Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Therapeutic response shortened
Clinical narrative: Itchy scalp; Wearing off effect; did not feel good; COVID-19; COVID-19; more itchy scalp; bad flare of plaque psoriasis; loosing of hair/Hair loss; Psoriasis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. Other Case identifier(s): 22K-163-4365197-00.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Batch/Lot number: unknown), on 21Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (ongoing) (Lot number: 1161377), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious) with onset Jan2021, outcome "recovered", described as "bad flare of plaque psoriasis"; PRURITUS (non-serious) with onset Jan2021, outcome "unknown", described as "more itchy scalp"; PSORIASIS (non-serious) with onset 2021, outcome "not recovered"; ALOPECIA (non-serious) with onset 2021, outcome "recovered", described as "loosing of hair/Hair loss"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19"; MALAISE (non-serious) with onset Jul2022, outcome "unknown", described as "did not feel good"; PRURITUS (non-serious), outcome "recovered", described as "Itchy scalp"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "unknown", described as "Wearing off effect". The action taken for risankizumab was dosage not changed. On unknown dates, close to next Skyrizi injection, patient had itchy scalp. In 2021, the patient experienced loosing of hair after taking booster of COVID-19 Vaccine and after taking second COVID-19 Vaccine patient brought with Psoriasis. On an unknown date, loosing of hair after taking booster of COVID-19 Vaccine resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect.  The reporter's assessment of the causal relationship of "covid-19", "itchy scalp", "wearing off effect", "did not feel good" and "more itchy scalp" with the suspect product(s) BNT162b2 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. The reporter considered "loosing of hair/hair loss", "psoriasis" and "bad flare of plaque psoriasis" related to BNT162b2.  Solicited report by a consumer of a 48-year-old female with events of non-serious losing hair after taking booster of COVID-19 vaccine, COVID-19, did not feel good, patient had itchy scalp when close to next Skyrizi injection/more itchy scalp month before injection due, after taking second COVID-19 vaccine patient brought out with psoriasis and bad flare of plaque psoriasis after first injection of COVID-19 vaccine with SkyrizI (Risankizumab). There was no reported medical history. On an unknown date, the patient experienced patient had itchy scalp when close to next Skyrizi injection/more itchy scalp month before injection due. In 2021, the patient experienced losing hair after taking booster of COVID-19 vaccine and after taking second COVID-19 vaccine patient brought out with psoriasis. In Jan2021, the patient experienced bad flare of plaque psoriasis after first injection of COVID-19 vaccine. In Jul2022, The patient experienced COVID-19 and did not feel good. on unknown dates, losing hair after taking booster of COVID-19 vaccine and bad flare of plaque psoriasis after first injection of COVID-19 vaccine resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. In Jan2021, the patient had a bad flare of plaque psoriasis after first injection of COVID-19. After taking second COVID-19 vaccine she brought out with psoriasis. She started losing hair after taking booster dose of COVID-19 vaccine. She was feeling good. She had COVID-19 in Jul2022. She felt it was like a sinus infection and did not felt good. She reported that when she was close to or month before next Skyrizi injection she had to have itchier scalp, but as soon as she got the Skyrizi injection it went away. She had no flakes but had a little more itching. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was related to COVID vaccine.  Causality for Skyrizi (Risankizumab) The reporter's causality for the event(s) of losing hair after taking booster of COVID-19 vaccine and after taking second COVID-19 vaccine patient brought out with psoriasis with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19, did not feel good, patient had itchy scalp when close to next Skyrizi injection/more itchy scalp month before injection due unknown onset and bad flare of plaque psoriasis after first injection of COVID-19 vaccine was not provided. The reporter's causality for the event(s) of patient had itchy scalp when close to next Skyrizi injection/more itchy scalp month before injection due unknown onset with Skyrizi (Risankizumab) was a reasonable possibility.   Change History On 01Aug2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of "COVID-19", "did not feel good" and "bad flare of plaque psoriasis after first injection of COVID-19 vaccine" were added. The event of "close to next skyrizi injection, patient had itchy scalp" was amended to "patient had itchy scalp when close to next skyrizi injection/more itchy scalp month before injection due".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Aug2022): This is a solicited follow-up report from a Non-interventional Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer. A contactable 48-year-old female consumer (patient) reported for herself that:  Updated information included: -Event added (COVID-19, did not feel good, more itchy scalp, bad flare of plaque psoriasis). -Suspect details added for Skyrizi [Risankizumab] (Lot no. added, Ongoing checked and updated action taken to dose not changed from unknown).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events "loosing of hair", "itchy scalp", "psoriasis",  malaise and the administration of the vaccine cannot be excluded. A causal relation between the reported event "wearing off effect" and the administration of the vaccine  BNT162b2 is unlikely.The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out.  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.