Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Neuralgia, Psoriasis, Skin mass
Clinical narrative: Skin mass; Nerve pain; Psoriasis flare-up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4284076-00 (Agency).  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 70 years as dose 3 (booster), 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). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 08Feb2021, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "felt ill", "fatigued"; Bnt162b2 (Dose 1), administration date: 08Feb2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose 2), administration date: 01Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: SKIN MASS (medically significant), outcome "unknown", described as "Skin mass"; NEURALGIA (non-serious), outcome "not recovered", described as "Nerve pain"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up". The action taken for risankizumab was unknown.  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. Agency's opinion is that the event of lump on left ear is not assessable. Agency's 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's assessment of the causal relationship of the (Skin mass, Nerve pain, Psoriasis flare-up) 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. 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.