Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Chronic spontaneous urticaria, Emotional distress, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733), administration date: 09Apr2021, when the patient was 27-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 27-year-old, for COVID-19 immunization. The following information was reported: ANGIOEDEMA (medically significant) with onset 10Dec2021, outcome "not recovered", described as "angioedema (swelling) of the lip"; CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset 10Dec2021, outcome "not recovered", described as "chronic idiopathic urticaria"; EMOTIONAL DISTRESS (non-serious) with onset 10Dec2021, outcome "not recovered"; URTICARIA (non-serious) with onset 10Dec2021, outcome "not recovered", described as "hives"; PRURITUS (non-serious) with onset 10Dec2021, outcome "not recovered", described as "severe itching". The events "angioedema (swelling) of the lip", "chronic idiopathic urticaria", "hives", "emotional distress" and "severe itching" required physician office visit. Therapeutic measures were taken as a result of angioedema, chronic spontaneous urticaria, urticaria, emotional distress, pruritus. Clinical course information: Three weeks after receiving the COVID booster patient began experiencing chronic idiopathic urticaria. She had two episodes of angioedema (swelling) of the lip. Prior to this she had never had hives or allergic reactions of this sort. At it's worst to get on a ten day does of steroids and carry an EpiPen in case of severe reaction. She have seen several doctors and it has been a long road seeking answers. The hives started out with just a few and then became severe around Mar and Apr2022. She was covered in hives and experienced severe itching and emotional distress. At this time Allegra/Pepcid help manage the hives but she can not get off the medications without having hives appear again. She received the treatment of steroids, antihistamines, Pepcid in high dosages. Patient did not had any other vaccine in four weeks and other medications in two weeks. No Covid prior to vaccination was reported. Covid tested post vaccination. Covid test post vaccination: Covid test type post vaccination; Nasal Swab, Covid test date 15Jan2022,covid test result-Positive. No known allergies. No other medical history were reported. No follow-up attempts are possible. No further information was expected. Sender's Comments: Based on the information given in narrative, the causal relationship between the event Angioedema, Chronic spontaneous urticaria, urticaria, emotional distress, and pruritis the suspect drug BNT162B2 cannot be excluded.