Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Vaccination site erythema
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT PROVIDED). The reporter is the patient. Other Case identifier(s): 21K-163-4168988-00, 22K-163-4284076-00. A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (ongoing) (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "Wisdom teeth removed" (unspecified if ongoing), notes: She had occasional nerve pain where wisdom teeth were removed when she was 21; "lump on left ear removed" (unspecified if ongoing), notes: The patient had lump on left ear removed. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 08Feb2021, when the patient was 69 years old, for Covid-19 Immunization, reaction(s): "red spots on injected arm", "Application site redness", "Rash on small of back going up the back/itchy". The following information was reported: MALAISE (medically significant) with onset Mar2021, outcome "unknown", described as "Feeling Ill"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Sore Arm/Pain in arm"; SKIN MASS (medically significant), outcome "unknown", described as "Skin mass"; NEURALGIA (medically significant), outcome "not recovered", described as "Nerve pain"; FATIGUE (medically significant) with onset Feb2021, outcome "unknown", described as "Fatigue"; PSORIASIS (medically significant), outcome "not recovered", described as "Psoriasis flare-up"; VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2021, outcome "unknown", described as "Vaccination site erythema". The action taken for risankizumab was dosage not changed. The reporter's assessment of the causal relationship of events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (28Feb2022): New information received by Pfizer (Mfr. Control No: 22K-163-4284076-00) from a contactable consumer included: Relevant medical history (Wisdom teeth removed and lump on left ear removed), Events (Sore Arm/Pain in arm, Skin mass, Nerve pain, Fatigue, and Psoriasis flare-up) and clinical information were updated. Clinical course: Upon follow up on 28Feb2022, Patient experienced nerve pain, sore arm, felt ill, and fatigued and plaque psoriasis flare up with Skyrizi (Risankizumab). The patient had a relevant medical history of wisdom teeth removed. On unknown dates, the patient experienced lump on left ear, nerve pain and plaque psoriasis flare up. In Feb2021, the patient experienced sore arm and felt ill and fatigued. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had lump on left ear removed. She had psoriasis flare up and her shoulders, chest and knees were itchy. She had occasional nerve pain where wisdom teeth were removed when she was 21. It was unknown if she was enrolled in a COVID-19 vaccine trial. She had Pfizer vaccines and first dose felt ill and fatigued. Had sore arm from all doses. The symptoms of itchy shoulders, chest and knees were unified under the diagnosis of psoriasis. She did not agree to have physician contacted. Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of lump on left ear was not provided. The reporter's causality for the event(s) of nerve pain, sore arm, felt ill and fatigued onset in Feb2021 and felt ill and fatigued onset in Feb2021 with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of plaque psoriasis flare up with Skyrizi (Risankizumab) was a reasonable possibility. Regulatory Authority opinion is that the event of lump on left ear is not assessable. Regulatory Authority opinion is that there is no reasonable possibility that the events of nerve pain, sore arm, felt ill, and fatigued onset in Feb2021, felt ill and fatigued onset in Feb2021 and plaque psoriasis flare up are related to Skyrizi (Risankizumab). The reporter considered "feeling ill" and "vaccination site erythema" related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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-202101662620.