Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: mycosis fungoides.; Started to get rash on head that was weeping. Cutaneous T Cell Lymphoma.; enlarged lymph node with with metabolic activity lower left cervical.; flushing and tingling and itchy feeling throughout body for about 3 months after the 2nd dose; flushing and tingling and itchy feeling throughout body for about 3 months after the 2nd dose; flushing and tingling and itchy feeling throughout body for about 3 months after the 2nd dose; developed a rash over left bicep.; developed red spots on legs.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: ER8731) at the age of 62 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 07Apr2021, for COVID-19 immunization. It was unknown that the patient tested for COVID-19 prior and post vaccination. The patient had other vaccine in four weeks is unknown. The following information was reported: RASH (non-serious) with onset Sep2021, outcome "not recovered", described as "developed a rash over left bicep." looked like group of mosquito bites.; RASH MACULAR (non-serious) with onset Sep2021, outcome "not recovered", described as "developed red spots on legs."; CUTANEOUS T-CELL LYMPHOMA (disability, medically significant, life threatening), outcome "not recovered", described as "mycosis fungoides."; CUTANEOUS LYMPHOMA (disability, medically significant, life threatening), outcome "not recovered", described as "Started to get rash on head that was weeping. Cutaneous T Cell Lymphoma."; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "enlarged lymph node with metabolic activity lower left cervical."; FLUSHING (non-serious), PARAESTHESIA (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "flushing and tingling and itchy feeling throughout body for about 3 months after the 2nd dose". The events "mycosis fungoides.", "started to get rash on head that was weeping. cutaneous t cell lymphoma.", "enlarged lymph node with metabolic activity lower left cervical.", "flushing and tingling and itchy feeling throughout body for about 3 months after the 2nd dose", "developed a rash over left bicep." and "developed red spots on legs." required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: The patient saw derm 1st week of Mar, CD2, 3, 4 30, notes: 30 (30 was large transformed atypical cells strongly expressing CD30); Flow cytometry: enlarged lymph node, notes: with metabolic activity lower left cervical; Positron emission tomogram: Stage 4a2 because of lymph node involvement, notes: Now on day 21 of chemo. For red spots on legs patient tried Triamcinolone. Was given Doxy, antihistamine and prednisone. For adverse event treatment patient was given Doxyratine (sp?), Atorvastatin and Levothyroxine. Therapeutic measures were taken as a result of cutaneous t-cell lymphoma, cutaneous lymphoma, lymphadenopathy, flushing, paraesthesia, pruritus, rash, rash macular.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.