Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chronic spontaneous urticaria, Product dose omission issue, Pruritus, Urticaria
Clinical narrative: Angioedema on lips at night; body covered with spontaneous hives; chronic spontaneous urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 (Lot number: EW0178) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant), outcome "unknown", described as "Angioedema on lips at night"; URTICARIA (non-serious), outcome "unknown", described as "body covered with spontaneous hives"; CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset Aug2021, outcome "not recovered", described as "chronic spontaneous urticaria". The events "angioedema on lips at night", "body covered with spontaneous hives" and "chronic spontaneous urticaria" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antinuclear antibody: (18Oct2021) normal; blood thyroid stimulating hormone: (18Oct2021) normal; c-reactive protein: (18Oct2021) normal; electrophoresis protein: (18Oct2021) normal; full blood count: (18Oct2021) normal; red blood cell sedimentation rate normal: (18Oct2021) normal. Therapeutic measures were taken as a result of angioedema, urticaria, chronic spontaneous urticaria.  Clinical course: She had one dose of the covid vaccine in Jun. She added she wants to know if we can tell when she called last time, she reported on having chronic hives. She wants to know if this has been reported before, someone having chronic continuous hives, urticaria, this is what she is having. Patient asked are there any other reports of chronic spontaneous urticaria after getting vaccinated" patient reported it's been since August, and she is still experiencing this. Took Pfizer dose1 25Jun2021 chronic spontaneous urticarial in summer, but initially thought it is bug bites. Around Aug2021 body covered with spontaneous hives, welts with unbearable itching and dematographia. Initially hives were on thigh and legs and by Sep-Oct2021 on whole body. Angioedema on lips at night. Met with primary doctor on 22Oct2021 who prescribed Zyrtec. She referred to immunologist. Did several lab tests and result did not identify the cause of hives, met immunologist 8Nov2021 and she diagnosed with chronic spontaneous urticaria. Currently still getting hives which are worst in morning and night. On Zertac daily just to control symptoms so that patient was able to continue working.  No follow-up attempts are possible. No further information is expected.  Follow-up(31Jan2022): The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on(31Jan2022), this case now contains serious adverse events reactions (body covered with spontaneous hives, Angioedema on lips at night). Information processed together.  Follow-up attempts are completed. No further information is expected.