key: cord-0958426-6jh2x8e4
authors: Drucker, Abigail; Corrao, Kellianne; Gandy, Mallory
title: Vulvar Aphthous Ulcer Following Pfizer-BioNTech COVID-19 Vaccine – A Case Report
date: 2021-10-28
journal: J Pediatr Adolesc Gynecol
DOI: 10.1016/j.jpag.2021.10.007
sha: dac45d37a279cecc52c54504a41d76871f6e69dd
doc_id: 958426
cord_uid: 6jh2x8e4

Background- In this case report, we describe a potential association between the Pfizer-BioNTech COVID-19 vaccine and development of a vulvar aphthous ulcer in a virginal 14-year-old girl. Case- A 14-year-old patient reported vulvar pain and visible lesion. Exam findings were consistent with vulvar aphthous ulcers. Two days prior to the onset of her symptoms she received her second Pfizer-BioNTech COVID-19 vaccine. The evening of vaccine administration, she experienced several hours duration of fatigue, muscle aching and insomnia but had otherwise been recently healthy and testing for common viral associations of vulvar ulcers was negative. Summary and conclusion- Vaccination, in general, has been associated with mucosal side-effects and oral ulceration has been reported in subjects who received Pfizer-BioNTech COVID-19 vaccine. It is reasonable to hypothesize that vulvar ulceration may be caused by a similar mechanism and should be considered a rare side effect of this vaccine.

Vaccination against SARS-CoV-2 is a vital tool for ending the current pandemic. With the advent of novel vaccines and wide-spread administration, information on efficacy and side-effect profiles continues to grow. Additionally, the circulation of misinformation about vaccine safety, particularly gynecologic side-effects, appears to be growing in parallel. Patients who are concerned about the possible side-effects of a novel vaccine may be unwilling to take it. It is imperative that the medical community reports all manifestations of possible side-effects from the vaccines. Though it is unclear if side-effect reporting will increase vaccine uptake, explanation of side-effects may be useful to assure the public they are understandable, rare and self-limited.

Case-A 14-year-old girl with no history of prior sexual activity complained of new-onset burning pain at the vaginal introitus. Upon onset of pain, her mother helped to examine the patient at home and noted three distinct lesions with yellow covering and surrounding erythema. Over the course of the next three days, the patient's symptoms worsened so that she reported not being able to sit down or walk without exquisite pain. Appointment was made in the gynecology clinic for consultation and, upon exam, she was noted to have three shallow-based ulcerations on the inferior, medial edges of the labia minora. The ulcers were purple-pink in color with sloughing yellow roof at the core and surrounding edema. The largest lesion, on the right side, was noted to be approximately 12mm in maximum diameter. No vesicles and no other vulvar or perianal skin changes were noted. Oral and pharyngeal exams were normal. No cervical or inguinal lymphadenopathy was noted. The patient did not have a known history of SARS-CoV-2 viral infection.

Two days prior to onset of vulvar pain symptoms, she had received her second dose of the Pfizer-BioNTech COVID-19 vaccine. While she did not experience any side-effects following her first vaccination, her mother indicated that, approximately twelve hours after the second vaccination, the patient experienced transient but severe symptoms of fatigue, body aches and insomnia, such that her mother sat up with her in bed all night. By the next morning, her symptoms had resolved and she went to school feeling well. She reported no known sickcontacts and, other than her symptoms following vaccination, had been well, with no complaints of recent fever or upper respiratory tract infection. Her medical history was significant for heavy menstrual bleeding and Type I von Willebrand disease for which she used extended cycle combination oral contraceptives. She did not have a personal or family history to suggest inflammatory bowel disease or auto-immune disease. She had no history of prior vulvar lesions nor oral ulceration. Results of a complete blood count were within normal parameters. There were no vesicles or fluid for direct viral HSV testing but type-specific serum antibody testing was done and negative. Given proximity in time to her second Pfizer-BioNTech COVID-19 vaccine, testing for active SARS-CoV-2 infection was done and negative. Serum Epstein-Barr antibody titers were obtained and negative. She was additionally found to be CMV antibody negative.

Based on her clinical presentation, she was diagnosed with vulvar aphthous ulcers. She was advised on skin care, sitz baths and prescribed topical lidocaine for pain control. She seemed to follow the natural history of aphthous ulcer course and, upon follow up via phone call ten days infection. An inflammatory response due to cytokine activation from systemic illness is the proposed mechanism of ulcer formation. 3 Reactions to vaccines are not uncommon with most being local responses such as pain, swelling, and erythema to the injection site. Systemic reactions including fever and rash occur less frequently and serious reactions such as anaphylaxis are rare, occurring at a rate of one per one million doses of vaccines. 4 Mucosal changes following vaccinations have been documented in the medical literature.

Bleeding gums, oral sores and ulcers have been reported following vaccines including diphtheria, tetanus, acelluar pertussis, and polio. 5 Lichen planus, a chronic inflammatory mucocutaneous disease that can affect oral and genital mucosa has been linked to the Hepatitis B vaccine. It is thought this mucosal change is caused by a T-cell mediated reaction to an induced antigenic change. 6 Though oral mucosal changes have been documented following vaccinations, our literature search did not identify any studies examining vulvar mucosal reactions, specifically, following vaccine administration.

As the Pfizer-BioNTech COVID-19 vaccine is a novel vaccine, studies assessing possible sideeffects are ongoing. Current data suggest the side-effect profile of this novel vaccine is similar to other vaccines and may include local and systemic reactions such as pain at the injection site, fatigue, fever, headache, and muscle pain. Reactions seem to be more common following the second dose. 7 A large, cross-sectional study of health care workers in the Czech Republic who received the Pfizer-BioNTech COVID-19 vaccine indicated that 13% of participants reported having at least one oral side effect following vaccination, blistering and ulceration being two of the most common complaints. 8 The acute appearance of painful genital ulcers, especially in young adolescents, may be a traumatic experience and efforts should be made to educate patients and families about possible etiologies. Several cases of aphthous ulceration have, thus far, been reported in conjunction with SARS-Co-V-2 infection. Mucosal ulceration is an established side effect of some vaccines and has been identified in cohorts receiving the Pfizer-BioNTech COVID-19 vaccine 8 . We believe this case demonstrates a possible novel association between the Pfizer vaccine and development of a vulvar aphthous ulcer in an adolescent patient. Concern for side effects, particularly gynecologic, is a topic that is currently circulating widely and is likely limiting community vaccination rates. It is important to identify and explain possible side-effects to help dispel hesitancy some patients may feel about receiving a novel vaccine. The formation of self-limited vulvar aphthous ulcers should be considered a rare but not unexplained, self-limited side-effect of the Pfizer-BioNTech COVID-19 vaccine.

certify that we have no conflicts of interest. References: 1. Deitch H, Huppert J, Adams Hillard P: Unusual vulvar ulcerations in young adolescent females

Acute genital ulcers in nonsexually active young girls: Case series, review of the literature, and evaluation and management recommendations

Vulvar aphthous ulcer in an adolescent with covid-19

Risk of anaphylaxis after vaccination of children and adolescents

Update: Vaccine side effects, adverse reactions, contraindications, and precautions: recommendations of the Advisory Committee on Immunization Practices (ACIP)

Hepatitis B vaccination and associated oral manifestations: a non-systematic review of literature and case reports

Prevalence of COVID-19 vaccine side effects among healthcare workers in the Czech Republic