Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Behcet's syndrome, Investigation, Mouth ulceration, Oropharyngeal pain, Pharyngeal ulceration
Clinical narrative: Behcet's disease; symptoms progressed to ulcerations in oral/throat/vaginal area; symptoms progressed to ulcerations in oral/throat/vaginal area; symptoms progressed to ulcerations in oral/throat/vaginal area; sore throat and tongue lesions/ symptoms reoccur with additional vaginal pain/burning; sore throat and tongue lesions/ symptoms reoccur with additional vaginal pain/burning; sore throat and tongue lesions/ symptoms reoccur with additional vaginal pain/burning; vaginal pain/burning; vaginal pain/burning; This is a spontaneous report received from a contactable reporter [other healthcare professional (HCP)] via company.  A 39 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm left, administration date 24Nov2021 (Lot number: 32030BD) at the age of 39 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "diagnosed with COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient had no known allergies (NKDA). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (dose 1, single, Lot number: 301358A, administration route and location: intramuscular, left arm), administration date: 07Oct2021, when the patient was 39 years old, for COVID-19 immunization, reactions: "sore throat" and "tongue lesions." Since the vaccination, the patient had been tested for COVID-19 with COVID-19 test result of negative post vaccination on an unspecified date. The following information was reported: BEHCET'S SYNDROME (hospitalization, medically significant), outcome "unknown," described as "Behcet's disease;" OROPHARYNGEAL PAIN (hospitalization), TONGUE DISORDER (hospitalization), and SYMPTOM RECURRENCE (hospitalization) all with onset 26Nov2021, outcome "unknown" and all described as "sore throat and tongue lesions/ symptoms reoccured with additional vaginal pain/burning;" VULVOVAGINAL PAIN (hospitalization) and VULVOVAGINAL BURNING SENSATION (hospitalization) both with onset 26Nov2021, outcome "unknown" and both described as "vaginal pain/burning;" and MOUTH ULCERATION (hospitalization), PHARYNGEAL ULCERATION (hospitalization), and VAGINAL ULCERATION (hospitalization) all with onset Dec2021, outcome "unknown" and all described as "symptoms progressed to ulcerations in oral/throat/vaginal area." All the events were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: extensive work-up: (2021) negative for infection and COVID-19 test: (unspecified date) negative, notes: post vaccination. Therapeutic measures were taken as a result of all the events. It was further reported that on 24Nov2021, the patient received 2nd dose and on 26Nov2021, the symptoms that developed during 1st Pfizer dose (sore throat and tongue lesions) reoccurred with additional vaginal pain/burning. Over the next month, symptoms progressed to ulcerations in oral/throat/vaginal area, for which she had multiple visits and hospitalization and an extensive work-up negative for infection. Ultimately, the patient was diagnosed with Bechet's disease; symptoms responded to steroids.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events BEHCET'S SYNDROME, OROPHARYNGEAL PAIN, TONGUE DISORDER, SYMPTOM RECURRENCE, VULVOVAGINAL PAIN, VULVOVAGINAL BURNING SENSATION, MOUTH ULCERATION, PHARYNGEAL ULCERATION, VAGINAL ULCERATION cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate