Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Elephantiasis, Hypersensitivity, Oxygen saturation, Peripheral swelling
Clinical narrative: feet swelled up a little bit; Elephantitis; Having trouble breathing/short of breath, she couldn't take a deep breath; allergic reaction; legs were itching; weird-looking rash, very bumpy and red; bubbly and itching; weird-looking rash, very bumpy and red; bubbly and itching; weird-looking rash, very bumpy and red; bubbly and itching; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 intramuscular, administered in Deltoid Left on 03Aug2021 (Batch/Lot Number: EW0177) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0177), at age of 63 years old, on Left deltoid for covid-19 immunisation on 13Jul2021. Reported an "allergic reaction" after receiving the Pfizer-BioNTech COVID-19 Vaccine, patient developed a "bumpy and bubbly rash". Patient clarified she had an allergic reaction. As soon as she got the shot. She got the shot at 14:30-15:30, and within 2 hours, by 16:00, she was having trouble breathing. She was short of breath, she couldn't take a deep breath. Her legs were itching. She had a weird looking rash- it's very bumpy and red. It looks like Elephantitis. She explains further it's a weird rash, it's not hives, it's a different kind of rash. She knew what hives was and it's not hives. The rash was bumpy and looks bubbly, she still had the rash. The rash was very itch and she still had scars from it. She mentioned her feet swelled up a little bit. When probed for the seriousness criteria of her reaction, the patient stated it could be life-threatening if you can't breathe. Her reaction began after her second dose. She received her second dose on 03Aug2021. The lot number is the same for both her first and second dose. She explains the amount of the dose was not on her vaccine record card. She felt the reaction was definitely caused from the vaccine. She stated there were no blood tests for this reaction. Her CO2, clarified as her oxygen level was between 95 and 97, which was okay. None of vaccines administered on same date of the Pfizer suspect. Patient went to emergency room urgent care because she couldn't breathe. None of Vaccinations administered within four weeks prior to the first administration date of the suspect vaccine. Reporter seriousness for short of breath, she couldn't take a deep breath was Life threatening Reporter considered that short of breath, she couldn't take a deep breath and weird-looking rash, very bumpy and red; bubbly and itching were related. The outcomes of events having trouble breathing/short of breath, she couldn't take a deep breath, Elephantitis and feet swelled up a little bit were unknown, while other events were not recovered.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events Elephantitis  and Breathing difficult . The case will be reassessed once new information is available   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.