Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Mental disorder, Rash, Rash macular
Clinical narrative: having red blotches on face, burning painful and hot; having red blotches on face, burning painful and hot; having red blotches on face, burning painful and hot; began having hissing sound, beeping and buzzing noises constantly in my ears; experiencing mental crisis episodes; extreme anxiety amongst other things; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm right, administration date 07Jan2021 13:00 (Lot number: El0140) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Generalized Anxiety disorder" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: El0140, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 17Dec2020, when the patient was 37 years old,  for COVID-19 immunization. The patient had no known allergies, the patient did not receive other vaccine within four weeks or other medications within two weeks.   The following information was reported: RASH (hospitalization), RASH MACULAR (hospitalization), BURNING SENSATION (hospitalization) all with onset 11Jan2021, outcome "not recovered" and all described as "having red blotches on face, burning painful and hot"; TINNITUS (hospitalization) with onset 11Jan2021, outcome "not recovered", described as "began having hissing sound, beeping and buzzing noises constantly in my ears"; MENTAL DISORDER (hospitalization) with onset 11Jan2021, outcome "not recovered", described as "experiencing mental crisis episodes"; ANXIETY (hospitalization) with onset 11Jan2021, outcome "not recovered", described as "extreme anxiety amongst other things". The patient was hospitalized for rash, rash macular, burning sensation, tinnitus, mental disorder, anxiety (hospitalization duration: 3 day(s)). The events "having red blotches on face, burning painful and hot", "began having hissing sound, beeping and buzzing noises constantly in my ears", "experiencing mental crisis episodes" and "extreme anxiety amongst other things" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-1 test: (11Jan2021) negative, notes: Covid test type post vaccination: Nasal Swab,covid test date: 11Jan2021, covid test result: Negative. Therapeutic measures were not taken as a result of rash, rash macular, burning sensation, tinnitus, mental disorder, anxiety. Clinical course: the patient: started having red blotches on face, burning painful and hot. These red burning skin blotches started moving around onto other body parts. Then the patient began having hissing sound, beeping and buzzing noises constantly in their ears, and started experiencing mental crisis episodes and extreme anxiety amongst other things.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. 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.