Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Nasopharyngitis
Clinical narrative: Had a Bell's palsy flare; The patient having a cold; FACILITATED COLLECT  This is a solicited report received from contactable consumer for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4155969-00.  Reaction Information: Age: 53 yrs  Sex: M Reaction date: 2021  Describe reaction(s) (include relevant test/lab data):  Bell's palsy - Recovered/resolved Cold - Unknown Solicited report by a consumer of a 53 year old male with events of non-serious Bell's Palsy Flare and Cold with SKYRIZI (RISANKIZUMAB). There was no reported medical history.  In 2021, the patient experienced Bell's palsy flare and cold. In 2021, the Bell's Palsy flare resolved. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. The patient having a cold. After first covid vaccine in Apr2021, nine days later patient had a Bell's palsy flare and was advised not to take the second covid vaccine shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer.  Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of Bell's Palsy flare and Cold was not provided.  Seq. No: 1 Reaction: Bell's palsy Start date: 2021 Stop date: 2021  Seq. No: 2 Reaction: Cold Start: 2021  Suspect drug information: Suspect drug(s) (include generic name) Treatment Unblinded: 1) Skyrizi (Risankizumab), Unknown 2) Pfizer BioNTech covid-19 vaccine (Tozinameran) (Tozinameran), Unknown  Daily dose: 1) Citrate free 2) (1 in 1 Once) Route of administration: 1) subcutaneous, 2) Intra-muscular Indications for use: 1) Moderate to severe chronic plaque psoriasis 2) Covid-19 Vaccination Therapy dates(from/to): 1) Unk 2) Apr2021  Product-reaction level: Seq.no: 1 Drug: Skyrizi (Risankizumab) Causality: 1) Bell's palsy Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not Reported Dechallenge: N/A 2) Cold Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not Reported Dechallenge: N/A  Seq.no: 2 Drug: Pfizer BioNTech covid-19 vaccine (Tozinameran) (Tozinameran), unknown Route of admin: 1) Intramuscular Therapy dates/duration: 1) Apr2021- Apr2021  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 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.; Sender's Comments: Based on the reported information and based on the temporal association, there is a reasonable possibility that the event of Bell's Palsy is causally related to BNT162B2. Event of nasopharyngitis is assessed as unrelated. Case will be reassessed should additional information become 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.