Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acquired epidermolysis bullosa, Biopsy skin, Blood test, Full blood count, Laboratory test
Clinical narrative: After biopsy I was diagnosed with autoimmune disease known as epidermolysis bullosa acquisita; I started to develop itching; It became severe and ultimately develop rashes; I started to develop itching; It became severe and ultimately develop rashes; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received bnt162b2, intramuscularly, administered in Arm Left (very near to shoulder area) on 09Jan2021 14:00 at age of 65-year-old (Lot Number: EK9231) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes, asthma, hypertension, cholesterol, obsessive-compulsive disorder, urinary tract infection, influenza immunisation from an unknown date and unknown if ongoing. Concomitant medication(s) included semaglutide (OZEMPIC) taken for diabetes; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA, Inhaler) taken for asthma; atorvastatin (LIPITOR) taken for blood cholesterol; fluoxetine hydrochloride (PROZAC) taken for obsessive-compulsive disorder; diazepam (DIAZEM) taken for hypertension; alfuzosin (ALFUZOSIN) taken for an unspecified indication; methenamine hippurate  taken for urinary tract infection; ipratropium bromide, salbutamol sulfate (COMBIVENT) taken for asthma exacerbation, all start and stop date were not reported. The patient historical vaccine included bnt162b2, intramuscularly, administered in Arm Left (very near to shoulder area) on 19Dec2021 14:00 at age of 65-year-old (Lot Number: EL0140) as DOSE 1, SINGLE for covid-19 immunisation; and Flu vaccine at least 6 month before the Covid vaccine for immunization via intramuscular on left arm also probably. The flu vaccine is most recent prior vaccine the patient had before that, don't recall when he had that but it was well before that. Family got it more recently than the patient got it. Wife has got the Pfizer and daughter was got the Pfizer and son was got the Moderna and none of them has had any problem. The patient had this Pfizer vaccine two shot. One was on 19Dec2021, second was 09Jan2021. Shortly after he got developed, not shortly but he would say he started to develop itching. It became severe and ultimately develop rashes and after biopsy he was diagnosed with autoimmune disease known as epidermolysis bullosa acquisita. Doesn't know if its because of the vaccine but given the fact that the messenger RNA vaccine and that it can't get into the nucleus therefore cannot form autoimmune disease. The patient wanted to report it you know in faith if there is any foster of these cases. The patient was having to take Prednisone for the skin disease he developed plus Dapsone. Actually he had got lab report and it was all pretty normal the CBC, the chemistry and blood test have been normal the diagnosis of the skin disease was made by the punch biopsy of the skin. The outcome of the event was unknown.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "Acquired epidermolysis bullosa" 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.