Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: getting very itchy across the back of my neck; this quickly spread across the rest of my body/ itching everywhere; skin was blotchy and a systemic reaction was kicking in; felt a burning sensation all over my skin; A rash and hives spread; A rash and hives spread; got very dizzy and lightheaded; tachycardic (HR in 140s); BP shot to 153/110; very high for me; fingers became very red; fingers became very red and warm to touch, as were other parts of my skin; felt altogether awful; throat began to feel "funny" (hard to describe); I was SOB; chest pain; nausea.; Systemic reaction; This is a spontaneous report from a contactable healthcare professional (patient). This 40-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0172) via an unspecified route of administration on 11May2021 at 16:15 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included irritable bowel syndrome (IBS), migraines, asthma, gastrointestinal (GI) bleeds, depression, anaphylaxis, and allergy to DURAPORE medical tape. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received diphenhydramine (BENADRYL); metoclopramide (REGLAN); codeine; tramadol; and oxycodone, paracetamol (PERCOCET) from unknown dates for unknown indications and experienced allergy. On 11May2021 at 16:30 (also reported as within 10 minutes of the vaccine) the patient experienced itchy, skin was blotchy, systemic reaction, burning sensation, rash, hives, dizzy, lightheaded, tachycardic, high blood pressure, fingers red and warm, felt altogether awful, throat felt funny, short of breath, chest pain, and nausea. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited an emergency room/department or urgent care and a doctor or other healthcare professional office/clinic as a result of the events. The clinical course was within 10 minutes of receiving the vaccine the patient began getting very itchy across the back of her neck. This quickly spread across the rest of her body. Emergency medical technicians (EMTs) examined her. Her skin was blotchy and a systemic reaction was kicking in. The patient felt a burning sensation all over her skin coupled with the itching everywhere. A rash and hives spread. She got very dizzy and lightheaded. She became tachycardic (heartrate in 140s). Her blood pressure (BP) shot to 153/110; very high for her. Her fingers became very red and warm to touch, as were other parts of her skin. She felt altogether awful. About 60 minutes after the vaccine and on route to the hospital (as reported) the patient's throat began to feel funny. She was short of breath (SOB) and experienced chest pain and nausea. The patient received treatment with dexamethasone (DECADRON), prednisone, additional medications, and intravenous (IV) fluids. Diphenhydramine could not be administered because she was allergic to it and had a history of anaphylaxis. The outcomes of itchy, skin was blotchy, systemic reaction, burning sensation, rash, hives, dizzy, lightheaded, tachycardic, high blood pressure, fingers red and warm, felt altogether awful, throat felt funny, short of breath, chest pain, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 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.