Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: experienced a papular rash on his chest, back, legs, and arms; itching/little scalp itching; eczema/spongiotic dermatitis; This is a spontaneous report received from contactable reporter (Physician) from medical information team and product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 76 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "back pain" (unspecified if ongoing); "sleep" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Surgery in left arm" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: in the past. Concomitant medication(s) included: LORTAB [LORATADINE] taken for back pain, sleep disorder (ongoing); FINASTERIDE (ongoing); FLUTICASONE taken for rhinitis allergic; VITAMIN D [VITAMIN D NOS] nasal; B12-VITAMIIN oral. Vaccination history included: BNT162b2 (dose 1, single, LOT: EH9899), administration date: 21Dec2020, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (dose 2, single, LOT: EL1284), administration date: 12Jan2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (dose 3, single, LOT: FF2888 (looks like), Anatomical location: Probably in right arm), administration date: 26Sep2021, when the patient was 76-year-old, for COVID-19 Immunization; flu (Dose number: Unknown, Manufacturer: unknown), administration date: 03Oct2022, when the patient was 77-year-old. The following information was reported: ECZEMA (medically significant) with onset Apr2022, outcome "unknown", described as "eczema/spongiotic dermatitis"; RASH PAPULAR (medically significant) with onset Apr2022, outcome "not recovered", described as "experienced a papular rash on his chest, back, legs, and arms"; PRURITUS (medically significant) with onset Apr2022, outcome "recovering", described as "itching/little scalp itching ". The events "experienced a papular rash on his chest, back, legs, and arms", "itching/little scalp itching " and "eczema/spongiotic dermatitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Full blood count: Ok, notes: All blood counts and chemistry counts have been ok; Hemoglobin: low, notes: very slight low but not much; Alpha-gal test: Negative; Chemistry: Ok, notes: All blood counts and chemistry counts have been ok. Therapeutic measures were taken as a result of rash papular, pruritus, eczema. Clinical course details: Patient described the rash as pretty severe dermatologically but not life-threatening. Patient stated that he received Dupixent on 12Oct2022 and will receive his next dose on 26Oct2022. Patient mentioned that Dupixent made his rash worse, but the itching has become better. Patient stated that he received Dupixent on 12Oct2022 and will receive his next dose on 26Oct2022. Patient mentioned that he was schedule for the bivalent vaccine in Nov2022. Patient mentioned that it has been 6 months when he had the rashes. Shortly thereafter, broke out in papular rash on chest, back of legs, arms, soles of feet and so on. Patient was very itchy and had 2 skin boxes that showed either eczema or drug reaction. Patient can't really tell the difference if it was eczematous reaction or drug reaction from the biopsy. Also had an Alpha-gal test that was negative. Patient was not aware of anything to likely have caused this. Patient has been on some long-term medication like, Finasteride 5mg a day, for several years. Patient had some chronic back issues that required him to take low dose Lortab in the middle of the night, for back pain and sleep. Patient has been on that several years. Patient thought it was a little unusual to experience a drug reaction for that length of time. Patient had seen 2 different dermatologists, and one put him on Dupixent. Patient had the rash probably within the end of the month (Apr2022), not the same day. Patient didn't get short of breath but was very itchy. Patient was on the actual back and front and back of legs, feet and arm, not much on the face. Patient maybe had a little scalp itching and still some trouble with the itching. The pathologist called them spongiotic dermatitis. Didn't sense any fungal element.; Sender's Comments: Based on available information and temporal association the causal role of suspect drug cannot be excluded for reported events Case will be reviewed on receipt of FU 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,Linked Report(s) : US-PFIZER INC-202201247037 Same patient/product, different dose/event;