Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash macular, Rash pruritic, Skin mass, Vaccination site erythema
Clinical narrative: Skin mass; Nerve pain; Psoriasis flare-up; Pain in arm; red spots on injected arm; Application site redness; felt ill; Fatigue; Rash on small of back going up the back/itchy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4168988-00 (Agency), 22K-163-4284076-00 (Agency).  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 08Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (ongoing) (Lot number: 1155977) for psoriasis. Relevant medical history included: "Wisdom Teeth Removed" (unspecified if ongoing), notes: wisdom teeth were removed when she was 21.; "occasional nerve pain" (unspecified if ongoing), notes: She had occasional nerve pain where wisdom teeth were removed when she was 21. The patient's concomitant medications were not reported. The following information was reported: RASH MACULAR (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "red spots on injected arm"; VACCINATION SITE ERYTHEMA (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "Application site redness"; RASH PRURITIC (medically significant) with onset 2021, outcome "not recovered", described as "Rash on small of back going up the back/itchy"; MALAISE (medically significant) with onset Feb2021, outcome "unknown", described as "felt ill"; FATIGUE (medically significant) with onset Feb2021, outcome "unknown", described as "Fatigue"; SKIN MASS (medically significant), outcome "unknown", described as "Skin mass"; NEURALGIA (medically significant), outcome "not recovered", described as "Nerve pain"; PAIN IN EXTREMITY (medically significant) with onset Feb2021, outcome "unknown", described as "Pain in arm"; PSORIASIS (medically significant), outcome "not recovered", described as "Psoriasis flare-up". The action taken for risankizumab was dosage not changed. Causality for SKYRIZI (RISANKIZUMAB) the reporter's causality for the event(s) of first covid vaccine caused red spots on injected arm, second Covid vaccine caused feeling ill and more red spots onset in Mar2021 and second covid vaccine caused feeling ill and more red spots onset in Mar2021 with Skyrizi(risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of rash on small of back going up the back/itchy with skyrizi (risankizumab) was a reasonable possibility. Causality with respect to Skyrizi (risankizumab): Application site redness (Application site erythema) Causality as per reporter (Drug/Vaccine): Probable and De challenge: N/A. for Itchy rash (Rash pruritic) Causality as per reporter (Drug/Vaccine): Not Reported and De challenge: N/A. for Vaccination site erythema (Vaccination site erythema) Causality as per reporter (Drug/Vaccine): Probable. Causality with respect to PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): Application site redness (Application site erythema) and Vaccination site erythema, Causality as per reporter (Drug/Vaccine): Probable and for Itchy rash (Rash pruritic) Causality as per reporter (Drug/Vaccine) was Not Reported. Upon follow-up on 28Feb2022, it was reported as, patient had events of Lump on Left Ear and non-serious Nerve Pain, Sore Arm, Felt Ill and Fatigued and Plaque Psoriasis Flare Up with SKYRIZI (RISANKIZUMAB). 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. The patient received second dose on 01Mar2021 and dose 3 on 26Oct2021. Causality for Humira (adalimumab) was reported as, 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). For SKYRIZI (RISANKIZUMAB) causality was reported as, for skin mass (Skin mass) Causality as per reporter (Drug/Vaccine) was Not Reported and Causality as per Mfr. (Drug/Vaccine) was Not assessable. For rest all the events causality as per reporter (Drug/Vaccine) was No reasonable possibility and Causality as per Mfr. (Drug/Vaccine) was No reasonable possibility. For PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (Injection). Causality for Skin mass (Skin mass), Nerve pain (Neuralgia) and Psoriasis flare-up (Psoriasis); Causality as per reporter (Drug/Vaccine) was Not Reported. For Pain in arm (Pain in extremity) and Felt ill (Malaise), Fatigue (Fatigue) Causality as per reporter (Drug/Vaccine) was Probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (28Feb2022): This is a solicited follow-up report based on the information received by Pfizer from Agency (Mfr. Control No. : 22K-163-4284076-00). A contactable 69-year-old female consumer reported that: Updated Information Included: Lot no of co-suspect, New Event 'Skin mass', 'Nerve pain', 'Pain in arm', 'Felt ill', 'Fatigue', 'Psoriasis flare-up'. Medically Significant was checked for all events conservatively. narrative was updated for additional information. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [28Feb2022], this case now contains serious adverse reaction(s). Information processed together.  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 information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be 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.,Linked Report(s) : US-PFIZER_INC-202101662621