Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: urticarial rash / initially on bilateral arms then spreading to thighs, buttocks and lower back / across chest and upper back at the base of the neck; pruritus/bilateral tone arms, upper arms shortly followed by red, slightly elevated diffuse to areas. Itching severity waxes and wanes during the day/night.; rash is symmetrical; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 08Dec2021 11:00 (Lot number: FF2590) at the age of 62 years as dose 2 , single for covid-19 immunisation. Relevant medical history included: "HTN", start date: 01Jan2001 (ongoing), notes: Illness/AE: HTN; "High Cholesterol", start date: 01Jan2001 (ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "If Covid prior vaccination: yes" (unspecified if ongoing); "Sleep" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "BP" (unspecified if ongoing); "Skin cancer" (unspecified if ongoing). Family history included: "Asthma", start date: 09Jul1959 (ongoing), notes: Onset Date: Birth. Concomitant medication(s) included: AMLODIPINE BESILATE taken for blood pressure measurement (ongoing); SPIRONOLACTONE; ATORVASTATIN CALCIUM; RAMIPRIL; ZOLPIDEM; AMBIEN taken for sleep disorder (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing); BENAZEPRIL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose number: 1, Date/Time: 17Nov2021, Time : 08:30, Anatomical site of injection : Right Deltoid, Route of administration : Intramuscular, Batch/Lot number : FF2590), administration date: 17Nov2021, when the patient was 62 years old, for COVID-19 immunization.The following information was reported: URTICARIA (disability) with onset 12Dec2021 13:00, outcome "not recovered", described as "urticarial rash / initially on bilateral arms then spreading to thighs, buttocks and lower back / across chest and upper back at the base of the neck"; PRURITUS (non-serious) with onset 12Dec2021 13:00, outcome "not recovered", described as "pruritus/bilateral tone arms, upper arms shortly followed by red, slightly elevated diffuse to areas. Itching severity waxes and wanes during the day/night."; RASH (non-serious) with onset 12Dec2021 13:00, outcome "not recovered", described as "rash is symmetrical". The events "urticarial rash / initially on bilateral arms then spreading to thighs, buttocks and lower back / across chest and upper back at the base of the neck", "pruritus/bilateral tone arms, upper arms shortly followed by red, slightly elevated diffuse to areas. itching severity waxes and wanes during the day/night." and "rash is symmetrical" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus, rash. Clinical course: Treatment for itching was taken with prednisone and hydroxyzine for 5 days. No specific relevant test for thromboembolic events with thrombocytopenia was done. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility type vaccine was Hospital. Developed with-in a week post 2nd vaccination urticarial rash and pruritus initially on bilateral arms then spreading to thighs, buttocks and lower back, rash is symmetrical and intensity of symptoms vary over the 24 hours. Developed new areas 2 months post 2nd dose across chest and upper back at the base of the neck. Approximately 1 weeks post 2nd covid dose pruritic event noted to bilateral tone arms, upper arms shortly followed by red, slightly elevated diffuse to areas. Itching severity waxes and wanes during the day/night. Areas eventually spreading to areas including upper thighs, bilateral buttocks posterior shoulders, under neck and to chest and abdomen. I have also noted that areola bilaterally remain erect with no previous history of this.; Sender's Comments: The event of Urticaria is assessed as possibly related to the suspect drug bnt162b2 based on temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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