Sex: M
Vaccine: COVID19
Symptoms: Nail hypertrophy, Onychomadesis, Psoriasis, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; Psoriasis aggravated; Nail loss; Nail hypertrophy; This is a solicited report based on the information received by Pfizer. (Mfr. Control No.: 21K-163-3994143-00). A contactable 87-year-old male consumer (patient) reported for himself that:  Age yrs: 87 Sex: M Reaction onset:2021 DESCRIBE REACTION(S) (include relevant test/lab data): Psoriatic arthritis (10037160) (Psoriatic arthropathy (10037162)) - Not recovered/not resolved Nail loss (10049281) (Onychomadesis (10049274)) - Not recovered/not resolved Nail hypertrophy (10028700) (Nail hypertrophy (10028700)) - Not recovered/not resolved Psoriasis aggravated (10037154) (Psoriasis (10037153)) - Not recovered/not resolved  Seq. No.: 1 Reaction: Psoriatic arthritis (10037160) (Psoriatic arthropathy (10037162))  Start Date: Jul2021 Seq. No.: 2 Reaction: Nail loss (10049281) (Onychomadesis (10049274)) Start Date: Jul2021 Seq. No.: 3 Reaction: Nail hypertrophy (10028700) (Nail hypertrophy (10028700))  Start Date: Jul2021 Seq. No.: 4 Reaction : Psoriasis aggravated (10037154) (Psoriasis (10037153)) Start Date: 2021   Solicited report by a consumer of an 87 year old male with events of non-serious Psoriatic Arthritis, Loss Of Fingernails, A Second Nail Growing Under The Top/Layer Of Nail and Psoriasis was on Ankles/Psoriasis Worsened Significantly/Psoriasis from head to toe/felt Psoriasis had spread with SKYRIZI (RISANKIZUMAB). There was no reported medical history.  In 2021, the patient experienced PSORIASIS was on Ankles/Psoriasis Worsened Significantly/Psoriasis from head to toe/felt psoriasis had spread. In July 2021, the patient experienced Psoriatic Arthritis, Loss of fingernails and a second nail growing under the top/layer of nail. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect.  The patient had stated that following the initial dose of SKYRIZI he had received the Pfizer Covid-19 vaccines. His psoriasis worsened significantly. The psoriasis was limited to his ankles prior to the vaccine. He had psoriasis from head to toe following the second covid vaccine. He had noted some improvement following week four SKYRIZI injection but following week 12 SKYRIZI injection he felt the psoriasis had spread. He was experiencing drying and flaking of skin in 2021. Specific dates of injection not provided. Since taking the SKYRIZI and the covid 19 vaccines he had developed psoriatic arthritis in Jul2021. He was experiencing the loss of his fingernails and a second nail growing under the top and layer of nail. Specific dates were not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient received first dose COVID-19 Vaccine manufactured by Pfizer in Jan2021. The patient received second dose COVID-19 Vaccine manufactured by Pfizer in 2021.  Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of Psoriatic Arthritis, Loss of fingernails, A second nail growing under the top/layer of nail and Psoriasis was on ankles/Psoriasis worsened significantly/Psoriasis from head to toe/felt Psoriasis had spread with SKYRIZI (RISANKIZUMAB) was a reasonable possibility.  SUSPECT DRUG(S) INFORMATION: SUSPECT DRUG(S) (include generic name) 1)SKYRIZI(RISANKIZUMAB), Unknown, Unknown, Unknown  SUSPECT DRUG(S) (include generic name): 2) PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), Unknown, Unknown  Product-Reaction level: Seq.No.: 1 Drug: SKYRIZI(RISANKIZUMAB), Unknown, Unknown, Unknown Daily Dose: 2) Week 4 (150 mg) 3) (150 mg,1 in 12 wk) Route of Admin: 1) Subcutaneous 2)Subcutaneous 3)Subcutaneous Therapy Dates/Duration: 1) 01Jan2021 - 01Jan2021 2) 01Feb2021 - 01Feb2021 3) ??-??-2021 - Ongoing  Causality 1)Psoriatic arthritis (10037160) (Psoriatic arthropathy (10037162)) Action(s) taken with drug:  Dose Not Changed Causality as per reporter (Drug/Vaccine):  Reasonable possibility Dechallenge:  N/A 2)Nail loss (10049281) (Onychomadesis (10049274)) [v.24.0] Action(s) taken with drug:  Dose Not Changed Causality as per reporter (Drug/Vaccine):  Reasonable possibility Dechallenge:  N/A 3)Nail hypertrophy (10028700) (Nail hypertrophy (10028700)) [v.24.0] Action(s) taken with drug:  Dose Not Changed Causality as per reporter (Drug/Vaccine):  Reasonable possibility Dechallenge:  N/A 4)Psoriasis aggravated (10037154) (Psoriasis (10037153)) [v.24.0] Action(s) taken with drug:  Dose Not Changed Causality as per reporter (Drug/Vaccine):  Reasonable possibility Dechallenge:  N/A  Seq.No.: 2 Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) (TOZINAMERAN), Unknown, Unknown Daily Dose: 2) (1 in 1 Once) Route of Admin: 1) Intramuscular  2)Intramuscular Therapy Dates/Duration: 1) Jan2021 - Jan2021 2) 2021 - 2021 Causality 1)Psoriatic arthritis (10037160) (Psoriatic arthropathy (10037162))  Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge:  N/A 2)Nail loss (10049281) (Onychomadesis (10049274))  Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge:  N/A 3)Nail hypertrophy (10028700) (Nail hypertrophy (10028700)) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge:  N/A 4)Psoriasis aggravated (10037154) (Psoriasis (10037153))  Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge:  N/A  Daily Dose: 1)Week 0 (150 mg) 2) (1 in 1 Once) ROUTE OF ADMINISTRATION: 1)Subcutaneous 2)Intramuscular Indications for Use: 1) PLAQUE PSORIASIS 2) COVID-19 VACCINATION THERAPY DATES(From/To): 1) 01Jan2021 2) Jan2021  Did Event Abate After Stopping Drug: N/A  Concomitant Drugs and History: Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported Other Relevant History: Not reported.  The reporter's assessment of the causal relationship of the event 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: The events of psoriatic arthritis, psoriasis aggravated, nail loss & nail hypertrophy are assessed as possibly related to the suspect BNT162B2 based on temporal association. However, underlying history of psoriasis and co-suspect risankizumab were confounders. 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 RAs, Ethics Committees, and Investigators, as appropriate.