Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red, swollen, painful, very hot to touch, itchy injection site reaction on left arm; Red, swollen, painful, very hot to touch, itchy injection site reaction on left arm; Red, swollen, painful, very hot to touch, itchy injection site reaction on left arm; Red, swollen, painful, very hot to touch, itchy injection site reaction on left arm; Trouble breathing; very hot to touch; Sore arm; headache; Skin looking uneven, a bit lumpy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 16:30 (Lot number: 30155BA) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Idiopathic urticaria" (ongoing); "allergic to own sweat" (unspecified if ongoing); "sun" (unspecified if ongoing); "Physical pressure" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR, start date: 05Oct2021, stop date: 05Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 43 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "not recovered", described as "Sore arm"; HEADACHE (non-serious) with onset 06Oct2021, outcome "not recovered", described as "headache"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 08Oct2021, outcome "not recovered" and all described as "Red, swollen, painful, very hot to touch, itchy injection site reaction on left arm"; SKIN LESION (non-serious) with onset Oct2021, outcome "not recovered", described as "Skin looking uneven, a bit lumpy"; DYSPNOEA (non-serious) with onset 08Oct2021, outcome "not recovered", described as "Trouble breathing"; HOT FLUSH (non-serious) with onset 08Oct2021, outcome "not recovered", described as "very hot to touch". Therapeutic measures were taken as a result of pain in extremity, headache, vaccination site erythema, vaccination site swelling, vaccination site pain, vaccination site pruritus, skin lesion.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested for COVID-19. She received most recent COVID-19 vaccine at hospital. She received Xolair injections, in the morning of 05Oct2021 (1 day before third dose) within 2 weeks of vaccination. She had sore arm and headache immediately after injection. Her skin was red, swollen, painful, and was very hot to touch. She had itchy injection site reaction on left arm appearing 2 days after dose. Her skin was looking uneven, a bit lumpy. No change was observed 14 hrs after taking Benadryl and Aleve. She had trouble breathing. She felt like a vice around neck and upper chest; thick and was unable to breathe deeply, like muscles were not able to work or expand. They were just solid feeling. She only noticed this when she tried to go for a jog. Felt like she could not get air in.  Follow-up attempts are completed. No further information is expected.