Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal swelling
Clinical narrative: still have neck pain on left side where injection was administer; Vaginal labia manora are swollen and skin is sensitive to touch; Vaginal labia manora are swollen and skin is sensitive to touch; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; ER diagnosis said I have a acquired disorder of genital organ.; Within 1.5 hr of vaccine started experiencing vaginal pain; Also experienced swollen lymph nodes under arm pit to enlarge; This is a spontaneous report received a contactable other healthcare professional, the patient. A 38-year-old [non-pregnant] adult female received the second dose of BNT162b2 (solution for injection; Lot unknown and expiry information not provided) as a single dose via unspecified route in the left arm on 20Apr2021 at 10:00 (at 38-years-old) for COVID-19 immunisation. Relevant medical history included Autoimmune Hashimoto's, penicillin allergy and known allergies to gluten, soy, dairy, wheat, malt and eggs. Concomitant medications sans therapy dates included levothyroxine sodium (TIROSINT) for thyroid; and liothyronine sodium (CYTOMEL) for thyroid. The patient previously received Covid-19 immunisation with first dose of BNT162b2 (Lot unknown) in left arm on 30Mar2021 at 10:00 (at 38-years-old). The patient denied COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 20Apr2021 at 12:00, reported as about one- and one-half hours after receiving the vaccine, the patient began to experience vaginal pain. The patient reported that she also experienced swollen lymph nodes under arm pit to enlarge, still have neck pain on left side where injection was administered. The patient explained that her labia majora are swollen, and the skin is sensitive to touch. The patient explained that she went to the emergency room (ER) because she could not walk or urinate as her vulva was irritated. The patient reported that the only thing that she did this week was get vaccinated and the ER diagnosis said she had an acquired disorder of genital organ and advised an obstetrical /gynecological consultation. The patient stated she never had this problem. The patient assessed the events serious (Disability or permanent damage). Relevant testing included a negative post-vaccination COVID-19 test via nasal swab on 20Oct2020 (as reported). There was unspecified treatment received for the events. The outcome of the events vaginal pain, swollen lymph nodes under arm pit to enlarge, neck pain on left side, labia majora are swollen, skin is sensitive to touch, vulva was irritated, was not recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and  BNT162b2  vaccine cannot be completely 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.