Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Lip swelling, SARS-CoV-2 test, Swelling face
Clinical narrative: swelling involving the forehead cheeks eyelids and lips/ facial swelling; swelling involving the forehead cheeks eyelids and lips; swelling involving the forehead cheeks eyelids and lips; Erythema; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 44-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "multiple myeloma" (unspecified if ongoing), notes: multiple myeloma with amyloidosis earlier this year, who is undergoing treatment with XRT, chemo,; "amyloidosis" (unspecified if ongoing), notes: multiple myeloma with amyloidosis earlier this year, who is undergoing treatment with XRT, chemo,; "XRT" (unspecified if ongoing), notes: multiple myeloma with amyloidosis earlier this year, who is undergoing treatment with XRT, chemo,; "chemo" (unspecified if ongoing), notes: multiple myeloma with amyloidosis earlier this year, who is undergoing treatment with XRT, chemo,. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP7533, Manufacture: Pfizer), administration date: 24Apr2021, when the patient was 43-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Manufacture: Pfizer), administration date: 03Apr2021, when the patient was 43-year-old, for Covid-19 immunization. The following information was reported: ERYTHEMA (hospitalization) with onset 25Dec2021, outcome "recovered"; EYE SWELLING (hospitalization), LIP SWELLING (hospitalization) all with onset 25Dec2021, outcome "recovered" and all described as "swelling involving the forehead cheeks eyelids and lips"; SWELLING FACE (hospitalization) with onset 25Dec2021, outcome "recovered", described as "swelling involving the forehead cheeks eyelids and lips/ facial swelling". The patient was hospitalized for swelling face, eye swelling, lip swelling, erythema (hospitalization duration: 3 day(s)). The events "swelling involving the forehead cheeks eyelids and lips/ facial swelling", "swelling involving the forehead cheeks eyelids and lips" and "erythema" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Mar2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of swelling face, eye swelling, lip swelling, erythema. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, treatment ae was IV Steroids. COVID tested post vaccination was yes. COVID test post vaccination: COVID test type post vaccination-Nasal Swab. COVID test name post vaccination-Cepheid Expert Xpress Assay COVID test date-14Mar2022, COVID test result-Negative. Known allergies was no. Other medical history: multiple myeloma with amyloidosis earlier this year, who is undergoing treatment with XRT, chemo.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event s - swelling face, eye swelling, lip swelling, erythema, and the suspect drug "BNT162B2" 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.