Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Pruritus, Rash
Clinical narrative: rash; her lips got bigger/lips were tingling and thick, bigger; tingling and itching; Itching; This is a spontaneous report from a contactable other health care professional nurse reported for herself. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection. Batch/Lot Number: FA7484) via an unspecified route of administration, administered in left arm on 09Aug2021 at 09:00 (at the age of 33-years-old) as Dose 1, Single for COVID-19 immunization. Medical history included hypersensitivity (e.g., rash, pruritus, urticaria, angioedema) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Patient history and investigation assessment: no. No other vaccines given the same day or 4 weeks prior and no problems with vaccines in past. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. No adverse events following prior vaccination. Patient medical History (including any illness at time of vaccination): none. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. Illness/Adverse event: None. Family Medical History Relevant to adverse events: none. Relevant tests: None. Vaccination facility type at physician Office. The patient was vaccinated with the Pfizer COVID vaccine almost 3 weeks ago, (09Aug2021) and within an hour the patient got tingling and itching and lips were tingling and thick, bigger. Then she broke out in a rash later that afternoon and still has the rash now and it's been 18 days and it keeps getting worse and nothing was helping. Has already sought medical attention and been on steroids. She wants to know if anything has been reported like this or other people reporting this or if there was anything else patient can do. Feels events were serious/medically significant due to the duration and daily occurrence. Treatment was given with steroids for the itching, tingling, and rash and clarifies steroid as Prednisone. No further details provided. Patient visited to physician office. The outcome of the events were not recovered.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event Rash, Lip swelling, Paraesthesia, Pruritus  and the suspect drug BNT162B2 cannot be 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.