccine but also additives can cause
vaccine-related drug eruption. Because influenza vaccine-
induced cutaneous adverse events are relatively rare, further
investigation is necessary to clarify their pathogenesis."1

Department of Pharmacy Practice, School of Pharmacy, Temple
University, Philadelphia, PA, USA
Corresponding Author:
Michael A. Mancano, Chair and Clinical Professor, Department of
Pharmacy Practice, School of Pharmacy, Temple University, Philadelphia,
PA 19019, USA.
Email: michael.mancano@temple.edu

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