Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Discomfort, Erythema, Off label use
Clinical narrative: Swelling in face and facial hives; Swelling in face and facial hives; rash on eyelids/ Had some rash on back to; Face was stretched to limit and really hurt and burned where I was severely uncomfortable.; Face was stretched to limit and really hurt and burned where I was severely uncomfortable.; Also had 104 temp the next day of shot; It was a burning sensation on face and face was very red and still red; It was a burning sensation on face and face was very red and still red; I took three shots that day TDap one arm and pneumoia and Covid other arm.; I took three shots that day TDap one arm and pneumoia and Covid other arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 at 11:30 as dose 3 (booster), single (Lot number: FK9894) at the age of 44 years, in right arm for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 29Apr2022 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ankylosis Spondylitis" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "IC" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN; ESTRADIOL; KEPPRA [LEVETIRACETAM]; POTASSIUM; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]. Past drug history included: Levofloxacin, reaction(s): "known Allergies: Levofloxacin"; Diltiazem, reaction(s): "known Allergies: Diltiazem"; Zoster vac recomb adjuvanted, reaction(s): "known Allergies: Zoster"; Fursemide, reaction(s): "known Allergies: fursemide". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EA6207, Dose administration time: 03:15 pm, Anatomical site: Left arm), administration date: 15Mar2021, when the patient was 43-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0151, Dose administration time: 01:15 pm, Anatomical site: Right arm), administration date: 05Apr2021, when the patient was 43-year-old, for Covid-19 Immunization; Shnigles, for Immunization, reaction(s): "facial swelling", "Severly hives". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Apr2022, outcome "unknown" and all described as "I took three shots that day TDap one arm and pneumoia and Covid other arm."; PYREXIA (non-serious) with onset 05May2022, outcome "recovering", described as "Also had 104 temp the next day of shot"; PAIN (non-serious), DISCOMFORT (non-serious) all with onset 05May2022, outcome "recovering" and all described as "Face was stretched to limit and really hurt and burned where I was severely uncomfortable."; BURNING SENSATION (non-serious), ERYTHEMA (non-serious) all with onset 05May2022, outcome "recovering" and all described as "It was a burning sensation on face and face was very red and still red"; SWELLING FACE (non-serious), URTICARIA (non-serious) all with onset 05May2022, outcome "recovering" and all described as "Swelling in face and facial hives"; RASH (non-serious) with onset 05May2022, outcome "recovering", described as "rash on eyelids/ Had some rash on back to". The events "swelling in face and facial hives", "rash on eyelids/ had some rash on back to", "face was stretched to limit and really hurt and burned where i was severely uncomfortable.", "also had 104 temp the next day of shot" and "it was a burning sensation on face and face was very red and still red" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling face, urticaria, rash, pain, discomfort, pyrexia, burning sensation, erythema.  Additional comment: The patient stated swelling in face and facial hives or rash on eyelids. Face was stretched to limit and really hurt and burned where she was severely uncomfortable. It starting to occur the next week but got worse on week 2 of shot. Also started Humira 5 days after shot. Also had 104 temp the next day of shot. Steroids did not respond to the shot. she started steroid pills on Monday June 16 and was worse Wednesday morning with eyes almost shut. Allergist gave her shot and put her on 2 Zyrtec and 2 Claritin and 4 tagments day. Still no response. getting better about four weeks. Had some rash on back to. It was a burning sensation on face and face was very red and still red. Rheumatologist said it was not thing related to her RA or Ankylosis Spondylitis. He took picture. The patient was allergic to the shingles shot severely Hives and facial swelling but different than this. she took three shots that day TDap one arm and pneumonia and Covid other arm. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.